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 April 26-28, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Discovery 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 and a plan of correction is due on May 24, 2011.
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Plan of Correction
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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 the review of patient records and discussion with the facility director, the facility failed to ensure the patient signed the informed consent prior to the administration of a narcotic agent in two of six patient records.
The findings include:
Twenty four patient records were reviewed April 26-28, 2011. Six records were reviewed for the informed consent having been signed prior to the administration of the narcotic agent.
Patient # 8 was admitted and dosed on December 8, 2010. There was no documentation of the informed consent having been signed.
Patient # 12 was admitted and dosed October 29, 2010. The documentation of the signed informed consent was dated November 26, 2010, twenty eight days after the patient began dosing.
The findings were discussed with the director, who agreed the consents were not signed prior to the dosing of patients # 8 and 12.
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Plan of Correction
The Program Director held a meeting on April 29, 2011, with the medical personal. Effective immediately the medical personal will monitor the electronic record to ensure that each new patient signs the informed consent prior to the administration of a narcotic agent. This will be monitored by the Medical Director and Program Director will do sporadic check to ensure compliance. |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
Based on the review of patient records and a discussion with the facility director, the facility failed to ensure the physician documented in the patient record the rationale for granting take home medication in four of six patient records.
The findings include:
Twenty four patient records were reviewed April 26-28, 2011. Six patient records were reviewed for take home medication documentation. Per regulation, the narcotic treatment physician shall document in the patient record the rationale for permitting take home medication. Patient records # 8, 13, 14 and 17 did not have the physician's rationale for granting the take home medication.
The facility director was provided with these findings and reviewed patient records # 8, 13, 14 and 17 and confirmed there was no documentation of the physician rationale for granting take home medication.
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Plan of Correction
The Program Director will hold a medical training 5/10/11 with the Medical Director to review regulatory requirements for documenting the physicians' rationale for granting take home medications. The Program Director will check take home orders to ensure the rationale is documented.
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