Madison Medical Center

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of 2021 and 2022 immunohematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical supervisor, the laboratory failed to successfully participate in PT. See D-tag 2181; unsatisfactory performance in two out of three consecutive compatibility PT challenges. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of immunohematology proficiency testing (PT) results for 2021, 2022 and phone interview with the technical supervisor, the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three consecutive PT events. Findings: 1. Review of the immunohematology PT results for the third event of 2021 revealed the laboratory obtained an unacceptable score of 0 percent for compatibility testing. 2. Review of the immunohematology PT results for the second event of 2022 revealed the laboratory obtained an unacceptable score of 80 percent for compatibility testing. 3. Phone interview with the technical supervisor on September 12, 2022 at 1:17 PM confirmed the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three consecutive PT events. -- 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 the performance verification procedures for the Gem 4000 Premier Plus blood gas analyzer and interview with the general supervisor, the laboratory failed to verify reference intervals (normal values). Findings: 1. Review of the verification procedures for the Gem 400 Premier Plus blood gas analyzer for pH, pCO2 and PO2 showed no verification of normal values. 2. Interview with the general supervisor on July 26, 2022 at 11:30 AM confirmed the laboratory failed to ensure the verification procedures for normal values for the Gem 4000 Premier plus blood gas analyzer were appropriate for the laboratory's patient population. 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. 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 review of Vidas 3 chemistry analyzer quality control (QC) and interview with the general supervisor, the laboratory failed to perform two control materials of different concentrations each day of procalcitonin (PCT) patient testing for 9 of 30 days and D-dimer patient testing for 2 of 30 days. Findings: 1. Review of Vidas 3 chemistry analyzer PCT patient testing in June 2022 showed QC was not performed on June 3, 7, 8,15, 19, 21, 23, 27 and 30. During these dates 13 patients were performed. 2. Review of Vidas 3 chemistry analyzer D-dimer patient testing in June 2022 showed QC was not performed on June 3 and 19. During these dates two patients were performed. 3. Interview with the general supervisor on July 26, 2022 at 11:30 AM confirmed the laboratory failed to perform two control materials of different concentrations each day of patient testing for PCT and D-dimer. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Sysmex CA-600 analyzer quality control (QC), patient results and interview with the general supervisor (GS), the laboratory failed to include two levels of control material each 8 hours of operation for prothrombin time (PT) and partial thromboplastin time (PTT) for 24 of 31 testing days in June and to date July 26, 2022. Findings: 1. Review of laboratory procedure "Quality Assessment Policies- Quality Control" states, "Quality Control Frequency - Coagulation 2 levels/8 hr". 2. Review of Sysmex CA-600 analyzer QC for June and July showed QC was not performed every 8 hours on June 26, June 28, June 29, June 30, July 1, July 2, July 3, July 4, July 5, July 6, July 7, July 8, July 9, July 10, July 11, July 15, July 16, July 17, July 19, July 20, July 21, July 22, July 23, and July 24. 3. Review of patient results showed two patient PT results were released without QC being performed on July 11, 2022. 4. Interview with the GS on July 26, 2022 at 11:30 AM confirmed the laboratory failed to perform two levels of PT and PTT QC each 8 hours of operation. -- 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 review of chemistry procedure manual's and interview with the general supervisor on August 31, 2020 at 12:15 PM the laboratory failed to have a written procedure for the Vitros XT 7600 analyzer. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)