Aeromd

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of 2024, 2025 i-STAT quality control documentation, Abbott i- STAT manufacturer's package insert, and interview with the technical consultant (TC), the laboratory failed to retain QC for two of seven months. Findings included: 1. Review of 2024, 2025 i-STAT QC documentation showed the laboratory failed to retain QC records and the package inserts with the expected values for November 2024 and April 2025. 2. Interview with the TC on August 25, 2025 at 4:20 PM confirmed the laboratory failed to retain the quality control results and package inserts. 3. The laboratory reports approximately 2400 chem 8 and 200 arterial blood gas patient results annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. 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 -- This CONDITION is not met as evidenced by: Based on review of procedures, quality control documentation, patient reports, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to follow their quality control procedure (Refer to D5401); failed to perform QC using the number and frequency established by the laboratory (Refer to D5445); and failed to perform twice yearly instrument comparisons for four of four Abbott i-STAT analyzers (Refer to D5775). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of the procedure manual, review of 2025 i-STAT quality control (QC) documentation for four of four i-STAT analyzers, and interview with the technical consultant (TC), the laboratory failed to follow the procedure for one of four months in 2025. Findings included: 1. Review of the procedure titled, ""Lab Quality Control and Quality Assurance Program" showed "Liquid QC is run when lots are changed and new shipments are received and if extensive maintenance is performed on the analyzer or every month." 2. Review of "Procedure for use of Abbott i-STAT Analyser" Section 10 Quality Control showed, "This is performed by laboratory staff: Aqueous assayed control solutions are used to verify the integrity of each batch of cartridges that are issued for use from stock in Biochemistry. Control solution i-STAT control level 1 and i-STAT tricontrol control level 3." 3. Review of level 3 QC for Chem 8 and CG4 cartridges for the i-STAT analyzer serial #445201 showed no level 3 QC performed for April 2025. 4. Interview with the TC on 8/25/2025 at 4:20 PM confirmed the laboratory failed to follow the procedure for QC. 5. The laboratory reports approximately 2400 chem 8 and 200 arterial blood gas patient results annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP), review of three months for 2024 and four months for 2025 of i-STAT quality control (QC) documentation, and interview with the technical consultant (TC), the laboratory failed to perform control procedures using the number and frequency established by -- 2 of 3 -- the laboratory. Findings included: 1. Review of the laboratory's IQCP "Lab Quality Control and Quality Assurance Program" showed "Liquid QC is run when lots are changed and new shipments are received and if extensive maintenance is performed on the analyzer or every month." 2. No QC documentation for February 2024 was available for review per their IQCP. 3. Review of November 2024 showed for the i- STAT analyzer serial #369993, the laboratory failed to perform QC for Chem 8 and CG4 cartridges. 4. Two patients were tested on 11/11/2024 and 11/14/2024 on the i- Stat analyzer serial #369993. 5. Interview with the TC on 8/25/2025 at 4:46 PM confirmed the laboratory failed to perform QC on the i-STAT analyzer #369993 for the month of November 2024. 6. Interview with the TC on 8/25/2025 at 4:50 PM confirmed there was confusion with the staff about frequency of QC and on which i- Stats. The TC confirmed the laboratory failed to perform QC using the number and frequency established by the laboratory. 7. The laboratory reports approximately 2400 chem 8 and 200 arterial blood gas patient results annually. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's instrument comparison procedure, review of four of four Abbott i-STAT instrument comparison documentation, and interview with the technical consultant (TC) #1, the laboratory failed to perform comparisons twice a year for 2024. Findings include: 1. Review of the procedure titled "Test Method Validation, Method Comparison" section VI showed, "Comparison Studies are completed on instruments at least twice a year, due to the low volume of patient samples an alternate method is used. Quality Control data may be used. AeroMD participates in the CAP Quality Cross Check Program." 2. No instrument comparison documentation for 2024 was available for review for four of four i-STAT analyzers for chemistry and hematology testing. 3. Interview with the TC #1 on 8/25/2025 at 3: 30 PM confirmed the laboratory failed to perform twice yearly instrument comparisons for four of four Abbott i-STAT analyzers. 4. The laboratory reports approximately 2400 chem 8 and 200 arterial blood gas patient results annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) federal surveyor conducted an announced CLIA recertification survey at AeroMD on June 15, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The findings were reviewed with the Laboratory Director and Technical Consultant at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1210; D5016: Routine Chemistry 493.1215; D5024: Hematology D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure the requirements were met for the subspecialty of Routine Chemistry. Findings include: 1. The laboratory failed to perform two levels of control materials each day of patient chemistry testing using the Chem 8+ cartridge and CG4+ cartridge with the iSTAT analyzer for 16 of 16 days of patient testing. Refer to D5447. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, 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 3 -- This CONDITION is not met as evidenced by: Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure the requirements were met for the subspecialty of Hematology. Findings include: 1. The laboratory failed to perform two levels of control materials each day of patient hematology testing using the Chem 8+ cartridge with the iSTAT analyzer for 16 of 16 days of patient testing. Refer to D5447 D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant (TC), the laboratory failed to perform two levels of control materials each day of patient testing for 16 of 16 days of patient testing. Findings include: 1. Interview with the TC on 06 /15/2023 at 10:30 AM confirmed the laboratory performed chemistry, hematology, and blood gas testing using the iSTAT system: a. Chem 8+ cartridge analytes - Sodium, Potassium, Chloride, TCO2, Ionized Calcium, Glucose, Urea Nitrogen, Creatinine, Hematocrit b. CG4+ cartridge analytes - pH, PCO2, PO2, Lactate 2. Interview with the TC on 05/15/2023 at 01:00 PM confirmed an Individualized Quality Control Plan (IQCP) was not available during the survey for the iSTAT test system. 3. Review of quality control (QC) and patient testing records from 01/05/2023 through 03/17/2023 revealed two levels of QC material were not performed each day of a patient testing for 16 of 16 days of patient testing. a. Chem 8+ Cartridge Patient 2300021 - test performed 01/09/2023 at 03:06 AM Patient 2200040 - test performed 01/11/2023 at 01:58 PM Patient 2200050 - test performed 01/13/2023 at 04:27 AM Patient 2200055 - test performed 01/15/2023 at 03:23 AM Patient 2300059 - test performed 01/16/2023 at 05:50 AM Patient 2300064 - test performed 01/18/2023 at 04:19 AM Patient 2300127 - test performed 02/03/2023 at 09:43 AM Patient 2300120 - test performed 02/05/2023 at 03:33 PM Patient 2300168 - test performed 02/14/2023 at 10:44 AM Patient 2300170 - test performed 02/15/2023 at 10:19 AM Patient 2300192 - test performed 02/20/2023 at 06:11 PM Patient 2300238 - test performed 03 /07/2023 at 01:17 PM Patient 2300248 - test performed 03/08/2023 at 01:44 PM Patient 2300255 - test performed 03/10/2023 at 10:53 AM Patient 2300259 - test performed 03/12/2023 at 08:20 AM Patient 2300289 - test performed 03/17/2023 at 07:34 PM b. CG4+ Cartridge Patient 2300014 - test performed 01/05/2023 at 09:20 AM Patient 2300021 - test performed 01/09/2023 at 03:02 AM Patient 2200040 - test performed 01/11/2023 at 01:54 PM Patient 2200050 - test performed 01/13/2023 at 04: 32 AM Patient 2200055 - test performed 01/15/2023 at 03:27 AM Patient 2300059 - test performed 01/16/2023 at 05:54 AM Patient 2300064 - test performed 01/18/2023 at 04:15 AM Patient 2300127 - test performed 02/03/2023 at 09:43 AM Patient 2300120 - test performed 02/05/2023 at 03:20 PM Patient 2300168 - test performed 02 /14/2023 at 10:49 AM Patient 2300170 - test performed 02/15/2023 at 10:15 AM Patient 2300192 - test performed 02/20/2023 at 06:07 PM Patient 2300238 - test performed 03/07/2023 at 01:13 PM Patient 2300289 - test performed 03/17/2023 at 07: -- 2 of 3 -- 31 PM Patient 2300259 - test performed 03/12/2023 at 08:20 AM Patient 2300289 - test performed 03/17/2023 at 07:34 PM 4. Interview with TC on 06/15/2023 at 02:00 PM confirmed the findings as indicated above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant (TC), the laboratory failed to include the address of the laboratory location for one of one patient report. Findings include: 1. Interview with the TC on 06/15/2023 at 10:30 AM confirmed the laboratory performed chemistry, hematology, and blood gas testing using the iSTAT system: a. Chem 8+ cartridge - Sodium, Potassium, Chloride, TCO2, Ionized Calcium, Glucose, Urea Nitrogen, Creatinine, Hematocrit b. CG4+ cartridge - pH, PCO2, PO2, Lactate 2. Record review on 06/15/2023 of a patient report (patient 23-00414 tested on 04/16/2023) revealed that for one of one report, the address of the laboratory was not included on the patient report. 3. Interview with the TC on 06/15 /2023 at 11:30 AM confirmed the findings as indicated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at AeroMD on September 22, 2021 by the Centers for Medicare and Medicaid Services (CMS) New York branch federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA requirements: Specific deficiencies cited are as follows: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on Proficiency testing (PT)records, lack of documentation and interview the laboratory failed document proficiency testing evaluation and review for unsatisfactory scores and the

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 interview with and confirmation by the laboratory director and technical consultant at around 10:30 am, the laboratory failed to conduct a competency assessment of the technical supervisor in 2018. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on interview with the laboratory director and technical consultant at around 10 am and review of personnel records, the laboratory failed to conduct competency assessment of 10 testing personnel hired since 2017. The findings included: a. Personnel records showed documentation of training on the proper use of the IStat instrument and a questionnaire to assess achievement of successful training. b. Seven of ten personnel had documentation of training within one month of hire. c. The training sheet did not include all criteria for competency assessment of testing personnel. d. The laboratory did not have other documentation of competency assessment. 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 --