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 December 18, 19, and 20, 2007 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Addiction Medicine and Health Advocates was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of correction is due on January 23, 2008.
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Plan of Correction
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715.5(1-5) STANDARD Patient capacity
The Department may increase or decrease the number of patients a narcotic treatment program may treat. The Department may raise the patient capacity, upon the written request of the narcotic treatment program, based upon the Department 's review of the narcotic treatment program. The factors the Department will consider include:
(1) Safety. Considerations include dispensing time, internal patient flow and external traffic patterns.
(2) Physical facility. Considerations include the number and size of counseling offices, waiting areas, restrooms, and dispensing and nursing windows.
(3) Staff size and composition. Considerations include the number of narcotic treatment physicians, dispensing and counseling staff.
(4) Ability to provide required services. Considerations include compliance with licensing and narcotic treatment program regulations as determined during licensing, monitoring and special visits to the narcotic treatment program.
(5) Availability and accessibility of service. Considerations include the location of the narcotic treatment program and the hours of operation.
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Observations
Based on administrative documentation and staff interviews, the facility has allowed the daily census of active patients to exceed the approved capacity. The approved capacity was 350 on December 14, 2007 and the census was documented as 362 patients on that same date.
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Plan of Correction
At the time of the inspection, we had several (15) patients who were incarcerated or in residential treatment. We were keeping their cases active with the intention that they would return to our program. Due to the length of time they had been absent from the program, they should have been discharged from our active roles prior to the inspection to bring our census under 350. We are in the process of discharging these patients, and any other patient who have since been identified as being absent for over 14 days from treatment. We plan to maintain this procedure in order to keep our current active patient census under the approved number of 350. The Clinical Coordinator will be responsible for implementation and monitoring. |
715.6(d) LICENSURE Physician Staffing
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients
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Observations
Based on review of program documentation and staff interviews, the facility failed to ensure at least 1 hour of onsite physician services for every ten patients. The documented census was 362 and the physician's schedule was for 35 hours.
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Plan of Correction
As a result of discharging patients who have been absent from the program for over 14 days, and maintaining an active patient census of under 350, our current physician hours will meet the standard as set forth in the regulations. The Executive Director and Clinical Coordinator will be responsible for maintaining a patient census of under 350. |
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 random review of patient records, the facility failed to, with patient consent, contact the previous narcotic treatment facility for the patient's treatment history there in three of three patient records reviewed, # 16, 17 and 18.
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Plan of Correction
The Clinical Coordinator has already spoken with the Intake Counselor regarding this deficiency. Starting immediately, if an applicant for our program reports that he or she has been on another narcotic treatment program in the past, we will secure patient consent and contact that program for information related to the patient's treatment at that facility. The consent form and attempts to secure the information will be maintained in the patient's record. The Clinical Coordinator will be responsible for implementing and monitoring this procedure. |
715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
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Observations
Based on the random review of 19 patient records, the facility failed to maintain the confidentiality in accordance with 709.28 relating to identifying specific information to be released by checking "other" on the consent to release form without identifying what the "other" information would be, and not identifying the purpose of the consent. In addition, the facility exceeded 4 Pa Code 255.5 by allowing physical examinations and blood work results to be released to the funding entity, BHSI.
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Plan of Correction
A staff training will be held to discuss the appropriate completion of consent to release forms which includes identifying what information is being sent if "other" is checked and identifying the purpose of the release.
We recently developed specific consent forms for entities (e.g. BHSI and CBH) that are only entitled to limited information as per the State and Federal confidentiality requirements. Those consents allow for only the release of information specified in 4 PA Code 255.5. Staff will be reminded in the training and in supervision for the need to use these specific consents. The Clinical Coordinator will be responsible for implementing and monitoring this. |
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 random review of 19 patient records, the facility failed to obtain a monthly random urine drug screens for patients # 2, 6, 14 and 15.
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Plan of Correction
AMHA will manually review the conmputer generated drug screen list each month to make sure all patients are scheduled that month. The Clinical Coordinator will monitor the filing of the hard copies of the drug screens to make sure the chart is in compliance with the State standards. The Nursing Supervisor will monitor the scheduling of drug screens. In addition, we will continue to monitor this process as part of our internal record review which is part of our Quality Improvement program. |
715.16(a)(1) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(1) A narcotic treatment program may give take-home medications only to a patient who the narcotic treatment physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program.
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Observations
Based on random review of 19 patient records, the facility failed to rescind approval for take home privileges for patient # 3 after this patient had positive urine drug screens for marijuana and non-prescribed opiates that were verified.
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Plan of Correction
The Nursing Supervisor and assigned counselor will review all drug screens to assure full compliance with all established take-home criteria. Additionally, the Clinical Coordinator and program physician will monitor all take-home schedules monthly. Patients no longer meeting the reduced schedule criteria, will have their schedules rescinded immediately. |
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 random review of 19 patient records and staff interviews, the facility has not restricted the determination of of the patient's dosing to the physician, but rather has allowed counselors and nursing staff to make these determinations. Counselors routinely "recommended" specific dose changes and the physician "reviewed and approved" these changes. Nursing staff routinely adjust the patient dose if the patient presents as intoxicated. A nurse may refuse to medicate an impaired patient, however, any change in the dose must be determined and ordered by the physician.
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Plan of Correction
A staff training was conducted on 1/10/08 to address this issue. The counselors have been instructed to recommend an increase or decrease only and not a specific amount. Upon presention to and review by the program physician, he will make a determination as to the amount, if one is warranted. The program physician will be responsible for following this procedure and established standard. Patients presenting for medication who appear to be intoxicated, will need to be seen by the program physician to determine if they should get medicated that day, and with what amount of medication. The program physician will be responsible for following this procedure and applicable standards. |
715.17(c)(5) 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:
(5) Security of all substances. A narcotic treatment program shall develop and implement written policies and procedures to minimize the likelihood of loss, theft or misuse of an agent or another controlled substance as well as a plan of action if a loss, theft or misuse does occur. In the event of loss, theft or misuse, the Federal and State statutes and regulations regarding reporting shall be followed.
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Observations
Based on the review of the program policy and procedure manual, the facility failed to develop policies and procedures to minimize the likelihood of loss, theft or misuse as well as an action plan if such would occur. The facility also failed to address reporting per incident reporting requirements, any events of loss, theft or misuse of an agent to the Department of Health, Division of Drug and Alcohol Program Licensure.
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Plan of Correction
AMHA will revise its policy and procedure manual to include the items listed in 715.17(c)(5) addressing the loss, theft or misuse of a controlled substance as well as an action plan if such where to occur. We will also include the procedure for reporting such incedents as per the State and Federal regulations. The Nursing Supervisor will be responsible for updating the manual and for monitoring adherence to the policy. |
715.19(1) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
Based on random review of 19 patient records and staff interviews, the facility failed to provide the minimum average of 2.5 therapy hours to patients # 17, 18 and 19.
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Plan of Correction
In a staff meeting held on 1/10/08, we reviewed the requirements surrounding minimum contact hours. We will continue to monitor adherence to this requirement via our internal monthly quality record review which is part of our Quality Improvement program. We will continue to identify and meet with staff memebers who appear to have difficulty meeting this requirement. The Clinical Coordinator will be responsible for monitoring this. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on review of administrative documentation in the policy and procedure manual and patient records, the facility has exceeded reasons acceptable for involuntary termination by adding loitering, being under the influence, not keeping counseling appointments, not swallowing the dose at the nurses station, dual enrollment as well as falsification of urine drug screens.
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Plan of Correction
AMHA will revise its policies and procedures to reflect only those reasons listed in the 715's as acceptable reasons for involuntary termination. The Clinical Coordinator will be responsible for making these changes and for ensuring that these policies are followed. |
715.23(b)(6) LICENSURE Patient records
(b) Each patient file shall include the following information:
(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.
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Observations
Based on random review of 19 patient records, the facility has consistently obtained serology tests three to four weeks after patient admission. A complete physical examination including laboratory test must be obtained within 14 days from admission
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Plan of Correction
AMHA will will have a phlebotomist on site once per week. Newly admitted patients will be scheduled for bloodwork on the next scheduled day which will be no more than 7 days after admission. The Nursing Supervisor will be responsible for scheduling the bloodwork and monitoring compliance. |
715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Based on random review of 19 patient records, the facility failed to ensure the treatment plan goals were written as goal statements, but were rather written as problem statements, making it difficult to measure the progress over time in treatment.
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Plan of Correction
In a staff meeting held on 1/10/08, staff were reminded that treatment plan goals need to be written as goals and not problem statements. These goals should be measureable and behaviorally defined. We will follow up on this information in our annual treatment plan training. The Clinical Coordinator will be responsible for monitoring this and meeting with staff who need additional supervision surrounding treatment planning. |
715.23(d)(1) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(1) The treatment plan shall identify the behavioral tasks a patient shall perform to complete each short-term goal.
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Observations
Based on random review of 19 patient records, the facility failed to ensure the behavioral tasks were written for the patient to complete each goal, but rather established the action steps the counselor would perform.
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Plan of Correction
In a staff meeting held on 1/10/08, staff were reminded that intervention strategies for achieving short-term goals (objectives)need to include specific behavioral tasks to be completed by patients. We will follow up with this in our annual treatment plan training. The Clinical Coordinator will be responsible for monitoring this and for scheduling supervison with staff who need additional supervision with treatment planning. |