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 19-20, 2014 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 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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715.10(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 a review of patient records, the facility failed to ensure 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 or dispensed by the program in comprehensive maintenance treatment, in one of five patient records.
The findings include:
Eighteen patient records were reviewed on March 19-20, 2014. Five of the patient records reviewed were for females that were admitted in the last year. The facility was required to include documentation of the possible risks associated with pregnancy and methadone maintenance treatment in all five patient records. Patient record #4 did not include documentation that the facility provided her with information regarding the risks associated with pregnancy and methadone maintenance treatment.
Patient #4 was admitted to treatment on October 4, 2013 and was pregnant at the time of admission. There was no documentation included in patient record #4 to demonstrate that the patient was notified of the possible risks 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 treatment.
The findings were discussed with the project director and were not disputed.
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Plan of Correction
Each female patient will be fully informed of the possible risks 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. The nursing supervisor or staff LPN will complete the documentation with the patient who will sign the form. The Nursing Supervisor will monitor compliance with this before the patient is medicated on their first day of treatment. |
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 a review of patient records, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment in one of seven patient records.
The findings include:
Eighteen patient records were reviewed on March 19-20, 2014. Seven patient records were reviewed for the completion of an informed, voluntary written consent prior to the administration of a narcotic agent. The facility failed to document the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent in patient record # 4.
Patient # 4 was admitted into treatment on October 4, 2013. The patient received their initial dose of methadone on October 7, 2013. There was no documentation of an informed, voluntary written consent prior to the administration of a narcotic agent in patient record # 4.
The findings were discussed with the project director and were not disputed.
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Plan of Correction
The Nursing Supervisor or staff LPN will be responsible for ensuring that all new or transferring patients sign the informed, voluntary consent prior to the administration of a narcotic agent for maintenance treatment. The Nursing supervisor will monitor all new admissions for compliance prior to administering the first dose of medication. |
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 a review of patient records, the facility did not have documentation of an initial drug-screening urinalysis for each prospective patient prior to dosing in three of three patient records.
The findings include:
Eighteen patient records were reviewed on March 19-20, 2014. Three of the patients reviewed were new admits and were not transferred from another clinic. All three of these patient records required documentation of a complete initial drug-screening urinalysis prior to dosing. Patient records #3, 4 and 6 did not include documentation of a complete initial drug-screening urinalysis prior to dosing.
Patient #3 was admitted and dosed on July 5, 2013. The initial urinalysis results documented in the patient record were dated July 7, 2013.
Patient #4 was admitted on October 4, 2013 and dosed on October 7, 2013. The initial urinalysis results documented in the patient record were dated October 8, 2013.
Patient #6 was admitted on January 23, 2014 and dosed on January 24, 2014. The initial urinalysis results documented in the patient record were dated January 25, 2014.
The project director and nursing supervisor were interviewed. There was no additional documentation available to show that the urinalysis results were obtained prior to dosing for the aforementioned patients. The findings were not disputed.
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Plan of Correction
Tadiso will ensure that all patients have documentation of drug-screening urinalysis for each prospective patient prior to receiving their initial dose. The Director of Clinical Services,the Assistant Director of Clinical Services, or the Nursing Supervisor will monitor compliance with this process and document the pertinent information in the patient chart. |
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
Based on a review of patient records, the facility failed to notify the patient, in writing, of a decision to involuntarily terminate the patient's treatment at the project, in two of three patient records.
The findings include:
Eighteen patient records were reviewed on March 19-20, 2014. Three of the patients reviewed were involuntarily terminated from treatment at the project. The facility failed to notify the patient, in writing, of a decision to involuntarily terminate the patient's treatment at the project, in patient records # 13 and 15.
Patient #13 was admitted into treatment on May 21, 2008 and was involuntarily terminated from the project on December 24, 2013. There was no documentation of written notification provided to the patient.
Patient #15 was admitted into treatment on October 8, 2002 and was involuntarily terminated from the project on August 9, 2013. There was no documentation of written notification provided to the patient.
The project director was interviewed and the findings were not disputed.
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Plan of Correction
All patients will be notified, in writing, of a decision to involuntarily terminate the patient from the program. The Director of Clinical Services will be responsible for monitoring all involuntary terminations to ensure compliance. |