Wheatland Memorial Healthcare Laboratory

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 5, 2025. At the time of the desk review, it was determined that the laboratory was not in compliance with all conditions required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 Code of Federal Regulations, Part 493 (42 C.F.R. 493). The following condition level deficiency was cited: 493.803 Condition: Successful participation. 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 an off-site review of the CMS-155 reports of proficiency testing performance, American Proficiency Institute proficiency testing scores, corresponding laboratory records, and email communication with the General Supervisor #1, the 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 -- laboratory failed to achieve satisfactory performance for blood bank compatibility testing for two consecutive proficiency testing events, resulting in an unsuccessful proficiency testing performance in 2025. See D2181 D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) 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 an off-site review of American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory proficiency testing records submitted by email on October 31, 2025, by General Supervisor (GS) #1, the laboratory failed to achieve a score of 100% for blood bank compatibility testing for two consecutive events performed in 2025. Findings: 1. A review of API's blood bank PT records on January 02, 2025, revealed the laboratory failed to achieve a satisfactory performance score of 100% for the following events: 2025 Compatibility Testing Event 1 - 80% 2025 Compatibility Testing Event 2 - 80% 2. An email communication with GS #1 on October 31, 2025, at 3:36 PM confirmed the laboratory's unsuccessful proficiency testing scores were due to the failure to resolve weak or inconclusive positive reactions at the time of testing. -- 2 of 2 --

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 a review of verification records, laboratory procedures, and an interview with general supervisor (GS) #1, the laboratory failed to verify precision over time, reportable range, and the manufacturer's normal reference ranges were appropriate for the laboratory's patient population prior to the laboratory director's approval from February 16, 2023, to July 24, 2024. Findings: 1. The laboratory failed to provide verification studies to verify the miniiSED's automated erythrocyte sedimentation rate (ESR) reportable range (1 to 130 mm/hr) and the manufacturer's normal reference ranges were appropriate for the laboratory's patient population prior to the laboratory director's final approval on May 18, 2023. 2. The laboratory failed to assess the repeatability of day-to-day variance and verify the normal reference ranges of Siemens Dimension EXL's analytes: N-terminal fragment of brain natriuretic peptide (NT-proBNP) (approved 11/14/23), glycated hemoglobin (HbA1c) (approved 10/30 /23), and vancomycin (approved 2/16/23) were appropriate for the laboratory's patient population prior to the laboratory director's approval dates. 3. Based on the test volume sheet, 132 ESR, 21 NT-proBNP, and 236 HbA1c patient tests were performed in the last 12 months. 4. The laboratory failed to provide a procedure to address how the laboratory verifies the performance of new assays, instruments, or methods. 5. An interview with GS #1 on July 24, 2024, at 10:30 AM confirmed the laboratory failed 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 -- to perform studies to either verify the reportable testing range, precision over time, or the manufacturer's normal reference ranges for analytes NT-proBNP, HbA1c, and vancomycin performed on the Siemens Dimension EXL and the automated miniiSed for ESR from February 16, 2023, to July 24, 2024. 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 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: REPEAT DEFICIENCY Cited previously on recertification survey dated April 26, 2021. Based on review of the calibration records, manufacturer's instructions, and interview with general supervisor (GS) #1, the laboratory failed to perform at least three-point (a minimal, mid-point, and a maximum) calibration verification every six months for sodium, potassium, chloride, and triglycerides from July 24, 2022, to July 24, 2024. Findings: 1. A review of the Siemens Dimension EXL 200 chemistry analyzer calibration records for triglycerides, sodium, potassium, and chloride lacked calibration verification records from July 24, 2022, to July 24, 2024. 2. An interview with GS #1 on July 24, 2024, at 10:30 AM confirmed the laboratory failed to perform at least a three-point calibration verification that covers the manufacturer's reportable range every six months for sodium, potassium, chloride, and triglycerides performed on the Siemens Dimension EXL 200 chemistry analyzer from July 24, 2022, to July 24, 2024. D5535 ROUTINE CHEMISTRY CFR(s): 493.1267(a)(d) For blood gas analyses, the laboratory must perform the following: (a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer. (d) Document all control procedures performed, as specified in this section. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of blood gas records, OPTI CCA-TS Operator's Manual, and an interview with General Supervisor (GS) #1, the laboratory failed to perform at least three-point (a minimal, mid-point, and maximum) calibration verification every six months per the manufacturer's instructions from July 24, 2022, to July 24, 2024. Findings: 1. No records of calibration verification studies performed every six months were available for review. 2. Review of the OPTI CCA-TS Operator's Manual revealed "4.4 Calibration Verification ... may be required by various regulatory agencies." 3. Based on the test volume sheet, 20 patient tests were performed for analytes pH, pCO2, and pO2 from July 24, 2023, to July 24, 2024. 4. Interview with the GS #1 on July 24, 2024, at 11:30 AM, confirmed the laboratory failed to perform calibration verification every six months on the OPTI CCA-TS Blood Gas Analyzer from July 24, 2022, to July 24, 2024. -- 3 of 3 --

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 D0000 Based on an on-site recertification survey conducted on 6/4/18-6/5/18, a deficiency was cited for Wheatland Memorial Healthcare Laboratory in Harlowton, MT. Based on an on-site complaint survey conducted on 6/4/18-6/5/18, no deficiencies were cited for Wheatland Memorial Healthcare Laboratory in Harlowton, MT. 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 observation, record review and interview, the laboratory failed to verify the accuracy of the urine drug screen tests twice a year from 1/18/18 to 6/4/18. The findings include: 1. On 6/4/18 at 10:10 a.m. the Medtox analyzer and the Medtox Profile V reagents for urine drug screens was observed in the laboratory. 2. A review on 6/4/18 at 10:50 a.m. of the American Proficiency Institute (API) binders lacked documentation of proficiency testing for urine drug screens. 3. On 6/4/18 at 10:50 a. m., staff member A stated the laboratory did not have enrollment for the Medtox. 4. A review on 6/4/18 at 11:15 a.m. of the API 2018 Order Confirmation list lacked urine drug screens. 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 --