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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 review of the package insert for the Quidel Triage Total 5 Control, review of laboratory freezer temperature logs from January 1, 2024 to date September 11, 2024 and interview with the testing personnel (TP) #3, the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for the Quidel Triage quality controls stored in freezer #1 for 254 of 254 testing days. Findings: 1. Review of the package insert for the Quidel Triage Total 5 Control states, "Store frozen at -20 degrees Celsius or colder in a non-defrosting freezer." 2. Review of laboratory freezer temperature logs from January 1, 2024 to date September 11, 2024 showed freezer #1 with an unacceptable temperature range for 254 of 254 testing days. 3. Interview with the testing personnel #3 on September 11, 2024 at 9:30 AM confirmed the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for the Quidel Triage quality controls stored in freezer #1. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) training documents and interview with the testing personnel #3, the laboratory director (LD) failed to ensure six of seventeen TP received the appropriate training prior to performing patient testing in 2023 and 2024. Findings: 1. Review of training documents showed TP #6 had no documented annual performance evaluation in 2023 and TP #11, TP #12, TP #13, TP #14 and TP #15 had no documented annual performance evaluation in 2024. 2. Interview with the TP #3 on September 11, 2024 at 9:30 AM confirmed the LD failed to ensure TP received the appropriate training prior to performing patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of quality control, patient records, and interview with the technical consultant (TC), the laboratory failed to retain records documenting all analytical systems activities, including instrument printouts for two years for the Triage, iStat and Sysmex XP-300 analyzers. Findings: 1. Review of quality control records and patient results from the Triage, iStat, and Sysmex XP-300 showed the laboratory failed to retain instrument printouts for two years. 2. Interview with the TC on January 18, 2023 at 10:00 AM confirmed the instrument printouts are not being retained for two years for the Triage, iStat, and Sysmex XP-300 analyzers. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with the technical consultant (TC), the laboratory failed to perform, two control materials of different 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 -- concentrations for d-dimer, BNP, cardiac panel and chemistry 8 panel in 2021 to date January 18, 2023. Findings: 1. Review of quality control records showed the laboratory failed to perform two levels of quality control material every day of patient testing following tests in 2021 to date January 18, 2023: d-dimer (Triage) BNP (Triage) troponin I, CKMB and myoglobin (Triage) Chemistry 8 panel- potassium, chloride, sodium, ionized calcium, glucose, creatinine, CO2, hematocrit and hemoglobin (iStat) 2. Interview with the TC on January 18, 2023 at 10:00 AM confirmed that the laboratory failed to perform two control materials of different concentrations for d-dimer, BNP, cardiac panel and chemistry 8 panel. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of records and interview with the technical consultant (TC), the laboratory failed to have a system that evaluates the same test using different instruments twice per year. Findings: 1. Lack of records showed the laboratory failed to perform test evaluations between the three Triage testing systems. There is no record of test evaluations twice per year for the following tests; D-dimer, troponin I, CKMB myoglobin, and BNP. 2. Interview with the TC on January 18, 2023 at 10:00 AM confirmed the laboratory failed to have a system that evaluates the same test using different instruments twice per year for the following tests: troponin I, CKMB, myoglobin, D-dimer, and BNP. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of employee competencies and interview with the technical consultant (TC), the TC failed to perform semiannual performance evaluation during the first year of employment for 1 of 3 testing personnel (TP). Findings: 1. Review of employee performance evaluations showed the TC failed to perform the semiannual performance evaluation for TP #9. 2 .Interview with TC on January 18, 2023 at 10:00 AM confirmed that the TC failed to perform the semiannual performance evaluation for TP #9. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least -- 2 of 3 -- annually, after the first year. This STANDARD is not met as evidenced by: Based on review of employee competencies and interview with the technical consultant (TC), the TC failed to perform annual performance evaluations for 2 of 9 testing personnel (TP) in 2022. Findings: 1. Review of employee performance evaluations showed the TC failed to perform the annual performance evaluations for TP #1 and TP #8 in 2022. 2. Interview with TC on January 18, 2023 at 10:00 AM confirmed that the TC failed to perform the annual performance evaluation for TP #1 and TP #8. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of "Laboratory Personnel Policies" and interview with the laboratory director, the laboratory failed to include a procedure for competency completed remotely by Zoom or FaceTime. Findings: 1. Review of "Laboratory Personnel Policies" did not include competencies could be performed remotely by Zoom or FaceTime. 2. Interview with the laboratory director stated competencies in 2020/2021 were performed by Zoom or FaceTime. 3. Interview with the laboratory director on March 30, 2021 at 10:30 AM confirmed the laboratory's personnel policies failed to include that competency could be performed remotely by Zoom or FaceTime. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of iSTAT procedure manual, iSTAT validation, iSTAT patient report and interview with laboratory director, the laboratory failed to ensure the iSTAT procedure manual reference ranges matched the references ranges on the iSTAT validation and patient report. Findings: 1. Review of the iSTAT procedure manual 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 -- showed the reference ranges as: Sodium 138 - 146 mmol/L Potassium 3.5 - 4.9 mmol /L Chloride 98 - 109 mmol/L Glucose 70- 105 mg/dL Ionized Calcium 1.12 - 1.32 mmol/L Creatinine 0.6 - 1.3 mg/dL BUN 8 - 26 mg/dL Hematocrit Female 38 - 46 Male 43 -51 %PCV 2. Review of the iSTAT validation and patient report showed the reference ranges as: Sodium 128 - 145 mmol/L Potassium 3.6 - 5.1 mmol/L Chloride 98 - 108 mmol/L Glucose 73 - 118 mg/dL Ionized Calcium 1.2 - 1.32 mmol/L Creatinine 0.6 - 1.2 mg/dL BUN 7 - 22 mg/dL Hematocrit Female 37 - 47 Male 42 -52 %PCV 3. Interview with laboratory director on March 30, 2021 at 10:30 AM confirmed that the iSTAT procedure reference ranges did not match the iSTAT validation and iSTAT patient report reference ranges. -- 2 of 2 --