Summary:
Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of performance verification records and interview with the technical consultant, the laboratory director failed to ensure the verification procedures were adequate for the PROFILE-V MEDTOXScan Drugs of Abuse Test System prior to implementation for patient testing on July 16, 2018. Findings include: 1. Review of performance verification records shows the laboratory uses a summary sheet to document completion and acceptance of each step in the verification process as well as the director's determination that the method is acceptable for use in patient testing. The "MEDTOX Test Method Summary AMG Midway Clinic Lab" summary sheet shows the laboratory director did not complete, sign or date the form. 2. Interview with the technical consultant on October 30, 2018 at 10:30 AM confirms that the lab director did not sign or date the performance verification studies for the PROFILE-V MEDTOXScan Drugs of Abuse Test System. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --