INITIAL COMMENTS
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This report is a result of an onsite follow-up inspection regarding the plans of correction for the November 10, 2016 licensure renewal inspection. The follow-up inspection was conducted on February 28, 2017 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the onsite follow-up inspection, Pyramid Healthcare, 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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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
The facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment in five of five client records reviewed on February 28, 2017.
Five client records were reviewed as inpatient maintenance records. All five were reviewed for the completion of an informed, voluntary written consent. There was no documentation of a written consent for maintenance treatment in client records # 8, 9, 10, 11 and 12.
Clients #8, 9, 10 and 12 were moved to maintenance treatment after being in detox. The informed consent that was signed by these clients stated specifically that they were consenting to the use of buprenorphine for the purposes of detoxification, there was no documentation of maintenance treatment on this consent form. Client #11 was on buprenorphine while admitted and the facility failed to document an informed consent prior to the administration of buprenorphine by facility staff.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All clients who are accepting
maintenance treatment will have an
informed, voluntary written consent
signed prior to initiation of the
treatment. The facility Medication
Assisted Therapy Nurse/Case
Manager will facilitate the consent
signature. The Nurse Manager will educate everyone involved in the maintenance treatment that viewing the consent is necessary prior to administering the first dose. Education by the Nurse Manager will be completed by 4/1/17. The Charge Nurse will monitor 100% of all MAT recipient records monthly to ensure consents are signed. Monitoring will continue until 2 consecutive months are 100% in 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
The facility failed to obtain a complete drug screen urinalysis prior to the administration of Subutex, a narcotic agent, in one of twelve client records. A complete drug screen includes receiving the results from the CLIA and Department of Health approved laboratory.
Twelve Subutex client records were reviewed on February 28, 2017. All twelve client records were required to have documentation of a complete a drug screen urinalysis prior to the administration of Subutex, a narcotic agent. The facility failed to obtain a complete drug screen urinalysis prior to the administration of Subutex, a narcotic agent in client record #7.
The facility has Department of Health and CLIA certificates as a lab and can perform dipstick tests onsite; however, not all client records reviewed had documentation of a dipstick test performed onsite.
Client # 7 was admitted on 1/7/17 and received their first dose of Subutex on 1/8/17. There were no dipstick or lab results documented prior to the first dose of Subutex on 1/8/17.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Re-education of all nursing staff that: copies of all CLIA certified urine
dipstick drug screens will be kept
with the clients medication
administration record for easy
access and reference and the nurse
administering the first dose will
check to ensure the client has a
dipstick on record prior to dosing
the first dose of Subutex. The nurse
who begins the Subutex will initial
the CLIA certified urine dipstick
screen indicating the test was done
prior to dosing of Subutex. The Nurse Manager will ensure retraining is completed by 4/1/2017. The Charge Nurse will monitor 100% of all detox resident charts, nightly to ensure the urine dipstick is recorded. The monitor will continue until 100% compliance is noted for 2 consecutive weeks.
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