Ste Genevieve 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 the "Rapidec Carba NP" procedure, review of microbiology quality control logs and interview with the technical supervisor (TS) #2, the laboratory failed to follow the Rapidec Carba NP procedure. Findings: 1. Review of the "Rapidec Carba NP" procedure states "After incubating for a maximum of 2 hours, reading is performed visually by comparing the color of a control well without imipenem to a reactions well containing imipenem." 2. Review of the Rapidec Carba NP quality control revealed no documentation to show imipenem reactions from January 2024 to date March 12, 2025. 3. Interview with the TS #2 on March 12, 2025 at 11:00 AM confirmed the laboratory failed to follow the Rapidec Carba NP procedure. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on observation of the bacteriology refrigerator, review of "QC Cumulative Report", and interview with testing personnel (TP) #4 and the technical supervisor (TS) #2 the laboratory failed to ensure Vitek 2 gram negative (GN) card box sticker that states "ready for use" had the correct date quality control was performed. Findings: 1. Observation of bacteriology refrigerator showed a box of Vitek 2 GN card lot number 2412765403 with sticker that stated "this lot is ready for use 9/7/24". 2. Review of "QC Cumulative Report" states Vitek 2 GN lot number 2412765403 with date quality control performed on October 5, 2025. 3. Interview with TP #4 stated the sticker with the wrong date was inadvertently put on box. 4. Interview with the TS #2 on March 12, 2025 at 10:00 AM confirmed the laboratory failed to ensure the Vitek 2 GN card box sticker was labeled with correct date quality control was performed. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the laboratory's individualized quality control plan (IQCP) for the BioFire blood culture identification panel, BioFire quality control (QC) records, and interview with the technical supervisor (TS) #2, the laboratory failed to ensure that the IQCP for the BioFire blood culture identification panel was followed for 2 of 5 months. Findings: 1. Review of the BioFire blood culture identification panel IQCP states "Each new lot/shipment will have both positive and negative QC performed. In addition, every 30 days positive and negative QC will be performed." 2. Review of the BioFire quality control (QC) records from October 2024 to February 2025 showed QC was not performed in November and December 2024. 3. Interview with the TS #2 on March 12, 2025, at 2:15 PM confirmed the laboratory failed to ensure the BioFire blood culture identification panel IQCP was followed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of the Biomerieux mini Vidas chemistry analyzer quality control (QC) from November 14, 2024, to date March 12, 2025, patient results, and interview with the technical supervisor (TS) #2, the laboratory failed to include two acceptable control materials of different concentrations for procalcitonin for 5 of 118 patient -- 2 of 3 -- testing days. Findings: 1. Review of the Biomerieux mini Vidas chemistry analyzer quality control (QC) from November 14, 2024, to date March 12, 2025 showed two acceptable levels of procalcitonin QC was not performed on January 1, 2025, January 7, 2025, January 17, 2025, February 8, 2025 and February 10, 2025. 2. Review of patient results showed the laboratory reported six procalcitonin patient result while QC was not acceptable. 3. Interview with the TS #2 on March 12, 2025, at 2:15 PM confirmed the laboratory failed to include two control materials each day of patient testing for procalcitonin. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) 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 October 2024 to January 2025 antimicrobial susceptibility testing (AST) records for the Vitek 2 compact analyzer, patient results and interview with the testing personnel (TP) #4 and technical supervisor (TS) #2, the laboratory failed to follow their procedure and use control organisms to check the procedure each week of patient testing for 2 of 16 weeks. Findings: 1. Review of the AST records for the Vitek 2 compact analyzer which performs bacteria identification and susceptibility revealed the laboratory failed to use the appropriate control organism Streptococcus pneumoniae for the week of December 2, 2024 for antimicrobial susceptibility on the Vitek 2. 2. Review of the AST records for Vitek 2 compact analyzer which performs bacteria identification and susceptibility revealed the laboratory failed to use the appropriate control organism Enterococcus faecali for the week of December 16, 2024 for antimicrobial susceptibility on the Vitek 2. 3. Interview with the TS #2 on March 12, 2025 at 10:00 AM confirmed the laboratory failed to use control organisms for AST weekly. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the procedure manual, personnel documentation, and interview with the General Supervisor (GS) #1, the laboratory failed to perform competency evaluations for 2020 and to date May 18, 2021 for 2 of 2 competency assessments for the position of technical supervisor and 1 of 1 competency assessments for the position of general supervisor. Findings: 1. Review of 2020, 2021 personnel documentation revealed the laboratory failed to perform competency evaluations for the position of technical supervisor #2 and #3 and general supervisor #1. 2. Review of the procedure manual revealed a lack of written policies and procedures to assess employees in the position of technical supervisor and general supervisor. 3. Interview with the GS #1 on May 18, 2021 at 11:00 AM confirmed the laboratory failed to have written policies and perform annual competencies for 2020 and to date May 18, 2021 for the positions of technical supervisor and general supervisor. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Review of immunohematology procedures, 2019/2020/2021 blood bank refrigerator alarm checks and interview with the general supervisor (GS) #1, the laboratory failed to follow "Blood Bank Temperature Alarm Check" procedure for seven of nine quarters. Findings: 1. Review of "Blood Bank Temperature Alarm Check" procedure states "The alarms systems for the blood bank refrigerator and freezer are verified on a quarterly basis during the months of March, June, September, and December". 2. Review of 2019 blood bank temperature alarm checks showed no alarm checks for 2019. Review of 2020 blood bank temperature alarm checks showed no blood bank alarm checks in March or June 2020. 3. Review of "Blood Bank Temperature Alarm Check" procedure states "This laboratory's Alarm Settings are: High Alarm +5.5 degrees Celsius Low Alarm +1.5 degrees Celsius". 4. Review of April 2021 blood bank alarm check showed the high alarm activated at 8.1 degrees Celsius. 5. Interview with the GS #1 on May 18, 2021 at 1:00 PM confirmed the laboratory failed to follow procedure to perform blood bank alarms quarterly and failed to ensure they activate at correct temperatures. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of Cardinal Health blood bank saline manufacturer's package insert, observation of saline 20 Liter saline box, Biorad liquichek Lot#60272 and 60271, freezer temperature logs for 16 out of 16 months and interview with general supervisor #1, the laboratory failed to follow manufacturer's instructions for reagent handling. Findings: 1. Review of the Cardinal Health package insert for the saline indicated open stability for saline is 30 days. 2. Observation of the saline box in use indicated open date April 12, 2021 on survey date of May 18, 2021. 3. Observation of the BioRad Liquichek Lot #60272 and 60271 bottles in freezer indicated storage requirement of -20 degree Celsius to -70 degree Celsius. 4. Review of the freezer temperature logs where BioRad Liquidchek was stored for 2020 and 2021 up to date of May 18, 2021 indicated the temperature for the Cardinal Health Freezer to be continually warmer than -20 degree Celsius. 4. Interview with GS#1 on May 18, 2021 at 11:30 AM confirmed the laboratory failed to follow manufacturer's instructions for reagent handling of saline and BioRad Liquidchek controls. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of performance specifications, quality control (QC) program, quality assessment programs, and chemistry QC, the laboratory director failed to provide -- 2 of 5 -- overall management and direction of the laboratory. The laboratory director failed to ensure performance specifications for the ABL 90 Flex Plus and the ACL Top were adequate before performing patient testing (Refer to D6086); the laboratory director failed to establish and maintain the QC program (Refer to D6093); the laboratory director failed to ensure quality assessment programs are established and maintained (Refer to D6094); and the laboratory director failed to ensure QC was within acceptable limits before reporting patients results (Refer D6097). D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Review of verification of performance specifications for the ABL 90 Flex Plus blood gas analyzer, ACL Top analyzer and interview with the general supervisor (GS) #1, the laboratory director (LD) failed to ensure verification procedures are adequate to determine pertinent performance characteristics of the method. Findings: 1. Review of the ABL 90 Flex Plus verifications of performance specifications showed no reportable range of test results for the ABL system and no verification that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for the analytes pH, pCO2, p02, HCO3, TCO2, and O2. 2. Review of the ACL Top verification of performance specifications showed no verification that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for the analytes prothrombin time, partial thromboplastin time, D-Dimer, fibrinogen and Anti-factor Xa. 3. Interview with the GS #1 on May 18, 2021 at 1:30 PM confirmed the LD failed to ensure verification procedures for the ABL 90 Flex Plus and the ACL Top were adequate to determine pertinent performance characteristics of the method. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Review of 2019/2020/2021 serum pregnancy kit test, medtox urine toxicology analyzer, TLiQ fetal fibronectin, Cepheid Genexpert and Amnisure ROM quality control (QC) and interview with the general supervisor (GS) #1, the laboratory director (LD) failed to ensure the quality control programs are established and maintained to assure the quality of laboratory services. Findings: 1. Review of the 2019/2020/2021 patient results reported and QC showed QC was not performed every day of patient testing for: Serum pregnancy kit showed 135 patients were resulted. Medtox urine toxicology showed 1061 patients were resulted. TLiQ fetal fibronectin showed 24 patients were resulted. Cepheid clostridium difficile 424 patients were resulted. Cepheid SARS CoV2 1009 patients were resulted. Cepheid CoV2/Flu AB 145 patients were resulted. Cepheid Flu AB 733 patients were resulted. Amnisure -- 3 of 5 -- ROM 155 patients were resulted. 2. Interview with the GS #1 on May 18, 2021 at 1: 45 PM confirmed the LD failed to ensure the quality control programs are established and maintained to assure the quality of laboratory services. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Review of the quality assurance policy, the Vitros 5600 Chemistry analyzer quality control (QC), Vitros 5600 Unity peer review and interview with the general supervisor (GS) #1, the laboratory director (LD) failed to ensure quality assessment programs are established and maintained. Findings: 1. Review of "Quality Assurance Control Plan" states "Specific rules used to accept or reject shift and/or run quality control are found in the laboratory procedure for each specific test. Quality data will be reviewed for shift and trends by monthly monitor and review of the cumulative data by the medical director, administrative director, manager, supervisor, or designee." No documentation in the Vitros 5600 procedure could be provided for shifts and trends. 2. Review of Vitros 5600 QC showed testing personnel accepting chemistry QC in the laboratories LIS system, with no levey jennings charts or graphs reviewed. No documentation of QC shifts or trends could be provided. 3. Review of Vitros 5600 chemistry peer review showed for March 2021 the indirect bilirubin, total bilirubin, creatinine kinase and Free thyroxine (T4) values were "above -2 and below 2" for method SDI. No documentation for the discrepancies were documented on the peer review cover page. 4. Interview with the GS #1 on May 18, 2021 at 1:30 PM confirmed the LD failed to ensure chemistry quality assessment programs are established and maintained. D6097 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(7) The laboratory director must ensure that patient test results are reported only when the system is functioning properly. This STANDARD is not met as evidenced by: Review of Vitros 5600 chemistry analyzer quality control (QC), patient results, and interview with the general supervisor (GS), the laboratory director (LD) failed to ensure the chemistry analyzer was functioning properly before patient test results were reported. Findings: 1. Review of the Vitros 5600 chemistry analyzer showed on May 6, 2021, level 2 control for total bilirubin (TBil) was not within acceptable limits. On May 6, 2021 the laboratory reported 40 TBil patient results. 2. Interview with the GS #1 on May 18, 2021 at 1:45 PM confirmed the LD failed to ensure the chemistry analyzer was functioning properly before patient test results were reported. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each -- 4 of 5 -- consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with General Supervisor #1, the laboratory director failed to specify, in writing, the responsibilities and duties of the technical supervisor engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing for immunohematology and failed to specifically delegate to qualified staff the competency evaluation duties being performed in immunohematology. 1. Review of the procedure manual reveal that laboratory director failed to specify in writing the responsibilities and duties for the technical supervisor of immunohematology. 2. Interview with the General Supervisor #1 on May 18, 2021 at 11:10 A.M. confirmed that the laboratory director had not specified in writing the responsibilities and duties for the technical supervisor of immunohematology. -- 5 of 5 --

Summary Statement of Deficiencies 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 review of procedure manual, maintenance documentation, observation of pipettes and interview with the general supervisor, the laboratory failed to define and perform a function check to verify the accuracy of 5 of 5 pipettes. Findings: 1. Review of the "Calibration of Pipettes" procedure showed to calibrate all pipettes at least annually. 2. No documentation was found to show the laboratory performed a function check protocol to verify the accuracy of the volumes of 2 of 2 Biohit pipettes for immunohematology testing and 3 of 3 MLA pipettes for routine chemistry testing. 3. Observation of the 100 microliter, 200 microliter, 1000 microliter MLA pipettes and 2 repeater Biohit pipettes located in the laboratory available for use showed no function check since 2014. 4. Interview with the general supervisor on October 23, 2018 at 1: 00 PM confirmed, the laboratory failed to define a protocol and perform a function check to verify the accuracy of the volumes of 5 of 5 pipettes. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 -- instruments, or performs the same test at multiple testing sites, the laboratory must 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 review of 2017, 2018 instrument comparison documentation and interview with the general supervisor, the laboratory failed to perform instrument comparisons for two of two iSTAT analyzer for blood gas testing two times a year. Findings: 1. Review of the laboratory instrument comparison documentation showed the laboratory failed to perform and document comparison studies for 2 of 2 iSTAT analyzers performing pH, pCO2, and pO2 analytes testing for 2017 and to date 2018. 2. Interview with the general supervisor on October 23, 2018 at 1:00 PM confirmed, the laboratory failed to perform instrument comparisons for two iSTAT analyzers twice a year for 2017 and to date 2018. -- 2 of 2 --

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 2017 and 2018 immunohematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the general 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 2017 and 2018 immunohematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the general supervisor, the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three testing events. Findings: 1. Review of the immunohematology PT results for the second event of 2017 revealed the laboratory obtained an unsatisfactory score of 80 percent for compatibility testing. 2. Review of the immunohematology PT results for the first event of 2018 revealed the laboratory obtained an unsatisfactory score of 80 percent for compatibility testing. 3. Interview with the general supervisor on May 21, 2018 at 3:00 PM confirmed the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three consecutive events in 2017 and 2018. -- 2 of 2 --