Los Angeles County

Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records for Bacteriology first event of 2024 (Q1-2024), two (2) randomly selected patients from 2/6/2024 and 3/27/2024, and interview with the laboratory director (LD) technical supervisor (TS), and compliance officer (CO); it was determined that the laboratory failed to participate the testing event which is unsatisfactory performance and resulted with a score of zero (0) for the testing event. The findings included: 1. Laboratory PT records showed the laboratory attained a score of 0% for Bacteriology testing during the Q1-2024 for the Module 5080 Enteric Pathogens which included 5 stool samples for analytes: Aeromonas, Campylobacter, E. coli 0157, Pleisomonas, Salmonella, shigella, Vibrio, and Yersinia. 2. The LD, TS, and CO affirmed on April 4, 2024, at approximately 11:30 a.m. the unsatisfactory score of 0% obtained by the laboratory for Bacteriology analytes Q1-2023 listed in 1. 3. Based on the annual test volume reported for 2024, the laboratory performed and reported approximately 284,123 bacteriology analytes. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient testing records, patient final testing reports, and interviews with the laboratory director (LD) and technical supervisor (TS) on 04/04/2024 at approximately 12:30 p.m. it was determined that for one (1) out of five (5) randomly chosen patient testing records reviewed, the laboratory failed to follow written policies and procedures for specimen analytical phase testing, through completion of testing and reporting results. The findings included: 1. Review of sample testing worksheet documentation and patient's final test report [electronic medical record (EMR)], it was found that patient test result reported did not follow testing procedure and reporting policy. a. Mycology standard operating procedure indicated identification of Aerobic Actinomycete using the biochemical Lysozyme test. b. Worksheet indicated no lysozyme biochemical testing was performed to identify the isolate. c. Protocol does not indicate identification of Nocardia spp. by morphology only. d. Final report reads " Organism colony morphology consistent with Nocardia species." e. Final report did not include reference to previous isolation of the organism and that biochemical test identification on specified date occurred. 2. The LD and TS affirmed that the patient testing in the mycology laboratory for Nocardia spp identification was different than the result in the patient's EMR. 3. Based on the laboratory's annual test volume declaration signed by the LD on 4/3/2024 the laboratory performed 136 mycology isolates identification to genus or genus and species. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, five (5) randomly chosen patients records, failure to submit proficiency testing results in a timely manner, and interviews with the laboratory director, technical supervisor, and testing personnel; it was determined that the laboratory director failed to ensure the maintenance of acceptable levels of analytical and post analytical performance. See D2021 and D5203. D6119 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(6) The technical supervisor is responsible for ensuring that patient test results are not reported until all

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 procedure manual, lack of documentation, and interview with the laboratory director (LD) 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 thermometers, vortexes, centrifuges, and timers. 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 including: digital thermometers used to verify automated digital temperature readings (Insensix) used for refrigerators, incubators, and freezers; vortexes, small centrifuges, and timers. 2. The LD and TP confirmed on April 7, 2022, at approximately 12:15 p.m. that the laboratory failed to follow SOP for maintenance and calibration of small equipment used in the laboratories for the year 2021. 3. According to the annual test volume declared by the laboratory on 4/7/2022 the laboratory performs approximately 457,681 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 used in the laboratories, and interview with the laboratory director and testing personnel; it was determined that the laboratory director failed to ensure the maintenance of acceptable levels of analytical performance. See D5429. D6148 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(a)(4) The general supervisor is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained. This STANDARD is not met as evidenced by: The general supervisors are cited herein for failing to monitor and verify temperature readings and preventive maintenance of small equipment to ensure that acceptable levels of analytical performance are maintained. See D5429. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing performance reports and interview with the laboratory director (LD) and technical supervisor (TS), it was determined that the laboratory failed to verify at least twice annually the accuracy of the Brucella Microagglutination Test (BMAT) the laboratory performed, which is not included in the subpart I of 42 CFR part 493. The findings included: 1. On the date of the survey 11/16/2020 at approximately 2:00 p.m. during proficiency testing and verification of accuracy of test results review, the LD failed to provide documentation for BMAT verification of test results accuracy for two consecutive years: 2018 and 2019. 2. The LD affirmed (11/16/2020 at approximately 4:30 p.m. that no documents were available for the evaluation of the accuracy of BMAT results for the years 2018 and 2019. 3. According to the laboratory testing declaration submitted on the day of the survey (11/16/2020), the laboratory performed General Immunology in 15,030 patient's samples annually including BMAT testing. 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: 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 -- Based on review of laboratory documentation records and interview with the laboratory director, it was determined that the laboratory director failed to ensure that the verification of the accuracy of test results of non-regulated analytes program was 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-5217 D6118 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(5) The technical supervisor is responsible for resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. This STANDARD is not met as evidenced by: Based on the deficiency cited (D5217), the Technical Supervisor is herein cited for deficient practice in his responsibilities for resolving technical problems revealed through the lack of at least twice annually verify accuracy of the Brucella Microagglutination Test for two concecutive years (2018 and 2019). See D5217. -- 2 of 2 --