INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and methadone monitoring inspection conducted on December 17, 2024 through December 18, 2024 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, The Family Center of Thomas Jefferson University (MATER) was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection:
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Plan of Correction
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704.8(a)(1) - (5) & (b) LICENSURE Qualification Level
704.8. Qualifications for the position of counselor assistant.
(1) A Master's Degree in a human service area.
(2) A Bachelor's Degree in a human service area.
(3) Licensure in this Commonwealth as a registered nurse.
(4) An Associate's Degree in a human service area.
(5) A high school diploma or General Education Development (GED) equivalent.
(b) A counselor assistant shall also complete the training requirements in 704.11 (relating to staff development program).
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Observations
Based on a review of personnel records, the facility failed to ensure and document all counselor assistants employed met the appropriate educational qualifications in two of two applicable personnel records reviewed. Employee #9 was hired as a counselor assistant on September 9, 2024 and was still in the position. At the time of inspection, the personnel record did not include documentation of any qualifying professional credentials, even though the employee's resume indicated having a bachelor's degree. Therefore, the Department representative was unable to verify if the educational qualifications were met prior to hiring, as there was no additional information provided during the inspection process.Employee #10 was hired as a counselor assistant on September 26, 2024 and was still in the position. At the time of inspection, the personnel record included documentation of a bachelor's degree; however, there was no major documented on the degree and there were no transcripts included in the personnel record. Therefore, the Department representative was unable to verify if the educational qualifications were met prior to hiring, as there was no additional information provided during the inspection process.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Prior to hiring counselor assistants/prior to interns start at MATER, the administrative assistant and the hiring supervisor will ensure that all required documentation as per Pa.Code 704.8 has been received.
The Clinical Program Director will create a check-list for hiring interns/counselor assistants. The checklist will reflect the required documents.
The administrative assistant will review the pre-hire documentation and will sign off on the checklist indicating that interns/counselor assistants are eligible to be hired.
Records for employee #10 have been corrected and the transcript for the bachelor's degree has been placed in their personnel file.
Records for employee #9: The administrative assistant and the counselor assistant supervisor will work together to obtain the required transcripts and the High school diploma. The required documents will be obtained by 2/7/2025 and will be placed in the personnel files. |
711.17(a)(3) LICENSURE Subchapter B.Approval Procedures.Refusal or
711.17. Refusal or revocation.
(a) The Department may revoke or refuse to issue a certificate of compliance for any of the following reasons:
(3) Failure to comply with a plan of correction approved by the Department, unless the Department approves an extension or modification of the plan of correction.
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Observations
Based on a review of patient records, the facility failed to comply with plans of correction that were approved by the Department. Plans of correction for ensuring that each patient received an annual evaluation, which is completed by the counselor and signed by the medical director, were submitted, and approved by the Department for the January 10, 2023 through January 11, 2023 and December 12, 2023 through December 13, 2023 annual licensing inspections. Failing to ensure that an annual clinical evaluation for each patient was completed was again found to be a deficiency in the December 17, 2024 through December 18, 2024 licensing inspection. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Program Director will conduct random chart audits on a quarterly basis to assess for compliance with the agency's stated plans of correction.
The audits will be performed and documented according to the schedule noted below:
Audit #1- By end of April, 2025
Audit #2- By end of July, 2025
Audit #3- By end of October, 2025
Audit #4- By end of December, 2025
The findings from the audit will be documented, reviewed, and, if necessary, addressed, with appropriate department leads and supervisors. |
715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
Based on a review of patient records, the narcotic treatment program failed to document, prior to administration of an agent, the results of a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug in two of three applicable patient records reviewed.Patient #1 was admitted on October 3, 2024 and was active at the time of inspection. The face-to-face determination was documented in the record on October 18, 2024; however, the patient was given their first, initial dose on October 4, 2024.Patient #2 was admitted on March 15, 2024 and was active at the time of inspection. There was no documentation of a face-to-face determination in the record at the time of the inspection.This is a repeat citation from the December 12, 2023 through December 13, 2023 annual licensing renewal inspection.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The NTP physician will have a face-to-face with a new admission client (including a transfer of a client from another DDAP licensed NTP) prior to administration of an agent. In the cases when the CRNP makes the initial evaluation, the CRNP will get a verbal or written approval from the NTP physician and document the approval prior to administration of an agent.
The Clinical Program Director will conduct random quarterly audit of new admissions to assess compliance with the above stated plan.
The Clinical Program Director will review the findings of the audit with the Medical Director and address any issues in order to solve them in a timely manner.
In order to prevent client timely access to treatment, and ensure interrupted care, In cases when a face-to-face determination cannot be made for clients already established/stabilized on methadone at a DDAP licensed NTP (transfers) or the hospital, documentation will be made in the client's chart indicating the circumstances necessitating admission prior to establishing a face-to-face encounter with a physician.
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715.15(a) LICENSURE Medication Dosage
(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient 's therapeutic dosage.
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Observations
Based on a review of patient records, the narcotic treatment facility failed to ensure the narcotic treatment physician reviewed patient dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine the patient's therapeutic dosage in one of five applicable patient records. Patient #7 was admitted on June 22, 2023 and was discharged on April 16, 2024. There was no dosage level review completed by the physician prior to discharge.This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Supervisor will review the policy for Dose Reviews with all therapists and will direct them to route the Dose Review form to the OTP provider for review and signature.
The OTP provider will review the dose reviews and sign them.
The Clinical Program Director will run a report on two separate occasions, two months apart within 6 months of POC effective date to monitor adherence to the dose review policy
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715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on a review of patient records, the narcotic treatment program failed to ensure the narcotic treatment physician determined the initial dosage level for patients in two of three applicable patient records.Patient #2 was admitted on March 15, 2024 and was active at the time of inspection. The initial dose level review was completed on March 18, 2024; however, there was documentation in the record indicating the dosage level was determined by a licensed practical nurse instead of a narcotic treatment physician.Patient #4 was admitted on August 22, 2024 and was discharged on November 5, 2024. The initial dose level review completed on August 27, 2024; however, there was documentation in the record indicating the dosage level was determined by a licensed practical nurse instead of a narcotic treatment physician.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The initial dose review will be signed by the physician.
The Clinical Program Director will conduct quarterly audits through December 2025 to ensure any non-compliance is identified and corrected in a timely manner.
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715.17(c)(3)(i-v) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
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Observations
Based on a review of administrative documentation, the narcotic treatment program failed to ensure all drug storage areas and the dispensing station were inspected at least quarterly to ensure the areas are maintained in compliance with Federal, State, and local laws and regulations.On December 18, 2024, at approximately 8:45am, the program was unable to provide documentation indicating the drug storage areas and the dispensing station were inspected at least quarterly from the date of last licensing inspection through the date of this inspection.This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Nurse Coordinator will develop an inspection log and will complete the inspection on a quarterly basis to ensure compliance with Federal, State, and local laws and regulations. In the absence of the Nurse Coordinator, the Lead Practical Nurse will conduct the inspection within the required timeframe.
The Certified Registered Nurse Practitioner (CRNP) will ensure the inspection log is completed on a quarterly basis. The CRNP will conduct quarterly review of the inspection log to ensure it is completed within the required timeline
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715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations
Based on a review of patient records, the narcotic treatment program failed to ensure an annual evaluation of each patient's status was completed by the patient's counselor and reviewed, dated, and signed by the medical director in two of three applicable patient records reviewed. Patient #3 was admitted on April 30, 2021 and was active at the time of inspection. At the time of the inspection, there was no documentation of an annual clinical evaluation for the April 2023 through April 2024 year.Patient #6 was admitted on June 1, 2017 and was discharged on September 17, 2014. There was an annual evaluation completed by the counselor on July 30, 2024; however, the evaluation was not signed by the medical director as of the date of the inspection.This is a repeat citation from the December 12, 2023 through December 13, 2023 and the January 10, 2023 through January 11, 2023 annual licensing renewal inspections.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Supervisor will review the Case Conference completion process with all therapists/counselors, and will retrain counselors to direct the annual case conference forms to the Medical Director or their designee for their review and signature.
The Clinical Program Director will instruct the Medical Director or their designee to sign the annual case conference forms.
The Clinical Supervisor will conduct quarterly audits through December, 2025 and will review audit findings with the Clinical Program Director.
The annual case conference form includes, and is not limited to, the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community support.
For Patient #3: there are annual evaluations (case conferences) that were completed on the following dates: 5/2/2023; 5/28/2024; 1205/2025. Those evaluations were not signed by the Medical Director. The Medical Director who would have evaluated the patient during the indicated timeframe is no longer with the agency.
The current medical provider or designee will be signing the annual case conferences moving forward.
Patient # 6: was discharged and records cannot be modified. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on a review of the unusual incident report logs and patient records, the narcotic treatment program failed to file a written unusual incident report with the Department within 48 hours following unusual incidents which include a death or serious injury due to trauma, suicide, medication error or unusual circumstances and a complaint of patient physical abuse.The facility was notified of the off-site death of a patient on January 5, 2024; however, the incident was reported to the Department on December 17, 2024.The facility was notified of the off-site death of a patient on February 16, 2024; however, the incident was reported to the Department on December 17, 2024.The facility was notified of the off-site death of a patient on April 26, 2024; however, the incident was reported to the Department on December 17, 2024.A patient ' s discharge note, dated December 28, 2023, indicated there was a physical assault by a patient against program staff; however, there was no documentation that the incident was reported to the Department as of the date of the inspection.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Program Director will submit the unusual incidents within the required timeline. The Clinical Supervisor will notify the Clinical Program Director by email of any unusual incidents within 24 business hours of the incident occurring/ or within 24 business hours of learning about the incident.
The Clinical Program Director will then complete the unusual incident report in the DDAP Event Reporting System.
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711.93(a)(7) LICENSURE Follow-up Information
711.93. Client records.
(a) Record requirements. There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. In addition to the requirements in 115.32 (relating to contents), the client record shall include the following:
(7) Follow-up information.
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Observations
Based on a review of client records, the facility failed to maintain a complete client record, which is to include the documentation of follow-up information, in two of three applicable records reviewed. Client #4 was admitted on August 22, 2024 and was discharged on November 5, 2024. There was no follow-up information documented in the record as of the date of the inspection. Client #7 was admitted on June 22, 2023 and was discharged on April 16, 2024. There was no follow-up information documented in the record as of the date of the inspection.This is a repeat citation from the December 12, 2023 through December 13, 2023 annual licensing renewal inspection.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The staff assigned to complete 30 day follow-up tasks (the CPS) will be re-trained about the process for completing 30 day follow up calls. The Clinical Supervisor will run weekly reports to identify clients that were discharged, and communicate any outstanding follow up calls to the CPS and their supervisor to ensure compliance with the 30 day follow -up |
711.95(b) LICENSURE Efficient Retrieval of Data
711.95. Uniform Data Collection System.
(b) A data collection system shall be developed that allows for the efficient retrieval of data needed to measure the project's performance.
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Observations
Based on an administrative review, the facility failed to maintain a data collection and recordkeeping system that allows for the efficient retrieval of data needed to measure the project's performance in relation to its stated goals and objectives.During the first day of the inspection, the facility was unable to provide the Department representative full access to the electronic record system. Complete client file access was requested at 8:45am and full access to the system was not provided/granted until 10:30am.This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The day prior to an upcoming DDAP audit, the clinical program director will ensure there is a working laptop for the auditor to access. The clinical program director will also ensure the auditor has working log in information to access electronic health records upon their arrival at the facility |