INITIAL COMMENTS
|
This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone in the provision of outpatient maintenance treatment for opioid dependence. This inspection was conducted on October 27-29, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, RHD Montgomery County Methadone Center 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 correction is due on December 17, 2008.
|
Plan of Correction
|
715.6(a)(2) LICENSURE Physician staffing
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
(2) When a narcotic treatment program is unable to hire a medical director who meets the qualifications in paragraph (1), the narcotic treatment program may hire an interim medical director. The narcotic treatment program shall develop and submit to the Department for approval a training plan for the interim medical director, addressing the measures to be taken for the interim medical director to achieve minimal competencies and proficiencies until the interim medical director meets qualifications identified in paragraph (1)(i), (ii) or (iii). The interim medical director shall meet the qualifications within 36 months of being hired.
|
Observations
Based on a review of the Interim Medical Director's personnel record on October 27, 2008, the narcotic treatment program failed to submit to the Department for approval a training plan for the interim medical director.
Findings:
No documentation was made available during the methadone monitoring inspection indicating the Department approved a training plan, developed by the Narcotic Treatment Program, for the Interim Medical Director.
|
Plan of Correction
All documentation regarding the credentials of our interim medical director will be submitted by the program director to DOH to include Resume, License and training plan. Date of Submission to be 01/05/2009 |
715.6(b)(1-9) LICENSURE Physician Staffing
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician 's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
|
Observations
Based on a review of the personnel record of physician hired to assist the medical director, the facility failed to ensure the physician was informed of the expected responsibilities and duties of the position.
Findings:
There was no job description to describe the responsibilities of the physician. The responsibilities were also not documented in the policy and procedure manual.
|
Plan of Correction
MCMC Medical Director job description has been revised by the Program Director and signed by the Medical Director to reflect the duties and responsibilities designated by 715.6(b)(1-9). The responsibilites have also been documented by the Program Director in the MCMC Policy and Procedure Manual
Completed 12/01/08 |
715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
|
Observations
Based on the review of the personnel records of the medical staff, the facility failed to restrict the responsibilities of the physician assistant to those allowed by regulations.
Findings:
The physician assistants job description was reviewed on October 27, 2008. The job description included language allowing the physician assistant to recommend specific dose levels to the physician, exceeding the responsibilities allowed.
|
Plan of Correction
The MCMC Physician Assistant's job description has been revised by the program director and signed by the physicians assistant to take out language which allowed the PA to recommend specific dose levels to the medical director. Completed 12/01/08 |
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).
|
Observations
Based on the review of client records, the facility failed to maintain a properly executed consent to release information in accordance with 42 CFR 2.22 and 28 Pa. Code in three of six patient records. In addition, the facility failed to maintain the client's confidentiality in one of the six records reviewed.
Findings:
Seventeen client records were reviewed on October 28-29, 2008. Six records were reviewed for the consents to release information. The facility did not document the expiration date of the consent, or the event or condition the occurrence of which will cause the consent to expire in client records # 13, 15 and 16. In client record # 15, the specific information to be released stated " to obtain requested records from above named facility, and to use these records as a permanent part of the client chart " without specifying what the specific information being released was to be. In addition, client record # 17 contained documentation of information being released that exceeded that which the consent to release signed by the client allowed.
|
Plan of Correction
Clinical meeting will be held by the program director to review 42 CFR and the specific information which may be released as well as specific expiration dates.Discussion of Information released shall not exceed the scope of the Code. Completion date 12/30/08 |
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.
|
Observations
Based on review of client records, the facility failed to ensure it was the physician reviewing the dosage levels in six of seven client records.
Findings:
Seventeen client records were reviewed on October 28-29, 2008. Semi-annual dose reviews were required in seven client records. The facility failed to ensure the physician documented the dose reviews in client records # 3, 11, 13, 14, 15 and 16. These dosage reviews were documented by the physician assistant or physician assistant students being supervised by the physician assistant.
|
Plan of Correction
Physicians Assistant's job descritpion has been revised by the program director and signed by the PA to take out language which allowed the PA to recommend dosage levels. Dosage reviews will no longer be done and documented by the PA or PA supervised students.
Completed 12/01/08 |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
|
Observations
Based on the review of client records, the facility failed to ensure that the physician documented the rationale for permitting take home medication in two of five client records.
Findings:
Seventeen client records were reviewed on October 28-29, 2008. Five records were reviewed for the physician's documentation. The physician did not document the rationale for permitting take home medication in client records # 9 and 10. Instead, staff other than the physician documented the justification.
|
Plan of Correction
A Clinical Meeting will be held by the Program Director with the staff to ensure that no one other than the Medical Director will document the rationale for permitting take home medication.Medical Director and Program Director will monitor this procedure for compliance. Completion 12/30/08 |
715.17(c)(4)(i-viii) 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:
(4) Method for control and accountability of drugs. A narcotic treatment program shall develop and implement written policies and procedures regarding who is authorized to remove drugs from the storage area and the method for accounting for all stored drugs. An agent or other drug prescribed or administered shall be documented on an individual medication record or sheet in a manner sufficient to maintain an accurate accounting of medication at all times and shall include:
(i) The name of the medication.
(ii) The date prescribed.
(iii) The dosage.
(iv) The frequency.
(v) The route of administration.
(vi) The date and time administered.
(vii) The name of the person administering the medication.
(viii) The take-home schedule, if applicable.
|
Observations
Based on the review of the policy and procedure manual on October 27, 2008, the facility failed to include all the components required regarding medications used by patients.
Findings:
The policy and procedure failed to include who, by job title, is authorized to remove drugs from the storage area.
|
Plan of Correction
MCMC Policy and Procedure Manual will be amended by the Program Director to include who, by job title, is authorized to remove drugs from storage area. Completion Date: 12/30/08 |
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.
|
Observations
Based on the review of the policy and procedure manual, the facility failed to ensure a complete procedure was included.
The findings include:
The policy and procedure manual was reviewed on October 27, 2008. The policy addressing the security of the medication was limited to client misuse only. There were no policies or procedures to minimize the the likelihood of loss, theft or misuse, or a written plan for instances where loss, theft or misuse occurs.
|
Plan of Correction
MCMC Policy and Procedure Manual will be amended by the Program Director to address the security of medication to include policies and procedures to minimize the likelihood of loss, theft and misuse and a written plan shall be included where loss, theft and misuse occurs. Completion: December 30, 2008 |
715.23(b)(15) LICENSURE Patient records
(b) Each patient file shall include the following information:
(15) Psychosocial evaluations of the patient.
|
Observations
Based on the review of client records, the facility failed to provide an evaluative assessment of the patient history obtained by clinical staff in four of four client records.
Findings:
Seventeen client records were reviewed on October 28-29, 2008. Psychosocial evaluations were reviewed for content in four client records. The facility did not document an evaluative summary that included the counselor's clinical analysis of the patient's problems/needs, assets/strengths, support systems, coping mechanisms, negative factors, patient's attitude toward treatment and overall impressions, but instead repeated the history or client reported statements in client records # 13, 15 and 16. In addition, there was no documentation of a psychosocial evaluation in client record # 14.
|
Plan of Correction
An inservice will be held by the program director to review the proper completion of psychosocial evaluations to include the counselor's clinical analysis of the patient's needs, etc rather than the repeating of the patient's history. Completion Date: December 30, 2008 |
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.
|
Observations
Based on the review of client records, the facility failed to document realistic goals based on the specific needs of each client in four of six client records.
Findings:
Seventeen client records were reviewed on October 28-29, 2008. Comprehensive treatment plans were required in six client records. The facility did not provide realistic goals based on the client's psychosocial evaluation, but instead completed the same goals for client records # 4, 10, 13, 15. In addition, client record # 4 was late according to program policy and procedure of being completed within 30 days of admission. Client # 4 was admitted 4-15-08 and the comprehensive treatment plan was not completed until 6-3-08.
|
Plan of Correction
An inservice will be held by the program director to address the timeliness of treatment plans as well as the need to address realistic goals based on client's psychosocial evaluations. Completion Date: 12/30/2008 |