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 buprenorphine, in the residential detoxification from opioid dependence. This inspection was conducted on January 3, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Caron Treatment Centers - Detox Unit, 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)(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
Based on the review of patient records, the narcotic treatment physician failed to document the determination for current opiate dependency in two of five records reviewed.
The findings include:
Five patient records were reviewed on January 3, 2012. All records were reviewed for documentation by the narcotic treatment physician documenting current opiate dependency. The narcotic treatment physician failed to document current dependency in patient records # 2 and 4.
Patient # 2 was admitted on December 30, 2012. The record documented the Certified Registered Nurse Practitioner determined opiate dependency and not the narcotic treatment physician.
Patient # 4 was admitted on December 26, 2012. The record documented the Certified Registered Nurse Practitioner determined opiate dependency and not the narcotic treatment physician.
This finding was reviewed with facility staff and was not disputed.
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Plan of Correction
Plan of Correction:
An individual progress note will be entered in the electronic record by the Physician documenting determination of opiate dependency for all patients ordered Buprenorphine.
The director of Nursing is responsible for compliance and will audit all Buprenophine records and the Medical Director will ensure compliance with staff through the Peer review process.
The new note will go into effect on Feb. 5, 2013
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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
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 detoxification treatment in one of five records reviewed.
The findings include:
Five patient records were reviewed on January 3, 2012. All 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 December 26, 2012. The patient received their initial dose of Subutex(buprenorphine) on December 28, 2012 at 11:30 AM. There was no documentation of an informed, voluntary written consent prior to the administration of a narcotic agent in patient record # 4 at the time of the review.
The quality assurance staff member confirmed this finding on January 3, 2012.
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Plan of Correction
We already have an informed consent process in place that was overlooked in this case. In addition we also have a checklist process that was not being utilized consistently. In order to prevent this from happening again our plan is to have an electronic approval process implemented in Sigmund (our electronic record) prior to the first dose being given. This is currently being investigated with our vendor. In the mean time we have created a paper check list that the staff will complete for each admission that requires Buprenorphine. The checklist will be signed and verified by the RN and will be kept on file until the audit of this item can by completed.
This will be effective on Jan. 28, 2013
The director of Nursing is responsible for compliance and will audit all Buprenophine records.
The Medical Director will ensure compliance with staff through the Peer review process.
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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
Based on a review of patient records, the narcotic treatment program failed to document the consultation between the narcotic treatment physician determining the initial dose and the Certified Registered Nurse Practitioner performing the physical examination in three of three records reviewed. Additionally, in one of five records reviewed someone other than the narcotic treatment physician determined the proper dosage level for the patient.
The findings include:
Five patient records were reviewed on January 3, 2012. In patient records # 1, 2 and 4, the narcotic treatment physician who determined the initial dose failed to document the consultation with the Certified Registered Nurse Practitioner (CRNP) that completed the physical examination, as required.
Patient # 1 was admitted on January 1, 2013 and received their initial dose of Subutex(buprenorphine) on January 2, 2013. The CRNP completed the history and physical examination on January 2, 2013. There was no documentation in the record that recorded a consultation took place between the narcotic treatment physician determining the initial dose and schedule and the CRNP that completed the patient examination. Additionally, a review of this record included documentation that the CRNP determined the initial dose and schedule. The initial order for Subutex was documented on January 2, 2012 by the CRNP and not the narcotic treatment.
Patient # 2 was admitted on December 30, 2012 and received their initial dose of Subutex (buprenorphine) on December 31, 2012. The CRNP completed the history and physical examination on December 31, 2012. There was no documentation in the record that recorded that a consultation took place between the narcotic treatment physician determining the initial dose and schedule and the CRNP that completed the patient examination.
Patient # 4 was admitted on December 26, 2012 and received their initial dose of Subutex (buprenorphine) on December 28, 2012. The CRNP completed the history and physical examination on December 27, 2012. There was no documentation in the record that recorded a consultation took place between the narcotic treatment physician determining the initial dose and schedule and the CRNP that completed the patient examination.
This finding was reviewed with facility staff on January 3, 2013.
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Plan of Correction
Plan of Correction:
The nurse practitioners will consult with the physician licensed to give Buprenophine . The licensed physician will enter a note in the electronic record reflecting the consultation between the physician and the nurse practitioner. The note will include determination of the Buprenophine dose based on assessment findings. In addition only a narcotic treatment physician will be able to determine the proper dose and write an order in the electronic record.
The Medical Director will ensure compliance with staff through the Peer review process.
This will go into effective on Jan. 30, 2013.
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715.29(4) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(4) The narcotic treatment program shall maintain documentation of the Department 's approval of an exception.
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Observations
Based on the review of patient records, the facility failed to follow the requirements included in an exception the facility received from the Department.
The findings include:
The facility received an exception from the Department on July 30, 2004 allowing for the modified narcotic treatment program physician to have 24 hours to see the patient after a verbal order for the initial dose of Buprenorphine (Subutex) is issued. The facility failed to document the narcotic treatment physician met with the patient within twenty-four hours in patient records # 2 and 4.
Patient record # 2 was admitted on December 30, 2012. The Certified Registered Nurse Practitioner completed the patient examination on December 31, 2012. The patient received their initial dose of Subutex (buprenorphine) on December 31, 2012 by verbal order from the narcotic treatment physician. A review of the record failed to include documentation that the narcotic treatment physician saw the patient within 24-hours of receiving their first dose of Subutex. Additional documentation in this record included the assessment that was completed to determine the need for Subutex was done by a Licensed Practical Nurse. The licensing alert issued in May 2012 requires, "an assessment tool, completed by at a minimum a registered nurse should include documentation of past and current drug dependency and treatment, drug use status and history, including prescription medications, licit or illicit, that may be contraindicated for buprenorphine, completion of a withdrawal scale such as the Clinical Opioid Withdrawal Scale, urine toxicology results, biographical data, and health and illness patterns...the physician must co-sign the various assessments when he signs the verbal order." This record failed to have the assessment co-signed by the physician and the assessment was not completed by the Registered Nurse.
Patient record # 4 was admitted on December 26, 2012. The Certified Registered Nurse Practitioner completed the patient examination on December 27, 2012. The patient received their initial dose of Subutex (buprenorphine) on December 28, 2012 by verbal order from the narcotic treatment physician. A review of the record failed to include documentation that the narcotic treatment physician saw the patient within 24-hours of receiving their first dose of Subutex.
These findings were reviewed with facility staff and were not disputed.
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Plan of Correction
If the physician is not available to see face to face prior to initiation of buprenorphine:
- A licensed RN will contact the buprenorphine licensed physician. She will inform the physician of relevant medical history, current medications, history of drug use and recent use, current findings of withdrawal, and COWs.
- The information obtained will be documented in the assessment tool utilized by the RN and entered into the electronic record.
- A Buprenorphine licensed Physician will give a verbal order to start buprenorphine.
- The Physician will document in a note the interaction with the RN providing him the information and reasons for starting the buprenorphine.
- Physician will place order for buprenorphine licensed physician to see the patient the next day.
- Physician seeing the patient face to face the following morning will document:
o Discussion with physician who gave verbal order for the initial dose of buprenorphine
o History of drug use
o Current drug use supporting a diagnosis of opioid dependence
o Evidence of opioid withdrawal or medical opinion of likelihood of impending withdrawal
o Need for buprenorphine with discussion of risks and benefits
The Medical Director is responsible for implementation and he will ensure compliance with staff through the Peer review process.
This will go into effect on Feb. 5, 2013 in the electronic record.
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715.29(5) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient 's record.
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Observations
Based on the review of the facility's policy and procedures and patient records, the facility failed to obtain an exception for dosing a patient under the age of 18 prior the patient's initial dose of Subutex (buprenorphine) in one of one record, as required.
The findings include:
The facility's policy and procedure manual was reviewed on January 3, 2012. According to the facility's policy and procedures, "In order to receive treatment using Buprenorphine, a patient must be 18 years of age. Patient's less than 18 years of age, must have a Buprenorphine Exception-Pennsylvania Department of Health (Department of Drug and Alcohol Programs) waiver form in order to receive treatment using Buprenorphine. This form is submitted to the Pennsylvania Department of Health (Department of Drug and Alcohol Programs) for review and approval."
Patient # 4 was admitted on December 26, 2012. According to the regulations, a patient must be 18 years of age to be eligible for admission into a modified narcotic treatment program. Patient # 4 was 17 years old and required written approval by the Department prior to administration of Subutex (buprenorphine). The Department received a faxed exception request on December 28, 2012 at 3:52 PM. The patient received their first dose of Subutex (buprenorphine) at 11:30 AM on December 28, 2012, prior to the Department receiving the exception request.
This finding was reviewed and confirmed by facility staff.
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Plan of Correction
As written in our policy Patient exceptions will be faxed to the Dept. of Drug and Alcohol programming prior to initiation of any Subutex for patients under the age of 18 years old.
- The exception form will include adequate data to confirm current opioid dependence, report of recent use and evidence of current opioid withdrawal.
The first dose will not be given until this process is completed. The Director of Nursing will be auditing this procedure to ensure compliance.
The Medical Director is responsible for compliance with staff and it will be audited through the Peer review process. This will go into effective on Jan. 30, 2013.
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