West Cancer Center

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 a review of calibration records, patient test reports, and staff interview, the laboratory failed to verify the calibration of the Magnesium analyte at least every six months in 2023 and 2024. The findings include: 1. A review of the calibration records for the Ortho Vitros 350 chemistry instrument revealed that Magnesium was not calibrated every six months as follows: Performed on 06/21/23-calibration was not performed in December 2023. Performed on 01/09/24. No other calibrations for 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 4 -- Magnesium analyte had been performed by the survey date (09/23/24). 2. A review of a patient test report revealed Magnesium reported on patient 578074 on 09/23/24 when the six-month calibration verification requirement for the Magnesium analyte had not been met. 3. During an interview on 09/23/24 at 4:00 p.m., the technical consultant confirmed the laboratory failed to verify the calibration of the Magnesium analyte every six months in 2023 and 2024. 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 observation, review of the laboratory's Complete Blood Count with automated White Blood Cell (WBC) Differential (CBC w/Diff) quality control (QC) records, final patient test reports, and staff interview, the laboratory failed to establish QC ranges for the Red Cell Distribution Width (RDW) and Mean Platelet Volume (MPV) for nine of nine lots reviewed from 2023 and 2024 with patient testing reported. The findings include: 1. Laboratory observation on 09/24/24 at 8:30 a. m. revealed Cell Dyn Emerald instruments (serial numbers 377 and 599) used for performing patient testing for CBC w/Diff. 2. A review of the laboratory's CBC w /Diff QC records revealed the following: QC lot number 3205 (low, normal, and high) was used from 09/11/23 to 11/09/23. QC lot number 3317 (low, normal, and high) was used from 12/28/23 to 02/29/24. QC lot number 4120 (low, normal, and high) was used beginning 06/20/24 with an expiration date of 08/16/24. The assigned assay value for both RDW and MPV were 49.9 with a limit of 49.9 resulting in a QC range of 0 - 99.8 for all nine lots. 3. A review of the manufacturer's quality control package inserts for lots 3205, 3317 and 4120 revealed the manufacturer did not provide QC ranges for the RDW and MPV analytes. 4. A review of patient test results revealed that RDW and MPV were reported on patient numbers 627573 on 10/27/23, 565748 on 02/14/24, and 613891 on 07/17/24 during the period when the laboratory did not have QC ranges for the RDW and MPV. 5. During an interview on 09/24/24 at 4:00 p. m., the technical consultant confirmed that the manufacturer did not provide QC ranges for the RDW and MPV analytes and the laboratory failed to establish its' own QC ranges. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 laboratory, staff interview, review of manufacturer package inserts, the form used for monitoring freezer temperatures, interview with the technical consultant, and subsequent email communication, the laboratory failed to define frozen storage ranges for the Ortho Vitros reagents, controls and calibrators that was consistent with manufacturer requirements, and failed to monitor temperature fluctuations that might occur as a result of freezer defrost cycles in 2022 and 2023 for four of four months reviewed. The findings include: 1. Observation of the laboratory on 09/07/23 at 8:30 am revealed frozen storage of reagents, calibrators, and controls that were used on the Ortho Vitros 350 chemistry instrument in a Midea refrigerator /freezer combo. The labeling on the chemistry boxes indicated a storage temperature of -18 degrees Celsius. No buildup of frost was observed in the freezer. 2. During an interview with the lead testing person on 09/07/23 at 8:45 am, the lead testing person stated that they never had to do anything to keep the freezer free of frost buildup and that the freezer defrosted itself. 3. Review of manufacturer package inserts for the reagents, calibrators and controls that were stored in the freezer revealed a storage requirement of -18 degrees Celsius or less when frozen. 4. Review of the form used for monitoring freezer temperatures revealed ranges that were inconsistent with manufacturer requirements for December 2022, February 2023, March 2023, and July 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 -- 2023. The range in use was -10 to -20 degrees Celsius. There was no record for monitoring of the minimum and maximum temperatures. 5. Interview with the technical consultant on 09/07/23 at 2:30 pm confirmed the laboratory failed to define freezer temperature ranges that were consistent with the manufacturer's requirements. 6. Email communication received on 09/12/23 at 3:14 pm with the technical consultant confirmed the laboratory did not have records for monitoring of temperature fluctuations that may occur during defrost cycles in 2022 and 2023. -- 2 of 2 --

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 observation of the laboratory, review of the laboratory procedure manual, review of selected patient testing dates, quality control (QC) records, and email communication, and interview with the technical consultant, the laboratory failed to follow its' own procedure for ensuring Complete Blood Count (CBC) QC was performed and acceptable prior to performing patient CBC testing in 2021 and 2022 with three patient affected on the dates selected. The findings include: 1. Observation of the laboratory on 06/15/2022 at 9 am revealed two CellDyn Emerald CBC instruments in use for patient CBC testing (ID#s 377 and 599). 2. Review of the laboratory's procedure manual revealed that quality control must be performed and acceptable before performing any patient testing. 3. Review of randomly selected patient testing dates, quality control records and email communication revealed quality control was not performed and acceptable prior to patient testing as follows: 12 /14/2021---patient 205641 released at 8:45 am prior to acceptable QC at 9:27 am 04/13 /2022---patient 240503 released at 9:20 am prior to acceptable QC at 9:27 am Review of email received from the technical consultant on 06/21/2022 revealed a total of three patients were reported on the dates in question prior to acceptable QC. 4. Interview with the technical consultant on 06/15/2022 at 4 pm confirmed the laboratory failed to follow its' own procedure for ensuring QC was performed and acceptable prior to performing patient CBC testing on 12/14/2021 and 04/13/2022. 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 --