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 January 4 through January 7, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Aldie Foundation Inc., 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 February 3, 2011.
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Plan of Correction
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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 patient records and a discussion with administrative staff, the facility failed to restrict the release of client specific information and exceeded the limits imposed by 4 Pa. Code 255.5 in one of eight records reviewed.
The findings include:
Twenty-three patient records were reviewed on January 5-7, 2011. Eight patient records were reviewed for release of information. Per regulation, the project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the patient record. The facility released specific client information that exceeded the limits imposed by Pa. Code 255.5 in client record #20.
Patient #20 was a admitted to the program on 11/10/11. The patient signed a release of information to the county probation office to include release of information including, assessment results, urine screens, and discharge summary.
This specific patient information released exceeded the limits imposed by 4 Pa. Code 255.5.
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Plan of Correction
The facility has developed a specific release of information for criminal justice entities, including county probation. The Pharmacotherapy Coordinator provided a training for the Pharmacotherapy clinical staff on 2/03/11, reviewing 4 PA Code 255.5 restrictions to disclosure of specific client information and reviewing the proper execution of agency release forms as outlined by facility policy. The Pharmacotherapy Coordinator will maintain oversight of adherence to this regulation through quarterly Quality Assurance review of charts and during individual supervision with clinicians. |
715.17(b) LICENSURE Medication control
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
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Observations
Based on the review of patient records and discussion with administrative staff, the facility failed to ensure the physician signed verbal orders within twenty four hours in two of four patient records.
The findings include:
Twenty-three patient records were reviewed January 5-7, 2011. Four records contained documentation of the physician's verbal orders. Patient records # 15 and 16 did not contain documentation that the physician signed the verbal orders within 24 hours.
Patient # 15 had a verbal order by the physician documented on December 17, 2010. The physician did not sign the verbal order until December 20, 2010.
Patient #16 had a verbal order by the physician on November 30, 2010. The physician did not sign the order until December 2, 2010.
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Plan of Correction
Written Policy and Procedure is in place to meet Federal and State statutes and regulations regarding verbal orders. The Program Coordinator has reviewed these policies and procedures with the Medical Director. The Medical Director will provide an inservice for NTP Physicians on or by Feb. 18, 2011, re: protocol specified by the facility's written policy for verbal orders. The Nursing Manager will monitor dispensing nursing staff compliance with agency policy for signing of verbal orders. The Program Coordinator and the Medical Director shall maintain oversight and insure compliance with this regulation through Quality Assurance record review process.
The program will file a request for exception with the DOH to address physician scheduling barriers for verbal orders obtained during weekend dispensing
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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 the review of patient records and a discussion with administrative staff, the facility failed to demonstrate the physician made the determination of the patient's dose in 2 of 23 patient records.
The findings include:
Twenty-three patient records were reviewed on January 5-7, 2011. Patient records were reviewed for physician's documentation of the patient's initial and subsequent dose and schedule.
Patient # 19 was admitted 11/8/2010. A standard order was used to order the initial dose and then the increases were left for the nursing staff to implement during the induction phase. The physician's order states: "MMTP build-up order 11/11/10-30 mg, 11/16/10-40 mg, 11/21/10-50 mg, 11/26/10-60 mg, 12/1/11-70 mg and 12/6/10-80 mg."
Patient # 20 was admitted 11/10/10. A standard order was used to order the initial dose and then the increases were left for the nursing staff implement during the induction phase.
The physician's order states: "MMTP build-up order 11/10/10-30 mg, 11/14/10-40 mg, 11/18/10-50 mg."
On September 4, 2007, all narcotic treatment programs were issued a letter regarding the use of standard orders, especially during the induction phase, by the Department of Health & Human Services, Substance Abuse and Mental Health Services Administration: (SAMHSA)
In part, the following is excerpted from the letter:
"Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. With repeated dosing, "methadone may be retained in the liver and released slowly, prolonging the duration of action despite low plasma concentrations." The drug labeling also states that "steady-state concentrations are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a longer period of time as tissue stores of methadone accumulate." Therefore, patients should be closely monitored during the induction phase, and the increase in dose should be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), ' Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling'. "
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Plan of Correction
The Operations Director shall add the following written procedure within the agency's Medication Control Policy and Procedures, and the Program Coordinator shall instruct the physician and nursing/dispensing staff regarding these procedures by Feb. 28, 2011.
Before implementing any physician ordered build-up changes in the patient's dose during the induction phase, the program physician shall either directly monitor and determine the appropriateness of each change and document this in the patient's record, or the nursing staff shall conduct a nursing assessment of the patient and communicate with the physician regarding the findings; the program physician shall then determine the appropriateness of implementing the ordered dosage change and instruct the nursing staff accordingly, and the nursing staff shall document in the patient record the program physician's monitoring and determination of any changes in the patient's dose.
The program coordinator shall insure compliance with this procedure through the quality assurance record review process.
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715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on the review of patient records and a discussion with administrative staff, the facility failed to complete the annual physical in two of four patient records as required per regulation.
The findings include:
Twenty-three patient records were reviewed on January 5-7, 2011. Four patient records were reviewed for annual physical examinations. Per regulation each patient file shall include the following information: "The results of all annual physical examinations given by the narcotic treatment program which includes and annual re-evaluation by the narcotic treatment physician."
Patient # 2 was admitted 10/31/03. There was no documentation of an annual physical in the patient record.
Patient # 7 was admitted 3/18/09. There was no documentation of an annual physical in the patient record.
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Plan of Correction
Written Policy and Procedure reflecting the Federal and State regulations that an annual physical examination take place on or before each patient's anniversary in treatment, including a form and format for clearly documenting Physicians' physical examinations, is in place at the facility. The Program Coordinator has reviewed these policies and procedures with the Medical Director. To insure future compliance, the Medical Director will provide an inservice to all NTP Physicians by 2/28/11 re: documenting the annual physical exam, utilizing this form. To ensure future compliance in a timely fashion, the Program Coordinator will generate a monthly report listing all patients requiring annual physicals no less than 30 days prior to patients' anniversary dates. The Medical Director will maintain oversight and insure compliance with this regulation through Quality Assurance review of charts. The Program Coordinator will review filing protocols with the Office Manager to assure that all documentation is present in each patient's chart. |
715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations
Based on the review of patient records and a discussion with administrative staff, the facility failed to complete the annual evaluation in four of four patient records as required per regulation.
The findings include:
Twenty-three patient records were reviewed on January 5-7, 2011. Four patient records were reviewed for annual evaluation of each patient's status.. Per regulation each patient file shall include the following information: "An annual reevaluation of each patient's status shall be completed by the patient's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient's admission to a narcotic treatment program and shall address the following areas: employment, education and training, legal standing, substance abuse, financial manage,ment abilities, physical and emotional health, fulfillment of treatment objectives and family and community support."
Patient # 1 was admitted 12/5/08. The annual evaluation was dated 9/17/10 with no signature by the counselor. The physician's signature was dated 12/20/10.
Patient # 2 was admitted 10/31/03. The annual evaluation was dated 9/15/10 with no counselor signature The physicians's signature was dated 1/6/11.
Patient #7 was admitted 3/18/09. There was no documentation of an annual evaluation in the patient record.
Patient #13 was admitted 7/23/07. The annual evaluation was signed and dated by the counselor on 9/17/10. The physician signed the evaluation on 12/13/10.
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Plan of Correction
Written Policy and Procedure reflecting State regulations that an annual evaluation take place for each patient is in place at the facility, including a form and format for clearly documenting Counselor reevaluation of each patient's status, medical director's review and signature of each. To insure future compliance, the Program Coordinator will generate a monthly report listing all patients due for annual review at least 30 days prior to patients' anniversary dates. On January 20, 2011, the Program Coordinator provided training to Counseling staff re: these policies and procedures and proper execution of this form. The Program Coordinator will maintain oversight and insure compliance with this regulation through Quality Assurance review of charts. The Program Coordinator will review filing protocols with the Office Manager to assure that this document is present and complete in each patient's chart. |
715.23(e) LICENSURE Patient records
(e) Patient file records, information and documentation shall be legible, accurate, complete, written in English and maintained on standardized forms or electronically.
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Observations
Based on a review of patient records, policy and procedure, and an interview with administrative staff, the facility failed to maintain a data collection and record keeping system that allows for the efficient retrieval of data needed to measure the project's performance.
The findings include:
Patient census reports, take home schedules and policy and procedure were reviewed on January 5-7, 2011. These reports as well as facility policy and procedure did not document accurate admission dates.
A discussion with the clinical coordinator for the narcotic treatment program stated that the practice has been to use the date the patient meets with the physician as the admit date to the clinic. This could not be verified through census reports, take home schedules or policy and procedure.
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Plan of Correction
The executive director has created a separate data field within the agency's electronic data system which has been assigned to specifically track the admission date separate from all other sentinel date fields.
The operations director shall make the appropriate revisions/additions to the agency's applicable policies and procedures to clarify and differentiate the admission date that is to be utilized according to each of the agency's various programs.
The program coordinator shall insure compliance with this procedure through the quality assurance record review process
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