Pratt Regional Medical Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on discussions on the laboratory's testing list, lack of documentation of histology testing on the CMS 116 and CMS 209, lack of documentation of accuracy checks from 6/15/23 to date of survey, and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of intraprocedure pathology reports (frozen section report) twice a year from 6/15/23 to date of survey. Findings: 1. During the opening survey discussions, the surveyor asked if the laboratory performed frozen section pathology on surgical samples, the general supervisor (GS) #1 stated that she would check with the LD when he arrived. 2. Review of the CMS 116 revealed no listing of histopathology testing and the and CMS209 form revealed no histopathology technical supervisor, general supervisor, or testing personnel. 3. Upon arrival of the LD, the surveyor asked if this laboratory performed frozen sections. The LD confirmed that histology testing of frozen sections. 4. The surveyor requested documentation of test reports and accuracy checks for histology testing. The laboratory provided three reports for 2023 and one report for 2024. 5. Review of "INTRAPROCEDURE/IMMEDIATE CONSULTATION REPORT" and corresponding fixed tissue pathology report on the same patient and tissue samples for the four patients revealed that the testing personnel on both reports was the LD. 6. No review by a different TP or pathologist was provided for the four of four patients tested in 2023 and 2024. 7. Interview with the LD on 4/22/25 at 2:05 p.m. confirmed, the laboratory failed to verify the accuracy of intraprocedure pathology reports (frozen section report) twice a year from 6/15/23 to date of survey. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) 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 manufacturer's instructions for RecombPlasTin 2G, quality control and quality assessment records for coagulation, observation of the laboratory's ACL TOP 350 and interview, revealed that the laboratory did not follow manufacturer's instructions for International Safety Index (ISI) upon utilizing a new lot number from 2/16/2023 to 6/14/2023 at time of survey. Findings: 1. Quality control and quality assessment records for the ACL TOP 350 coagulation analyzer on 06/14/2023 determined the Prothrombin Time (PT) and International Normalized Ratio (INR) for patients could be affected with the current lot of RecombPlasTin 2G in use. 2. The manufaturer's current lot of RecombPlasTin 2G (N0925455 Exp: 09 /2024) listed the ISI for the ACL TOP family/ACL TOP family 50 Series as 0.97. 3. The ACL TOP 350 being utilized in the laboratory for PTs and International Normalized Ratio (INR)s had the ISI listed as 1.00. 4. From 2/16/2023 through 6/14 /2023 there were 1625 PTs and INRs reported on patients with the incorrect ISI in the ACL TOP 350 for the current lot number of RecombPlasTin 2G. 5. Interview with Technical Consultant #1, General Supervisor #4 and the Laboratory Director on 6/14 /2023 at 10:15 a.m. confirmed, the laboratory failed follow manufacturer's instructions for the International Safety Index (ISI) upon utilizing a new lot number for RecombPlasTin 2G from 2/16/2023 to 6/14/2023. D5783

Summary Statement of Deficiencies D5785

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) and interview, the laboratory failed to evaluate proficiency testing performance (refer to D5215 and D5221). These are repeat deficiencies from survey conducted 8/3/2018. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's 2018 and 2019 American Proficiency Institute (API) proficiency testing (PT) documentation, policies and procedures, and interview with the Technical Supervisor (TS) #5, the laboratory failed to verify the accuracy of hematology, and microbiology analytes that were assigned a proficiency testing score Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- that did not reflect the laboratory's test performance. Findings Include: 1. Review of the laboratory's 2018 and 2019 API PT documentation for hematology and microbiology found the following "Not Graded" results: Microbiology 3rd Event 2018: Educational Suseptability ES-03, 11 results. CPL-05 Microbiology 1st Event 2019: Educational Suseptability ES-01, 14 results. CSF Culture MIC SF-01, 12 results. CSF Culture Suseptability SF-01, 12 results. Urine Culture MIC UR-01, 14 results. Microbiology 2nd Event 2019: Educational Suseptability ES-02, 15 results. Hematology 2nd Event 2019: Blood Cell Identification: DIF-02, 4 results, ECI- 06,07,08,09,10 Hematology 5C: COU-07 Nucleated RBC. 2. Review of the laboratory's PT review and

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) policy and procedure, American Proficiency Institute (API) proficiency testing documentation, hematology instrument result printouts, staff schedules, and interview with the Technical Supervisor (TS), the laboratory failed to test the 2017 3rd testing event hematology samples the same number of times that it routinely tests patient samples. Findings Include: 1. Review of the laboratory's policy and procedure titled "PROFICIENCY TESTING" states: "B. All surveys are to be treated and tested only in accordance with the written directions and in accordance with all CLIA regulations." 2. Review of the laboratory's API PT documentation for the 3rd testing event of 2017 in the specialty of hematology found Testing Personnel (TP) #3 signed the attestation form stating they performed analysis on PT sample COU-12 on 11/20/2017. The API PT due date for the hematology/coagulation 3rd testing event of 2017 was 12/01/2017. 3. Review of the laboratory's hematology instrument printouts included with the API PT documentation found three separate analyses of PT sample COU-12: Sample ID: API COU-12 Date: 11/20/2017 Time: 07:52 Sample ID: 17API_COU-12 Date: 11/29 /2017 Time: 15:31 Sample ID: 17API_COU-12 Date: 11/29/2017 Time: 15:34 3. Review of the laboratory's staff schedule found that TP #3 was not scheduled to be present in the laboratory on 11/29/2017 at 15:30. The schedule states that TP #3's shift ended at 14:30 on 11/29/2017. 4. The TS confirmed that it is not routine laboratory practice for a patient's sample to be reanalyzed nine days after the first analysis by a different TP. The TS stated they were unable to provide any laboratory policies or procedures that stated patient samples would be handled in a manner similar to the testing process described above. The interview occurred 08/03/2018 at 12:05 PM. 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 -- 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 laboratory's policies and procedures, 2017 and 2018 proficiency testing documentation, and interviews with the Technical Supervisor (TS) and anonymous Testing Personnel (TP), the laboratory failed to document and maintain documentation of the handling, preparation, processing, examination, and each step of the testing and reporting of results for all proficiency testing (PT) samples for a minimum of two years from the date of the proficiency testing event. Findings Include: 1. Review of the laboratory's American Proficiency Institute (API) PT documentation for 2017 and 2018 found the following altered results: Hematology 2018 - 1st Testing Event: Blood Cell Identification: Sample BCI-01 "Lymphocyte, normal" crossed out, "Hairy Cell" filled in - no testing documentation located Fibrinogen instrument printout results unreadable, results handwritten on instrument printout - laboratory unable to locate electronic copy of results or readable printout of results 2017 - 3rd Testing Event: Urinalysis & HCG: Samples UA-05 and UA-06 Result UA-05: 1.009 crossed out, 1.025 written below Result UA-06: 1.009 crossed out, 1.015 written below No documentation explaining the 1.009 results located Coagulation: Samples COA-11, COA-12, COA-13, COA-14, and COA-15 Fibrinogen instrument printout results unreadable, results handwritten on instrument printout - laboratory unable to locate electronic copy of results or readable printout of results Chemistry 2017 - 2nd Testing Event: Body Fluid Crystals: Sample CYS-04 Laboratory log sheet: dated 10/19/2017 and result "Calcium oxalate (dehydrate) crystals observed" documented API Result Form: result "Calcium oxalate crystal(s)" crossed out, "Crystals seen, referred for ID" filled in - corrections dated 11/2/17 Cell Count: Sample BFL-04 Laboratory log sheet: Count 1: WBC - 94 Count 2: WBC - 100 API Result Form: WBC (manual-CSF/BF) result of 83 crossed out, 94 written above - no documentation explaining the 83 result located 2017 - 1st Testing Event: Blood Gas: Sample BG-03 API Result Form: pH 7.43 crossed out, 7.26 written above pCO2 18 crossed out, 54 written above pO2 227 crossed out, 159 written above Original results (crossed out) dated 2/6/17 and initialed by TP #3, results written above dated 2/7 and initialed by TP #6 No instrument printout for the original results dated 2/6/17 located. Immunology/Immunohematology 2017 - 2nd Testing Event: CRP Quantitative: Sample QCP-04 Result QCP-04: 0.1 crossed out, 6.5 written above - no documentation explaining the 0.1 result located 2. Review of the laboratory's policy and procedure titled "PROFICIENCY TESTING" found no mention or reference to PT documentation retention requirements or practices. 3. Anonymous TP stated the TP submit the instrument printouts from PT analysis and the completed API bubble sheets to the TS. The TP stated they did not participate in PT result submission after that point. The TP further stated that the TS would, on occasion, come back and -- 2 of 5 -- ask the TP to rerun the PT samples after reviewing the instrument printout and bubble sheets the TP had submitted to the TS. The anonymous interviews occurred 08/03 /2018 at 11:30 AM. 4. The TS confirmed the TP submitted the instrument printouts and completed API bubble sheets to them but was unable to provide and explanation for the results missing instrument printouts or the numerous changes to the results. The interview occurred 08/03/2018 at 12:20 PM. 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 the laboratory's 2018 American Proficiency Institute (API) proficiency testing (PT) documentation and documentation by the Technical Supervisor (TS), the laboratory failed to attain a score of at least 80 percent of acceptable responses for the pO2 analyte resulting in unsatisfactory analyte performance for the 2nd testing event of 2018. Findings Include: 1. Review of the laboratory's API PT documentation for the 2nd testing event of 2018 found the laboratory scored a 60 percent for the analyte pO2 after obtaining unacceptable results for samples BG-07 and BG-09. 2. The TS confirmed the laboratory received unacceptable scores for the pO2 analyte on samples BG-07 and BG-09 on the PT