Big Horn Hospital Association

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 1, 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 a proficiency testing desk review from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2025 records, the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of General Immunology for the analyte Rubella Antibody. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the 2025 American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte for two consecutive proficiency testing events in the specialty of General Immunology for the analyte Rubella Antibody. Findings: 1. A review of the CASPER 0155 report revealed the following results: General Immunology 2025 - 1st Event: The laboratory received an unsatisfactory score of 60% for Rubella Antibody. General Immunology 2025 - 2nd Event: The laboratory received an unsatisfactory score of 60% for Rubella Antibody. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. -- 2 of 2 --

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 a record review, procedure, and an interview with the technical supervisor (TS) #1, the laboratory failed to ensure reagents were not used past their expiration date for 18 of 18 patients tested with Helicobacter Pylori (H Pylori) kits and 15 of 15 patients tested with Rubella kits from May 2, 2022 to April 20, 2023. Findings: 1. A review of H. Pylori log-in sheet revealed the laboratory used expired kits to perform patient testing on eleven patients from 6-9-22 to 10-4-22 using lot# 241B11 exp 5-31- 2022 and seven patients from 4-11-23 to 4-20-23 using lot# 241L11 exp 2-28-2023. 2. A review of the Rubella log-in sheet revealed the laboratory used expired kits to perform patient testing on three patients from 5-2-22 to 6-6-22 using lot# B33782 exp 4-14-22 and 12 patients from 2-1-23 to 4-6-23 using lot# 1M22G3 exp 1-31-23. 3. A review of H. pylori's and Rubella's individualized quality control plan (IQCP) revealed the laboratory lacked instruction to not use expired kits. 4. An interview on May 31, 2023, at 10:00 a.m. with TS #1 confirmed the laboratory failed to ensure H. pylori and Rubella kits were not used past their expiration dates for 33 patients tested from May 2, 2022, to April 20, 2023. 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 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 -- 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 review of coagulation records, procedures, and interview with technical supervisor (TS) #1, the laboratory failed to verify new lots of Activated Partial Thrombin Time (aPTT) reagents performed on the STA Satellite normal values from May 31, 2021, to May 31, 2023. Findings: 1. A review of "Partial Thromboplastin Time, aPTT-STA Satellite" procedure revealed the laboratory failed to have a step-by- step procedure for verifying new lots of reagents. 2. No rollover studies containing a calculated geometric mean, standard deviation and reference range check for new lots of aPTT reagents were available for review. 3. A review of the test volume sheet revealed 211 aPTT tests were resulted from May 23, 2022, to May 23, 2023 (12- month period). 4. An interview with the TS #1 on May 31, 2023, at 4:53 PM, confirmed the laboratory failed to verify new lots of reagents for aPTT from May 31, 2021, to May 31, 2023. 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 observation, review of maintenance records and interview with technical supervisor (TS) #1, the laboratory failed to recertify one of one Biosafety Cabinet located in the Microbiology Section from May 31, 2021 to May 31, 2023. Findings: 1. Observed one Microbiology Biosafety Cabinet with a certification sticker that had expired in 2021. 2. No certification or maintenance records for the Biosafety Cabinet were available for review from May 31, 2021 to May 31, 2023. 3. An interview on May 31, 2023 at 8:30 AM with (TS) #1, confirmed the Biosafety Cabinet certification had expired in 2021. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records, procedures, manuals, and interview with the Technical Supervisor (TS) #1, the laboratory failed to establish acceptable criteria (mean and standard deviation) for new lots of Bio-Rad liquid unassayed multiqual controls performed on the Ortho VITROS 5600 chemistry analyzer from May 31, 2021, to May 31, 2023. Findings: 1. The laboratory failed to follow the manufacturer's Statistical Tools of Quality Control: Training Module as stated, "The mean must be calculated or evaluated before a new lot number of quality- control material is used because each lot number has its own concentration of the analyte.", and "For VITROS Systems, you should re-evaluate means when new lot numbers of slides, VITROS Reference Fluid, or Immuno-Wash Fluid are put into use." 2. No correlations studies for new lots of quality control materials to establish statistical limits for the Ortho VITROS 5600 chemistry analyzer were available for review. 3. No studies for re-evaluating the mean for new lots of VITROS reagents (slides, Reference Fluid, or Immuno-Wash Fluid) were available for review. 4. Chemistry procedures lacked instructions for evaluating new lots of QC and new lots of reagents. 5. A review of the test volume sheet revealed 63,484 chemistry results were reported from May 23, 2022, to May 23, 2023 (12-month period). 6. An interview with (TS) #1 on May 31, 2023, at 3:00 PM, confirmed the laboratory failed to establish acceptable QC statistical parameters for each analyte tested on the Ortho VITROS 5600 chemistry analyzer from May 31, 2021, to May 31, 2023. -- 3 of 3 --

Summary Statement of Deficiencies 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) proficiency testing scores for chemistry and interview with the Technical Supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for 25-OH Vitamin D for two out of three events in 2021. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores for 2021 Chemistry Core revealed unsuccessful proficiency testing for 25-OH Vitamin D with a 50% score for 2021 Event 1 and 50% score for 2021 Event 2. 2. Interview with the TS #1 on October 26, 2021 at 3:22 PM confirmed the laboratory failed to achieve satisfactory performance for 25-OH Vitamin D for two out of three events in 2021. 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 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 -- 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 review of calibration records for the Abbott i-STAT Analyzer using EG6+ cartridge (Sodium, Potassium, Hematocrit, pH, PCO2, PO2) and G3+ cartridge (pH, PO2, PCO2) and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform at least a three-point (a minimal, mid-point, and maximum) calibration verification every six months or after CLEW software updates for years 2020 and 2021. Findings: 1. Review of 2020 and 2021 calibration records for Abbott i- STAT analyzer for analytes Sodium, Potassium, Hematocrit, pH, PCO2, PO2 revealed the laboratory failed to perform a calibration verification including, at least, a minimal, midpoint, and maximum value for each analyte, performed every six months or after CLEW software updates for years 2020 and 2021. 2. Interview with the TS #1 on October 27, 2021 at 9:24 AM, confirmed the laboratory failed to perform at least a three-point calibration verification for analytes Sodium, Potassium, Hematocrit, pH, PCO2, PO2, on the i-STAT analyzer every six months or after CLEW software updates for years 2020 and 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review on 11/4/19, deficiencies were cited for Big Horn County Memorial Hospital in Hardin, MT. 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for digoxin for two consecutive events (2019 event 2 and 2019 event 3), resulting in unsuccessful proficiency testing performance. See D2118. D2118 TOXICOLOGY 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 -- CFR(s): 493.845(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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for digoxin in two consecutive events in 2019, resulting in unsuccessful performance. The findings include: 1. During a review on 11/4/19 at 7: 45 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Big Horn County Memorial Hospital with unsuccessful proficiency testing scores for digoxin. 2. During a review on 11/4/19 at 8:00 a.m. of the CMS-155 report, the American Proficiency Institute (API) digoxin score for event 2 of 2019 was 20%. 3. During a review on 11/4/19 at 8:00 a.m. of the CMS-155 report, the API digoxin score for event 3 of 2019 was 40%. 4. On 11/4/19 at 12:39 p.m., the laboratory manager stated the failing test scores were due to cartridge storage. -- 2 of 2 --