INITIAL COMMENTS
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Based on the concerns arising from COVID-19, The Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment, has implemented temporary procedures for conducting an annual renewal inspection.
The inspection will be divided into two parts.
1, an abbreviated off-site inspection, will be conducted off site, and will require the submission of administrative information via email to a Licensing Specialist.
2, an abbreviated on-site inspection, will be conducted on-site at a later date and will include a review of client/patient records, and a physical plant inspection.
This report is a result of Part 2, an abbreviated on-site inspection, conducted on September 29 - 30, 2020 by staff from the Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment. Not all regulations were reviewed, the remainder of the regulations were reviewed during Part 1.
Based on the findings of Part 2, an abbreviated on-site inspection, ARC Manor 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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715.9(a)(1) 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:
(1) Verify that the individual has reached 18 years of age.
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Observations
The facility failed to document the individual had reached eighteen years of age prior to the administration of buprenorphine, a narcotic agent, in two residential patient records and two outpatient records reviewed on September 29 - 30, 2020.
The following residential patient records did not include verification the individual had reached eighteen years of age:
Patient # 2 was admitted April 7, 2020 and discharged May 4, 2020. Patient # 2 was administered buprenorphine on April 9, 2020.
Patient # 3 was admitted June 5, 2020 and discharged June 30, 2020. Patient # 3 was administered buprenorphine on June 11, 2020.
The following outpatient records did not include verification the individual had reached eighteen years of age:
Patient # 5 was admitted July 1, 2020 and discharged August 17, 2020. Patient # 5 was prescribed buprenorphine on August 1, 2020.
Patient # 7 was admitted May 8, 2020. Patient # 7 was prescribed buprenorphine on May 21, 2020.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Director reviewed the regulation with clinical staff to ensure that the policy of obtaining verification of identity, including age, is enacted and recorded in the client file. Clients that are under the age of 18 will not be permitted to enroll in the MAT program. This was reviewed with clinical staff at the weekly staff meeting on 10/22/20. A client will be unable to meet with the physician without a verification of identity and age. The clinician that refers a client for the MAT program will be responsible to obtain verification of the age and to ensure that the client is at least 18 years old and will record this information in the clinical record. The nurse will then review this information prior to the client meeting with the physician. |
715.9(a)(2) 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:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
The facility failed to document the individual's identity including name, address and date of birth prior to the administration of buprenorphine, a narcotic agent, in two residential patient records and two patient records reviewed on September 29 - 30, 2020.
The following residential patient records did not include verification of the individual's identity including name, address and date of birth:
Patient # 2 was admitted April 7, 2020 and discharged May 4, 2020. Patient # 2 was administered buprenorphine on April 9, 2020.
Patient # 3 was admitted June 5, 2020 and discharged June 30, 2020. Patient # 3 was administered buprenorphine on June 11, 2020.
The following outpatient records did not include verification of the individual's identity including name, address and date of birth:
Patient # 5 was admitted July 1, 2020 and discharged August 17, 2020. Patient # 5 was prescribed buprenorphine on August 1, 2020.
Patient # 7 was admitted May 8, 2020. Patient # 7 was prescribed buprenorphine on May 21, 2020.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Director reviewed the regulation with clinical staff to ensure that the policy of obtaining verification of identity, including age, address, and emergency contact, is enacted. This was reviewed with clinical staff at the weekly staff meeting on 10/22/20. A client will be unable to meet with the physician without a verification of identity. The clinician that refers a client for the MAT program will be responsible to obtain verification of identity and will record this information in the clinical record. The nurse will then review this information prior to the client meeting with the physician. |
715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
The facility failed to document an informed, voluntary, written consent before a narcotic agent, buprenorphine, was administered to the patient for maintenance treatment in residential patient record # 3.
Patient # 3 was admitted June 5, 2020 and discharged June 30, 2020. Patient # 3 was administered buprenorphine on June 11, 2020. No consent for buprenorphine treatment was documented.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The policy was reviewed by the Clinical Director with clinical staff to ensure that all clients being referred to the physician have completed the MAT consent form. This was reviewed with clinical staff at the weekly staff meeting on 10/22/20. The nurse will review these materials before having the client meet with the physician. The clinician that refers a client for the MAT program will be responsible to obtain the MAT consent and will record this information in the clinical record. The nurse will then review this information prior to the client meeting with the physician. |
715.13(b) LICENSURE Patient identification
(b) A narcotic treatment program shall maintain onsite a photograph of each patient which includes the patient 's name and birth date. The narcotic treatment program shall update the photograph every 3 years.
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Observations
The facility failed to provide documentation of an onsite photograph of each patient which includes the patient's name and birth date in two residential patient records and two outpatient records reviewed on September 29 - 30, 2020.
The following residential records did not include a patient photograph:
Patient # 2 was admitted April 7, 2020 and discharged May 4, 2020.
Patient # 3 was admitted June 5, 2020 and discharged June 30, 2020.
The following outpatient records did not include a patient photograph:
Patient # 5 was admitted July 1, 2020 and discharged August 17, 2020.
Patient # 7 was admitted May 8, 2020.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The regulation has been reviewed by the Clinical Director with the clinical staff to ensure that the policy of obtaining verification of identity by maintaining a photograph of each client is enacted. This was reviewed with clinical staff at the weekly staff meeting on 10/22/20. A client will be unable to meet with the physician without a photo identification, with date of birth, being in the clinical record. The clinician that refers a client for the MAT program will be responsible to obtain the photo identification, with date of birth, and will record this information in the clinical record. The nurse will then review this information prior to the client meeting with the physician. |
715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
The facility failed to document an initial drug screening urinalysis and a random monthly urinalysis for each patient in three of four outpatient buprenorphine records reviewed on September 29 - 30, 2020.
The following patients were prescribed buprenorphine during the outpatient activity:
Patient # 4 was admitted February 27, 2020 and discharged May 21, 2020. No monthly drug screen was documented for April 2020.
Patient # 6 was admitted August 19, 2019. No monthly drug screens were documented for March, April, May, June, July and August 2020.
Patient # 7 was admitted August 19, 2019. No initial drug screen was documented, and no monthly drug screen was documented for August 2020.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Due to COVID, clients were provided treatment through telehealth and did not complete the required drug screens. The Clinical Director reviewed with clinical/nurse staff that clients are required to complete a monthly drug screening effective 10/22/20. The nurse navigator is responsible to obtain the samples for the drug screens and will ensure that these are completed at the initial appointment and monthly thereafter with the Clinical Director completing random chart audits to ensure these are completed and documented. |
715.14(a)(1) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
(1) Each test shall be for opiates, methadone, amphetamines, barbiturates, cocaine and benzodiazepines.
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Observations
The facility failed to provide documentation of a drug screening urinalysis that included a test for barbiturates in three of three residential patient records reviewed on September 29, 2020.
Patient # 1 was admitted January 24, 2020 and discharged February 20, 2020. Barbiturates were not tested for the February 2020 drug screens.
Patient # 2 was admitted April 7, 2020 and discharged May 4, 2020. Barbiturates were not tested for the April 2020 drug screens.
Patient # 3 was admitted June 5, 2020 and discharged June 30, 2020. Barbiturates were not tested for the June 2020 drug screens.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The regulation was reviewed by the Executive Director with relevant staff (Clinical Director and Nurse) on 10/22/20. The agency has adjusted the drug screens to ensure all required substances are tested. The Clinical Director obtained barbiturate tests and will ensure that any tests sent to an external lab will include barbiturates. The nurse navigator will ensure that these tests are being completed for each client in the MAT program with the Clinical Director overseeing this process. |
715.14(d) LICENSURE Urine testing
(d) A narcotic treatment program shall ensure that a laboratory that performs the testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments of 1998 (42 U.S.C.A. §§ 201 note, 263 and 263a notes), and State requirements, specifically the Pennsylvania Clinical Laboratory Act (35 P.S. §§ 2151-2165) and Chapter 5 (relating to clinical laboratories).
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Observations
The facility failed to document that a drug screening urinalysis was completed by a laboratory in compliance with the Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the State of Pennsylvania Clinical Laboratory Act in three of three residential patient records reviewed on September 29, 2020.
Drug screens in the following clinical records were not in compliance with the Federal CLIA and Pennsylvania State laboratory requirements:
Patient # 1 was admitted January 24, 2020 and discharged February 20, 2020.
Patient # 2 was admitted April 7, 2020 and discharged May 4, 2020.
Patient # 3 was admitted June 5, 2020 and discharged June 30, 2020.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The regulation was reviewed by the Clinical Director with nursing staff on 10/22/20. The agency utilizes an external lab that meets the requirements. The Executive Director will also apply for a CLIA/DOH certificate by 12/1/20 for any onsite drug tests that are conducted. All clients in the MAT program will be drug screened by a DOH/CLIA approved lab. |