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 Suboxone and Methadone, in the residential detoxification from opioid dependence. This inspection was conducted on August 13-15, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, BGI of Brandywine, 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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715.9(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 facility failed to ensure that the narcotic treatment physician was the only person determining the patient's diagnosis of narcotic dependency and determining the patient's course of treatment.
The findings include:
Thirteen patient records were reviewed for documentation by the narcotic treatment physician, specifically that the physician was determining that the patient was currently and physiologically dependent upon a narcotic drug. All records included a medical history and physical exam. Six records documented a medical history and physical examinations completed by the Certified Physician Assistant (PA-C). The medical history and physical are completed prior to the narcotic treatment physician documenting the face-to-face determination of whether the patient is currently physiologically dependent upon a narcotic drug. The Certified Physician Assistant (PA-C) diagnosed the patients as being opiate dependent and assessed the plan of treatment for the patients in records # 1, 2, 3, 9, 12 and 13. This determination must be made by the narcotic treatment physician.
Patient # 1 was admitted July 25, 2012. The medical history and physical examination was completed by the PA-C on July 26, 2012. The PA-C documented that the patient was opiate dependent and developed a plan for the patient to continue in methadone maintenance treatment. This cannot be documented by anyone other than the narcotic treatment physician.
Patient # 2 was admitted on July 18, 2012. The medical history and physical examination was completed by the PA-C on July 19, 2012. The PA-C documented that the patient was opiate dependent and developed a plan for the patient to continue in methadone maintenance treatment. This cannot be documented by anyone other than the narcotic treatment physician.
Patient # 3 was admitted on July 10, 2012. The medical history and physical examination was completed by the PA-C on July 11, 2012. The PA-C documented that the patient was opiate dependent and developed a plan for the patient to continue in methadone maintenance treatment. This cannot be documented by anyone other than the narcotic treatment physician.
Patient # 9 was admitted on August 7, 2012. The medical history and physical examination was completed by the PA-C on August 7, 2012. The PA-C documented that the patient was opiate dependent and developed a plan for the patient to start an opiate detox protocol and methadone taper. This cannot be documented by anyone other than the narcotic treatment physician.
Patient # 12 was admitted on May 27, 2012. The medical history and physical examination was completed by the PA-C on May 28, 2012. The PA-C documented that the patient was opiate dependent and developed a plan for the patient to start an opiate detox protocol with a methadone taper. This cannot be documented by anyone other than the narcotic treatment physician.
Patient # 13 was admitted on March 21, 2012. The medical history and physical examination was completed by the PA-C on March 22, 2012. The PA-C documented that the patient was opiate dependent and developed a plan for the patient to start the protocol for pregnant patients and Subutex Maintenance. This cannot be documented by anyone other than the narcotic treatment physician.
This finding was reviewed with the PA-C on August 15, 2012 and was not disputed.
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Plan of Correction
As of 10/1/2012 H&P form will be revised to reflect that the PA-C portion ends at physical exam. The NTP will then review H & P and complete the remainder including Axis I diagnoses and treatment plan portion during the face to face. Compliance of this standard will be done by Director of Nursing with random quarterly chart audits of each NTP and PA-C. Results will be shared with the NTP and/or PA-C of findings not consistent with this standard. |
715.9(c) LICENSURE Intake
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
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Observations
Based on the review of patient records, the facility failed to contact the previous narcotic treatment facility for the patient's treatment history in one of one patient records reviewed.
The findings include:
Thirteen patient records were reviewed August 13-15, 2012. One patient record required contacting the prior narcotic treatment facility for the previous treatment history that was reported by the patient.
Patient record # 8 contained documentation that the patient had received narcotic treatment services previously at other narcotic treatment programs. The facility failed to document any attempt to obtain the patient's prior treatment history from the previously attended narcotic treatment facility.
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Plan of Correction
As of 8/31/2012 the nursing assessment was amended to contain direct question regarding "any and all MAT's patient enrolled prior to admission. Where this is applicable, consents are obtained and prior treatment facilities are then contacted. An in-service was held on 8/31/2012 by the Director of Nursing informing all nursing staff regarding this standard. Compliance of this standard will be done by Director of Nursing with random monthly audits. Non-compliance will be documented through supervision and/or an EIP (Employee Improvement Plan) where/when applicable. |
715.10(a)(2) LICENSURE Pregnant patients
(a) A narcotic treatment program may place a pregnant patient, regardless of age, who has had a documented narcotic dependency in the past and who may return to narcotic dependency, on a comprehensive maintenance regime.
(2) Evidence of all findings and the criteria used to determine the findings shall be recorded in the patient's record by the admitting narcotic treatment physician before the initial dose is administered to the patient.
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Observations
Based on the review of patient records, the facility failed to have the narcotic treatment physician document all the findings and criteria used to determine the patients admission before the initial dose is administered.
The findings include:
Thirteen patient records were reviewed on August 13-15, 2012. Seven records reviewed were pregnant patients. One patient record required documentation by the narcotic treatment physician documenting the criteria used to determine that the patient should be dosed with Subutex, specifically record # 4.
Patient # 4 was admitted to the program on July 21, 2012. Documentation in the record indicated that the patient was admitted 18 weeks pregnant, had been incarcerated and did not have a year narcotic dependency prior to admission. The urine drug screen analysis that was provided on July 21, 2012 resulted in a negative urinalysis drug screen. The narcotic treatment physician failed to document the rationale prior to dosing the patient with Subutex on July 22, 2012.
This finding was confirmed by the director of nursing.
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Plan of Correction
As of 8/31/2012 all urine drug screens will be received and reviewed prior to dosing regardless of clinic statement.
The drug screen must reflect "positive" for opiates. If it is not, the NTP MUST document in the chart rationale for dosing. Compliance of this standard will be done by random quarterly chart audits by the Director of Nursing. Non compliance with this standard will be shared with the NTP, PA-C and any applicable nursing staff and documented through supervision or EIP (Employee Improvement Plan) where/when applicable. |
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 failed to document that the initial urinalysis drug screen was reviewed by the facility's physician prior to induction in two of thirteen records reviewed.
The findings include:
Thirteen patient records were reviewed on August 13-15, 2012. All records were reviewed for documentation by the narcotic treatment physician prior to induction. The narcotic treatment physician documented inaccurate urinalysis results in patient records # 4 and 6.
Patient # 4 was admitted on July 21, 2012. The narcotic treatment physician documented a face to face meeting with the patient on July 21, 2012 at 7:00 a.m. The narcotic treatment physician "checked" that the urine was positive for opiates on the Current Physiological Opiate Dependence Determination Form. However, the results the facility received on July 21, 2012 at 12:56 p.m. did not document a positive opiate urine.
Patient # 6 was admitted on August 10, 2012. The narcotic treatment physician documented a face to face meeting with the patient on August 11, 2012 at 7:00 a.m. The narcotic treatment physician "checked" that the urine was positive for opiates on the current physiological opiate dependence determination form. However, the results of the drug urinalysis results were not received by the facility at the time the face to face was completed. The information documented in the record showed the facility received the urinalysis results back at 11:42 a.m.
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Plan of Correction
As of 10/1/2012 all Face to Face opiate dependency determination forms to be amended to remove "urine positive opiates" as this is documented on actual orders for dosing. All negative urine drug screens are to be documented and NTP to be notified. Review of the urine screen is documented by the NTP signing the actual urine screen results. Compliance of this standard will monitored by Director of Nursing with random quarterly chart audits. Non-compliance of this standard will be shared with the NTP, PA-C and any applicable nursing staff and documented in supervision or EIP (Employee Improvement Plan) where applicable. |
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 facility failed to document the consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination in 1 of 3 records, as required.
The findings include:
Thirteen patient records were reviewed on August 13-15, 2012. In patient record # 12, the narcotic treatment physician determining the initial dose failed to document the consultation with the narcotic treatment physician completing the physical examination.
Patient # 12 was admitted on May 27, 2012. The Physician Assistant, employee # 3, documented the history and physical examination. The narcotic treatment physician, employee # 1, documented the face to face and determined the patient's initial dose. Employee # 1 failed to document a consultation took place with employee # 3 who performed the patient examination before determining the patient's initial dose and schedule.
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Plan of Correction
A meeting with the NTPs and PA-Cs was held 9/7/2012 to assure understanding of this standard. Consultation will be documented by the NTP on the Face to Face Form that confirms Opiate Dependency. Compliance of this standard will be monitored by Director of Nursing with random quarterly chart audits. Non-compliance of this standard will be shared with the NTP, PA-C and any applicable nursing staff and documented in supervision or EIP (Employee Improvement Plant) where applicable. |
715.17(c)(6)(i-iv) 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:
(6) Inventories. A narcotic treatment program shall conduct monthly inventories of agents and other controlled substances stored. Each inventory record shall include:
(i) The date the inventory was conducted.
(ii) The time of day it was conducted.
(iii) The name and amount of each product on hand at the time of the inventory.
(iv) The name of the individual conducting the inventory.
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Observations
Based on the review of the medication inventories, the facility failed to document the name of the persons conducting the inventory.
The findings include:
The facility's policy and procedures were reviewed on August 13, 2012. According to the facility's policy, the Director of Nursing will assure that the Daily Administration Log and the Daily Inventory forms are completed immediately after administration of methadone is completed. The facility's Methadone, Subutex, and Suboxone Daily Inventory forms all require the signature of two nurses when the inventory is conducted. The medication inventory was reviewed on August 14, 2012. Three Methadone daily inventory sheets, eight Suboxone daily inventory sheets, and eight Subutex inventory sheets were reviewed. Three entries on the Methadone daily inventory sheets failed to have two nurses' signatures. Three entries failed to have the inventory documented. Seven entries on the Suboxone daily inventory sheets failed to have two nurses' signatures. Six entries on the Subutex daily inventory sheets failed to have two nurses' signatures.
The inventory conducted on the day shift on May 22, 2012 failed to include the off-going nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the day shift on May 22, 2012 failed to include the off-going nurse's signature on the Subutex daily inventory sheet.
The inventory conducted on the evening shift on June 1, 2012 failed to include the off-going nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the evening shift on June 1, 2012 failed to include the off-going nurse's signature on the Subutex daily inventory sheet.
The inventory conducted on the evening shift on June 19, 2012 failed to include the off-going nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the evening shift on June 19, 2012 failed to include the off-going nurse's signature on the Subutex daily inventory sheet.
The inventory conducted on the overnight shift on July 14, 2012 failed to include the off-going nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the overnight shift on July 14, 2012 failed to include the off-going nurse's signature on the Subutex daily inventory sheet.
The inventory conducted on the day shift on July 21, 2012 failed to include the on-coming nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the overnight shift on July 22, 2012 failed to include the off-going nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the night shift on July 29, 2012 failed to have the count documented on the methadone daily inventory sheet.
The inventory conducted on the evening shift on July 31, 2012 failed to include the off-going nurse's signature on the Suboxone daily inventory sheet.
The inventory conducted on the evening shift on July 31, 2012 failed to include the off-going nurse's signature on the Subutex daily inventory sheet.
The inventory conducted on the evening of July 31, 2012 failed to have the signature from the off-going nurse documented on the inventory sheet.
The inventory conducted on August 4, 2012 failed to have the on-coming nurse's signature on the inventory sheet. Additionally, the count was not documented on methadone daily inventory sheet.
The inventory conducted on the overnight shift on August 5, 2012 failed to have the off-going nurse's signature on the Subutex inventory sheet.
The inventory conducted on August 9, 2012 failed to have the off-going day shift nurse's signature documented with the on-coming evening nurse's signature.
The inventory conducted on August 12, 2012 on the day shift failed to document the count on the methadone inventory sheet. There were 58 pills documented, however, there was a strike through the number with error written. There was no corrected number written to fix the error.
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Plan of Correction
As of 8/31/2012 all nurses who failed to sign, count and/or acknowledge in medication inventories immediately received EIP's (Employee Improvement Plan) and an in service by Director of Nursing. Compliance of this standard will be done by Director of Nursing doing random weekly checks of each narcotic inventory book. Feedback will be documented in supervision and/or EIP (Employee Improvement Plan) where applicable. |
715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations
Based on a review of client records and a review of the facility's policy and procedures manual, the facility failed to document case consultation notes in accordance with facility policy and procedures.
The findings include:
The facility policy states: "For all clients requiring additional counseling during involvement with the program, the counselor will complete the case consultation note documenting the following information: client being reviewed, client number, date of review, staff attending (name, credentials and discipline), reason for review, discussion summary, disposition of the case, assessment/action plan, counselor signature, title and date. Every client will have a minimum of one case consult during the course of treatment. For clients in treatment longer than 90 days, their case will be reviewed a minimum of every 90 days."
On August 13-15, 2012, thirteen patient records were reviewed. Two records reviewed had documentation of a case consultation. The facility did not document a case consultation note in accordance with facility policy in two of two records, specifically # 4 and 10.
Record # 4 documented a case consultation on August 10, 2012. The case consultation failed to document what staff attended the consultation (name, credentials and discipline).
Record # 10 documented a case consultation on May 31, 2012. The case consultation failed to document what staff attended the consultation (name, credentials and discipline).
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Plan of Correction
An In-Service was held as of 8/31/2012 for all clinical staff by the Clinical Director assuring proper understanding of this standard.
Counselors will document case consults within 14 days of a person's admit or every 30 days for any patient who stays past 30 days. All case consults will include signatures of those parties involved in the consultation.
Compliance will be done by the clinical director doing random monthly chart audits. Results will be documented in supervision and/or in an EIP (Employee Improvement Plan) where applicable. |
715.23(e) LICENSURE Patient records
(e) Patient file records, information and documentation shall be legible, accurate, complete, written in English and maintained on standardized forms or electronically.
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Observations
Based on the review of patient records, the facility failed to ensure that the documentation in the record was legible.
The findings include:
Based on the review of patient records, the facility failed to ensure that the documentation included in the patient record was legible in all records reviewed. Thirteen patient records were reviewed on August 13-15, 2012. All records included documentation by the narcotic treatment physician and/or the medical director that was not legible. Facility staff was asked to translate the information in the patient record. This finding was confirmed by facility staff.
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Plan of Correction
As of 9/7/2012 this was discussed at medical meeting with all NTPs and PA-C. The expectation of legibility as it relates to this standard was discussed. Compliance of this standard will be done by Director of Nursing with random quarterly audits of each doctor/physician assistant. Non-compliance with this standard will be shared with NTPs, PA-C and any applicable nursing staff and will be documented through supervision or EIP (Employee Improvement Plan) where applicable. |
709.32(b) LICENSURE Medication Control
709.32. Medication control.
(b) Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.
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Observations
Based on the review of patient records, the facility failed to ensure that verbal medication orders were signed off by the prescribing physician within twenty-four hours in two of two records reviewed.
The findings include:
Thirteen patient records were reviewed on August 13-15, 2012. Two patient records had verbal orders documented that failed to have the prescribing physician sign off within twenty-four hours, specifically patient records # 8 and 10.
Patient # 8's record included a verbal order from the medical director, employee #2, on August 3, 2012. The narcotic treatment physician, employee # 1, who signed off on the verbal order on August 4, 2012 was not the prescribing physician.
Patient # 10's record included a verbal order from the medical director, employee # 2, on May 26, 2012. The narcotic treatment physician, employee # 1, who signed off on the verbal order on May 26, 2012 was not the prescribing physician.
This finding was confirmed by the medical director.
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Plan of Correction
As of 8/31/2012 on call doctor on Fridays will be doctor on site for Saturday and Sunday. On call doctor for Sunday will be doctor on site for Monday. Compliance of this standard will be done by Director of Nursing with random quarterly chart audits of each doctor. Non-compliance with this standard will be shared with NTPs and PA-C and documented through supervision and/or EIP (Employee Improvement Plan) where applicable. |