INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on July 18-19, 2018 by staff from the Division of Drug and Alcohol Program Licensure, with the inspection also conducted for the approval to use Buprenorphine in the treatment of narcotic addiction. Based on the findings of the on-site inspection, Malvern Institute 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:
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Plan of Correction
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709.34 (c) (4) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(c) To the extent permitted by State and Federal confidentiality laws, the project shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:
(4) Event at the facility requiring the presence of police, fire or ambulance personnel.
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Observations
The facility's documentation of unusual incidents was reviewed on July 19, 2018. The facility failed to report to the Department documented events at the facility that required the presence of ambulance personnel, with the events occurring on February 13, 2018 and July 9, 2018.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
All incidents are currently reported to the safety committee and the compliance manager. Effective immediately the compliance manager will review these incident reports each business day for unusual incidents. Any unusual incident including incidents that involve ambulance, police or fire personnel will be promptly reported within 3 days to DDAP. The records of any reported incidents will be kept in a file for review.The Chief Clinical officer will have a weekly review of unusual incidents with the compliance manager to ensure that no unusual incidents were missed. |
715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
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Observations
Seven client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 18-19, 2018. The facility failed to document the countersignature of either the medical director or a narcotic treatment physician on records pertaining to functions performed by the physician assistant for client records # 2, 4, and 5.
Client # 2 was admitted into inpatient detoxification treatment on July 16, 2018 and was still active in treatment. The client's record contained documentation of a physical examination conducted by the physician assistant on July 17, 2018. The physical examination record was not countersigned by a physician.
Client # 4 was admitted into inpatient detoxification treatment on June 25, 2018 and was transferred into inpatient rehabilitation treatment on June 29, 2018. The client was discharged from treatment on June 30, 2018. The client's record contained documentation of a physical examination conducted by the physician assistant on June 26, 2018. The physical examination record was not countersigned by a physician.
Client # 5 was admitted into inpatient detoxification treatment on June 25, 2018 and was transferred into inpatient rehabilitation treatment on June 30, 2018. The client was still active in treatment. The client's record contained documentation of a physical examination conducted by the physician assistant on June 26, 2018. The physical examination record was not countersigned by a physician.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective immediately, all records completed by the physician's assistant will be countersigned by the physician on staff. This will be tracked by the Director of Nursing through monthly chart checks |
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
Seven client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 18-19, 2018. For client record # 3, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent.
Client # 3 was admitted into inpatient detoxification treatment on July 15, 2018 and was still active in treatment. Documentation in the client's record indicated that the client received an initial dose of Subutex on July 16, 2018, at 12:58 pm. Documentation on the informed consent found in the client's record indicated that the form was signed by the client at 1:17 pm, on July 16, 2018.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective immediately, prior to the administration of a narcotic agent, all clients will sign an informed consent. This consent includes the risks and possible adverse effects from continued use of illicit drugs and from use of, or withdrawal from, a narcotic drug administered in treatment. All nursing staff will be trained on on the importance of this standard. This will be verified by monthly chart checks conducted by Director of Nursing. |