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 methadone, in the treatment of narcotic addiction. This inspection was conducted on March 23-24, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pinnacle Treatment Centers PA-V, LLC 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 and a plan of correction is due on April 21, 2011.
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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 an interview with the facility director, the facility failed to document that a narcotic treatment physician determined evidence of a 1 year history of addiction to a narcotic drug prior to administration of an agent, in one of six patient records.
The findings include:
Twenty two patient records were reviewed on March 23-24, 2011. Six of those patient records were reviewed to determine if the required documentation by the narcotic treatment physician demonstrating there was evidence of a 1 year history of addiction to a narcotic drug was included in the patient record. Per regulation, prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall: 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. The facility did not document the evidence of a 1 year history of addiction to a narcotic drug in patient record # 1.
Patient #1 was admitted on December 14, 2010. There was no documentation provided that the narcotic treatment physician determined the evidence of a 1 year history of addiction to a narcotic drug prior to the administration of an agent.
An interview with the facility director on March 21, 2011 confirmed that there was no documentation provided that the narcotic treatment physician determined the evidence of a 1 year history of addiction to a narcotic drug prior to the administration of an agent in patient record #1.
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Plan of Correction
The Facility Director will review the admission regulations with the medical director, as well as the interim doctor. The physician will complete all required components of the initial physical with the patient and ensure that they are appropriate to begin treatment using their medical discretion. The facility director will provide additional copies of the regulations and PTSA policy and procedures to the physicians in order to review for compliance. The medical staff will review all initial paperwork prior to the patient receiving their initial dose to insure compliance with this regulation. |
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 and an interview with the facility director, the facility failed to ensure that the patient was initially dosed following the completion of a drug-screen urinalysis in one of six patient records.
The findings included:
Twenty two patient records were reviewed on March 23-24, 2011. Six patient records were reviewed for drug screen urinalysis results prior to a patient's initial dose. Per regulation, a narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient record # 7.
Patient # 7 was admitted into treatment on October 12, 2010. Patient # 7 received a dose of 30 mg on October 12, 2010, the same date that the patient had submitted a urine specimen for a drug-screen urinalysis. The drug screen urinalysis results were not received by the program until October 14, 2010.
The facility director was interviewed on March 23, 2011 and confirmed that the patient had been dosed before the results of the urinalysis had been received.
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Plan of Correction
It is the responsibility of the Physician to determine dependency in accordance with regulation.
The Facility Director will review the admission regulations with the medical director, as well as the interim doctor. The facility director will provide additional copies of the regulations and PTSA policy and procedures to the physicians in order to review for compliance. The Physician's Assistant/CRNP will be responsible for reviewing all initial paperwork prior to the patient receiving their initial dose, which is ordered by the physician.
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715.16(b)(1-8) LICENSURE Take-home privileges
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient 's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient 's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
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Observations
Based on a review of patient records and an interview with the facility director, the facility failed to consider the criteria for take-home privileges in one of six patient records.
The findings include:
Twenty two patient records were reviewed on March 23-24, 2011. Six patient records were reviewed for compliance with the regulations regarding take-home medications. Per regulation, the narcotic treatment physician shall consider the following in exercising reasonable clinical judgment;
A patient is responsible in handling narcotic drugs.
Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
Regular narcotic treatment program attendance.
Absence of serious behavioral problems at the narcotic treatment program.
Absence of known recent criminal activity.
Stability of the patient 's home environment and social relationships.
Length of time in comprehensive maintenance treatment.
Assurance that take-home medication can be safely stored within the patient 's home.
Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
The facility failed to consider the criteria for take-home privileges in patient record # 11.
Patient # 11 was admitted into treatment on March 18, 2010. The patient, per physician's order, receives a two day take home supply of methadone. There was no documentation that the criteria had been considered for take-home privileges in patient record # 11.
The facility director was interviewed on March 24, 2011 and confirmed that there was no documentation in patient record # 11 that the criteria had been considered prior to granting take-home privileges.
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Plan of Correction
The Facility Director and Clinical Supervisor will work with both clinical and medical staff to ensure all required documentation is being completed and reviewed prior to patient's privileges beginning. The CRNP and nursing staff will ensure that a copy is placed in both the clinical and medical chart to ensure that there is no further question of the 8 point criteria being met. The Facility director will actively review and meet with clinical and medical staff regularly to ensure this standard is being met.
Patient #11's record will be reviewed by clinical and medical staff and documentation supporting that she has met the 8 point criteria will be placed in both the clinical and medical record. |
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 an interview with the facility director, the facility failed to document that the narcotic treatment physician determined the patient 's dosing schedule in one of seven patient records.
The findings include:
Twenty two patient records were reviewed on March 23-24, 2011. Seven patient records were reviewed to determine compliance with the requirement that the Narcotic Treatment Physician (NTP) determine the patient's dosing schedule. The facility did not document the NTP's determination of the patient 's dosing schedule in patient record # 23.
Patient record # 23 was admitted in 2009. The patient currently receives 3 1/2 days split dose take homes. There was no documentation of the NTP's determination of the need for the split dose take home schedule.
An interview with the facility director on March 24, 2011, confirmed that the NTP's determination of the need for the split dose take home schedule was not documented.
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Plan of Correction
The facility is responsible for compliance with regulation regarding the utilization of split dosing.
The Facility Director will work with the medical staff to ensure that each patient who is receiving split dosing is still appropriate for this level of take home medication. The physician will meet with each patient and document the patient's need for split dosing appropriately. In the event that a patient had been awarded split dosing in the past and is no longer appropriate for this type of dosing, the physician will create a schedule to address reducing the dose appropriately to one dose per day. The physician will appropriately document in both situations to support her decision.
Ongoing compliance for this area will be monitored by the CRNP along with the Facility Director.
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