Fresno County Public Health Laboratory

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual and interview with the technical supervisor (TS); it was determined that the laboratory failed to provide a protocol in place signed and dated by the laboratory director when reporting SARS-CoV-2 positive results to CALRedie. The findings included: 1. On the day of the survey May 7, 2024, at approximately 11:00 a.m. the policies and procedure manual in place did not include a reporting policy signed and dated by the laboratory director for the reporting of positive SARS-CoV-2 tests to CALRedie. 2. The TS affirmed on May 7, 2024; that the laboratory failed to have a policy in place indicating a step by step protocol for the current reporting practice of laboratory positive SARS- CoV-2 testing to CALRedie. 4. The laboratory's testing declaration form stated that the laboratory processes approximately 2,525 Virology samples including SARS-CoV- 2 test annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 -- This STANDARD is not met as evidenced by: Based on the incomplete laboratory's verification of performance characteristics for high complexity testing for Clostridium difficile and carbapenem-resistant Enterobacterales (CRE) by Rapid PCR Diagnostic Testing using the |Cepheid GeneXpert instrument, interview with the laboratory's technical supervisor (TS), and review of five (5) randomly selected patient test records from 12/26/2022 to 03/16 /2024; the laboratory failed to demonstrate that it established performance specifications comparable to those established by the manufacturer. The findings included: 1. The laboratory had only partial documentation to show for performance specifications, lacking precision testing performance characteristic and documentation. The laboratory must be able to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics and those to be approved by the laboratory director before starting testing patients' samples: (A) Accuracy (B) Precision (C) Reportable range (D) Reference Range 2. The laboratory was unable to provide for review additional documents using patient samples to establish precision performance specification for Clostridium difficile and CRE testing by Rapid PCR using the |Cepheid GeneXpert instrument. 3. The TS affirmed at the time of the survey on 05/07 /2024 at approximately 11:30 a.m. that no additional documents could be retrieved to show that precision performance specification was performed prior to reporting patient test results when the laboratory went live testing and reporting Clostridium difficile and CRE diagnostic tests. 4. Based on the estimated annual tests volumes reported on 05/06/2024 signed by the laboratory director; the laboratory performed and reported approximately 11 Bacteriology test which include Clostridium difficile and CRE diagnostic tests. The precision of the reported tests results could not be assured. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records, policies and procedures, patients' test results records, verification of performance specifications documentation, and interviews with the laboratory's technical supervisor on May 7, 2024; it was determined that the laboratory director failed to ensure that several aspects of the analytic phase of the laboratory testing were monitored. See D5407 and D5421. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies & procedures, performance specifications verification records, and interview with the laboratory's technical supervisor on May 7, 2024, at approximately 11:30 a.m.; the laboratory director failed to perform verification of precision performance characteristic for the detection of Clostridium difficile and carbapenem-resistant Enterobacterales (CRE) by Rapid PCR Diagnostic Testing using the |Cepheid GeneXpert instrument. Findings include See D5421. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's SARS-CoV-2 RNA (COVID-19) Polymerase Chain Reaction (PCR) testing, and interviews with the laboratory director (LD), technical supervisors (TS), and testing personnel (TP) on April 26, 2022 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the PCR procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, master mix and reagents preparation, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of SARS-CoV-2 using various methods: Abbot, Perkin Elmer, and the CDC Multiplex procedures. 2. During the laboratory tour on April 26, 2022, at approximately 12:15 p.m. the surveyor observed that processing of the specimens, preparation of reagents, and sample template addition were all performed in the same open area without unidirectional flow. 3. The LD, TS, and TP confirmed by interview on 4/26/2022 that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in a unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately18,113 SARS-CoV-2 Real Time PCR molecular diagnostic tests annually. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory's reagent materials used for decontamination of surface areas and other reagents used in the laboratory and interview with the laboratory director (LD) and testing personnel (TP); it was determined that the laboratory failed to label various reagents to indicate the reagent's name, opening, preparation, and expiration dates when such reagents are used in the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory tour on April 26, 2022, at approximately 12:45 pm.; no opening, preparation, or expiration date labels were used or documented for various reagents used throughout the laboratory (Alcohols, 1:10 Sodium hypochlorite and sterile water). 2. The laboratory's LD affirmed in an interview conducted April 26, 2022, at approximately 1:00 p.m. that the reagents mentioned in statement 1 were not labeled with the name, opening, preparation, and expiration dates or documented. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 18,113 test samples. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observations of the laboratory's SARS-CoV-2 PCR testing processes and interview with the laboratory's director, technical supervisor, and testing personnel on April 26, 2022; the laboratory director failed to ensure that the physical plant and environmental conditions of the laboratory were appropriate for the PCR testing performed. Findings include: See D3005. -- 2 of 2 --