INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone, in the treatment of narcotic addiction. This inspection was conducted on November 6, 7, 8 and 9, 2007 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, WPIC Narcotic Addiction Treatment Program was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of corrections are due on December 7, 2007.
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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
Based on random review of patient records, the facility failed to verify in four patient records, #2, 4, 9 and 16, that the individual had reached 18 years of age prior to the administration of methadone.
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Plan of Correction
The Facility Director and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all individuals are screened to determine eligibility for admission prior to administration of methadone or buprenorphine. That verification shall include proof that the individual has reached age 18 as well as evidence that the proof of the individual's identity is indeed factual and valid and meets best practice standards for such determination. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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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
Based on random review of patient records, the facility failed to verify for patient records, #2, 4, 9 and 16 the individual's identity prior to the administration of methadone.
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Plan of Correction
The Facility Director and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all individuals are screened to determine eligibility for admission prior to administration of methadone or buprenorphine. That verification shall include proof that the individual has reached age 18 as well as verify the individual's name, address, date of birth, emergency contact and other identifying data. The Facility Director and/or the Clinical Supervisor at a staff meeting will convey the necessity of inclusion of this information to staff by 1/1/07. The reviews and supervision will begin immediately.
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715.9(b)(2) LICENSURE Intake
(b) Exceptions to the requirements in subsection (a) are:
(2) Upon readmitting a patient who has been out of a narcotic treatment program for 6 months or less after a voluntary termination, the narcotic treatment program shall update the information in and review the patient 's file to show current opiate narcotic dependency, but need not conduct a physical examination and applicable laboratory tests. Privileges earned during the previous treatment may be reinstated at the discretion of the narcotic treatment physician.
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Observations
Based on random review of patient records, the facility failed to document in the patient record current opiate dependency in two of three re-admitted patients, #17 and 18.
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Plan of Correction
The Facility Director and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all individuals who are readmitted be assessed to affirm current opiate dependence, and that the patient record is updated to reflect that assessment. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
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Observations
Based on random review of electronic patient records, the facility failed to secure the confidentiality of patient records by allowing full access to drug and alcohol patient specific records by individuals who are not part of the narcotic treatment program nor of the WPIC drug and alcohol service line. These unknown individuals are employed or affiliated with WPIC at non-drug and alcohol treatment programs.
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Plan of Correction
WPIC Addiction Medicine Services has met with the Division of Drug and Alcohol Program Licensure on 2/29/08 in regard to the WPIC electronic medical records system which is used in five of the WPIC AMS programs licensed by the Division. WPIC AMS continues to work through a process pursuant to the outcome of this meeting in collaboration the Division. |
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 random review of patient records, the facility failed to ensure that patient #18 was given a physical examination when admitted in May of 2007, and readmitted and dosed in August 2007. Patient #18 was given a physical examination in September 2007.
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Plan of Correction
The Facility Director, Medical Director, and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all individuals who are admitted, have their proper dosage level determined by an appropriate physician. Additionally, the Attending Physician shall take a medical history and perform a physical examination as required by both best practice standards and licensing standard. The history and physical shall lead to a face-to-face attestation of opioid dependence last at least one year prior to the examination. This in turn shall lead to the determination of dosage level. The Facility Director and Medical Director shall review this with all medical personnel by 1/1/08. The reviews and supervision will begin immediately.
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715.17(c)(5) 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:
(5) Security of all substances. A narcotic treatment program shall develop and implement written policies and procedures to minimize the likelihood of loss, theft or misuse of an agent or another controlled substance as well as a plan of action if a loss, theft or misuse does occur. In the event of loss, theft or misuse, the Federal and State statutes and regulations regarding reporting shall be followed.
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Observations
Based on the review of the program policy and procedure manual, the facility failed to address an internal procedure addressing possible misuse of the controlled substance.
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Plan of Correction
The Clinical Administrator for WPIC Addiction Medicine Services shall develop the required policy for inclusion into the policy manual. The policy change will also be submited to WPIC senior administration for review and approval by the president and CEO and board of directors. This will be completed by 1/15/08 and presented to clinical staff by 2/1/08.
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715.20(1) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(1) The transferring narcotic treatment program shall transfer patient files which include admission date, medical and psychosocial summaries, dosage level, urinalysis reports or summary, exception requests, and current status of the patient, and shall contain the written consent of the patient.
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Observations
Based on random review of patient records and staff interviews, the facility failed to transfer the required components of patient #14's record.
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Plan of Correction
The Facility Director and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all individuals being transferred to another NATP for continued maintenance, detoxification or another treatment activity, have their patient records transferred to that facility as well. The information shall include the at minimum the admission date, the medical and psycho-social summaries, the dosage level, any urinalysis reports or summary, any exception requests, and the current status of the patient. It will also contain the written consent of the patient. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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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 random review of patient records, the facility failed to ensure the annual evaluations completed by the counselor was reviewed, signed and dated by the medical director for patient records # 7, 9, 10 and 11.
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Plan of Correction
The Facility Director, Medical Director and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all annual evaluations of patient status completed by the primary clinician are reviewed, dated, and signed by the Medical Director. The Facility Dorector and Clinical Supervisor shall ensure that the annual evaluation period starts on the date of the patient's admission to the program and addresses the following areas at minimum: Employment, Education and Training, Legal standing, Substance Abuse, Financial Management Abilities, Emotional Health, Fulfillment of Treatment Objectives, and Family and Community Supports. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Based on random review of patient records, the facility failed to develop individualized treatment goals based on the specific needs identified in the patient's biopsychosocial history and evaluation.
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Plan of Correction
Compliance to developing individualized treatment plans in timely fashion will be evidenced by periodic quality reviews by the Facility Director and Clinical Supervisor combined with monitoring and sharing of feedback about particular cases reviewed in supervision with the Therapists. Training about the regulations and completion of treatment plans will occur as a group in treatment team meeting by the Facility Director and Clinical Supervisor. Particular focus shall be placed upon the individualization of treatment goals for each specific area of need identified through the assessment process. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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715.23(d)(1) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(1) The treatment plan shall identify the behavioral tasks a patient shall perform to complete each short-term goal.
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Observations
Based on random review of patient records, the facility failed to identify specific, measurable behavioral tasks the patient would perform to complete the short-term goals for patient records # 5, 9, 10, 16, 23, 25, 26 and 27.
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Plan of Correction
Compliance to developing individualized treatment plans in timely fashion will be evidenced by periodic quality reviews by the Facility Director and Clinical Supervisor combined with monitoring and sharing of feedback about particular cases reviewed in supervision with the Therapists. Training about the regulations and completion of treatment plans will occur as a group in treatment team meeting by the Facility Director and Clinical Supervisor. Particular focus shall be placed upon ensuring goals and action steps are realistic and measureable. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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715.23(d)(2) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(2) The narcotic treatment physician or the patient 's counselor shall review, reevaluate, modify and update each patient 's treatment plan as required by Chapters 157, 709 and 711 (relating to drug and alcohol services general provisions; standards for licensure of freestanding treatment activities; and standards for certification of treatment activities which are a part of a health care facility).
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Observations
Based on random review of patient records, the facility failed to consistently review and document all patient's treatment plans. The content lacked goal specific review of progress, goals were not changed to reflect the changes of the patient needs during treatment, and treatment plan reviews were not always completed when due.
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Plan of Correction
Compliance to developing individualized treatment plan updates in timely fashion will be evidenced by periodic quality reviews by the Facility Director and Clinical Supervisor combined with monitoring and sharing of feedback about particular cases reviewed in supervision with the Therapists. Training about the regulations and completion of treatment plan updates will occur as a group in treatment team meeting by the Facility Director and Clinical Supervisor. Particular focus will be placed upon the review of progress and any specific updates to the identified goals as guided by patient progress in the treatment process. Additionally, quality assurance chart review will focus upon compliance with identified timeframes for completion of updates and all other documentation. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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715.23(f) LICENSURE Patient records
(f) If a narcotic treatment program keeps patient information in more than one file or location, it is the responsibility of the narcotic treatment program to provide the entire patient record to authorized persons conducting narcotic treatment program approval activities at the narcotic treatment program, upon request.
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Observations
Based on random review of patient records and staff interviews, the facility failed to ensure that the provision of the paper record and the two electronic record systems for review provided a complete and congruent patient record.
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Plan of Correction
The Facility Director shall meet with the WPIC Director of Health Information Management, the Director of Information Security, and the Chief Information Officer and review the current patient record management system utilized by the NATP. Solutions to the continuity problems created by the need to navigate through 2 separate electronic records, as well as a hardcopy medical record will be explored and prioritized for implementation. The meeting will occur by 1/1/08. Solution to be implemented as identified. Templates for all available "patient signature forms" will be submitted for creation within the electronic records system. A signature pad will be purchased thus allowing individuals to sign forms electronically and thus allow the form to be retained electronically. A copy shall be offered via printing to the patient. The signature pad will be purchased by 1/31/08. Templates will be created for signature forms possible also by 1/31/08. As much of the patient record that can be maintained electronically will so be done. The initial work will begin by the time the forms and signature pad are in place. Further streamlining of the medical record will take place over the course of the next six months.
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715.29(5) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient 's record.
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Observations
Based on random review of patient records, the facility failed to ensure that call backs were done according to program policy and procedure for two of three patient records reviewed, # 8 and 11, and due to the lack of documentation for #10, unable to determine compliance.
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Plan of Correction
The Facility Director and Clinical Supervisor will ensure, through supervision and quality assurance chart review that all individuals on weekly, bi-weekly, 6-day, and 13-day take-home dosing schedules are subject to quarterly call-backs in addition to drug-testing as a tool to monitor compliance with medication schedules. This is as permitted and required by the May 2005 communication for the Division regarding "Criteria for Schedule Change." Additionally, documentation of these callbacks will be retained and included in the patient medical record. The Facility Director and/or the Clinical Supervisor will convey the necessity of inclusion of this information during a staff meeting by 1/1/07. The reviews and supervision will begin immediately.
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