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 treatment of narcotic addiction. This inspection was conducted on July 11-12, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, White Deer Run of York 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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715.9(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 and discussion with administrative staff, the facility failed to ensure the physician made a face to face determination of the current dependency of an individual prior to admission and administered a narcotic.
The findings include:
Five patient records were reviewed July 11-12, 2011. Five patient records required a face to face determination of current dependency prior to the administration of the narcotic. Patients # 1 and 2 were medicated prior to the face to face determination of current dependency.
Patient # 1 was admitted March 8, 2011 at 8:30 PM, according to admission documentation. The patient was administered her first dose of a narcotic on March 8, 2011 at 8:45 PM. The patient was seen by the physician for a face to face determination on March 9, 2011 at 8:24-8:27 PM, almost 24 hours after the first dose was administered. In addition, the nurse manager had documented an incident report because the patient was admitted and dosed without the benefit of meeting with a physician.
Patient # 2 was admitted May 10, 2011 at 1200 AM, according to admission documentation. The patient was administered his first dose of a narcotic on May 11, 2011 at 2:00 PM. The patient was seen by the physician for a face to face determination on May 11, 2011 at 10:25 PM, about eight hours after the patient's first dose. The documentation of current dependency by the physician was dated May 11, 2011 at 8:28 PM, prior to the documented face to face.
The facility utilizes a document that is entitled "Required documentation prior to the administration of Suboxone" which was completed for the five patients reviewed. There are eleven points listed on this document. The eighth line states "if administration of Suboxone is required prior to the H&P date and time of verbal order authorizing first dose. Date ______ Time______. The patient # 2 had the date and time filled in. May 10, 2011 @ 18:00 hours (6:00 PM). This was the same time the onsite urine drug screen was completed, according to the documentation in the patient record.
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Plan of Correction
10-18-2011 Plan of Correction:
In two of five patient records reviewed, a face to face determination of current dependency was not made prior to administration of buprenorphine. Effective 10/31/11 the facility will follow stated policy regarding face to face examination by physician prior to initial dosing. Staff will be re-educated by the Nurse Coordinator prior to 10/31/11 and ongoing compliance will be maintained through chart audits by the Nurse Coord. beginning 11/1/11. The facility has re-submitted a Request for Exception to the Department on 9-23-2011. The facility has requested a meeting with the department as it believes that in order to not compromise current patient care and safety in these emergency instances, that an Exemption is appropriate.
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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 review of the patient records, the facility failed to obtain a complete drug screen urinalysis prior to the administration of Suboxone, a narcotic agent, in one of five patient records. A complete drug screen includes receiving the results from a confirmation test from the CLIA and Department of Health approved laboratory when the onsite drug screening urinalysis resulted in an unexpected positive report.
The findings include:
Five patient records were reviewed on July 11-12, 2011. Five patient records were required to complete a drug screen urinalysis prior to the administration of Suboxone, a narcotic agent. The use of Suboxone is contraindicated when the patient is also using methadone. Methadone in combination with buprenorphine (Subutex and Suboxone) can precipitate withdraw, increase the risk of central nervous system (CNS) depression and psychomotor impairment.
Patient # 3 was admitted February 17, 2011. An admission urine drug screen was completed onsite on February 17, 2011 at 9:00 PM. The results indicated the patient had methadone in his system. Upon review of the entire record, there was no documentation of the patient reporting the use of methadone. There was no documentation the physician explored this with the patient. There was no documentation the specimen was sent to a CLIA and Department of Health approved laboratory for a confirmation test. Instead, the patient was medicated with Suboxone on February 18, 2011 at 1:00 PM.
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Plan of Correction
Per 715.14:
Current On-Site Testing panel includes screening for Methadone. If Methadone is present in the on-site screen, the patient will not be dosed until a confirmatory urine drug test has been obtained using the original sample.
The Nursing Manager has re-educated all nursing staff as of 7/18/11 on the policy for confirmation urines in the presence of an unreported result as well as the importance of obtaining a comprehensive drug history to include the use of Methadone. To insure compliance by all staff, beginning 7/25/11, three suboxone client charts will be audited on a weekly basis by the Nursing Manager until 9/5/11 when these checks will continue every other week. Non-compliance will result in additional re-education/improvement plans which will be used to further insure compliance at which time chart audits will revert back to weekly by the Nursing Manager who is the responsible staff.
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715.17(b) LICENSURE Medication control
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
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Observations
Based on the review of patient records and discussion with administrative staff, the facility failed to document the issuance of a verbal order as required.
The findings include:
Five patient records were reviewed July 11-12, 2011. One patient record contained documentation of a verbal order having been issued.
The facility utilizes a document that is entitled "Required documentation prior to the administration of Suboxone" which was completed for the five patients reviewed. There are eleven points listed on this document. The eighth line states "if administration of Suboxone is required prior to the H&P date and time of verbal order authorizing first dose. Date ______ Time______. The document for patient # 2 had the date and time filled in. May 10, 2011 @ 18:00 hours (6:00 PM).
The entire patient record was reviewed by the licensing specialist and the nurse manager and documentation of a verbal order, including the physician's signature, was not in the patient record.
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Plan of Correction
Nurse Manager gave an inservice on 7/18/2011 to review suboxone policies with all nursing staff. The importance of transcribing orders correctly and immediately was of significant issue. The specific taking of a Verbal Order to include Date/Time will be documented on the order or dosing can not take place. Physician will sign VO immediately upon next rounds and evaluate patient. Both Physician and Nursing Manager will be responsible for ensuring corrective action/ongoing compliance. Beginning 7/25/2011, 3 suboxone client charts will be audited on a weekly basis by the Nursing Manager until 9/5/2011 when these charts checks will be every other week. Non-compliance will result in additional re-education/improvement plans which will be used to further insure compliance at which time chart audits will revert back to weekly by the Nursing Manager who is the responsible staff. |
715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on the review of patient records and discussion with administrative staff, the facility failed to ensure the physician determined the patient's dose and schedule in two of five patient records.
The findings include:
Five patient records were reviewed July 11-12, 2011. Five patient records required the physician to determine the patient's dose and schedule. Two patient records contained documentation indicating other staff documented the information prior to the physician signing it.
Patient # 4 was admitted July 4, 2011. However, there were inconsistent dates throughout the patient record with different dates identified for admission, assessment and physician orders.
The physician signed a document that was the standard physician's orders for the opiate detox protocol. The physician dated the order July 2, 2011. In addition the same form contained documentation by the nursing staff that the order had been "noted" signed by the nurse and dated July 2, 2011. Since the patient was not actually admitted until July 4, 2011, there was no way to determine if the physician or the nurse determined the dose and schedule for the patient.
A discussion with the nursing manager on July 12, 2011 at approximately 2:00 PM revealed that there is a "tradition", of nursing staff on one shift to learn of a pending admission for another shift, and starting to complete the intake paperwork to "help out". If intake paperwork is completed before the the patient actually shows up, the physician will be put into a position of signing documents based on the dictates of the person pre-completing the information without benefit of the patient's actual needs.
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Plan of Correction
Per 715.17:
When there is an immediate need for the administration of buprenorphine and the physician is no longer on the grounds, the BTP nurse conducts the initial evaluation by completing the nursing assessment and COWS. The nurse calls the BTP physician and reviews the assessment findings with the physician. The BTP physician then approves or disapproves administration of buprenorphine.
Investigation:
As noted in the citation, the chart was made, and dated, prior to a client's admission. The physician also wrote orders for the client prior to the client's arrival.
POC:
It was reinforced with staff that creating charts prior to a client's admission is unacceptable and obtaining orders prior to the client's admission could be fraudulent. Disciplinary action was taken in this instance against the nurse. Physicians were also reminded this is unacceptable practice.
Ongoing compliance will be the responsibility of the Nurse Manager. |