Blackfoot Medical Center

Summary Statement of Deficiencies 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: Based on record review of calibration documentation for the Siemens Immulite and an interview with the laboratory manager on 8/16/2023, the laboratory failed to perform calibration verification at least every 6 months in 2022 and 2023. The findings include: 1. A record review of calibration and calibration verification documentation for the Siemens Immulite 2000XPi identified that the laboratory failed to perform calibration verification which included a minimal, mid-point and maximum value at 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 -- least every 6 months for follicle stimulating hormone (FSH), lutenizing hormone (LH), progesterone, insulin, parathyroid hormone (PTH), sex hormone binding globulin (SHBG) and testosterone in 2022 and 2023. 2. An interview with the laboratory manager on 8/16/2023 at 3:19 pm confirmed that the laboratory failed to perform calibration verification for the above analytes in 2022 and 2023. 3. The laboratory reports performing 2,217 patient tests annually on the Siemens Immulite 2000XPi analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on a review of patient test reports and an interview with the laboratory technical consultant (TC) on 9/22/2021, laboratory failed to specify the correct test method for Prostate Specific Antigen (PSA) testing on patient test reports. The findings include: 1. A review of patient reports for PSA testing identified that the laboratory failed to list the correct analyzer and method used for performing the test. 2. An interview with the TC on 9/22/2021 at 3:24 pm confirmed that the laboratory failed to list the correct analyzer and method on PSA test reports. 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 --

Summary Statement of Deficiencies 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 a proficiency testing (PT) record review and an interview with the previous technical supervisor, the laboratory director failed to sign the American Proficiency Institute (API) attestation statements for the specialties of chemistry and hematology since the last survey on October 11, 2017. Findings: 1. A record review of the API attestation statements revealed the laboratory director failed to sign the attestation statements for the specialties of chemistry and hematology since the last survey. 2. An interview on July 17, 2019 at 8:50 AM, with the previous technical supervisor, confirmed the laboratory director failed to sign the API attestation statements forms. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This CONDITION is not met as evidenced by: The laboratory failed to monitor and evaluate the overall quality and acceptability of testing performance for the Immtox toxicology analyzer since December 2018. Refer to D5403, D5423, D5437, D5439, D5469, and D5783. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a record review and an interview with previous technical supervisor, the laboratory failed to write a procedure for the Dimension EXL 200 chemistry analyzer received in November 2018. Findings: 1. A record review of the laboratory's procedure manual revealed the laboratory failed to write a procedure for the Dimension EXL 200 chemistry analyzer received in November 2018. 2. The laboratory performed approximately 162,000 chemistry, endocrinology, and cardiac tests since July 2018. 3. An interview with the previous technical supervisor on July 17, 2019 at 12:20 PM, confirmed the laboratory failed to write a procedure for the analytes performed on the Dimension EXL 200 and that the testing personnel would look up operating instructions on the internet. 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)