Shoshone Medical Center

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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory manager on 3/11/2025, the laboratory failed to follow written procedures to assess testing personnel competency in 2024. The findings include: 1. The CMS 209 identified ten testing personnel (TP) performing moderate and high complexity testing. 2. A review of laboratory procedures identified that the laboratory established a procedure to assess TP initial training, semiannual and annual competency. 3. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for one TP performing testing in 2024. 4. An interview with the laboratory manager on 3/11 /2025 at 8:27 am confirmed the above findings. 5. The laboratory reports performing 79,784 tests annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal 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 -- values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the verification of performance specifications for the Alcor Scientific miniiSED ESR Analyzer and an interview with the laboratory manager on 3 /11/2025, the laboratory failed to ensure test performance specifications were established and verified before patient testing began in August 2023. The findings include: 1. A review of documentation for verification of performance specifications for erythrocyte sedimentation rate (ESR) testing on the miniiSED identified that the laboratory failed to verify precision and reportable range prior to performing patient testing in August 2023. 2. A review of documentation for verification of performance specifications for ESR testing identified that the laboratory failed to have the Laboratory Director review and approve the performance verification prior to performing patient testing. 3. An interview with the laboratory manager on 3/11/2025 at 3:20 pm confirmed the above findings. 4. The laboratory reports performing 472 ESR tests annually. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 a review of calibration records, linearities, instrument documents for the Ortho Vitros 4600 and an interview with the laboratory manager on 3/12/2025, the laboratory failed to verify the reportable range at least once every six months for total iron-binding capacity (TIBC) and Hemoglobin A1c (HbA1c) in 2023 and 2024. The findings include: 1. A review of calibration records for the Vitros 4600 identified that TIBC had a two point calibration and HbA1c had a one point calibration. 2. A review of instrument documents and linearities for TIBC and HbA1c identified that the laboratory failed to perform verifications of the reportable range for TIBC and HbA1c at least every six months in 2023 and 2024. 3. An interview with the laboratory manager on 3/12/2025 at 8:44 am confirmed that the laboratory failed to verify the reportable range of TIBC and HbA1c at least once every six months in 2023 and 2024. 4. The laboratory reports performing 300 TIBC and 1,030 HbA1c tests annually. -- 2 of 3 -- 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 a review of Quality Control (QC) records, patient records and interviews with the laboratory manager on 3/11/2025 and 3/12/2025, the laboratory failed to successfully perform two levels of QC each day of patient testing for prothrombin time and total bilirubin in 2023 and 2024. The findings include: 1. A review of QC documents for the Sysmex CA660 for 2023 and 2024 identified that the laboratory failed to have at least two acceptable levels of QC for prothrombin time on 9/20/2024. A patient record review identified one patient (MRN 28902) with results reported on 9 /20/2024. 2. An interview with the laboratory manager on 3/11/2025 at 2:09 pm confirmed the prothrombin time finding. 3. A review of QC documents for the Vitros 4600 for 2023 and 2024 identified that the laboratory failed to have at least two acceptable levels of QC for total bilirubin on 4/14/2023. A patient record review identified 13 patients (MRNs 0056438, 0089124, 0061788, 0075336, 0085083, 0063409, 0053222, 0079992, 0088493, 0079122, 0069348, 0034045, 0036742) with total bilirubin results reported on 4/14/2023. 4. An interview with the laboratory manager on 3/12/2025 at 12:45 pm confirmed the total bilirubin finding. 5. The laboratory reports performing 324 prothrombin time and 2,662 total bilirubin tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the bioMerieux Vidas 3 maintenance logs and an interview with the laboratory manager on 3/22/2023, the laboratory failed to perform instrument maintenance as required by the manufacturer. The findings include: 1. A review of maintenance records for the bioMerieux Vidas 3 identified that the laboratory failed to complete monthly maintenance which included cleaning the SPR block since the last inspection (5/10/2021). 2. A review of maintenance records for the bioMerieux Vidas 3 identified that the laboratory failed to complete six month maintenance which included cleaning the housing and front cover, cleaning vials, tubes and disposables rack, cleaning waste drawer, cleaning reagent strip sections and cleaning the touch screen since the last inspection. 3. An interview with the laboratory manager on 3/22 /2023 at 12:38 pm confirmed that the required monthly maintenance for the bioMerieux Vidas 3 was not performed. 4. The laboratory reports performing 77 procalcitonin tests on the bioMerieux Vidas 3 annually. 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 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 -- 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 a review of calibration records, instrument documents for the bioMerieux Vidas 3 and an interview with the laboratory manager on 3/22/2023, the laboratory failed to verify the reportable range at least once every six months for procalcitonin in 2021 and 2022. The findings include: 1. A review of calibration records and documents for the bioMerieux Vidas 3 identified that the laboratory failed to perform verifications of the reportable range for the analyte procalcitonin at least every six months in 2021 and 2022. 2. An interview with the laboratory manager on 3/22/2023 at 12:42 pm confirmed that the laboratory had not verified the reportable range of procalcitonin at least once every six months in 2021 and 2022. 3. The laboratory reports performing 77 procalcitonin tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and an interview with the laboratory manager on 5/11/2021, the Laboratory Director failed to approve, sign and date the laboratory policies and procedures. The findings include: 1. A record review of laboratory policies and procedures identified that the laboratory has 250 policies and procedures electronically stored on the hospitals computer system in the program PolicyTech. The Laboratory Director failed to approve, sign or date 154 of the 250 laboratory policies and procedures. 2. An interview with the laboratory manager on 5 /11/2021 at 8:50 am, confirmed that the Laboratory Director has not approved, signed or dated 154 of the laboratory policies and procedures. 3. The laboratory reports performing 92,546 moderate and high complexity tests annually. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random record review of Quality Control (QC) documentation and 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 -- interviews with the laboratory manager on 5/10/2021 and 5/11/2021, the laboratory failed to successfully perform two levels of QC daily for each quantitative procedure. The findings include: 1. A random record review of QC from the Tosoh AIA identified that the laboratory did not have an acceptable result for level 1 and level 2 QC for Beta-human chorionic gonadotropin (B-hCG) on 4/7/2020. The laboratory performed and released one patient B-hCG test on 4/7/2020. 2. A random record review of QC from the Ortho Vitros 4600 identified that the laboratory did not have an acceptable result for level 1 QC for creatine kinase (CK) on 4/10/2020. The laboratory performed and released one patient CK test on 4/10/2020. 3. Interviews with the laboratory manager on 5/10/2021 and 5/11/2021 confirmed that the laboratory failed to have acceptable QC for the above dates and tests. -- 2 of 2 --

Summary Statement of Deficiencies 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 an observation, a record review, and an interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions to calculate the mean normal patient Prothrombin time (MNPT) and enter the new international sensitivity index (ISI) for one new lot of Innovin in use since November 2018. Findings: 1. On April 2, 2019 at 10:10 AM, an observation of the laboratory revealed a Siemens CA-660 coagulation analyzer. 2. On April 2, 2019 at 10:10 AM, an observation of the analyzer settings revealed an Innovin lot number 549701 with an ISI of 1.03 and MNPT of 10.0. The lot of Innovin in use was 549709 with the manufacturer's stated ISI of 1.01. 3. A review of the laboratory's procedure for Prothrombin time (PT) revealed no instruction on how to perform the MNPT or change the ISI information in the analyzer as needed to calculate the international normalized ratio (INR). 4. The laboratory performed approximately 1040 PT tests in 2018. 5. An interview on April 2, 2019 at 10:20 AM, with the laboratory manager, confirmed the laboratory failed to update the CA-660 with the correct lot of Innovin, ISI value, and MNPT. 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 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 -- 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 a record review and an interview with the laboratory manager, the laboratory failed to perform and document calibration verification procedures for blood alcohol, chloride, and D-dimer analytes since the last survey on March 1, 2017. Findings: 1. A review of calibration documents revealed the laboratory failed to perform and document calibration verification procedures for blood alcohol and chloride performed on the Vitros 4600 chemistry analyzer and D-dimer performed on the Siemens CA-660 coagulation analyzer since the last survey. 2. The laboratory performed approximately 4600 chloride, 250 alcohol, and 230 D-dimer tests in 2018. 3. An interview on April 2, 2019 at 10:45 AM, with the laboratory manager, confirmed the laboratory failed to perform calibration verification procedures for the analytes. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on a record review and an interview with the laboratory manager, the laboratory failed to perform quality control each day of patient testing or establish an Individualized Quality Control Plan (IQCP) for the Meridian test kit for Clostrium difficile (C. difficile) and carboxyhemoglobin and methemoglobin performed on the A-Vox system. B. Based on a record review and an interview with the laboratory manager, the laboratory failed to establish a Quality Control Plan (QCP) and a Quality Assessment Plan (QAP) as part of the laboratory's Individualized Quality Control Plan -- 2 of 5 -- (IQCP) for kit tests: human immunodeficiency virus (HIV), human chorionic gonadotropin (hCG), and infectious mononucleosis, as well as, creatine kinase MB (CK-MB), troponin, and proB-natriuretic peptide (BNP) performed on the Triage Alere and blood gases performed on the iStat since the last survey on March 1, 2017. Findings: 1. A record review of procedures revealed the laboratory failed to perform quality control at least once each day or write an IQCP for C. difficile and for carboxyhemoglobin and methemoglobin since the last survey. 2. A review of the IQCPs for hCG, HIV, mononucleosis, CK-MB, troponin, BNP, and blood gases revealed the procedures failed to include the QCP and the QAP as part of the IQCP for each test system. 3. The laboratory performed the CK-MB, BNP, and troponin as a backup test method to the Vitros 4600. 4. The laboratory performed approximately 30 HIV tests, 106 blood gases, 20 carboxyhemoglobin and methemoglobin, 80 Clostrium difficile, 12 infectious mononucleosis, and 170 hCG tests in 2018. 5. An interview on April 2, 2019 at 12:50 PM, with the laboratory manager, confirmed the laboratory failed to establish the IQCPs or include procedures for the QCP and QAP. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 a record review and an interview with the laboratory manager, the laboratory failed to establish a system that evaluated the relationship between complete blood counts (CBCs) performed on the Horiba ABX hematology analyzer and microscopic manual differentials at least twice a year since the last survey on March 1, 2017. Findings: 1. A record review revealed the laboratory failed to establish a system to evaluate the comparison of microscopic manual differentials and CBCs results from the Horiba analyzer since the last survey. 2. The laboratory performed approximately 429 CBCs and manual differentials in 2018. 3. An interview on April 2, 2019 at 10:20 AM, with the laboratory manager, confirmed the laboratory failed to evaluate the relationship between manual differentials and the CBC analyzer at least twice a year. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on reviews of policies and procedures and an interview with the laboratory manager, the laboratory failed to establish and/or follow the laboratory's Quality Assurance policy to identify and correct problems in quality controls and instrument function procedures since the last survey on March 1, 2017. Findings: 1. A review of -- 3 of 5 -- the laboratory's Quality Assurance policy revealed a procedure that stated to update the manufacturer's quality control data into the laboratory information system (LIS) as necessary. 2. A review of quality control results for creatinine and human chorionic gonadotropin (hCG) from February 2019, revealed the laboratory failed to update the manufacturer's quality control reference range in the LIS. 3. The laboratory failed to establish a system to identify, correct, and monitor problems with the Siemens CA- 660 coagulation specific instrument function necessary for patient prothrombin time test results. See D5411. 4. An interview on April 2, 2019 at 1:30 PM, with the laboratory manager, confirmed the Quality Assurance policy stated to update the control range information in the LIS, but was not done, as well as, failed to update the CA-660. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the laboratory manager, the laboratory failed to document training for 3 out of 3 testing personnel performing patient tests in chemistry and hematology since the last survey on March 1, 2017. Findings: 1. A record review of personnel documents revealed 3 out of 3 laboratory assistants failed to have documentation of training for the Horiba ABX hematology analyzer, Siemens CA-660 coagulation analyzer, and the Vitros 4600 chemistry analyzer prior to testing patients since the last survey. 2. An interview on April 2, 2019 at 8:30 AM, with the laboratory manager, confirmed the 3 laboratory assistants failed to have documented training for the test systems prior to testing patient samples. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 a proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Alanine aminotransferase. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review and the laboratory ' s graded results from the Wisconsin State Laboratory of Hygiene, the laboratory failed to achieve satisfactory performance in two consecutive testing events for Alanine aminotransferase (ALT). Findings: Analyte: ALT 2018 event 2 Score: 60% Analyte: ALT 2018 event 3 Score: 60% -- 2 of 2 --