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 August 11, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO, 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 found 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 clinical documentation, the facility, particularly the physician, failed to accurately document the basis for determining current and one year history of dependency in one of six patient records.
The findings include:
Six patient records were reviewed August 11, 2011. All of the patient records were reviewed for physician documentation of the basis for determining current and one year history of dependency.
Patient # 6 was re-admitted to treatment on July 8, 2011. Documentation specified the patient had previously been in treatment and had been incarcerated during the past year for approximately nine months. The only documentation by the physician for determining at least one year history of dependence was the patient statement to the physician. Given the stated history provided in patient record # 6, this patient did not have a one year history prior to admission.
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Plan of Correction
The Program Director met with the Medical Director to review regulations regarding 715.9(a)(4). The Medical Director was advised to contact the PA Department of Health staff regarding any questionable admission prior to accepting the patient and prescribing the dosage of methadone.
A change in the process of admissions was instituted so that patients meet with a counselor prior to seeing the physician. At that appointment the counselor will obtain a drug history, complete the biopsychosocial history, and will assume responsibility for obtaining previous treatment records. All of this documentation will be made available to the physician at admission. This change in process was reviewed and discussed at the general staff meeting on September 7, 2011.
The procedure for methadone induction has also been changed and the new procedure, which will begin on September 21, 2011, is designed to prevent admissions for those patients who do not meet criteria for maintenance. Included in these changes are instructions for the to assess any discrepancies in drug history between what the patient reports to the counselor vs. the physician. If a patient is identified at any step in this process as potentially failing to meet admission criteria for maintenance, the admission process will be halted and the treatment team will discuss the case at the weekly Multi-disciplinary team meeting, at which point a decision about admission will be made.
The Clinical Director will ensure compliance by consulting with counseling staff at the time that the patient comes in for the first appointment and the drug history is obtained. Questionable admissions will be referred to the treatment team at that point in the admission process. In addition the Clinical Director will review the biopsychosocial history as well as all signed consents and relevant intake forms for a period of six months. |
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 ten patient records.
The findings included:
Six patient records were reviewed on August 11, 2011; all were required to provide documentation that indicated a drug screen urinalysis was completed prior to a patient's initial dose. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient record # 2.
Patient # 2 was admitted into treatment on July 8, 201 and received a initial dose of 30 mg on the same date. A review of the patient record revealed that the facility had not conducted a drug-screen urinalysis since patient # 2's admission to the facility.
This finding was discussed with the facility director and it was confirmed that patient # 2 did not participate in a urine drug screening prior to admission into treatment.
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Plan of Correction
The process for admitting a patient has been changed. When a prospective patient requests admission, he or she is first scheduled to meet with a counselor and a nurse prior to scheduling the admission physical. The nurse meets with the patient to complete a medical screening. It is at this point that the drug screen urinalysis is obtained. The patient will not be scheduled to see the physician until the results of the drug screen are obtained and entered into the system. In addition, the Medical Director and Narcotic Treatment Physician have met with the Program Director and the regulation has been reviewed with them. The physicians will ensure that no patient is admitted until the results of the urinalysis are entered into the electronic chart.
The Nurse Manager will monitor this process to ensure compliance on all admissions for the next six months. The Nurse Manager and Program Director, jointly, will be responsible for ensuring that this problem does not recur, by following the procedure described above. |
715.14(a)(2) 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.
(2) If the narcotic treatment program determines that other drugs are abused in that narcotic treatment program 's locality or have been identified in the patient 's drug and alcohol history as being a drug of abuse or use, a narcotic treatment program may conduct a test or analysis for other drugs as well.
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Observations
Based on a review of patient records and policy and procedures, the facility failed to include drug-screen urinalysis testing for drugs that are reported as being abused by patients, specifically marijuana.
The findings include:
Six patient records and the facility's policy and procedure manual were reviewed on August 11, 2011. Documentation in the patient record and the facility's policies and procedures regarding drug-screen urinalysis were reviewed. The facility failed to provide drug-screen urinalysis testing for patient # 3 who identified a history and current use of marijuana. Patient # 3 submitted to a drug-screen urinalysis at the time of his March 23, 2011 admission and the results indicated use of marijuana. A review of patient record # 3 revealed that that there is no documentation of subsequent urinalysis testing to address patient # 3's marijuana use. The facility maintained a policy specific to an individual patient's drug history that indicated they would provide drug-screen urinalysis testing for other drugs known to be used by a patient.
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Plan of Correction
All new and readmitted patients are routinely tested for marijuana. Since the admission process has been modified, counselors are meeting with patients prior to admission and completing the biopsychosocial history. At the staff meeting that took place on September 7, 2011, counselors were instructed to report any information they obtain regarding marijuana use to the Nurse Manager at the time of admission.
All patients who test positive for marijuana at admission, as well as all patients who are reported to the Nurse Manager by the counselors, and all current patients who test positive for marijuana will be retested monthly and this test will include screening for the presence of THC. This monthly testing will continue until one year has elapsed with no evidence of marijuana use. These same patients will then be tested randomly thereafter.
The Nurse Manager will maintain a list of the relevant patients and will ensure that the test results are entered into the electronic chart.
At the weekly Multi-disciplinary Team meeting, the Program Director, Clinical Director, Nurse Manager and Medical Director will review the list of active patients and identify any new names to be added to the list for testing.
The Program Director will monitor adherence to this procedure weekly for three months. The Program Director will be responsible for ensuring that the corrective action is implemented and the procedure is followed. |
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.
The findings include:
Six patient records were reviewed on August 11, 2011, four patient records were required to document a consult between the narcotic treatment physician/physician extender determining the initial dose and the narcotic treatment physician performing the physical examination in one of the four records.
Patient # 4 was admitted into treatment on June 13, 2011. Documentation in patient record # 4's record revealed his physical examination was conducted by employee # 2, a narcotic physician. Employee # 1, also a narcotic treatment physician determined the initial dose on June 14, 2011, but failed to document the consultation with the physician who completed the physical examination.
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Plan of Correction
The Program Director reviewed the relevant regulations with the Medical Director and the Narcotic Treatment Physician. Beginning on September 15, 2011, the consultation between prescribing physicians will be documented in the patient chart. This consultation will include the fact that the presciber will note in the record that he/she reviewed the History and Physical if performed by a different physician, and any prescribing will be based on the History and Physical. If the prescriber then feels further consultation is indicated, it will be conducted by telephone and will be documented in the chart as a General Contact Note or a Case Consult. The Program Director will monitor the process to ensure compliance, and will meet with the Medical Director and Narcotic Treatment Program physician at least once per month to review the process and its implementation.
The Clinical Director will monitor compliance with documentation for all admissions for four months. The Program Director, in cooperation with the Medical Director, will be responsible for ensuring that the corrective action is implemented and the procedure is followed. |
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, the facility failed to ensure the physician signed and dated the verbal order within twenty hours of issuance of the verbal order.
The findings include:
Six patient records were reviewed August 11, 2011. Three records contained documentation of a physician's verbal orders, two of these records did not provide documentation that the physician signed verbal orders within 24 hours of the order.
Patient record #1 contained documentation that the physician gave a verbal order for a methadone dose increase on April 22, 2011; this order was not signed by the physician until April 25, 2011.
Patient record # 2 contained documentation that the physician gave a verbal order for a methadone dose increase on July 8, 2011; this order was not signed by the physician until July 11, 2011.
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Plan of Correction
The Medical Director and the Narcotic Treatment Program physician have been instructed to bring in their home (laptop) computers so that the Habit OPCO Information Technology staff can install the patient management software for their use from their homes. This will be completed by September 30, 2011.
In the interim, both physicians have been instructed to come in to the program on weekends to sign any verbal orders as needed. The nursing staff has been instructed to contact the physicians to notify them of any unsigned verbal orders at the end of each working day, including weekends.
The Nurse Manager will review all medical orders each day to ensure compliance. This will be done daily for 6 months, and then weekly thereafter. |
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, the facility failed to demonstrate the physician made a determination of the patient's dose during the induction phase of treatment.
The findings include:
Six patient records were reviewed August 11, 2011. Six patient records were reviewed for physician's documentation of the patient's initial and subsequent dose and schedule. Four of the six records revealed the physician's practice of issuing standard orders during patient induction into treatment.
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Plan of Correction
The Program Director met with the Medical Director and reviewed the policies on Medication Control. The Medical Director and Narcotic Treatment Program Physician instituted a change in the induction process and eliminated standing orders as of August 17, 2011. The temporary procedure instituted was that the physician would write the initial order and the patient would remain at the admission dose until he or she were seen by the physician for reassessment. The physician would then write a new order at the time of the follow up appointment, and so on. The physician's assessment would include the use of the COWS form at each appointment.
As of September 21, 2011, the procedure will be further refined. These changes include policies and procedures which assist the physician in determining Standard vs. Increased Risk inductions. Dose increases will be based on the continued use of COWS, and will include a change in the Admission Medication Order form.
On September 20, 2011, the corporate Director of Nursing will conduct in-person training for medical staff on the above changes. Following that meeting compliance with the new procedures will be monitored by the Nurse Manager for every admission on an ongoing basis. |