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 June 9, 10, 11 and 12, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Alliance Medical Services, Ensign I, 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 July 11, 2008.
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Plan of Correction
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715.9(a)(4) 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:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
Based on a review of 17 patient records, the facility failed to document the physician's face-to-face determination of current dependency in three of nine patient records reviewed for admission content; patient records # 3 and 5 did not contain documentation of current dependency when readmitted to the facility and patient record # 4 revealed documentation that the physician's assistant had determined the current dependency of the patient. Only the physician can determine current dependency.
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Plan of Correction
Only the physician is responsible for determining dependancy at the time of admission or readmission. This will be based on his evaluation of each patient based on current usage. The physician will make this evaluation through a face to face interview with each prospective patient.
The procedure has been reviewed with the physician and he is responsible for compliance in this area.
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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 a review of 17 patient records with one record reviewed for content of readmission within six months of a voluntary discharge, the facility failed to document current dependency for patient # 5. Specifically, when the patient was readmitted on 1/17/08, the patient's urinalysis drug screen was negative for illicit substances and the physician did not document the basis of the determination of current dependency.
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Plan of Correction
The physician is responsible to assure that each candidate for readmission is appropriate for treatment based on an evaluation of current dependancy. In cases where a patient seeking readmission tests negative for illicit substances, the physician must document current dependancy based on signs and symptoms of withdrawl or current usage through a face to face evaluation.The physician has been made aware of the plan of correction and will be responsible for the ongoing compliance. The Facility Director, Physician Assistant and the Medical Director met on 7/10/2008 to clarify this issue.
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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
Based on a review of 17 patient records, 11 of which were reviewed for content of urine drug testing, the facility failed to ensure the completion of random urine drug screens at least monthly in one record, # 2; there was no documentation of a urinalysis drug screen for patient # 2 in March, 2008.
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Plan of Correction
The facility failed to provide monthly urine drug testing for all patients.
Further training will occur for all staff who at any time may be responsible for compliance. In addition, staff will become more proficient in the usage of the automated system that generates random drug screening requirements.
The clinical director, clinical supervisor , and the receptionist will be responsible for training in this area. The clinical supervisor will be responsible for ongoing compliance in for this requirement through monitoring of the automated system.. |
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 the review of 17 patient records, the facility failed to provide verify that the physician who determined the dose had consulted with the physician's assistant who had performed the patient examination. Specifically, in 3 of 10 records reviewed for dose determination content, patient records # 3, 4, and 16 did not contain documentation of a consultation between the physician and the physician's assistant.
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Plan of Correction
The physician is responsible for determining the appropriate dosage for each patient. The physician may consult with the physicians assistant regarding the examination to assist in making this determination. The physician will document consultation with the physicians assistant to determine appropriate dosage.
The physician has been made aware that he is responsible for all consults of this nature. Ongoing compliance is the responsibility of the physician. |
715.15(d) LICENSURE Medication dosage
(d) A narcotic treatment program shall label all take-home medication with the patient 's name and the narcotic treatment program 's name, address and telephone number and shall package all take-home medication as required by Federal regulation.
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Observations
Based on observation and staff interview, the facility failed to include the physician's name on the new computer generated labels for patient's take-home bottles. Staff reported that approximately 50% of the labels had been corrected to include the required information.
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Plan of Correction
The facility failed to include all necessary information on patient take home labels.
A programming error through the automated system has been corrected, insuring the proper labeling of all take home bottles.
The physician's assistant/lead nurse are responsible for ongoing monitoring and compliance with this regulation. |
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 on a review of 17 patient records, seven of which required documentation of dose reviews, the facility failed to ensure the physician was the person who determined the patient's dose; patient # 2's annual physical reexamination included documentation by the physician's assistant that she evaluated the patient's dose. Only a physician can make the determination that the current dose is correct for that specific patient.
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Plan of Correction
The physician is responsible for determining the appropriate dosage for each patient. The physician may consult with the physicians assistant regarding the annual rexamination to assist in making this determination. The physician will document consultation with the physicians assistant to determine appropriate dosage if necessary.
The physician has been made aware that he is responsible for all consults of this nature. Ongoing compliance is the responsibility of the physician. Monitoring of this issue will be the responsibility of the lead nurse through ongoing record review.
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715.23(a) LICENSURE Patient records
(a) A narcotic treatment program shall maintain patient records in conformance with 42 CFR 2.16 and 2.22 (relating to security for written records; and notice to patients of Federal confidentiality requirements) and State statutes and regulations. A narcotic treatment program shall maintain a complete file on the premises for each present and former patient of the narcotic treatment program for at least 4 years after the patient has completed treatment or treatment has been terminated. Files shall be updated regularly so that the information is current.
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Observations
Based on a review of 17 patient records, the facility failed to maintain a complete record in 1 of 6 records reviewed for closed chart content. The facility failed to present the clinical record for patient # 6, therefore, compliance with discharge summary, aftercare plan, and follow-up requirements could not be determined.
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Plan of Correction
It is the responsibility of the program to ensure compliance with closed records. In this case a requested record could not be produced and as a result was in non compliance with regulatory requirements.
A process has been established to prevent further loss of closed records by having all closed cases be presented at the weekly staff meeting and checked off against a list of discharges provided by the supervisor. It is the responsibility of the clinical supervisor to assure compliance with these regulations. |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on a review of 17 patient records, two records were reviewed for content of the annual evaluation. The facility failed to document in 1 of 2 patient records reviewed that the physician documented the need for ongoing narcotic treatment during the annual reevaluation of patient # 4.
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Plan of Correction
The physician must determine the need for ongoing narcotic treatment during the annual reevaluation.
This requirement has been addressed with the physician and the physicians assistant.
The physician is responsible for ongoing compliance in this area.7/12/2008 |
715.23(b)(6) LICENSURE Patient records
(b) Each patient file shall include the following information:
(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.
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Observations
Based on the review of 17 patient records, documentation in patient record # 6 revealed that the Mantoux tuberculosis test provided to the patient exceeded the 72 hour timeframe required for review; the Mantoux test was administered on 12/6/07 and not read until 12/10/07.
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Plan of Correction
The review for Mantoux testing was not completed within the required time frame.
All tests will be read within 72 hours. In any situation that the 72 hours has been exceeded prior to review, the test will be administered again.This has been a directive to both nursing staff to comply with this regulation. The Physician's assistant will be responsible for ongoing monitoring and compliance in this area. |
715.23(b)(11) LICENSURE Patient records
(b) Each patient file shall include the following information:
(11) Counselor notes regarding patient progress and status.
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Observations
Based on a review of 17 patient records, 6 were reviewed for counselor note content. The facility failed to document complete group progress notes that addressed the specific group process, the assessment of the patient's participation, and the plan for further treatment in 2 of 6 records, patients # 2 and 3. Additionally, in 2 of 6 patient records, the facility failed to document treatment plan issues in the individual progress notes, patients # 15 and 16.
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Plan of Correction
The facility failed to document complete group progress notes to include the specific group process, an individual assessment of each patient's participation and the plan for further treatment. The current group progress note will be amended to include those identified areas. during the regular clinical meeting. In addition, staff failed to document treatment planning issues in the individual progress notes on a consistent basis. All counseling staff will be trained on 8/4/2008 by the Clinical Supervisor. Ongoing compliance will be guaranteed through regular chart review and supervision by the clinical supervisor beginning on 8/12/2008. |
715.23(b)(22) LICENSURE Patient records
(b) Each patient file shall include the following information:
(22) Aftercare plan, if applicable.
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Observations
Based on a record review of 17 patients, one record was required to contain an aftercare plan. The facility failed to provide an aftercare plan that was specific to the needs of patient # 9 at the time of his March 2008 discharge; the plan contained documentation that was prepared in August 2005 and was not specific to patient needs at the time of discharge.
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Plan of Correction
The facility did not provide an after care plan that was appropriate to the needs of the patient at the time of discharge.
Staff will be trained on 8/11/2008 during the regular clinical meeting to understand the development of the aftercare plan as a fluid document, developed and amended throughout treatment, but specific to the needs of each patient at the time of discharge.
The clinical supervisor is responsible for providing appropriate training and ongoing monitoring and supervision of the counseling staff in this area.Chart review for compliance will begin on 8/18/2008 and will be conducted on an ongoing basis and coordinated by the clinical supervisor.
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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 a review of 17 patient records, eight were required to have treatment plans. The facility failed to develop treatment plans in 4 of 8 records reviewed that contained short term goals with measurable steps; patient records # 2, 3, 4, and 8 contained vague, non-specific steps to reach goals and the time frames were generalized rather than realistically specific to the action steps.Additionally, documentation in patient record # 15 revealed that the patient's comprehensive treatment plan was completed prior to of the patient's social history and drug and alcohol history.
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Plan of Correction
The facility failed to develop treatment plans that contained short term goals with measurable steps. In addition, records did not contain clear, specific steps to reach goals or time frames that were specific to the necessary actions.In addition, the comprehensive treatment plan was completed prior to the patient's social, drug and alcohol history.
The clinical supervisor will provide training to address these issues on 8/18/2008 during the regular clinical meeting. Ongoing compliance will be the responsiblity of the clinical supervisor through individual supervision and regular chart review that occurs on a daily basis. |