Initial Comments:
Based on the findings of an onsite unannounced home health agency state re-licensure survey conducted onsite on December 5, 2023 and December 6, 2023 and offsite on December 16, 2023, TBM Health Services, LLC., 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:
601.21(c) REQUIREMENT
GOVERNING BODY
Name - Component - 00
601.21(c) Governing Body. A governing
body (or designated persons so
functioning) assumes full legal
authority and responsibility for the
operation of the agency. The
governing body appoints: (i) a
qualified administrator, (ii) arranges
for professional service, (iii) adopts
and periodically reviews written
bylaws or an acceptable equivalent,
and (iv) oversees the management and
fiscal affairs of the agency. The
name and address of each officer,
director, and owner are disclosed to
the State agency with changes reported
promptly.
Observations:
Based on a review of agency policies, Governing Board meeting documents, and an interview with the administrator, the agency failed to document that the governing board approved the annual budget, annual review of policies and procedures, and annual program evaluation.
Findings include:
A review of agency policy titled " Governing Body " was conducted on December 16, 2023, at approximately 1:00 pm. Policy states, " Policy: It is the policy of the Agency that the Governing Body (GB) assumes full legal and operational authority, responsibility and accountability for the performance of its organization ...Responsibilities of the GB include: c. Holding management accountable for fiscal solvency of the organization and adequacy of financial resources, including approval of budgets and capital expenditures ...m. Developing and approving a strategic plan. N. Appointing an Advisory Committee to develop policies and procedures consistent with the organization ' s mission, philosophy, and purpose; annually review/revise policies; prepare an annual evaluation in relation to its philosophy, mission, and purpose; and assist in identifying goals/measuring accomplishment of the organization ' s operations. "
A review of agency policy titled "Policy and Procedure Development Process" was conducted on December 16, 2023, at approximately 1:45 pm. Policy states, "Procedure: The Governing Body will review and approve any new or revised policies or procedures presented by administrative staff..."
A review of the Governing Body meeting minutes was conducted on December 6, 2023, at approximately 10:45 am. The Governing Body minutes dated 12/28/2022 did not contain any documentation of approval for the annual budget, annual review of policies and procedures, or the annual program evaluation. The agency did provide an operating budget for the period January 1, 2023 to December 2023 and did provide the annual program evaluation for 2022 that was approved by the Professional Advisory Committee (PAC).
An interview with the administrator was conducted on December 6, 2023, starting at 1:00 pm confirmed the above findings.
Plan of Correction:Going forward in accordance with TBM Health Services policy on Governing Body meetings as well as in compliance with PA Dept of Health rules and regulations; the agency will ensure that approval of the annual budget is documented. The agency will also ensure that it is clearly documented that the annual review of policies and procedures and annual program evaluation has been completed. These changes will take place effective immediately.
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 review of agency policy, personnel files (PF), Centers for Disease Control Tuberculosis Testing Guidelines, and an interview with administrator, the agency failed to provide documentation of signed job descriptions for seven (7) of seven (6) PF's reviewed, (PF #1, 2, 3, 4, 5, 6, and 7); failed to provide Federal Bureau of Investigation (FB) fingerprint clearance for one (1) of seven (7) PF ' s reviewed, (PF #4); failed to provide documentation of an initial competency evaluation for five (5) of seven (7) PF's reviewed, (PF #1, 2, 3, 4, and 5); failed to provide orientation documentation for seven (7) of seven (7) PF's reviewed, (PF #1, 2, 3, 4, 5, 6, and 7); failed to provide Hepatitis B vaccination/declination documentation for two (2) of seven (7) PF's reviewed, (PF #4 and 6); and failed to provide documentation of tuberculosis symptom screening and risk assessment at hire for four (4) of seven (7) PF's reviewed, (PF# 1, 2, 3, and 4)
Findings Include:
A review of agency policy titled "Hiring and Personnel Files" was conducted on December 16, 2023, at approximately 2:30 pm states, "Maintaining personnel files: Designated agency staff will maintain accurate, complete, and current individual personnel files for all agency staff, direct hire and contracted, at our office location ...Pre-Hire: Criminal Background Check from PA State Police and if applicable, FBI Cogent fingerprint check (if PA resident less than 2 years) and Childline Verification Check (if agency serves persons under the age of 18 years old) ...On Hire: Orientation instruction page ...Health Information: TB (tuberculosis) testing on hire ...TB questionnaires, Hepatitis B: acceptance or declination ..."
A review of agency policy titled, " Job Descriptions" was conducted on December 15, 2023, at approximately 2:15 pm states, "Procedure: 2. Job descriptions are distributed during the orientation process. Reviewed with each new hire to assure understanding of the expected tasks and accountability of the role. Also reviewed when a change of position occurs. Employee signature/initials on the job description affirming said understanding of tasks..."
A review of agency policy titled, "Orientation" was conducted on December 15, 2023, at approximately 2:15 pm. Policy states, "Policy: All personnel, including direct care contract agency personnel, are required to attend an orientation program upon employment ...Procedure: 4. An orientation checklist will be completed for each new personnel. New personnel will sign and date when orientation has been completed and the checklist will be placed in their personnel file..."
A review of agency policy titled, "Competency Skills Testing Clinical Staff " was conducted on December 15, 2023, at approximately 1:50 pm. Policy states, "Policy: It is the policy of TBM Health Services LLC to provide skills competency evaluations at the time of hire and annually thereafter ...Skills competency checklist will be utilized to evaluate employee competency..."
A review of agency policy titled, " Performance Evaluations: was conducted on December 15, 2023, at approximately 2:40 pm. Policy states, " Policy: Our Agency conducts formal, written employee performance evaluations on 90 days and annually thereafter on the anniversary of the date of hire ...Procedure: Maintained in the personnel file upon completion ... "
In May 2019, the CDC updated its recommendations for TB testing of health care personnel. The CDC guidelines state that all Health Care Workers (HCW) should: 1: receive baseline tuberculosis screening upon hire by using: a two-step tuberculin skin test (TST), a single blood assay for tuberculosis (TB), or a negative chest x-ray to test for infection with tuberculosis. 2. Completion of a tuberculosis symptom questionnaire. And 3. Completion of a tuberculosis risk assessment. After baseline testing for infection with tuberculosis, HCWs should receive TB education annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(5-16-19)
A review of PF's conducted on December 6, 2023, from approximately 10:00 am to 10:45 am and offsite on December 8, 2023, revealed the following:
PF #1, Date of Hire: 11/13/2023, did not contain any documentation of: a signed job description for alternate director of nursing; orientation documentation; initial competency; and tuberculosis symptom screening or risk assessment at hire.
PF#2, Date of Hire: 10/7/2023, did not contain any documentation of: a signed job description for director of nursing; orientation documentation; initial competency evaluation; and a tuberculosis symptom screening or risk assessment at hire.
PF #3, Date of Hire: 6/6/2022, did not contain any documentation of: a signed job description; orientation documentation; initial competency; annual competency for 2023; performance evaluation for 2022; a tuberculosis symptom screening or risk assessment at hire; and annual tuberculosis education for 2023.
PF #4, Date of Hire: 9/20/2022, did not contain any documentation of: a signed job description for either director of human resources and administrator; FBI fingerprint clearance (lives in Delaware); and orientation documentation.
PF#5, Date of Hire: 1/31/2022, did not contain any documentation of: a signed job description for alternate administrator; orientation documentation; and performance evaluation for 2023.
PF#6, Date of Hire: 11/22/2023, did not contain any documentation of: a signed job description; orientation documentation; and Hepatitis B vaccination documentation/declination.
PF #7, Date of Hire: 11/20/2023, did not contain any documentation of: a signed job description and orientation documentation.
An interview with the administrator on December 6, 2023, at approximately 1:00 pm confirmed the above findings.
Plan of Correction:
Objective:
The objective of this plan is to systematically identify and rectify missing documents in employee files to ensure compliance with regulatory requirements, enhance record-keeping accuracy, and maintain a comprehensive and organized personnel documentation system.
I. Document Assessment: In partnership with TBM's compliance team and the Home Health Administrative Team, we will:
a)Conduct a comprehensive review of each employee file to identify missing documents.
b)Create a checklist of required documents for each employee based on organizational and regulatory standards.
c)Categorize missing documents into essential and supplementary categories.
II. Communication:
a)Notify all department heads and managers about the document review process.
b)Communicate the importance of complete and accurate employee files in ensuring regulatory compliance and effective human resource management.
c)Request cooperation and assistance in collecting and submitting missing documents.
III. Employee Outreach:
a)Communicate directly with employees to request any missing documents.
b)Provide a clear and concise list of required documents.
c)Set a deadline for the submission of missing documents.
d)Offer assistance and support to employees who may need guidance in obtaining the necessary documents.
IV. Document Collection:
a)Designate a central collection point for employees to submit missing documents.
b)Implement a secure and organized system for document submission to prevent loss or mishandling.
c)Monitor the progress of document collection and follow up with employees as needed.
V. Document Verification:
a)Assign a designated personnel or team to verify the completeness and accuracy of submitted documents.
b)Cross-reference collected documents with the checklist to ensure nothing is overlooked.
c)Address any discrepancies or missing information promptly.
VI. Record Keeping Enhancement:
a)Implement measures to enhance ongoing record-keeping practices, such as bi-weekly status meetings.
b)Train relevant personnel on proper document filing and maintenance procedures.
c)Regularly audit employee files to proactively identify and address any future missing document issues.
VII. Compliance Monitoring:
a.Establish a system for ongoing monitoring of compliance with document retention policies and regulatory requirements.
b.Conduct regular audits to ensure that all employee files remain complete and up-to-date.
c.Implement corrective actions promptly if any issues are identified during audits.
IX. Reporting:
a.Generate regular reports on the status of document collection and verification.
b.Communicate progress and completion of the plan to relevant stakeholders.
X. Documentation of Corrections:
a. Maintain a record of corrective actions taken to address missing documents.
b. Document the steps taken, individuals involved, and outcomes achieved.
By implementing this plan, we aim to strengthen our documentation processes, enhance compliance, and foster a more robust employee file management system. This plan will be regularly reviewed and updated to adapt to changing needs and regulatory requirements.
601.22(d) REQUIREMENT
CLINICAL RECORD REVIEW
Name - Component - 00
601.22(d) Clinical Record Review. At
least quarterly, appropriate health
professionals, representing at least
the scope of the program, review a
sample of both active and closed
clinical records to assure that
established policies are followed in
providing services (direct as well as
services under arrangement). There is
a continuing review of clinical
records for each 60-day period that a
patient receives home health services
to determine adequacy of the plan of
treatment and appropriateness of
continuation of care.
Observations:
Based on a review of facility documentation, review of policy and procedure, and interview with administrator, the facility failed to ensure at least quarterly, appropriate health professionals, representing at least the scope of the program, review a sample of both active and closed clinical records to determine whether established policies are followed in furnishing services directly or under arrangement.
Findings include:
Review of policy titled, "Care/Services Routinely Assessed/CRR" on December 16, 2023, at approximately 1:45 pm states, "Policy: The adequacy, appropriateness, effectiveness, and outcomes of care/services provided to Agency patients are assessed ongoing through clinical record reviews ...Clinical Outcome Committee Responsibilities: 1. Clinical Record Review (CRR) Quarterly through the QA (Quality Assessment) Clinical Outcomes Committee. Reviews are based on specific criteria and include, but not limited to: Services rendered, Following established agency policies, Plan of Care, Need for continued services . . ."
Review of " Clinical Record Review " documentation on December 5, 2023, at approximately 11:50 am revealed there was no documentation of any quarterly record reviews for the second or third quarter of 2023.
Agency documentation revealed first patient was admitted on 4/27/2023.
Interview with administrator on December 6, 2023, at approximately 1:00 pm confirmed the above finding.
Plan of Correction:Objective:
The objective of this plan is to systematically identify and rectify missing clinical record reviews to ensure the completeness and accuracy of patient records, compliance with regulatory standards, and the provision of high-quality patient care.
II. Communication:
a.Notify relevant healthcare providers, department heads, and clinical staff about the clinical record review assessment process.
b.Emphasize the importance of comprehensive clinical record reviews in maintaining patient safety, quality care, and regulatory compliance.
c.Request cooperation and support in conducting and documenting timely reviews.
II. Training and Education:
a.Provide training sessions for relevant staff on the importance of clinical record reviews.
b.Offer guidance on the proper procedures and documentation requirements for each type of clinical review.
c.Ensure that staff members are aware of the regulatory standards governing clinical record reviews.
III. Corrective Actions:
a.Implement corrective actions to address specific issues identified in missing clinical record reviews.
b.Assign responsibilities for each corrective action and establish timelines for completion.
c.
IV. Compliance Audits:
a.Conduct periodic audits to assess overall compliance with clinical record review requirements.
b.Utilize audit findings to identify trends, areas for improvement, and opportunities to enhance the review process.
c.Implement corrective actions based on audit results.
V. Reporting:
a.Generate regular reports on the status of clinical record reviews, including completed reviews and any outstanding issues.
b.Communicate progress and completion of the plan to relevant stakeholders.
This plan is designed to address and rectify missing clinical record reviews, with a focus on continuous improvement and sustained compliance with regulatory standards. Regular reviews and updates will be conducted to ensure the ongoing effectiveness of the plan.
Prior to the state audit, the agency did learn that the reviews were not being conducted by the responsible individual at that time. That individual has since been replaced. The team in place now will ensure that the action plan above is implemented.
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 review of clinical records (CR), review of agency policy, and an interview with the administrator, the agency failed to follow its policy regarding items to be included in the plan of care for five (5) of seven (7) CR reviewed, (CR #3, 4, 5, 6, and 7); and failed to follow its policy for medication review for five (5) of seven (7) CR's reviewed, (CR #2, 3, 4, 5, and 7).
Findings include:
Review of agency policy was conducted on December 16, 2023, at approximately 2:00 pm, titled " Acceptance of Patient " . Policy states, " Policy: Each patient is accepted for treatment on the basis of a reasonable expectation that the patient ' s medical, nursing, and social needs in conjunction with family and/or other community services can be met by the Agency in the patient ' s place of residence. The care provided by the Agency follows a written plan of care established and periodically reviewed by a physician and care continued under the supervision of a physician until goals are met when appropriate and anticipated discharge from the agency occurs ...Plan of Care (POC): 3. POC approved by the physician ...The POC (developed in consultation with Agency staff) covers ...types of services and equipment required, frequency of visits ... "
Review of agency policy titled "Medication Management" was conducted on December 15, 2023 at approximately 12:10 pm. Policy states, "8. Assessment of Medications: Comprehensive assessment of patient/consumer medications includes a review of all current medications...b. Documentation supports a review of all medications by the qualified clinician, pharmacist or physician to identify potential contraindications, drug reactions, significant adverse reactions, interations and/or duplicate drug therapy, effectiveness of pain medicaton, ineffective drug therapy and non-compliance with drug treatment regimens: i. at admission, resumption of care, and recertifications...Document medication assessment and interventions in the visit notes."
Review of clinical records was conducted on December 5, 2023, from approximately 11:00 am through 2:00 pm and on December 6, 2023, from approximately 9:30 am through 10:30 am revealed the following:
CR #2; Start of Care:11/3/2023; Review of Home Health Certification and Plan of Care (POC), certification period 11/3/2023 through 1/1/2024; did not contain any documentation of a clinician signed medication assessment at the start of care to identify potential contraindications, drug reactions, significant adverse reactions, interations and/or duplicate drug therapy, effectiveness of pain medicaton, ineffective drug therapy and non-compliance with drug treatment regimens.
CR #3; Start of Care: 11/15/2023; Review of Home Health Certification and Plan of Care (POC), certification period 11/15/2023 through 1/13/2024; did not contain orders for skilled nursing (SN) services. SN services are being provided three (3) times per week per visit documentation. File contained a medication assessment that was not signed by a clinician stating medications were reviewed to identify potential contraindications, drug reactions, significant adverse reactions, interations and/or duplicate drug therapy, effectiveness of pain medicaton, ineffective drug therapy and non-compliance with drug treatment regimens.
CR #4, Start of Care: 11/16/2023; Review of Home Health Certification and Plan of Care (POC), certification period 11/16/2023 through 1/14/2024, did not contain orders for SN, Physical Therapy (PT), or Occupational Therapy (OT). SN services are being provided two (2) times per week. PT evaluation was completed on 11/20/23 with visits ordered two (2) times per week for four (4) weeks. OT evaluation was completed on 11/22/2023 with visits ordered one (1) time for one (1) week then two (2) visits per week for three (3) weeks. File did not contain any documentation of a clinician signed medication assessment at the start of care to identify potential contraindications, drug reactions, significant adverse reactions, interations and/or duplicate drug therapy, effectiveness of pain medicaton, ineffective drug therapy and non-compliance with drug treatment regimens.
CR #5, Start of Care: 11/21/2023; Review of Home Health Certification and Plan of Care (POC), certification period 11/21/2023 through 1/19/2024, did not contain orders for SN, PT, or OT. SN services are being provided two (2) times per week for nine (9) weeks. PT evaluation was completed on 11/28/2023 with visits ordered one (1) time for one (1) week then two (2) times per week for three (3) weeks. OT evaluation was completed on 11/27/2023 with visits ordered two (2) times per week for four (4) weeks. File did not contain any documentation of a clinician signed medication assessment at the start of care to identify potential contraindications, drug reactions, significant adverse reactions, interations and/or duplicate drug therapy, effectiveness of pain medicaton, ineffective drug therapy and non-compliance with drug treatment regimens.
CR #6, Start of Care: 8/10/2023, Discharge Date: 10/4/2023; Review of Home Health Certification and Plan of Care (POC), certification period 8/10/2023 through 10/4/2023, did not contain any orders for PT or OT. PT evaluation was completed on 8/14/23 with orders for PT two (2) times per week for two (2) weeks. OT evaluation was completed on 8/24/23 with orders for OT one (1) time for one (1) week.
CR #7, Start of Care: 8/9/2023, Discharge Date: 10/4/2023; Review of Home Health Certification and Plan of Care (POC), certification period 8/9/2023 through 10/4/2023, did not contain any orders for PT. PT evaluation was completed on 8/21/23 with orders for PT two (2) times for two (2) weeks. File did not contain any documentation of a clinician signed medication assessment at the start of care to identify potential contraindications, drug reactions, significant adverse reactions, interations and/or duplicate drug therapy, effectiveness of pain medicaton, ineffective drug therapy and non-compliance with drug treatment regimens.
An interview with the administrator on December 6, 2023, at approximately 1:00 pm confirmed the above findings.
Plan of Correction:The infractions found here coincide with the lack of clinical reviews being completed. The agency was aware that there were several deficiencies revolved around timeliness and completion of patient records by the previous Clinical Manager who was responsible for this information. That individual has since been replaced. The new team in place is committed to ensuring that all documentation is completed in a timely manner, with accuracy including ensuring that the appropriate medication reviews are conducted, medication assessments are signed and that plan of cares are both established and executed as written and the orders are clearly communicated. Agency will also ensure that it is clearly communicated in patient records why a visit did not take place as ordered.
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 clinical records (CR), agency policy, and an interview with the administrator, the agency failed to maintain the clinical record in accordance with accepted professional standards for four (4) of seven (7) CR's reviewed, (CR #1, 5, 6, and 7).
Findings include:
Agency did not have a policy that pertains to patient receiving admission paperwork that include patient ' s rights and the acknowledgement of receipt of these documents.
A review of agency policy titled "Discharge/Reduction In Services" was conducted on December 15, 2023 at approximately 2:40 pm. Policy states, " 2. Discharge Documentation: iii. A discharge summary will be completed for all discharged patients. A discharge summary is sent to the primary care ... "
A review of CR's was conducted on December 5, 2023, from approximately 11:00 am through 1:30 pm and on December 6, 2023, from approximately 11:00 am through 12:30 pm.
CR #1; Start of Care:11/3/2023; Certification period reviewed: 11/3/2023 through 1/1/2024; did not contain any documentation of acknowledgment that the patient received admission paperwork that includes patient ' s rights.
CR #5; Start of Care: 11/21/2023; Certification period reviewed: 11/21/2023 through 1/119/2024; did not contain any documentation of acknowledgment that the patient received admission paperwork that includes patient ' s rights.
CR #6; Start of Care: 8/10/2023; Discharge Date: 10/4/2023; Certification period reviewed: 8/10/2023 through 10/4/2023; did not contain any documentation of SN discharge summary.
CR #7; Start of Care: 8/9/2023; Discharge Date: 10/4/2023; Certification period reviewed: 8/9/2023 through 10/4/2023; did not contain any documentation of acknowledgment that the patient received admission paperwork that includes patient ' s rights.
An interview with the administrator on December 6, 2023, at approximately 1:00 pm confirmed the above findings.
Plan of Correction:The infractions found here coincide with the lack of clinical reviews being completed. The agency was aware that there were several deficiencies revolved around timeliness and completion of patient records by the previous Clinical Manager who was responsible for this information. That individual has since been replaced. The new team in place is committed to ensuring that all documentation is completed in a timely manner, with accuracy including ensuring that patients receive appropriate paperwork at Start of Care, that the appropriate documentation is obtained and retained at discharge, and that appropriate admission paperwork is obtained and retained. A weekly review with the Administrator, Clinical Manager, and office manager will take place to ensure this concern is mitigated.
Initial Comments:
Based on the findings of an onsite unannounced home health agency state re-licensure survey conducted onsite December 5, 2023 and December 6, 2023 and offsite on December 8, 2023, TBM Health Services, LLC., 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 unannounced home health agency state re-licensure survey conducted onsite on December 5, 2023 and December 6, 2023 and offsite on December 8, 2023, TBM Health Services, LLC., was found to be in compliance with the requirements of 35 P.S. 448.809 (b).
Plan of Correction:
|