Air St Luke's - Treasure Valley

Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with CLIA regulations (42 CFR Part 493 effective April 24, 2003.), all previous deficiencies found were corrected. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a lack of laboratory temperature and humidity logs and an interview with technical consultant 1 (TC1) on 6/16/2025, the laboratory failed to establish and monitor the testing temperature and humidity and storage temperature for the Siemens epoc Blood Analysis System in mobile units. The findings include: 1. A lack of the laboratory temperature and humidity logs identified the laboratory failed to establish and monitor testing temperature and humidity per the Siemens epoc Blood Analysis System requirements. 2. A lack of the laboratory temperature logs identified the laboratory failed to establish and monitor reagent storage temperature in the two ambulances per the Siemens epoc Blood Analysis System requirements. 3. An interview with TC1 on 6/16/2025 at 2:15 pm confirmed that the laboratory failed to monitor temperature and humidity on the ambulances. 4. The laboratory reports performing 1418 tests annually. 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 -- D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on a review of laboratory policies, a lack of documentation and an interview with technical consultant 1 (TC1) on 6/16/2025, the laboratory failed to establish and follow a policy for laboratory director on-site visits at least once every six months. the findings include: 1. A review of laboratory policies identified that the laboratory failed to establish a policy for laboratory director on-site visits every 6 months. 2. A lack of documentation identified that the laboratory failed to perform an on-site visit since the regulation went into effect on December 28, 2024. 3. An interview with TC1 on 6/16/2025 at 1:39 pm confirmed the above findings. 4. The laboratory reports performing 1,418 tests annually. -- 2 of 2 --

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, competency assessment records and an interview with technical consultant 1 (TC1) on 6/21/2023, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2022. The findings include: 1. The CMS 209 identified thirteen (13) testing personnel performing testing on the Siemens EPOC which includes the following analytes: pH, pCO2, pO2, TCO2, ionized calcium, creatinine, chloride, glucose, potassium, sodium, hematocrit and lactic acid. 2. A review of competency assessment records identified seven (7) of thirteen (13) testing personnel failed to have an annual competency assessment for 2022. 3. An interview with TC1 on 6/21/2023 at 11:50 am and by email on 6/23/2023 confirmed the above finding. 4. The laboratory reports performing 1600 tests annually on the Siemens EPOC analyzers. 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 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 -- 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 Siemens EPOC calibration verification documents and an interview with the point of care testing (POC) manager on 6/21/2023, the laboratory failed to verify the reportable range at least once every six months for their two Siemens EPOC analyzers for 2022 and 2023. The findings include: 1. A review of calibration verification documents identified that the laboratory failed to perform verifications of the reportable ranges for pH, pCO2, pO2, TCO2, ionized calcium, creatinine, chloride, glucose, potassium, sodium, hematocrit and lactic acid on one (1) of two (2) EPOC analyzers (27766, 28040) every six months in 2022 and 2023. 2. An interview with the POC manager on 6/21/2023 at 10:13 am confirmed that the laboratory had not performed verifications of reportable range for analytes at least once every six months on both EPOC analyzers. 3. The laboratory reports performing 1600 tests annually on the Siemens EPOC analyzers. 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 lack of documentation and an interview with the point of care testing (POC) manager on 6/21/2023, the laboratory failed to evaluate results for analytes performed on multiple analyzers to ensure that they are within the allowed acceptable difference between analyzers. The finding include: 1. A lack of documentation for analyte result comparison between the laboratories two Siemens EPOC analyzers identified that the laboratory failed to evaluate test results for pH, pCO2, pO2, TCO2, ionized calcium, creatinine, chloride, glucose, potassium, sodium, hematocrit and lactic acid to ensure that they were within the allowed acceptable difference between the two analyzers. 2. An interview with the POC manager on 6/21/2023 at 10:32 confirmed that the laboratory failed to compare analyte results between analyzers to ensure accurate patient testing. 3. The laboratory reports performing 1600 tests annually on the Siemens EPOC analyzers. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review and an interview with the laboratory supervisor, the laboratory failed to test the College of American Proficiency (CAP) PT samples by the same personnel who routinely performed blood gas analyses since the last survey on August 23, 2017. Findings: 1. A review of CAP PT records and laboratory documents revealed the laboratory testing personnel who perform patient blood gas analysis on the EPOC test system failed to test PT samples since the last survey. 2. The laboratory performed approximately 2400 blood gas analytes in 2018. 3. An interview with the laboratory supervisor on June 20, 2019 at 9:35 AM, confirmed the laboratory failed to test CAP PT samples by the testing personnel who routinely performed patient blood gas analyses since the last survey. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. 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 -- This STANDARD is not met as evidenced by: Based on a record review of personnel documents and an interview with the laboratory supervisor, the laboratory supervisor, who was also listed as the technical consultant, failed to qualify as a technical consultan in order to provide technical oversight and consultation for the laboratory performance of blood gas analysis on the EPOC since the last on August 23, 2017. Findings: 1. A review of personnel documents revealed the laboratory supervisor failed to meet the education and training requirements to qualify for the position of technical consultant. 2. An interview with the laboratory supervisor on June 20, 2019 at 9:15 AM, confirmed the laboratory supervisor failed to meet the education requirements to qualify for the position of technical consultant. -- 2 of 2 --