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 residential detoxification from opioid dependence. This inspection was conducted on January 12 & 13, 2009 by staff from the Division of Drug and Alcohol Program Licensure. 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. Deficiencies were identified during this inspection and plan of correction is due on February 16, 2009.
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Plan of Correction
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715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
Based on a review of patient records, the facility failed to document the physician's determination of opiate dependency in four of six patient records.
The findings include:
Eleven patient records were reviewed on January 12 & 13, 2009. Documentation of physician determination of opiate dependency was required in six patient records. The facility utilized a form to assist the physician in making determinations of dependency. The physician circled areas on the form that stated the patient was opiate dependent, however there was no supporting documentation by the physician that indicated the physician's findings or assessment of patients # 1, 2, 3, 6 and 7.
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Plan of Correction
Form will be updated to indicate a determiniation bu physician for opiate dependence. It will include specific criteria including evidence of track marks, prior tx history, positive UDS, obvious withdrawal symptoms. This will assist with supporting documentation. This process will be monitored by the Medical Director |
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, the facility failed to document they had offered treatment information to patients in four of ten patient records.
The findings include:
Eleven patient records were reviewed on January 12 & 13, 2009. Ten records were required to contain documentation that a consent to treatment had been reviewed and signed by patients at the time of their admission to treatment. Patient records # 6, 7, 8 and 9 did not contain signed consent to treatment forms.
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Plan of Correction
Consent to Treatment form will be included in the Suboxone Packet for all patients. Patients will not be given suboxone until consent to treatment is signed by patient and witnessed by staff member. This process will be monitored by Nursing Supervisor and Executive Director. |
715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on a review of patient records, the facility failed to ensure that the narcotic treatment physician who determined the dosage level for a patient had consulted with the certified registered nurse practitioner (CRNP) who completed the patient's physical examination in two of nine patient records.
The findings include:
Eleven patient records were reviewed on January 12 & 13, 2009. Nine records required documentation of the physician's determination of the dosage level for the patient. In the patient records where the certified registered nurse practitioner (CRNP) performed the initial patient examination, documentation of consultation between the CRNP and the physician who assessed the dosage level was required. In patient records # 1 & 2, the patients received initial evaluations from the CRNP and were then assessed by the physician who determined the dosage level. There was no documentation of consultation between the physician and the CRNP in either of the two cases.
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Plan of Correction
Only the Medical Director or Physician under Medical Director's direction will determine dosage level for the patient. CRNP will not determine dosage orders. Physician will document any consults between CRNP and self if not completing the phsycial examination. This process will be monitored by the Medical Director. |
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 licensing inspector observation and a review of facility policy and procedure, the facility failed to dispense buprenorphine to a patient in a manner consistent with policy and procedure.
The findings include:
On January 12, 2009, patient # 3 was observed while receiving Suboxone. The patient sat in the dispensing area along with other patients. The dispensing nurse provided the medication and continued to perform other tasks while the patient sat unattended. The patient asked several different nurses if the medication had dissolved in his mouth. The facility failed to maintain observation of the patient while he ingested the medication and the fact that other patients and staff were in the dosing area created a disruption for the patient as he had to request assistance from nursing staff.
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Plan of Correction
Nursing station is going to be re-designed to have private dispensing areas. Patients will be seen one at a time by the nurse and nurse will attend to patient while dispensing. Staff traffic will be tapered down by allowing only one entrance where dispensing does not occur. Nurses will observe patients while patient taking medication until completion. Once a nurse attends to a patient, that same nurse will see the process through. Nursing Supervisor and Executive Director will monitor this process. |
715.23(b)(24) LICENSURE Patient records
(b) Each patient file shall include the following information:
(24) Follow-up information regarding the patient.
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Observations
Based on a review of patient records, the facility failed to complete patient follow-ups in accordance with facility policy in two of five records.
The findings include:
Eleven patient records were reviewed on January 12 & 13, 2009. Five were required to have follow-up information. Facility policy required that follow-ups were completed within seven days of discharge. Patient # 2 was discharged on 12/01/08; the follow-up was completed 12/9/08. Patient # 8 was discharged on 12/15/08; the follow-up was completed 1/07/09.
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Plan of Correction
Follow-up calls will be monitored by Director of UM - all continuing care plans will be copied to UM Director and will ensure calls are made within 7 days of patient DC. This will be monitored by Executive Director. |