INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection, and a methadone monitoring inspection conducted on January 26 - 27, 2016 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Esper Treatment Center 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 identified during this inspection.
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Plan of Correction
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704.11(c)(1) LICENSURE Mandatory Communicable Disease Training
704.11. Staff development program.
(c) General training requirements.
(1) Staff persons and volunteers shall receive a minimum of 6 hours of HIV/AIDS and at least 4 hours of tuberculosis, sexually transmitted diseases and other health related topics training using a Department approved curriculum. Counselors and counselor assistants shall complete the training within the first year of employment. All other staff shall complete the training within the first 2 years of employment.
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Observations
Based on a review of personnel records, the facility failed to ensure staff persons received a minimum of 6 hours of HIV/AIDS and at least 4 hours of tuberculosis, sexually transmitted diseases and other health related topics training in one of two personnel records.The findings include:Six personnel records were reviewed on January 26, 2016. Two personnel records were reviewed for documentation of HIV/AIDS and tuberculosis, sexually transmitted diseases (TB/STD) and other health related topics training. The facility failed to ensure employee # 6 received a minimum of 6 hours of HIV/AIDS and at least 4 hours of TB/STD training.Employee # 6 was hired as a counselor on August 4, 2012. HIV/AIDS and TB/STD training was due to completed no later than August 4, 2013. There was no documentation of HIV/AIDS and TB/STD training in personnel record # 6, as of January 26, 2016.The findings were reviewed with facility staff during the licensing process.This is a repeat citation from the January 13 - 14, 2015 licensing inspection.
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Plan of Correction
The Project Director will ensure that the appropriate training that is required for the counselor will be completed within 60 of the POC. Going forward the Clinical Director will ensure that all counselors will receive all mandated trainings within the first year of employment. The Clinical Director will utilize the sheet with all required trainings in the personnel record and note in the file when the training was completed and certificates of completion will also be stored in the training file. |
715.3(a)-(h) LICENSURE Approval of narcotic treatment programs
(a) An entity shall apply for and receive approval as required from the Department, DEA and CSAT or an organization designated by the Substance Abuse and Mental Health Services Administration (SAMHSA), under the authority of section 303 of the Controlled Substances Act (21 U.S.C.A. § 823) and sections 501(d), 509(a), 543, 1923, 1927(a) and 1976 of the Public Health Service Act (42 U.S.C.A. §§ 290aa(d), 290bb-2(a), 290dd-2, 300x-23, 300x-27(a) and 300y-11), prior to offering services within this Commonwealth as a narcotic treatment program. Application for approval shall be made simultaneously to the Department, DEA and CSAT or SAMHSA designee.
(1) The Department will forward a recommendation for approval to the Federal officials after a review of policies and procedures and an onsite inspection by an authorized representative of the Department and after a determination has been made that the requirements for approval under this chapter have been met.
(2) The decision of the Federal officials set forth in 21 CFR Chapter II (relating to Drug Enforcement Administration, Department of Justice) or other Federal statutes shall constitute the final determination on the application for approval by DEA and CSAT or SAMHSA designee.
(b) A narcotic treatment program shall be licensed under the Department's regulations for drug and alcohol facilities in Chapter 157, 704, 705, 709 or 711. When a licensee applies to operate a narcotic treatment program, the history component of the application of the licensee shall include the licensee's record of operation of any facility regulated by any State or Federal entity. A narcotic treatment program may not be recommended for approval unless licensure has been obtained under Chapters 157, 704, 705, 709 or 711.
(c) The Department will grant approval as a narcotic treatment program after an onsite inspection and review of narcotic treatment program policies, procedures and other material, when the Department determines that the requirements for approval have been met.
(d) The Department will inspect a narcotic treatment program at least annually to determine compliance with State narcotic treatment program regulations. This inspection shall consist of an onsite visit and shall include an examination of patient records, reports, files, policies and procedures, and other similar items to enable the Department to make an evaluation of the status of the narcotic treatment program. The Department may inspect the narcotic treatment program without notice during any regular business hours of the narcotic treatment program.
(e) During the inspection process, a narcotic treatment program shall make available to the authorized staff of the Department full and free access to its premises, facilities, records, reports, files and other similar items necessary for a full and complete evaluation. The Department may make copies of materials it deems necessary under 42 CFR 2.53 (relating to audit and evaluation activities) and §§ 709.15 and 711.15 (relating to right to enter and inspect; and right to enter and inspect).
(f) The authorized Department representative may interview patients and staff as part of the inspection process.
(g) The Department may grant approval as a narcotic treatment program after an onsite inspection when the Department determines that a narcotic treatment program satisfies the following:
(1) It has substantially complied with applicable requirements for approval.
(2) It is complying with a plan of correction approved by the Department with regard to any outstanding deficiencies.
(3) Its existing deficiencies will not adversely alter the health, welfare or safety of the facility 's patients.
(h) Notification of deficiencies involves the following:
(1) The authorized Department representative will provide the program director with a record of deficiencies with instructions to submit a plan of correction.
(2) The narcotic treatment program shall complete the plan of correction and submit it to the Department within 21 days after the last day of the onsite inspection.
(3) The Department will not grant approval as narcotic treatment program until the Department receives and approves a plan of correction.
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Observations
Based on a review of administrative materials, patient record lists and patient records, the facility was conducting narcotic treatment services utilizing buprenorphine without applying for and receiving the Department's approval.The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Project Director has submitted a request for certificate of approval to dispense buprenorphine in the same fashion that methadone is dispensed. Administration understands that the Certificate of Approval allows the dr. to order buprenorphine the same way they order for methadone and have it dispensed to the patient at the facility. Administration also understands that the buprenorphine waiver allows the dr to write a prescription for buprenorphine to a patient and that patient takes that prescription to the pharmacy to have it filled. If the request for approval is denied the Project Director, Clinincal Director and Medical Director will evaluate the needs of the patient and determine the best course of action. The actions include but not limited to transitioning each patient over to methadone or refer patients to other buprenorphine providers in the area. |