Edwards County Medical Center

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 manufacturer's package insert instructions, freezer temperature logs for the time period of 1/01/2024 thru 3/26/2024, and interview, the laboratory failed to store quality control (QC) materials under conditions consistent with the manufacturer's instructions in one of one freezers for 53 days out of 86 days. Findings: 1. Review of the Bio-Rad Liquichek Cardiac Markers Plus Control LT package insert and the Bio-Rad Liquid Assayed Multiqual package insert indicated that the storage temperature range was -20 degrees Centigrade to -70 degrees Centigrade for both QC materials. These materials were stored in the lab freezer since they were received. 2. Review of the "Edwards County Medical Center Freezer Logs" obtained from the Laboratory Information System "Orchard" for the temperature readings on the one laboratory freezer from 1/01/2024 to 3/26/2024 revealed: a. Temperatures were out of the controls' required range (-20 degrees Centigrade to -70 degrees Centigrade) for 53 days out of 86 days storage period. b. The "Edwards County Medical Center Freezer Logs" obtained from the Laboratory Information System "Orchard" was not updated to correct the temperature requirements of the QC material and listed with an acceptable range of -15 degrees Centigrade to -70 degrees 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 -- Centigrade. 3. Interview with the technical consultant #1 on 3/26/2024 at 2:00 p.m. confirmed the laboratory failed to store QC materials under conditions consistent with the manufacturer's instructions in one of one freezers for 53 days out of 86 days. -- 2 of 2 --

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a lack of policies, procedures, specimen rejection logs, test request review documentation and interview, the laboratory failed to have written policies, procedures, and quality assurance (QA) documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic sytem. Findings: 1. A request was made to review the preanalytical policies and procedures. None were made availiable at the time of survey. 2. A request was made to review the specimen rejection log and test request review for QA documentation. None were made availiable at the time of survey. 3. Interview with the general supervisor (GS) 6/8/22 at 11:55 a.m. confirmed, the laboratory failed to have written policies, procedures, and QA documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic sytem. 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 the review of the manufacturer's instructions, test complexity, procedure manual, quality control (QC) records and patient test results from 1/1/21 to the date of survey, and interview, the laboratory failed to perform QC at least once each day of patient testing for quantitative procedures, to include two control materials of different concentrations for 42 of 47 patient results reported. Findings: 1. Review of the OPTI CCA TS Analyzer Operator's Manual revealed "OPTI Medical Systems recommends that QC solutions be run, as a minimum, with each new lot number of cassettes and at monthly intervals thereafter." 2. The OPTI CCA TS Analyzer can conduct basic testing of hydrogen ion concentration (pH), carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), sodium (Na+), potassium (K+), ionized calcium (Ca++), chloride (Cl-), glucose (Glu), blood urea nitrogen (BUN), lactate (Lac), total hemoglobin concentration (tHb) and hemoglobin oxygen saturation (SO2) which are categorized as moderate complexity tests and require quality control at least once a day of patient testing with two control materials of different concentrations per 493. 1256. 3. Review of the laboratory's procedure "OPTI CCA TS Analyzer" revealed under "Quality Control Recommendations:" item 2. "Run one level of liquid control every day of patient testing. 4. Review of QC logs revealed that less than two controls of different concentrations were performed on 35 of 39 patient testing days for 42 of 47 patients. 5. Interview with the GS on 6/8/22 at 11:00 a.m. confirmed, the laboratory failed to perform QC at least once each day of patient testing for quantitative procedures, to include two control materials of different concentrations for 42 of 47 patient results reported from 1/1/21 to 6/8/22. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API) and staff interview, the laboratory failed to evaluate its proficiency testing results. Findings: 2019 Hematology/Coagulation - 1st Event PT. 1. Four analyte/method scores of Unacceptable, 2. Eight analyte/method scores of Not Graded 3. No evidence of evaluation was available at the time of survey. 2019 Microbiology 3rd Event PT. 1. All results scored acceptable. 2. No evidence of evaluation was available at the time of survey. Interview with General Supervisor (GS) on September 16, 2020 at 12:30 p.m. confirmed, the laboratory failed to evaluate its proficiency testing results. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. 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 an absence of thermometer function check records or certificates of accuracy and interview, the laboratory failed to define a function check protocol for the thermometers. Findings include: 1. No documentation was available for function checks on 4 of 4 thermometers for a 2 year period. 2. No documentation was available for the certification of accuracy (NIST traceble) on 4 of 4 thermometers for a 2 year period. 2. Interview with GS on 9/16/2020 at 3:10 p.m. confirmed, the laboratory failed to define a function check protocol for the thermometers. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review with the General Supervisor and the review of package inserts and patient test logs, the laboratory failed to perform external quality control (QC) for moderate complexity testing SERUM HCG and C-DIFF testing each day of patient testing. 1. Review of the patient logs showed external QC was not performed each day of patient testing 20 out of 20 days for C-DIFF and 10 out of 10 different days reviewed for SERUM HCG. 2. No IQCP has been completed to allow the lab to reduce the frequency for QC for SERUM HCG and C-DIFF which requires QC for Moderate Complexity to be performed each day of patient testing. The interview occurred on 10/30/2018 @ 1145. 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 --