Intermountain Life Flight

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 direct observation and interview with technical consultant (TC), the laboratory failed to ensure the Radiometer Safe Clinitubes used for whole blood samples were not used past the expiration date. The laboratory performs approximately 12,909 tests per year. Findings include: 1. Direct observation of inventory on 12/13/2023 at 1:25 P.M. revealed Radiometer Safe Clinitubes with an expiration date of 9/30/2023. 2. Interview with TC on 12/13/2023 at 1:25 P.M. confirmed the Radiometer Safe Clinitubes used for whole blood samples were expired and the laboratory used the tubes to collect patient specimens. 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 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 record review and an interview with the technical consultant, the laboratory failed to have a policy or procedure to assess the competency for two out of two technical consultants for the position of technical consultant. Findings Include: 1. The laboratory performed approximately 20,960 tests a year with the Abbott i-STAT blood gas, CG4+/CG8+, and Activated Clotting Time cartridges. 2. A review of the laboratory procedures revealed the laboratory failed to have a policy or procedure to assess the competency of the position of technical consultant for two out of two technical consultants. 3. An interview on 12/08/2021, at 1:00 PM, with the technical consultant, confirmed the laboratory failed to have a policy or procedure to assess the competency for the position of technical consultant. 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 record review and interview with the technical consultant, the laboratory 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 -- failed to have a procedure available for tests performed on the Abbott i-STAT that was specific for the life flight location. Findings include: 1. A review of the procedure manual revealed the laboratory failed to have an Abbott i-STAT procedure specific for the tests performed by the life flight location. 2. The laboratory performed approximately 20,960 tests a year with the Abbott i-STAT blood gas, CG4+/CG8+, and Activated Clotting Time cartridges. 3. An interview on 12/08/2021, at 1:15 PM, with the technical consultant, confirmed the laboratory failed to have a procedure specific for the life flight location. -- 2 of 2 --

Summary Statement of Deficiencies 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 laboratory qualify assessment records review, quality control records review, and interview with the laboratory staff, the laboratory failed to ensure the twice a year evaluation of i-STAT test instruments compared the relationship between tests results for 14 of 16 different i-STAT instruments. Findings include: 1. The laboratory quality assessment records failed to include test values they compared more than two of the 16 instruments to each other at least twice annually in 2017 and 2018 for reporting test results for pH, partial pressure oxygen, partial pressure carbon dioxide, base excess, oxygen saturation, bicarbonate, sodium, potassium, chloride, total carbon dioxide, glucose, lactate, hemoglobin, and hematocrit using two test cartridges (CG4+ and CG8+). 2. The laboratory quality control records review failed to include instrument to instrument comparison using the same quality control materials at least twice annually. 3. In an interview conducted on 01/17/2019 at 11:40 A.M., the technical consultant stated the laboratory did not have a method to compare all 16 of the i-STAT instruments in use at the 5 base locations twice a year. The technical consultant stated the laboratory method was to compare two different units twice annually. The laboratory performed approximately 17,000 tests per year using the CG4+ and CG8+ cartridges on the 16 i-STAT unit use instruments. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require