Orange County Public Health

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the laboratory's standard operating procedures, lack of documentation, and interview with the laboratory director (LD), technical supervisor (TS), and testing personnel (TP); it was determined that the laboratory failed to perform and document maintenance and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory's digital timers used throughout the laboratory. The findings included: 1. The laboratory's standard operating procedure (SOP) indicated that annual maintenance and calibration be performed (by a contracted equipment service) according to manufacturer's requirements on small equipment. 2. The LD, TS, and TP confirmed on May 9, 2023, at approximately 3:30 p.m. that the laboratory failed to follow SOP for maintenance and manufacturer's instructions on the calibration of small equipment (timers) used in the laboratory since 2017. 3. According to the annual test volume declared by the laboratory,s director on 5/9/2023 the laboratory performs approximately 500,815 tests annually. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each 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 2 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, lack of preventive maintenance records for all small equipment (timers) used in the laboratory, and interview with the laboratory director, tecnical consultant, and testing personnel; it was determined that the laboratory director failed to ensure the maintenance of acceptable levels of analytical performance. See D5429. -- 2 of 2 --

Summary Statement of Deficiencies D2056 VIROLOGY CFR(s): 493.831(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent is unsatisfactory performance. The findings included: a. The laboratory performed viral antigen detection testing, in order to evaluate the proficiency testing performance for these testing systems, the laboratory enrolled with CAP (College of American Pathologists) PT VR 2016 Virology Ag Detect DFA. b. The laboratory attained an overall score of 67 % for the 2nd 2016 PT event, which was unsatisfactory performance. c. The laboratory performed viral load testing in approximately 500 patient samples each month. d. The laboratory confirmed that the laboratory attained an overall score of 67 % for the 2nd 2016 PT event, which was unsatisfactory performance. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings included: See D- 2056 -- 2 of 2 --