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 11, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Caron Foundation Detox Unit 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 12, 2008.
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Plan of Correction
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715.2(a)(b) LICENSURE Relationship of Federal and State Regulations
(a) A narcotic treatment program shall comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.
(b) This chapter is intended to supplement the Federal regulations governing narcotic treatment programs in 21 CFR Chapter II, 1300-1399 (relating to Drug Enforcement Administration, Department of Justice).
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Observations
The facility failed to obtain the needed Drug Enforcement Administration (DEA) registration in the facility's name and concurrent CSAT approval required when the facility is providing Subutex. The facility was ordering bulk Subutex in the facility's name without the needed registration and CSAT approval as an Opioid Treatment Program. A physician may order bulk Subutex under his or her DEA registration if the registration address is the same as the facility's address. This would not require separate CSAT and DEA approval.
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Plan of Correction
This was corrected 1-14-08. The responsible person: Director of Nursing contacted the pharmacy and changed the automated ordering practice to the name of the Medical Director who is DEA controlled substance registered. The automated process will insure ongoing compliance. |
715.9(a)(1) 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:
(1) Verify that the individual has reached 18 years of age.
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Observations
Based on staff interviews and a random review of 5 patient records, the facility failed to provide documentation verifying that the individual had reached the age of 18. Additionally, the facility admitted and treated with the agent Subutex, individuals who had not reached the age of 18. Specifically, patient # 3 was 17 years old and patient # 4 was 16 years old. The facility failed to request an exception from the Division to treat individuals under the age of 18.
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Plan of Correction
This was corrected by: automating the NTP Admission Criteria Exception Form and physicians trained in completing for each patient under the age of 18 prior to initiating the Subutex. This was completed 2/11/08. It is the responsibility of the Medical Director to insure this standard in compliance. Monthly quality control chart audits sent to the Director of Nursing for review will insure ongoing compliance.
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715.9(a)(2) 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:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
Based on staff interviews and a random review of 5 patient records, the facility failed to document that the individual's identity including name, address, date of birth, and visual identity had been verified.
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Plan of Correction
This was corrected by documenting and scanning into the electronic medical record the photo identification of the patient. The admission counselor completes this. The medication nurse is responsible to insure this is completed prior to starting Subutex. Ongoing compliance will be insured by the process of admissions notifying the medical unit if no visual identification is available. Training by Director of Referral Relations for admission staff and nursing completion date by 3/1/08. |
715.9(a)(3) 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:
(3) Obtain a drug use history and current drug use status of the individual.
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Observations
The facility failed to develop a complete drug use history. The computerized format addresses drug use for the past 30 days only. The severity of the individual's drug use beyond 30 days cannot be determined.
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Plan of Correction
This information is placed in the electronic medical record in the clinical domain under the substance history folder. It is also found in the assessment folder. The information was present in the clinical records at the time of the review. The Quality Analyst revised a guide to the EMR for the surveyors 2/7/08. Ongoing compliance will be insured by supplying the guide for all surveyors.
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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
The facility failed to document in 5 of 5 patient records the basis for the physician's determination of current opioid dependence. The buprenorphine physician's evaluation form was completed 3 days to 4 months after the patient was admitted and medicated using the agent Subutex.
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Plan of Correction
This was corrected by the evaluation being completed by the physician prior to ordering the Subutex. Ongoing compliance will be insured with a daily list of evaluations required. This correction is the responsibility of the Medical Director. Training will occur by the VP of Clinical Services by 3/1/08 with ongoing supervision to insure ongoing compliance. The exception granted 7/30/04 by the Division of Alcohol Program Licensure will be followed. |
715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
The facility failed to obtain a complete urine drug screen prior to the administration of Subutex, a narcotic agent. A complete urine drug screen is not complete until the results from the CLIA and Department of Health approved laboratory have been received.
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Plan of Correction
A local hospital is being contracted to run these urine drug screens 24 hours per day 7 days per week with results faxed or phoned prior to intiating Bup. This is the responsibility of the Director of Nurses with target date of 4/1/08.
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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 a review of patient records and staff interviews, the facility failed to develop a basic evaluation of the patient using information collected during the detoxification experience.
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Plan of Correction
In order to correct this deficiency, the evaluative summary progress note titled Nursing Admit Note has been instituted effective 2/12/08. The DON has trained the nursing staff in the use of this note. This note provides an evaluative summary of the nursing assessment including any patient pressing issues as well as major findings concerning the patient. On going compliance will be insured with short-term chart review process by Quality for 3-6 months following implementation. |
715.23(f) LICENSURE Patient records
(f) If a narcotic treatment program keeps patient information in more than one file or location, it is the responsibility of the narcotic treatment program to provide the entire patient record to authorized persons conducting narcotic treatment program approval activities at the narcotic treatment program, upon request.
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Observations
The facility failed to provide access to the components of the computerized record. The facility's information technology department failed to give the required clearances in a timely manner for access to the patient records and supporting documentation. Licensing staff were denied access to critical components upon initial attempts to access the information.
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Plan of Correction
This was corrected by having the two Pa.Department of Health access accounts (PA State 1 and PA State 2) added to the QI and Training Group in the Caron IMS Active Directory control. Over time, access to specific repositories can change. Since QI is one of the few approved groups to have access to basically all types of data, IMS felt the best approach would be to add these two access ID's to that group. That way, should anything change before the next audit, no one will need to remember to update the security for the State. Since they will inherit the access rights of the QI Group, all documents should be accessible. Any new access requirements given to QI will automatically be available to the Department of Health. |
715.26(b) LICENSURE Security
(b) Each narcotic treatment program shall provide the Department with a specific plan describing the efforts it will make to avoid disruption of the community by its patients and the actions it will take to assure responsiveness to the community. This plan shall designate a staff member to act as community liaison.
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Observations
The facility failed to develop a specific plan to minimize community disruption that may be caused by the facility, its patients or staff. The plan needs to address who is doing what activity at what frequency to foster positive community relationships and maintain an open dialogue on issues critical to the community.
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Plan of Correction
The corrective action will include: The EC 101 policy will be revised to include specific plans to minimize community disruption caused by the facility and/or patients. This will include who is doing what activity at what frequency to foster community relationships and maintain an open dialogue to issues critical to the community. The Director of Quality will do this by 5/1/07. |