INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and buprenorphine monitoring inspection conducted on October 24 - 25, 2017 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Stepping Stones Unit @ Meadville Medical Center 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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715.9(a)(1) 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:
(1) Verify that the individual has reached 18 years of age.
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Observations
The facility failed to verify the individual had reached 18 years of age prior to administration of buprenorphine in one of four detoxification patient records reviewed during the annual licensing inspection conducted on October 24 - 25, 2017.
Patient # 14 was admitted on 10/9/17 and discharged 10/14/17. Patient # 14 was administered buprenorphine on 10/11/17.
The findings were reviewed with facility staff during the inspection process.
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Plan of Correction
Intake Coordinators have been assigned to insure that each patient admitted has a photo identification card and insurance card or insurance printout verifying same birthdate that patient reports, as part of their medical record. If patient fails to bring those documents at time of admission, Intake Coordinator will tag chart and notify Program Supervisor. Patient's significant others or case managers, as applicable, will be contacted by Intake Coordinator to provide the necessary identification. Patient will wear ID band from time of admission with information they have given to the hospital regarding their identity and will continue to wear this as ID verification is conducted. If patient does not have photo identification due to not having a valid driver's license, means of obtaining another suitable photo identification card will be explored and executed. The unit list used to inform referring providers what documents are needed on prospective patients has been amended to include these documents stated above. Staff has been oriented to this procedure. This procedure is underway and all current patients have been included in this process. The Intake Coordinator will check all new admissions to the program and will update Program Supervisor accordingly. |
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 identity including name, address and date of birth prior to administration of buprenorphine in one of four detoxification patient records reviewed during the annual licensing inspection conducted on October 24 - 25, 2017.
Patient # 14 was admitted on 10/9/17 and discharged 10/14/17. Patient # 14 was administered buprenorphine on 10/11/17.
The findings were reviewed with facility staff during the inspection process.
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Plan of Correction
Patient is asked for name, address, date of birth and other demographic and identifying information upon registration to the Emergency department by registration staff and again by Emergency Department Registered nurses. When patient is transferred to Stepping Stones, Registered nursing staff or licensed practical nursing staff again verify this information and place ID band on patient's wrist with what patient has reported. If patient is a direct admission, upon arrival to the unit the patient is asked for this information by the unit Registered Nurse who checks it against records received from the referring facility. Patient belongings are checked and any identification cards and insurance information is checked, scanned and locked up for safekeeping. Intake Coordinators have been assigned to insure that each patient admitted has a photo identification card and insurance card or insurance printout verifying same birthdate that patient reports, as part of their medical record. If patient fails to bring those documents at time of admission, Intake Coordinator will tag chart and investigate means to have those documents provided to this facility or to have copies obtained from entities of origin. If patient does not have photo identification due to not having a valid driver's license, means of obtaining another suitable photo identification card will be explored and executed. The Intake Coordinator will spearhead this process and report all findings, especially if patients do not have this identification, to Program Supervisor.The unit list used to inform referring providers what documents are needed on prospective patients has been amended to include these documents stated above. Staff has been oriented to this procedure. Intake Coordinator has begun this process and all current patients have been checked for identification and results reported to Program Supervisor. |
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 in the patient's record the basis for determination of current dependency prior to administration of buprenorphine in four of four detoxification patient records reviewed during the annual licensing inspection conducted on October 24 - 25, 2017.
Patient # 9 was admitted 10/21/17 and was administered buprenorphine on 10/22/17.
Patient # 10 was admitted 5/16/17 and discharged on 5/20/17. Patient #10 was administered buprenorphine on 5/17/17.
Patient # 12 was admitted 9/29/17 and discharged on 10/10/17. Patient #12 was administered buprenorphine on 10/1/17.
Patient # 14 was admitted 10/9/17 and discharged on 10/14/17. Patient #12 was administered buprenorphine on 10/11/17.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Physicians have been educated regarding the regulations for determining physiological dependence. Prompts for physician substance abuse assessment (physician history and physical examination) shall include the following under History of Present Illness (HPI). These will be instituted by the Clinical Informatics technicians into the electronic medical record. Physicians continue to document any additional information found during their face-to-face examination of the patient and historical documentation that may be over and above this checklist. The Program Supervisor and Nurse Manager (Facility Director) will audit each chart of patients with the potential to receive buprenorphine, to insure that this template is being used and the validation of the face-to-face examiniation results of physiologic dependnency has been established and documented.
The following are indicative of current physiological addiction to heroin or other opiates for this patient. Based on my face-to-face determination, it is my best judgment as a physician that this patient shows evidence of current physiologic addiction to heroin or other opiate drugs.
Early signs of opiate withdrawal
lacrimation
rhinorrhea
pupillary dilation
piloerection
nausea/vomiting
abdominal cramping
complaints of muscle twitching or spasms
yawning
insomnia
SOWS score of ____
Loss of appetite
Increased body temperature, pulse rate, blood pressure and respiratory rate
Positive urine test for opiates
Negative test for opiates in patient who give history of recently taking buprenorphine, and/or participation in buprenorphine maintenance program which can be verified by PDMP or collateral data from MAT program
Other signs of recent use noted such as fresh track marks
Patient is a transfer from another facility where clinical information and medical record indicate history of opiate use and/or withdrawal
Patient with history of past admissions to this facility with same evidence of opiate addiction
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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 administration of buprenorphine in one of four detoxification patient records reviewed during the annual licensing inspection conducted on October 24 - 25, 2017.
Patient # 9 was admitted on 10/21/17 and was administered buprenorphine on 10/22/17.
In addition, the written consent did not include that buprenorphine is transmitted to the unborn child and will cause physical dependence in three of four detoxification patient records.
Patient # 10 was admitted 5/16/17 and discharged on 5/20/17. Patient #10 was administered buprenorphine on 5/17/17.
Patient # 12 was admitted 9/29/17 and discharged on 10/10/17. Patient #12 was administered buprenorphine on 10/1/17.
Patient # 14 was admitted 10/9/17 and discharged on 10/14/17. Patient #12 was administered buprenorphine on 10/11/17.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
#M095
Staff on duty at time of deficiency have been counseled by Program Supervisor regarding process. All nursing staff have been educated regarding all steps of the process. Consent form has been amended to include that "buprenorphine is transmitted to the unborn child and will cause physical dependence". This change has been requested as a priority project for our electronic forms access. All female patients admitted are currently given a serum pregnancy test with results available prior to ordering of medications. Hospital Informatics technician will add a "flagging" mechanism for nursing staff medication administration that will require the staff to indicate that this consent has been signed before the first ordered dose of suboxone may be given. New admission checklist has had an item added specific to obtaining a signed consent. And finally, staff work schedule will have an indication for a specific night shift staff person each night to check all consents on all charts for completeness.
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715.14(a)(1) 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.
(1) Each test shall be for opiates, methadone, amphetamines, barbiturates, cocaine and benzodiazepines.
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Observations
The facility failed to complete an initial drug screening urinalysis for each prospective patient that included a test for methadone in four of four detoxification patient records reviewed during the annual licensing inspection conducted on October 24 - 25, 2017.
Patient # 9 was admitted 10/21/17. The initial drug screen was completed on 10/21/17.
Patient # 10 was admitted 5/16/17 and discharged on 5/20/17. The initial drug screen was completed on 5/16/17.
Patient # 12 was admitted 9/29/17 and discharged on 10/10/17. The initial drug screen was completed on 9/29/17.
Patient # 14 was admitted 10/9/17 and discharged on 10/14/17. The initial drug screen was completed on 10/9/17.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Processes explored with in-house laboratory and outside lab used for confirmations, comprehensive toxicologies and chain-of-custody toxicologies, as well as with additional vendors. Current in-house 10-panel toxicology will continue to be utilized on urine specimens obtained in Meadville Medical Center Emergency Departments for all patients admitted via that route. These results are available with less than one hour turnaround. All positive results are sent to Quest Diagnostics Lab outside the medical center for confirmation. Tests for methadone are not available in-house with an immediate result, so when the patient is admitted, a reader cup will be utilized for methadone testing on all patients with potential to receive buprenorphine. This availability has been determined by the Program Supervisor after discussion with Redwood Lab representative and another provider who uses this laboratory satisfactorily. All patients coming directly to the unit from outside facilities will also have a split specimen obtained, one sent to the MMC laboratory for the 10-panel and another utilizing the reader cup for the methadone test. CLIA certification accompanies the purchase of the reader cups. A single intervention for this methadone testing will be added to the electronic medical record allowing nursing staff to document the presence or absence of methadone in the specimen.
All nursing staff are responsibole upon patient's admission for obtaining the specimen in the reader cup and documenting the results of the testing. The Program Supervisor and the Nurse Manager (Facility Director) will follow up on all admission of patients who may possibly be candidates for buprenorphine administration by checking that the specimen for methadone toxicology has been obtained prior to first administration of suboxone. |