INITIAL COMMENTS |
This report is a result of an administrative review of the written report of the findings of an on-site methadone monitoring inspection conducted for the approval to use a narcotic agent, specifically Methadone, in the treatment of narcotic addiction. This inspection was conducted on September 18, 19 and 20, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the administrative review of findings from the on-site inspection, John F. Kennedy Behavioral Health Center, 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 administrative review: |
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 the review of clinical documentation, the physician failed to accurately document the basis for determining a minimum one year history of dependency in one of one patient record.
The findings include:
Sixteen patient records were reviewed September 18-20, 2012. One patient record was reviewed for physician documentation of the basis for determining a current and minimum one year history of dependency.
Patient # 1 was admitted April 9, 2012. The physician utilized a check list to document the justification for determining one year or more of narcotic addiction. The options were (1)patient statement; (2) re-admission; (3) transfer patient. None of the options on this form pertained to the patient who was a new admission. The patient statement was not sufficient justification.
This same form is used for all admissions. The physician must document the determining factors for his/her decision to admit a patient into a narcotic treatment program for methadone maintenance.
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Plan of Correction On October 15, 2012 our physician's justification form was revised and our physician and nursing staff received training on the proper completion of this document to clearly reflect the physician's justification for admitting a new patient to methadone maintenance. The Clinical Supervisor will monitor patient records at admission to ensure compliance. |
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, the facility failed to ensure that the patient signed the informed consent to treatment prior to the administration of a narcotic agent in three of eight patient records.
The findings include:
Sixteen patient records were reviewed on September 18-20, 2012. Informed consent to treatment documentation was reviewed in eight patient records. The facility did not include documentation of informed patient consent to treatment prior to the administration of a narcotic agent in patient records # 6, 10 and 14.
Patient # 6 was admitted and dosed November 16, 2011. A signed, informed patient consent to treatment prior was not documented in the patient record until December 1, 2011.
Patient # 10 was admitted March 12, 2012 and dosed on March 13, 2012. A signed, informed patient consent to treatment prior was not documented in the patient record until June 7, 2012.
Patient # 14 was admitted and dosed January 5, 2012. A signed, informed patient consent to treatment prior was not documented in the patient record until January 13, 2012.
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Plan of Correction On October 15, 2012 the procedure for obtaining patient consent to methadone maintenance was revised to ensure that the patient's written consent is obtained before methadone is administered to the patient. The Lead Nurse will monitor this procedure for all admissions to ensure compliance. |
715.14(b) LICENSURE Urine testing
(b) A narcotic treatment program shall develop and implement policies and procedures to ensure that urine collected from patients is unadulterated. These policies and procedures shall include random observation which shall be conducted professionally, ethically and in a manner which respects patient privacy.
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Observations Based on physical plant inspection and discussion with facility staff, the facility implemented a new urine drug screen monitoring camera system with the monitoring screen located in the clinical supervisor's office where patients, staff and visitors could potentially access the system and violate the patient's privacy.
The findings include:
The clinical supervisor is not a licensed medical professional. The monitoring camera in the lavatory used to collect urine for routine drug screens projects to the clinical supervisor's computer monitor. This is an unacceptable violation of the patient's privacy.
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Plan of Correction On October 10, 2012 the urine drug screen monitor was placed in the pharmacy. All urine drug screens are monitored by medical staff only. |
715.16(a)(1) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(1) A narcotic treatment program may give take-home medications only to a patient who the narcotic treatment physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program.
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Observations Based on the review of patient records, the facility failed to ensure the patients with take home privileges continued to be responsible and able to handle narcotic drugs outside the facility in three of four patient records reviewed.
The findings include:
Sixteen patient records were reviewed September 18-20, 2012. Four patient records required documentation the patient continued to remain in compliance with the criteria used to determine eligibility for take home privileges.
Patient # 4 received two weekly take home bottles. Upon review of the patient's dosing records, it was noted the patient is regularly absent one or two days a week in addition to his take home days. This was brought to the attention of the supervisor and dosing nurse, who confirmed the patient was usually absent on Mondays and this is not a take home day. None of the absences have been addressed. Regular attendance is a criteria for take home bottle privileges.
Patient # 12 receives five take home bottles per week. The patient provided an adulterated urine specimen in September 2012. This was not addressed as a potential for rescinding take home privileges.
Patient record # 14 contains documentation that demonstrates the patient was initially granted exception take home bottles for three weeks in 2008, but take home privileges were continued. In 2009, the patient had a suicide attempt and take home privileges were continued. December 30, 2011 documentation noted illicit and prescribed use of benzodiazapine medication. Take home privileges have continued without benefit of anyone reviewing the lack of adherence to the criteria.
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Plan of Correction In October of each year, the Clinical Supervisor will formally review all patients who have take-home privileges to ensure they continue to be responsible and capable of managing their medication outside the facility. This review will be documented in each person's record by the Clinical Supervisor. |
715.20(3) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(3) The transferring narcotic treatment program shall document what materials were sent to the receiving narcotic treatment program.
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Observations Based on a review of patient records, the narcotic treatment program failed to document what materials were sent to the receiving narcotic treatment program in three of four patient records.
The findings include:
Sixteen patient records were reviewed on September 18-20, 2012. Two records required documentation of the materials sent to the receiving provider of the transfer. In patient records # 14 and 16 there was no documentation of the materials sent to the receiving narcotic treatment program.
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Plan of Correction On October 15, 2012 a transfer material documentation form was created to clearly indicate what materials were sent to the receiving methadone clinic. A copy of the fax receipt will also be attached to the form as further evidence that materials were sent to the receiving narcotic program. The Clinical Supervisor will review all transfer-out records to ensure compliance. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations Based on the review of patient records, the facility failed to restrict the reasons for involuntary termination to those reasons allowed by regulation in one of one patient record.
The findings include:
Sixteen patient records were reviewed September 18-20, 2012. One patient record was reviewed for involuntary, or therapeutic, discharge.
Patient # 6 was admitted November 16, 2011. The patient was given notice on April 20, 2012 that the counselor had decided to give the patient a 14 day detoxification due to missing counseling sessions in March and April, 2012.
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Plan of Correction Effective 11/01/2012 all patient terminations will be restricted to those allowed by State regulation. A staff training on the appropriate termination process will be conducted on 11/6/2012 by the Clinical Supervisor. The Clinical Supervisor will also monitor involuntary terminations to ensure compliance.
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715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations Based on the review of patient records, the facility failed to complete case consultations as required in six of eight patient records reviewed.
The findings include:
Sixteen patient records were reviewed on September 18-20, 2012. Eight patient records were reviewed for case consultations.
Patient # 1 was admitted April 9, 2012. A quarterly case consultation should have been completed in July 2012. There was no case consultation in the patient record as of September 20, 2012.
Patient # 2 was admitted in May 2010. An annual case consultation should have been completed in May 2012. There was no case consultation in the patient record as of September 20, 2012.
Patient # 4 was admitted December 26, 1996. An annual case consultation should have been completed in December 2011. The only case consultation in the patient record at the time of the monitoring was dated March 28, 2012, three months late.
Patient # 8 was admitted April 26, 2005. An annual case consultation should have been completed in April 2012. There was no case consultation in the patient record as of September 20, 2012.
Patient # 10 was admitted March 12, 2012. A quarterly case consultation should have been completed in June and September 2012. There were no case consultations in the patient record as of September 20, 2012.
Patient # 13 was admitted January 28, 2003. An annual case consultation should have been completed in January 2012. There was no case consultation in the patient record as of September 20, 2012.
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Plan of Correction On October 23, 2012 a staff training will be held to improve the timely documentation on case consultations. We will utilize colored paper to make it easier to locate this form in each client's record. The Clinical Supervisor will monitor client records to ensure compliance. |
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, the facility failed to complete annual evaluations in accordance with the regulations in three of six patient records reviewed.
The findings included:
Sixteen patient records were reviewed September 18-20, 2012. Six patient records required documentation of an annual clinical review. Three were not completed as required.
Patient # 4 was admitted December 26, 1996. An annual evaluation of the patient's status was to have been completed by December 2011. There was no annual evaluation in the patient's record as of September 20, 2012.
Patient # 5 was admitted February 24, 1977. An annual evaluation of the patient's status was to have been completed by February 2012. There was no annual evaluation in the patient's record as of September 20, 2012.
Patient # 8 was admitted April 26, 2005. An annual evaluation of the patient's status was to have been completed by April 2012. There was no annual evaluation for April 2012 in the patient's record as of September 20, 2012. The last annual evaluation was documented April 26, 2011.
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Plan of Correction On October 30, 2012 a staff training will be held to improve the timely completion on annual evaluations. We will also utilize colored paper to make this form easier to locate annual evaluations in the client's record. The Clinical Supervisor will monitor client records to ensure compliance. |