INITIAL COMMENTS
|
This report is a result of an on-site complaint investigation conducted on March 06, 2017 by staff from the Division of Accountability and Program Improvement. Based on the findings of the on-site complaint investigation, Clear Choices, LLC was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility.
|
Plan of Correction
|
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).
|
Observations
A physical plant review was conducted on March 6, 2017. Based on this review, the facility failed to secure and maintain the confidentiality of all patient records.
It was observed by DDAP staff, in the reception area closet, that closed client files were not being stored in locked file cabinets but were stacked on top of the file cabinets.
|
Plan of Correction
Facility Director will hold an in house in service for all staff by 4/28/17 to ensure their knowledge of maintaining closed files in locked cabinets. Additionally, closed files will be organized, scanned for retention and shredded as needed to ensure they are maintained correctly in locked containers on site by 4/28/2017. Documentation of the training and the physical plant will be available for review at the next facility inspection. |
715.14(c) LICENSURE Urine testing
(c) A narcotic treatment program shall develop and implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.
|
Observations
A physical plant review was conducted on March 6, 2017. Based on this review, the facility failed to implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.
It was observed by DDAP staff, in nurse's area of the dosing window, an unpackaged urine specimen indicating that the "chain of command" had be broken.
|
Plan of Correction
Facility Director will have an in house in service by 4/28/17 for all Medical Staff to ensure that they understand chain of custody as related to urine specimen collection and packaging. Facility Director will monitor through random observation and will maintain documentation of the training on site for review. |
715.17(c)(2) 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:
(2) Drug storage areas. A narcotic treatment program shall develop and implement written policies and procedures regarding storage of medications and access to the medication storage area. Agents shall be stored in a locked safe that has been approved by the DEA under 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls).
|
Observations
Interviews with facility staff were conducted on March 6, 2017. Based on this review, the facility failed to secure agents in a locked safe .
The Facility Director confirmed with DDAP staff that the lock on the methadone safe was not operable and had been so for over one month.
|
Plan of Correction
Facility Director will obtain the services of a Locksmith to inspect and address issues related to the tumblers in the safe by 4/28/2017. Documentation of the repairs will be maintained on-site for review at the next facility inspection. |
715.23(a) LICENSURE Patient records
(a) A narcotic treatment program shall maintain patient records in conformance with 42 CFR 2.16 and 2.22 (relating to security for written records; and notice to patients of Federal confidentiality requirements) and State statutes and regulations. A narcotic treatment program shall maintain a complete file on the premises for each present and former patient of the narcotic treatment program for at least 4 years after the patient has completed treatment or treatment has been terminated. Files shall be updated regularly so that the information is current.
|
Observations
Client file reviews were conducted on March 6, 2017. Based on this review, the facility failed to maintain a complete file on the premises for each present and former patient of the narcotic treatment program for at least 4 years after the patient has competed treatment or treatment has been terminated.
One of the client files requested by DDAP staff was unable to be located by facility staff.
|
Plan of Correction
Facility Director will hold an in house in service for all staff related to chart documentation and maintenance by 4/28/2017. Facility Director and Counselors will monitor compliance of chart maintenance through random chart audits. Documentation of the training will be maintained for review at the next facility inspection. |