INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on July 10, 2018 by staff from the Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment, Division of Accountability and Program Improvement. Based on the findings of the on-site inspection, Warren General Hospital 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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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
During the annual inspection on July 10, 2018, the facility was conducting narcotic treatment services utilizing buprenorphine without applying for and receiving the Department's approval.
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Plan of Correction
Application for utilizing buprenorphine was submitted and approved by Department on 7/30/18. Policy and Procedure Manual was updated to include use of Buprenorphine with opiate detox patients. |
710.23(a) LICENSURE Patient Records
§ 710.23. Patient records.
(a) In addition to the requirements contained in § 115.32 (relating to contents), the patient ' s medical record shall contain a drug and alcohol support plan, follow-up information, and an aftercare plan, if applicable.
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Observations
The facility failed to document follow up information in three of five client records.
Client records were reviewed on July 10, 2018. Five of the clients were discharged and required follow up contact. Client records #3, 4 and 5 did not have documentation of follow up information.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Policy and Procedure for Follow-up was updated to include calling patients who left AMA, went home or refused formal treatment following the completion of detox to question the patients if they needed further assistance with follow-up. The patients who did follow with treatment the agencies would be contacted to see if they kept the appointment. All calls will be made within 15 days of the patient's discharge from the detox unit. The counselor or designee will document these correspondences in the electronic medical record, and if a patient doesn't answer three attempts will be made upon the third unsuccessful attempt contact will stop. The designee will preform an compliance audit for three months of at least 100% of compliance. The audit will be found in a binder in the counselors office. |
710.23(b) LICENSURE Patient Records
§ 710.23. Patient records.
(b) Patient records shall be kept confidential in accordance with applicable Federal drug and alcohol regulations and the confidentiality requirements in 4 Pa. Code § § 255.4 and 255.5 (relating to UDCS: confidentiality and access to information and projects; and coordinating bodies: disclosure of client-oriented information).
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Observations
The facility failed to limit information to those items permissible in PA Code 255.5 in three of seven client records.
Client record #4 contained a signed release of information that gave permission to release treatment notes to a probation officer.
Client record #6 contained a signed release of information that gave permission to release medications to an insurance company.
Client record #7 contained a signed release of information that gave permission to release medications and treatment recommendations to an insurance company.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Education of 4 PA Code Section 255.5 will be reviewed in a mandatory training session for all employees who have any direct care contact with detox patients and signature sheet will be completed to show all staff competency. The training session will be held no later than 8/31/18. Audit will be completed for three months following the session until 100% compliance.
The responsibility of implementation of this plan is the Drug and Alcohol Counselor. |