INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and methadone monitoring inspection conducted on March 13-15, 2019 by staff from the Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment. Based on the findings of the on-site inspection, Pinnacle Treatment Center PA-VI, LLC d/b/a Greenfield Counseling 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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704.11(a)(3) LICENSURE Training Feedback
704.11. Staff development program.
(a) Components. The project director shall develop a comprehensive staff development program for agency personnel including policies and procedures for the program indicating who is responsible and the time frames for completion of the following components:
(3) A mechanism to collect feedback on completed training.
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Observations
The facility failed to document a mechanism to collect feedback on completed training in four of five personnel records. Five employee records were reviewed on March 13-15, 2019. Four were reviewed for documentation of feedback. There was no documentation that feedback was collected for completed trainings. These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
704.11 Executive Director has initiated a return to paper feedback forms for trainings that will be included in personnel files. Executive Director will ensure that feedback form is completed and will review personnel charts every three months. |
705.28 (d) (4) LICENSURE Fire safety.
705.28. Fire safety.
(d) Fire drills. The nonresidential facility shall:
(4) Maintain a written fire drill record including the date, time, the amount of time it took for evacuation, the exit route used, the number of persons in the facility at the time of the drill, problems encountered and whether the fire alarm or smoke detector was operative.
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Observations
The facility failed to maintain a written fire drill log that documented the time it took for evacuation.The fire drills logs for the time period of May 2018 to February 28, 2019 were reviewed on March 13-15, 2019. The fire drills reviewed did not document the time it took for evacuation. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
P P279 Executive Director retrained the Health and Safety Officer on how to correctly complete the drill reporting forms. Executive Director will review the completed forms for accuracy after the completion of each drill. |
709.1-709.5 LICENSURE Subchapter A. General Provisions
Chapter 709. Standards for Licensure of Freestanding Treatment Activities
709.1. Scope.
(a) This chapter establishes the procedures for the issuance of a license by activity to freestanding drug and alcohol treatment facilities. The term, facility, applies to the physical location from which drug and alcohol services are provided. A facility may provide more than one service.
(b) This chapter provides standards by activity for the licensure of freestanding drug and alcohol treatment facilities, under the powers and duties contained in Articles IX and X of the Public Welfare Code (62 P. S. Subsections 901-922, 1001-1031, and 1051-1059).
709.2. Policy.
(a) Persons, partnerships and corporations, or other legal entities intending to provide drug and alcohol treatment services, shall first be licensed by the Department.
(b) No drug or alcohol freestanding treatment facilities may receive funds from the Department without a license issued under this chapter.
709.3. Legal base.
The authority of the Department to license drug and alcohol treatment activities is established under the powers and duties contained in Articles IX and X of the Public Welfare Code (62 P. S. Subsections 901-922, 1001-1031, and 1051-1059) as transferred to the Department by Reorganization Plan No. 2 of 1977 (P.L. 372) (71 P. S. subsection 751-25) and No. 4 of 1981 (P. L. 610) (71 P. S. subsection 751-31).
709.4. Exceptions.
(a) The Department may, within its discretion, and for good reasons, grant exceptions or extensions of time to this chapter when the policy objectives of this chapter are met, but no exception may be granted which contravenes the authorizing statute.
(b) The project director shall submit a written request for an exception which shall include the approval of the governing body.
(c) Exceptions will not be granted for a situation in which a provisional license would be appropriate.
709.5. Revocation of exceptions.
(a) An exception granted under this chapter may be revoked by the Department. Notice of revocation will be in writing and include the reason for the action of the Department and a specific date upon which the exception will be terminated.
(b) In revoking an exception, the Department will provide for a reasonable time between the date of written notice of revocation and the date of termination of an exception for the project to come into compliance with this part.
(c) If a project wishes to request a reconsideration of a denial or revocation of an exception, it must do so in writing to the Department within 30 days of receipt of the adverse notification.
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Observations
The facility failed to submit a written request for an exception to conduct outpatient services at an alternative site. The facility is providing counseling services to inmates at a correctional facility. No documentation of a written request for an exception or the granting of the exception was provided. These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
L 0111 Executive Director will file an updated exception with the Department by 5/30/19. Should the exception request be rejected it will become necessary to file an appeal as the exception is for the provision of services to a federally identified priority population, opioid effected pregnant women, for whom there is currently no other viable to provide services without the exception. Should an appeal fail this facility will no longer be able to provide the services and will terminate the contract for these services with the Department of Corrections. |
709.28 (a) (1) LICENSURE Confidentiality
§ 709.28. Confidentiality.
(a) A written procedure shall be developed by the project director which shall comply with 4 Pa. Code § 255.5 (relating to projects and coordinating bodies: disclosure of client-oriented information). The procedure must include, but not be limited to:
(1) Confidentiality of client identity and records. Procedures must include a description of how the project plans to address security and release of electronic and paper records and identification of the person responsible for maintenance of client records.
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Observations
The facility failed to maintain the confidentiality of the client in five of five client records. Twelve client records were reviewed on March 13-15, 2019. Five client records were found not to be in compliance with the security of the client's record. Clients # 3, 4, 7, 8 and 9 were the records reviewed. In an interview with the project/facility director, it was determined that persons from an outside organization had been present in the room with the clients during the client intake interview. It was also determined that these individuals were in the room with the client during the clients medical appointments and when the client was providing a urine specimen. No consent to release information was documented for the presence of the individuals. Information presented in the intake, at medical appointments and during drug screenings exceeds that which is permitted by 4 PA code 255.5. for the individuals present. These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
L 0271 Executive Director will monitor and ensure that all Correctional Officers who enter the facility are required to sign a confidentiality agreement and patients are briefed on the Department of Corrections requirement for Correctional Officers to be present onsite and asked to sign a release that is valid under 42 CFR Part 2. Executive Director has informed DoC of conflict between DoC policy and 4 PA code 255.5 and that Correctional Officers will be required to maintain observation in ways that do not allow them to hear discussion between staff and inmates, such as through a window. This will be enforced going forward. Executive Director will monitor on an ongoing basis. |
709.34 (c) (4) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(c) To the extent permitted by State and Federal confidentiality laws, the project shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:
(4) Event at the facility requiring the presence of police, fire or ambulance personnel.
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Observations
The facility failed to file a written unusual incident report within 3 business days for an incident involving the police. The unusual incident reports were reviewed on March 13-15, 2019. An unusual incident report was completed on July 19, 2018 due to the presence of the police on site. There was no documentation provided that the incident report was reported to the Department within 3 business days. These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
L 0362 Executive Director failed to file a report with DDAP. Executive Director will ensure any such reportable incident is reported to DDAP within the required timeframe. |
715.2(a)(b) LICENSURE Relationship of Federal and State Regulations
(a) A narcotic treatment program shall comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.
(b) This chapter is intended to supplement the Federal regulations governing narcotic treatment programs in 21 CFR Chapter II, 1300-1399 (relating to Drug Enforcement Administration, Department of Justice).
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Observations
The facility failed to comply with Federal laws and regulations regarding the initial dose level for a patient in one of eight patient records.Twelve patient records were reviewed on March 13-15, 2019. Eight of the twelve patients reviewed were new admissions. The facility failed to comply with Federal laws and regulations, specifically, 42 CFR, Part 8, which states, "For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams" in patient record # 8. Patient #8 was admitted on July 18, 2018. The patient's initial dose was 35 mgs on July 18, 2018. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
N M003 Executive Director, assisted by the Physician Assistant and/or Nurses as well as the assigned primary counselor will ensure that there is always documentation, either through medical records provided by the Institution or obtained through phone conference with nursing staff at the Institution verifying that inmate patient is already on a dose higher than 30 milligrams through DoC or another provider at time of admission to this facility and that this documentation is in the clinical and medical chart prior to the initial dose by this facility being dispensed. |
715.10(f) LICENSURE Pregnant patients
(f) The narcotic treatment program shall ensure that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.
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Observations
The facility failed to ensure that the female patients were fully informed of the risks in three of three patient records. Twelve patient records were reviewed on March 13-15, 2019. Eight records reviewed were female patients. Patient records # 7, 8 and 9 were missing the required information.In patient records # 7, 8 and 9 there was no documentation provided that the female patients were informed of the risks to the patient and her unborn child. These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
N M091 Executive Director re-trained the prior Medical Director and assigned the Physician Assistant and the nurses to verify that the Medical Director was using and correctly completing the proper documentation, with the Executive Director performing further checks. The new Medical Director was trained in these procedures and follow-up by the Physician Assistant, Nurses, and Executive Director continues on an ongoing basis. |
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 obtain an an informed, voluntary, written consent before an agent was administered to the patient for maintenance in four of eight patient records. Twelve methadone patient records were reviewed on March 13-15, 2019. Eight were reviewed as new admissions. Patient records # 7, 8, 9 and 12 did not document an informed and voluntary consent. In patient records # 7, 8, 9 and 12, the consent to treatment signed by the patient was a consent to treatment for buprenorphine/Vivitrol. Patients were receiving methadone. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
N M095 Executive Director re-trained the prior Medical Director and assigned the Physician Assistant and the nurses to verify that the Medical Director was using and correctly completing the proper documentation, with the Executive Director performing further checks. The new Medical Director was trained in these procedures and follow-up by the Physician Assistant, Nurses, and Executive Director continues on an ongoing basis. |