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 April 29, 2008 to May 1, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Center For Behavior Health-Pa, Inc. 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 June 3, 2008.
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Plan of Correction
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715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
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Observations
Based on the review of administrative documentation in the policy and procedure manual and the job description for the Certified Nurse Practitioner (CRNP), it was determined that the job description allows functions exceeding those allowed by regulation, specifically allowing the CRNP to prescribe methadone and ensure an appropriate dose.
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Plan of Correction
Human Resources has corrected the CRNP's job description to conform with regulation. As soon as it is approved, the CRNPs will review and sign. |
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 25 patient records, six patient records were reviewed to determine compliance for face to face determination of current and at least one year opioid dependency. In two patient records, the determination by the physician was documented as completed after the patients were admitted and dosed. Specifically, patient #12 was admitted on January 18, 2008, was first dosed on January 25, 2008, but the physician documented the face to face contact as occurring January 31, 2008. In addition, patient #13 was admitted and dosed on August 24, 2007 and the physician documented that the face to face observation occurred on August 28, 2007.
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Plan of Correction
Program Director has brought this to the Medical Director's attention. All patients will have documentation of face to face evaluation from Medical Director before medicating. Patient will not be admitted by administrator until documentation is complete. Program Director or Manager will review to ensure this task is being followed according to PA Department of State regulations. |
715.15(a) LICENSURE Medication Dosage
(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient 's therapeutic dosage.
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Observations
Based on the review of 25 patient records, nine records were reviewed to determine compliance with the required semi-annual dose review. Three patient records were difficult to determine when the dose review was actually completed as patient #3 had a dose review documented on 2-16-08 and not signed by the physician until 3-20-08; patient #8 had a dose review dated for 1-30-08 and signed by the physician on 1-31-08, and patient #23 had a dose review documented as completed on March 9, 2008 and the physician signed and dated the review on March 20, 2008.
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Plan of Correction
Program Director has brought this to the attention of the Medical Director. Medical Director has been directed to "save complete" the dose reviews on the date the notes had been started to prevent confusion. Program Manager will review the dose review notes when completing Chart Audits. Program Director will oversee. This deficiency has already been addressed and has been completed. |
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 upon review of 25 patient records, 11 records were reviewed for take-home privileges. Patient record #3 continued to receive take-home doses despite continued positive urine drug screens for cannabis and benzodiazepine without a current, verified prescription. In addition, this patient record had documentation demonstrating an unstable living environment of moving from house to house and residing in a shelter. The record of patient #1 contained documentation of an instable home life of a very depressed spouse and having to assume all the care-taking of three children.
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Plan of Correction
Clinical supervisor will conduct a training to reinforce the FDA 8 point criteria for take home status. Clinical supervisor will monitor patient take home status in weekly supervision. Program Director to oversee task is completed. |
715.19(2) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(2) A narcotic treatment program shall provide each patient at least 1 hour per month of group or individual psychotherapy during the third and fourth year of treatment. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
Based on the review of 25 patient records, 5 records were reviewed for reduced counseling schedule. Patient record #20, who was in the fourth year of continuous maintenance treatment, was only seen for counseling every 2 to 3 months without any documentation that patient was scheduled for counseling on a more frequent basis.
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Plan of Correction
Clinical Supervisor will review "Quality Services Report" with each counselor in weekly supervision to ensure that each patient is obtaining the minimal required counseling hours each month. Program Manager will conduct clinical quality audits to assure this task is being completed. This deficiency has already been presented to Clinical Supervisor and is already being followed through. |
715.20(1) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(1) The transferring narcotic treatment program shall transfer patient files which include admission date, medical and psychosocial summaries, dosage level, urinalysis reports or summary, exception requests, and current status of the patient, and shall contain the written consent of the patient.
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Observations
Based on the review of 25 patient records, 4 patient records were reviewed for compliance with the requirements to transfer a patient. Four of four patient records, #15, 23, 24 and 25, were missing documentation verifying the information that was transferred.
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Plan of Correction
Clinical Supervisor will conduct a training so Associates know which information to send when a patient transfers (as long as patient consents to such information) and to document that information had been sent when transferring a patient. When conducting discharge audits, the Program Manager will confirm documentation is in place. |
715.20(4) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.
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Observations
Based on the review of 25 patient records, 3 records were reviewed to determine compliance with notifying the transferring program of the admission and date of first dose of the transferred patient. Of the 3 records reviewed, 2 records, # 1 and 11, did not contain documentation of the required information, but rather documented that the patient's medication dose was confirmed with the prior program.
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Plan of Correction
Clinical supervisor will conduct a training to educate counselors how to complete the transfer acknowledgement form, send this form to the transferring facility as a follow up and then document this task had been completed. Program Manager and Program Director will oversee. |
715.21 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.
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Observations
Based on the review of 25 patient records, 6 records of patients who were involuntary terminated were reviewed. Patient records #9, 11, 16 and 17 did not contain documentation showing that the program attempted all other efforts to retain these patients prior to termination.
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Plan of Correction
Clinical Supervisor will conduct a training to ensure that Associates document all attempts at retaining a patient prior to termination. Program Director will oversee by conducting spot chart audits. |
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 the review of 25 patient records, 6 records were reviewed for involuntary terminations. Patients #9 and 16 were involuntarily terminated for not paying for treatment. Patient #9 lost insurance coverage and failed to pay for 2 weeks when patient was placed on a 10 day involuntary detoxification. Patient #16 had documentation in a note dated April 4, 2008 that stated that patient was "unable to pay today" and was placed on a medically supervised detoxification schedule. In addition, the patient's handbook contains statements that patients can be involuntary terminated from treatment for wearing hats and/or sunglasses, or bringing beverages or children to the dosing window.
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Plan of Correction
Program Director will conduct training for all Associates to reinforce that no patients are discharged for financial reasons. Program Director will ensure that all patient discharges are the result of patients best interst and health, safety. Program Director will review medical orders daily to monitor which patients have been placed on a medically supervised withdrawal to monitor. This action will be taken immediately. Program Director has consulted with corporate compliance regarding patient handbook. The handbooks will be recalled from all PA clinics immediately and new handbooks will be furnished. The time to complete will depend upon the time needed to print new handbooks. Before then, all handbooks that will be distributed will be corrected and the portion regarding patient sunglassess, hats, etc will be deleted. Corporate Compliance to complete and Program Director to oversee and monitor. |
715.22(c) LICENSURE Patient grievance procedures
(c) Penalties may not be initiated prior to final resolution with the exception that penalties may be initiated against patients who have committed acts of physical violence or who have threatened to commit acts of physical violence in or around the narcotic treatment program premises.
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Observations
Based on the review of 25 patient records, one record was reviewed to determine compliance with the program's grievance policy and regulation. Patient record #10 was determined to be non-compliant. This patient was placed on an involuntary detoxification schedule starting August 16, 2007 and patient was continued on the schedule after the grievance appeal was filed. The grievance was finalized on September 7, 2007.
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Plan of Correction
Since grievances go through the Program Director, the Program Director will ensure that no action will be taken against a patient during the grievance process. The Program Director will ensure the process has been finalized before action will be taken upon patient's treatment. This will begin immediately. Program Director to enforce immedately. Corporate compliance to oversee. |
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 the review of 25 patient records, 4 patient records were reviewed to determine compliance with laboratory testing. Of the 4 patient records reviewed, 3 records, #1, 2, and 12, did not contain documentation of the patient having blood serological test for Syphilis completed as required. In addition, patient record #4 contained a statement that patient had previously tested positive for Tuberculosis and periodically obtained chest x-rays, but there was no supporting documentation to this statement, and there were no referrals documented to obtain more current information.
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Plan of Correction
CRNP will conduct medical chart audits after each admission to ensure all documentation continues to be in place. Program Manager will oversee by conducting clinical and medical chart audits 14 days after a patient's admission. |
715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations
Based on the review of 25 patient records, 5 patient records were reviewed for compliance with the annual evaluation. Of the 5 patient records reviewed, 4 were found to non-compliant. Specifically, patient #3' annual evaluation failed to include information regarding financial management and was not signed by the medical director. Patient records #6, 14, and 21 were not dated and signed by the medical director.
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Plan of Correction
Medical Director has been directed to sign annual evaluations in a timely manner. Clinical Supervisor will preform training so that Associates from each department document all required information on annual evaluations. *This training had already taken place on 06/05/08*. Program Director to oversee that these tasks are completed. |
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 the review of 25 patient records, 6 patient records were reviewed for compliance with the treatment plan requirements. Six of the 6 patient records reviewed were determined to be non-compliant based on the goals that were written that were not being based on the patient's clinical assessment, but rather were case management statements. Patient record # 5 had a goal statement of " I will continue to address this problem by attaining these goals " and patient # 6 had goal statements of " utilizing coping skills" and "exploring spirituality" with an objective to "pay treatment fees on time." In addition, support services were not included as part of the treatment plans reviewed.
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Plan of Correction
Clinical Supervisor will conduct a treatment plan training to ensure documentation of patient progress or lack of is clearly identified. Clinical supervisor will monitor goal statments before approving treatment plans to rid of case management statements. In addition, Clinical Supervisor will ensure that support services are included in treatment planning before approving a treatment plan. Program Director will oversee that this task is completed. Program Manager will conduct spot audits on charts to mark improvement in 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 the review of 25 patient records, 3 patient records were reviewed for compliance with behavioral tasks that related to the short term goals. The behavioral tasks for 3 of 3 patient records reviewed focused on how the counselor was going to help the patient, but failed to include specific steps for the patient to follow to reach the goals established. Specifically, patient records #3, 5, and 13.
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Plan of Correction
Clinical supervisor will conduct a training outlining ways to properly document behavioral tasks. Program Director to oversee task is complete. Program Manager to conduct spot chart audits to mark improvement. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on the review of administrative documentation of unusual incidents and patient records, the facility failed to submit written reports for unusual incidents that included a report that patients were fighting on 12-06-07 and the police were called to the facility; 12-06-07 patient #1745 left a lock-box with take-home bottles on a chair in the lobby; two patient deaths that occurred on 12-18-07 and 12-25-07; and patient 5252 was intoxicated onsite and EMT's were called. the patient became combative and police were called, the patient resisted and was arrested.
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Plan of Correction
Program Director already conducted a training for all associates on how to properly document incident reports and regulations on reporting sentinal events. Program Director will oversee that each incident report is properly reported. |
715.29(5) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient 's record.
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Observations
Based on the review of 25 patient records, 5 patient records were reviewed that had 13 day take home doses. The facility failed to comply with the conditions of the exception granted by the Division regarding thirteen day take-home privileges. Patients on thirteen day privilege status based on the exception must have quarterly call backs (an unscheduled return to the facility within 24 hours) that includes an inventory of patient's remaining take home supply, drug testing or methadone plasma levels, and a review as to whether the reduced take-home schedule should continue. The facility failed to conduct quarterly call backs for patients # 5, 6, 7, 8 and 19.
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Plan of Correction
Training has been conducted and associates are aware that call backs need to be conducted on all patients who have 13 day take home status. Clinical Supervisor will utilize patient by take home report and schedule patients who are on 13 day take home status are scheduled for call backs. Program Manager to oversee this task is completed. |