Ray County Memorial Hospital

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 laboratory procedures, gram stain quality control (QC) records from January 2026 to date May 12, 2026, patient results, and interview with the technical supervisor (TS) #1, the laboratory failed to follow the written procedure for gram stains for 117 of 132 days in 2026. Findings: 1. Review of laboratory procedure "Gram Stain" states "Check the Gram stain reagents in use at least once daily to make sure they are staining properly". 2. Review of gram stain QC records from January 2026 to date May 12, 2026 showed no gram stain QC documented on 117 days. 3. Review of patient results showed the laboratory performed 3 gram stains from January 2026 to date May 12, 2026. 4. Interview with the technical supervisor (TS) #1 on May 12, 2026 at 11:00 AM confirmed the laboratory failed to follow the written procedure for gram stains. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and review of American Proficiency Institute (API) 2025 proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in compatibility testing (Refer to D2181). D2181 COMPATIBILITY TESTING 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 -- CFR(s): 493.863(e) (e) 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, review of American Proficiency Institute (API) 2025 proficiency testing records and email correspondence with the technical supervisor #1 on January 8, 2026, at 3:28 PM, the laboratory failed to achieve satisfactory performance for compatibility testing for two out of three consecutive proficiency testing events. Findings: 1. Review of the CASPER 0155 report showed the following results: Compatibility testing 2025-1st event the laboratory received an unsatisfactory score of 80 percent for compatibility testing. Compatibility testing 2025-3rd event the laboratory received an unsatisfactory score of 80 percent for compatibility testing. 2. Review of the American Proficiency Institute (API) 2025 proficiency testing records confirmed the CASPER 0155 report results. 3. Email correspondence with the technical supervisor #1 on January 8, 2026, at 3:28 PM, confirmed the laboratory failed to achieve satisfactory performance for compatibility testing for two out of three consecutive proficiency testing events. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Siemens Dimension EXL 200 chemistry analyzer quality control (QC) from December 1, 2023 to December 31, 2023, patient results, and interview with technical supervisor (TS) #1, the laboratory failed to include two acceptable control materials of different concentrations for Albumin (ALB) for 2 of 31 patient testing days. Findings: 1. Review of laboratory procedure "Quality Control Policy" states "Occurs when two consecutive control values fall outside the same 2SD. The run is rejected." 2. Review of the Siemens Dimension EXL 200 chemistry analyzer QC from December 1, 2023 to December 31, 2023 showed two acceptable levels of ALB QC was not performed on December 13 and 14, 2023. 3. Review of the patient results showed the laboratory reported 6 ALB patients on December 13, 2023 and 12 ALB patients on December 14, 2023 while QC was not acceptable. 4. Interview with the TS #1 on February 6, 2024 at 10:00 AM confirmed the laboratory failed to include two control materials each day of patient testing for ALB. 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 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 -- 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 laboratory analyzers, lack of instrument comparisons, and interview with the technical supervisor (TS) #1, the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using different instruments in 2022, 2023 and to date February 6, 2024. Findings: 1. Observation of the laboratory analyzers showed an iSTAT analyzer in the laboratory and a second iSTAT analyzer in the respiratory department, both analyzers perform sodium, potassium, chloride, calcium, glucose, blood urea nitrogen (BUN), carbon dioxide (CO2), creatinine, pH, partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2). 2. Lack of instrument comparisons showed the laboratory had no documentation to evaluate and define the relationship between the two iSTAT analyzers twice a year in 2022, 2023 and to date February 6, 2024. 3. Interview with the TS #1 on February 6, 2024 at 11:00 AM, confirmed the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using different instruments. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --