INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on December 4 - 6, 2017 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Tadiso Inc. 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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709.28 (c) LICENSURE Confidentiality
§ 709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record.
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Observations
The facility failed to document an informed and voluntary consent from the client for the disclosure of information contained in the client record in seven of fifteen client records reviewed during the annual licensing inspection conducted on December 4 - 6, 2017.
The name and diagnosis of client # 4 was faxed to the medical insurance company to request prior authorization for medication without the client's written consent.
Client # 4 was admitted on February 24, 2017 and discharged on May 30, 2017. The disclosure occurred on February 24, 2017.
The consent to the medical insurance company completed during the intake process did not include the purpose of disclosure and exceeded 4 Pa. Code 255.5 by allowing for the release of drug test results, medical history, labwork results, discharge summary, treatment plan and intake summary in the following client records.
Client # 1 was admitted on January 6, 2017.
Client # 2 was admitted on July 20, 2017.
Client # 3 was admitted on August 31, 2017.
Client # 5 was admitted on May 16, 2017 and discharged on August 31, 2017.
Client # 6 was admitted on May 11, 2017.
Client # 7 was admitted on July 27, 2017 and discharged on September 19, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The 4 PA Code 255.5 regulations, have been reviewed with the suboxone program staff members who are responsible for obtaining authorization from the insurance company. This review was completed by the Program Director. Medical insurance companies have been verbally informed by the suboxone staff members, that they can not release information other than what is allowed in 4PA Code 255.5. The consent form in the electronic health record for the suboxone program has been modified by the IT Coordinator and reviewed by the Operations Director and only includes the five points permitted in the regulation, and includes purpose for the disclosure. The suboxone intake staff members have been trained by the Operations Director and the Program Director, to have the consent form signed the day of admission and the form will be limited to the 5 points allowed by the regulations. Prior to releasing any information, the suboxone staff members will review the release authorizations to be sure there is a valid release containing a patient signature. The Coordinator of the Suboxone program will be responsible for overseeing these tasks. The Operations Director will ensure this is in compliance. Tadiso will be in compliance effective today, December 12,2017. |
709.33 (a) LICENSURE Notification of termination.
§ 709.33. Notification of termination.
(a) Project staff shall notify the client, in writing, of a decision to involuntarily terminate the client ' s treatment at the project. The notice shall include the reason for termination.
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Observations
Project staff failed to document the client was notified in writing of a decision to involuntarily terminate their treatment at the project in two of four client records reviewed during the annual licensing inspection conducted on December 4 - 6, 2017.
Client # 5 was admitted on May 16, 2017 and involuntarily terminated from treatment on October 31, 2017.
Client # 7 was admitted on July 27, 2017 and involuntarily terminated from treatment on September 19, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Tadiso staff will add 2 forms into the Suboxone electronic health record. Administrative Withdrawal is a notice of withdrawal that will be signed by the patients when they are told that they are being placed on a withdrawal from treatment at Tadiso. The second form, is Withdrawal from Suboxone, to be signed by the patient if they chose to discontinue treatment. The Operations Director will be responsible for adding the forms to the electronic health record. The Coordinator of the program will be responsible for having the patient sign the forms, when applicable. Tadiso will be in compliance with this standard on December 12, 2017. |
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
The facility failed to verify the individual's emergency contact prior to the administration of buprenorphine in seven of seven patient records reviewed during the annual licensing inspection conducted on December 4 - 6, 2017.
Patient # 1 was admitted on January 6, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on January 17, 2017.
Patient # 2 was admitted on July 20, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on July 21, 2017.
Patient # 3 was admitted on August 31, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on September 5, 2017.
Patient # 4 was admitted on February 24, 2017 and discharged on May 30, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on February 24, 2017.
Patient # 5 was admitted on May 16, 2017 and discharged on August 31, 2017 and was prescribed 8 mg/2 mg Suboxone three times daily on May 16, 2017.
Patient # 6 was admitted on May 11, 2017 and was prescribed 8 mg Subutex twice daily on May 12, 2017.
Patient # 7 was admitted on July 27, 2017 and discharged on September 19, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on July 28, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Tadiso staff will attempt to obtain an Emergency Contact for all patients at the time of intake. A Release of Information will also be signed at the time of intake. If the patient refuses to provide an Emergency Contact, it will be noted in the electronic health record. The Coordinator is responsible for all intake duties. The Operations Director will ensure compliance with this standard. Tadiso will be in compliance with this standard effective December 12, 2017. |
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's physician failed to document the basis for the determination of current dependency and evidence of at least a one year history of addiction prior to the administration of buprenorphine in four of seven patient records reviewed during the annual licensing inspection conducted on December 4 - 6, 2017.
Patient # 1 was admitted on January 6, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on January 17, 2017. The physician's documentation of current dependency and one year history was not completed until January 31, 2017.
Patient # 2 was admitted on July 20, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on July 21, 2017. The physician's documentation of current dependency and one year history was not completed until August 1, 2017.
Patient # 4 was admitted on February 24, 2017 and discharged on May 30, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on February 24, 2017. The physician's documentation of current dependency and one year history was not completed until April 11, 2017.
Patient # 7 was admitted on July 27, 2017 and discharged on September 19, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on July 28, 2017. The physician's documentation of current dependency and one year history was not completed until August 1, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Narcotic Treatment Physician is responsible for signing the Documentation of Addiction form ON THE SAME DAY, that he meets with the patient, prior to the writing of the prescription. The Coordinator of the program will oversee compliance and the Operations Director will ensure compliance with this standard which will be in effect, December 12, 2017. |
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 narcotic treatment program failed to document that each female patient was 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 by the program in three of three patient records reviewed during the annual inspection conducted on December 4 - 6, 2017.
Patient # 2 was admitted on July 20, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on July 21, 2017.
Patient # 4 was admitted on February 24, 2017 and was prescribed 8 mg/2 mg Suboxone twice daily on February 24, 2017.
Patient # 6 was admitted on May 11, 2017 and was prescribed 8 mg Subutex twice daily on May 12, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Consent to Treat with Buprenorphine has been amended to include a section for female patients, who are, or who may become pregnant while in treatment at Tadiso. The approved form used for the methadone program, has been duplicated and is included for Tadiso's Suboxone program. The Program Director is responsible for completing this task and ensuring compliance with this regulation. This will be effective December 12, 2017. |
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 narcotic treatment program failed to complete a random monthly urinalysis that included a CLIA waived test for methadone in seven of seven patient records reviewed during the onsite annual licensing inspection conducted on December 4 - 6, 2017.
Patient # 1 was admitted on January 6, 2017.
Patient # 2 was admitted on July 20, 2017.
Patient # 3 was admitted on August 31, 2017.
Patient # 4 was admitted on February 24, 2017 and discharged on May 30, 2017.
Patient # 5 was admitted on May 16, 2017 and discharged on August 31, 2017.
Patient # 6 was admitted on May 11, 2017.
Patient # 7 was admitted on July 27, 2017 and discharged on September 19, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Tadiso will change the rapid testing device to a CLIA approved rapid testing device, which will also test for methadone. In addition, methadone has been added to the testing panel of drugs, at the certified off site lab. The Operations Director is responsible for this task. The Operations Director will ensure that this standard is in compliance on December 12, 2017. |
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
Prior to determining the initial dose, the facility's physician failed to document a consultation with the CRNP (certified registered nurse practitioner) that performed the patient examination in four of four patient records reviewed during the annual licensing inspection conducted on December 4 - 6, 2017.
Patient # 9 was admitted on April 12, 2017.
Patient # 10 was admitted on June 6, 2017.
Patient # 11 was admitted on May 19, 2017 and discharged on August 8, 2017.
Patient # 12 was admitted on March 14, 2017.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The program physician will consult the CRNP, if the CRNP has conducted the intake physical exam and the physician will document his consultation in the case history. The Director of Medical Services is responsible for ensuring compliance with this standard, effective December 14, 2017. |