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 Methadone, in the treatment of narcotic addiction. This inspection was conducted on March 26 and 27, 2014, by staff from the Department of Drug and Alcohol Programs, Program Licensure Division. Based on the findings of the on-site inspection, Horsham Clinic 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.
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Plan of Correction
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715.3(a)-(h) LICENSURE Approval of narcotic treatment programs
(a) An entity shall apply for and receive approval as required from the Department, DEA and CSAT or an organization designated by the Substance Abuse and Mental Health Services Administration (SAMHSA), under the authority of section 303 of the Controlled Substances Act (21 U.S.C.A. § 823) and sections 501(d), 509(a), 543, 1923, 1927(a) and 1976 of the Public Health Service Act (42 U.S.C.A. §§ 290aa(d), 290bb-2(a), 290dd-2, 300x-23, 300x-27(a) and 300y-11), prior to offering services within this Commonwealth as a narcotic treatment program. Application for approval shall be made simultaneously to the Department, DEA and CSAT or SAMHSA designee.
(1) The Department will forward a recommendation for approval to the Federal officials after a review of policies and procedures and an onsite inspection by an authorized representative of the Department and after a determination has been made that the requirements for approval under this chapter have been met.
(2) The decision of the Federal officials set forth in 21 CFR Chapter II (relating to Drug Enforcement Administration, Department of Justice) or other Federal statutes shall constitute the final determination on the application for approval by DEA and CSAT or SAMHSA designee.
(b) A narcotic treatment program shall be licensed under the Department's regulations for drug and alcohol facilities in Chapter 157, 704, 705, 709 or 711. When a licensee applies to operate a narcotic treatment program, the history component of the application of the licensee shall include the licensee's record of operation of any facility regulated by any State or Federal entity. A narcotic treatment program may not be recommended for approval unless licensure has been obtained under Chapters 157, 704, 705, 709 or 711.
(c) The Department will grant approval as a narcotic treatment program after an onsite inspection and review of narcotic treatment program policies, procedures and other material, when the Department determines that the requirements for approval have been met.
(d) The Department will inspect a narcotic treatment program at least annually to determine compliance with State narcotic treatment program regulations. This inspection shall consist of an onsite visit and shall include an examination of patient records, reports, files, policies and procedures, and other similar items to enable the Department to make an evaluation of the status of the narcotic treatment program. The Department may inspect the narcotic treatment program without notice during any regular business hours of the narcotic treatment program.
(e) During the inspection process, a narcotic treatment program shall make available to the authorized staff of the Department full and free access to its premises, facilities, records, reports, files and other similar items necessary for a full and complete evaluation. The Department may make copies of materials it deems necessary under 42 CFR 2.53 (relating to audit and evaluation activities) and §§ 709.15 and 711.15 (relating to right to enter and inspect; and right to enter and inspect).
(f) The authorized Department representative may interview patients and staff as part of the inspection process.
(g) The Department may grant approval as a narcotic treatment program after an onsite inspection when the Department determines that a narcotic treatment program satisfies the following:
(1) It has substantially complied with applicable requirements for approval.
(2) It is complying with a plan of correction approved by the Department with regard to any outstanding deficiencies.
(3) Its existing deficiencies will not adversely alter the health, welfare or safety of the facility 's patients.
(h) Notification of deficiencies involves the following:
(1) The authorized Department representative will provide the program director with a record of deficiencies with instructions to submit a plan of correction.
(2) The narcotic treatment program shall complete the plan of correction and submit it to the Department within 21 days after the last day of the onsite inspection.
(3) The Department will not grant approval as narcotic treatment program until the Department receives and approves a plan of correction.
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Observations
Based on a review of administrative documentation, and an a discussion with facility staff, the facility failed to provide a copy of the narcotic treatment program policies and procedures manual relating to the narcotic treatment program.
The findings include:
Administrative documentation was reviewed on March 26 -27, 2014. The facility's policies and procedures manual relating to the narcotic treatment program was not among the documentation presented to the Licensing Specialist. When facility staff were asked to present a copy of the manual outlining the policies and procedures relating to the narcotic treatment program, they were unable to present it.
This findings were discussed with the director.
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Plan of Correction
A flash drive containing all the policies related to the Narcotic Treatment Program was sent to the Department of Drug And Alcohol Programs via certified mail. A receipt of delivery was signed on 4/21/14. Policies were placed in a binder, maintained by the Director of Quality Improvement, and is available for on site review upon request. |
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 patient records, the facility failed to ensure that the narcotic treatment physician documented the basis for determination of dependency in three of three records reviewed.
The findings included:
Ten patient records were reviewed during the on-site inspection. Three patient records were identified as receiving opiate medication for detoxification, # 6, 7 and 8.
Patient # 6 was admitted on 3/19/2014. There was no documentation of the basis for determination of dependency in the patient record at the time of the review.
Patient # 7 was admitted on 2/19/2014 and discharged on 3/11/2014. There was no documentation of the basis for determination of dependency in the patient record at the time of the review.
Patient # 8 was admitted on 3/11/2014. There was no documentation of the basis for determination of dependency in the patient record at the time of the review.
This findings were discussed with the director.
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Plan of Correction
The Chief Executive Officer met with the NTP treating physicians and re-trained them regarding the expectation and need to document dependency prior to the use of a narcotic agent. The Director of Quality Improvement will audit 50 charts per month to ensure ongoing compliance. |
715.10(f) LICENSURE Pregnant patients
(f) The narcotic treatment program shall ensure that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.
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Observations
Based on the review of patient records, the facility failed to ensure that each female client was informed of the risks to her or her unborn child in one of three records reviewed.
The findings included:
Ten patient records were reviewed during the on-site inspection. Three patient records were identified as receiving opiate medication for detoxification. One record was of a female patient, # 7. The patient record did not contain documentation of informing the female patient of the required information at the time of the review.
This findings were discussed with the director.
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Plan of Correction
The Chief Executive Officer met with the NTP treating physicians and retrained them regarding the need to inform female patients of risks to themselves and their unborn children. The Director of Quality Improvement will aduit 50 charts per month to ensure ongoing 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 obtain an informed, voluntary, written consent prior to the administration of a narcotic agent in three of three records reviewed.
The findings included:
Ten patient records were reviewed during the on-site inspection. Three patient records were identified as receiving opiate medication for detoxification, # 6, 7 and 8. The patient records did not contain documentation of an informed, voluntary, written consent with the required information at the time of the review.
This findings were discussed with the director.
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Plan of Correction
The Chief Executive Officer met with the NTP treating Physicians and retrained them regarding the need to obtain written consent prior to the use of a narcotic agent. The Director of Quality Improvement will audit 50 charts per month to ensure ongoing compliance. |
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
Based on the review of patient records, the facility failed to document a complete initial drug-screening urinalysis prior to the administration of a narcotic agent in three of three records reviewed.
The findings included:
Ten patient records were reviewed during the on-site inspection. Three patient records were identified as receiving opiate medication for detoxification, # 6, 7 and 8.
Patient # 6 was admitted on 3/19/2014. 20 mg of methadone was given to the patient on 3/19/2014 at 1 p.m. An instant drug test was used on admission. A complete initial drug-screening urinalysis was not documented in the record at the time of the review.
Patient # 7 was admitted on 2/19/2014 and discharged on 3/11/2014. 10 mg of methadone was given to the patient on 2/19/2014 at 8 p.m. A complete initial drug-screening urinalysis was not documented in the record at the time of the review.
Patient # 8 was admitted on 3/11/2014. 25 mg of methadone was given to the patient on 3/11/2014 at 7:50 p.m. An instant drug test was documented on 3/11/2014 at 11 a.m. that was negative for opiates. A second instant drug test was documented on 3/11/2014 at 7:15 p.m. that was reviewed on 3/12/2014 at 11:15 a.m. A complete initial drug-screening urinalysis was not documented in the record at the time of the review.
This findings were discussed with the director.
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Plan of Correction
Horsham Clinic will utilize the facility's lab vendor, LabCorp, for drug screenig urinalyses prior to the adminsitration of Methadone. The Director of Nursing or designee will audit 40 active charts each month to ensure ongoing compliance to standard. results of the audits will be discussed and reviewed by the Performance Improvement Committee on a quarterly basis. |