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 August 15, 16, and 17, 2007 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Alliance Medical Services, Ensign II 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 and a plan of correction is due on September 7, 2007.
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Plan of Correction
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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 the review of records for patients readmitted to treatment, the facility failed to update the patient record to show current opiate dependency in one of two (#12) patient records. The record showed patient #12 was readmitted on July 6, 2007 without benefit of having an urine drug screen completed. The facility obtained a urine drug screen on July 7, 2007 for patient #12 and did not receive the results until July 13, 2007. The facility administered the first dose of methadone on July 6, 2007.
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Plan of Correction
The facility will routinely require a urine drug screen of previous patients seeking readmission. The prospective patient will not be admitted and dosed until the results establish current dependancy. In certain cases the Medical Director may establish dependancy through other approved methods. The Medical Director is responsible for oversite in this matter with the participation of the Facility Director. |
715.9(d) LICENSURE Intake
(d) A narcotic treatment program shall explain to each patient treatment options; pharmacology of methadone, LAAM and other agents, including signs and symptoms of overdose and when to seek emergency assistance; detoxification rights; grievance procedures; and clinic charges, including the fee agreement signed by the patient.
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Observations
Based on record review and observation, the facility failed to include the signs and symptoms of an overdose and when to seek emergency treatment during the orientation of the patient in 17 of 17 patient records reviewed, #1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11,12, 13,14, 15, 16, and 17.
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Plan of Correction
The facility will update the intake process to include information on signs and symptoms of overdose, other medications, and what to do in case of an overdose. The Director/ Clinical Supervisor are responsible for implementation and ongoing compliance.
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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 record review, the facility failed to obtain a complete consent for information to be released to Bureau of Drug and Alcohol Programs (BDAP). The facility used a general release of information statement in the patient rights form that did not contain the elements required for a valid consent to release information in seven of seven random patient records reviewed, # 1, 2, 3, 4, 5, 6, 8 and 12.
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Plan of Correction
Since a release for non-identifying information is not needed, each individual counselor will review the existing signed document in the patient chart and cross out the statement about the release. The counselor and the patient will then initial and date the voided area indicating approval of the edit. The statement has been removed from the patient rules form. |
715.14(c) LICENSURE Urine testing
(c) A narcotic treatment program shall develop and implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.
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Observations
Based upon review of the policies and procedures manual, the facility failed to provide policy and procedures that ensure accurate tracking of the urine specimen from collection to shipment to the laboratory.
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Plan of Correction
Policy and procedure will be updated to include an appropriate chain of custody for all urinalysis and lab tests to be secure. The Medical Director, Facility Director, and the Clinical Supervisor are responsible for developing and implementing procedures insuring appropriate tracking.
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715.16(a)(2) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(2) The narcotic treatment physician shall make this determination after consultations with staff involved in the patient's care.
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Observations
Based upon random record review, the facility failed to ensure that the form used for documentation clearly demonstrated that the physician was determining take home privileges in seven of seven patient records reviewed, #2, 4, 5, 6, 8, 10, and 11 .
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Plan of Correction
The Take Home Request form will be amended to reflect that the Physician is responsible for determining privileges. The Clinical Supervisor will provide oversite to insure compliance. |
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.
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Observations
Based upon a random record review, the facility failed to ensure the physician had documented his rationale for permitting take-home medication in seven of seven patient records reviewed, #2, 4, 5, 6, 8, 10, and 11.
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Plan of Correction
The Medical Director will document his rationale for permitting take home doses in the comment section of the take home request form. The Medical Director and the Clinical Supervisor are responsible for ongoing compliance. |
715.16(a)(4) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(4) A narcotic treatment physician may rescind take-home medication privileges.
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Observations
Based upon record review and observation, the facility failed to ensure the physician rescinded the take-home medication privilege in one of one patient record (#8) that was reviewed. The counselor and clinical supervisor rescinded the take-home privileges and the physician signed the request after the patient was informed of the removal of take-home privileges.
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Plan of Correction
The clinical supervisor will insure that the physician is responsible for the suspension or removal of take home doses. The supervisor and clinical staff will consult with the Medical Director to assist in decision making.
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715.16(b)(1-8) LICENSURE Take-home privileges
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient 's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient 's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
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Observations
Based upon review of the policy and procedure manual and record review, the facility failed to rescind take-home privileges for patient # 8 despite the consistent documentation of positive urine drug screen results that confirmed cocaine use since admission.
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Plan of Correction
The clinical supervisor will provide staff training to both clinical and medical staff and will monitor compliance with standard. In particular, attention needs to be paid to transferring patients who may have been on probationary status at a previous clinic due to positive urinalysis and subsequent testing at AMS. The AMS physician will be responsible for compliance with the eight federal standards in this regard, and his/her activity to be monitored by the facility director.
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715.17(c)(1)(i-vi)) 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:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based upon random review of patient records, the facility failed to demonstrate that the treatment physician determined the subsequent methadone dose and schedule changes in five of five patient records reviewed, #2, 3, 4, 5 and 10. Based upon observation of the dosing process and interview with the medical staff, the facility failed to ensure that only one patient was at a dosing window at one time. The facility failed to protect the patients from disruption from the other patients waiting to be medicated at either of the two dosing windows.
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Plan of Correction
The Medical Director shall make the determination regarding all methadone dosage or schedule changes. The physician assistant may consult but has no responsibility for these changes.
The clinical supervisor and medical director will instruct dosing staff regarding the need to only allow one patient per window while dosing. The Supervisor and Physician Assistant are responsible for oversight .
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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 upon random review of patient records, the facility failed to develop treatment plans that contained realistic and measurable treatment-related goal statements in six of six patient records reviewed, # 1, 2, 5, 6, 8, and 11.
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Plan of Correction
The clinical supervisor will provide individual training to assure that realistic and measurable treatment goals are provided. Ongoing compliance will be monitored by the Clinical Supervisor and through the regular record review process.
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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 upon a random review of patient records, the facility failed to document the progress or lack of progress in achieving the goal statements from the prior treatment plan in three of three patient records reviewed, # 2, 5 and 11.
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Plan of Correction
The clinical supervisor will provide individual training to assure that progress or lack of progress in achieving the goal statements from the previous plan is provided. Ongoing compliance will be monitored by the Clinical Supervisor and through the regular record review process |