Regional Medical Center

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration and calibration verification records and confirmed by interview with General Supervisor (GS) #1 at 12:50 pm on 03/13/2025, the laboratory failed to perform calibration verification procedures for procalcitonin testing every six months for five out of five time periods from 01/01/2023 - 03/13/2025. The findings include: 1. The laboratory used the Ortho Vitros XT 7600 test system to perform procalcitonin testing. 2. At the time of the survey, GS #1 confirmed the laboratory did not perform calibration verification procedures which included a minimal (zero) value, a mid-point value, and maximum value for procalcitonin from 01/01/2023- 03 /13/2025. 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 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: A. Based on review of patient test reports and confirmed by laboratory personnel identifier #13 (refer to the Laboratory Personnel Report) at approximately 11:45 am on 04/27/2023, the laboratory failed to include the test report date for six out of nine patient test reports (patient identifiers A-F) reviewed from November 2022. The findings include: 1. The test reports for patient identifiers A-F all included specimen collection dates for testing performed. 2. Personnel identifier #13 stated that the laboratory collected and performed most testing on the same date, but not always. 3. At the time of the survey, personnel identifier #13 confirmed that the test reports for patients A-F did not include the final report date for the testing performed. B. Based on review of patient test reports, the Laboratory Test List & Annual Volume form, and confirmed by laboratory personnel identifier #13 (refer to the Laboratory Personnel Report) at approximately 1:15 pm on 04/27/2023, the laboratory failed to indicate the name and address of the testing facility for one out of nine patient test reports (patient identifier A) reviewed from November 2022. The findings include: 1. Patient identifier A's test report indicated they had the following testing performed on 11/02/2022: ABO group and D (Rho) typing, antibody screen, compatibility, and antibody identification. 2. The Laboratory Test List & Annual Volume form did not 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 -- indicate that the laboratory performs antibody identification testing. 3. Personnel identifier #13 stated that the laboratory does not perform antibody identification testing and that all positive antibody screening tests are sent to a reference laboratory for the antibody identification testing. 4. At the time of the survey, personnel identifier #13 confirmed that the test report did not indicate the name and address of the testing facility for the antibody identification testing performed on 11/02/2022 for patient identifier A. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Ortho Vitros chemistry calibration verification records and confirmed by laboratory personnel identifiers #10 and #20 (refer to Laboratory Personnel Report) at approximately 1:00 pm on 06/02/2021, the laboratory failed to perform calibration verification every six months for two out of two time periods for the analyte, vitamin B12. The findings include: 1. The laboratory installed the Ortho Vitros 7600 chemistry analyzer in March 2020. 2. At the time of the survey, the 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 -- laboratory did not have calibration verification records for the analyte, vitamin B12. 3. The laboratory personnel confirmed that the laboratory failed to perform calibration verification for the analyte, vitamin B12, from the time of installation through the survey date. 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: (A) Based on review of i-STAT and Ortho Vitros chemistry analyzers comparison records, observations made during the survey and interviews with laboratory personnel identifiers #10 and #20 (refer to Laboratory Personnel Report) at approximately 9:30 am and 4:00 pm on 06/02/2021, the laboratory failed to perform comparisons between the chemistry tests performed on both the Ortho Vitros and i- STAT analyzers twice annually for two out of two semiannual time periods (May 2020 - May 2021). The findings include: 1. A tour of the laboratory at 9:30 am indicated that the laboratory performed chemistry testing on the Ortho Vitros 7600 analyzer and i-STAT analyzer. 2. Laboratory personnel identifiers #10 and #20 confirmed that the laboratory performed the majority of the chemistry testing using the Ortho Vitros. They also confirmed that the laboratory used the i-STAT analyzer for backup for the following analytes: troponin, glucose, urea nitrogen, calcium, potassium, sodium, chloride and CO2. 3. At the time of the survey, the laboratory did not have documentation of comparisons performed between the Ortho Vitros and i- STAT analyzers. (B) Based on review of immunohematology records, observations made during the survey, and interviews with the laboratory personnel identifiers #10 and #20 (refer to Laboratory Personnel Report) at approximately 9:30 am and 4:00 pm on 06/02/2021, the laboratory failed to perform comparisons between the automated Ortho Vision, Ortho MTS gel card system and manual tube method for immunohematology testing twice annually for two out of two semiannual time periods (May 2020 - May 2021). The findings include: 1. A tour of the laboratory at 09:30 am indicated that the laboratory performed immunohematology testing using the automated Ortho Vision analyzer, Ortho MTS gel card manual tube methods. 2. Laboratory personnel identifiers #10 and #20 confirmed that the laboratory performed immunohematology testing using all three methods for ABO and Rh typing, antibody screens and compatibility testing. 3. At the time of the survey, the laboratory did not have documentation of comparisons performed between the three immunohematology methods. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of Abbott ci4100 chemistry analyzer performance specification records and confirmed by laboratory personnel identifier #10 (refer to Laboratory Personnel Report) at approximately 1:40 pm on 03/12/2019, the laboratory failed to perform and verify the performance specification of reportable range for the analyte, procalcitonin. The findings include: 1. The laboratory started performing patient testing for the analyte, procalcitonin, in September of 2017. 2. At the time of the survey, the laboratory did not have documentation verifying the reportable range for this analyte. 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. 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 observations made during the survey and interview with laboratory personnel identifier #10 (refer to Laboratory Personnel Report) at approximately 10: 00 am on 03/12/2019, the laboratory failed to perform comparisons between the Bactec FX40 and Bactec 9050 blood culture analyzers twice annually for four out of four semiannual time periods (March 2017 - March 2019). The findings include: 1. A tour of the laboratory indicated that the laboratory performed blood cultures using both the Bactec FX40 and the Bactec 9050 analyzers. 2. Laboratory personnel identifier #10 confirmed that the laboratory performed the majority of blood cultures on the Bactec FX40, but used the Bactec 9050 as a backup analyzer. 2. At the time of the survey, the laboratory did not have documentation of comparisons performed between the Bactec FX40 and Bactec 9050 analyzers. -- 2 of 2 --