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 June 9, 10, 11 and 12, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Alliances Medical Services, Ensign II, 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 July 10, 2008.
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Plan of Correction
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715.7(a)(1-2) LICENSURE Dispensing or administering staffing
(a) A narcotic treatment program shall be staffed as follows:
(1) If it operates an automated dispensing system, one full-time nurse or other person authorized by law to administer or dispense a controlled substance shall be available for every 200 patients.
(2) If it operates a manual or nonautomatic dispensing system, one full-time nurse or other person authorized by law to administer or dispense a controlled substance shall be available for every 150 patients.
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Observations
Based upon documentation and staff interviews, the facility failed to maintain adequate nurse supports to operate their dispensing system. The facility used a manual system that required 1 nurse for every 150 patients; at the time of the inspection there was one currently employed nurse identified to provide services to 209 patients.
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Plan of Correction
The facility did not maintain adequate nursing coverage to comply with the required 150:1 ratio.
Additional nursing staff have been hired and an automated dosing system implemented to be in compliance with the required 200:1 ratio.
The Facility Director is responsible for ongoing compliance with this regulation |
715.8(1)(vi) LICENSURE Psychosocial Staffing
A narcotic treatment program shall comply with the following staffing ratios as established in Chapter 704 (relating to staffing requirements for drug and alcohol treatment activities):
(vi) Outpatients. The counseling caseload for one FTE counselor in an outpatient narcotic treatment program may not exceed 35 active patients.
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Observations
Based on a review of counseling caseloads, the facility exceeded the counseling caseload of one full-time equivalent (FTE) counselor for every 35 patients. Specifically, a counselor was on maternity leave, yet was identified by facility staff as having a current caseload.
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Plan of Correction
The facility exceeded the 35:1 ratio for each caseload. In error, the facility identified an employee on maternity leave as having a full caseload. There was also an additional counselor vacancy at the facility.
The Facility Director has removed the caseload from the FMLA counselor until she returns to work at AMS. One vacant position has been filled as of 7/14/2008 and the existing caseload of the FMLA counselor is being temporarly managed by existing staff, including the clinical supervisor, until the vacant counselor position is filled. The cases have been assigned according to seniority and the counselors will be compensated for the additional hours required to provide mandated services.
If the FMLA counselor should decide not to return to work on 9/1/2008, the Facility Director will immediately begin recruitment efforts to fill the position.
The Facility director and Clinical Supervisor are responsible for the recruitment efforts as well as ongoing compliance with this regulation. |
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 a review of 16 patient records, four were required to have documentation of the physician's determination of a one year narcotic history and current dependency. The facility failed to document the physician's determination of current dependency and history of addiction in 1 of 4 records. The determination of addiction history and current dependency for patient record #9 was determined by the physician's assistant.
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Plan of Correction
Only the physician is responsible for determining dependancy at the time of admission or readmission. This will be based on his evaluation of each patient based on current usage. The physician will make this evaluation through a face to face interview with each prospective patient.
The procedure has been reviewed with the physician and he is responsible for compliance in this area. The lead nurse will monitor for compliance through regular record review.
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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
Five of 16 patient records were reviewed for documentation that the physician who determined the dose had consulted with the physician's assistant who had performed the patient examination. In three of the five records, the facility failed to document that the case consultation occurred, specifically patient records # 7, 9, and 10.
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Plan of Correction
The physician is responsible for determining the appropriate dosage for each patient. The physician may consult with the physicians assistant regarding the examination to assist in making this determination. The physician will document consultation with the physicians assistant to determine appropriate dosage.
The physician has been made aware that he is responsible for all consults of this nature. Ongoing compliance is the responsibility of the physician and oversite provided by the lead nurse through regular record review.
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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 a review of 16 patient records, the facility failed to ensure that only the physician made dose determinations. Specifically, patient record #4 contained documentation that the patient's counselor had recommended a 10 mg dose increase; the recommendation was approved by the physician. The physician must make the actual dose determination; a counselor may recommend an increase and report the patient's symptoms to the physician.
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Plan of Correction
The facility failed to ensure that dosage determination is solely determined by the physician.
The physician is responsible for determining the appropriate dosage for each patient. The counselor or other staff may assist in the assessment for appropriateness in adjusting the dose, but may only be approved by the physician.
The physician and counseling staff have been trained regarding this issue. Ongoing compliance will be monitored by the lead nurse and facility director to maintain compliance. |
715.17(c)(3)(i-v) 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:
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
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Observations
Based on a review of policy and procedure, documentation, and staff interviews, the facility failed to follow their policy and procedure as they did not complete a quarterly inspection of the drug storage area during the months of September and December 2007.
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Plan of Correction
An appropriate quarterly inspection of the drug storage area as dictated by our policy and procedure was not conducted within a delineated time frame.
The Physician Assistant and the Lead Nurse are responsible to routinely conduct the inspections. They have created a process in conjunction with the automated system to insure compliance.
The Facility Director is responsible for ongoing compliance in this area. |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on a review of 16 patient records, four were required to have documentation of an annual re-evaluation by the physician. The facility failed to have the physician document in either the annual evaluation or the annual physical examination that patient #10 was in need of continued treatment; the physical examination that was completed by the physician's assistant did not include documentation of the physician's re-evaluation.
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Plan of Correction
The physician must determine the need for ongoing narcotic treatment during the annual reevaluation.
This requirement has been addressed with the physician and the physicians assistant.
The physician is responsible for ongoing compliance in this area. The lead nurse is responsible for monitoring for compliance through regular chart review. |
715.23(b)(11) LICENSURE Patient records
(b) Each patient file shall include the following information:
(11) Counselor notes regarding patient progress and status.
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Observations
Six of 16 patient records were reviewed for counselor note content. The facility failed to document complete group progress notes that addressed the specific group process, the assessment of the patient's participation, and the plan for further treatment in patient's # 4, 6, and 10 records.
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Plan of Correction
The facility failed to document complete group progress notes to include the specific group process, an individual assessment of each patient's participation and the plan for further treatment.
The current group progress note will be amended to include those identified areas by 7/25/2008. In addition, staff failed to document treatment planning issues in the individual progress notes on a consistent basis. Staff will be trained for compliance in this area during a regular inservice training meeting on 7/28/2008. The clinical supervisor will meet individually with each counselor to clarify the requirement and provide additional training as needed. This will be completed by 8/1/2008 Ongoing compliance will be guaranteed through regular chart review and weekly supervision by the clinical supervisor. |
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
Nine of 16 patient records were reviewed for treatment plans that contained short term goals with measurable steps. In 5 of 9 records; patients records # 9, 10, 11, 12, and 13, the treatment goals that were vague and had non-specific steps to reach the goals and the time frames were generalized rather than realistically specific to the action steps. Further, the treatment plans failed to identify support services needed by the patient in 3 of 9 records.
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Plan of Correction
The facility failed to develop treatment plans that contained short term goals with measurable steps. In addition, records did not contain clear, specific steps to reach goals or time frames that were specific to the necessary actions.In addition, the comprehensive treatment plan was completed prior to the patient's social, drug and alcohol history.
The clinical supervisor will provide training to address these issues during an inservice meeting on 7/23/2008. The clinical supervisor will then meet with each counselor during the week of 7/23 for clarification and further training. Ongoing compliance will be the responsiblity of the clinical supervisor through weekly individual supervision and regular chart review. It is expected that all records will be in compliance with the regulation by 8/1/2008.
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