QA Investigation Results

Pennsylvania Department of Health
CRITICARE HOME AND NURSING SERVICES
Health Inspection Results
CRITICARE HOME AND NURSING SERVICES
Health Inspection Results For:


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Initial Comments:Based on the findings of an unannounced on-site Medicare recertification survey conducted February 14, 2024, through February 16, 2024, and February 20, 2024, Criticare Home and Nursing Services 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.
Plan of Correction:




484.50(c)(5) ELEMENT
Receive all services in plan of care

Name - Component - 00
Receive all services outlined in the plan of care.

Observations: Based on the review of agency policies, clinical records (CR), and interviews with agency staff, the agency failed to ensure that staff documented that services were provided in accordance with the plan of care for four (4) of seven (7) CR reviewed. (CR # 2, 3, 4, and 7) Findings include: Review of agency Policy #C-2.0 "Acceptance of Patients, Plan of Care, and Medical Supervision" on February 20, 2024, at approximately 3:10 P.M. stated, "Procedure: 2. Plan of Care: Care follows a written plan of care established and periodically reviewed by a doctor of medicine or osteopathy (the physician)... B. The plan includes: ... iv. The types of services, supplies, and equipment required...xvii. Patient-specific interventions and education... 3. Conformance with Physician Orders: B. Plan of Care: must be sent to the physician for signature. i. It is the physician's responsibility to review, sign and return the plan of care to Criticare Home Health and Nursing Services within fourteen (14) days... Review of agency Policy #C-6.0 "Administration of Medications and Therapies" on February 20, 2024, at approximately 3:20 P.M. stated, "Procedure: 2. Medication Review/Patient Education and Documentation: C. The Medication Profile is utilized to fully document all components of medication oversight and care management including: ... iii. Patient's drug regimen... iv. Who will administer the medication..." Review of CR on February 14, 2024, from approximately 10:00 A.M. to 2:00 P.M. and February 16, 2024, from approximately 9:30 A.M. to 2:00 P.M. revealed the following: CR #2, start of care November 27, 2019. Certification period reviewed: January 8, 2024, through March 5, 2024. The POC contained orders as follows: SN (skilled nurse): 110 Hrs (hours)/wk (week) for 10 wks starting from 01/06/2024. Review of nursing flow sheets revealed that SN services were only provided on January 10, January 24, January 31, 2024, and February 7, 2024, from 11:00 P.M. to 7:00 A.M., January 17, 2024, from 11:00 P.M. to 1:00 A.M., and January 29, 2024, from 3:45 P.M. to 4:45 P.M. There was no documentation that the case was shared with another agency and no physician notifications that services were not provided in accordance with the POC. There were no verbal orders to amend the duration and/or frequency of services provided. Review of the medications ordered on the POC revealed four (4) medications to be given daily, three (3) medication to be given two (2) times per day, and eight (8) medications to be given PRN. There were no medications documented as given on any of the dates that services were provided. The electronic record contained no documentation of the times that the medications were scheduled to be given. CR #3, start of care July 26, 2023. Certification period reviewed: January 22, 2024, through March 21, 2024. The POC contained orders as follows: SN 91 Hrs (hours)/wk (week) for 10 wks starting from 1/22/2024 - Criticare nurse attends school with the patient and normally works a 10 AM to 5 PM workday Monday - Friday. Review of nursing flow sheets revealed that SN services were provided Monday through Friday from January 22, 2024, through February 12, 2024, from 10:00 A.M. to 11:00 A.M, and 2:15 P.M. to 5:00 P.M. on all days except January 30, 2024, and February 5, 2024, when services were provided 2:15 P.M. to 3:00 P.M., and February 7, 2024, when services were provided 2:15 P.M. to 3:15 P.M. There was no documentation that the physician was notified that services were not provided in accordance with the POC. There was no documentation of a verbal order to amend the times that services were provided. The patient has a G/J tube (tube inserted through the abdomen into the stomach and the small intestine for feedings and medications). There was no documentation of the date of the last tube change. The POC contained no documentation of the type or size of tube, the frequency of replacement of the tube, emergency procedures if the tube becomes dislodged or blocked. There were no orders for care of the G/J tube and/or any water flushes to be completed with medications and/or feedings. The patient has a central venous catheter (CVC) (a surgically placed intravenous line inserted into a large vein in the chest) for TPN (total parenteral nutrition, complete nutrition provided intravenously). The CVC is managed by an infusion company and the mother. The POC does not contain any orders for emergency procedures if there would be a problem with the CVC, frequency of dressing changes, frequency of changes of the CVC lines, or the solution to be used for KVO (keep vein open), which is ordered to run at 5 ml (milliliters) per hour. Review of the medications ordered on the POC revealed eight (8) medications to be given daily, five (5) medication to be given two (2) times per day, two (2) medications to be give three (3) times per day, and ten (10) medications to be given PRN. The electronic record contained no documentation of the times that the medications were scheduled to be given. CR #4, start of care October 23, 2023. Certification period reviewed: December 22, 2023, through February 19, 2024. The POC contained orders as follows: SN [Insurance company] has authorized 91 Hrs/wk for 10 wks starting 12/22/2023. Nurse accompanies [patient] to school but this service is covered by the [school district]. Nurse performs nursing care in the home after school, half days, sick days and days off from school - covered by insurance. The POC was not signed by the physician with the allotted timeframe. Review of nursing flow sheets revealed services were provided mainly after school from 3:45 P.M. to approximately 5:00 P.M. Monday through Friday. There were occasional days that services were provided for a full or half day, but never for 91 hours per week. There was no documentation that the physician was notified that services were not provided in accordance with the POC. The POC did not contain orders for G-tube care to be provided. Review of the medications ordered on the POC revealed two (2) medications to be given daily, three (3) medication to be given two (2) times per day, and six (6) medications to be given PRN. The electronic record contained no documentation of the times that the medications were to be given. No medications were documented as given on January 4, January 8, January 16, January 18, January 22, January 30, and February 9, 2024. CR #7, start of care September 19, 2023. Certification period reviewed: September 25 ,2023, through November 23, 2023. The POC contained orders as follows: SN: 1W10 starting from 09/25/2023. PRN Visits/Hours: 4 (chronic htn) (hypertension, high blood pressure). Review of nursing flow sheets revealed that services were not provided during the week of October 1, 2023, through October 7, 2023. There was no documentation that the physician was notified of the missed visit. There were no verbal orders to amend the duration and/or frequency of services provided. An interview with the Director of Nursing, HR Coordinator, VP of Operations, and the Chief Financial Officer on February 16, 2024, at approximately 3:00 P.M. confirmed the above findings.

Plan of Correction:

1. The Agency will conduct a mandatory in-service with all admitting and supervising clinicians related to the use of the EMR and how to create a "patient-specific care plan".
a. The Inservice/Education will focus on requirements of frequency and duration (hours of service) as per the orders obtained from the medical practitioner.
b. The Inservice/Education will provide information on proper documentation of shared cases and delineation of how services are shared and documented.
c. Inservice/Education will also provide information on the requirements for missed visit(s) reporting and recording to include medical practitioner notification and verbal orders.
d. Inservice/Educational records to be audited to assure compliance with training on this policy and the requirements for creation of the patient-specific care plan.
e. PERSON RESPONSIBLE: Administrator
Completion date: 3/25/24
2. The Director of Nursing (DON) and/or other qualified clinical staff will conduct a clinical record review on all current episode skilled patient orders (485), plans of care, treatment plans, and medication records to assure compliance with regulations for patient-specific plan of care, including the following items:
a. Frequency and duration are documented appropriately based on medical practitioner orders.
b. Explanation of shared services is documented in the record, including requirements of this agency related to the shared services (frequency of shifts, hours, services).
c. Documentation of missed visits, including notification and verbal orders is completed and located in the record.
d. Plan of care outlines all required nursing interventions and procedures, specific to the client and ordered by the medical practitioner.
e. Any record not in compliance with patient-specific treatment and goals will be updated and re-sent to the physician or allowed medical practitioner for review and signature.
f. PERSON RESPONSIBLE: Director of Nursing (DON)


3. The Agency will conduct an Inservice/Education on the required elements of documentation for client care, including all treatment orders and procedures that are client specific.
a. The agency will review all required elements of the assessment and service plan related to client service. This must include all client specific care requirements.
i. The Inservice/Education will utilize agency policy related to plan of care elements and documentation requirements (C-2.0).
b. Specific assessment, orders, procedures, and documentation instructions are to be provided for clinical care such as G-tube care and documentation.
c. Specific assessment, orders, procedures, and documentation instructions are to be provided for clinical care for I.V. management including Central Venous Catheters (CVC).
d. Inservice/Educational records to be audited to assure compliance with training on this policy and the requirements for creation of the patient-specific care plan.
e. PERSON RESPONSIBLE: Administrator

4. On-going compliance. The Director of Nursing (DON) or other qualified clinical staff will conduct a complete record review on each new or recertification admission assessment and plan of care to assure compliance with this regulatory requirement, including proper documentation for client care and related nursing actions and procedures.
a. The Director of Nursing (DON) or other qualified clinical staff will conference with the admitting staff to complete the required changes prior to sending them to the physician or allowed practitioner for review and signature.
b. PERSON RESPONSIBLE: Director of Nursing (DON)
Completion date: 4/10/24


484.55(c)(5) ELEMENT
A review of all current medications

Name - Component - 00
A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy.

Observations: Based on the review of agency policies, clinical records (CR), and interviews with agency staff, the agency failed to ensure that the medication profiles contained times of medication administration for three (3) of seven (7) CR reviewed. (CR # 2, 3, and 4) Findings include: Review of agency Policy #C-6.0 "Administration of Medications and Therapies" on February 20, 2024, at approximately 3:20 P.M. stated, "Procedure: 2. Medication Review/Patient Education and Documentation: C. The Medication Profile is utilized to fully document all components of medication oversight and care management including: ... iii. Patient's drug regimen... iv. Who will administer the medication..." Review of CR on February 14, 2024, from approximately 10:00 A.M. to 2:00 P.M. and February 16, 2024, from approximately 9:30 A.M. to 2:00 P.M. revealed the following: CR #2, start of care November 27, 2019. Certification period reviewed: January 8, 2024, through March 5, 2024. Review of the medications ordered on the POC revealed four (4) medications to be given daily, three (3) medication to be given two (2) times per day, and eight (8) medications to be given PRN. There were no medications documented as given on any of the dates that services were provided. The electronic record contained no documentation of the times that the medications were scheduled to be given. CR #3, start of care July 26, 2023. Certification period reviewed: January 22, 2024, through March 21, 2024. Review of the medications ordered on the POC revealed eight (8) medications to be given daily, five (5) medication to be given two (2) times per day, two (2) medications to be give three (3) times per day, and ten (10) medications to be given PRN. The electronic record contained no documentation of the times that the medications were scheduled to be given. CR #4, start of care October 23, 2023. Certification period reviewed: December 22, 2023, through February 19, 2024. Review of the medications ordered on the POC revealed two (2) medications to be given daily, three (3) medication to be given two (2) times per day, and six (6) medications to be given PRN. The electronic record contained no documentation of the times that the medications were to be given. No medications were documented as given on January 4, January 8, January 16, January 18, January 22, January 30, and February 9, 2024. An interview with the Director of Nursing, HR Coordinator, VP of Operations, and the Chief Financial Officer on February 16, 2024, at approximately 3:00 P.M. confirmed the above findings.

Plan of Correction:

1. An audit to be completed of the medication administration record in the electronic medical record of all patients for administration or lack of administration of patient medications.
a. Any patient identified as having medication ordered that was not administered by the licensed nurse to be addressed by the Director of Nursing (DON) or designee and documented in the personnel record for that assigned clinician.
b. The Director of Nursing (DON) or designee will be responsible for completing this action item.
c. This action item will be completed by 4/10/202.
2. Licensed nurses will be educated on the Policy titled "C-6.0 – Administration of Medications and Therapies" with emphasis on providing patient medications per the medical practitioner orders and documenting on the medication administration record.
a. This education will include the documentation of all required elements to medication administration, including documenting times to be given (and the "5 Rights of Medication Administration").
b. The Director of Nursing (DON) or designee will be responsible for providing this education.
c. A record of this Inservice/Education will be maintained by the agency.
d. Education will be completed by 4/17/2024.

3. The DON or designee will randomly audit (5) patients weekly for 4 weeks then monthly for 3 months via the Medication Administration audit portal in the EMR to ensure that patients are receiving their medications per the medical practitioner orders.
a. Any identified lack of administration will be addressed to the licensed nurse responsible for the administration.
b. Any action taken related to the missed medication administration will be documented in the personnel file.
c. This corrective action plan will occur over 4 months and will end on 8/1/2024.



484.60(a)(2)(i-xvi) ELEMENT
Plan of care must include the following

Name - Component - 00
The individualized plan of care must include the following:
(i) All pertinent diagnoses;
(ii) The patient's mental, psychosocial, and cognitive status;
(iii) The types of services, supplies, and equipment required;
(iv) The frequency and duration of visits to be made;
(v) Prognosis;
(vi) Rehabilitation potential;
(vii) Functional limitations;
(viii) Activities permitted;
(ix) Nutritional requirements;
(x) All medications and treatments;
(xi) Safety measures to protect against injury;
(xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors.
(xiii) Patient and caregiver education and training to facilitate timely discharge;
(xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient;
(xv) Information related to any advanced directives; and
(xvi) Any additional items the HHA or physician or allowed practitioner may choose to include.

Observations: Based on the review of agency policies, clinical records (CR), and interviews with agency staff, the agency failed to ensure that the plan of care contained orders for all care to be provided for two (2) of seven (7) CR reviewed. (CR # 3 and 4) Findings include: Review of agency Policy #C-2.0 "Acceptance of Patients, Plan of Care, and Medical Supervision" on February 20, 2024, at approximately 3:10 P.M. stated, "Procedure: 2. Plan of Care: Care follows a written plan of care established and periodically reviewed by a doctor of medicine or osteopathy (the physician)... B. The plan includes: ... iv. The types of services, supplies, and equipment required...xvii. Patient-specific interventions and education... 3. Conformance with Physician Orders: B. Plan of Care: must be sent to the physician for signature. i. It is the physician's responsibility to review, sign and return the plan of care to Criticare Home Health and Nursing Services within fourteen (14) days... Review of CR on February 14, 2024, from approximately 10:00 A.M. to 2:00 P.M. and February 16, 2024, from approximately 9:30 A.M. to 2:00 P.M. revealed the following: CR #3, start of care July 26, 2023. Certification period reviewed: January 22, 2024, through March 21, 2024. The patient has a G/J tube (tube inserted through the abdomen into the stomach and the small intestine for feedings and medications). The POC contained no documentation of the type or size of tube, the frequency of replacement of the tube, emergency procedures if the tube becomes dislodged or blocked. There were no orders for care of the G/J tube and/or any water flushes to be completed with medications and/or feedings. The patient has a central venous catheter (CVC) (a surgically placed intravenous line inserted into a large vein in the chest) for TPN (total parenteral nutrition, complete nutrition provided intravenously). The CVC is managed by an infusion company and the mother. The POC does not contain any orders for emergency procedures if there would be a problem with the CVC, frequency of dressing changes, frequency of changes of the CVC lines, or the solution to be used for KVO (keep vein open), which is ordered to run at 5 ml (milliliters) per hour. CR #4, start of care October 23, 2023. Certification period reviewed: December 22, 2023, through February 19, 2024. The patient has a G-tube. The POC did not contain orders for G-tube care to be provided. An interview with the Director of Nursing, HR Coordinator, VP of Operations, and the Chief Financial Officer on February 16, 2024, at approximately 3:00 P.M. confirmed the above findings.

Plan of Correction:

1. The Agency will conduct a mandatory Inservice/Education with all admitting and supervising clinicians related to the use of the EMR and how to create a patient-specific care plan to include all nursing actions and procedures.
a. The agency will utilize Policy "C-2.0 Acceptance of Patients, Plan of Care, and Medical Supervision" as the basis for the information provided in the Inservice/Education.
b. The Director of Nursing (DON) is responsible for the completion of this corrective action.
c. Inservice/Educational records to be maintained for training on this policy and the requirements for creation of the patient-specific care plan.

2. The Director of Nursing (DON) and other qualified clinical staff will conduct a clinical record review on all current episode skilled patient orders and plans of care to assure compliance with regulations for patient-specific plan of care.
a. Any record not in compliance with patient-specific treatment and goals will be updated and re-sent to the physician or allowed medical practitioner for review and signature.

3. The Director of Nursing (DON) or other qualified clinical staff will conduct a complete record review on each new or recertification admission assessment and plan of care to assure compliance with this regulatory requirement.
a. The agency will utilize an audit tool designed to address the requirements of this action plan. This will be maintained in the record.
b. The Director of Nursing (DON) or other qualified clinical staff will conference with the admitting staff to complete the required changes prior to sending to the physician or allowed practitioner for review and signature.



484.70(a) STANDARD
Infection Prevention

Name - Component - 00
Standard: Infection Prevention.
The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases.

Observations: Based upon review of agency policy, accepted nursing practice, observation of agency staff during home visits, and interview with agency staff, employees failed to follow basic infection control practices for one (1) of three (3) observations (OBS). (OBS # 2). Findings include: Review of agency Policy #IC-8.0 "Clinical Bag Technique" on February 20, 2024, at approximately 3:30 P.M. stated, "Procedure: 5. Remove needed items from bag and place on a clean barrier. Clean each reusable item prior to use on the next patient. 6. Decontaminate hands prior to re-entering bag for any reason. 7. Following care: clean, reusable items (for example, blood pressure cuff, etc.) are returned to the bag..." Review of agency policy #IC-2.0 "Standard Precautions" on February 20, 2024, at approximately 3:40 P.M. stated, "Procedure: 2. B. Hands and other skin surfaces should always be washed immediately before and after patient contact, after any contact with bodily fluids and after removing gloves..." Observations of patient care during a home visits conducted on February 14, 2024, from approximately 2:35 P.M. to 3:15 P.M., and February 15, 2024, from approximately 11:00 A.M. to 2:00 P.M. revealed the following: OBS #2 on February 15, 2024, at approximately 11:10 A.M., Employee (EMP) #6, a licensed practical nurse (LPN) was observed providing care to patient #2. The LPN was venting (releasing air from) the G-tube (tube inserted through the abdomen into the stomach). The LPN was not wearing gloves for the procedure. The LPN disconnected the syringe used to vent the G-tube and repositioned patient #2 in the bed. The LPN walked to the other side of the bed and connected the G-tube feeding tube to the G-tube extension tubing. The LPN did not perform hand hygiene or don gloves during these procedures. The registered nurse (RN) set up the nursing bag on a barrier and performed hand washing but did not don gloves. The RN removed the pulse oximeter (measures oxygen in the blood) and measured patient #2's oxygen saturation, then placed the pulse oximeter back into the bag. The RN also used the blood pressure monitor and stethoscope, placing each back into the bag after use. The RN did not decontaminate the equipment after use. The RN did not perform hand hygiene prior to re-entering the bag. An interview with the Director of Nursing, HR Coordinator, VP of Operations, and the Chief Financial Officer on February 16, 2024, at approximately 3:00 P.M. confirmed the above findings.

Plan of Correction:

1. DON will conduct a mandatory infection control prevention and management in-service with all nursing personnel.
a. All nursing staff will be instructed on infection control policies and procedures paying particular attention to handwashing/hand hygiene.
a. Clinical scenarios will be given with appropriate rationales.
b. The importance of integrating glove use along with routine hand hygiene being recognized as the best practice for preventing healthcare-associated infections will be reviewed.
c. Copies of infection control information including clean and sterile dressing procedures and handwashing/hand hygiene will be given to all licensed nursing personnel during the in-service.

2. DON or qualified professional staff will monitor nursing staff personnel, using scheduled and unannounced supervisory visits for compliance with proper handwashing/hand hygiene.
a. This targeted monitoring will be in effect until all field nursing personnel have been supervised on hand washing protocols.
b. Where this monitoring cannot be completed in the field, the monitoring will be conducted in the office location.
c. This targeted monitoring will be completed on all staff by April 19, 2024.
d. Documentation using a field supervision note will be placed in the employee file to demonstrate compliance.

3. The DON will document the monitoring results and report those findings monthly during the facility's Quality Assurance and Performance Improvement (QAPI) meeting.
a. The QAPI Committee will assess and modify the action plan as needed to ensure continued compliance.
b. Any employee not following agency policy relating to infection control prevention and management and handwashing/hand hygiene will have disciplinary actions taken on an individual basis.



Initial Comments:Based on the findings of an unannounced on-site Medicare recertification survey conducted February 14, 2024, through February 16, 2024, and February 20, 2024, Criticare Home and Nursing Serices was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.
Plan of Correction:




Initial Comments:Based on the findings of an unannounced on-site state re-licensure survey conducted February 14, 2024, through February 16, 2024, and February 20, 2024, Criticare Home and Nursing Services 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:




601.31(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 the review of agency policies, clinical records (CR), and interviews with agency staff, the agency failed to ensure that staff followed the plan of care for five (5) of seven (7) CR reviewed. (CR # 2, 3, 4, 5, and 7) Findings include: Review of agency Policy #C-2.0 "Acceptance of Patients, Plan of Care, and Medical Supervision" on February 20, 2024, at approximately 3:10 P.M. stated, "Procedure: 2. Plan of Care: Care follows a written plan of care established and periodically reviewed by a doctor of medicine or osteopathy (the physician)... B. The plan includes: ... iv. The types of services, supplies, and equipment required...xvii. Patient-specific interventions and education... 3. Conformance with Physician Orders: B. Plan of Care: must be sent to the physician for signature. i. It is the physician's responsibility to review, sign and return the plan of care to Criticare Home Health and Nursing Services within fourteen (14) days..." Review of agency Policy #C-6.0 "Administration of Medications and Therapies" on February 20, 2024, at approximately 3:20 P.M. stated, "Procedure: 2. Medication Review/Patient Education and Documentation: C. The Medication Profile is utilized to fully document all components of medication oversight and care management including: ... iii. Patient's drug regimen... iv. Who will administer the medication..." Review of agency Policy #C-19.0 "Therapy Assessment/Reassessment of Patients" on February 20, 2024, at approximately 3:00 P.M. stated, "Procedure: 2. Reassessment at least every 30 days (performed in conjunction with an ordered therapy service). A. At least once every thirty (30) days, for each therapy discipline for which services are provided, a qualified therapist (instead of an assistant) must provide the ordered therapy service, functionally reassess the patient, and compare the resultant measurement to prior assessment measurements..." Review of CR on February 14, 2024, from approximately 10:00 A.M. to 2:00 P.M. and February 16, 2024, from approximately 9:30 A.M. to 2:00 P.M. revealed the following: CR #2, start of care November 27, 2019. Certification period reviewed: January 8, 2024, through March 5, 2024. The POC contained orders as follows: SN (skilled nurse): 110 Hrs (hours)/wk (week) for 10 wks starting from 01/06/2024. Review of nursing flow sheets revealed that SN services were only provided on January 10, January 24, January 31, 2024, and February 7, 2024, from 11:00 P.M. to 7:00 A.M., January 17, 2024, from 11:00 P.M. to 1:00 A.M., and January 29, 2024, from 3:45 P.M. to 4:45 P.M. There was no documentation that the case was shared with another agency and no physician notifications that services were not provided in accordance with the POC. There were no verbal orders to amend the duration and/or frequency of services provided. Review of the medications ordered on the POC revealed four (4) medications to be given daily, three (3) medication to be given two (2) times per day, and eight (8) medications to be given PRN. There were no medications documented as given on any of the dates that services were provided. The electronic record contained no documentation of the times that the medications were scheduled to be given. CR #3, start of care July 26, 2023. Certification period reviewed: January 22, 2024, through March 21, 2024. The POC contained orders as follows: SN 91 Hrs (hours)/wk (week) for 10 wks starting from 1/22/2024 - Criticare nurse attends school with the patient and normally works a 10 AM to 5 PM workday Monday - Friday. Review of nursing flow sheets revealed that SN services were provided Monday through Friday from January 22, 2024, through February 12, 2024, from 10:00 A.M. to 11:00 A.M, and 2:15 P.M. to 5:00 P.M. on all days except January 30, 2024, and February 5, 2024, when services were provided 2:15 P.M. to 3:00 P.M., and February 7, 2024, when services were provided 2:15 P.M. to 3:15 P.M. There was no documentation that the physician was notified that services were not provided in accordance with the POC. There was no documentation of a verbal order to amend the times that services were provided. The patient has a G/J tube (tube inserted through the abdomen into the stomach and the small intestine for feedings and medications). There was no documentation of the date of the last tube change. The POC contained no documentation of the type or size of tube, the frequency of replacement of the tube, emergency procedures if the tube becomes dislodged or blocked. There were no orders for care of the G/J tube and/or any water flushes to be completed with medications and/or feedings. The patient has a central venous catheter (CVC) (a surgically placed intravenous line inserted into a large vein in the chest) for TPN (total parenteral nutrition, complete nutrition provided intravenously). The CVC is managed by an infusion company and the mother. The POC does not contain any orders for emergency procedures if there would be a problem with the CVC, frequency of dressing changes, frequency of changes of the CVC lines, or the solution to be used for KVO (keep vein open), which is ordered to run at 5 ml (milliliters) per hour. Review of the medications ordered on the POC revealed eight (8) medications to be given daily, five (5) medication to be given two (2) times per day, two (2) medications to be give three (3) times per day, and ten (10) medications to be given PRN. The electronic record contained no documentation of the times that the medications were scheduled to be given. CR #4, start of care October 23, 2023. Certification period reviewed: December 22, 2023, through February 19, 2024. The POC contained orders as follows: SN [Insurance company] has authorized 91 Hrs/wk for 10 wks starting 12/22/2023. Nurse accompanies [patient] to school but this service is covered by the [school district]. Nurse performs nursing care in the home after school, half days, sick days and days off from school - covered by insurance. The POC was not signed by the physician with the allotted timeframe. Review of nursing flow sheets revealed services were provided mainly after school from 3:45 P.M. to approximately 5:00 P.M. Monday through Friday. There were occasional days that services were provided for a full or half day, but never for 91 hours per week. There was no documentation that the physician was notified that services were not provided in accordance with the POC. The POC did not contain orders for G-tube care to be provided. Review of the medications ordered on the POC revealed two (2) medications to be given daily, three (3) medication to be given two (2) times per day, and six (6) medications to be given PRN. The electronic record contained no documentation of the times that the medications were to be given. No medications were documented as given on January 4, January 8, January 16, January 18, January 22, January 30, and February 9, 2024. CR #5, start of care August 31, 2023. Certification period reviewed: December 29, 2023, through February 26, 2024. The POC contained orders as follows: SN: 1 visit for Every 60 days - Starting from 12/29/2023, PT (physical therapy) 2W10 (2 times per week for ten weeks) starting from 12/29/2023, PT twice a week. Review of PT visit notes revealed that only one (1) visit was conducted the week of January 14, 2024, through January 20, 2024. There was no documentation that the physician was notified of the missed visit. There was no documentation of a reassessment visit conducted every 30 days, per agency policy. CR #7, start of care September 19, 2023. Certification period reviewed: September 25 ,2023, through November 23, 2023. The POC contained orders as follows: SN: 1W10 starting from 09/25/2023. PRN Visits/Hours: 4 (chronic htn) (hypertension, high blood pressure). Review of nursing flow sheets revealed that services were not provided during the week of October 1, 2023, through October 7, 2023. There was no documentation that the physician was notified of the missed visit. There were no verbal orders to amend the duration and/or frequency of services provided. An interview with the Director of Nursing, HR Coordinator, VP of Operations, and the Chief Financial Officer on February 16, 2024, at approximately 3:00 P.M. confirmed the above findings.

Plan of Correction:

1. The Director of Nursing will hold a staff meeting with the professional staff on their responsibility to develop an appropriate Home Health Care Plan and will specifically address the ordering of and the expected frequency of tasks to be performed.
a. The DON will address the process to follow in the event of open shifts or missed visits.
b. The DON will also address the responsibility of the RN to perform all skills called for in the Care Plan.
c. Development of the Care Plan and clinical responsibility is included in the orientation plan/checklist.
d. The DON will address Medication Administration principles, including the "5 Rights of Medication Administration" to reinforce education provided in this CAP.

2. The DON will arrange for a review by clinical staff of all current clinical records to ensure that the care plan is appropriate, that the RNs are conducting the required clinical procedures required and that they following the written instructions provided.
a. The DON or designee will review 100% of all records until 95% compliance is attained, then 10% or at least 5 applicable records will be reviewed twice a month until 90% is achieved and then quarterly to maintain compliance within 90%.
b. Staff retraining and increased record reviews will occur as needed to restore compliance if the compliance falls below the compliance expectation.
c. Staff retraining and/or disciplinary actions will be taken by DON where needed. The Director of Nursing is ultimately responsible for the plan of corrections.
3. The DON or designee will review 100% of all records until 95% compliance is attained, then 10% or at least 5 applicable records will be reviewed twice a month until 90% is achieved and then quarterly to maintain compliance within 90%.
a. Staff retraining and increased record reviews will occur as needed to restore compliance if the compliance falls below the compliance expectation.
b. Staff retraining and/or disciplinary actions will be taken by DON where needed.
c. The Director of Nursing is ultimately responsible for the plan of correction.



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 upon review of agency policy, accepted nursing practice, observation of agency staff during home visits, and interview with agency staff, employees failed to follow basic infection control practices for one (1) of three (3) observations (OBS). (OBS # 2). Findings include: Review of agency Policy #IC-8.0 "Clinical Bag Technique" on February 20, 2024, at approximately 3:30 P.M. stated, "Procedure: 5. Remove needed items from bag and place on a clean barrier. Clean each reusable item prior to use on the next patient. 6. Decontaminate hands prior to re-entering bag for any reason. 7. Following care: clean, reusable items (for example, blood pressure cuff, etc.) are returned to the bag..." Review of agency policy #IC-2.0 "Standard Precautions" on February 20, 2024, at approximately 3:40 P.M. stated, "Procedure: 2. B. Hands and other skin surfaces should always be washed immediately before and after patient contact, after any contact with bodily fluids and after removing gloves..." Observations of patient care during a home visits conducted on February 14, 2024, from approximately 2:35 P.M. to 3:15 P.M., and February 15, 2024, from approximately 11:00 A.M. to 2:00 P.M. revealed the following: OBS #2 on February 15, 2024, at approximately 11:10 A.M., Employee (EMP) #6, a licensed practical nurse (LPN) was observed providing care to patient #2. The LPN was venting (releasing air from) the G-tube (tube inserted through the abdomen into the stomach). The LPN was not wearing gloves for the procedure. The LPN disconnected the syringe used to vent the G-tube and repositioned patient #2 in the bed. The LPN walked to the other side of the bed and connected the G-tube feeding tube to the G-tube extension tubing. The LPN did not perform hand hygiene or don gloves during these procedures. The registered nurse (RN) set up the nursing bag on a barrier and performed hand washing but did not don gloves. The RN removed the pulse oximeter (measures oxygen in the blood) and measured patient #2's oxygen saturation, then placed the pulse oximeter back into the bag. The RN also used the blood pressure monitor and stethoscope, placing each back into the bag after use. The RN did not decontaminate the equipment after use. The RN did not perform hand hygiene prior to re-entering the bag. An interview with the Director of Nursing, HR Coordinator, VP of Operations, and the Chief Financial Officer on February 16, 2024, at approximately 3:00 P.M. confirmed the above findings.

Plan of Correction:

1. DON will conduct a mandatory infection control prevention and management in-service with all nursing personnel. All nursing staff will be instructed on infection control policies and procedures paying particular attention to handwashing/hand hygiene.
a. All nursing staff will be instructed on proper bag technique and disinfection of dirty equipment.
b. Clinical scenarios will be given with appropriate rationales.
c. The importance of integrating glove use along with routine hand hygiene being recognized as the best practice for preventing healthcare-associated infections will be reviewed.
d. Copies of infection control information including clean and sterile dressing procedures and handwashing/hand hygiene will be given to all licensed nursing personnel during the in-service.

2. DON or qualified professional staff will monitor nursing staff personnel, using scheduled and unannounced supervisory visits for compliance with proper handwashing/hand hygiene.
a. This targeted monitoring will be in effect until all field nursing personnel have been supervised on hand washing protocols.
b. Where this monitoring cannot be completed in the field, the monitoring will be conducted in the office location.
c. This targeted monitoring will be completed on all staff by April 19, 2024.
d. Documentation using a field supervision note will be placed in the employee file to demonstrate compliance.
e. Any employee not following agency policy relating to infection control prevention and management and handwashing/hand hygiene will have disciplinary actions taken on an individual basis.


Initial Comments:Based on the findings of an unannounced on-site state re-licensure survey conducted February 14, 2024, through February 16, 2024, and February 20, 2024, Criticare Home and Nursing Services 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 unannounced on-site state re-licensure survey conducted February 14, 2024, through February 16, 2024, and February 20, 2024, Criticare Home and Nursing Services was found to be in compliance with the requirements of 35 P.S. &;sect; 448.809 (b).
Plan of Correction: