QA Investigation Results

Pennsylvania Department of Health
CAREGIVERS AMERICA SE
Health Inspection Results
CAREGIVERS AMERICA SE
Health Inspection Results For:


There are  9 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

Based on the findings of an onsite unannounced home health agency Medicare recertification survey conducted April 22, 2024 through April 25, 2024, and May 6, 2024, Caregivers America SE,was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.




Plan of Correction:




484.102(a)(3) STANDARD
EP Program Patient Population

Name - Component - 00
403.748(a)(3), 416.54(a)(3), 418.113(a)(3), 441.184(a)(3), 460.84(a)(3), 482.15(a)(3), 483.73(a)(3), 483.475(a)(3), 484.102(a)(3), 485.68(a)(3), 485.542(a)(3), 485.625(a)(3), 485.727(a)(3), 485.920(a)(3), 491.12(a)(3), 494.62(a)(3).

[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:]

(3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.**

*[For LTC facilities at 483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following:
(3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.

*NOTE: ["Persons at risk" does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.]

Observations: Based on a review of agency policy, emergency preparedness documentation, and interview with the agency Administrator, the agency failed to develop an emergency plan that addressed patient population, including, but not limited to, persons at-risk; the types of services the agency had the ability to provide in an emergency; and continuity of operations, including delegation of authority and succession plans. Findings include: Review of agency policy titled "Emergency Management Policy and Disaster Plan" conducted on April 23, 2024, at approximately 12:00 P.M. states, "Upon admission each patient is classified into one of the 3 risk categories below. Factors used to determine the level include, but are not limited to, medical diagnosis/condition, functional status, equipment needs, caregiver support and psychosocial needs. During an emergency the classification system, along with a triage approach, will be used to determine patient needs. The system will help determine what patients need to be seen and what patients need to have alternate arrangements made..." A review of agency emergency preparedness documentation on April 23, 2024, at approximately 12:20 P.M. revealed no evidence of an emergency plan that addressed patient/client population, including, but not limited to, persons at-risk; the types of services the facility had the ability to provide in an emergency; and continuity of operations, including delegation of authority and succession plans. An interview with the Administrator, Vice President, and Director of Operations on April 25, 2024, at approximately 12:00 P.M. confirmed the above findings.

Plan of Correction:

CORRECT
1. Administrator or designee will create a template to be used for Emergencies by 6/24/24. The template will include type of Emergency, patient population / census, including, persons at-risk using risk classifications, the types of services provided during emergency, collaboration with outside resource (i.e. OEM, fire department, police department, FEMA, Shelters) and continuity of operations, including delegation of authority and succession plans.
2. Administrator or designee will update the agency's Emergency Management Policy to include the new template and procedures for using the template during emergencies by 6/24/24.
PROTECT
1. Administrator or designee will ensure the alternate administrator, all RNCMs, and Branch staff are oriented to the new template and policy updates by 6/24/24.
PREVENT
1. Administrator or designee will ensure he/she only uses the template provided by the Director of Quality Assurance. This template will be established no later than 6/24/24.
2. Administrator or designee will review the Emergency Management Policy and Disaster Plan, inclusive of the Communication Plan annually as part of the Annual Agency Evaluation to ensure all components of the COPs are incorporated.
MONITOR/SUSTAIN
1. Quality Assurance and Performance Improvement (QAPI) Team will incorporate a review of the Emergency Management Policy and Disaster Plan and Implementation of the new emergency template tool as part of the Annual Agency Evaluation and the Biannual administrative review study tool.


484.102(c)(1) STANDARD
Names and Contact Information

Name - Component - 00
403.748(c)(1), 416.54(c)(1), 418.113(c)(1), 441.184(c)(1), 460.84(c)(1), 482.15(c)(1), 483.73(c)(1), 483.475(c)(1), 484.102(c)(1), 485.68(c)(1), 485.542(c)(1), 485.625(c)(1), 485.727(c)(1), 485.920(c)(1), 486.360(c)(1), 491.12(c)(1), 494.62(c)(1).

[(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:]

(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians
(iv) Other [facilities].
(v) Volunteers.

*[For Hospitals at 482.15(c) and CAHs at 485.625(c)] The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians
(iv) Other [hospitals and CAHs].
(v) Volunteers.

*[For RNHCIs at 403.748(c):] The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Next of kin, guardian, or custodian.
(iv) Other RNHCIs.
(v) Volunteers.

*[For ASCs at 416.45(c):] The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.

*[For Hospices at 418.113(c):] The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Hospice employees.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other hospices.

*[For HHAs at 484.102(c):] The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.

*[For OPOs at 486.360(c):] The communication plan must include all of the following:
(2) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Volunteers.
(iv) Other OPOs.
(v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA).

Observations: Based on a review of agency policy, and an interview with the administrator, vice president, and director of operations, the agency failed to demonstrate that the emergency preparedness communication plan included the Names and Contact Information for the following: Staff, Entities providing services under arrangement, Patients' physicians and Volunteers. Findings include: A review of the Emergency Management Policy and Disaster Plan on April 23, 2024, at approximately 12:00 PM found that neither the Emergency Preparedness Plan nor the Emergency Preparedness Policy and Procedure included the names and contact information for all agency staff and patients' physicians. An interview conducted with the administrator, vice president, and director of operations on April 25, 2024, starting at 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT & PROTECT
1. Administrator or designee will update the agency's emergency preparedness communication plan and policy by 6/24/24 to include Names and Contact Information for the following: Staff, Entities providing services under arrangement, Patient physicians, and Volunteers.
PROTECT
1. Administrator or designee will ensure the alternate administrator, all RNCMs and Branch staff are oriented to the new communication plan and policy updates by 6/24/24.
PREVENT
1. Administrator or designee will review the Emergency Management Policy and Disaster Plan, inclusive of the Communication Plan annually as part of the Annual Agency Evaluation to ensure all components of the COPs are incorporated.
MONITOR/SUSTAIN
1. Quality Assurance and Performance Improvement (QAPI) Team will incorporate a review of the Emergency Management Policy and Disaster Plan, inclusive of the Communication Plan as part of the Annual Agency Evaluation and the Biannual administrative review study tool.


484.102(c)(2) STANDARD
Emergency Officials Contact Information

Name - Component - 00
403.748(c)(2), 416.54(c)(2), 418.113(c)(2), 441.184(c)(2), 460.84(c)(2), 482.15(c)(2), 483.73(c)(2), 483.475(c)(2), 484.102(c)(2), 485.68(c)(2), 485.542(c)(2), 485.625(c)(2), 485.727(c)(2), 485.920(c)(2), 486.360(c)(2), 491.12(c)(2), 494.62(c)(2).

[(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:

(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.

*[For LTC Facilities at 483.73(c):] (2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) The State Licensing and Certification Agency.
(iii) The Office of the State Long-Term Care Ombudsman.
(iv) Other sources of assistance.

*[For ICF/IIDs at 483.475(c):] (2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(iii) The State Licensing and Certification Agency.
(iv) The State Protection and Advocacy Agency.

Observations: Based on a review of agency policy, agency's emergency preparedness plan, and an interview with the administrator, vice president, and director of operations, it was determined the agency failed to establish and maintain an emergency preparedness communication plan that included contact information for local/regional/state/federal emergency preparedness staff. Findings include: A review of the agency policy "Emergency Management Policy and Disaster Plan" was conducted on April 23, 2024, at approximately 12:00 pm. Policy states, "Instructions...14. In the event of an emergency, every effort will be made by the agency to provide vehicles or transportation of employees to patient homes. State and local officials (local 911, police, sheriff, and/or emergency management offices) will be notified of patients with specific and imminent needs requiring services from agency staff... 25.If the emergency management plan is implemented: It will be evaluated for effectiveness and documentation will be on file...2. This will be in coordination with local/ state Emergency Services and PA Healthcare Coalition...27. *Please note that all documents referred to below are located on Google Drive in a folder called Home Health Emergency Preparedness Information. All of the documents are shared with every Home Health employee. a. Emergency Personnel * Contact information for individuals in the below positions is available on the Home Health Phone List on Google Drive and in Netsmart...iii. Communication with community emergency management agencies or personnel. In the event that alerts are provided via text from the state's Emergency Management System or FEMA, follow directions and avoid calls to these agencies or 911 to prevent overload of lines. Only call when absolutely necessary...i. Referral/Emergency Contact Information by County - A list of contact information for local healthcare facilities and hospitals ii. Emergency Management Office by County - A list of contact information for all emergency management offices in agency's service area. Also includes some local utility service company contacts." Review of agency's emergency preparedness plan on April 23, 2024, at approximately 12:30 pm, revealed no documentation of a printed copy of the communication plan that included contact information for local/regional/state/federal emergency preparedness staff. An interview with the administrator, vice president, and director of operations on April 25, 2024, at approximately 12:00 pm confirmed the above findings.

Plan of Correction:

CORRECT
1. Administrator or designee will establish and maintain an emergency preparedness communication plan that includes contact information for local/regional/state/federal emergency preparedness staff by 6/24/24.
PROTECT
1. Administrator or designee will ensure the alternate administrator, all RNCMs and Branch staff are oriented to the new communication plan, inclusive of the contact information for local/regional/state/federal emergency preparedness by 6/24/24.
PREVENT
1. Administrator or designee will review the Emergency Management Policy and Disaster Plan, inclusive of the Communication Plan annually as part of the Annual Agency Evaluation to ensure contact information for local/regional/state/federal emergency preparedness staff is present.
MONITOR/SUSTAIN
1. Quality Assurance and Performance Improvement (QAPI) Team will incorporate a review of the Emergency Management Policy and Disaster Plan, inclusive of the Communication Plan as part of the Annual Agency Evaluation and the Biannual administrative review study tool.


Initial Comments:

Based on the findings of an unannounced onsite Medicare recertification survey conducted April 22, 2024, through April 25, 2024, and May 6, 2024. Caregivers America SE, was found not to be in compliance with the requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

As a result of the survey, four (4) Conditions and sixteen (16) Standard level deficiencies were cited resulting in an Immediate Jeopardy.








Plan of Correction:




484.55 CONDITION
Comprehensive Assessment of Patients

Name - Component - 00
Condition of participation: Comprehensive assessment of patients.
Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment.

Observations: Based on review of agency policies/procedures, clinical records (CR), home visit observation (OBS), and staff/administrative interview, it was determined that the agency failed to ensure a patient-specific, comprehensive assessment is completed at the time of the initial assessment visit and/or updated and revised as frequently as the patient's condition warrants to attain and maintain the highest practicable functional capacity including providing optimal care to achieve the goals and outcomes identified in the patients' plans of care. This condition was not met based on non-compliance with above standards, and the nature and potential severity of the deficient practices. Findings include: Cross Reference: 484.55 (c) Standard: Content of the Comprehensive Assessment. the Comprehensive Assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: 484.60 (d) Standard: Update of the Comprehensive Assessment...Not Less Frequently than -

Plan of Correction:

The Governing Body understands the seriousness of this Conditional citation. The agency stopped accepting any new referrals (referrals in process continued to support patient care) effective 4/25/24 to focus on remediating the deficiencies identified.
CORRECT
1. Administrator or designee will ensure all outstanding Comprehensive assessments due are completed by 5/31/24. A late visit note will be entered by the RNCM in the client's electronic medical record.
2. By 5/24/24, the Director of Quality Assurance will complete corrective counseling for RNs who did not complete assessments timely.
PROTECT
1. The Administrator ran a report 5/17/24 of all patients to identify when the most recent patient assessment was completed to ensure all patients have received a comprehensive assessment and all outstanding comprehensive assessments are completed by 5/31/24.
PREVENT
1. Starting 5/17/24, the Administrator or designee will run visit reports weekly to identify upcoming assessments due and ensure all assessments are completed timely. Any assessment that is not completed in a timely manner will be addressed with RNCM and a note will be entered into the Client Electronic Medical Record (EMR) to reflect the patient-driven reason. Late assessments not driven by patient request/need will be completed within 2 days and addressed via the Corrective Counseling process. A late visit note will be entered into the EMR.
2. The Administrator or designee will ensure all newly admitted and due assessments are completed timely by running a weekly list of assessment visits due and assuring all assessments are completed in the Electronic Medical Record timely and accurately. This process will begin on 5/14/24 and continue on-going.
MONITOR/SUSTAIN
1. The Quality Assurance Specialist or designee will request a copy of the weekly report weekly for one month to monitor compliance with assessment visits beginning 5/17/24 to ensure compliance with timely assessments.
2. Quality Assurance Specialist or designee will review 100% of client files quarterly by running a visit report and ensuring compliance with timely assessments.
3. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure the assessment is completed in the electronic medical record.


484.55(c)(1) ELEMENT
Health, psychosocial, functional, cognition

Name - Component - 00
The patient's current health, psychosocial, functional, and cognitive status;

Observations: Based on a review of agency policy/procedures, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to properly document the patient's current health, psychosocial, functional, and cognitive status for two (2) of nine (9) CRs reviewed, (CR#1 and 5). Findings include: A review of agency policy titled "Comprehensive Patient Assessment" conducted on April 25, 2024, at approximately 10:20 am, states, "Policy: a thorough, well organized, comprehensive and accurate assessment, consistent with a patient's immediate needs and current status will be completed for all patients in a timely manner...Instructions: 7. The comprehensive assessment will include, but not be limited to the following: b; Current health, psychosocial, functional and cognitive status..." A review of agency policy titled "Pain Assessment/Management" conducted on April 24, 2024, at approximately 2:00 PM, states "Policy: All patients admitted to the Agency will receive a comprehensive assessment that includes identification of pain and its impact on function as well as the treatment and efficacy of treatment...Purpose: To support the patient's right to expect that pain will be recognized and addressed appropriately. To coordinate the efforts of all members of the team in effective pain management. To assess the effectiveness of interventions and strive for effective pain management. To provide a safe and therapeutic environment for accurate reporting and documenting of pain. Special Instructions: 1. Pain assessment is an integral part of the initial comprehensive assessment and the patient's right to expect appropriate assessment and management is explained and honored. If the patient has pain that interferes with activity or movement on a daily basis or is determined to be intractable, pain management will be a specific intervention on the plan of care. 2. The registered nurse or therapist completes the assessment. The assessment includes a measure of pain intensity and quality (character, frequency, location, and duration). The patient's self-report or report of family/caregiver is the primary indicator of pain and will identify the need for reassessment for pain management. 3. Pain is assessed on every home visit and documented on a pain or symptom flow sheet. 4. The nurse/therapist will use a standardized agency accepted pain assessment tool that evaluates the location, duration, severity (rating scale), alleviating factors, exacerbating factors, current treatment (medication and non-medication) and response to treatment. 5. The follow up assessments will address effectiveness of the pain management program and identify if there is a need for referral for additional alternative therapy. If the established plan is ineffective and the pain management needs cannot be met within the agency pain management parameters, a referral will be made to an alternate provider. 6. Assessment of presence of pain and treatment/response will be incorporated into all agency assessments/ reassessment tools...Documentation Guidelines: General status of the patient including vital signs; Patient description of pain including location, quality, and self-rating of the pain level; Treatments/interventions and response; Physician notification as appropriate; Other findings as necessary..." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Contained documentation of an initial assessment completed on12/30/2020 which stated under the heading "Physical/Pain evaluation" "Current pain regimen: No current pain and no recent history of pain" There is no documentation to provide pain management in the event the patient reports pain. A review of Nursing Progress Notes dated 4/17/2024 and 4/28/2024 revealed the following: On 4/17/2024, nurse documents patient has pain "present", location: "head and body". There is no documentation as to how the nurse knew the patient had pain (he is nonverbal), no description of pain, and no documentation of relief measures taken and what the outcome of the relief measures were. On 4/18/2024, nurse documents patient has pain "present". There is no documentation as to how the nurse knew the patient had pain (he is nonverbal), location of pain, no description of pain, and no documentation of relief measures taken and what the outcome of the relief measures were. CR#5, Start of Care: 11/3/2021. Contained documentation of an initial assessment completed on 11/04/2021. Under the "Physical section, it is indicated that the consumer orientation to Person, Place. However, the communication section indicates that the consumer is non-verbal. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. RNCM will conduct a new patient assessment for CR #1 by 5/17/24 to include an assessment of the patient's pain and document a plan to provide pain management in the event the patient has pain. The assessment will include a means to identify if the patient, who is non-verbal, is experiencing pain.
2. RN #2 is no longer employed by the agency.
3. The initial assessment for CR #5 cannot be corrected.
4. The RNCMs who completed the assessments for CR #1 & CR #5 will receive Corrective Counseling by 5/24/24.
PROTECT
1. Quality Assurance Specialist or designee will audit 100% of current patients by 5/31/24 to ensure pain was assessed at the most recent assessment and that there is a documented plan to provide pain management in the event the patient has pain. This will include ensuring there is a documented means to identify if a non-verbal patient is experiencing pain.
2. Quality Assurance Specialist or designee will audit 100% of current patients who are non-verbal by 5/31/24 to ensure the assessment of the patient's cognitive includes the method by which the RNCM determined orientation.
PREVENT
1. Administrator or designee will update the Pain Assessment/Management policy to include guidelines for identifying and addressing pain in patients who are non-verbal by 6/7/24.
2. Administrator or designee will train all RNCM on ensuring assessments include a documented plan to provide pain management in the event the patient has pain and, if the patient is non-verbal, there is a means to identify if the patient is experiencing pain. Education will be documented via attestation and completed by 6/7/24.
3. Administrator or designee will train all RNCM, RN, and LPN on the revised Pain Assessment/Management policy, including documenting how the nurse determined the patient had pain, a description of pain, documentation of relief measures taken, and what the outcome of the relief measures were. Education will be documented via attestation and completed by 6/7/24.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will conduct a quarterly record review using a 10% sample of client records starting 7/1/24 to ensure the patient's pain was assessed, there is a documented plan to provide pain management in the event the patient has pain, and a means to identify if the patient, who is non-verbal, is experiencing pain.


484.55(d)(1)(i,ii,iii) ELEMENT
Last 5 days of every 60 days unless:

Name - Component - 00
The last 5 days of every 60 days beginning with the start-of-care date, unless there is a-
(i) Beneficiary elected transfer;
(ii) Significant change in condition; or
(iii) Discharge and return to the same HHA during the 60-day episode.

Observations: Based on a review of agency policy and procedures, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to complete an update of the comprehensive assessment as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than the last five (5) days of every sixty (60) days for six (6) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, 5 and 9). CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024 and 4/05/2024 through 6/03/2024. File did not contain any documentation of an updated comprehensive assessment for certification period reviewed. CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024-4/21/2024 and 4/22/2024-6/20/2024. File did not contain any documentation of an updated comprehensive assessment for the certification period reviewed. CR#9, Start of Care: 11/4/2021. Discharge date: 2/26/2023. Certification period reviewed: 1/4/2022 through 3/4/2022 and 3/5/2022 through 5/3/2022. A review of Supervising RN recertification assessments revealed the note was on a paper titled "team note" printed on 2/11/2022 and 7/20/2022. Notes were not completed on OASIS assessment form, was informal, unorganized, "jotted", did not contain a date the note was written, and did not contain a complete systems assessment. There were no other nursing assessments documented in the file. Findings include: A review of agency policy titled "Comprehensive Patient Assessment" conducted on April 24, 2024, at approximately 10:35 A.M. states, "Updates to the comprehensive assessments: 2. Comprehensive assessments must be updated and revised no less frequently then: a. recertification comprehensive assessments will take place no less frequently than the last 5 days of every 60 days beginning with the start of care date...If, for any reason, a comprehensive assessment is not completed within the designated timeframe there must be documentation in the chart with the reason. Physician notification must be documented..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title, and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of agency policy titled "Flow Sheet" conducted on April 24, 2024, at approximately 9:45 AM, states "Policy: Agency personnel shall use appropriate flow sheets to document ongoing patient assessment, care, and needs when visits are made frequently, when specific services are provided during each visit, or when specific parameters are to be followed. The Flow Sheets will include date, time, assessment and teaching parameters/interventions, response to intervention and comments as appropriate. Each entry will be signed and dated...Special Instructions: 3. The Nurse must document each visit on the flow sheet. The patient assessment, care provided, the patient's response to therapy, and the patient and/or caregiver instructions are also documented in the appropriate section. 4. If an area listed on the flow sheet is not addressed, an NA (Not Applicable) should be placed in that area. 5. All charting must be signed by each Nurse that charts on the flow sheet. A first initial and last name must appear at least one time on each sheet. After that, initials are sufficient. 6. The appropriate areas on the flow sheets shall be completed the day service is rendered and incorporated into the clinical record within seven (7) days of that date. 7. Findings and/or changes in condition that are not pertinent to the flow sheet parameters must be documented on clinical progress notes." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024 and 4/13/2024 through 6/11/2024. A review of Supervising Registered Nurse (RN) recertification assessment dated 4/10/2024 revealed note was not completed on OASIS assessment form, was informal, unorganized, "jotted", and did not contain a complete systems assessment. CR# 2, Start of Care: 09/09/2020. Certification period reviewed: 02/21/2024 through 04/20/2024. A review of Supervising RN recertification assessment dated 2/16/2024 revealed note was not completed on OASIS assessment form and was informal, unorganized, "jotted", and did not contain a complete systems assessment. CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain any documentation of an updated comprehensive assessment for the certification period reviewed. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. Comprehensive assessment for CR #3 for period 4/5/24 6/3/24 completed on 4/4/24 documented 5/7/23. Neither the timeliness of comprehensive assessment nor documentation can be corrected.
2. Comprehensive assessment for CR #5 for period 2/22/24-4/21/24 completed on 2/19/24 and documented 4/22/24. Comprehensive assessment for CR #5 for period 4/22/24 6/20/24 completed on 4/18/24 and documented 4/22/24. Neither the timeliness of the comprehensive assessments nor documentation can be corrected.
3. Comprehensive assessments for CR #9 cannot be corrected.
4. Comprehensive assessment completed on 4/10/24 for CR #1 cannot be corrected. RNCM will re-assess CR #1 to ensure comprehensive assessment includes a complete systems assessment.
5. Comprehensive assessment for CR #4 for period 3/8/24 5/6/24 completed on 3/6/24 and documented 4/30/24. Neither the timeliness of comprehensive assessment nor documentation can be corrected.
6. Corrective Counseling will be completed with Supervising RN re: Comprehensive Patient Assessment, Clinical Documentation, and Flow Sheet policies by 5/24/24.
PROTECT
1. Quality Assurance Specialist or designee will audit 100% current patient episodes by 5/31/24 to ensure there is a Comprehensive Assessment completed and that the assessment contains a complete systems assessment.
2. Quality Assurance Specialist or designee will audit 100% of current patient episodes by 5/31/24 to determine if a reassessment was completed late, and if it was that a reason was documented, and physician notification occurred.
PREVENT
1. Administrator or designee will train all RNCM on the Comprehensive Assessment, Clinical Documentation, and Flow Sheet policies by 6/7/24. Training will include expectations regarding timeliness of completing and documenting assessments and physician notification for late reassessments. Education will be documented via attestation.
SUSTAIN
1. Starting 5/15/24, the Administrator or designee will run visit reports weekly to identify upcoming assessments due in the last 5 days of every episode and ensure all assessments are completed timely. Any assessment that is not completed timely will be addressed with RNCM and a note will be entered into the Client Electronic Medical Record (EMR) to reflect the patient-driven reason. Late assessments not driven by patient request/need will be completed and addressed via the Corrective Counseling process. A late visit note will be entered into the EMR.
2. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure the assessment was completed and documented timely. If an assessment is completed late, the Quality Assurance Specialist or designee will ensure there is documentation of physician notification and the reason for the late assessment.


484.60 CONDITION
Care planning, coordination, quality of care

Name - Component - 00
Condition of participation: Care planning, coordination of services, and quality of care.
Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice.

Observations:

Based on review of agency policies/procedures, clinical records (CR), home visit observation (OBS), and staff/administrative interview, the facility failed to ensure that patient medication administration records (MARs) were in the patient's home and failed to notify the physician of critical lab values.
This condition was not met based on non-compliance with above standards, and the nature and potential severity of the deficient practices. The cumulative effects of these deficient practices resulted in the agency's inability to ensure the health and safety of patients and resulted in Immediate Jeopardy. As a result of the systemic deficient practice that led to significant patient safety risk, an immediate jeopardy situation was identified on 4/24/2024 9:20 AM. A first Removal Plan received from agency on 4/24/2024 at 2:17 PM and was rejected on 4/24/2024 at 2:53 PM. A second Removal Plan received from agency on 4/25/2024 at 9:20 AM with approval of Second Removal Plan on 4/25/2024 at 9:23 AM.
On-site verification completed May 6, 2024, from approximately 9:45 AM-1:30 PM verified that the agency completed implementation of the removal plan approved on April 25, 2024 removing the immediate jeopardy (IJ) through observations, review of agency documentation, and clinical records.




Cross Reference:
484.60 (a) Standard: Plan of Care
484.60 (b) Standard: Conformance with the physician or allowed practitioner orders.
484.60 (c) Standard: Review and revision of the plan of care.
484.60(c)(1) The HHA (Home Health Agency) must promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.
484.60 (c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care.
484.60 (d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities.










Plan of Correction:

The Governing Body understands the seriousness of this Immediate Jeopardy. As a result of the Immediate Jeopardy Citation, the agency stopped accepting any new referrals (referrals in process continued to support patient care) effective 4/25/24 to focus on remediating the deficiencies identified. In addition to the IJ Abatement Plan, the agency will implement the following.
CORRECT:
1. The Administrator or designee will ensure all new nurses receive a thorough orientation of all nursing documentation including, physicians' orders Medication Administration Record, Treatment plan, and nursing progress notes. The RNCM will continue to utilize the new RN/LPN supervision form to guide and remind the case manager of the areas to review during all nursing supervisions.
PROTECT:
1. The RNCM, during client visits, will ensure an up-to-date physician's order and any updates in medications are addressed on the MAR. The RNCM will instruct clients and family members on the importance of communicating any changes in medications or treatments to the homecare nurse or supervisor in the absence of the nurse so that current treatments and medications are administered safely to the client. RNCMs were educated by the Administrator and Director of Quality Assurance 5/3/24.
PREVENT:
1. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies. Training will include expectations regarding timeliness of completing and documenting POC. Education will be completed by 6/7/24 and documented via attestation.
2. Director of Quality Assurance updated the policy regarding Physician's Orders and notification 04/29/2024.
3. Administrator and Director of Quality Assurance educated all RNs, LPNs, and RN Case Managers to ensure all are oriented to the Physician Order Policy, inclusive of physician notification 05/03/2024. This included but was not limited to scenario-based education on Blood Sugars outside of parameters established on Physician orders. Education was documented via attestation.
4. Director of Quality Assurance updated the RN Supervision Visit Policy to include requirements of physician verbal orders, MAR & PRN medications, patient chart inclusive of current 485 and that a copy will be present in the patient's home, and nurses notes inclusive of any changes 04/29/2024.
5. The Administrator or designee trained all RNs, LPNs, and RN Case Managers on the updated Supervisory Visit and policy 05/03/2024. Education was documented via attestation.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure each patient has an individualized plan of care, and there is evidence of physician notification when applicable.
2. RN Case Managers will review the MAR at every supervisory visit to ensure it is present in the patient's home. This was updated in the RN Supervision Template 04/24/2024.
3. The Administrator or designee will conduct quarterly home visits for 10% of the active patients to ensure each patient has a complete patient file, inclusive of MARs.


484.60(a)(1) STANDARD
Plan of care

Name - Component - 00
Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan.

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to ensure that each patient receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration for two (2) of nine (9) CRs reviewed, (CR#7 and 9). Findings include: A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ... 2. The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date ($484.60(c) (1)) ..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title, and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024 The agency failed to ensure that each patient receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry. The file did not contain any documentation of a completed Home Health Certification and Plan of Care for the certification period reviewed. CR#9, Start of Care: 11/4/2021. Discharge date: 2/26/2023. Certification periods reviewed: 1/04/2022 through 3/04/2022 and 3/05/2022 through 5/03/2022. The agency failed to ensure that each patient receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry. The file did not contain any documentation of a completed Home Health Certification and Plan of Care for the certification periods after 5/3/2022 until discharge. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. The RNCM will complete the POC for CR #7 and send to the physician for signature by 5/21/24.
2. Unsigned POC for CR #9 cannot be corrected.
3. By 5/24/24, The Director of Quality Assurance will complete corrective counseling for RNs regarding the Comprehensive Assessment & Clinical Documentation Policies.
PROTECT
1. Quality Assurance Specialist or designee will audit 100% of current patient episodes by 5/31/24 to ensure there is a completed POC and that it is either signed by the MD or the agency is following due diligence in obtaining MD signature.
2. Administrator or designee will pull a report of any current unsigned POC by 5/17/24 to ensure due diligence is completed.
PREVENT
1. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies by 6/24/24. Training will include expectations regarding timeliness of completing and documenting POC. Education will be documented via attestation.
MONITOR/SUSTAIN
1. Administrator or designee will pull a report weekly starting 5/15/24 of upcoming episodes to ensure a POC is completed and sent to the MD for signature.
2. Administrator or designee will pull a report weekly starting 5/17/24 of unsigned POC to ensure due diligence is completed.
3. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure the POC was completed, documented, and sent to the Physician for signature timely.


484.60(b)(1) ELEMENT
Only as ordered by a physician

Name - Component - 00
Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner.

Observations: Based on review of agency policy, clinical records (CR), and interview with the administrator, vice president, and director of operations, the agency failed to ensure compliance with the physician's orders for four (4) of nine (9) CRs reviewed, (CR#1, 2, 4, and 7). Findings Include: A review of agency policy titled "Standards of Practice" was conducted on April 24, 2024, at approximately 12:10 PM. Policy states, "Policy: Agency will provide services that are in complaint with acceptable professional standards for the home care industry as well as all state and federal laws and identified agency performance improvement standards...Special Instructions: 1. The agency will practice within the guidelines of their stated discipline. 2. All staff will be knowledgeable regarding laws and regulations governing home health care. 3. Patient care will be provided under the plan of care established by a physician when required by law and regulation...4. Agency staff will deliver services based on each patient's unique and individualized needs...Care will be provided in a coordinated, effective, appropriate, cost-conscious, and safe manner in accordance with agency goals, objectives, and philosophy. 5. The national patient safety goals for ACHC will be incorporated into standards, performance expectations, orientations, and policy and procedure where applicable." A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...4. The Plan of Care will include, but not be limited to ($484.60(a) (2) and HH5-3A).: n. All medications (dose/frequency/route) and treatments...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ...8. Revisions to the plan of care made as a result of a change in patient condition/health status and/or discharge will be communicated to the patient, representative (if any), caregiver, and relevant physicians. The clinical record shall reflect the communication and any new/changed orders (The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60m days, beginning with the start of care date ($484.60(c) (1)) ..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title, and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care (485) contains orders for the following medications: Metformin By Mouth Tablet 500 MG 2 Tablet twice a day; Ibuprofen By Mouth Tablet 400 MG 1 Tablet every 6 hours as needed for pain; Acetaminophen By Mouth Tablet 325 MG 2 Tablet every 6 hours as needed for pain; Melatonin By Mouth Tablet 3 MG 2 Tablet at bedtime Lantus SoloStar Subcutaneous Solution Pen-injector 100 unit/ml, 70 Units daily; Vitamin D (Ergocalciferol) By Mouth Capsule 1.25 MG (50000 UT); Trulicity Subcutaneous Solution Pen-injector 0.75 MG/O.5ML weekly; Abilify By Mouth Tablet 20 MG daily with 5mg tab; clonidine HCI By Mouth Tablet 0.1 MG twice a day; Abilify By Mouth Tablet 5 MG with 20 mg tab; Albuterol Sulfate HFA Inhaler Aerosol Solution 108 (90 Base) mcg/act, 2 Puffs every 4 hours as needed for cough or wheezing use with spacer; and Baqsimi Two Pack Nose Powder 3 mg dose, 1 Spray daily as needed for severe hypoglycemia. During home visit observation (OBS) conducted on April 23, 2024, at approximately 2:00 PM, SN on duty (RN#2) was asked to provide to surveyor the medication administration records (MARs) for the current month as per the patient's current Home Health Certification and Plan of Care (485). RN#2 stated that the MARs were not at the patient's residence, and she only has them "sometimes". When asked by surveyor where the medications are listed and where administration is documented, she stated, "I give the same meds every day." Surveyor asked supervising RN (RN#1) if MARs are provided to the home and RN#1 replied "yes". Review of daily Nursing Progress Notes dated 2/25/2024 through 4/20/2024 revealed medication administered for that shift is documented on the daily nursing progress note with a time of administration. If any PRN medication was given there is no documentation of follow up for result/effectiveness of PRN medication that was given. There is no documentation that a medication reconciliation was completed at the time of the recertification assessment completed on 4/10/2024. Several medications documented as given per the daily Nursing Progress Notes are not listed on the current 485 and/or different doses and times of a medication were documented. The medications are: Trazadone 100 mg by mouth daily at 8 pm (new); Clonidine 0.2 mg by mouth daily at 8 pm (change and/or incorrect); Abilify By Mouth Tablet 5 MG with 20 mg tab (change and/or incorrect); Metformin 500 mg by mouth twice daily (change and/or incorrect); Clonazepam 1 mg by mouth (no frequency is listed) PRN (no reason is listed) (new); There is no documentation that a verbal order to add/change medications from those listed on the current 485 was present in the clinical record for any of the unordered medications and/or different dose and time of medication administered. Home Health Certification and Plan of Care (485) also contained orders for the certification period reviewed that states: "Private Duty SN frequency: twelve (12) to (17) hours per day, three (3) to seven (7) days per week. Authorized frequency is as follows: SN seventeen (17) hours per day Monday through Friday and thirteen (13) hours per day on Saturday and Sunday." A review of patient's visit calendar for April 2024, conducted on April 24, 2024, at approximately 1:15 PM, revealed the following: All Monday through Friday shifts were only scheduled for sixteen (16) hours. There is no documentation of reason for the missing time each day and no documentation that the physician was notified of the missed time. CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. Home Health Certification and Plan of Care (485) contains orders for "Private Duty Home Health Aide (HHA) frequency: six (6) to ten (10) hours per day, three (3) to six (6) days per week. Authorized frequency is as follows: HHA up to six (6) hours per day, five (5) days per week after school and ten (10) hours per day on non-school days including Saturdays." A review of patient's visit calendar for March 2024 and April 2024 revealed the following: March: Saturday, 3/2: Shift only scheduled for nine (9) hours. Friday, 3/8: Shift only scheduled for nine (9) hours. Saturday, 3/9: Shift only scheduled for nine (9) hours. Saturday, 3/16: Shift only scheduled for nine (9) hours. Saturday, 3/23: Shift only scheduled for nine (9) hours. Monday, 3/25: Shift only scheduled for nine (9) hours. Tuesday, 3/26: Shift only scheduled for nine (9) hours. Wednesday, 3/27: Shift only scheduled for nine (9) hours. Thursday, 3/28: Shift only scheduled for nine (9) hours. Friday, 3/29: Shift only scheduled for nine (9) hours. April: Thursday, 4/4: Shift only scheduled for eight (8) hours. Friday, 4/5: Shift only scheduled for eight (8) hours. Saturday, 4/6: Shift only scheduled for nine (9) hours. Saturday, 4/13: Shift only scheduled for nine (9) hours. There is no documentation of reason for the missing time each day and no documentation that the physician was notified of the missed time. Home Health Certification and Plan of Care (485) also contains orders for "SN: HHA supervisory visit no less than monthly". Review of Supervising RN documentation reveals HHA supervisory visits were conducted on 2/1/2024 and 4/1/2024. There is no documentation of a supervisory visit for the month of March 2024. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings. CR# 2, Start of Care: 09/09/2020. Certification period reviewed: 02/21/2024 through 04/20/2024. Home Health Certification and Plan of Care (485) contains orders for "Private Duty Home Health Aide (HHA) frequency: six (6) to ten (10) hours per day, three (3) to five (5) days per week. Authorized frequency is as follows: HHA ten (10) hours per day, Monday through Friday." A review of the patients calendars for March 2024 and February 2024 revealed the following: February: Friday 02/16/2024- shift only scheduled for six (6) hours. March: Friday 03/22/2024 shift only scheduled for nine (9) hours. CR# 7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024.Home Health Certification and Plan of Care (485) contains orders for "Private Duty Home Health Aide (HHA) frequency: nine (9) hours per day, five (5) days per week. Authorized frequency is as follows: HHA nine (9) hours per day, five (5) days per week" No documentation provided for onsite HHA supervisory visits per 485 orders stating "HHA supervisory visits no less frequently than monthly". A review of the patient's calendar for April 2024 revealed the following: April: Wednesday 04/03/2024 shift only scheduled for six (6) hours. Home Health Certification and Plan of Care (485) also contains orders for "SN: HHA supervisory visit no less than monthly". There is no documentation of a supervisory visit for the month of April 2024.

Plan of Correction:

CORRECT
1. RN #2 relieved from duty 4/23/24 and is no longer employed by the agency as of 5/3/24.
2. RNCM completed medication reconciliation, reconciliation of all physician's orders, updated POC, and reconciled with signing physician for CR #1 on 04/25/2024.
3. RNCM reconciled facilitated Coordination of Care between CR #1's primary physician (signing physician), neurologist, and endocrinologist from the period 04/25/2024 ongoing. CR #1 was overdue for endocrinologist visit, and RNCM facilitated appointment for 6/5/24. Medication reconciliation with endocrinologist to occur following visit.
4. RNCM ensured a current MAR was present in the patient's home on 4/25/24, prior to the provision of care. RNCM ensured an updated MAR based upon the Coordination of Care was present in the patient's home prior to the provision of care. If there are changes to the patient's medications due to the endocrinologist visit on 6/5/24, RNCM will update physician's orders and the MAR and ensure it is present in the patient's home timely.
5. RNCM will update the POC for CR #1 based upon the specific skilled nursing needs of the patient and notify primary physician of changes made by endocrinologist by 6/6/24.
6. The Administrator or designee will update the Clinical documentation policy regarding timeframes to obtain nurses' notes in the branch by 6/24/24.
7. The Administrator or designee will implement the policy and orient RNs and LPNs to the new policy and expectations by 6/24/24.
8. The Director of Quality Assurance updated the supervisory visit to include a review of all nursing documentation including physician orders, applicable logs, and nursing notes on 4/25/24.
9. The Administrator and Director of Quality Assurance provided education to all Nurses regarding physician's orders and notification, supervisory visits, new supervisory form, new blood glucose log on 5/3/24. Education documented via attestation.
10. For CR#2, 7 and all existing patients, the Administrator or designee will educate all RNs to stop the practice of adding visit hour ranges on any new 485s by 6/24/24. Any new certification period (485) will contain a patient specific number of hours to be provided and ordered by physician.
11. For CR#7, This patient receives only nonmedical services, and the calendar was incorrect. CR#7's calendar will be corrected by 6/7/24 by the Client Care Coordinator.
PROTECT
1. RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication and Nursing documentation of progress throughout nursing shift is completed. This was updated in the RN Supervision Template 04/24/202. This practice will ensure the safety and well-being of all patients is maintained.
2. Quality Assurance Specialist or designee will conduct a 100% audit of all supervisory visits and 485 to ensure compliance and safety of all patients.
PREVENT
1. For CR #1, 2, 4, 7 & all existing patients, the RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete, and up to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication. This was updated in the RN Supervision Template 04/24/2024.
2. RN Case Managers will review all Physician's Orders to ensure any changes in medications have been updated both via order and on the MAR at every supervisory visit. This was updated in the RN Supervision Template as of 04/29/2024.
3. RN Case Managers will review the patient's chart in the home to ensure it includes the current 485 at every supervisory visit. This was updated in the RN Supervision Template as of 04/29/2024.
4. Administrator or designee updated the RN Supervision Visit Policy to include requirements of physician verbal orders, MAR & PRN medications, patient chart inclusive of current 485 and that a copy will be present in the patient's home, and nurses notes inclusive of any changes 04/29/2024.
5. The Administrator or designee trained all RNs, LPNs, and RN Case Managers on the updated Supervisory Visit and policy 05/03/2024. Education was documented via attestation.
6. The Administrator or Designee will orient all RNs, and LPNs to Home Health Regulations COPs and how they relate to their scope of practice by 6/24/24.
SUSTAIN/MONITOR
1. RN Case Managers will complete Supervisory Visits every 14 days through 06/30/2024 to ensure compliance. Thereafter, at a minimum, supervisory visits will be completed every 30 days (skilled cases) or 60 days (non-skilled) cases ongoing.
2. Quality Assurance Specialist or designee will conduct a 10% audit of all client records to include supervisory visits, physician's orders and nursing notes quarterly starting 7/1/24 to ensure on-going compliance.
3. The Administrator or designee will conduct quarterly home visits for 10% of the active patients starting 7/1/24 to ensure each patient has a complete patient file, inclusive of MARs.


484.60(c)(1) ELEMENT
Reviewed, revised by physician every 60 days

Name - Component - 00
The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date.

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to ensure that the plan of care was reviewed and revised by the physician who is responsible for the home health plan of care and the agency as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date for nine (9) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, 5, 6, 7, 8, and 9). Findings include: A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ... 2. The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60m days, beginning with the start of care date ($484.60(c) (1)) ..." A review of agency policy titled "Physician Orders" conducted on April 24, 2024, at approximately 11:25 AM, states "Policy: Agency will ensure that all drugs, services, and treatments are administered only as ordered by a physician (The orders may be initiated via telephone or in writing and must be countersigned by the physician in a timely manner. All medications and treatments, that are part of the patient's plan of care, must be ordered by the physician. Orders will be accepted only from physicians who have a current license. Electronic signatures are acceptable...Instructions: 1. The individualized patient plan of care must be periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification or registration (2. The Plan of Care is a living document. All subsequent patient care orders, verbal or written, received (after the initial 485) will be considered part of the patient Plan of Care ($484.60(a)(3)). 3. Orders entered into the software system will have the electronic signature, including name, title, time and date, of the operator entering the order. 4. As needed (PRN) orders will include the reason the patient requires (or could require) an additional visit. 5.All orders for medications must contain the name of the drug, dosage, route of administration, and directions for use. Orders must be written completely and not contain any of the dangerous abbreviations, acronyms or signals that may contribute to medication or treatment errors. 7. Every effort will be made to have orders sent, signed, and returned within 30 days. To do this, the agency will use the following process: a. Plans of Care/485s will be created in the software based on the patient assessment. They will be reviewed, approved, and sent to the physician. b. Upon receipt of a verbal order, it will be entered into the software system. c. Supervisors will pull order runs on a regular basis, no less frequently than 2-3 times per week. Orders will be reviewed for accuracy, approved, and faxed to the physician. Orders may also be printed and mailed, or hand delivered to physicians. d. New orders will be faxed/sent out upon approval...f. If a faxed order has not been signed and returned after 5-7 days, the order will be re-faxed. If after 2 fax attempts the order is still not signed and returned the physician will be contacted...h. Upon receipt of the signed and returned order, the order will be marked back in the software system and filed in the patient medical record...12. Electronic signatures are acceptable for records that a maintained in the electronic medical record (EMR). All entries must be appropriately authenticated and dated. Authentication includes signatures, written initials, or computer secure entry by a unique identifier of a primary author who has reviewed and approved the entry." A review of agency policy titled "Physician Summary" conducted on April 24, 2024, at approximately 11:10 AM, states "Policy: A summary report will be provided to the physician no less than every sixty (60) days. The summary will provide a written report of the patient's current condition, the treatment/services provided, and the patient's response to the current treatment and/or medications, and pertinent changes in the patient's physical, emotional, or environmental condition since the last report. The physician summary will provide the progress report required by the Medicare Conditions of Participation...Special Instructions: 1. The progress note/physician summary will be completed by the professional completing the Plan of Care. The summary note will include: 1. Clinical summary of the care, treatment and services provided during the previous sixty (60) day episode of care. 2. Patient response to the services and progress toward established goals. 3.Summary of current needs and involvement of other community/family caregivers or services. 4. Date sent to physician and the name of the physician." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. File did not contain any documentation of a sixty (60) day summary for the certification period reviewed. CR#8, Start of Care: 10/28/2022. Date of Discharge: 12/21/2022. Certification period reviewed: 10/28/2022 through 12/26/2022. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings. CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that the plan of care was reviewed and revised by the MD no less frequently than every 60 days CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024-4/21/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that the plan of care was reviewed and revised by the MD no less frequently than every 60 days. CR#9 , Start of Care: 11/4/2021. Certification period reviewed: 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that the plan of care was reviewed and revised by the MD no less frequently than every 60 days. CR#2, Start of Care: 09/09/2020. Certification period reviewed: 2/21/2024 through 4/20/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#6, Start of Care: 12/07/2020. Certification period reviewed: 03/16/2024 through 05/14/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days.

Plan of Correction:

CORRECT
1. The Administrator, RNCM or designee for CR#1, 2, 3 4, 5, 6 and 7 will send outstanding POC to physician for signature by 5/21/24 and document all attempts to obtain.
PROTECT
1. Administrator or designee will pull a report of any current unsigned POC starting 5/17/24 to ensure due diligence is completed.
2. Quality Assurance Specialist or designee will conduct a 100% audit of current patient episodes to ensure there is a completed POC and that it is either signed by the MD or the agency is following due diligence in obtaining MD signature to ensure safety.
PREVENT
1. Administrator or designee will update the Physician Orders policy to reflect appropriate due diligence expectations by 5/24/24.
2. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies. Training will include expectations regarding timeliness of completing and documenting POC by 6/24/24. Education will be documented via attestation.
3. Administrator or designee will pull a report weekly starting 5/17/24 of upcoming episodes to ensure a POC is completed and sent to the MD for signature.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will audit 10% POCs quarterly starting 7/1/24 to ensure the POC was completed, documented, and sent to the Physician for signature timely.


484.60(c)(1) ELEMENT
Promptly alert relevant physician of changes

Name - Component - 00
The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.

Observations: Based on a review of agency policy and procedures, clinical records (CR), home visit observation (OBS), and an interview with staff/administration, the agency failed to promptly notify the physician of critical lab values based upon orders contained in the Home Health Certification and Plan of Care for one (1) of nine (9) CRs reviewed, (CR#1). Findings include: A review of agency policy titled "Skilled Nursing Services" was conducted on April 23, 2024, at approximately 10:10 AM. Policy states, "Special Instructions: 1. The registered nurse: e. Informs the physician and other personnel of changes in the patient condition and needs..." A review of agency policy titled "Reporting of Critical Values" was conducted on April 23, 2024, at approximately 10:15 AM. Policy states, "Policy: The agency will review all critical test result values and promptly notify the physician or their designee of the critical values. Purpose: To ensure accurate and timely reporting of reporting of test results that could affect the patient care plan and health status. Special Instructions: 1. The nurse or other individual receiving the critical value immediately contacts the ordering physician by telephone..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care contains orders that includes: "SN: Notify physician if patient has three (3) or more glucose levels over 200 in one day." And "SN: Assist patient to test blood sugar before breakfast and bedtime and prn signs/symptoms of hypoglycemia. If sugar is higher than 240 or when ill, test for ketones." A review of SN documentation from 2/25/2024 through 4/20/2024, indicates blood sugars are documented in nursing progress notes only one time per day and there is no documentation of the time the test was performed. Fifty-four (54) notes indicate a blood sugar result greater than 200. One (1) note did not document any blood sugar result. Out of the fifty-four (54) blood sugar results over 200, thirty-seven (37) were documented over 240 and no documentation is provided if a test for ketones was completed. Dates and results of the blood sugar test over 200 are as follows: February: 2/25/2024: Blood sugar result: 265 2/26/2024: Blood Sugar result: 240 2/27/2024: Blood Sugar result: 206 2/28/2024: Blood Sugar result: 212 2/29/2024: Blood Sugar result: 250 March: 3/1/2024: Blood Sugar result: 290 3/2/2024: Blood Sugar result: 238 3/3/2024: Blood Sugar result: 282 3/4/2024: Blood Sugar result: 290 3/5/2024: Blood Sugar result: 272 3/6/2024: Blood Sugar result: 240 3/7/2024: Blood Sugar result: 238 3/8/2024: Blood Sugar result: 224 3/9/2024: Blood Sugar result: 290 3/10/2024: Blood Sugar result: 294 3/11/2024: Blood Sugar result: 240 3/12/2024: Blood Sugar result: 210 3/14/2024: Blood Sugar result: 212 3/15/2024: Blood Sugar result: 242 3/16/2024: Blood Sugar result: 210 3/18/2024: Blood Sugar result: 224 3/19/2024: Blood Sugar result: 284 3/20/2024: Blood Sugar result: 290 3/21/2024: Blood Sugar result: 238 3/22/2024: Blood Sugar result: 286 3/23/2024: Blood Sugar result: 270 3/24/2024: Blood Sugar result: 250 3/25/2024: Blood Sugar result: 286 3/26/2024: Blood Sugar result: 248 3/27/2024: Blood Sugar result: 294 3/28/2024: Blood Sugar result: 288 3/29/2024: No documented result 3/30/2024: Blood Sugar result: 272. Note states: "Blood sugar elevated, no orders for sliding scale." 3/31/2024: Blood Sugar result: 202 April: 4/1/2024: Blood Sugar result: 212 4/2/2024: Blood Sugar result: 210 4/3/2024: Blood Sugar result: 244 4/4/2024: Blood Sugar result: 280 4/5/2024: Blood Sugar result: 294 4/6/2024: Blood Sugar result: 284 4/7/2024: Blood Sugar result: 230 4/8/2024: Blood Sugar result: 224 4/9/2024: Blood Sugar result: 240 4/10/2024: Blood Sugar result: 272 4/11/2024: Blood Sugar result: 288 4/12/2024: Blood Sugar result: 290 4/13/2024: Blood Sugar result: 280 4/14/2024: Blood Sugar result: 298 4/15/2024: Blood Sugar result: 288 4/16/2024: Blood Sugar result: 252 4/17/2024: Blood Sugar result: 224 4/18/2024: Blood Sugar result: 282 4/19/2024: Blood Sugar result: 290 4/20/2024: Blood Sugar result: 286 When surveyor asked SN (RN#2) on duty how often blood sugars are completed and if they are documented anywhere besides on the nursing note, RN#2 replied she completes two (2) blood sugar tests per day with meals and mom completes the bedtime sugar and that all results are kept on RN #2's cell phone. There is no documentation that if indicated, the physician was notified of the elevated blood sugars or if testing for ketones was completed with the results of ketone testing. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. RN #2 relieved from duty 04/23/24 and is no longer employed by the agency as of 5/3/24.
2. RNCM will update the POC for CR #1 based upon the specific skilled nursing needs of the patient and notify primary physician of changes made by endocrinologist by 6/6/24.
PROTECT
1. Quality Assurance Specialist or designee will conduct a 100% audit of all current patient episodes to review documentation and ensure compliance in alerting physician of clinical changes and/or critical lab values to ensure ongoing safety of all patients.
PREVENT
1. Administrator or designee will re-orient all RNCMs to policy on reporting of critical lab values and documentation of physician follow up by 06/24/2024.
2. The Administrator and Director of Quality Assurance provided Education to all RNs, LPNs and RNCM regarding physician's orders and notification, supervisory visits, new supervisory form, new blood glucose log on 5/3/24.
3. Administrator or designee will update the Clinical documentation policy regarding timeframes to obtain nurses' notes in the branch by 6/24/24.
4. The Administrator or designee will implement the policy and orient RNs and LPNs to the new policy and expectations by 6/24/24.
5. Administrator or designee will orient all RNs, and LPNs to Home Health Regulations COPs and how they relate to their scope of practice by 6/24/24.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will conduct a 10% audit of all client records to include supervisory visits, physician's orders, and nursing notes quarterly to ensure on-going compliance and appropriate escalation of clinical changes and/lab values to Physician quarterly starting 7/1/24.


484.60(c)(2) ELEMENT
Revised plan of care

Name - Component - 00
A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care.

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to update the patient's medication profile at the time of care plan revision was completed for five (5) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, and 9). Findings include: A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...4. The Plan of Care will include, but not be limited to ($484.60(a) (2) and HH5-3A).: n. All medications (dose/frequency/route) and treatments...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ... 2. The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60m days, beginning with the start of care date ($484.60(c) (1)) ..." A review of agency policy titled "Medication Profile" was conducted on April 24, 2024, at approximately 10:45 AM. Policy states, "Policy: The registered Nurse or Therapist will complete a medication profile for each patient at the time of admission. The medication profile shall include all prescription and nonprescription including regularly scheduled, medications and those taken intermittently or as needed. The profile will be reviewed and updated as needed to reflect current medications the patient is taking. Purpose: To provide a complete list of medications the patient is taking and an evaluation of the patient's knowledge of the effects of these medications...and to identify discrepancies between patient profile and physician and/ or agency profile...To provide documentation of changes in the medication regime as they happen, and support changes needed to the plan of care. Special Instructions: 1. At the time of admission, the admitting professional shall check all medications a patient may be taking to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication. The clinician shall promptly report any identified problems to the physician. 2. The nurse/therapist shall record on the medication profile, all prescribed and over the counter medications the patient is currently taking...Clients who reside in private homes will have either a printout of the medication list from Allscripts or a handwritten medication list left in the client's folder. 3. The medication profile shall document: Allergies, date medication ordered, or care initiated, medication name (full name with no abbreviations), medication dosage (using only accepted abbreviations), route and frequency of administration, contraindications or special precautions, medication side effects, discontinuation date, ineffective drug therapy, drug or food-drug interactions, duplicated drug therapy, non-compliance. At this time a drug-to-drug interaction screen will be run by the nurse/therapist...5. If the physician changes the medication orders, the nurse/therapist must add newly ordered drugs or medication changes to the medication profile...6. When a medication has been changed it may be indicated by placing a C in the N/C column and then the reasons for the medication change may be documented in the clinical note tab or in the medication section of the assessment. 7. Telephone orders documenting medication changes must also be written by the nurse/therapist in the medication tab and documented in the note or the assessment...The change shall be documented on the medication profile and included in the next plan of care." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed 4/13/2024 through 6/11/2024. File did not contain an updated/reviewed medication profile for the certification period reviewed. File did not contain any documentation of an updated/reviewed medication profile since 8/17/2022. CR#4, Start of Care: 3/25/2024, Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain an updated/reviewed medication profile for the certification period reviewed. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings. CR#3, Start of Care: 2/5/2024 Certification period reviewed: 2/5/2024 through 4/04/2024 and 4/05/2024 through 6/03/2024. File did not contain an updated/ reviewed medication profile for the certification period reviewed. File indicated that one medication review had been completed but no date was referenced. CR#9 , Start of Care: 11/4/2021 Certification period reviewed: 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022. File did not contain an updated/reviewed medication profile for the certification period reviewed. File did not indicate any documentation from the start of care until the consumer was discharged from services on 2/26/2023. CR#2, Start of Care: 09/092020. Certification period reviewed 02/21/2024 through 04/20/2024. File did not contain an updated/reviewed medication profile for the certification period reviewed. File did not contain any documentation of an updated/reviewed medication profile since 06/32/2023.

Plan of Correction:

CORRECT
1. Administrator or designee updated the RN Supervision Visit Policy to include requirements of physician verbal orders, MAR & PRN medications, patient chart inclusive of current 485 and that a copy will be present in the patient's home, and nurses notes inclusive of any changes 04/29/2024.
2. RN Case Managers will review all Physician's Orders to ensure any changes in medications have been updated both via order and on the MAR at every supervisory visit. This was updated in the RN Supervision Template as of 04/29/2024.
3. RNCM completed medication reconciliation, reconciliation of all physician's orders, updated POC, and reconciled with signing physician for CR #1 on 04/25/2024.
4. CR #3 cannot be corrected, patient RN CM completed supervisory visit with medication reconciliation for CR#3 on 4/4/24 for certification period of 4/05/2024 through 6/03/2024 and documented 5/7/24.
5. Medication Profile and Start of Care cannot be updated for CR#4 certification period of 3/8/2024 through 5/6/2024. Discharged on 4/30/2024.
6. Medication Profile and Start of Care cannot be updated for CR#9 for following certification periods 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022.
7. Medication Profile and Start of Care cannot be updated for CR#2 for following certification periods 02/21/2024 through 04/20/2024.
PROTECT
1. RNCMs will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication and Nursing documentation of progress throughout nursing shift is completed. This was updated in the RN Supervision Template 4/24/202. This practice will ensure the safety and well-being of all patients is maintained.
2. Quality Assurance Specialist or designee will conduct a 100% audit of all supervisory visits and 485 to ensure and updated medication profile by 5/31/24.
PREVENT
1. For all existing patients, the RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete, and up to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication. This was updated in the RN Supervision Template 4/24/2024.
2. Administrator and Director of Quality Assurance trained all RNs, LPNs, and RN Case Managers on the updated Supervisory Visit and policy 5/3/2024. Education was documented via attestation.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will conduct a 10% audit of all active client records to include supervisory visits, physician's orders and nursing notes quarterly starting 7/1/24 to ensure on-going compliance.
2. The Administrator or designee will conduct quarterly home visits starting 7/1/24 for 10% of the active patients to observe the medication reconciliation process and ensure it follows organizational policy.


484.60(d)(4) ELEMENT
Coordinate care delivery

Name - Component - 00
Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities.

Observations: Based on review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and the director of operations, the agency failed to ensure documentation of care coordination (case conference) was included in the clinical record for five (5) of nine (9) CRs reviewed, (CR#1, 2, 4, 5, and 9). Findings include: A review of agency policy titled "Coordination of Patient Services" conducted on April 24, 2024, at approximately 11:25 AM, states "Policy: All personnel furnishing services shall maintain communications with the patient Case Manager and/or the Assistant/Clinical Supervisor to assure that their efforts are coordinated effectively and support the objectives outlined in the Plan of Care. This may be done through secure e-mail, telephone conference, other verbal interaction and maintaining complete, current Care Plans. Purpose: To ensure services are coordinated between members of the interdisciplinary team, and branches, respectively. To ensure appropriate, quality care is being provided to patients. To ensure effective interchange, reporting, and coordination of patient care occurs. To assure that the efforts of agency personnel effectively complement one another and support the objectives outlined in the Plan of Care. To modify the Plan of Care to reflect needs or changes identified by members of the team and avoid duplication of services. To evaluate the adequacy of treatment and the effect of services provided. To determine the continuation of services and/or future plans for care. To provide the attending physician with an ongoing assessment of the patient and identify the patient's response to services provided. To identify potential for abuse or actual patient abuse and/or neglect. To ensure continuity of care. Special Instructions: 1. Communication will occur as necessary to establish coordinated evaluation between all disciplines involved in the patient's care. Formal care conferences are not required to demonstrate care coordination...3. Interdisciplinary communication shall be conducted as often as necessary to respond to changes in the patient's needs, services, care, or goals...6. Ongoing interdisciplinary communication shall be conducted to evaluate the patient's status and progress. Any problems will be discussed, and an action plan developed...9. The primary care Nurse or Therapist will assume responsibility for updating/changing the Care Plan and communicating changes to caregivers within twenty-four (24) hours following the changes. The physician will be contacted when his/her approval for that change as necessary and to alert physician to changes in patient condition. Active records will be reviewed on an ongoing basis by the Nursing Supervisor or designated Registered Nurse/Therapist.10. All caregivers, including any contracted services, shall have access to the patient Plan of Care and will be expected to participate in coordination of care activities, as appropriate. 11. The agency will identify a communication system to assure that all disciplines and departments are informed of changes to plan and/or need for modification..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." CR#1, Start of Care: 12/30/2020. Certification period reviewed 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care contains orders that includes: "Skilled nursing (SN): Notify physician if patient has three (3) or more glucose levels over 200 in one day." And "SN: Assist patient to test blood sugar before breakfast and bedtime and prn signs/symptoms of hypoglycemia. If sugar is higher than 240 or when ill, test for ketones." A review of SN documentation from 2/25/2024 through 4/20/2024, indicates blood sugars are documented in nursing progress notes only one time per day and there is no documentation of the time the test was performed. Fifty-four (54) notes indicate a blood sugar result greater than 200. One (1) note did not document any blood sugar result. Out of the fifty-four (54) blood sugar results over 200, thirty-seven (37) were documented over 240 and no documentation is provided if a test for ketones was completed. Dates and results of the blood sugar test over 200 are as follows: February: 2/25/2024: Blood sugar result: 265 2/26/2024: Blood Sugar result: 240 2/27/2024: Blood Sugar result: 206 2/28/2024: Blood Sugar result: 212 2/29/2024: Blood Sugar result: 250 March: 3/1/2024: Blood Sugar result: 290 3/2/2024: Blood Sugar result: 238 3/3/2024: Blood Sugar result: 282 3/4/2024: Blood Sugar result: 290 3/5/2024: Blood Sugar result: 272 3/6/2024: Blood Sugar result: 240 3/7/2024: Blood Sugar result: 238 3/8/2024: Blood Sugar result: 224 3/9/2024: Blood Sugar result: 290 3/10/2024: Blood Sugar result: 294 3/11/2024: Blood Sugar result: 240 3/12/2024: Blood Sugar result: 210 3/14/2024: Blood Sugar result: 212 3/15/2024: Blood Sugar result: 242 3/16/2024: Blood Sugar result: 210 3/18/2024: Blood Sugar result: 224 3/19/2024: Blood Sugar result: 284 3/20/2024: Blood Sugar result: 290 3/21/2024: Blood Sugar result: 238 3/22/2024: Blood Sugar result: 286 3/23/2024: Blood Sugar result: 270 3/24/2024: Blood Sugar result: 250 3/25/2024: Blood Sugar result: 286 3/26/2024: Blood Sugar result: 248 3/27/2024: Blood Sugar result: 294 3/28/2024: Blood Sugar result: 288 3/29/2024: No documented result 3/30/2024: Blood Sugar result: 272. Note states: "Blood sugar elevated, no orders for sliding scale." 3/31/2024: Blood Sugar result: 202 April: 4/1/2024: Blood Sugar result: 212 4/2/2024: Blood Sugar result: 210 4/3/2024: Blood Sugar result: 244 4/4/2024: Blood Sugar result: 280 4/5/2024: Blood Sugar result: 294 4/6/2024: Blood Sugar result: 284 4/7/2024: Blood Sugar result: 230 4/8/2024: Blood Sugar result: 224 4/9/2024: Blood Sugar result: 240 4/10/2024: Blood Sugar result: 272 4/11/2024: Blood Sugar result: 288 4/12/2024: Blood Sugar result: 290 4/13/2024: Blood Sugar result: 280 4/14/2024: Blood Sugar result: 298 4/15/2024: Blood Sugar result: 288 4/16/2024: Blood Sugar result: 252 4/17/2024: Blood Sugar result: 224 4/18/2024: Blood Sugar result: 282 4/19/2024: Blood Sugar result: 290 4/20/2024: Blood Sugar result: 286 When surveyor asked SN (RN#2) on duty how often blood sugars are completed and if they are documented anywhere besides on the nursing note, RN#2 replied she completes two (2) blood sugar tests per day with meals and mom completes the bedtime sugar and that all results are kept on RN #2's cell phone. There is no documentation that if indicated, the physician was notified of the elevated blood sugars or if testing for ketones was completed with the results of ketone testing. There is no documentation that the supervising RN was notified of any of the abnormal blood sugars and/or if the physician was notified and/or if further testing was required/documented. CR#4, Start of Care: 3/25/2021: Certification period reviewed 3/8/2024 through 5/6/2024. File did not contain any documentation of care coordination between the supervising RN and home health aide (HHA) for care provided during the certification period reviewed. CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024 through 4/21/2024. File did not contain any documentation of care coordination between the supervising RN and home health aide (HHA) for care provided during the certification period reviewed. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings. CR#9 , Start of Care: 11/4/2021 Certification period reviewed: 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022. File did not contain any documentation of care coordination between the supervising Registered Nurse and the home health aide for care provided during the certification period reviewed. CR#2, Start of Care: 09/09/2020. Certification period reviewed 2/21/2024 through 04/20/2024. File did not contain any documentation of care coordination between the supervising RN and SN for care provided during the certification period reviewed.

Plan of Correction:

CORRECT
1. RN #2 relieved from duty 4/23/24 and is no longer employed by the agency as of 5/3/24.
2. RNCM completed medication reconciliation, reconciliation of all physician's orders, updated POC, and reconciled with signing physician for CR #1 on 4/25/2024.
3. RNCM reconciled facilitated Coordination of Care between CR #1's primary physician (signing physician), neurologist, and endocrinologist from the period 04/25/2024 ongoing. CR #1 was overdue for endocrinologist visit, and RNCM facilitated appointment for 6/5/24. Medication reconciliation with endocrinologist to occur following visit.
4. For CR#2, 4, 5, 9 and all existing patients RNCM will perform supervisory visits every 14 days through 6/30/2024 ensure proper care coordination as applicable, thereafter supervisory visits will occur a minimum of every 30 days(medical)/60 days(nonmedical) and as applicable.
PROTECT
1. RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication and Nursing documentation of progress throughout nursing shift is completed. This was updated in the RN Supervision Template 4/24/202. This practice will ensure the safety and well-being of all patients is maintained. Supervisory visits to be performed every 14 days through 6/30/2024.
PREVENT
1. Administrator or designee will re-orient all RNCMs and LPNS to policy on Coordination of Patient Services by 6/24/2024.
2. Administrator or designee will update the Clinical documentation policy regarding timeframes to obtain nurses' notes in the branch by 6/24/24.
3. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies. Training will include expectations regarding timeliness of completing and documenting POC. Education will be documented via attestation by 6/24/2024.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will conduct quarterly audits starting 7/1/24 including 10% of all clients to review supervisory visits, physician's orders and nursing notes quarterly to ensure on-going compliance and documentation of care coordination.


484.80 CONDITION
Home health aide services

Name - Component - 00
Condition of participation: Home health aide services.
All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section.

Observations: Based on a review of agency policy, personnel files (PF), and an interview with the administrator, vice president, and director of operations, the agency failed to provide home health aides (HHAs) who meet the personnel requirements specified in paragraph (a) of this section. Cross Reference: 484.80 (a) Standard: Home Health Aide Qualifications (b) Standard: Content and duration of home health aide classroom and supervised practical training. (d) Standard: In-service training (g) (2) A home health aide provides services that are: (i) Ordered by the physician; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training.

Plan of Correction:

The Governing Body understands the seriousness of this Condition citation. The agency stopped accepting any new referrals (referrals in process continued to support patient care) effective 4/25/24 to focus on remediating the deficiencies identified.
CORRECT:
1. Due to the urgency and time constraint of when the agency must meet compliance with statement of deficiencies, the Director of Quality Assurance has established a competency evaluation program under 484.80 (a). ii for all existing caregivers identified as not meeting requirements under 484.80 (a) and agency previous policy. 484.80 (a)(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section.
2. Administrator will ensure PF#2, 4, 5, & 6 will complete a competency evaluation program administered by a Registered Nurse that reviews all the skills specified in 484.80 (a) paragraph (c) in a classroom setting and a written and oral exam by 6/07/2024.
PROTECT:
1. Administrator or designee will identify any other caregiver who did not complete training requirements by 5/10/24. All HHAs will be scheduled to complete the competency evaluation program by 6/7/24.
2. Client Care Coordinator will establish a tracking spreadsheet with all current HHA needing to complete a competency evaluation program and track when each HHA has completed their Competency Evaluation Program. If a HHA has not completed the program by 6/7/24, he/she will not be allowed to continue caring for any clients.
PREVENT:
1. The Governing Body acknowledges letter dated May 8, 2024, from the Pennsylvania Department of Health and will not conduct any HHA training for 2 years under current agency Medicare license.
2. Administrator or designee will update the Home Health Aide Training policy to align to the COP guidelines regarding aide training and certification by 6/7/24.
3. The agency will identify an alternate agency who is not excluded from conducting HHA Training and Competency to conduct future training for any new HHAs.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will monitor progress with Competency Program weekly until 6/7/24 and ensure no HHA works beyond 6/7/24 if he/she has not completed the competency evaluation program.
2. Quality Assurance Specialist or designee will audit 10% of HHA employe files every quarter beginning 7/1/24 to ensure there is evidence of the HHA meeting the personnel requirements specified.


484.80(a)(1)(i-iv) ELEMENT
A qualified HH aide successfully completed:

Name - Component - 00
A qualified home health aide is a person who has successfully completed:
(i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or
(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or
(iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of 483.151 through 483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or
(iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section.

Observations: Based on a review of agency policy, home health aide (HHA) training manual, personnel files (PF), and an interview with the administrator, vice president, and director of operations, the agency failed to ensure the HHA training program met the requirements listed in 484.80 (a) A qualified HHA is a person who has successfully completed: (i)A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii)A nurse aide training and competency evaluation program approved by the state...and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section and 484.80 (b) (2) A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours for four (4) of nine (9) PFs reviewed, (PF#2, 4, 5, and 6). A review of agency policy titled "Home Health Aide Training" conducted on April 24, 2024, at approximately 1:20 PM, states "Policy: With the exception of licensed health professionals and volunteers, home health aide training and competency evaluation requirements apply to all individuals who are employed by or work under contract with a Medicare certified Home Health Agency and who provide "hands-on" patient care services regardless of the title of the individual. It is the function of the Aide that determines the need for training and competency evaluation. Purpose: To outline the procedure for deeming a Home Health Aide competent to provide services to a patient. In doing so, CareGivers America ensures patients and Aides can safely perform/receive services from this Agency. Procedure: It is this Agency's policy to test all Home Health Aides for competency initially and annually unless they have an active professional license which verifies the competency level, such as LPN or RN or certification (CNA). The aide training program must address the following subject areas through classroom and supervised practical training totaling at least 75 hours, of which 60 of the training hours applies regardless of whether the Home Health Aide can pass a competency exam, and with at least 16 hours devoted to supervised practical training..." A review of PFs was conducted on April 22, 2024, from approximately 12:25 P.M. to 1:30 P.M. and on April 23, 2024, from approximately 9:45 A.M. to 11:40 A.M. PF#2, Date of Hire: 2/22/2023. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#4, Date of Hire: 9/15/2023. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#5, Date of Hire: 7/21/2023. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#6, Date of Hire: 1/18/2024. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. Due to the urgency and time constraint of when the agency must meet compliance with statement of deficiencies, the Director of Quality Assurance has established a competency evaluation program under 484.80 (a). ii for all existing caregivers identified as not meeting requirements under 484.80 (a) and agency previous policy. 484.80 (a)(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section.
2. The Administrator will ensure PF#2, 4, 5, & 6 will complete a competency evaluation program administered by a Registered Nurse that reviews all the skills specified in 484.80 (a) paragraph (c) in a classroom setting and a written and oral exam by 6/7/2024.
PROTECT
1. Administrator or designee will identify any other caregiver who did not complete training requirements by 5/10/24. All HHAs will be scheduled to complete the competency evaluation program by 6/7/24.
2. Client Care Coordinator will establish a tracking spreadsheet with all current HHA needing to complete a competency evaluation program and track when each HHA has completed their Competency Evaluation Program. If a HHA has not completed the program by 6/7/24, he/she will not be allowed to continue caring for any clients.
PREVENT:
1. The Governing Body acknowledges letter dated May 8, 2024, from the Pennsylvania Department of Health and will not conduct any HHA training for 2 years under current agency Medicare license.
2. Administrator or designee will update the Home Health Aide Training policy to align to the COP guidelines regarding aide training and certification by 6/7/24.
3. The agency will identify an alternate agency who is not excluded from conducting HHA Training and Competency to conduct future training for any new HHAs.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will monitor progress with Competency Program weekly until 6/7/24 and ensure no HHA works beyond 6/7/24 if he/she has not completed the competency evaluation program.
2. Quality Assurance Specialist or designee will audit 10% of HHA employe files every quarter beginning 7/1/24 to ensure there is evidence of the HHA having successfully completed an aide training or certification program in alignment with 484.80(a)(1).


484.80(b)(2) ELEMENT
Minimum hours of training

Name - Component - 00
A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours.

Observations: Based on a review of agency policy, home health aide (HHA) training manual, personnel files (PF), and an interview with the administrator, vice president, and the director of operations, the agency failed to demonstrate a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse for four (4) of nine (9) PFs reviewed, (PF#2, 4, 5, and 6). Findings include: A review of agency policy titled "Home Health Aide Training" conducted on April 24, 2024, at approximately 1:20 PM, states "Policy: With the exception of licensed health professionals and volunteers, home health aide training and competency evaluation requirements apply to all individuals who are employed by or work under contract with a Medicare certified Home Health Agency and who provide "hands-on" patient care services regardless of the title of the individual. It is the function of the Aide that determines the need for training and competency evaluation. Purpose: To outline the procedure for deeming a Home Health Aide competent to provide services to a patient. In doing so, CareGivers America ensures patients and Aides can safely perform/receive services from this Agency. Procedure: It is this Agency's policy to test all Home Health Aides for competency initially and annually unless they have an active professional license which verifies the competency level, such as LPN or RN or certification (CNA). The aide training program must address the following subject areas through classroom and supervised practical training totaling at least 75 hours, of which 60 of the training hours applies regardless of whether the Home Health Aide can pass a competency exam, and with at least 16 hours devoted to supervised practical training..." A review of agency document "Home Health Aide Training Manual" was conducted on April 23, 2024, at approximately 9:50 AM. Manual did not contain any documentation that states how many hours of classroom training time is provided and how many hours of practical training time is provided. A review of PFs was conducted on April 22, 2024, from approximately 12:25 P.M. to 1:30 P.M. and on April 23, 2024, from approximately 9:45 A.M. to 11:40 A.M. PF#2, Date of Hire: 2/22/2023. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#4, Date of Hire: 9/15/2023. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#5, Date of Hire: 7/21/2023. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#6, Date of Hire: 1/18/2024. File revealed Home Health Aide (HHA) job description. File did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. Administrator or designee will update the HHA training policy to include all elements of 484.80(a)(1) by 6/7/24.
2. Due to the urgency and time constraint of when the agency must meet compliance with statement of deficiencies, the Director of Quality Assurance has established a competency evaluation program under 484.80 (a). ii for all existing caregivers identified as not meeting requirements under 484.80 (a) and agency previous policy. 484.80 (a)(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section.
3. The Administrator or designee will ensure PF#2, 4, 5, & 6 will complete a competency evaluation program administered by a Registered Nurse that reviews all the skills specified in 484.80 (a) paragraph (c) in a classroom setting and a written and oral exam by 6/7/2024.
PROTECT:
1. Administrator or designee will identify any other HHA who did not complete training requirements by 5/10/24. All caregivers will be scheduled to complete the competency evaluation program by 6/7/24.
2. Client Care Coordinator will establish a tracking spreadsheet with all current HHA needing to complete a competency evaluation program and track when each HHA has completed their Competency Evaluation Program. If a HHA has not completed the program by 6/7/24, he/she will not be allowed to continue caring for any clients.
PREVENT:
1. The Governing Body acknowledges letter dated May 8, 2024, from the Pennsylvania Department of Health and will not conduct any HHA training for 2 years under current agency Medicare license.
2. The agency will identify an alternate agency who is not excluded from conducting HHA Training and Competency to conduct future training for any new HHAs.
3. Administrator or designee will update the Home Health Aide Training policy to align to the COP guidelines regarding aide training and certification by 6/7/24.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will monitor progress with Competency Program weekly until 6/7/24 and ensure no HHA works beyond 6/7/24 if he/she has not completed the competency evaluation program.
2. Quality Assurance Specialist or designee will audit 10% of HHA employe files every quarter beginning 7/1/24 to ensure there is evidence of the HHA having successfully completed a an aide training or certification program in alignment with 484.80(a)(1).


484.80(g)(2) ELEMENT
Services provided by HH aide

Name - Component - 00
A home health aide provides services that are:
(i) Ordered by the physician or allowed practitioner;
(ii) Included in the plan of care;
(iii) Permitted to be performed under state law; and
(iv) Consistent with the home health aide training.

Observations: Based on review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and the director of operations, the agency failed to ensure the home health aide care plan was followed for three (3) of nine (9) CRs reviewed, (CR#3, 4, and 6). Findings include: A review of agency policy titled "Home Health Aide Services" conducted on April 24, 2024, at approximately 1:30 PM, states, "Policy: Home Health Aide services will be provided to appropriate patients on an intermittent, part-time, or full-time basis, under the direct supervision of the Agency Registered Nurse/Therapist in accordance with a medically approved Plan of Care. The duties of the Home Health Aide include the provision of hands-on personal care, performance of simple procedures as an extension of therapy or nursing services, assistance in administering medications that are ordinarily self-administered. All individuals providing Home Health Aide services will be qualified through training and/or competency evaluations. Purpose: To abide by state/federal guidelines and offer guidelines to the agency staff, physicians, and community for the appropriate utilization of Home Health Aide services. Special Instructions: 2. The nurse or therapist assesses the need for personal care services and includes the services in the physician plan of care (orders). A specific care plan is developed documenting the Aide services to be provided. 3. The Aide will follow the care plan and will not initiate new services or developed documenting the Aide services to be provided. discontinue services without contacting Case Manager, Assistant Clinical Supervisor/Clinical Supervisor, or therapist...5. Home Health Aides must document each visit at the time care is provided and submit documentation to the agency within seven (7) days. 6 All services provided by the Home Health Aide shall be documented in the clinical record." A review of agency policy titled "Home Health Care Plan" conducted on April 24, 2024, at approximately 1:45 PM, states "Policy: A complete and appropriate Care Plan, identifying duties to be performed by the Home Health Aide, shall be developed by a Registered Nurse or Therapist. All home health aide staff will follow the identified plan. The Care Plan will be available to all persons involved in patient care, including contracted providers. Purpose: To provide a means of assigning duties to the Home Health Aide that are clear to the Nurse, Home Health Aide, and to the patient/caregiver being served. To provide documentation that the supervising Nurse oriented the assigned Aide to the patient's care before initiating the care. To provide documentation that the patient's care is individualized to his/her specific needs. Special Instructions: 1. Following the initial nursing assessment and consultation with the patient/caregiver, a written plan identifying personal care and supportive care services are prepared by a Registered Nurse or Therapist, as appropriate. 2. The Care Plan shall be developed in plain, non-technical lay terms and identify the duties to be performed...3. The Home Health Aide shall be assigned to a particular patient by the Assistant Clinical Supervisor/Clinical Supervisor after physician orders are obtained...6. The Home Health Aide Care Plan shall be reviewed and updated by the Registered Nurse/Therapist minimally every sixty (60) days, or more frequently when there is a significant change in the patient's condition, thus resulting in a change in Aide services..." A review of agency policy titled "Home Health Aide: Documentation" conducted on April 24, 2024, at approximately 1:50 PM, states "Policy: Home Health Aides will document care/services provided on the Home Health Aide Weekly Record. Care/services provided should be in accordance with direction provided in the Home Health Aide Care Plan. Purpose: To provide documentation of the care performed by the Home Health Aide on each visit. To provide documentation of the Home Health Aide's observations on each visit and evidence of patient progress toward goals. To provide documentation that will identify the ongoing need for Home Health Aide services. Special Instructions: 1. The Home Health Aide shall utilize the appropriate Home Health Aide Weekly Record or charting form to document services rendered to the patient. 2.The Home Health Aide shall be responsible for reporting any changes in the patient's condition or other pertinent observations to the Supervising RN/Therapist..." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. Home Health Aide Plan of Care dated 3/5/2024 includes the following tasks to be completed by the home health aide (HHA): Nail Care weekly; Fluids every visit (There is no documentation provided on care plan as to what the task is. Form states with check boxes: Offer fluids; Thicken fluids; Fluid restriction). A review of two (2) weeks of HHA Weekly Record documentation revealed for the week of 3/4/2024 through 3/9/2024 and the week of 3/11/2024 through 3/16/2024, there is no documentation that the task for nail care or fluids were completed. CR#3, Start of Care: 2/5/2024 . Certification period reviewed: 2/5/2024 through 4/04/2024. Home Health Aide Plan of Care dated 2/05/2024 includes the tasks of Medication reminder, Assist with Mobility, and provide Fluids during each visit. None of the tasks were checked off as being provided to the patient during the week of 3/3/2024- 3/9/2024 and 3/10/2024-3/16/2024. In addition, the tasks of Medication reminder, assist with Mobility, and provide fluids each visit, providing toileting activities and provide hair care, were not provided during the week of 3/3/2024 - 3/09/2024. CR#6, Start of Care: 12/07/2020. Certification period reviewed: 3/16/2024 through 5/14/2024. Home Health Aide Plan of Care dated 3/13/2024 includes the following tasks to be completed by the home health aide (HHA): Toileting every visit: Assist with toileting (no documentation on specific toileting methods. Form states with check boxes: Assist to commode/toilet, incontinence briefs, catheter care, ostomy care, assist with bedpan/urinal). A review of two (2) weeks of HHA Weekly Record documentation revealed for the week of 04/07/2024 through 04/13/2024 and the week of 04/14/204 through 04/20/2024 showed no toileting documentation. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. The RNCM will review the Home Health Aide POC for CR# 3, 4 & 6 and evaluate whether the tasks identified on the POC continue to meet client needs by 6/7/24. The RNCM will then review the Home Health Aide POC with the assigned HHA and reinforce documentation requirements and expectations.
2. The RNCM will visit 100% of clients by 6/7/24 and compare the HHA POC and compliance with HHA documented tasks. The RNCM will identify any HHA needing re-education regarding documentation requirements and reinforce training during the home visit. The RNCM will document training on the HHA supervision.
PROTECT:
1. The RNCM will ensure he/she reviews the HHA POC to ensure the POC is meeting client needs by 6/7/24. The RNCM will ensure that the HHA is carrying out the task identified on the POC during every visit for 100% of clients.
PREVENT:
1. The RNCM will continuously review the HHA documentation of task during every home visit and will address any non-compliance immediately and document this on the HHA supervision.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will audit 10% client records including HHA Task sheets every quarter beginning 7/1/24 and compare them with the HHA POC to ensure it matches. Findings of non-compliance to the Administrator for corrective counseling.


484.80(h)(2) ELEMENT
Non-skilled direct observation every 60 days

Name - Component - 00
If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care.

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to conduct onsite non-skilled home health aide (HHA) supervisory visits every sixty (60) days for four (4) of nine (9) CRs reviewed, (CR#2, 3, 7, and 9). Findings include: A review of agency policy titled "Home Health Aide (HHA) Supervision" conducted on April 24, 2024, at approximately 1:55 PM, states "Policy: CareGivers America shall provide Home Health Aide services under the direction and supervision of a Registered Nurse/Therapist when personal care services are indicated and ordered by the physician. The frequency of supervision will be in response to Medicare regulations, Agency policy and other state or federal requirements. Purpose: To observe the Aide in providing care to patients, and to assess competency in basic skills, as well as delegated nursing tasks. To provide the Aide with the opportunity for direct interaction with nurse and patient as it relates to the current plan of care. Special Instructions: 3. Supervisory visits of Home Health Aides shall be according to the following frequency: a. If the patient is receiving skilled care as well as aide services, the registered nurse or other appropriate professional must make a supervisory visit to the patient's home at least once every 2 weeks. If the aide is an employee of the agency, at least one of these visits each month must be made while the aide is providing care to the patient. If the aide is not an employee of the agency, the agency must perform all supervisory visits of that aide while the aide is providing care to the patient. If the patient is receiving home health aide services but is not receiving skilled care, the supervisory visit must occur not less than once every 60 days..." CR#2, Start of Care: 09/09/2020. Certification period reviewed 02/21/2024 through 04/20/2024. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) ten (10) hours per day, Monday through Friday and states "HHA supervisory visits no less frequently than monthly". File did not any documentation for onsite non-skilled HHA supervisory visits since 07/19/2023. CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) seven (7) nights per week, 8 PM to 6 AM and states "HHA supervisory visits no less frequently than monthly". File did not contain any documentation for an onsite non-skilled HHA Supervisory visit performed during the certification period. CR#7, Start of Care: 03/27/2024. Certification period reviewed 03/27/2024 through 05/25/24. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) nine (9) hours per day, five (5) days per week and states "HHA supervisory visits no less frequently than monthly". File did not any documentation for onsite non-skilled HHA supervisory visits for the certification period reviewed. CR#9, Start of Care: 11/4/2021. Discharge Date: 2/26/2023. Certification period reviewed: 1/04/2022 through 3/04/2022 and 3/05/2022 through 5/03/2022. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) eight (8) hours per day, seven (7) days per week and states "HHA supervisory visits no less frequently than monthly". File contained documentation of only one (1) supervisory visit that did not contain a date for both certification periods reviewed and file did not contain any documentation of supervisory visits for any certification period from 5/4/2022 to the discharge date. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

The agency recognizes CR#2, 3, 7, 9 were required under contract to be seen every 30 days, as per orders and the RNCM was following Standard 484.80-2 i A and did not follow physician's orders.
CORRECT
1. Non-timely supervisions for CR#2, 3, 7, 9 cannot be corrected.
2. Administrator or designee will identify all clients requiring a more stringent requirement for Home Health Aide Supervision by 5/20/24.
3. All RNCMs will be oriented to contracts that require a frequency of every 30-days for Home Health Aide Supervision and to ensure they follow physician's orders by 6/7/24.
PROTECT
1. Effective 5/6/24, All Client's will be visited by an RNCM every 14-days until 6/30/24 to ensure each client gets back on track with visit requirements as ordered.
2. Quality Assurance Specialist or designee will audit 100% of all client records to ensure the RNCM is following physician's orders for supervision of all Home Health Aides by 5/31/24.
PREVENT
1. All new RNCM will be oriented to any contract requiring a more stringent frequency of Home Health Aide Supervisions.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will audit 10% of client records quarterly starting 7/1/24 to ensure the RNCM is following physician's orders for supervision of all Home Health Aides.


484.105 CONDITION
Organization and administration of services

Name - Component - 00
Condition of participation: Organization and administration of services.
The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished.

Observations: Based on review of agency policies/procedures, clinical records (CR), home visit observation (OBS), and staff/administrative interview, the facility failed to ensure that patient medication administration records (MARs) were in the patient's home and failed to notify the physician of critical lab values. This condition was not met based on non-compliance with above standards, and the nature and potential severity of the deficient practices. The cumulative effects of these deficient practices resulted in the agency's inability to ensure the health and safety of patients and resulted in Immediate Jeopardy. As a result of the systemic deficient practice that led to significant patient safety risk, an immediate jeopardy situation was identified on 4/24/2024 9:20 AM. A first Removal Plan received from agency on 4/24/2024 at 2:17 PM and was rejected on 4/24/2024 at 2:53 PM. A second Removal Plan received from agency on 4/25/2024 at 9:20 AM with approval of Second Removal Plan on 4/25/2024 at 9:23 AM. On-site verification completed May 6, 2024, from approximately 9:45 AM-1:30 PM verified that the agency completed implementation of the removal plan approved on April 25, 2024 removing the immediate jeopardy (IJ) through observations, review of agency documentation, and clinical records. Cross Reference: 484.105 (b)(1) The administrator must: (ii) Be responsible for all day-to-day operations of the HHA; 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice.

Plan of Correction:

The Governing Body understands the seriousness of this Condition citation. The agency stopped accepting any new referrals (referrals in process continued to support patient care) effective 4/25/24 to focus on remediating the deficiencies identified.
CORRECT
1. Administrator ensured CR#1 had a MAR 4/25/24.
2. Administrator completed medication reconciliation and reconciliation of all physician's orders (including Blood Sugars) on 4/25/2024.
3. Administrator updated 485 and reconciled with the patient's physician on 4/25/2024.
4. Administrator notified physician of Blood Sugars outside of identified parameters on 4/25/2024.
5. The Administrator was re-educated on 5/3/24 and will receive Corrective Counseling by 5/24/24.
PROTECT
1. RN Case Managers will complete Supervisory Visits every 14 days through 6/30/2024 to ensure compliance, then follow visit cadence as ordered thereafter.
2. RN Case Managers will review all Physician's Orders to ensure any changes in medications have been updated both via order and on the MAR at every supervisory visit. This was updated in the RN Supervision Template as of 4/29/2024.
3. RN Case Managers will review the patient's chart in the home to ensure it includes the current 485 at every supervisory visit. This was updated in the RN Supervision Template as of 4/29/2024.
4. Director of Quality Assurance updated the RN Supervision Visit Policy to include requirements of physician verbal orders, MAR & PRN medications, patient chart inclusive of current 485 and that a copy will be present in the patient's home, and nurses notes inclusive of any changes 4/29/2024.
5. Administrator and Director of Quality Assurance trained all RNs, LPNs, and RN Case Managers on the updated Supervisory Visit and policy 5/3/2024. Education was documented via attestation.
PREVENT
1. All RNCMs were oriented on 5/3/24 to a new RN/LPN supervisory form which includes a review of all home documentation requirements.
2. Any new RNCM will be trained in documentation requirements during home supervisions.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure compliance with the RN/LPN Supervision form, including a review of the MAR and there is evidence of physician notification when applicable other home documentation is reviewed and completed.
2. Administrator or designee will conduct quarterly home visits starting 7/1/24 for 10% of the active patients to ensure each patient has a complete patient file, inclusive of MARs.


484.105(b)(1)(ii)  ELEMENT
Responsible for all day-to-day operations

Name - Component - 00
(ii) Be responsible for all day-to-day operations of the HHA;

Observations: Based on a review of agency policy, personnel files (PF), clinical records (CR), and an interview with the administrator, vice president, and director of operations, the administrator failed to be responsible for the day-to-day operations of the agency for the requirements of personnel records for six (6) of six (6) PFs reviewed, (PF#1, 2, 3, 4, 5, and 6); and for the documentation requirements of pain management documentation for one (1) of nine (9) CRs reviewed, (CR#1); and the documentation of nursing notes for one (1) of nine (9) CRs reviewed, (CR#8). Findings include: A review of agency policy titled "Personnel Records" conducted on April 23, 2024, at approximately 10:20 AM, states "Purpose: The purpose of this policy is to identify the content of personnel files and a system for maintaining accurate, complete, and current information. Special Instructions: l. Personnel Records - the employee personnel record will include, but not be limited to: Competency testing tor home health aides and specific competencies per job title...Signed job description, Skills checklist, Orientation checklist -- completed and signed...c. Ongoing employment: Competency reviews (written and observed as indicated) ...d. Medical History/Health Status: Hepatitis B declination or immunization record, Tuberculosis screening..." A review of agency policy titled "Health Screening" conducted on April 23, 2024, at approximately 10:00 AM, states "Policy: Each employee having direct contact with patients must have documentation of baseline health screening prior to providing care to patients. Therapists, nurses, social workers, nurse aides, and any staff that will have contact with a patient are required to have a Tuberculosis screening upon hire and annually in accordance with CDC guidelines. Testing will be offered at no cost to the employee...Instructions: B. Tuberculosis Screening: There are two kinds of tests that are used to determine if a person has been with TB bacteria: l. TB skin test (also known as PPD for purified protein derivative, or TST). 2. TB blood tests (also known as interferon-gamma release assays or IGRAs, or BAMT) ... Procedure: l. Upon hire, the agency requires evidence that the individual is free of TB. 2. The agency can accept evidence of previous TB screenings. This protocol will be considered met if the following evidence can be provided: a. Evidence of a negative two step PPD screening, both steps having been performed within one year of the date of hire. In this scenario, the employee may begin to work immediately with patients. However, an additional screening questionnaire must be completed upon hire to ensure the individual is free from TB signs/symptoms in order to have met this protocol. b. Evidence of a negative TB blood test performed within one year of the date of hire. In this scenario, the employee may begin to work immediately with patients. c. Evidence of a previous negative chest x-ray may be accepted by the agency. In this scenario, the employee may begin to work immediately with patients. However, an additional screening questionnaire must be competed upon hire to ensure the individual is free from TB signs/ symptoms in order to have met this protocol. d. Evidence of a negative one step PPD test performed within one year of hire may be accepted by the agency. In this scenario, the employee may begin to work immediately with patients. However, an additional one step negative PPD test must be performed at the time of hire to meet this protocol. 3. If an applicant or employee does not have evidence of previous screenings within one year, the agency may accept the following to have met this protocol: a. A negative 2-step PPD test. The applicant or employee may begin working after receiving negative results of the 1st step but must still meet the deadlines for the 2nd step administration and reading as indicated above in the 2 Step TB Skin Test (PPD) Guidelines. b. A negative TB blood test performed at hire. The applicant or employee may begin working with patients when the results of this screening are received by the agency...4. Annually, the agency Quality Manager or other appropriate staff, must conduct a risk assessment review for all counties serviced by the agency. If the agency is found to be medium risk in a county, all employees in that county will be required to have a one-step PPD screening upon their annual evaluation. If the agency is found to be low risk in a county, all employees in that county will be required to complete a screening questionnaire confirming they are free from signs and symptoms of TB upon their annual evaluation...C. Hepatitis B Vaccine: The Hepatitis B vaccine and vaccination series shall be made available to all employees who are at risk for exposure to blood and body fluids/substance. (Refer to the Hepatitis B Vaccination policy.) This vaccine must be provided at no cost to the employee and acceptance, or refusal of the vaccine must be documented...F. Documentation: Information obtained (other than occupational exposure and post-exposure evaluation and follow-up) during the health screening shall be documented and maintained in the employee's personnel file..." A review of agency policy titled "Employee Orientation" conducted on April 23, 2024, at approximately 11:35 AM, states "Policy: Each employee of CareGivers America who provides direct care, supervision of direct care, or management of services, will participate in an orientation program specific to his/her educational background and experience, type of care provided, physical and mental condition of patients, and the roles and responsibilities as an employee of CareGivers America. Orientation will be provided by an Administrator-appointed qualified employee or staff member...When the initial orientation is completed, the employee will sign the orientation checklist and a copy will be retained in the personnel record." A review of agency policy titled "Competency Assessment" conducted on April 23, 2024, at approximately 11:35 AM, states "Competency of all staff will be assessed during the interview process, orientation program and ongoing throughout employment. (Direct Care Staff will be assessed for competencies annually) Assessments of competency will be a component of the annual performance review..." A review of agency policy titled "Pain Assessment/Management" conducted on April 24, 2024, at approximately 2:00 PM, states "Policy: All patients admitted to the Agency will receive a comprehensive assessment that includes identification of pain and its impact on function as well as the treatment and efficacy of treatment...Purpose: To support the patient's right to expect that pain will be recognized and addressed appropriately. To coordinate the efforts of all members of the team in effective pain management. To assess the effectiveness of interventions and strive for effective pain management. To provide a safe and therapeutic environment for accurate reporting and documenting of pain. Special Instructions: 1. Pain assessment is an integral part of the initial comprehensive assessment and the patient's right to expect appropriate assessment and management is explained and honored. If the patient has pain that interferes with activity or movement on a daily basis or is determined to be intractable, pain management will be a specific intervention on the plan of care. 2. The registered nurse or therapist completes the assessment. The assessment includes a measure of pain intensity and quality (character, frequency, location, and duration). The patient's self-report or report of family/caregiver is the primary indicator of pain and will identify the need for reassessment for pain management. 3. Pain is assessed on every home visit and documented on a pain or symptom flow sheet. 4. The nurse/therapist will use a standardized agency accepted pain assessment tool that evaluates the location, duration, severity (rating scale), alleviating factors, exacerbating factors, current treatment (medication and non-medication) and response to treatment. 5. The follow up assessments will address effectiveness of the pain management program and identify if there is a need for referral for additional alternative therapy. If the established plan is ineffective and the pain management needs cannot be met within the agency pain management parameters, a referral will be made to an alternate provider. 6. Assessment of presence of pain and treatment/response will be incorporated into all agency assessments/ reassessment tools...Documentation Guidelines: General status of the patient including vital signs; Patient description of pain including location, quality, and self-rating of the pain level; Treatments/interventions and response; Physician notification as appropriate; Other findings as necessary..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title, and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of agency policy titled "Flow Sheet" conducted on April 24, 2024, at approximately 9:45 AM, states "Policy: Agency personnel shall use appropriate flow sheets to document ongoing patient assessment, care, and needs when visits are made frequently, when specific services are provided during each visit, or when specific parameters are to be followed. The Flow Sheets will include date, time, assessment and teaching parameters/interventions, response to intervention and comments as appropriate. Each entry will be signed and dated...Special Instructions: 3. The Nurse must document each visit on the flow sheet. The patient assessment, care provided, the patient's response to therapy, and the patient and/or caregiver instructions are also documented in the appropriate section. 4. If an area listed on the flow sheet is not addressed, an NA (Not Applicable) should be placed in that area. 5. All charting must be signed by each Nurse that charts on the flow sheet. A first initial and last name must appear at least one time on each sheet. After that, initials are sufficient. 6. The appropriate areas on the flow sheets shall be completed the day service is rendered and incorporated into the clinical record within seven (7) days of that date. 7. Findings and/or changes in condition that are not pertinent to the flow sheet parameters must be documented on clinical progress notes." A review of PFs was conducted on April 22, 2024, from approximately 12:25 P.M. to 1:30 P.M. and on April 23, 2024, from approximately 9:45 A.M. to 11:40 A.M. PF#1, Date of Hire: 5/24/2023. File did not contain any documentation of tuberculosis testing, a completed tuberculosis symptom questionnaire, and a tuberculosis risk assessment at hire. PF#2, Date of Hire: 2/22/2023. File did not contain any documentation the employee completed the minimum requirement of seventy-five (75) hours of training for home health aides (HHA) and documentation of annual tuberculosis education for 2024. PF#3, Date of Hire: 8/6/2021. File did not contain any documentation of a registered nurse (RN) orientation and RN initial competency. File contained a negative tuberculosis QuantiFERON test dated 4/24/2022 which is eight (8) months after hire. PF #4, Date of Hire: 9/15/2021. File did not contain any documentation of a signed job description, orientation documentation, documentation of completion of the minimum requirement of seventy-five (75) hours of training for HHAs, initial competency at hire, annual competencies for 2022 and 2023, emergency preparedness training at hire and for 2023, infection control training at hire and for 2022 and 2023, tuberculosis testing at hire, annual tuberculosis education for 2022 and 2023, and employee documented that they would like to receive the Hepatitis B vaccine, but there is no documentation that the employee received the vaccine. PF#5, Date of Hire: 7/21/2023. File did not contain any documentation of completion of the minimum requirement of seventy-five (75) hours of training for HHAs. PF#6, Date of Hire: 1/18/2024. File did not contain any documentation of orientation, and documentation of completion of the minimum requirement of seventy-five (75) hours of training for HHAs. A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024. Home Health Certification and Plan of Care contained an order for Acetaminophen by mouth tablet 325 mg, 2 tablets every 6 hours as needed for pain. A review of Nursing Progress Notes dated 4/17/2024 and 4/28/2024 revealed the following: On 4/17/2024, nurse documents patient has pain "present", location: "head and body". There is no documentation as to how the nurse knew the patient had pain (he is nonverbal), no description of pain, and no documentation of relief measures taken and what the outcome of the relief measures were. On 4/18/2024, nurse documents patient has pain "present". There is no documentation as to how the nurse knew the patient had pain (he is nonverbal), location of pain, no description of pain, and no documentation of relief measures taken and what the outcome of the relief measures were. CR#8, Start of Care: 10/28/2022. Date discharged: 12/21/2022. Certification period reviewed: 10/28/2022 through 12/26/2022. A review of nursing notes for the certification period reviewed revealed file did not contain any formal documentation of skilled nursing (SN) notes on an agency appointed form. Notes were "jotted" and did not contain a complete nursing note. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. Effective 4/29/24, the Administrator reports directly to the Director of Quality Assurance who will provide clinical oversight of the Administrator and program.
Personnel Records
1. PF#1 Unable to correct deficiency; last day of work for the employee was 1/15/2024. Employee is no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect an inactive status by 5/24/24.
2. PF#2 Unable to correct deficiency; employee has not provided services to a client at any time throughout the length of employment and is no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect an inactive status by 5/24/24.
3. PF #3 Unable to correct deficiency; employee was removed from duty on 4/23/2024 and voluntarily resigned on 5/3/2024. Employees status was updated 5/6/24 to reflect the termination to adhere to the Immediate Jeopardy abatement.
4. PF#4 Unable to correct deficiency; last day of work for the employee was 10/20/2022. Employee no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect a terminated status by 5/24/24.
5. PF#5 Employee has not provided services to any clients and post survey has been changed to a pending status. Employee will be required to complete all components of the hiring process inclusive of ensuring home health aide qualifications have been met within accordance to the Conditions of Participation prior to the provision of any client care. The administrator or designee is responsible for ensuring all personnel requirements are met. Employees' failure to comply with requirements will result in an inactive status change in all EHR's. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect a terminated status.
6. PF#6 Employee will be required to complete all components of orientation and to ensure home health aide qualifications have been met within accordance to the Conditions of Participation by 6/7/24. Administrator or designee is responsible for ensuring all personnel requirements are met. Employees' failure to comply with the requirements will result in the employee being removed from active duty and placed in a hold status until compliance is achieved. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect the appropriate status.
Client Records:
1. CR#1 The employee for this client is no longer with the company and never reported client was in pain in previous supervisory visits or nursing documentation. During the week of 4/17/24, client was diagnosed with the flu. Administrator, who has been overseeing case, confirmed client is non-verbal, however client can comprehend when asked questions and can point or nod head.
2. RNCM will conduct a new patient assessment for CR #1 by 5/17/24 to include an assessment of the patient's pain and document a plan to provide pain management in the event the patient has pain. The assessment will include a means to identify if the patient, who is non-verbal, is experiencing pain.
3. CR#8 All nursing documentation completed on 5/11/24, MD orders faxed on 5/11/24 waiting for signature of MD. Administrator will receive Corrective Counseling by 5/24/24.
PROTECT:
Personnel Records
1. Private Duty Nursing Care Coordinator will audit 100% of currently active staff to ensure all staff are appropriately categorized in all EHR's by 6/7/24.
2. Quality Assurance Manager or designee will conduct 100% audit to ensure compliance with Conditions of Participants and organizations policies & procedures by 6/7/24. All staff identified to be noncompliant will be brought into compliance.
Client Records:
1. RNCM visited client on 4/25/24 for medication reconciliation. Client's physician chose to keep standing order of Tylenol for pain as needed for future comfort measures.
2. Quality Assurance Specialist or designees will audit 100% of current patients by 5/31/24 to ensure pain was assessed at the most recent assessment and that there is a documented plan to provide pain management in the event the patient has pain. This will include ensuring there is a documented means to identify if a non-verbal patient is experiencing pain.
3. Quality Assurance Specialist or designee will audit 100% of current patients who are non-verbal by 5/31/24 to ensure the assessment of the patient's cognitive includes the method by which the RNCM determined orientation.
PREVENT:
Personnel Records
1. Administrator or designee will review and revise the following policies to ensure compliance with Conditions of Participation: Personnel Records, Health Screening, Employee Orientation & Competency Assessment by 6/7/24.
2. Administrator or designee to revise the onboarding checklist to include all required elements by 6/7/24.
3. Administrator, Human Resources and Care Coordinators will receive training conducted by the Quality Assurance Director or designee by 6/7/24. The training will cover the requirements of 601.21(f) and the organizational policies named above. Training will be documented via attestation.
Client Records:
1. Administrator or designee will update the Pain Assessment/Management policy to include guidelines for identifying and addressing pain in patients who are non-verbal by 6/7/24.
2. Administrator or designee will train all RNCM on ensuring assessments include a documented plan to provide pain management in the event the patient has pain and, if the patient is non-verbal, there is a means to identify if the patient is experiencing pain. Education will be documented via attestation and completed by 6/7/24.
3. Administrator or designee will train all RNCM, RN, and LPN on the revised Pain Assessment/Management policy, including documenting how the nurse determined the patient had pain, a description of pain, documentation of relief measures taken, and what the outcome of the relief measures were. Education will be documented via attestation and completed by 6/7/24.
MONITOR/SUSTAIN:
Personnel Records
1. Administrator, Human Resources and Care Coordinators will be required to utilize a personnel checklist at the completion of onboarding all new employees to ensure compliance with all requirements. The checklist will be implemented by 6/7/24.
2. All newly hired field employees placed in an active status must be approved by the Quality Assurance Director or designee prior to the employee's first shift. This approval process will be in place until 100% compliance is achieved for 2 consecutive months.
3. Quality Assurance Specialist or designee will conduct ongoing quarterly audits starting 7/1/24 consisting of a 10% sample of active employees.
Client Records
1. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure compliance with the RN/LPN Supervision form, including a review of the MAR and there is evidence of physician notification when applicable other home documentation is reviewed and completed.
2. The Administrator or designee will conduct quarterly home visits starting 7/1/24 for 10% of the active patients to ensure each patient has a complete patient file, inclusive of MARs.


484.105(f)(2)  ELEMENT
In accordance with current clinical practice

Name - Component - 00
All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice.

Observations: Based on review of agency policies/procedures, clinical records (CR), home visit observation (OBS), and staff/administrative interview, the facility failed to ensure that patient medication administration records (MARs) were in the patient's home; medications updated and current, and medications given were as ordered by the physician for one (1) of two (2) CRs where home visit observations were conducted, (CR#1). Findings include: A review of agency policy titled "Medication Profile" was conducted on April 24, 2024, at approximately 10:45 AM. Policy states, "Policy: The registered Nurse or Therapist will complete a medication profile for each patient at the time of admission. The medication profile shall include all prescription and nonprescription including regularly scheduled, medications and those taken intermittently or as needed. The profile will be reviewed and updated as needed to reflect current medications the patient is taking. Purpose: To provide a complete list of medications the patient is taking and an evaluation of the patient's knowledge of the effects of these medications...and to identify discrepancies between patient profile and physician and/ or agency profile...To provide documentation of changes in the medication regime as they happen, and support changes needed to the plan of care. Special Instructions: 1. At the time of admission, the admitting professional shall check all medications a patient may be taking to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication. The clinician shall promptly report any identified problems to the physician. 2. The nurse/therapist shall record on the medication profile, all prescribed and over the counter medications the patient is currently taking...Clients who reside in private homes will have either a printout of the medication list from Allscripts or a handwritten medication list left in the client's folder. 3. The medication profile shall document: Allergies, date medication ordered, or care initiated, medication name (full name with no abbreviations), medication dosage (using only accepted abbreviations), route and frequency of administration, contraindications or special precautions, medication side effects, discontinuation date, ineffective drug therapy, drug or food-drug interactions, duplicated drug therapy, non-compliance. At this time a drug-to-drug interaction screen will be run by the nurse/therapist...5. If the physician changes the medication orders, the nurse/therapist must add newly ordered drugs or medication changes to the medication profile...6. When a medication has been changed it may be indicated by placing a C in the N/C column and then the reasons for the medication change may be documented in the clinical note tab or in the medication section of the assessment. 7. Telephone orders documenting medication changes must also be written by the nurse/therapist in the medication tab and documented in the note or the assessment...The change shall be documented on the medication profile and included in the next plan of care." A review of agency policy titled "Medication Administration - Pediatrics" was conducted on April 24, 2024, at approximately 11:00 AM. Policy states, "Policy: Medications and treatments will be administered as ordered by the physician, in accordance with professional and state licensing boards, other regulatory bodies, and Caregivers America policies and procedures...Purpose: To assure that medications and treatments are administered as ordered. To assure that medications patient is taking and/or that agency is administering have current and accurate orders for safe administration. 1. General: 2. All orders for medications will contain the name of the drug, dosage, frequency, and method of administration. 2. All medications administered by nursing staff will be ordered by the physician; the order is to include the name of the medication, dose, route, and the administration interval...8. Verbal orders and changes in medication orders will be taken by a Registered Nurse who will verify the order by reading it back to the prescriber, signing the order and sending it to the physician within 48 hours for signature... 14.Prior to the administration of any medication by any route, the nurse will verify: a) Medication is correct by comparing physician order with medication label...d) Medication is the correct dose, route, and time." A review of agency policy titled "Patient Information Required for Medication Management" was conducted on April 24, 2024, at approximately 11:55 AM. Policy states, "Policy: Agency staff that is required to completed assessments, set up medications, provide medication education, or otherwise manage medications will have specific patient information available and accessible to them. The agency will make patient information readily available and accessible to staff who are responsible for managing patient's medication. Purpose: To provide adequate information to clinical staff who are managing patient medications...Special Instructions: 1. The minimum amount of information about the patient that is to be available for staff involved in medication management includes: b. All current medications including over the counter and herbal medications..." A review of agency policy titled "Medication Management" was conducted on April 24, 2024, at approximately 12:05 PM. Policy states, "Policy: The agency has a medication management system that supports patient safety and improves quality of care treatment and services by reducing practice variation, errors, and misuse of medications. The agency has established a mechanism for identifying and reporting potential and actual errors, and a process to improve systems and performance in the area of medication administration and management. Purpose: To reduce errors and improve quality of care and promote safety throughout the home care program. To standardize processes throughout the agency to improve medication systems...Program Specifics: Comprehensive patient assessment performed at start of care and other defined points in time include review of all medications the patient is taking (prescribed, samples, over the counter, herbal remedies, PRN medications) and records this in the patient record...Medications in the home are reviewed with the patient/family to determine current medications and patient understanding of the medications actions and side effects...Medication Administration: . When agency staff are administering medications, the following steps will be taken: a. Clinician will verify that the medication is he correct one based on the order and the product label. b. Clinician will verify that the... medication has been properly stored and has not expired. c. Clinician will verify that the dose and the medication is not contraindicated at that time. d. Clinician will verify that the medication is being administered at the correct time, in the correct dose and by the correct route. e. Patient will be informed, as appropriate, about any potential clinically significant adverse reaction or other concerns before giving a new medication...Monitoring effects of Medications: 4. Laboratory values will be evaluated as ordered and other clinical responses noted in the record and reported to the physician as indicated..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of agency policy titled "Standards of Practice" was conducted on April 24, 2024, at approximately 12:10 PM. Policy states, "Policy: Agency will provide services that are in complaint with acceptable professional standards for the home care industry as well as all state and federal laws and identified agency performance improvement standards...Special Instructions: 1. The agency will practice within the guidelines of their stated discipline. 2. All staff will be knowledgeable regarding laws and regulations governing home health care. 3. Patient care will be provided under the plan of care established by a physician when required by law and regulation...4. Agency staff will deliver services based on each patient's unique and individualized needs...Care will be provided in a coordinated, effective, appropriate, cost-conscious, and safe manner in accordance with agency goals, objectives, and philosophy. 5. The national patient safety goals for ACHC will be incorporated into standards, performance expectations, orientations, and policy and procedure where applicable." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care (485) contains orders for the following medications: Metformin By Mouth Tablet 500 MG 2 Tablet twice a day; Ibuprofen By Mouth Tablet 400 MG 1 Tablet every 6 hours as needed for pain; Acetaminophen By Mouth Tablet 325 MG 2 Tablet every 6 hours as needed for pain; Melatonin By Mouth Tablet 3 MG 2 Tablet at bedtime Lantus SoloStar Subcutaneous Solution Pen-injector 100 unit/ml, 70 Units daily; Vitamin D (Ergocalciferol) By Mouth Capsule 1.25 MG (50000 UT); Trulicity Subcutaneous Solution Pen-injector 0.75 MG/O.5ML weekly; Abilify By Mouth Tablet 20 MG daily with 5mg tab; clonidine HCI By Mouth Tablet 0.1 MG twice a day; Abilify By Mouth Tablet 5 MG with 20 mg tab; Albuterol Sulfate HFA Inhaler Aerosol Solution 108 (90 Base) mcg/act, 2 Puffs every 4 hours as needed for cough or wheezing use with spacer; and Baqsimi Two Pack Nose Powder 3 mg dose, 1 Spray daily as needed for severe hypoglycemia. During home visit observation (OBS) conducted on April 23, 2024, at approximately 2:00 PM, SN on duty (RN#2) was asked to provide to surveyor the medication administration record (MARs) for the current month as per the patient's current Home Health Certification and Plan of Care (485). RN#2 stated that the MARs were not at the patient's residence, and she only has them "sometimes". When asked by surveyor where the medications are listed and where administration is documented, she stated, "I give the same meds every day." Surveyor asked supervising RN (RN#1) if MARs are provided to the home and RN#1 replied "yes". Review of daily Nursing Progress Notes dated 2/25/2024 through 4/20/2024 revealed medication administered for that shift is documented on the daily nursing progress note with a time of administration. If any PRN medication was given there is no documentation of follow up for result/effectiveness of the PRN medication that was given. There is no documentation that a medication reconciliation was completed at the time of the recertification assessment completed on 4/10/2024. Several medications documented as given per the daily Nursing Progress Notes are not listed on the current 485 and/or different doses and times of a medication were documented. The medications are: Trazadone 100 mg by mouth daily at 8 pm (new); Clonidine 0.2 mg by mouth daily at 8 pm (change and/or incorrect); Abilify By Mouth Tablet 5 MG with 20 mg tab (change and/or incorrect); Metformin 500 mg by mouth twice daily (change and/or incorrect); Clonazepam 1 mg by mouth (no frequency is listed) PRN (no reason is listed) (new); There is no documentation that a verbal order to add/change medications from those listed on the current 485 was present in the clinical record for any of the unordered medications and/or different dose and time of medication administered. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. Administrator ensured CR#1 had a MAR 4/25/24.
2. Administrator completed medication reconciliation and reconciliation of all physician's orders (including Blood Sugars) on 4/25/2024.
3. The Administrator updated 485 and reconciled with the patient's physician on 4/25/2024.
4. Administrator notified physician of Blood Sugars outside of identified parameters on 4/25/2024.
5. RN Case Managers will complete Supervisory Visits every 14 days through 6/30/2024 to ensure compliance, then follow visit cadence as ordered thereafter.
6. The Administrator was re-educated on 5/3/24 and will receive Corrective Counseling by 5/24/24.
PROTECT
1. RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication. This was updated in the RN Supervision Template 4/24/2024.
2. Director of Quality Assurance updated the RN Supervision Visit Policy to include requirements of physician verbal orders, MAR & PRN medications, patient chart inclusive of current 485 and that a copy will be present in the patient's home, and nurses notes inclusive of any changes 04/29/2024.
3. Administrator and Director of Quality Assurance trained all RNs, LPNs, and RN Case Managers on the updated Supervisory Visit and policy 05/03/2024. Education was documented via attestation.
PREVENT
1. All RNCMs were oriented on 5/3/24 to a new RN/LPN supervisory form which includes a review of all home documentation requirements.
2. Any new RNCM will be trained in documentation requirements during home supervisions.
MONITOR/SUSTAIN
1. Quality Assurance Specialists or designee will conduct a quarterly record reviews starting 7/1/24 using a 10% sample of client to ensure compliance with the RN/LPN Supervision form, including a review of the MAR and there is evidence of physician notification when applicable other home documentation is reviewed and completed.
2. The Administrator or designee will conduct quarterly home visits starting 7/1/24 for 10% of the active patients to ensure each patient has a complete patient file, inclusive of MARs.


484.110(a)(6)(i-iii) ELEMENT
Discharge and transfer summaries

Name - Component - 00
(i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or
(ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or
(iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer.

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to send a completed discharge summary to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge within 5 business days after the patients discharge from the agency for two (2) of two (2) discharged patient clinical records (CR) reviewed (CR#8 and 9). Findings include: A review of agency policy titled "Discharge Policy" conducted on April 24, 2024, at approximately 11:30 AM, states "Policy: A discharge summary will be completed for patients from agency...Special Instructions: 1. When a patient is discharged from the agency, the last clinical modality (SN, PT, ST) in, shall complete a discharge summary form within the time frame defined by the agency. A copy will be mailed to the physician upon request. 2. The discharge summary will incorporate findings from the discharge OASIS assessment and shall include, but not be limited to: a. Discharge date b. Services provided c. Diagnosis d. Status upon admission e. Status at time of discharge f. Notification at time of discharge g. Reason for discharge h. Transfer information, if applicable i. Unmet needs, referrals made j. Instructions provided for the family. 3. The registered nurse/therapist will assure that the treatment goals and patient outcomes have been met. If unmet needs are present, the registered nurse/therapist will assure that appropriate referrals are made to agencies/institutions to meet continuing patient needs (with patient consent). 4. If the patient is being referred to another agency or facility, a transfer summary form shall also be completed. 5. The original discharge summary shall be filed in the clinical record." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#8, Start of Care: 10/28/2022. Date discharged: 12/21/2022. File contained a discharge summary completed on 4/23/2024. There is no documentation of the discharge summary being sent to the physician responsible for providing care and services to the patient within 5 business days. CR#9 , Start of Care: 11/4/202. Date discharged: 2/26/2023. File contained a discharge summary completed on 2/26/2023. There is no documentation of the discharge summary being sent to the physician responsible for providing care and services to the patient within 5 business days. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. Administrator or designee will update the agency's Discharge policy to include all requirements of 484.110 (a)(6)(i-iii) by 6/7/24.
2. All RNCMs will be oriented to new discharge policy change and required time frame a discharge must be completed by. This training will occur no later than 6/7/24 and be documented via attestation.
3. CR#8 and 9 discharge summaries faxed to MD by 5/17/24.
PROTECT
1. Quality Assurance Specialist or designee will conduct a 100% audit of all patients discharged in the past 30 days and all active patients to ensure that a discharge/transfer summary was sent. The review will be completed by 5/31/24.
PREVENT
1. Director of Quality Assurance or designee will include a timely discharge summary review as part of a performance improvement project by 6/24/24.
2. Administrator or designee will identify a report to monitor discharged and/or transferred patients by 6/7/24. The report will be used to ensure timely summaries are sent to the physician.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will conduct quarterly audits starting 7/1/24 including 10% of clients discharged or transferred in the prior quarter to ensure discharge/transfer summaries were sent timely.


484.110(d) STANDARD
Protection of records

Name - Component - 00
Standard: Protection of records.
The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164.

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and the director of operations, the agency failed to safeguard the contents of the clinical record against loss or unauthorized use for one (1) of nine (9) CRs reviewed, (CR#1). Findings include: A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of agency policy titled "Clinical Record Confidentiality" conducted on April 24, 2024, at approximately 11:45 AM, states "Policy: All patient information shall be treated as confidential and will be available only to authorized users. Purpose: To assure that confidentiality of data and information is preserved. To assure security measures are in place to safeguard the integrity of information in clinical and billing records. Special instructions: 4. All individuals who collect, handle, or disseminate information will be informed of their responsibility to protect data..." A review of agency policy titled "Clinical Records/Medical Records Retention" conducted on April 24, 2024, at approximately 11:55 AM, states "Purpose: To safeguard the integrity of information maintained in clinical and billing records. Patient records are kept in an electronic format that is in compliance with federal and state EMR requirements. Special instructions: Protection of Records: 1. Clinical record information shall be safeguarded against loss or unauthorized use. 3. Protected Health Information will be available only to those who must use it. Procedures will be followed to assure that this information is protected, and consents or authorizations are signed before information is released. In situations where consent is not required, only specifically required information will be released..." CR#1, Start of Care: 12/30/2020. Certification period reviewed 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care contains orders that includes: "SN: Notify physician if patient has three (3) or more glucose levels over 200 in one day." And "SN: Assist patient to test blood sugar before breakfast and bedtime and prn signs/symptoms of hypoglycemia. If sugar is higher than 240 or when ill, test for ketones." A review of SN documentation from 2/25/2024 through 4/20/2024, indicates blood sugars are documented in nursing progress notes only one time per day and there is no documentation of the time the test was performed. Fifty-four (54) notes indicate a blood sugar result greater than 200. One (1) note did not document any blood sugar result. Out of the fifty-four (54) blood sugar results over 200, thirty-seven (37) were documented over 240 and no documentation is provided if a test for ketones was completed. Dates and results of the blood sugar test over 200 are as follows: February: 2/25/2024: Blood sugar result: 265 2/26/2024: Blood Sugar result: 240 2/27/2024: Blood Sugar result: 206 2/28/2024: Blood Sugar result: 212 2/29/2024: Blood Sugar result: 250 March: 3/1/2024: Blood Sugar result: 290 3/2/2024: Blood Sugar result: 238 3/3/2024: Blood Sugar result: 282 3/4/2024: Blood Sugar result: 290 3/5/2024: Blood Sugar result: 272 3/6/2024: Blood Sugar result: 240 3/7/2024: Blood Sugar result: 238 3/8/2024: Blood Sugar result: 224 3/9/2024: Blood Sugar result: 290 3/10/2024: Blood Sugar result: 294 3/11/2024: Blood Sugar result: 240 3/12/2024: Blood Sugar result: 210 3/14/2024: Blood Sugar result: 212 3/15/2024: Blood Sugar result: 242 3/16/2024: Blood Sugar result: 210 3/18/2024: Blood Sugar result: 224 3/19/2024: Blood Sugar result: 284 3/20/2024: Blood Sugar result: 290 3/21/2024: Blood Sugar result: 238 3/22/2024: Blood Sugar result: 286 3/23/2024: Blood Sugar result: 270 3/24/2024: Blood Sugar result: 250 3/25/2024: Blood Sugar result: 286 3/26/2024: Blood Sugar result: 248 3/27/2024: Blood Sugar result: 294 3/28/2024: Blood Sugar result: 288 3/29/2024: No documented result 3/30/2024: Blood Sugar result: 272. Note states: "Blood sugar elevated, no orders for sliding scale." 3/31/2024: Blood Sugar result: 202 April: 4/1/2024: Blood Sugar result: 212 4/2/2024: Blood Sugar result: 210 4/3/2024: Blood Sugar result: 244 4/4/2024: Blood Sugar result: 280 4/5/2024: Blood Sugar result: 294 4/6/2024: Blood Sugar result: 284 4/7/2024: Blood Sugar result: 230 4/8/2024: Blood Sugar result: 224 4/9/2024: Blood Sugar result: 240 4/10/2024: Blood Sugar result: 272 4/11/2024: Blood Sugar result: 288 4/12/2024: Blood Sugar result: 290 4/13/2024: Blood Sugar result: 280 4/14/2024: Blood Sugar result: 298 4/15/2024: Blood Sugar result: 288 4/16/2024: Blood Sugar result: 252 4/17/2024: Blood Sugar result: 224 4/18/2024: Blood Sugar result: 282 4/19/2024: Blood Sugar result: 290 4/20/2024: Blood Sugar result: 286 When surveyor asked SN (RN#2) on duty how often blood sugars are completed and if they are documented anywhere besides on the nursing note, RN#2 replied she completes two (2) blood sugar tests per day with meals and mom completes the bedtime sugar and that all results are kept on RN #2's cell phone. There is no documentation that if indicated, the physician was notified of the elevated blood sugars or if testing for ketones was completed with the results of ketone testing. An interview with the administrator (ADM), who is also the supervising registered nurse (RN), on April 23, 2024, at approximately 11:00 AM revealed that ADM stated she often communicates information regarding patient's status/care to other staff via text message on her cell phone and this information is not recorded in the clinical record. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. RN #2 relieved from duty 04/23/24 and is no longer employed by the agency as of 5/3/24.
PROTECT
1. Quality Assurance Specialist or designee will conduct a 100% audit of all current patients to ensure notes are entered for each visit/shift provided. Missing documentation will be sent to administrator to determine if late entry is needed. The audit will be conducted by 5/31/24.
PREVENT
1. Administrator or designee will train all RNCM, RNs, LPNs on the Plan of Care and Clinical Documentation policies by 6/24/24. Training will include expectations regarding acceptable storage of clinical records and timeliness of completing all documentation in record. Education will be documented via attestation.
2. Administrator or designee will re-orient all RNCM on the Clinical Record Confidentiality policies by 6/24/24 understanding documented via attestation.
3. Administrator or designee will re-orient all RNCM on the Clinical Record Retention policies by 6/24/24 understanding documented via attestation.
MONITOR/SUSTAIN
1. Quality Assurance Specialists or designees will conduct quarterly audits starting 7/1/24 including 10% of client records to review visits and associated nursing notes to ensure on-going compliance and documentation of visits.


Initial Comments:


Based on the findings of an unannounced onsite home health agency state re-licensure survey conducted April 22, 2024 through April 25, 2024, and May 6, 2024, Caregivers America SE, was found not to be in compliance with the requirements of 28 Pa. Code, Part IV, Health facilities, Subpart G. Chapter 601.





Plan of Correction:




601.6 LICENSURE
Definitions.

Name - Component - 00
The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:


Observations:


Based on a review of agency policy, personnel files (PF), and an interview with the administrator, vice president, and the director of operations, the agency failed to ensure that the home health aides had evidence of the required mandated training for four (4) of nine (9) PFs reviewed, (PF#2, 4, 5, and 6).


Findings Include:

A review of agency policy titled "Home Health Aide Training" conducted on April 24, 2024, at approximately 1:20 PM, states "Policy: With the exception of licensed health professionals and volunteers, home health aide training and competency evaluation requirements apply to all individuals who are employed by or work under contract with a Medicare certified Home Health Agency and who provide "hands-on" patient care services regardless of the title of the individual. It is the function of the Aide that determines the need for training and competency evaluation. Purpose: To outline the procedure for deeming a Home Health Aide competent to provide services to a patient. In doing so, CareGivers America ensures patients and Aides can safely perform/receive services from this Agency. Procedure: It is this Agency's policy to test all Home Health Aides for competency initially and annually unless they have an active professional license which verifies the competency level, such as LPN or RN or certification (CNA). The aide training program must address the following subject areas through classroom and supervised practical training totaling at least 75 hours, of which 60 of the training hours applies regardless of whether the Home Health Aide can pass a competency exam, and with at least 16 hours devoted to supervised practical training..."
A review of PFs was conducted on April 22, 2024, from approximately 12:25 P.M. to 1:30 P.M. and on April 23, 2024, from approximately 9:45 A.M. to 11:40 A.M.

PF#2, Date of Hire: 2/22/2023. File did not contain any documentation of completion of an aide training program totaling at least sixty (60) hours.

PF#4, Date of Hire: 2/15/2021. File did not contain any documentation of completion of an aide training program totaling at least sixty (60) hours.

PF#5, Date of Hire: 7/21/2023. File did not contain any documentation of completion of an aide training program totaling at least sixty (60) hours.

PF#6, Date of Hire: 1/18/2024. File did not contain any documentation of completion of an aide training program totaling at least sixty (60) hours.

An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.






Plan of Correction:

The Governing Body understands the seriousness of this Licensure citation. The agency stopped accepting any new referrals (referrals in process continued to support patient care) effective 4/25/24 to focus on remediating the deficiencies identified.
CORRECT:
1. Due to the urgency and time constraint of when the agency must meet compliance with statement of deficiencies, the Director of Quality Assurance has established a competency evaluation program under 484.80 (a). ii for all existing caregivers identified as not meeting requirements under 484.80 (a) and agency previous policy. 484.80 (a)(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section.
2. The Administrator will ensure PF#2, 4, 5, & 6 will complete a competency evaluation program administered by a Registered Nurse that reviews all the skills specified in 484.80 (a) paragraph (c) in a classroom setting and a written and oral exam by 6/7/2024.
PROTECT
1. Administrator or designee will identify any other caregiver who did not complete training requirements by 5/10/24. All HHAs will be scheduled to complete the competency evaluation program by 6/7/24.
2. Client Care Coordinator will establish a tracking spreadsheet with all current HHA needing to complete a competency evaluation program and track when each HHA has completed their Competency Evaluation Program. If a HHA has not completed the program by 6/7/24, he/she will not be allowed to continue caring for any clients.
PREVENT:
1. The Governing Body acknowledges letter dated May 8, 2024, from the Pennsylvania Department of Health and will not conduct any HHA training for 2 years under current agency Medicare license.
2. Administrator or designee will update the Home Health Aide Training policy to align to the COP guidelines regarding aide training and certification by 6/7/24.
3. The agency will identify an alternate agency who is not excluded from conducting HHA Training and Competency to conduct future training for any new HHAs.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will monitor progress with Competency Program weekly until 6/7/24 and ensure no HHA works beyond 6/7/24 if he/she has not completed the competency evaluation program.
2. Quality Assurance Specialist or designee will audit 10% of HHA employee files every quarter beginning 7/1/24 to ensure there is evidence of the HHA having successfully completed an aide training or certification program in alignment with 484.80(a)(1).


601.21(d) REQUIREMENT
ADMINISTRATOR

Name - Component - 00
601.21(d) Administrator. The
qualified administrator, who may also
be the supervising physician or
registered nurse: (i) organizes and
directs the agency's ongoing
functions, (ii) maintains ongoing
liaison among the governing body, the
group of professional personnel, and
the staff, (iii) employs qualified
personnel and ensures adequate staff
education and evaluations, (iv)
ensures the accuracy of public
information materials and activities,
and (v) implements an effective
budgeting and accounting system. A
qualified person is authorized in
writing to act in the absence of the
administrator.

Observations: Based on a review of agency policy, personnel files (PF), clinical records (CR), and an interview with the administrator, vice president, and director of operations, the administrator failed to be responsible for the day-to-day operations of the agency for the documentation requirements of pain management documentation for one (1) of nine (9) CRs reviewed, (CR#1); and the documentation of nursing notes for four (4) of nine (9) CRs reviewed, (CR#1, 2, 8, and 9). Findings include: A review of agency policy titled "Pain Assessment/Management" conducted on April 24, 2024, at approximately 2:00 PM, states "Policy: All patients admitted to the Agency will receive a comprehensive assessment that includes identification of pain and its impact on function as well as the treatment and efficacy of treatment...Purpose: To support the patient's right to expect that pain will be recognized and addressed appropriately. To coordinate the efforts of all members of the team in effective pain management. To assess the effectiveness of interventions and strive for effective pain management. To provide a safe and therapeutic environment for accurate reporting and documenting of pain. Special Instructions: 1. Pain assessment is an integral part of the initial comprehensive assessment and the patient's right to expect appropriate assessment and management is explained and honored. If the patient has pain that interferes with activity or movement on a daily basis or is determined to be intractable, pain management will be a specific intervention on the plan of care. 2. The registered nurse or therapist completes the assessment. The assessment includes a measure of pain intensity and quality (character, frequency, location, and duration). The patient's self-report or report of family/caregiver is the primary indicator of pain and will identify the need for reassessment for pain management. 3. Pain is assessed on every home visit and documented on a pain or symptom flow sheet. 4. The nurse/therapist will use a standardized agency accepted pain assessment tool that evaluates the location, duration, severity (rating scale), alleviating factors, exacerbating factors, current treatment (medication and non-medication) and response to treatment. 5. The follow up assessments will address effectiveness of the pain management program and identify if there is a need for referral for additional alternative therapy. If the established plan is ineffective and the pain management needs cannot be met within the agency pain management parameters, a referral will be made to an alternate provider. 6. Assessment of presence of pain and treatment/response will be incorporated into all agency assessments/ reassessment tools...Documentation Guidelines: General status of the patient including vital signs; Patient description of pain including location, quality, and self-rating of the pain level; Treatments/interventions and response; Physician notification as appropriate; Other findings as necessary..." A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..." A review of agency policy titled "Flow Sheet" conducted on April 24, 2024, at approximately 9:45 AM, states "Policy: Agency personnel shall use appropriate flow sheets to document ongoing patient assessment, care, and needs when visits are made frequently, when specific services are provided during each visit, or when specific parameters are to be followed. The Flow Sheets will include date, time, assessment and teaching parameters/interventions, response to intervention and comments as appropriate. Each entry will be signed and dated...Special Instructions: 3. The Nurse must document each visit on the flow sheet. The patient assessment, care provided, the patient's response to therapy, and the patient and/or caregiver instructions are also documented in the appropriate section. 4. If an area listed on the flow sheet is not addressed, an NA (Not Applicable) should be placed in that area. 5. All charting must be signed by each Nurse that charts on the flow sheet. A first initial and last name must appear at least one time on each sheet. After that, initials are sufficient. 6. The appropriate areas on the flow sheets shall be completed the day service is rendered and incorporated into the clinical record within seven (7) days of that date. 7. Findings and/or changes in condition that are not pertinent to the flow sheet parameters must be documented on clinical progress notes." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024. Home Health Certification and Plan of Care contained an order for Acetaminophen by mouth tablet 325 mg, 2 tablets every 6 hours as needed for pain. A review of Nursing Progress Notes dated 4/17/2024 and 4/28/2024 revealed the following: On 4/17/2024, nurse documents patient has pain "present", location: "head and body". There is no documentation as to how the nurse knew the patient had pain (he is nonverbal), no description of pain, and no documentation of relief measures taken and what the outcome of the relief measures were. On 4/18/2024, nurse documents patient has pain "present". There is no documentation as to how the nurse knew the patient had pain (he is nonverbal), location of pain, no description of pain, and no documentation of relief measures taken and what the outcome of the relief measures were. A review of Supervising Registered Nurse (RN) recertification assessment dated 4/10/2024 revealed note was not completed on agency appointed form, was informal, "jotted", and did not contain a complete assessment. CR#2, Start of Care: 09/09/2020. Certification period reviewed 02/21/2024 through 04/20/2024. A review of Supervising RN recertification assessment dated 2/16/2024 revealed note was not completed on agency appointed form and was informal, "jotted", and did not contain a complete assessment. CR#8, Start of Care: 10/28/2022. Date discharged: 12/21/2022. Certification period reviewed: 10/28/2022 through 12/26/2022. A review of nursing notes for the certification period reviewed revealed file did not contain any formal documentation of skilled nursing (SN) notes on an agency appointed form. Notes were "jotted" and did not contain a complete nursing note. CR#9, Start of Care: 11/4/2021. Discharge date: 2/26/2023. Certification period reviewed: 1/04/2022 through 3/04/2022 and 3/05/2022 through 5/03/2022. A review of Supervising RN recertification assessments revealed the note was on a paper titled "team note" printed on 2/11/2022 and 7/20/2022. Notes were not completed on agency appointed form, were informal, "jotted", did not contain a date the note was written, and did not contain a complete assessment. There were no other nursing assessments documented in the file. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. Effective 4/29/24, the Administrator reports directly to the Director of Quality Assurance who will provide clinical oversight of the Administrator and program.
Personnel Records
1. PF#1 Unable to correct deficiency; last day of work for the employee was 1/15/2024. Employee is no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect an inactive status by 5/24/24.
2. PF#2 Unable to correct deficiency; employee has not provided services to a client at any time throughout the length of employment and is no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect an inactive status by 5/24/24.
3. PF #3 Unable to correct deficiency; employee was removed from duty on 4/23/2024 and voluntarily resigned on 5/3/2024. Employees status was updated 5/6/24 to reflect the termination to adhere to the Immediate Jeopardy abatement.
4. PF#4 Unable to correct deficiency; last day of work for the employee was 10/20/2022. Employee no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect a terminated status by 5/24/24.
5. PF#5 Employee has not provided services to any clients and post survey has been changed to a pending status. Employee will be required to complete all components of the hiring process inclusive of ensuring home health aide qualifications have been met within accordance to the Conditions of Participation prior to the provision of any client care. The administrator or designee is responsible for ensuring all personnel requirements are met. Employees' failure to comply with requirements will result in an inactive status change in all EHR's. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect a terminated status.
6. PF#6 Employee will be required to complete all components of orientation and to ensure home health aide qualifications have been met within accordance to the Conditions of Participation by 6/7/24. Administrator or designee is responsible for ensuring all personnel requirements are met. Employees' failure to comply with the requirements will result in the employee being removed from active duty and placed in a hold status until compliance is achieved. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect the appropriate status.
Client Records:
1. CR#1 The employee for this client is no longer with the company and never reported client was in pain in previous supervisory visits or nursing documentation. During the week of 4/17/24, client was diagnosed with the flu. Administrator, who has been overseeing case, confirmed client is non-verbal, however client can comprehend when asked questions and can point or nod head.
2. RNCM will conduct a new patient assessment for CR #1 by 5/17/24 to include an assessment of the patient's pain and document a plan to provide pain management in the event the patient has pain. The assessment will include a means to identify if the patient, who is non-verbal, is experiencing pain.
3. CR#8 All nursing documentation completed on 5/11/24, MD orders faxed on 5/11/24 waiting for signature of MD.
4. CR#2 and CR#9 All nursing documentation completed by 5/21/24.
5. Administrator will receive Corrective Counseling by 5/24/24.
PROTECT:
Personnel Records
1. Private Duty Nursing Care Coordinator will audit 100% of currently active staff to ensure all staff are appropriately categorized in all EHR's by 6/7/24.
2. Quality Assurance Manager or designee will conduct 100% audit to ensure compliance with Conditions of Participants and organizations policies & procedures by 6/7/24. All staff identified to be noncompliant will be brought into compliance.
Client Records:
1. RNCM visited client on 4/25/24 for medication reconciliation. Client's physician chose to keep standing order of Tylenol for pain as needed for future comfort measures.
2. Quality Assurance Specialist or designee will audit 100% of current patients by 5/31/24 to ensure pain was assessed at the most recent assessment and that there is a documented plan to provide pain management in the event the patient has pain. This will include ensuring there is a documented means to identify if a non-verbal patient is experiencing pain.
3. Quality Assurance Specialist or designee will audit 100% of current patients who are non-verbal by 5/31/24 to ensure the assessment of the patient's cognitive includes the method by which the RNCM determined orientation.
4. Quality Assurance Specialist or designee will audit 100% of current patients by 5/31/24 to ensure nursing notes and assessments are documented.
PREVENT:
Personnel Records
1. Administrator or designee will review and revise the following policies to ensure compliance with Conditions of Participation: Personnel Records, Health Screening, Employee Orientation & Competency Assessment by 6/7/24.
2. Administrator or designee to revise the onboarding checklist to include all required elements by 6/7/24.
3. Administrator, Human Resources and Care Coordinators will receive training conducted by the Quality Assurance Director or designee by 6/7/24. The training will cover the requirements of 601.21(f) and the organizational policies named above. Training will be documented via attestation.
Client Records:
1. Administrator or designee will update the Pain Assessment/Management policy to include guidelines for identifying and addressing pain in patients who are non-verbal by 6/7/24.
2. Administrator or designee will train all RNCM on ensuring assessments include a documented plan to provide pain management in the event the patient has pain and, if the patient is non-verbal, there is a means to identify if the patient is experiencing pain. Education will be documented via attestation and completed by 6/7/24.
3. Administrator or designee will train all RNCM, RN, and LPN on the revised Pain Assessment/Management policy, including documenting how the nurse determined the patient had pain, a description of pain, documentation of relief measures taken, and what the outcome of the relief measures were. Education will be documented via attestation and completed by 6/7/24.
4. Administrator or designee will train all RNCM, RN, and LPN on Clinical Documentation expectations by 6/7/24.
MONITOR/SUSTAIN:
Personnel Records
1. Administrator, Human Resources and Care Coordinators will be required to utilize a personnel checklist at the completion of onboarding all new employees to ensure compliance with all requirements. The checklist will be implemented by 6/7/24.
2. All newly hired field employees placed in an active status must be approved by the Director of Quality Assurance or designee prior to the employee's first shift. This approval process will be in place until 100% compliance is achieved for 2 consecutive months.
3. Quality Assurance Specialist or designee will conduct ongoing quarterly audits starting 7/1/24 consisting of a 10% sample of active employees.
Client Records
1. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure compliance with the RN/LPN Supervision form, including a review of the MAR, there is evidence of physician notification when applicable, nursing notes/assessments are completed, and other home documentation is reviewed and completed.
2. The Administrator or designee will conduct quarterly home visits starting 7/1/24 for 10% of the active patients to ensure each patient has a complete patient file, inclusive of MARs.


601.21(f) REQUIREMENT
PERSONNEL POLICIES

Name - Component - 00
601.21(f) Personnel Policies.
Personnel practices and patient care
are supported by appropriate, written
personnel policies. Personnel records
include qualifications, licensure,
performance evaluations, health
examinations, documentation of
orientation provided, and job
descriptions, and are kept current.

Observations: Based on a review of agency policy, personnel files (PF), and an interview with the administrator, vice president, and director of operations, the agency failed to follow its policies for the requirements of personnel records for six (6) of six (6) PFs reviewed, (PF#1, 2, 3, 4, 5, and 6). Findings include: A review of agency policy titled "Personnel Records" conducted on April 23, 2024, at approximately 10:20 AM, states "Purpose: The purpose of this policy is to identify the content of personnel files and a system for maintaining accurate, complete, and current information. Special Instructions: l. Personnel Records - the employee personnel record will include, but not be limited to: Competency testing tor home health aides and specific competencies per job title...Signed job description, Skills checklist, Orientation checklist -- completed and signed...c. Ongoing employment: Competency reviews (written and observed as indicated) ...d. Medical History/Health Status: Hepatitis B declination or immunization record, Tuberculosis screening..." A review of agency policy titled "Health Screening" conducted on April 23, 2024, at approximately 10:00 AM, states "Policy: Each employee having direct contact with patients must have documentation of baseline health screening prior to providing care to patients. Therapists, nurses, social workers, nurse aides, and any staff that will have contact with a patient are required to have a Tuberculosis screening upon hire and annually in accordance with CDC guidelines. Testing will be offered at no cost to the employee...Instructions: B. Tuberculosis Screening: There are two kinds of tests that are used to determine if a person has been with TB bacteria: l. TB skin test (also known as PPD for purified protein derivative, or TST). 2. TB blood tests (also known as interferon-gamma release assays or IGRAs, or BAMT) ... Procedure: l. Upon hire, the agency requires evidence that the individual is free of TB. 2. The agency can accept evidence of previous TB screenings. This protocol will be considered met if the following evidence can be provided: a. Evidence of a negative two step PPD screening, both steps having been performed within one year of the date of hire. In this scenario, the employee may begin to work immediately with patients. However, an additional screening questionnaire must be completed upon hire to ensure the individual is free from TB signs/symptoms in order to have met this protocol. b. Evidence of a negative TB blood test performed within one year of the date of hire. In this scenario, the employee may begin to work immediately with patients. c. Evidence of a previous negative chest x-ray may be accepted by the agency. In this scenario, the employee may begin to work immediately with patients. However, an additional screening questionnaire must be competed upon hire to ensure the individual is free from TB signs/ symptoms in order to have met this protocol. d. Evidence of a negative one step PPD test performed within one year of hire may be accepted by the agency. In this scenario, the employee may begin to work immediately with patients. However, an additional one step negative PPD test must be performed at the time of hire to meet this protocol. 3. If an applicant or employee does not have evidence of previous screenings within one year, the agency may accept the following to have met this protocol: a. A negative 2-step PPD test. The applicant or employee may begin working after receiving negative results of the 1st step but must still meet the deadlines for the 2nd step administration and reading as indicated above in the 2 Step TB Skin Test (PPD) Guidelines. b. A negative TB blood test performed at hire. The applicant or employee may begin working with patients when the results of this screening are received by the agency...4. Annually, the agency Quality Manager or other appropriate staff, must conduct a risk assessment review for all counties serviced by the agency. If the agency is found to be medium risk in a county, all employees in that county will be required to have a one-step PPD screening upon their annual evaluation. If the agency is found to be low risk in a county, all employees in that county will be required to complete a screening questionnaire confirming they are free from signs and symptoms of TB upon their annual evaluation...C. Hepatitis B Vaccine: The Hepatitis B vaccine and vaccination series shall be made available to all employees who are at risk for exposure to blood and body fluids/substance. (Refer to the Hepatitis B Vaccination policy.) This vaccine must be provided at no cost to the employee and acceptance, or refusal of the vaccine must be documented...F. Documentation: Information obtained (other than occupational exposure and post-exposure evaluation and follow-up) during the health screening shall be documented and maintained in the employee's personnel file..." A review of agency policy titled "Employee Orientation" conducted on April 23, 2024, at approximately 11:35 AM, states "Policy: Each employee of CareGivers America who provides direct care, supervision of direct care, or management of services, will participate in an orientation program specific to his/her educational background and experience, type of care provided, physical and mental condition of patients, and the roles and responsibilities as an employee of CareGivers America. Orientation will be provided by an Administrator-appointed qualified employee or staff member...When the initial orientation is completed, the employee will sign the orientation checklist and a copy will be retained in the personnel record." A review of agency policy titled "Competency Assessment" conducted on April 23, 2024, at approximately 11:35 AM, states "Competency of all staff will be assessed during the interview process, orientation program and ongoing throughout employment. (Direct Care Staff will be assessed for competencies annually) Assessments of competency will be a component of the annual performance review..." A review of PFs was conducted on April 22, 2024, from approximately 12:25 P.M. to 1:30 P.M. and on April 23, 2024, from approximately 9:45 A.M. to 11:40 A.M. PF#1, Date of Hire: 5/24/2023. File did not contain any documentation of tuberculosis testing, a completed tuberculosis symptom questionnaire, and a tuberculosis risk assessment at hire. PF#2, Date of Hire: 2/22/2023. File did not contain any documentation the employee completed the minimum requirement of sixty (60) hours of training for home health aides (HHA) and documentation of annual tuberculosis education for 2024. PF#3, Date of Hire: 8/6/2021. File did not contain any documentation of a registered nurse (RN) orientation and RN initial competency. File contained a negative tuberculosis QuantiFERON test dated 4/24/2022 which is eight (8) months after hire. PF #4, Date of Hire: 9/15/2021. File did not contain any documentation of a signed job description, orientation documentation, documentation of completion of the minimum requirement of sixty (60) hours of training for HHAs, initial competency at hire, annual competencies for 2022 and 2023, emergency preparedness training at hire and for 2023, infection control training at hire and for 2022 and 2023, tuberculosis testing at hire, annual tuberculosis education for 2022 and 2023, and employee documented that they would like to receive the Hepatitis B vaccine, but there is no documentation that the employee received the vaccine. PF#5, Date of Hire: 7/21/2023. File did not contain any documentation of completion of the minimum requirement of sixty (60) hours of training for HHAs. PF#6, Date of Hire: 1/18/2024. File did not contain any documentation of orientation, and documentation of completion of the minimum requirement of sixty (60) hours of training for HHAs. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT:
1. PF#1 Unable to correct deficiency; last day of work for the employee was 1/15/2024. Employee is no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect an inactive status by 5/24/24.
2. PF#2 Unable to correct deficiency; employee has not provided services to a client at any time throughout the length of employment and is no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect an inactive status by 5/24/24.
3. PF #3 Unable to correct deficiency; employee was removed from duty on 4/23/2024 and voluntarily resigned on 5/3/2024. Employees status was updated 5/6/24 to reflect the termination to adhere to the Immediate Jeopardy abatement.
4. PF#4 Unable to correct deficiency; last day of work for the employee was 10/20/2022. Employee no longer employed with the organization. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect a terminated status by 5/24/24.
5. PF#5 Employee has not provided services to any clients and post survey has been changed to a pending status. Employee will be required to complete all components of the hiring process inclusive of ensuring home health aide qualifications have been met within accordance to the Conditions of Participation prior to the provision of any client care. The administrator or designee is responsible for ensuring all personnel requirements are met. Employees' failure to comply with requirements will result in an inactive status change in all EHR's. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect a terminated status.
6. PF#6 Employee will be required to complete all components of orientation and to ensure home health aide qualifications have been met within accordance to the Conditions of Participation by 6/7/24. Administrator or designee is responsible for ensuring all personnel requirements are met. Employees' failure to comply with the requirements will result in the employee being removed from active duty and placed in a hold status until compliance is achieved. The Private Duty Nursing Care Coordinator will be responsible for updating all EHR's to reflect the appropriate status.
PROTECT:
1. Private Duty Nursing Care Coordinator will audit 100% of currently active staff to ensure all staff are appropriately categorized in all EHR's by 6/7/24.
2. Quality Assurance Manager or designee will conduct 100% audit to ensure compliance with Conditions of Participants and organizations policies & procedures by 6/7/24. All staff identified to be noncompliant will be brought into compliance.
PREVENT:
1. Administrator or designee will review and revise the following policies to ensure compliance with Conditions of Participation: Personnel Records, Health Screening, Employee Orientation & Competency Assessment by 6/7/24.
2. Administrator or designee to revise the onboarding checklist to include all required elements by 6/7/24.
3. Administrator, Human Resources and Care Coordinators will receive training conducted by the Quality Assurance Director or designee by 6/7/24. The training will cover the requirements of 601.21(f) and the organizational policies named above. Training will be documented via attestation.
MONITOR/SUSTAIN:
1. Administrator, Human Resources and Care Coordinators will be required to utilize a personnel checklist at the completion of onboarding all new employees to ensure compliance with all requirements. The checklist will be implemented by 6/7/24.
2. All newly hired field employees placed in an active status must be approved by the Quality Assurance Director or designee prior to the employee's first shift. This approval process will be in place until 100% compliance is achieved for 2 consecutive months.
3. Quality Assurance Specialist or designee will conduct ongoing quarterly audits starting 7/1/24 consisting of a 10% sample of active employees.


601.21(h) REQUIREMENT
COORDINATION OF PATIENT SERVICES

Name - Component - 00
601.21(h) Coordination of Patient
Services. All personnel providing
services maintain liason to assure
that their efforts effectively
complement one another and support the
objectives outlined in the plan of
treatment. (i) The clinical record
or minutes of case conferences
establish that effective interchange,
reporting, and coordinated patient
evaluation does occur. (ii) A
written summary report for each
patient is sent to the attending
physician at least every 60 days.

Observations:


Based on review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and the director of operations, the agency failed to ensure documentation of care coordination (case conference) was included in the clinical record for five (5) of nine (9) CRs reviewed, (CR#1, 2, 4, 5, and 9).

Findings include:
A review of agency policy titled "Coordination of Patient Services" conducted on April 24, 2024, at approximately 11:25 AM, states "Policy: All personnel furnishing services shall maintain communications with the patient Case Manager and/or the Assistant/Clinical Supervisor to assure that their efforts are coordinated effectively and support the objectives outlined in the Plan of Care. This may be done through secure e-mail, telephone conference, other verbal interaction and maintaining complete, current Care Plans. Purpose: To ensure services are coordinated between members of the interdisciplinary team, and branches, respectively. To ensure appropriate, quality care is being provided to patients. To ensure effective interchange, reporting, and coordination of patient care occurs. To assure that the efforts of agency personnel effectively complement one another and support the objectives outlined in the Plan of Care. To modify the Plan of Care to reflect needs or changes identified by members of the team and avoid duplication of services. To evaluate the adequacy of treatment and the effect of services provided. To determine the continuation of services and/or future plans for care. To provide the attending physician with an ongoing assessment of the patient and identify the patient's response to services provided. To identify potential for abuse or actual patient abuse and/or neglect. To ensure continuity of care. Special Instructions: 1. Communication will occur as necessary to establish coordinated evaluation between all disciplines involved in the patient's care. Formal care conferences are not required to demonstrate care coordination...3. Interdisciplinary communication shall be conducted as often as necessary to respond to changes in the patient's needs, services, care, or goals...6. Ongoing interdisciplinary communication shall be conducted to evaluate the patient's status and progress. Any problems will be discussed, and an action plan developed...9. The primary care Nurse or Therapist will assume responsibility for updating/changing the Care Plan and communicating changes to caregivers within twenty-four (24) hours following the changes. The physician will be contacted when his/her approval for that change as necessary and to alert physician to changes in patient condition. Active records will be reviewed on an ongoing basis by the Nursing Supervisor or designated Registered Nurse (RN)/Therapist.10. All caregivers, including any contracted services, shall have access to the patient Plan of Care and will be expected to participate in coordination of care activities, as appropriate. 11. The agency will identify a communication system to assure that all disciplines and departments are informed of changes to plan and/or need for modification..."
A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M.
CR#1, Start of Care: 12/30/2020. Certification period reviewed: 4/13/2024 through 6/11/2024. File did not contain any documentation of care coordination between the supervising RN and skilled RN (SN) for care provided during the certification period reviewed.
CR#2, Start of Care: 09/09/2020. Certification period reviewed: 2/21/2024 through 04/20/2024. File did not contain any documentation of care coordination between the supervising RN and SN for care provided during the certification period reviewed.
CR#4, Start of Care: 3/25/2021: Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain any documentation of care coordination between the supervising RN and home health aide (HHA) for care provided during the certification period reviewed.
CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024 through 4/21/2024. File did not contain any documentation of care coordination between the supervising RN and home health aide (HHA) for care provided during the certification period reviewed.
CR#9, Start of Care: 11/4/2021 Certification period reviewed: 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022. File did not contain any documentation of care coordination between the supervising Registered Nurse and the home health aide for care provided during the certification period reviewed.


An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.






Plan of Correction:

CORRECT
1. RN #2 relieved from duty 4/23/24 and is no longer employed by the agency as of 5/3/24.
2. RNCM completed medication reconciliation, reconciliation of all physician's orders, updated POC, and reconciled with signing physician for CR #1 on 4/25/2024.
3. RNCM reconciled facilitated Coordination of Care between CR #1's primary physician (signing physician), neurologist, and endocrinologist from the period 04/25/2024 ongoing. CR #1 was overdue for endocrinologist visit, and RNCM facilitated appointment for 06/05/2024. Medication reconciliation with endocrinologist to occur following visit.
4. For CR#2, 4, 5, 9 and all existing patients RNCM will perform supervisory visits every 14 days through 6/30/2024 ensure proper care coordination as applicable, thereafter supervisory visits will occur a minimum of every 30 days(medical)/60 days(nonmedical) and as applicable.
PROTECT
1. RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication and Nursing documentation of progress throughout nursing shift is completed. This was updated in the RN Supervision Template 04/24/202. This practice will ensure the safety and well-being of all patients is maintained. Supervisory visits to be performed every 14 days through 6/30/2024
PREVENT
1. The Administrator or designee will re-orient all RNCMs and LPNs to policy on Coordination of Patient Services by 6/24/2024.
2. The Director of Quality Assurance or designee will update the Clinical documentation policy regarding timeframes to obtain nurses' notes in the branch by 6/24/24.
3. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies. Training will include expectations regarding timeliness of completing and documenting POC. Education will be documented via attestation by 6/24/2024.
MONITOR/SUSTAIN
1. Quality Assurance Specialists or designees will conduct quarterly audits starting 7/1/24 including 10% of all clients to review supervisory visits, physician's orders and nursing notes quarterly to ensure on-going compliance and documentation of care coordination.


601.22(b) REQUIREMENT
ADVISORY AND EVALUATION FUNCTION

Name - Component - 00
601.22(b) Advisory and Evaluation
Function. The group of professional
personnel meets at least annually to
advise the agency on professional
issues, participate in the evaluation
of the agency's program and assist the
agency in maintaining liason with
other health care providers in the
community information program. Its
meetings are documented by dated
minutes. Note dates of last two
meetings.

Observations: Based on a review of agency policy, Professional Advisory Committee (PAC) documentation, and an interview with the administrator, vice president, and the director of operations, the agency failed to ensure that the Professional Advisory Committee included at least one member who is neither an owner nor an employee of the agency. Findings include: A review of agency policy titled "Professional Advisory Committee" conducted on April 23, 2024, at approximately 10:45 AM, states "Policy: A group of professional personnel that shall meet annually for the purposes stated below. The group should consist of at least one physician, one registered nurse, one community liaison, and at least one representative from each of the following disciplines: physical therapy, occupational therapy, speech therapy and social work." A review of agency PAC meeting minutes dated December 27, 2023, was conducted on April 23, 2024, at approximately 10:50 AM. According to meeting minutes at which attendance is documented, a consumer (one member who is neither an owner nor an employee of the agency) was not present at the Professional Advisory Committee meeting. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. Administrator or designee will appoint a consumer for its PAC by 6/24/24.
PROTECT
1. The Administrator or designee will ask all current clients and family members if they want to take part in our meetings to represent our client population and voice any needs, concerns or satisfaction of care and services.
PREVENT
1. The Director of Quality Assurance or designee who is a member of the PAC will not conduct a meeting until a consumer is present.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will include a review of the PAC members to ensure a member has been obtained by 6/24/24. The administrator must document she spoke to the consumer and he/she has agreed to be a member.


601.31(b) REQUIREMENT
PLAN OF TREATMENT

Name - Component - 00
601.31(b) Plan of Treatment. The
plan of treatment developed in
consultation with the agency staff
covers all pertinent diagnoses,
including:
(i) mental status,
(ii) types of services and equipment
required,
(iii) frequency of visits,
(iv) prognosis,
(v) rehabilitation potential,
(vi) functional limitations,
(vii) activities permitted,
(viii) nutritional requirements,
(ix) medications and treatments,
(x) any safety measures to protect
against injury,
(xi) instructions for timely
discharge or referral, and
(xii) any other appropriate items.
(Examples: Laboratory procedures and
any contra-indications or
precautions to be observed).

If a physician refers a patient under
a plan of treatment which cannot be
completed until after an evaluation
visit, the physician is consulted to
approve additions or modifications to
the original plan.

Orders for therapy services include
the specific procedures and modalities
to be used and the amount, frequency,
and duration.
The therapist and other agency
personnel participate in developing
the plan of treatment.

Observations:

Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to ensure that each patient receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration for two (2) of nine (9) CRs reviewed, (CR#7 and 9).

Findings include:
A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ... 2. The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date ($484.60(c) (1)) ..."
A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M.

CR#7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024 File did not contain any documentation of a completed Home Health Certification and Plan of Care for the certification period reviewed.

CR#9, Start of Care: 11/4/2021. Discharge date: 2/26/2023. Certification periods reviewed: 1/04/2022 through 3/04/2022 and 3/05/2022 through 5/03/2022. File did not contain any documentation of a completed Home Health Certification and Plan of Care for the certification periods after 5/3/2022 until discharge.

An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.






Plan of Correction:

CORRECT
1. RNCM will complete the POC for CR #7 and send to the physician for signature by 5/21/24.
2. Unsigned POC for CR #9 cannot be corrected.
3. By 5/24/24, The Director of Quality Assurance will complete corrective counseling for RNs regarding the Comprehensive Assessment & Clinical Documentation Policies.
PROTECT
1. Quality Assurance Specialist or designee will audit 100% of current patient episodes by 5/31/24 to ensure there is a completed POC and that it is either signed by the MD or the agency is following due diligence in obtaining MD signature.
2. Administrator or designee will pull a report of any current unsigned POC by 5/17/24 to ensure due diligence is completed.
PREVENT
1. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies by 6/24/24. Training will include expectations regarding timeliness of completing and documenting POC. Education will be documented via attestation.
MONITOR/SUSTAIN
1. Administrator or designee will pull a report weekly starting 5/15/24 of upcoming episodes to ensure a POC is completed and sent to the MD for signature.
2. Administrator or designee will pull a report weekly starting 5/17/24 of unsigned POC to ensure due diligence is completed.
3. Quality Assurance Specialist or designee will conduct a quarterly record review starting 7/1/24 using a 10% sample of client records to ensure the POC was completed, documented, and sent to the Physician for signature timely.


601.31(c) REQUIREMENT
PERIODIC REVIEW OF PLAN OF TREATMENT

Name - Component - 00
601.31(c) Periodic Review of Plan of
Treatment. The total plan of
treatment is reviewed by the attending
physician and agency personnel as
often as the severity of the patient's
condition requires, but at least once
every 60 days. Agency professional
staff promptly alert the physician to
any changes that suggest a need to
alter the plan of treatment

Observations: Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to ensure that the plan of care was reviewed and revised by the physician who is responsible for the home health plan of care and the agency as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date for nine (9) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, 5, 6, 7, 8, and 9). Findings include: A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ... 2. The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60m days, beginning with the start of care date ($484.60(c) (1)) ..." A review of agency policy titled "Physician Orders" conducted on April 24, 2024, at approximately 11:25 AM, states "Policy: Agency will ensure that all drugs, services, and treatments are administered only as ordered by a physician (The orders may be initiated via telephone or in writing and must be countersigned by the physician in a timely manner. All medications and treatments, that are part of the patient's plan of care, must be ordered by the physician. Orders will be accepted only from physicians who have a current license. Electronic signatures are acceptable...Instructions: 1. The individualized patient plan of care must be periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification or registration (2. The Plan of Care is a living document. All subsequent patient care orders, verbal or written, received (after the initial 485) will be considered part of the patient Plan of Care ($484.60(a)(3)). 3. Orders entered into the software system will have the electronic signature, including name, title, time and date, of the operator entering the order. 4. As needed (PRN) orders will include the reason the patient requires (or could require) an additional visit. 5.All orders for medications must contain the name of the drug, dosage, route of administration, and directions for use. Orders must be written completely and not contain any of the dangerous abbreviations, acronyms or signals that may contribute to medication or treatment errors. 7. Every effort will be made to have orders sent, signed, and returned within 30 days. To do this, the agency will use the following process: a. Plans of Care/485s will be created in the software based on the patient assessment. They will be reviewed, approved, and sent to the physician. b. Upon receipt of a verbal order, it will be entered into the software system. c. Supervisors will pull order runs on a regular basis, no less frequently than 2-3 times per week. Orders will be reviewed for accuracy, approved, and faxed to the physician. Orders may also be printed and mailed, or hand delivered to physicians. d. New orders will be faxed/sent out upon approval...f. If a faxed order has not been signed and returned after 5-7 days, the order will be re-faxed. If after 2 fax attempts the order is still not signed and returned the physician will be contacted...h. Upon receipt of the signed and returned order, the order will be marked back in the software system and filed in the patient medical record...12. Electronic signatures are acceptable for records that a maintained in the electronic medical record (EMR). All entries must be appropriately authenticated and dated. Authentication includes signatures, written initials, or computer secure entry by a unique identifier of a primary author who has reviewed and approved the entry." A review of agency policy titled "Physician Summary" conducted on April 24, 2024, at approximately 11:10 AM, states "Policy: A summary report will be provided to the physician no less than every sixty (60) days. The summary will provide a written report of the patient's current condition, the treatment/services provided, and the patient's response to the current treatment and/or medications, and pertinent changes in the patient's physical, emotional, or environmental condition since the last report. The physician summary will provide the progress report required by the Medicare Conditions of Participation...Special Instructions: 1. The progress note/physician summary will be completed by the professional completing the Plan of Care. The summary note will include: 1. Clinical summary of the care, treatment and services provided during the previous sixty (60) day episode of care. 2. Patient response to the services and progress toward established goals. 3.Summary of current needs and involvement of other community/family caregivers or services. 4. Date sent to physician and the name of the physician." A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M. CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#2, Start of Care: 09/09/2020. Certification period reviewed: 2/21/2024 through 4/20/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that the plan of care was reviewed and revised by the MD no less frequently than every 60 days. CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. File did not contain any documentation of a sixty (60) day summary for the certification period reviewed. CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024-4/21/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that the plan of care was reviewed and revised by the MD no less frequently than every 60 days. CR#6, Start of Care: 12/07/2020. Certification period reviewed: 03/16/2024 through 05/14/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#8, Start of Care: 10/28/2022. Date of Discharge: 12/21/2022. Certification period reviewed: 10/28/2022 through 12/26/2022. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that plan of care was reviewed and revised by MD no less frequently than every 60 days. CR#9, Start of Care: 11/4/2021. Certification period reviewed: 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022. File did not contain any documentation of a physician signed Home Health Certification and Plan of Care for the certification period reviewed. File did not contain any documentation that the plan of care was reviewed and revised by the MD no less frequently than every 60 days. An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.

Plan of Correction:

CORRECT
1. The Administrator, RNCM or designee for CR#1, 2, 3 4, 5, 6 and 7 will send outstanding POC to physician for signature by 5/21/24 and document all attempts to obtain.
PROTECT
1. Administrator or designee will pull a report of any current unsigned POC starting 5/17/24 to ensure due diligence is completed.
2. Quality Assurance Specialist or designee will conduct a 100% audit of current patient episodes to ensure there is a completed POC and that it is either signed by the MD or the agency is following due diligence in obtaining MD signature to ensure safety.
PREVENT
1. Administrator or designee will update the Physician Orders policy to reflect appropriate due diligence expectations by 5/24/24.
2. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies. Training will include expectations regarding timeliness of completing and documenting POC by 6/24/24. Education will be documented via attestation.
3. Administrator or designee will pull a report weekly starting 5/17/24 of upcoming episodes to ensure a POC is completed and sent to the MD for signature.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will audit 10% POCs quarterly starting 7/1/24 to ensure the POC was completed, documented, and sent to the Physician for signature timely.


601.31(d) REQUIREMENT
CONFORMANCE WITH PHYSICIAN'S ORDERS

Name - Component - 00
601.31(d) Conformance With
Physician's Orders. All prescription
and nonprescription (over-the-counter)
drugs, devices, medications and
treatments, shall be administered by
agency staff in accordance with the
written orders of the physician.
Prescription drugs and devices shall
be prescribed by a licensed physician.
Only licensed pharmacists shall
dispense drugs and devices. Licensed
physicians may dispense drugs and
devices to the patients who are in
their care. The licensed nurse or
other individual, who is authorized by
appropriate statutes and the State
Boards in the Bureau of Professional
and Occupational Affairs, shall
immediately record and sign oral
orders and within 7 days obtain the
physician's counter-signature. Agency
staff shall check all medicines a
patient may be taking to identify
possible ineffective drug therapy or
adverse reactions, significant side
effects, drug allergies, and
contraindicated medication, and shall
promptly report any problems to the
physician.

Observations:

Based on review of agency policy, clinical records (CR), and interview with the administrator, vice president, and director of operations, the agency failed to ensure compliance with the physician's orders for four (4) of nine (9) CRs reviewed, (CR#1, 2, 4, and 7).


Findings Include:

A review of agency policy titled "Standards of Practice" was conducted on April 24, 2024, at approximately 12:10 PM. Policy states, "Policy: Agency will provide services that are in complaint with acceptable professional standards for the home care industry as well as all state and federal laws and identified agency performance improvement standards...Special Instructions: 1. The agency will practice within the guidelines of their stated discipline. 2. All staff will be knowledgeable regarding laws and regulations governing home health care. 3. Patient care will be provided under the plan of care established by a physician when required by law and regulation...4. Agency staff will deliver services based on each patient's unique and individualized needs...Care will be provided in a coordinated, effective, appropriate, cost-conscious, and safe manner in accordance with agency goals, objectives, and philosophy. 5. The national patient safety goals for ACHC will be incorporated into standards, performance expectations, orientations, and policy and procedure where applicable."
A review of agency policy titled "Plan of Care" was conducted on April 24, 2024, at approximately 12:15 PM. Policy states, "Policy: Home care services are furnished under the supervision and direction of the patient's physician. The Plan of Care is based on a comprehensive assessment and information provided by the patient/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that patient needs are met, and will be updated as necessary, but at least every sixty (60) days. Purpose: There is an individualized written plan of care for each patient accepted to services that is specific to the needs of the patient ($484.60). Instructions: 1. Each patient will receive an individualized written plan of care, including any revisions or additions. The plan of care will specify what is needed to meet the needs of the patient as identified in the comprehensive assessment...4. The Plan of Care will include, but not be limited to ($484.60(a) (2) and HH5-3A).: n. All medications (dose/frequency/route) and treatments...7. The agency will obtain physician orders prior to initiating care and will notify the relevant physician(s), promptly, of any changes in the patient's condition/needs that suggest that outcomes are not being achieved and/or indicate a need for change in the plan of care ($484.60(c)(1) and HHS-3A) ...8. Revisions to the plan of care made as a result of a change in patient condition/health status and/or discharge will be communicated to the patient, representative (if any), caregiver, and relevant physicians. The clinical record shall reflect the communication and any new/changed orders (The individualized plan of care must be reviewed and revised by the agency and the physician responsible for the home health plan of care as frequently as the patient's condition or needs require, but no less frequently than once every 60m days, beginning with the start of care date ($484.60(c) (1)) ..."

A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title, and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..."

A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M.

CR#1, Start of Care: 12/30/2020. Certification period reviewed: 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care (485) contains orders for the following medications: Metformin By Mouth Tablet 500 MG 2 Tablet twice a day; Ibuprofen By Mouth Tablet 400 MG 1 Tablet every 6 hours as needed for pain; Acetaminophen By Mouth Tablet 325 MG 2 Tablet every 6 hours as needed for pain; Melatonin By Mouth Tablet 3 MG 2 Tablet at bedtime Lantus SoloStar Subcutaneous Solution Pen-injector 100 unit/ml, 70 Units daily; Vitamin D (Ergocalciferol) By Mouth Capsule 1.25 MG (50000 UT); Trulicity Subcutaneous Solution Pen-injector 0.75 MG/O.5ML weekly; Abilify By Mouth Tablet 20 MG daily with 5mg tab; clonidine HCI By Mouth Tablet 0.1 MG twice a day; Abilify By Mouth Tablet 5 MG with 20 mg tab; Albuterol Sulfate HFA Inhaler Aerosol Solution 108 (90 Base) mcg/act, 2 Puffs every 4 hours as needed for cough or wheezing use with spacer; and Baqsimi Two Pack Nose Powder 3 mg dose, 1 Spray daily as needed for severe hypoglycemia.
During home visit observation (OBS) conducted on April 23, 2024, at approximately 2:00 PM, SN on duty (RN#2) was asked to provide to surveyor the MARs for the current month as per the patient's current Home Health Certification and Plan of Care (485). RN#2 stated that the MARs were not at the patient's residence, and she only has them "sometimes". When asked by surveyor where the medications are listed and where administration is documented, she stated, "I give the same meds every day." Surveyor asked supervising RN (RN#1) if MARs are provided to the home and RN#1 replied "yes".
Review of daily Nursing Progress Notes dated 2/25/2024 through 4/20/2024 revealed medication administered for that shift is documented on the daily nursing progress note with a time of administration. If any PRN medication was given there is no documentation of follow up for result/effectiveness of PRN medication that was given. There is no documentation that a medication reconciliation was completed at the time of the recertification assessment completed on 4/10/2024. Several medications documented as given per the daily Nursing Progress Notes are not listed on the current 485 and/or different doses and times of a medication were documented. The medications are: Trazadone 100 mg by mouth daily at 8 pm (new); Clonidine 0.2 mg by mouth daily at 8 pm (change and/or incorrect); Abilify By Mouth Tablet 5 MG with 20 mg tab (change and/or incorrect); Metformin 500 mg by mouth twice daily (change and/or incorrect); Clonazepam 1 mg by mouth (no frequency is listed) PRN (no reason is listed) (new); There is no documentation that a verbal order to add/change medications from those listed on the current 485 was present in the clinical record for any of the unordered medications and/or different dose and time of medication administered.
Home Health Certification and Plan of Care (485) also contained orders for the certification period reviewed that states: "Private Duty SN frequency: twelve (12) to (17) hours per day, three (3) to seven (7) days per week. Authorized frequency is as follows: SN seventeen (17) hours per day Monday through Friday and thirteen (13) hours per day on Saturday and Sunday." A review of patient's visit calendar for April 2024, conducted on April 24, 2024, at approximately 1:15 PM, revealed the following: All Monday through Friday shifts were only scheduled for sixteen (16) hours. There is no documentation of reason for the missing time each day and no documentation that the physician was notified of the missed time.
CR# 2, Start of Care: 09/09/2020. Certification period reviewed: 02/21/2024 through 04/20/2024. A review of HHA visit calendars via HHA Exchange for March 2024 and February 2024 revealed missing hours with no missed visit documentation for 4 hours on 02/16/2024 and 1 hour on 03/22/2024.
CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. Home Health Certification and Plan of Care (485) contains orders for "Private Duty Home Health Aide (HHA) frequency: six (6) to ten (10) hours per day, three (3) to six (6) days per week. Authorized frequency is as follows: HHA up to six (6) hours per day, five (5) days per week after school and ten (10) hours per day on non-school days including Saturdays." A review of patient's visit calendar for March 2024 and April 2024 revealed the following:
March:
Saturday, 3/2: Shift only scheduled for nine (9) hours.
Friday, 3/8: Shift only scheduled for nine (9) hours.
Saturday, 3/9: Shift only scheduled for nine (9) hours.
Saturday, 3/16: Shift only scheduled for nine (9) hours.
Saturday, 3/23: Shift only scheduled for nine (9) hours.
Monday, 3/25: Shift only scheduled for nine (9) hours.
Tuesday, 3/26: Shift only scheduled for nine (9) hours.
Wednesday, 3/27: Shift only scheduled for nine (9) hours.
Thursday, 3/28: Shift only scheduled for nine (9) hours.
Friday, 3/29: Shift only scheduled for nine (9) hours.
April:
Thursday, 4/4: Shift only scheduled for eight (8) hours.
Friday, 4/5: Shift only scheduled for eight (8) hours.
Saturday, 4/6: Shift only scheduled for nine (9) hours.
Saturday, 4/13: Shift only scheduled for nine (9) hours.
There is no documentation of reason for the missing time each day and no documentation that the physician was notified of the missed time.
Home Health Certification and Plan of Care (485) also contains orders for "SN: HHA supervisory visit no less than monthly". Review of Supervising RN documentation reveals HHA supervisory visits were conducted on 2/1/2024 and 4/1/2024. There is no documentation of a supervisory visit for the month of March 2024.

CR# 7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024. A review of HHA visit calendars via HHA Exchange for April 2024 revealed missing hours with no missed visit documentation for 3 hours on 04/03/2024. No documentation provided for onsite HHA supervisory visits per 485 orders stating "HHA supervisory visits no less frequently than monthly".

An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.






Plan of Correction:

CORRECT
1. RN #2 relieved from duty 4/23/24 and is no longer employed by the agency as of 5/3/24.
2. RNCM completed medication reconciliation, reconciliation of all physician's orders, updated POC, and reconciled with signing physician for CR #1 on 04/25/2024.
3. RNCM reconciled facilitated Coordination of Care between CR #1's primary physician (signing physician), neurologist, and endocrinologist from the period 04/25/2024 ongoing. CR #1 was overdue for endocrinologist visit, and RNCM facilitated appointment for 6/5/24. Medication reconciliation with endocrinologist to occur following visit.
4. RNCM ensured a current MAR was present in the patient's home on 4/25/24, prior to the provision of care. RNCM ensured an updated MAR based upon the Coordination of Care was present in the patient's home prior to the provision of care. If there are changes to the patient's medications due to the endocrinologist visit on 6/5/24, RNCM will update physician's orders and the MAR and ensure it is present in the patient's home timely.
5. RNCM will update the POC for CR #1 based upon the specific skilled nursing needs of the patient and notify primary physician of changes made by endocrinologist by 6/6/24.
6. The Administrator or designee will update the Clinical documentation policy regarding timeframes to obtain nurses' notes in the branch by 6/24/24.
7. The Administrator or designee will implement the policy and orient RNs and LPNs to the new policy and expectations by 6/24/24.
8. The Director of Quality Assurance updated the supervisory visit to include a review of all nursing documentation including physician orders, applicable logs, and nursing notes on 4/25/24.
9. The Administrator and Director of Quality Assurance provided education to all Nurses regarding physician's orders and notification, supervisory visits, new supervisory form, new blood glucose log on 5/3/24. Education documented via attestation.
10. For CR#2, 7 and all existing patients, the Administrator or designee will educate all RNs to stop the practice of adding visit hour ranges on any new 485s by 6/24/24. Any new certification period (485) will contain a patient specific number of hours to be provided and ordered by physician.
11. For CR#7, This patient receives only nonmedical services, and the calendar was incorrect. CR#7's calendar will be corrected by 6/7/24 by the Client Care Coordinator.
PROTECT
1. RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication and Nursing documentation of progress throughout nursing shift is completed. This was updated in the RN Supervision Template 04/24/202. This practice will ensure the safety and well-being of all patients is maintained.
2. Quality Assurance Specialist or designee will conduct a 100% of all supervisory visits and 485 by 5/31/24 to ensure compliance and safety of all patients.
PREVENT
1. For CR #1, 2, 4, 7 & all existing patients, the RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete, and up to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication. This was updated in the RN Supervision Template 04/24/2024.
2. RN Case Managers will review all Physician's Orders to ensure any changes in medications have been updated both via order and on the MAR at every supervisory visit. This was updated in the RN Supervision Template as of 04/29/2024.
3. RN Case Managers will review the patient's chart in the home to ensure it includes the current 485 at every supervisory visit. This was updated in the RN Supervision Template as of 04/29/2024.
4. Administrator or designee updated the RN Supervision Visit Policy to include requirements of physician verbal orders, MAR & PRN medications, patient chart inclusive of current 485 and that a copy will be present in the patient's home, and nurses notes inclusive of any changes 04/29/2024.
5. The Administrator or designee trained all RNs, LPNs, and RN Case Managers on the updated Supervisory Visit and policy 05/03/2024. Education was documented via attestation.
6. The Administrator or Designee will orient all RNs, and LPNs to Home Health Regulations COPs and how they relate to their scope of practice by 6/24/24.
SUSTAIN/MONITOR
1. RN Case Managers will complete Supervisory Visits every 14 days through 06/30/2024 to ensure compliance. Thereafter, at a minimum, supervisory visits will be completed every 30 days (skilled cases) or 60 days (non-skilled) cases ongoing.
2. Quality Assurance Specialist or designee will conduct a 10% audit of all client records to include supervisory visits, physician's orders and nursing notes quarterly starting 7/1/24 to ensure on-going compliance.
3. The Administrator or designee will conduct quarterly home visits for 10% of the active patients starting 7/1/24 to ensure each patient has a complete patient file, inclusive of MARs.


601.32(b) REQUIREMENT
DUTIES OF THE REGISTERED NURSE

Name - Component - 00
601.32(b) Duties of the Registered
Nurse. The registered nurse:
(i) makes the initial evaluation
visit,
(ii) regularly reevaluates the
patient's nursing needs,
(iii) initiates the plan of treatment
and necessary revisions,
(iv) provides those services
requiring substantial specialized
nursing skill,
(v) initiates appropriate
preventive and rehabilitative nursing
procedures,
(vi) prepares clinical and progress
notes,
(vii) coordinates services, and
(viii) informs the physician and other
personnel of changes in the patient's
condition and needs, counsels the
patient and family in meeting nursing
and related needs, participates in
inservice programs, and supervises and
teaches other nursing personnel.

Observations:


Based on a review of agency policy and procedures, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to complete an update of the comprehensive assessment as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than the last five (5) days of every sixty (60) days for five (5) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, and 5); and the agency failed to update the patient's medication profile at the time of care plan revision was completed for five (5) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, and 9).

Findings include:
A review of agency policy titled "Comprehensive Patient Assessment" conducted on April 24, 2024, at approximately 10:35 A.M. states, "Updates to the comprehensive assessments: 2. Comprehensive assessments must be updated and revised no less frequently then: a. recertification comprehensive assessments will take place no less frequently than the last 5 days of every 60 days beginning with the start of care date...If, for any reason, a comprehensive assessment is not completed within the designated timeframe there must be documentation in the chart with the reason. Physician notification must be documented..."

A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..."

A review of agency policy titled "Medication Profile" was conducted on April 24, 2024, at approximately 10:45 AM. Policy states, "Policy: The registered Nurse or Therapist will complete a medication profile for each patient at the time of admission. The medication profile shall include all prescription and nonprescription including regularly scheduled, medications and those taken intermittently or as needed. The profile will be reviewed and updated as needed to reflect current medications the patient is taking. Purpose: To provide a complete list of medications the patient is taking and an evaluation of the patient's knowledge of the effects of these medications...and to identify discrepancies between patient profile and physician and/ or agency profile...To provide documentation of changes in the medication regime as they happen, and support changes needed to the plan of care. Special Instructions: 1. At the time of admission, the admitting professional shall check all medications a patient may be taking to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication. The clinician shall promptly report any identified problems to the physician. 2. The nurse/therapist shall record on the medication profile, all prescribed and over the counter medications the patient is currently taking...Clients who reside in private homes will have either a printout of the medication list from Allscripts or a handwritten medication list left in the client's folder. 3. The medication profile shall document: Allergies, date medication ordered, or care initiated, medication name (full name with no abbreviations), medication dosage (using only accepted abbreviations), route and frequency of administration, contraindications or special precautions, medication side effects, discontinuation date, ineffective drug therapy, drug or food-drug interactions, duplicated drug therapy, non-compliance. At this time a drug-to-drug interaction screen will be run by the nurse/therapist...5. If the physician changes the medication orders, the nurse/therapist must add newly ordered drugs or medication changes to the medication profile...6. When a medication has been changed it may be indicated by placing a C in the N/C column and then the reasons for the medication change may be documented in the clinical note tab or in the medication section of the assessment. 7. Telephone orders documenting medication changes must also be written by the nurse/therapist in the medication tab and documented in the note or the assessment...The change shall be documented on the medication profile and included in the next plan of care."
A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M.
CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024 and 4/13/2024 through 6/11/2024. File did not contain any documentation of an updated comprehensive assessment for either of the certification periods reviewed. File did not contain an updated/reviewed medication profile for the certification period reviewed. File did not contain any documentation of an updated/reviewed medication profile since 8/17/2022.
CR#2, Start of Care: 09/09/2020. Certification period reviewed: 2/21/2024 through 04/20/2024. File did not contain any documentation of an updated comprehensive assessment for the certification period reviewed. File did not contain an updated/reviewed medication profile for the certification period reviewed. File did not contain any documentation of an updated/reviewed medication profile since 6/21/2023.
CR#3, Start of Care: 2/5/2024 Certification period reviewed: 2/5/2024 through 4/04/2024 and 4/05/2024 through 6/03/2024. File did not contain an updated/ reviewed medication profile for the certification period reviewed. File indicated that one medication review had been completed but no date was referenced.

CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain any documentation of an updated comprehensive assessment for the certification period reviewed. File did not contain an updated/reviewed medication profile for the certification period reviewed.
CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024 through 4/21/2024. File did not contain any documentation of an updated comprehensive assessment for the certification period reviewed. File did not contain an updated/reviewed medication profile for the certification period reviewed.
CR#9, Start of Care: 11/4/2021 Certification period reviewed: 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022. File did not contain an updated/reviewed medication profile for the certification period reviewed. File did not indicate any documentation from the start of care until the consumer was discharged from services on 2/26/2023.

An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.







Plan of Correction:

CORRECT
1. RNCM completed medication reconciliation, reconciliation of all physician's orders, updated POC, and reconciled with signing physician for CR #1 on 4/25/2024.
2. Medication Profile and Start of Care cannot be updated for CR#2 for following certification periods 02/21/2024 through 04/20/2024.
3. RNCM completed supervisory visit with medication reconciliation for CR#3 on 5/7/24 for certification period of 4/05/2024 through 6/03/2024.
4. Medication Profile and Start of Care cannot be updated for CR#4 certification period of 3/8/2024 through 5/6/2024. Discharged on 4/30/2024.
5. Medication Profile and Start of Care cannot be updated for CR#9 for following certification periods 1/04/2022- 3/04/2022 and 3/05/2022 - 5/03/2022.
PROTECT
1. Quality Assurance Specialist or designee will conduct a 100% audit of current patient episodes by 5/31/24 to ensure there is a completed POC and that it is either signed by the MD or the agency is following due diligence in obtaining MD signature to ensure safety.
2. Quality Assurance Specialist or designee will audit 100% of current patient episodes by 5/31/13 to ensure there is a Comprehensive Assessment completed and that the assessment contains a complete systems assessment.
PREVENT
1. Administrator or designee will train all RNCM on the Comprehensive Assessment, Clinical Documentation, and Flow Sheet policies by 6/7/24. Training will include expectations regarding timeliness of completing and documenting assessments and physician notification for late reassessments. Education will be documented via attestation.
2. RN Case Managers will review the MAR at every supervisory visit to ensure it is present, complete to date, includes PRN medications, and matches the patient's medications. This will also include all PRN Medications and ensuring if a PRN Medication is given, documentation is present on the result/effectiveness of the PRN Medication and Nursing documentation of progress throughout nursing shift is completed. This was updated in the RN Supervision Template 4/24/2024. This practice will ensure the safety and well-being of all patients is maintained.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will conduct a 10% audit of all supervisory visits, physician's orders and nursing notes quarterly starting 7/1/24 to ensure on-going compliance and documentation of care coordination.


601.35(b) REQUIREMENT
ASSNMNT & DUTIES OF HOME HEALTH AIDE

Name - Component - 00
601.35(b) Assignment and Duties of
the Home Health Aide. The home health
aide is assigned to a particular
patient by a registered nurse. Written
instructions for patient care are
prepared by a registered nurse or
therapist as appropriate. Duties
include:
(i) the performance of simple
procedures as an extension of therapy
services,
(ii) personal care,
(iii) ambulation and exercise,
(iv) household services essential to
health care at home,
(v) assistance with medications
that are ordinarily self-administered,
(vi) reporting changes in the
patient's conditions and needs, and
(vii) completing appropriate
records.

Observations:

Based on review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and the director of operations, the agency failed to ensure the home health aide care plan was followed for three (3) of nine (9) CRs reviewed, (CR#3, 4, and 6).


Findings include:

A review of agency policy titled "Home Health Aide Services" conducted on April 24, 2024, at approximately 1:30 PM, states, "Policy: Home Health Aide services will be provided to appropriate patients on an intermittent, part-time, or full-time basis, under the direct supervision of the Agency Registered Nurse/Therapist in accordance with a medically approved Plan of Care. The duties of the Home Health Aide include the provision of hands-on personal care, performance of simple procedures as an extension of therapy or nursing services, assistance in administering medications that are ordinarily self-administered. All individuals providing Home Health Aide services will be qualified through training and/or competency evaluations. Purpose: To abide by state/federal guidelines and offer guidelines to the agency staff, physicians, and community for the appropriate utilization of Home Health Aide services. Special Instructions: 2. The nurse or therapist assesses the need for personal care services and includes the services in the physician plan of care (orders). A specific care plan is developed documenting the Aide services to be provided. 3. The Aide will follow the care plan and will not initiate new services or developed documenting the Aide services to be provided.

discontinue services without contacting Case Manager, Assistant Clinical Supervisor/Clinical Supervisor, or therapist...5. Home Health Aides must document each visit at the time care is provided and submit documentation to the agency within seven (7) days. 6 All services provided by the Home Health Aide shall be documented in the clinical record."

A review of agency policy titled "Home Health Care Plan" conducted on April 24, 2024, at approximately 1:45 PM, states "Policy: A complete and appropriate Care Plan, identifying duties to be performed by the Home Health Aide, shall be developed by a Registered Nurse or Therapist. All home health aide staff will follow the identified plan. The Care Plan will be available to all persons involved in patient care, including contracted providers. Purpose: To provide a means of assigning duties to the Home Health Aide that are clear to the Nurse, Home Health Aide, and to the patient/caregiver being served. To provide documentation that the supervising Nurse oriented the assigned Aide to the patient's care before initiating the care. To provide documentation that the patient's care is individualized to his/her specific needs. Special Instructions: 1. Following the initial nursing assessment and consultation with the patient/caregiver, a written plan identifying personal care and supportive care services are prepared by a Registered Nurse or Therapist, as appropriate. 2. The Care Plan shall be developed in plain, non-technical lay terms and identify the duties to be performed...3. The Home Health Aide shall be assigned to a particular patient by the Assistant Clinical Supervisor/Clinical Supervisor after physician orders are obtained...6. The Home Health Aide Care Plan shall be reviewed and updated by the Registered Nurse/Therapist minimally every sixty (60) days, or more frequently when there is a significant change in the patient's condition, thus resulting in a change in Aide services..."

A review of agency policy titled "Home Health Aide: Documentation" conducted on April 24, 2024, at approximately 1:50 PM, states "Policy: Home Health Aides will document care/services provided on the Home Health Aide Weekly Record. Care/services provided should be in accordance with direction provided in the Home Health Aide Care Plan. Purpose: To provide documentation of the care performed by the Home Health Aide on each visit. To provide documentation of the Home Health Aide's observations on each visit and evidence of patient progress toward goals. To provide documentation that will identify the ongoing need for Home Health Aide services. Special Instructions: 1. The Home Health Aide shall utilize the appropriate Home Health Aide Weekly Record or charting form to document services rendered to the patient. 2.The Home Health Aide shall be responsible for reporting any changes in the patient's condition or other pertinent observations to the Supervising RN/Therapist..."
A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M.
CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024. Home Health Aide Plan of Care dated 2/05/2024 includes the tasks of Medication reminder, Assist with Mobility, and provide Fluids during each visit. None of the tasks were checked off as being provided to the consumer during the week of 3/3/2024 through 3/9/2024; and the week of 3/10/2024 through 3/16/2024. In addition, the tasks of Medication reminder, assist with Mobility, and provide fluids each visit, providing toileting activities and provide hair care, were not provided during the week of 3/3/2024 through 3/09/2024.
CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. Home Health Aide Plan of Care dated 3/5/2024 includes the following tasks to be completed by the home health aide (HHA): Nail Care weekly; Fluids every visit (There is no documentation provided on care plan as to what the task is. Form states with check boxes: Offer fluids; Thicken fluids; Fluid restriction). A review of two (2) weeks of HHA Weekly Record documentation revealed for the week of 3/4/2024 through 3/9/2024 and the week of 3/11/2024 through 3/16/2024, there is no documentation that the task for nail care or fluids were completed.
CR#6, Start of Care: 12/07/2020. Certification period reviewed: 3/16/2024 through 5/14/2024. Home Health Aide Plan of Care dated 3/13/2024 includes the following tasks to be completed by the home health aide (HHA): Toileting every visit: Assist with toileting (no documentation on specific toileting methods. Form states with check boxes: Assist to commode/toilet, incontinence briefs, catheter care, ostomy care, assist with bedpan/urinal). A review of two (2) weeks of HHA Weekly Record documentation revealed for the week of 04/07/2024 through 04/13/2024 and the week of 04/14/204 through 04/20/2024 showed no toileting documentation.
An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.








Plan of Correction:

CORRECT:
1. RNCM will review the Home Health Aide POC for CR# 3, 4 & 6 and evaluate whether the tasks identified on the POC continue to meet client needs by 6/7/24. The RNCM will then review the Home Health Aide POC with the assigned HHA and reinforce documentation requirements and expectations.
2. RNCM will visit 100% of clients by 6/7/24 and compare the HHA POC and compliance with HHA documented tasks. The RNCM will identify any HHA needing re-education regarding documentation requirements and reinforce training during the home visit. The RNCM will document training on the HHA supervision.
PROTECT:
1. RNCM will ensure he/she reviews the HHA POC to ensure the POC is meeting client needs by 6/7/24. The RNCM will ensure that the HHA is carrying out the task identified on the POC during every visit for 100% of clients.
PREVENT:
1. RNCM will continuously review the HHA documentation of task during every home visit and will address any non-compliance immediately and document this on the HHA supervision.
MONITOR/SUSTAIN:
1. Quality Assurance Specialist or designee will audit 10% client records including HHA Task sheets every quarter beginning 7/1/24 and compare them with the HHA POC to ensure it matches. Findings of non-compliance to the Administrator for corrective counseling.


601.35(c) REQUIREMENT
SUPERVISION

Name - Component - 00
601.35(c) Supervision. The
registered nurse, or appropriate
professional staff member, if other
services are provided, makes a
supervisory visit to the patient's
residence at least every 2 weeks,
either when the aide is present to
observe and assist, or when the aide
is absent to assess the relationships
and determine whether goals are being
met.

Observations:

Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to conduct onsite home health aide (HHA) supervisory visits every sixty (60) days for four (4) of nine (9) CRs reviewed, (CR#2, 3, 7, and 9)

Findings include:

A review of agency policy titled "Home Health Aide (HHA) Supervision" conducted on April 24, 2024, at approximately 1:55 PM, states "Policy: CareGivers America shall provide Home Health Aide services under the direction and supervision of a Registered Nurse/Therapist when personal care services are indicated and ordered by the physician. The frequency of supervision will be in response to Medicare regulations, Agency policy and other state or federal requirements. Purpose: To observe the Aide in providing care to patients, and to assess competency in basic skills, as well as delegated nursing tasks. To provide the Aide with the opportunity for direct interaction with nurse and patient as it
relates to the current plan of care. Special Instructions: 3. Supervisory visits of Home Health Aides shall be according to the following frequency: a. If the patient is receiving skilled care as well as aide services, the registered nurse or other appropriate professional must make a supervisory visit to the patient's home at least once every 2 weeks. If the aide is an employee of the agency, at least one of these visits each month must be made while the aide is providing care to the patient. If the aide is not an employee of the agency, the agency must perform all supervisory visits of that aide while the aide is providing care to the patient. If the patient is receiving home health aide services but is not receiving skilled care, the supervisory visit must occur not less than once every 60 days..."

CR#2, Start of Care: 09/09/2020. Certification period reviewed 02/21/2024 through 04/20/2024. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) ten (10) hours per day, Monday through Friday and states "HHA supervisory visits no less frequently than monthly". File did not any documentation for onsite non-skilled HHA supervisory visits since 07/19/2023.
CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) seven (7) nights per week, 8 PM to 6 AM and states "HHA supervisory visits no less frequently than monthly". File did not contain any documentation for an onsite non-skilled HHA Supervisory visit performed during the certification period.
CR#7, Start of Care: 03/27/2024. Certification period reviewed 03/27/2024 through 05/25/24. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) nine (9) hours per day, five (5) days per week and states "HHA supervisory visits no less frequently than monthly". File did not any documentation for onsite non-skilled HHA supervisory visits for the certification period reviewed.
CR#9, Start of Care: 11/4/2021. Discharge Date: 2/26/2023. Certification period reviewed: 1/04/2022 through 3/04/2022 and 3/05/2022 through 5/03/2022. Home Health Certification and Plan of Care contained orders for Home Health Aide (HHA) eight (8) hours per day, seven (7) days per week and states "HHA supervisory visits no less frequently than monthly". File contained documentation of only one (1) supervisory visit that did not contain a date for both certification periods reviewed and file did not contain any documentation of supervisory visits for any certification period from 5/4/2022 to the discharge date.

An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.







Plan of Correction:

The agency recognizes CR#2, 3, 7, 9 were required under contract to be seen every 30 days, as per orders and the RNCM was following Standard 484.80-2 i A and did not follow physician's orders.
CORRECT
1. Non-timely supervisions for CR#2, 3, 7, 9 cannot be corrected.
2. Administrator or designee will identify all clients requiring a more stringent requirement for Home Health Aide Supervision by 5/20/24.
3. All RNCMs will be oriented to contracts that require a frequency of every 30-days for Home Health Aide Supervision and to ensure they follow physician's orders by 6/7/24.
PROTECT
1. Effective 5/6/24, All Client's will be visited by an RNCM every 14-days until 6/30/24 to ensure each client gets back on track with visit requirements as ordered.
2. Quality Assurance Specialist or designee will audit 100% of all client records to ensure the RNCM is following physician's orders for supervision of all Home Health Aides by 5/31/24.
PREVENT
1. All new RNCM will be oriented to any contract requiring a more stringent frequency of Home Health Aide Supervisions.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will audit 10% of client records quarterly starting 7/1/24 to ensure the RNCM is following physician's orders for supervision of all Home Health Aides.


601.36(a) REQUIREMENT
MAINTENANCE AND CONTENT OF RECORD

Name - Component - 00
601.36(a) Maintenance and Content of
Record. A clinical record is
maintained in accordance with accepted
professional standards and contains:
(i) pertinent past and current
findings,
(ii) plan of treatment,
(iii) appropriate identifying
information,
(iv) name of physician,
(v) drug, dietary, treatment and
activity orders,
(vi) signed and dated clinical
progress notes (clinical notes are
written the day service is rendered
and incorporated no less often than
weekly),
(vii) copies of summary reports sent
to the physician, and
(viii) a discharge summary.

Observations:

Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and director of operations, the agency failed to ensure the clinical record was maintained in accordance with accepted professional standards for nine (9) of nine (9) CRs reviewed, (CR#1, 2, 3, 4, 5, 6, 7, 8, and 9).


A review of agency policy titled "Clinical Records/Medical Record Retention" conducted on April 24, 2024, at approximately 9:50 AM states, "Policy: A clinical record will be maintained for every patient receiving home health services. All patient information shall be regarded as confidential and available only to authorized users. Clinical records are legal documents containing comprehensive, accurate, and organized information concerning the patient's health and emotional status, treatments, and services rendered by the registered professional nurses (RN) and other health team members...Special Instructions: Clinical Record: 1. A confidential clinical record containing pertinent past and current findings in accordance with accepted professional standards is maintained for every patient receiving home health services. 2. In addition to the Plan of Care, the clinical record shall contain appropriate identifying information, but not limited to: g. Comprehensive Assessment Form/Admission Assessment/ Reassessment...j. Physician's Plan of Care/485. K. Doctor's orders...m. Medication Profile...o. Signed and dated clinical and progress notes of nurses, therapists, and social workers. p. Home Health Aide Care Plan, if applicable. q. Home Health Aide Notes, if applicable. r. Supervisory notes as needed. s. Copies of summary reports sent to the attending physician. t. Care conference/ communication notes...v. Discharge Summary..."

A review of CRs was conducted on April 22, 2024, from approximately 12:00 P.M. to 12:30 P.M. and on April 23, 2024, from approximately 9:30 A.M. to 12:00 P.M, and on April 25, 2024, from approximately 10:00 A.M. to 11:40 A.M.

CR#1, Start of Care: 12/30/2020. Certification period reviewed: 2/13/2024 through 4/12/2024. File did not contain any documentation of the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care; a reviewed and updated medication profile; missed visit/hours documentation; physician orders for addition/change and/or removal of medications; care coordination documentation; and completed skilled nursing (SN) recertification assessments on agency approved forms.
CR#2, Start of Care: 09/09/2020. Certification period reviewed 02/21/2024 through 04/20/2024. File did not contain any documentation of the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care; a reviewed and updated medication profile; missed visit/hours documentation; care coordination documentation; supervisory visits of home health aides (HHAs); and completed skilled nursing (SN) recertification assessments on agency approved forms.
CR#3, Start of Care: 2/5/2024. Certification period reviewed: 2/5/2024 through 4/04/2024 and 4/05/2024 through 6/03/2024. File did not contain any documentation of the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care; a reviewed and updated medication profile; supervisory visits of home health aides (HHAs); and completed skilled nursing (SN) recertification assessments on agency approved forms.
CR#4, Start of Care: 3/25/2021. Certification period reviewed: 3/8/2024 through 5/6/2024. File did not contain any documentation the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care; a reviewed and updated medication profile; missed visit/hours documentation; care coordination documentation; and completed skilled nursing (SN) recertification assessments on agency approved forms.
CR#5, Start of Care: 11/3/2021. Certification period reviewed: 2/22/2024-4/21/2024 and 4/22/2024-6/20/2024. File did not contain any documentation of the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care.
CR#6, Start of Care: 12/07/2020. Certification period reviewed: 03/16/2024 through 05/14/2024. File did not contain any documentation of the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care.
CR#7, Start of Care: 03/27/2024. Certification period reviewed: 03/27/2024 through 05/25/2024. File did not contain any documentation of the following for the certification period reviewed: a completed Home Health Certification and Plan of Care; a physician signed and reviewed Home Health Certification and Plan of Care; a reviewed and updated medication profile; missed visit/hours documentation; care coordination documentation; and supervisory visits of home health aides (HHAs).
CR#8, Start of Care: 10/28/2022. Date of Discharge: 12/21/2022. Certification period reviewed: 10/28/2022 through 12/26/2022. File did not contain any documentation of the following for the certification period reviewed: a physician signed and reviewed Home Health Certification and Plan of Care; completed skilled nursing (SN) assessments on agency approved forms; and notification the physician was notified of discharge.
CR#9, Start of Care: 11/4/2021. Discharge date: 2/26/2023. Certification periods reviewed: 1/04/2022 through 3/04/2022 and 3/05/2022 through 5/03/2022. File did not contain any documentation of the following for the certification periods reviewed: a physician signed and reviewed Home Health Certification and Plan of Care for either certification period reviewed or for any of the certification periods after 5/3/2022 until discharge; a completed Home Health Certification and Plan of Care for the certification periods after 5/3/2022 until discharge; a reviewed and updated medication profile; care coordination documentation; completed skilled nursing (SN) recertification assessments on agency approved forms; sixty (60) day summaries for the certification periods reviewed or any of the certification periods after 5/3/2022 until discharge; and notification the physician was notified of discharge.

An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.






Plan of Correction:

CORRECT
1. The Administrator, RNCM or designee for CR#1, 2, 3 4, 5, 6 and 7 will send outstanding POC to physician for signature by 5/21/24 and document all attempts to obtain.
PROTECT
1. Administrator or designee will pull a report of any current unsigned POC starting 5/17/24 to ensure due diligence is completed.
2. Quality Assurance Specialist or designee will conduct a 100% audit of current patient episodes to ensure there is a completed POC and that it is either signed by the MD or the agency is following due diligence in obtaining MD signature to ensure safety.
PREVENT
1. Administrator or designee will update the Physician Orders policy to reflect appropriate due diligence expectations by 5/24/24.
2. Administrator or designee will train all RNCM on the Plan of Care and Clinical Documentation policies. Training will include expectations regarding timeliness of completing and documenting POC by 6/24/24. Education will be documented via attestation.
3. Administrator or designee will pull a report weekly starting 5/17/24 of upcoming episodes to ensure a POC is completed and sent to the MD for signature.
MONITOR/SUSTAIN
1. Quality Assurance Specialist or designee will audit 10% POCs quarterly starting 7/1/24 to ensure the POC was completed, documented, and sent to the Physician for signature timely.


601.36(c) REQUIREMENT
PROTECTION OF RECORDS

Name - Component - 00
601.36(c) Protection of Records.
Clinical record information is
safeguarded against loss or
unauthorized use. Written procedures
govern use and removal of records and
conditions for release of information.
Patient's written consent is required
for release of information not
authorized by law.

Observations:

Based on a review of agency policy, clinical records (CR), and an interview with the administrator, vice president, and the director of operations, the agency failed to safeguard the contents of the clinical record against loss or unauthorized use for one (1) of nine (9) CRs reviewed, (CR#1)

Findings include:

A review of agency policy titled "Clinical Documentation" conducted on April 24, 2024, at approximately 11:50 AM, states, "Policy: Agency will document each direct contact with the patient. This documentation will be completed by the skilled professional rendering care...Special Instructions: 1. All skilled services provided by Nursing, Therapy or Social Services will be documented in the clinical record. 2. A separate note will be completed for each visit/shift and signed with title and dated by the appropriate professional. Actual time of the patient visit will be documented in the note. 3. Additional information that is pertinent to the patient's care or condition may be documented in a clinical note. 4. Telephone or other communication with patients, physicians, families, or other members of the healthcare team will be documented in the clinical notes. 5. Documentation of services ordered on the plan of care will be completed the day service is rendered and is expected to be complete in the computer and synched within 48 hours after the care has been provided. Paperwork is expected to be in the office within 48 hours. Consideration will be given to the outlying treating clinicians to return paperwork to the "home" office no later than 5 working days. 6. Services not provided and the reason for missed visits will be documented and reported to the physician...8. If problems are encountered with the computer software the office must be contacted as soon as the issue arises..."

A review of agency policy titled "Clinical Record Confidentiality" conducted on April 24, 2024, at approximately 11:45 AM, states "Policy: All patient information shall be treated as confidential and will be available only to authorized users. Purpose: To assure that confidentiality of data and information is preserved. To assure security measures are in place to safeguard the integrity of information in clinical and billing records. Special instructions: 4. All individuals who collect, handle, or disseminate information will be informed of their responsibility to protect data..."

A review of agency policy titled "Clinical Records/Medical Records Retention" conducted on April 24, 2024, at approximately 11:55 AM, states "Purpose: To safeguard the integrity of information maintained in clinical and billing records. Patient records are kept in an electronic format that is in compliance with federal and state EMR requirements. Special instructions: Protection of Records: 1. Clinical record information shall be safeguarded against loss or unauthorized use. 3. Protected Health Information will be available only to those who must use it. Procedures will be followed to assure that this information is protected, and consents or authorizations are signed before information is released. In situations where consent is not required, only specifically required information will be released..."

CR#1, Start of Care: 12/30/2020. Certification period reviewed 4/13/2024 through 6/11/2024. Home Health Certification and Plan of Care contains orders that includes: "SN: Notify physician if patient has three (3) or more glucose levels over 200 in one day." And "SN: Assist patient to test blood sugar before breakfast and bedtime and prn signs/symptoms of hypoglycemia. If sugar is higher than 240 or when ill, test for ketones."
A review of SN documentation from 2/25/2024 through 4/20/2024, indicates blood sugars are documented in nursing progress notes only one time per day and there is no documentation of the time the test was performed. Fifty-four (54) notes indicate a blood sugar result greater than 200. One (1) note did not document any blood sugar result. Out of the fifty-four (54) blood sugar results over 200, thirty-seven (37) were documented over 240 and no documentation is provided if a test for ketones was completed. Dates and results of the blood sugar test over 200 are as follows:
February:
2/25/2024: Blood sugar result: 265
2/26/2024: Blood Sugar result: 240
2/27/2024: Blood Sugar result: 206
2/28/2024: Blood Sugar result: 212
2/29/2024: Blood Sugar result: 250
March:
3/1/2024: Blood Sugar result: 290
3/2/2024: Blood Sugar result: 238
3/3/2024: Blood Sugar result: 282
3/4/2024: Blood Sugar result: 290
3/5/2024: Blood Sugar result: 272
3/6/2024: Blood Sugar result: 240
3/7/2024: Blood Sugar result: 238
3/8/2024: Blood Sugar result: 224
3/9/2024: Blood Sugar result: 290
3/10/2024: Blood Sugar result: 294
3/11/2024: Blood Sugar result: 240
3/12/2024: Blood Sugar result: 210
3/14/2024: Blood Sugar result: 212
3/15/2024: Blood Sugar result: 242
3/16/2024: Blood Sugar result: 210
3/18/2024: Blood Sugar result: 224
3/19/2024: Blood Sugar result: 284
3/20/2024: Blood Sugar result: 290
3/21/2024: Blood Sugar result: 238
3/22/2024: Blood Sugar result: 286
3/23/2024: Blood Sugar result: 270
3/24/2024: Blood Sugar result: 250
3/25/2024: Blood Sugar result: 286
3/26/2024: Blood Sugar result: 248
3/27/2024: Blood Sugar result: 294
3/28/2024: Blood Sugar result: 288
3/29/2024: No documented result
3/30/2024: Blood Sugar result: 272. Note states: "Blood sugar elevated, no orders for sliding scale."
3/31/2024: Blood Sugar result: 202
April:
4/1/2024: Blood Sugar result: 212
4/2/2024: Blood Sugar result: 210
4/3/2024: Blood Sugar result: 244
4/4/2024: Blood Sugar result: 280
4/5/2024: Blood Sugar result: 294
4/6/2024: Blood Sugar result: 284
4/7/2024: Blood Sugar result: 230
4/8/2024: Blood Sugar result: 224
4/9/2024: Blood Sugar result: 240
4/10/2024: Blood Sugar result: 272
4/11/2024: Blood Sugar result: 288
4/12/2024: Blood Sugar result: 290
4/13/2024: Blood Sugar result: 280
4/14/2024: Blood Sugar result: 298
4/15/2024: Blood Sugar result: 288
4/16/2024: Blood Sugar result: 252
4/17/2024: Blood Sugar result: 224
4/18/2024: Blood Sugar result: 282
4/19/2024: Blood Sugar result: 290
4/20/2024: Blood Sugar result: 286
When surveyor asked SN (RN#2) on duty how often blood sugars are completed and if they are documented anywhere besides on the nursing note, RN#2 replied she completes two (2) blood sugar tests per day with meals and mom completes the bedtime sugar and that all results are kept on RN #2's cell phone. There is no documentation that if indicated, the physician was notified of the elevated blood sugars or if testing for ketones was completed with the results of ketone testing.
An interview with the administrator, vice president, and director of operations conducted on April 25, 2024, at approximately 12:00 PM confirmed the above findings.







Plan of Correction:

CORRECT
1. RN #2 relieved from duty 04/23/24 and is no longer employed by the agency as of 5/3/24.
PROTECT
1. Quality Assurance Specialist or designee will conduct a 100% audit of all current patients to ensure notes are entered for each visit/shift provided. Missing documentation will be sent to administrator to determine if late entry is needed. The audit will be conducted by 5/31/24.
PREVENT
1. Administrator or designee will train all RNCM, RNs, LPNs on the Plan of Care and Clinical Documentation policies by 6/24/24. Training will include expectations regarding acceptable storage of clinical records and timeliness of completing all documentation in record. Education will be documented via attestation.
2. Administrator or designee will re-orient all RNCM on the Clinical Record Confidentiality policies by 6/24/24 understanding documented via attestation.
3. Administrator or designee will re-orient all RNCM on the Clinical Record Retention policies by 6/24/24 understanding documented via attestation.
MONITOR/SUSTAIN
1. Quality Assurance Specialists or designees will conduct quarterly audits starting 7/1/24 including 10% of client records to review visits and associated nursing notes to ensure on-going compliance and documentation of visits.


Initial Comments:

Based on the findings of an onsite unannounced home health agency state re-licensure survey conducted April 22, 2024 through April 25, 2024, and May 6, 2024, Caregivers America SE, was found to be in compliance with the requirements of 28 Pa. Code, Health Facilities, Part IV, Chapter 51, Subpart A.




Plan of Correction:




Initial Comments:

Based on the findings of an onsite home health agency re-licensure survey completed April 22, 2024 through April 25, 2024 and May 6, 2024. Caregivers America SE, was found to be in compliance with the requirements of 35 P.S. 448.809 (b).





Plan of Correction: