Coffey County Hospital Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was completed on September 9, 2024. Coffey County Hospital laboratory was found not in compliance with the following CONDITIONAL LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant D6033 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2023, and 2024 to date of survey American Proficiency Institute (API) proficiency testing (PT) documentation, CMS 209 personnel form, and interview with technical consultant (TC) #1, the laboratory failed to update the

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 the review of the sysmex Dimension EXL (SN 12251151) analyzer calibration verification records for analytes and interview with the Technical Consultant (TC), the laboratory failed to perform calibration verification once every six months on analytes with less than three calibrators at time of survey. Findings: 1. Review of the calibration verification records of the Dimension EXL for the following analytes with less than three calibrators: Sodium (NA), Potassium (K+) and Chloride 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 -- (CL-); revealed the laboratory performed the last six month calibration verification on December 31, 2021, but failed to perform the calibration verification that was due in June 2022. 2. Interview with the TC on October 11, 2022 at 12:24 p.m. confirmed, the laboratory failed to perform calibration verification once every six months on the Dimension EXL with analytes with less than three calibrators. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. 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 the laboratory's immunohematology procedures, thermographic temperature charts, daily temperature logs, high/low temperature alarm check records, and interview with technical consultant (TC), the laboratory failed to store immunohematology blood and blood products under appropriate conditions that included the regular inspection of the temperature alarm system at time of survey. Findings: 1. Review of the "Temperature Monitoring Blood Bank Refrigerator" procedure states "The alarm on the refrigerator should be checked periodically for proper functioning." 2. Review of the laboratory's 2021 and to date 10/11/22 thermographic temperature charts and Transfusion Services documents for one blood bank refrigerator showed: a. No identifiers on the thermographic temperature charts to differentiate the "high" and "low" alarms were for performed for the refrigerator that stored packed Red Blood Cells (pRBCs) units. b. The most recent alarm checks for the Blood Bank refrigerator could not be provided at time of survey. c. The TC provided a standard form to be utilized for performing the Blood Bank refrigerator alarm checks, but at time of survey no completed forms could be provided. 7. Interview with TC on October 11, 2022 at 12:04 p.m. the laboratory failed to store immunohematology blood and blood products under appropriate conditions that included the regular inspection of the temperature alarm system at time of survey. -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of performance verification documentation for the Siemens Dimension EXL analyzer, non-waived test list and interview, the laboratory failed to verify that the reference intervals (normal values) for 45 of 45 analytes were appropriate for the laboratory's patient population. This is a repeat deficiency from a survey conducted 1/11/2019. See D5421. 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: 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 -- Based on review of performance verification documentation for the Siemens Dimension EXL analyzer, non-waived test list, and interview, the laboratory failed to verify that the reference intervals (normal values) for 45 of 45 analytes were appropriate for the laboratory's patient population. Findings: 1. Review of the KS- CLIA-PS01, Laboratory Test List and Annual Volumes dated 12/21/2020 lists 45 analytes are performed on the Siemens Dimension EXL. 1. Review of Siemens Dimension EXL analyzer, S/N DR251762 verificiation documentation dated 10/5 /2020 revealed that reference intervals (normal values) vertification studies were not performed for 45 of 45 analytes. 2. Interview with the General Supervisor (GS) on 12 /30/2020 at 2:30 p.m. confirmed, the laboratory failed to verify that the reference intervals (normal values) for 45 of 45 analytes were appropriate for the laboratory's patient population. 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. This STANDARD is not met as evidenced by: Based on an absence of pipette and thermometer function check protocols, records or certificates of accuracy and interview, the laboratory failed to define and perform a function check protocol for the pipettes and thermometers. Findings: 1. No documentation of a function check protocol for the pipettes and thermometers was available at the time of survey. 1. No documentation was available for performance of function checks on 2 of 2 pipettes and 9 of 9 thermometers for a 2 year period. 2. No documentation was available for the certification of accuracy on 2 of 2 pipettes and 9 of 9 thermometers for a 2 year period. 2. Interview with the GS on 12/30/2020 at 11: 30 a.m. confirmed, the laboratory failed to define and perform a function check protocol for the pipettes and thermometers. -- 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 performance verification procedures for the Biofire microbiology 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 Biofire analyzer for respiratory and gastrointestinal panels showed no verification of normal values. 2. Interview with the general supervisor on January 11, 2019 at 11:30 AM confirmed the laboratory failed to ensure the verification procedures for normal values for the Biofire analyzer were appropriate for the laboratory's patient population. 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 --