INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on August 4 - 5, 2016 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, WPIC Narcotic Addiction Treatment Program was found not to be in compliance with the applicable chapters of 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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715.10(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
The facility failed to document that each female patient was fully informed of the possible risks to her or her unborn child in two of two female patient records reviewed during the annual licensing inspection conducted on August 4 - 5, 2016.
Patient # 9 was admitted into treatment on November 25, 2015 and discharged on April 7, 2016. Patient # 9 was prescribed Suboxone on November 25, 2015.
Patient # 10 was admitted into treatment on September 28, 2015 and discharged on March 3, 2016. Patient # 10 was prescribed Suboxone on October 5, 2015.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Under the direction of the Facility Director or designee:
A.)All physicians will be advised that all female individuals will be informed of possible risk should they become pregnant while on buprenorphine by 9/15/16.
B.)A review of harmful effects will be completed and signed by the physician and the individual on the first physician appointment beginning 9/16/16.
C.)Monthly chart audits will be conducted by the program supervisors beginning 10/1/16 for 4 months to verify that a Harmful Effects document has been signed by female individuals.
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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 complete a random urinalysis for each patient prescribed Suboxone in two of four patient records reviewed during the annual licensing inspection conducted on August 4 - 5, 2016.
Patient # 8 was admitted into treatment on December 12, 2012. Monthly drug screens were not documented for the following months: November 2015, January 2016, May 2016 and July 2016.
Patient # 10 was admitted into treatment on September 25, 2016 and discharged on March 3, 2016. A monthly drug screen was not documented for February 2016.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Under the direction of the Facility Director or designee:
A.)Effective 8/31/16, all staff will be reminded that all Buprenorphine individuals must have a monthly drug screen. These monthly drug screens will be random.
B.)Effective 9/1/16, Program Supervisors will review of urine drug screen results of Buprenorphine individuals monthly for four months to verify compliance with this practice.
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715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
The facility's physician failed to adhere to the dosing protocol listed on the medication by ordering that single dose Suboxone film be cut in one of four patient records reviewed during the annual licensing inspection conducted on August 4 - 5, 2016.
Per the manufacturer's dosing and administration instructions "Suboxone sublingual film must be administered whole". Prescriptions need to be for the manufactured quantities of 12 mg/3 mg, 8 mg/2 mg, 4 mg/1 mg or 2 mg/.5 mg doses.
Patient # 10 was admitted into treatment on September 28, 2015 and discharged on March 3, 2016. The physician prescribed 1/8 film of Suboxone 8 mg/2 mg daily on October 5, 2016 and February 8, 2016.
The findings were reviewed with facility staff during the licensing process.
This is a repeat citation from the June 8 - 9, 2015 licensing inspection.
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Plan of Correction
Under the direction of Facility Director or designee:
A.) All physicians who prescribe Buprenorphine will receive continued education on knowing the manufacturer's directions for prescribing. Continued education will be provided by Addiction Medicine Medical Director and will be completed by 10/1/16.
B.) All new Buprenorphine individual records and records for individuals tapering off Buprenorphine will be reviewed for 3 months beginning 10/1/16 for prescribing practice.
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711.93(c)(1)(i) LICENSURE Confidentiality - Client Identity/Records
711.93. Client records.
(c) Confidentiality.
(1) A written procedure shall be developed by the project director which complies with 4 Pa. Code 255.5 (relating to projects and coordinating bodies: disclosure of client-oriented information). The procedure shall include, but not be limited to:
(i) Confidentiality of client identity and records.
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Observations
The facility failed to obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record in six of six client records reviewed during the annual licensing inspection conducted on August 4 - 5, 2016.
The facility utilizes a form (3CNTB number 0421-1015-(M)(P)(l)-KEY) entitled "UPMC - Consent for Mental Health and Drug and Alcohol Treatment, Payment and Health Care Operations (TPO)". This form is a combination of a consent to treatment and a consent to release information. The client is required to sign the consent form during the intake process in order to receive treatment services. This is not a voluntary consent, as the client cannot receive treatment without also consenting to release information at the same time. In addition, the form is not compliant with Federal and State confidentiality laws and regulations as follows:
Section I - number 4, Section IV - numbers 3 and 4 and Section V - numbers 3 and 7 violate Federal Law 42 CFR Part 2, Subpart C, in that they are a general consent to release information. The components of a valid consent are not included as required by 42 CFR Part 2, Subpart C, 2.31.
Section IV - number 2 - The statement pertaining to UPMC privacy practices, limits information released to agencies/individuals that are not restricted by 4 Pa. Code 255.5 (b).
The last section titled "minor able to consent for care" does not take into consideration the drug and alcohol laws and regulations pertaining to minors (71 P.S. 1690.112 (a)(b) and 42 CFR Part 2, Subpart B, 2.14 (b).
Client # 1 was admitted into treatment on September 21, 2015 and discharged on April 13, 2016. The UPMC consent form was signed on September 21, 2015.
Client # 9 was admitted into treatment on November 25, 2015 and discharged on April 7, 2016. The UPMC consent form was signed on November 25, 2015.
Client # 10 was admitted into treatment on September 28, 2015 and discharged on March 3, 2016. The UPMC consent form was signed on September 28, 2015.
Client # 11 was admitted into treatment on June 8, 2016. The UPMC consent form was signed on June 8, 2016.
Client # 13 was admitted into treatment on February 29, 2016. The UPMC consent form was signed on February 29, 2016.
Client # 14 was admitted into treatment on June 13, 2016. The UPMC consent form was signed on June 13, 2016.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Under the direction of the Facility Director or designee:
A.)Effective 9/1/16, individuals will be offered releases of information to sign to insurance providers upon admission and then annually. The release will be voluntary and separate from the consent to treatment. For all active patients identified in this citation (1,9,10,13,14) separate releases to insurance providers will be reviewed and signed by 10/1/16.
B.)Monthly chart audits will be conducted by the program supervisors beginning 10/1/16 for 4 months to verify that releases of information have been offered to individuals for their insurance company and documented in the medical record.
C.)Consents utilized will be compliant with federal and State confidentially laws and regulations.
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