Madison Co Memorial Hospital Clinical Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Madison Co Memorial Hospital Clinical Laboratory on 10/31/2024 - 11/20/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5200 General Laboratory Systems 493.1230 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the procedure manual and the America Proficiency Institute (API) proficiency testing (PT) records; and interview, the Laboratory Director failed to sign the attestations for four (2023 1st, 2nd, 3rd, 2024 1st) of five events (2023 1st, 2nd, 3rd; 2024 1st, 2nd) for Chemistry Core; and two (2023 3rd, 2024 1st) of five events (2023 1st, 2nd, 3rd; 2024 1st, 2nd) for Microbiology; and the laboratory testing personnel failed to sign the attestation for two (2023 1st, 2nd) of six events (2023 1st, 2nd, 3rd; 2024 1st, 2nd, 3rd) for Chemistry Core. Findings included: 1. Review of the procedure title Proficiency Testing noted "The lab manager signs the attestation statement as director." The procedure also noted "The technologist performing the testing signs printed attestation statement. Review of the attestation form noted "For all PT results, an attestation must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." The form indicates the attestation can be signed by a designee instead of the laboratory director. 2. Review of the attestation forms showed their was no signature for the laboratory director of designee for Chemistry Core for 2023 1st, 2nd, 3rd, and 2024 1st events and for Microbiology for 2023 3rd, and 2024 1st events. Review of the attestation forms showed their was no signature for the testing personnel for 2023 1st and 2nd events for Chemistry Core. 3. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- During an interview on 10/31/24 at 4:30 PM, the Technical Supervisor acknowledged the attestations were not signed. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the procedure manual and the America Proficiency Institute (API) proficiency testing (PT) records; and interview, the laboratory failed to retain all the API Work Cards used to record the reactions for Immunohematology testing for three (2023 1st, 3rd; 2024, 2nd) of five events (2023 1st, 2nd, 3rd; 2024 1st, 2nd) reviewed. Findings included: 1. Review of the procedure title Proficiency Testing Policy noted "Primary records related to PT and alternative assessment testing are retained for two years (unless a longer retention is required elsewhere in this checklist for specific analytes or disciplines). These include all instrument tapes, work cards, computer printouts, evaluation reports, evidence of review, and documentation of follow-up /

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 27, 2022. Madison County Memorial Hospital Clinical Laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager, the laboratory failed to include all Respiratory Testing Personnel (TP) for the testing of Blood Gas Proficiency samples for four testing events in 2021 and 2022. Findings include: Review of the CMS-209 Laboratory Personnel Report signed and dated by the Laboratory Director on 9/16/2022 revealed there were eight Respiratory TP (#A, #B, #C, #D, #E, #F, #G, #H). Record review of American Proficiency Institute attestation sheets for three testing events in 2021 and one testing event in 2022, revealed Respiratory TP #A tested all Blood Gas Proficiency samples in all four testing events. Interview with the Laboratory Manager on 9/27/2022 at 06:00 p.m. confirmed only Respiratory TP #A tested Proficiency samples for three testing events in 2021 and one testing event in 2022. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 record review and interview, the laboratory failed to perform and document competency evaluations for Testing Personnel (TP) #A for 2021 and 2022. Findings include: Review of the CMS-209 Laboratory Personnel Report revealed nine TP (#A, #B, #C, #D, #E, #F, #G, #H, #I). Review of employee competency records found no annual competency evaluations for TP #A had been documented for 2021 and 2022. Interview with the Technical Supervisor (who is also TP #A) on 9/27/2022 at 06:00 p. m. confirmed no competency evaluation had been performed and documented for 2021 and 2022. This is a repeat deficiency. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor (TS) failed to document a semiannual competency for 1 out of 9 Testing Personnel (TP) in 2021. Findings include: Review of the CMS-209 Laboratory Personnel Report signed and dated by the Laboratory Director (LD) on 9/16/2022 revealed there were nine TP (#A, #B, #C, #D, #E, #F, #G, #I.) Review of Laboratory Employee personnel records revealed there was no semiannual evaluation on TP #G hired in March of 2021. Interview with the TS on 9/27/2022 at 06:00 p.m., confirmed no semiannual competency had been documented on TP #G. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Madison County Memorial Hospital Laboratory on October 1-2, 2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Proficency Institute (API ) and interview with the Laboratory Supervisor, the laboratory failed to score at least 80% for 5 analytes (Albumin, Total Calcium, Potassium, Total Protein, Alcohol) in the Specialty of Chemistry for 1 ( 1st event 2020 ) out of 6 testing events ( 3rd 2018, 1st, 2nd, 3rd 2019 and 1st, 2nd 2020) reviewed for 2 years ( 2018-2020). Findings Included: Review of API proficiency testing revealed a score of 60 % for albumin, 60 % Total Calcium, 60 % Potassium, 40 % Total Protein and 60 % for Alcohol in the 1st testing event of 2020 . During an interview on 10/1/2020 at 10:30 AM, the Laboratory Supervisor confirmed the failed proficiency testing scores. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. 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 American Proficiency Institute (API) proficiency testing results and interview with the Laboratory Supervisor, the laboratory failed to score 100% on Compatibility Testing for 1 ( 1st event 2020 ) out of 6 testing events ( 3rd 2018, 1st, 2nd, 3rd 2019 and 1st, 2nd 2020) reviewed for 2 years ( 2018-2020). Findings Included: Review of API proficiency testing results for the 1st testing event in 2020 revealed a score of 60% for Compatibility Testing. During an interview on 10/01/20 at 10:30 AM , the Laboratory Supervisor confirmed the proficiency testing failure. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Supervisor, the laboratory failed to have competency evaluations on 8 out of 17 testing personnel in 2019 for 2 out of 2 (2018-2020) years reviewed. Findings Included: Review of competency evaluations found that Testing Person # C, D,E F,G,H,I and J did not have competency evaluations completed for 2019. During an interview on 10/02/20 at 10: 30 AM, the Laboratory Supervisor confirmed that the competency evaluations were not completed in 2019 for Testing Person # C,D,E,F,G,H,I and J. 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 review of proficiency testing records, and interview with the Laboratory Supervisor, the laboratory failed to review proficiency test scores for 3 of 3 events for 2019 out of 2 years ( 2018-2020 ) reviewed for Chemistry, Hematology, Immunohematology and Bacteriology. Findings Included: 1. Review of American Proficiency Institute ( API ) proficiency test records revealed the laboratory failed to review test scores for the Specialties of Chemistry , Hematology, Immunohematology and Subspecialty of Bacteriology for 1st, 2nd, and 3rd events in 2019. 2. During interview on 10/02/20 at 1:00 PM, the Laboratory Supervisor confirmed the laboratory did not document review of proficiency test scores for the specialties and events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 1, 2018. Madison County Memorial Hospital Laboratory had one deficiency found at the time of the visit. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform yearly preventive maintenance on Nikon microscope being used for manual cell identification in hematology and the general lab for 2 years ( 2016-2018). Findings included: Review of the equipment maintenance records for August 2016 to 2018 showed that no documentation for annual preventive maintenance was done on the microscope. Interview on 8/1/18 at 11:00 AM , personnel # 1 confirmed that the regular cleaning of the microscope was done but the annual peventive maintenance which calibrates the quality of the lenses was not performed and not included in the equipment maintenance routine for the lab. 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 --