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 and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on September 14 and 15, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Discovery House was found not to be compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and a plan of correction is due on October 11, 2010. .
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Plan of Correction
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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 dosing observation and an interview of the nurse, the facility failed to physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR Part 2, Subpart B, 2.22 (relating to notice to patients of Federal confidentiality requirements) and 28 Pa. Code 709.28 (relating to confidentiality).
The findings include:
During the observation of the methadone dispensing on September 15, 2010 between 8:40 AM and 9:15 AM, patients were observed returning their take home bottles to the nurse. The nurse then placed the bottles in the trash. The trash in this can is placed in with the general trash; which could be accessed by the public. Upon removing take home bottles from the trash can, it was observed that several bottles had patient first and last names that were clearly visible. This practice did not ensure that the patient's confidentiality was physically secured and maintained, as required by Federal and State regulations.
The dosing nurse was interviewed on September 15, 2010, following the completion of methadone dispensing. The dosing nurse reported the patients are given the option of crossing their names off the take home bottles. If the patients do not want to cross their names off the bottle; the bottles are still thrown into the general trash with the name visible. The dosing nurse confirmed she was unaware that all patient names must be removed from the bottles before placing into the general trash.
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Plan of Correction
Program Director and Clinic Supervisor will provide training to all staff on securing and maintaining the confidentiality of all patient information. Medical staff will be informed that all patient identifying information on take home medication bottles is to be properly blacked out to keep patient information confidential. This process has started as of this date 09/16/10 and will be monitored by the program director. Staff currently has been advised verbally and a comprehensive training will be conducted within 30 days. |
715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
Based on a review of patient records and an interview with the facility director, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment.
The findings include:
Sixteen patient records were reviewed on September 14 - 15, 2010. Eight patient records required the completion of an informed, voluntary written consent prior to the administration of a narcotic agent. The facility failed to document the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent in patient record # 9.
Patient # 9 was admitted into treatment on July 23, 2010. The patient received their initial dose of methadone on July 23, 2010. There was no documentation of an informed, voluntary written consent prior to the administration of a narcotic agent in patient record # 9.
The facility director was interviewed on September 15, 2010 at approximately 11:45 AM. The facility director confirmed that a written consent for treatment had not been obtained since the client's readmission into treatment on July 23, 2010. The facility director reported since the client was readmitted into the program; they did not realize a new consent would need to be obtained.
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Plan of Correction
Program Director and Clinical Supervisor will provide training to all clinical staff on informed, voluntary, written consent which will include having new consents done for new patients entering the program as well as readmitted patients. Staff currently has been advised verbally and a comprehensive training will be conducted within 30 days. Program Director will monitor for compliance. |
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 patient records and an interview with the facility director, the facility failed to ensure that the patient was initially dosed following the completion of a drug-screen urinalysis in two of eight patient records.
The findings included:
Sixteen patient records were reviewed on September 14 - 15, 2010. Eight patient records were reviewed for drug screen urinalysis results prior to a patient's initial dose. Per regulation, a narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient records # 7 and 8.
Patient # 7 was transferred into treatment on February 22, 2010. Patient # 7 received an initial 215 mg dose of methadone on February 22, 2010. The first urinalysis was not completed by the facility until March 15, 2010. The patient's transfer records indicated the last urinalysis was completed on January 4, 2010. The patient record did not include a copy of the urinalysis results from the laboratory.
Patient # 8 was readmitted into treatment on May 21, 2010. Patient # 8 received an initial 25 mg dose of methadone on May 21, 2010. The first urinalysis was not completed by the facility until June 25, 2010.
The facility director was interviewed on September 15, 2010 and confirmed that patients # 7 and 8 had been dosed before the completion of a urinalysis.
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Plan of Correction
Program Director and Clinic Supervisor will provide training to all staff on obtaining an initial drug-screening urinalysis and a random urinalysis monthly thereafter. Although this process had previously been addressed and corrections were made, continued compliance will be monitored by the program director. Staff currently has been advised verbally and a comprehensive training will be conducted within 30 days. |
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 dosing observation and staff interviews, the facility failed to conduct dosing in a manner that protects the patient from disruption.
The findings include:
Dosing was observed on September 15, 2010 from 8:40 AM through 9:15 AM. Per regulation, a narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum: administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals. During the process of administering and dispensing methadone to patients; the only nurse in the dispensing station stopped the dosing process two separate times to answer a telephone call. This caused disruption during the administration and dispensing of methadone to the patients.
The dosing nurse was interviewed on September 15, 2010, following the completion of methadone dispensing. The nurse reported the facility did have a second nurse who is no longer employed at the program. The second nurse was available to assist with phone calls and administrative tasks; while the other nurse handled the dosing process. Per an interview with the facility director on September 15, 2010, the facility is in the process of hiring another nurse to assist in the dispensing area.
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Plan of Correction
Program Director and Clinic Supervisor will provide training to all staff on protecting patients from disruptions of annoyance from other individuals while the medication administration process occurs. Staff will be instructed to contact the dispensing nurse only in emergency situations while medication is being administered to patients. This process has started as of this date 09/16/10 and will be monitored by the program director. Staff currently has been advised verbally and a comprehensive training will be conducted within 30 days. |
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 a review of patient records and staff interviews, the facility failed to document in writing that it notified the transferring narcotic treatment program of the date of the initial dose given to the patient by the receiving narcotic treatment program.
The findings include:
Sixteen patient records were reviewed on September 14 and 15, 2010. Four patients were transferred into treatment from a narcotic treatment program. Per regulation, 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. The facility failed to document in writing that it notified the transferring narcotic treatment program of the date of the initial dose given to the patient in records # 4, 6, 7, and 12.
Patient # 4 was transferred from a narcotic treatment program and admitted into treatment on August 20, 2010. There was no documentation that the facility notified the transferring narcotic treatment program of the date of the initial dose given to the patient.
Patient # 6 was transferred from a narcotic treatment program and admitted into treatment on August 4, 2010. There was no documentation that the facility notified the transferring narcotic treatment program of the date of the initial dose given to the patient.
Patient # 7 was transferred from a narcotic treatment program and admitted into treatment on February 22, 2010. There was no documentation that the facility notified the transferring narcotic treatment program of the date of the initial dose given to the patient.
Patient # 12 was transferred from a narcotic treatment program and admitted into treatment on December 16, 2009. There was no documentation that the facility notified the transferring narcotic treatment program of the date of the initial dose given to the patient.
The facility director was interviewed on September 14 and 15, 2010. The facility director reviewed patient records # 4, 6, 7, and 12 and confirmed there was no documentation that the transferring narcotic treatment program had been notified of the date of the initial dose given to the patient by the receiving facility. The facility director reported the nursing staff is assigned the responsibility of calling the transferring facilities. The facility director reported the nurses were calling the transferring facility to confirm when the patient last dosed there and the amount of the last dose. The nurses were not documenting whether they called the transferring facility back to confirm the date of the initial dose given at the receiving facility.
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Plan of Correction
Program Director and Clinic Supervisor will provide training to medical staff on notifying the transferring narcotics treatment program of the date of the initial dose given to the patient by the receiving narcotic treatment program. Medical staff will be informed that in addition to notifying the transferring narcotics treatment program of the date of the initial dose given to the patient, they must document in writing that the transferring program was notified of the date of initial dose given to the patient by the receiving narcotic treatment program. This process has started as of this date 09/16/10 and will be monitored by the program director. Staff currently has been advised verbally and a comprehensive training will be conducted within 30 days. |