Southern Nevada Public Health Laboratory

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, laboratory procedure review, and laboratory testing personnel interview, it was determined that the laboratory failed to ensure that all reagents, solutions, culture media, control materials, calibration materials, and other supplies were not available for use when they have exceeded their expiration date. Findings include: a. During a tour of the Bacteriology laboratory on day of survey, April 4, 2023, Oxoid Diagnostic Reagents, E.coli O157 Latex Kit, Lot #3406211, date opened September 9, 2022, expiration date March 22, 2023, was found in the same storage area as other reagents and culture media used for patient testing, and therefore available for use in patient testing. b. According to the laboratory's Quality Assurance Plan protocol, 'reagents must be used within their expiration date, processed and stored according to manufacturer's guidelines.' c. The technical supervisor and testing personnel confirmed on April 4, 2023 at 9.15 a.m. that the reagent kit was stored available for use in patient testing when it had exceeded its expiration date. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 laboratory procedure review and laboratory testing personnel interview, the laboratory failed to document all quality control (QC) procedures performed. a. Based on testing personnel interview, it is the practice of the laboratory to perform monthly QC maintenance checks of commercially obtained lyophilized ATCC microorganisms, rehydrated and stored at -70C for use in the QC testing of culture media. b. According to laboratory procedure, "Microbiology Quality Control," quality control organisms including reference strains available from ATCC are stored frozen at -70C, subcultured to appropriate culture media and passed twice before use in QC testing. c. Documentation of monthly QC maintenance checks of rehydrated ATCC microorganisms stored frozen at -70 C was not provided to the surveyors for review at the time of the survey on April 4, 2023 and April 5, 2023. d. Testing personnel (TP#1) affirmed on April 4, 2023 at 9.18 a.m. that monthly QC maintenance checks were not documented. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the COVID-19 and immunology testing rooms, review of the Thermo Fischer 7500 Fast Track DX Real-Time PCR and Quant Studio DX manufacturer's operating instructions, review of the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) reagent storage instructions, lack of humidity documentation, review of patient results, and interview with the technical supervisors (TS) #1, #2, the laboratory failed to monitor humidity and store reagents according to manufacturer's instructions. Findings: 1. Observation of the COVID-19 testing room showed two 7500 Fast Track DX Real-Time PCR and two Quant Studio DX analyzers for COVID-19 PCR testing. 2. Review of the manufacturer's instructions for proper environmental specifications revealed to operate with a humidity of 20%-80% for the 7500 Fast Track DX Real-Time PCR and 15%-80% for the Quant Studios DX analyzers. 3. No humidity log was available for review. 4. Observation of the -80 degree freezer in the immunology testing room showed eight boxes of HIV/HCV quality control (QC) materials with the manufacturer's required storage range of -15 to -35 degrees Celsius (C) being stored at -77 degrees C. 5. 29,272 COVID-19 results, 124 HIV results, and 4 HCV results were reported between January 1, 2021 and May 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 -- 12, 2021. 6. Interview with the TS #1, #2 on May 12, 2021 at 10:00AM confirmed the laboratory failed to monitor humidity in the COVID-19 testing room and failed to appropriately store QC material as required by the manufacturer. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of 2 of 14 laboratory information system (LIS) test reports and interviews with the laboratory director ( LD), technical supervisor (TS) #1, #2, the laboratory failed to include the name and address of the performing laboratory. Findings: 1. Review of the printed test report for sample with Orchard ID 232678 with test result for Syphilis Total Antibody IgG & IgM showed that the performing laboratory name and address were not indicated. 2. Review of the printed test report for sample with Orchard ID 232261 with test result for HCV RNA Quant showed that the performing laboratory name and address were not indicated 3. Interviews with the LD and TS #1 and #2 on May 12th, 2021 at 10:30 AM confirmed that result reports for Syphilis Total Antibody IgG & IgM and HCV RNA Quant did not indicate performing laboratory name and address. 4. Between January 1, 2020 and May 12, 2021, the laboratory performed 8,552 Syphilis Total Antibody IgG & IgM tests and 60 HCV RNA Quant tests. Based on a review of 2 of 2 LIS test reports, manufacturer instructions for use, manufacturer result guidance for providers, manufacturer result guidance for patients, and interviews with LD and TS #1 and #2, the laboratory failed to include a clear result interpretation. Findings: 1. Review of the LIS report for Orchard ID 0000217354 2019 Novel Coronavirus Real-time RT PCR (CDC) test, shows that the report indicates both a discrete result of "Not Detected" as well as a comment indicating "Negative based on CDC guielines (SP) for testing". a. Review of the manufacturer instructions for use CDC-006-00019, Revision: 02 (2019-nCoV rRT- PCR Diagnostic Panel Results Interpretation Guide; chart on page 32), the result interpretation should be indicated as "Not Detected". b. Review of CDC provided required accompanying materials (Fact Sheet for Patients and Fact Sheet for Healthcare Providers) reference test results as "Negative", not as "Not Detected". 2. Interviews with the LD and TS #1 and #2 on May 12th, 2021 at 10:30 AM confirmed that there was more than one interpretation included in the result for the 2019 Novel Coronavirus Real-time RT PCR (CDC) test. 3. Between January 1, 2020 and May 12, 2021, the laboratory performed 106,185 2019 Novel Coronavirus Real-time RT PCR (CDC) tests. -- 2 of 2 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory personnel interview and mycobacteriology quality control record review on March 19, 2019, the laboratory failed to establish statistical parameters for unassayed quality control materials used to monitor patient Quantiferon TB Gold Plus testing over time through concurrent testing of quality control materials having previously determined statistical parameters. Findings included: a. In mycobacteriology, the laboratory used the Quantiferon TB Gold Plus test system to detect possible patient Mycobacterium tuberculosis (TB) infections. It was the practice of the laboratory to use unassayed quality control materials to monitor Quantiferon TB Gold Plus patient test runs. b. Laboratory records indicated that on March 18, 2019 the laboratory tested 20 patient samples using the Quantiferon TB Gold Plus test system. The laboratory maintained no documentation to indicate that the statistical parameters for the positive and negative unassayed quality control materials used to monitor the March 18, 2019 Quantiferon TB Gold Plus patient test 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 -- run had been established over time through concurrent testing of quality control materials having previously determined statistical parameters. c. Laboratory personnel confirmed that the statistical parameters for the unassayed quality control materials used to monitor patient Quantiferon TB Gold Plus testing had not been established over time by the laboratory through concurrent testing of quality control materials having previously determined statistical parameters. d. According to laboratory personnel, the laboratory performed approximately 50 patient Quantiferon TB Gold Plus tests weekly. -- 2 of 2 --