Medicine Lodge Memorial Hospital

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 the review of performance verification documentation for the lipase assay LIPL and extended range C-reactive protein assay RCRP on the Siemens Dimension EXL 200, and interview with the general supervisor GS, the laboratory failed to verify the lipase and C-reactive protein reference intervals (normal values) were appropriate for the laboratory's patient population prior to reporting patient results. Findings: 1. Review of the performance verification documentation of the lipase assay LIPL on the Siemens Dimension EXL 200 revealed no verification of normal values for the laboratory's patient population. Patient testing began on 11/17/23. 2. Lipase test volume from 11/17/23 to date of survey was 114 patient test results. 3. Review of the performance verification documentation of the extended range C-reactive protein assay RCRP on the Siemens Dimension EXL 200 revealed no verification of normal values for the laboratory's patient population. Patient testing began on 10/30/23. 4. Extended range C-reactive protein test volume from 10/30/23 to date of survey was 167 patient test results. 5. Interview with GS on 6/26/24 at 10:20 a.m. confirmed, the laboratory failed to verify the lipase and C-reactive protein reference intervals (normal values) were appropriate for the laboratory's patient population prior to reporting patient results. 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 -- 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 quality control (QC) documentation on the Quidel Triage Meter Pro for D-Dimer, lack of an individualized quality control plan (IQCP), patient test results, and interview with the GS, the laboratory failed to perform QC every eight hours of patient testing on the Quidel Triage Meter Pro for D-Dimer testing. Findings: 1. Review of the D-Dimer QC documents for the Quidel Triage Meter Pro test system revealed the laboratory failed to perform external QC every eight hours of patient testing. 2. No approved IQCP for the Quidel Triage Meter Pro test system was provided at the time of survey. 3. From 10/11/22 to 6/26/24, 168 patient results were reported without acceptable QC performed within eight hours of patient testing. 4. Interview with the GS on 6/26/24 at 12:30 p.m. confirmed the laboratory failed to perform QC every eight hours each day of patient testing on the Quidel Triage Meter Pro for D-Dimer testing. -- 2 of 2 --

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the manufacturers' package insert instructions, direct observation, laboratory's policy and procedure manual, and interview with Testing Personnel (TP) # 2, the laboratory failed to ensure that reagents were not used when they had exceeded their expiration dates. Findings Include: 1. Direct observation of the laboratory's reagent refrigerators at 10:23 AM on the date of survey found the following reagents: Dade Actin - dated 7/23 CA Clean - not dated Dade Innovin - dated 7/26 MAS Urinalysis level 1 and 2 quality control fluids - not dated Chemistry enzyme diluent - no reconstitution date 2. Review of the manufacturers' package insert instructions for the reagents Dade Actin, CA Clean, Dade Innovin, MAS urinalysis level 1 and 2 quality control fluids, and chemistry enzyme diluent found the following stability guidelines: Dade Actin: stable for 7 days once opened and stored at 2 - 8 degrees Celcius (C) CA Clean: stable for 1 month once opened and stored at 2 - 8 degrees C Dade Innovin: stable for 10 days once opened and stored at 2-8 degrees C MAS Urinalysis level 1 and 2 quality control fluids: stable for 3 months once opened and stored at 2 - 8 degrees C Chemistry enzyme diluent: stable for 7 days once opened and stored at 2 - 8 degrees C 3. Review of the laboratory's policy and procedure titled "Control Storage" found the following directions for the MAS urinalysis controls: "Opened bottles are stable for 3 months at 2 - 8 degrees C" Review of the laboratory's policy and procedure titled "Reagent Storage" found the following directions for the chemistry enzyme diluent: "Reagents: store at 2 - 8 degrees C until exp date." Review of the laboratory's policy and procedure titled "Sysmex CA-Series ACTIVATED PARTIAL THROMBOPLASTIN TIME" found the following directions for the Dade 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 -- Actin, CA Clean, and Dade Innovin: "Dade Actin - Reagent Stability: 2 - 15 degrees C: 7 days [once opened] CA Clean - Stability once opened at 2 - 8 degrees C: 30 days in closed container" Review of the laboratory's policy and procedure titled "SYSMEX CA-SERIES - PROTHROMBIN TIME" found the following directions for the Dade Innovin: "Dade Innovin - Stability after Reconstitution: 2 - 8 degrees C 10 days (closed vial)" 4. Testing Personnel #2 stated the laboratory uses the above reagents until the bottles were empty and had not been adhering to the manufacturers' stability requirements. The interview occurred 08/01/2018 at 10:31 AM. 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 direct observation, review of the laboratory's policies and procedures, and interview with Testing Personnel (TP) #2, the laboratory failed to perform two levels of quality control material each time the non-manual coagulation reagents were changed on the Sysmex CA-1500 analyzer. Findings Include: 1. Review of the laboratory's policies and procedures titled "Sysmex CA-series ACTIVATED PARTIAL THROMBOPLASTIN TIME and SYSMEX CA-SERIES PROTHROMBIN TIME" found directions stating that quality control should be performed once every eight hours of patient testing. Review of the procedures failed to find any mention of removing the reagents between each patient test or performing quality control when reagents had been loaded onto the analyzer. 2. Direct observation of the laboratory's Sysmex CA-1500 analyzer on the date of survey AT 10:15 AM found no reagents present on the analyzer. 3. TP #2 stated the laboratory did not leave the coagulation reagents on the analyzer in between patient testing. The TP removed the reagents after a patient's test was complete and placed the reagents back in the refrigerator. The reagents were only placed back on the instrument when a subsequent sample required analysis. TP #2 further stated the laboratory only performed quality control testing once per day of patient testing and did not perform quality control each time the reagents were placed back on the analyzer. The interview occurred 08/01 /2018 at 10:17 AM. D5783