Mid-South Transplant Foundation

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 observation of the laboratory, review of manufacturer documents, lack of records, donor test records and staff interview, the laboratory failed to verify the calibration of the tests performed on the two i-STAT instruments used for performing chemistry testing using the CG8+ cartridge and blood gas testing using the CG4+ cartridge every six months in 2022, 2023 and 2024. The findings include: 1. Observation of the laboratory on 01/10/24 at 8:15 am revealed two i-STAT 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 -- instruments used for performing testing on brain-dead organ donors. i-STAT instrument serial numbers observed were 337295 and 328956. During observations, the technical consultant stated the following: The CG4+ cartridge was used for performing donor testing for Lactic Acid, pH, pO2, and pCO2. The Chem 8+ cartridge was used for performing donor testing for Sodium, Potassium, Chloride, Total Carbon Dioxide (TCO2), Blood Urea Nitrogen (BUN), Creatinine, Glucose, and ionized Calcium. 2. Review of the Abbott i-STAT document titled "CALIBRATION VERIFICATION" (Art:714377-00V, Rev. Date: 17-Feb-2023) revealed the following: "The Electronic Simulator simulates two levels of electronic signals that stress the analyzer's signal detection function both below and above the reportable ranges." 3. There was no documentation that calibration verification was performed every six months in 2022, 2023 or 2024 using a low, mid, and high value to verify the laboratory's reportable range. 4. Review of donor number AJLX397 revealed reporting of both blood gas and chemistry results on 12/26/22; blood gas and chemistry results were reported for donor number AKJY177 on 10/26/23. 5. Interview with the point-of-care testing supervisor on 01/10/24 at 3:30 pm confirmed the laboratory failed to perform calibration verification every six months for the blood gas and chemistry tests performed using the CG4+ and Chem 8+ cartridges on the two i- STAT instruments in 2022, 2023, or 2024. Word Key: pO2= partial pressure of oxygen pCO2=partial pressure of carbon dioxide 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 observation of the laboratory, lack of records, and staff interviews, the laboratory failed to compare results between the tests performed on the two i-STAT instruments in use for performing chemistry testing using the CG8+ cartridge and blood gas testing using the CG4+ cartridge twice a year in 2022, 2023 or 2024. The findings include: 1. Observation of the laboratory on 01/10/24 at 8:15 am revealed two i-STAT instruments used for performing testing on brain-dead organ donors. i- STAT instrument serial numbers observed were 337295 and 328956. During observations, the technical consultant stated the following: The CG4+ cartridge was used for performing donor testing for Lactic Acid, pH, pO2, and pCO2. The Chem 8+ cartridge was used for performing donor testing for Sodium, Potassium, Chloride, Total Carbon Dioxide (TCO2), Blood Urea Nitrogen (BUN), Creatinine, Glucose, and ionized Calcium. 2. There was no documentation that comparisons between the two instruments were performed twice a year in 2022, 2023, or 2024. 3. Interview with the point-of-care testing supervisor on 01/10/24 at 3:30 pm confirmed the laboratory failed to compare results between the two i-STAT instruments used for performing chemistry tests on organ donors in 2022, 2023, and 2024. Word Key: pO2= partial pressure of oxygen pCO2=partial pressure of carbon dioxide -- 2 of 2 --

Summary Statement of Deficiencies D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, quality control records for the i- STAT instrument, patient/donor records, and interview with the technical consultant, the laboratory failed to perform one level of quality control (QC) each 8 hours of patient/donor arterial blood gas testing in 2017 and 2018. The findings include: 1. Review of the laboratory's procedure manual for the i-STAT instrument revealed: "will perform 2 levels of external controls every 24 hours of testing on authorized brain dead donors." 2. Review of quality control records and patient/donor records for the i-STAT arterial blood gas instrument revealed the following: Patient/donor #1 12.10.18--QC performed at 17:56. Patient testing performed beginning at 18:38 with the last patient test performed on 12.11.18 at 04:45. No QC was performed after the first 8 hour period. Patient/donor #2 06.22.18--QC performed at 09:52. Patient testing performed beginning at 15:46 with the last patient test performed on 6.23.18 at 04:59. No QC was performed after the first 8 hour period. 6.23.18--QC performed at 08:35. Patient testing performed after QC performance beginning at 10:10 with the last patient test performed at 18:22. No QC was performed after the first 8 hour period. Patient/donor #3 12.7.17--QC performed at 21:35. Patient testing performed beginning 12.08.17 at 06:11 with the last patient test performed 12.08.17 at 13:41. No QC was performed after first 8 hour period. Patient/donor #4 05.19.17 QC performed at 21:23. Patient testing performed beginning 05.20.17 at 02:25 with the last patient test performed on 05.20.17 at 18:15. No QC was performed after the first 8 hour period. 5.20.17 QC performed at 22:55. Patient testing was performed beginning at 23: 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 -- 27 with the last patient test performed on 5.21.17 at 12:31. No QC was performed after the first 8 hour period. 3. Interview with technical consultant number two on 01.03.2019 at 12:30 confirmed the laboratory did not perform at least one level of QC each 8 hours of patient/donor arterial blood gas testing in 2017 and 2018. The laboratory does not have an Individualized Quality Control Plan in place for the reduced QC frequency. -- 2 of 2 --