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 July 25-27, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Discovery House, Inc. was found not to be in compliance with the applicable chapters of 4 PA Code and 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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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 the review of patient records, the facility failed to demonstrate the physician made the determination of the patient's initial and subsequent dose in seven of eight patient records.
The findings include:
Twenty three patient records were reviewed July 25-27, 2011. Eight patient records were reviewed for physician's documentation of the patient's initial and subsequent dose and schedule. The initial dose order was documented as an incremental order. It covered the first week to ten days of the patient's treatment.
Patient # 2 was admitted November 1, 2010. The initial order issued by the physician was labeled an incremental order with the first dose to be 30 milligrams, 40 milligrams 2nd day, 50 milligrams 3rd day; 55 milligrams on the 6th day and 60 milligrams on the 10th day. The order further stated to the staff responsible for administering the narcotic to "dose according to symptoms" leaving the determination to staff not permitted to make the dosing decisions.
Patient # 4 was admitted March 16, 2011. The initial order issued by the physician was labeled an incremental order with the first dose to be 30 milligrams, 40 milligrams 2nd day, 50 milligrams 3rd day and 60 milligrams on the 4th day.
Patient # 6 was admitted November 10, 2010. The initial order issued by the physician was labeled an incremental order with the first dose to be 30 milligrams, 40 milligrams 2nd day, 50 milligrams 3rd day and 60 milligrams on the 4th day.
Patient # 15 was admitted April 27, 2011. The initial order issued by the physician was labeled an incremental order with the first dose to be 20 milligrams, 30 milligrams 2nd day, 40 milligrams 3rd day and 50 milligrams on the 4th day. The plan was then documented for the patient to see the physician again at 7 to 10 days of the admission.
Patient # 16 was admitted March 16, 2011 as a transfer. The initial order issued by the physician was labeled an incremental order with the first dose to be 40 milligrams 1st day, 50 milligrams 2nd day and 60 milligrams on the 3rd day.
Patient # 17 was admitted March 23, 2011. The initial order issued by the physician was labeled an incremental order with the first dose to be 20 milligrams, 30 milligrams 2nd day, 40 milligrams 3rd day and 50 milligrams on the 4th day.
Patient # 18 was admitted July 25, 2011. The initial order issued by the physician was labeled an incremental order with the first dose to be 30 milligrams, 40 milligrams 2nd day, 50 milligrams 3rd day and 60 milligrams on the 4th day. The plan was then documented for the patient to see the physician again at 7 to 10 days of the admission.
Patient # 19 was admitted May 23, 2011. The initial order issued by the physician was labeled an incremental order with the first dose to be 30 milligrams, 2nd day 40 milligrams and 3rd day 50 milligrams.
On September 4, 2007, all narcotic treatment programs were issued a letter regarding methadone dose orders, especially during the induction phase, by the Department of Health & Human Services, Substance Abuse and Mental Health Services Administration: (SAMHSA)
In part, the following is excerpted from the letter:
"Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. With repeated dosing, "methadone may be retained in the liver and released slowly, prolonging the duration of action despite low plasma concentrations." The drug labeling also states that "steady-state concentrations are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a longer period of time as tissue stores of methadone accumulate." Therefore, patients should be closely monitored during the induction phase, and the increase in dose should be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), ' Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling'. "
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Plan of Correction
The Program Director will document the training with the Medical Team to educate them on the nature of the defeciency and re-affirm the process of initial and subsequent dose orders.
The program Physician will make the determination of the patient's initial dose based on the patient's needs. The Physician will document the order for medication. All subsequent dose changes, if clinically indicated, will require an individual order.
The Medical Director will audit a selection of charts each month to ensure the Physician's are following protocol.
The Program Director is responsible for ensuring ongoing compliance with the protocol.
The target date for the development and implementation of the process is 9/1/2011. |
715.20(3) 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.
(3) The transferring narcotic treatment program shall document what materials were sent to the receiving narcotic treatment program.
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Observations
Based on a review of patient records, the narcotic treatment program failed to document what materials were sent to the receiving narcotic treatment program in one of one patient records.
The findings include:
Twenty three patient records were reviewed July 25-27, 2011. Four patient records reviewed were discharged patient records. One of the four patients was transferred to another narcotic treatment program and required documentation of what materials were sent to the receiving narcotic treatment provider. The facility failed to document what information was forwarded to the receiving facility.
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Plan of Correction
The Program Director will provide a staff in-service on when, how, and where to document what materials were sent to the receiving narcotic treatment program when a patient transfer occurs.
The primary Counselor will document, in the patient chart, what materials were sent to the receiving narcotic treatment program when a patient transfer occurs.
The Clinical Supervisor will audit transferring patient's charts to ensure the documentation is completed.
The Program Director is responsible for ensuring ongoing compliance with the protocol.
The target date for the development and implementation of the process is 9/1/2011. |
715.20(4) 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.
(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.
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Observations
Based on the review of patient records, the facility failed to document that it notified the referring facility of the admission and initial dosing of the patient in two of two patient records.
The findings include:
Twenty three patient records were reviewed July 25-27, 2011. Two patient records were reviewed for documentation of notification to the referring facility of the admission and dosing of the referred patient.
Patient #16 was admitted as a transfer patient on July 25, 2011. There was no documentation the referring facility was notified of the admission and first dose of the patient at the time of the record review, July 27, 2011.
Patient # 21 was admitted March 23, 2011 as a transfer patient. There was no documentation that the referring facility was notified of the admission and date of first dose of the patient.
Discussion with the facility director on July 27, 2011 confirmed this information was not documented in the record.
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Plan of Correction
The Program Director will provide a staff in-service with the Admission Team to ensure they are trained on the process of notifiying the referring facility of an admission to Discovery House and their dose.
The Admission Team will notify and document that a referring facility was notified of the admission to Discovery House and the initial dosing of medication.
The Program Director will audit transferring patient charts to ensure ongoing compliance with this procedure.
The target date for the development and implementation of the process is 9/1/2011. |
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 the review of patient records and discussion with administrative staff, the facility failed to complete the annual physical with a reevaluation by the physician in four of four patient record reviewed.
The findings include:
Sixteen patient records were reviewed July 25, 26 and 27, 2011. Four of these records were required to provide documention of the physician's annual reevaluation of a patient.
Patient # 7 was admitted 10-21-08. The annual physical exam was completed on 10-6-09 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician.
Patient # 8 was admitted 8-2-05. The annual physical exam was completed on 8-14-09 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician.
Patient # 10 was admitted 10-11-04. The last annual physical exam was dated 10-16-07.
Patient # 11 was admitted 1-28-08. The annual physical exam was completed on 1-30-09
by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician.
Discussion with the facility director regarding the the re-evaluation confirmed it was not completed by the physician as required.
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Plan of Correction
The Director will provide an inservice to train the Medical Team on to properly document the annual physical with the re-evaluation.
The Annual Physical with a reevaluation will always be completed and/or reviewed by the program physician. The program Physician will always sign/co-sign the Annual Physical and Reevaluation.
The Medical Director will audit charts monthly to ensure program Physician's are following protocol.
The Program Director is responsible for implementing the process and ensuring ongoing compliance.
The target date for the development and implementation of the process is 9/1/2011. |
709.32(b) LICENSURE Medication Control
709.32. Medication control.
(b) Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.
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Observations
Based on a review of client records and interviews with the medical and clinical directors, the facility failed to ensure that the physicians signed verbal orders in within 24 hours of issuing them, in two of two patient records as required by this regulation.
The findings included:
Twenty three patient records were reviewed for physician orders. Two of the twenty three patient records had documented verbal orders by the physician. The verbal orders were not signed by the physician within 24 hours as required.
Patient # 4 was admitted March 16, 2011. There was documentation of three separate occasions where a verbal order was issued. One verbal order, dated April 8, 2011, was not signed until April 13, 2011.
Patient # 14 was admitted July 19, 2010. There was documentation of a physician's verbal order dated May 18, 2011. The verbal order was not signed by the issuing physician until May 22, 2011.
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Plan of Correction
The Program Director will provide an inservice to review with the physician protocol for signing verbal orders. The Program Director provided the Nurse Manager w/ an inservice on how to monitor veral orders.
The program Physician's will check daily and sign all verbal orders within 24-hours of issuing them.
The Nurse Manager will audit orders daily to ensure ongoing compliance.
The Program Director is responsible for implementing the process and ensuring ongoing compliance with the procedure.
The target date for the development and implementation of the process is 9/1/11. |