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 Buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on December 14, 2007 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pyramid Healthcare Inc. - Transitions 2 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 corrections are due on January 17, 2008. .
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Plan of Correction
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715.2(a)(b) LICENSURE Relationship of Federal and State Regulations
(a) A narcotic treatment program shall comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.
(b) This chapter is intended to supplement the Federal regulations governing narcotic treatment programs in 21 CFR Chapter II, 1300-1399 (relating to Drug Enforcement Administration, Department of Justice).
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Observations
Based on a review of the DEA registration on December 14, 2007, the facility failed to provide a DEA registration for this facility address.
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Plan of Correction
Dr. Frank Kush, Medical Director, has been directed to provide Pyramid Healthcare with his DEA licnese at our address. The ADON will monitor for compliance and complete by 2/1/08. |
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).
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Observations
Based on a review of the patient records on December 14, 2007, the facility failed to provide a relevant purpose on the release of information forms for probation officers and the insurance companies. These deficiencies were documented in three of three patient records. Refer to patient records # 1, 2 and 3.
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Plan of Correction
The Pyramid Healthcare nursing staff will be re-trained in how to legally and properly complete all client releases. The Program Director will train and the ADON will monitor for compliance after 2/1/08. |
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 the patient records on December 14, 2007, the facility failed to provide a medication order that included the time of day. There was no way to determine if the order was written prior to dispensing the first dose. This deficiency was noted in two of three patient records. Refer to patient records # 1 and 3.
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Plan of Correction
Rubber stamps that require name, date and time for all medication orders will be used effective 2/1/08. ADON will monitor for compliance. |