Guardian Flight, Llc

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Guardian Flight Point of Care Policy and Procedures implemented on June 1, 2011 and an interview with the Technical Consultant (TC1), the laboratory failed to ensure procedural changes for the Abbott i-STAT including current tests offered, specimen collection and processing, quality control, calibration verification, and current critical values were updated, approved, signed and dated by the laboratory director. Findings include: 1. A review of the Guardian Flight Point of Care Policy and Procedures for i-STAT testing on 9/11/25 at 2:00 PM revealed the following: a. The reagent section on page 22 indicated use of the EG8+ cartridges and the reference range section on page 34 included a reference range for ACT cartridges; the laboratory is currently using CG8+ and Chem8+ cartridges. b. The procedure references collecting capillary specimens; the laboratory collects venous and arterial samples. c. The electronic control frequency, type of control material used, and the frequency of liquid control does not match their current practices. d. The calibration verification (Cal/Ver) section on page 5 states cal/vers will be performed with new lots, after major maintenance, and every 6 months following the CLEW updates; the laboratory does not currently perform calibration verifications. e. The critical values listed on page 32 for sodium, potassium, BUN, hemoglobin, hematocrit, pH, PCO2, TCO2, HCO3, base excess, and anion gap do not match the i-STAT Results worksheet transported with the patient and given to the receiving facility. 2. An on- site interview with TC1 on 9/11/2025 at 3:30 PM in Anchorage confirmed the procedure did not match current practices. 3. The laboratory reports performing approximately 1,280 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 -- 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 observations, lack of documentation, an interview with the Technical Consultant (TC1), and a review of the Guardian Flight Point of Care Policy and Procedures implemented on June 1, 2011, the laboratory failed to monitor and document the room temperature at seven (7) of seven (7) sites to ensure the manufacture instructions are followed where Abbott i-STAT cartridges are stored. Findings include: 1. Observations in the laboratory supply storage area on 9/11/25 at 11:00 AM in Anchorage revealed the laboratory stores i-STAT cartridges at room temperature until the expiration date but there is no documentation of room temperatures. 2. An on-site interview with the TC1 on 9/11/25 at 11:00 AM in Anchorage confirmed that room temperatures are not monitored or recorded for any of the sites where cartridges are stored (Anchorage, Deadhorse, Fairbanks, Juneau, Kenai, Ketchikan, and Sitka bases). 3. Review of the laboratory ' s i-STAT Testing procedure 9/11/25 at 2:00 PM revealed "cartridges may be stored at room temperature (18 - 30 C)". 4. Review of the i-STAT CG8+ Cartridge procedure reveals room temperature storage conditions are 18 - 30 C. 5. The laboratory reports performing approximately 1,280 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control log sheets from May to November 2021 and interview with the Technical Consultant, the laboratory did not test, at a minimum 2 levels of external quality control (QC) material to monitor the accuracy and precision of the Abbott i-STAT Chem-8+ cartridges each day patient samples were tested. Findings include: 1. Quality control logs for the i-STATs for May through November of 2021 showed that external quality control was performed with each lot or shipment of cartridges occurring on 5/6/21, 6/4/21, 7/16/21, 9/1/21, 9/29/21, and 11/19/21. 2. The laboratory uses approximately 140 i-STAT Chem 8+ cartridges annually, resulting in approximately 1120 individual patient tests. 3. The Technical Consultant confirmed these finding on 12/3/21 at 3:00 pm. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and staff interview, the laboratory did not test, at a minimum, two levels of external quality control material to monitor the accuracy and precision of the Abbott i-STAT EC8+ cartridges each day of patient testing. 1. The i-STAT procedure states external quality controls (QC) will be performed with each new lot and or shipment of cartridges. 2. A review of the i-STAT quality control logs for 2018 and 2019, revealed the laboratory had documented 3 levels of external quality control for a shipment of cartridges on 10/11/19. 3. Documentation was missing for all other quality control tests on the i- i-STAT CG8+ cartridges. 4. The laboratory performs approximately 825 patient tests on the i- i- STAT annually. 5. The testing coordinator confirmed these finding on 10/17/19 at 15: 45 pm. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor 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 -- of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records and staff interview, the laboratory did not have copies of diplomas or transcripts for testing personnel. Findings: 1. The laboratory had 31 new testing personnel since the previous survey on 8/22/17. 10 of the 31 were missing diplomas or transcripts to verify education. 2. The human resources department was responsible for obtaining the diploma, transcript, or equivalent for newly hired testing personnel. 3. The testing coordinator confirmed these findings on 10/17/19 at 15:45 pm. -- 2 of 2 --