South Dakota Public Health Laboratory

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 patient test reports and interview with general supervisor #3, the laboratory failed to ensure patient test reports included the address of the reference laboratory location for one of one patient test report. Findings include: 1. On 07/09 /25, GS #3 confirmed the laboratory sent patient samples to a reference laboratory for antibiotic susceptibility testing (AST). 2. Record review of one patient report (patient #712453) sent to a reference laboratory revealed the laboratory failed to include the address of the reference laboratory. 3. Interview on 07/10/25 at 11:30 am, confirmed the findings above. 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 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of COVID-19 procedure manual, maintenance logs and general supervisor (GS) interview, the laboratory failed to follow procedures to clean and decontaminate the PCR COVID-19 extraction room area. Findings include: 1. Review of the PCR COVID-19 procedure manual states, "work surfaces, pipettes, and centrifuges should be cleaned and decontaminated with cleaning products such as 10% bleach, DNAZap, or RNaseAWAY to minimize risk of nucleic acid contamination". 2. No documentation was available for the cleaning and decontamination of the PCR COVID-19 extraction room area for 2020 and 2021. The laboratory currently performs approximately 30 COVID-19 extractions daily. 3. In an interview conducted on March 18, 2021 at 10:00 AM, GS #4 confirmed the laboratory did not kept a log for documenting the cleaning and decontamination of the PCR COVID-19 extraction room area. 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. 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 -- (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 1 Vidas SARS-COV-2 IgG antibody kit and 10 Vidas SARS- COV-2 IgM antibody kits stored in the refrigerator, review of manufacturer's instructions, review of documentation of refrigerator temperatures, and interview with the laboratory director (LD), the laboratory failed to follow the manufacturer's instructions for storage of reagents. Findings: 1. Observation on March 17, 2021 at 10: 20 AM of the laboratory refrigerator located in the microbiology media room showed 1 Vidas SARS-COV-2 IgG antibody kit and 10 Vidas SARS-COV-2 IgM antibody kits available for use in the laboratory. 2. Review of the manufacturer's instructions for Vidas SARS-COV-2 IgM and IgG antibody kits showed the kits must be stored at 2-8 degrees Celsius (C). 3. No refrigerator temperature monitoring documentation was available for review. 4. Interview with the LD on March 17, 2021 at 11:00 AM confirmed the laboratory failed to properly monitor the refrigerator and store reagent materials per manufacturer's instructions. Based on observation of 2 of 2 COVID-19 PCR laboratory rooms, the tuberculosis bacillus (TB) anti-room and the specimen receiving area, review of manufacturer's instructions, temperature and humidity monitoring logs, and interview with the technical supervisor #1 (TS), the laboratory failed to monitor and document room temperature and humidity. Findings: 1. Observation of the specimen receiving area on March 17, 2021 at 9:20 AM showed Abbott COVID-19 ID NOW kits and COVID-19 Ag BinaxNOW cards stored on shelves in the hallway. 2. Observation of 2 of 2 rooms used for COVID-19 PCR testing showed 5 Applied Biosystems 7500 Fast Dx Real-Time PCR analyzers. Observation of the TB anti-room showed one Maldi analyzer for identification. 3. Review of the manufacturer's instructions for Abbott COVID-19 ID NOW kits and COVID-19Ag BinaxNOW cards showed to store the kits at 2-30 degrees C. 4. Review of the manufacturer's instructions for the Maldi analyzer showed to operate in a temperature of 16-30 degrees C with 20-75 perent noncondensing humidity. 5. Review of the manufacturer's procedure for Applied Biosystems 7500 Fast Dx Real- Time PCR instrument showed to operate the systems at a temperature of 15-30 degrees C and 20-28 percent relative humidity noncondensing. 6. No temperature monitoring and documentation for the specimen receiving area and 2 of 2 rooms used for COVID-19 PCR testing was available for review. No documentation was available for humidity monitoring for all areas of the laboratory. 6. Interview with the TS #1 on March 18, 2021 at 10:00 AM confirmed the laboratory failed to monitor temperature and humidity for proper storage of reagents and test system operation. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficient testing documentation and interview with the technical supervisor, the laboratory director and testing personnel failed to sign the attestation statement on proficiency testing modules. Findings include: 1. Review of WSLH Measles and Mumps proficiency testing modules revealed the attestation statement was not signed by the laboratory director and the testing personnel for 2 of 4 PT events in 2017 (2017-1) and 2018 (2018-2). 2. Review of WSLH Frozen Media proficiency testing modules revealed the attestation statement was not signed by the laboratory director and the testing personnel for 1 of 2 PT events in 2018 (2018-1). 3. Review of WSLH CRE proficiency testing modules revealed the attestation statement was not signed by the laboratory director and the testing personnel for 1 of 2 PT events in 2018 (2018-2). 4. During an interview conducted on 01/15/2019 at approximately 1:00 PM, the technical supervisor confirmed the laboratory director and testing personnel failed to sign the attestation statement on proficiency testing modules mentioned above. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 proficiency testing documentation (PT) and staff interview, the laboratory failed to document