INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use narcotic agents, specifically methadone and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on October 26 & 27, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Freedom Healthcare Services, Llc 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 a plan of correction is due on November 19, 2010.
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Plan of Correction
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715.6(c) LICENSURE Physician Staffing
(c) A narcotic treatment physician shall be otherwise available for consultation and verbal medication orders at all times when a narcotic treatment program is open and a narcotic treatment physician is not present.
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Observations
Based on the review of administrative documentation and staff interviews, the facility failed to provide documentation that indicated the facility provided on call services at times when the facility was not open.
The findings include:
A review of administrative documentation and staff interviews on October 26 and 27, 2010, revealed that the facility was unable to provide documentation of physician availability during hours when the facility was not open.
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Plan of Correction
As stated during visit on October 26th and 27th, Freedom Healthcare's Medical Director is and has been on call during hours when the facility is not open. However, our policy did not reflect that. Our policy has been revised as of October 28th to state that the Medical Director is on call during hours when the facility is not open. Also, the Medical Director's job description was revised and signed off on by the Medical Director and the Project Director as of October 28th to state the requirement of 24 hour on call status. |
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 documentation and staff interviews the facility failed to secure a written consent for treatment prior medication induction in one of twelve patient records.
The findings include:
A review of patient record documentation on October 26 & 27, 2010, revealed that patient # 5 had been admitted to treatment and dosed on the March 26, 2010. Documentation of consent for treatment that was contained in the patient record specified that the date of the signature for this document was March 29, 2010. In a staff interview it was explained that the date was incorrect as the document was actually signed on the date of admission, however this information was not verifiable.
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Plan of Correction
On October 29,2010, Nursing Supervisor reviewed consent in the medical chart with patient #5 and the patient initialled off that the date was actually March 26, 2010. After referencing the clinical chart, there was also a duplicate consent that was completed by the counselor that was actually dated correctly for March 26, 2010. The Medical Director and Facility Director reviewed with all staff on November 1, 2010 that they must make sure all forms are dated correctly. The Medical Director and/or Nursing Supervisor will continue to audit medical charts to make sure all dates are correct as well as Facility Director will continue to audit clinical charts. |
715.16(a)(5) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(5) A narcotic treatment program shall develop written policies and procedures relating to granting and rescinding take-home medication privileges.
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Observations
Based on a review of the narcotic treatment program's policies and procedures and staff interviews, the facility failed to develop written policies and procedures relating to the granting and rescinding of take-home medication privileges.
The findings include:
A review of facility policy and procedure on October 26 & 27, 2010, revealed that the facility failed to maintain a policy and procedure to address take-home privileges. An interview with administrative staff confirmed that the facility did not not have a policy to address the granting and rescinding of take-home medication privileges.
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Plan of Correction
The Medical Director, Project Director, Facility Director and Nursing Supervisor met on November 18, 2010 to review and develop a take-home policy that icludes granting and rescinding of privileges. A guideline was developed and a rough draft will be reviewed on November 29. 2010. By December 3, 2010, a final policy will be instituted into Freedom Healthcare's policy and procedures. On December 6, 2010, the policy will be reviewed with all staff. The primary counselor of the one patient that currently has transferred privileges will be directed by the Facility Director to review this policy with the patient and have the patient sign off that it was reviewed. All other patients will review the take home policy with their primary counselor and sign off that it has been reviewed. The patient handbook will also be updated to reflect this change and redistributed to all patients. The Medical Director and Facility Director will continue to monitor all patients compliance with the take home policy. |
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 review of the patient records, the facility failed to document that the narcotic treatment physician determined the patient 's initial and subsequent dose and schedule in three of twelve patient records.
The findings include:
Twelve patient records were reviewed on October 26 & 27, 2010, all patient records are required to document that the narcotic treatment physician determined the patient 's initial and subsequent dose and schedule. A standard physician order was utilized for the narcotic agent, methadone. Three of the twelve patient records reviewed contained a "standing order", which includes instruction by the physician that designate an increase in the patient dose without physician contact. The practice of utilizing standing order is not permitted.
Record # 6 - The patient was admitted on September 22, 2010. The physician ordered an initial dose for the patient and then documented instructions to increase the dose. Documentation in the patient record revealed that the dose was increased but there was no documentation by the physician that specified he had assessed the patient for the increase.
Record #10 - The patient was admitted on July 15, 2010. The physician ordered an initial dose for the patient and then documented instructions to increase the dose. Documentation in the patient record revealed that the dose was increased but there was no documentation by the physician that specified he had assessed the patient for the increase.
Record #11 - The patient was admitted on March 10, 2010. The physician ordered an initial dose for the patient and then documented instructions to increase the dose. Documentation in the patient record revealed that the dose was increased but there was no documentation by the physician that specified he had assessed the patient for the increase.
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Plan of Correction
On October 28, 2010, the Project Director and Facility Director spoke with the Medical Director of results from survey. The Medical Director was told that there can not be instruction for a "standing order" to increase a patient at any time. The Medical Director was also informed that a physician must assess the patient in order to increase or decrease a patient's dose and that change in dose must be documentated specifically by that physician in the patient's clinical file. Freedom Healthcare's policy was revised as of October 28, 2010 to specifically include these issues and reviewed with the Medical Director. The Medical Director reviewed this policy with the other prescribing physician on November 1, 2010. The Medical Director will be responsible for reviewing all patient care in regards to their dosage to make sure for compliance of this policy. |
715.23(b)(15) LICENSURE Patient records
(b) Each patient file shall include the following information:
(15) Psychosocial evaluations of the patient.
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Observations
Based on the review of patient records and administrative documentation, the facility failed to ensure the psychosocial evaluations were a clinical assessment of the historical data collected in five of nine records.
The findings include:
Twelve patient records were reviewed on October 26 & 27, 2010; nine patient records were reviewed for psychosocial evaluations. Patient records # 1, 2, 5, 6 and 10 contained documentation of a psychosocial evaluation but none of items of documentation contained a clinical assessment.
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Plan of Correction
The Project DIrector/ Facility DIrector reviewed findings of audit with staff on 10/27/2010. All clinical staff will be turning in completed psycho-social evaluations to the Facility Director for review. Each psycho-social will be reviewed with the individual counselor that completed it and any necessary changes/suggestions made. The facility director will provide training to all staff in regards to assessment skills when completing a psycho-social. Any necessary training identified after that will be done on a one on one basis between the counselor and the facility director during counselor's supervision time. The facility director will keep project director updated as to all progress made. |