Aurora Life Sciences Llc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 review of patient test logs, maintenance records, manufacturer's inserts, and interview with technical supervisor (TS 1), the laboratory failed to monitor and document proper storage of AMiDot Autotimmune reagents stored in the Frigidaire Inventory Cold Storage Unit #3 refrigerator (Unit 3) for two of four days in February of 2022, impacting seven patients tests results. Findings Include: 1. Surveyor review of the "1-05-2022" maintenance sheet, documenting refrigerator temperatures for the Unit 3 refrigerator, found the laboratory failed to document temperatures for two of four days (02/03/2022 and 02/04/2022) in February of 2022. 2. Interview with TS 1 on 01/31/2023, at 1:03 p.m., confirmed that AMiDot Autoimmune reagents used for Autoimmune 30+ analytes testing are stored in the Unit 3 refrigerator. 3. Surveyor review of manufacturer's inserts for the following AMiDot reagents confirmed AMiDot Reagent Packs, Autoimmune Abdominal Panel Slide Packs, and Autoimmune Fatigue Panel Slide Packs must be stored at 2-8 degrees Celsius. 4. Review of patient test logs revealed seven patients (Patient Identification Numbers: ALS-1005FBP44480720, INT-44574-2, TWW-1016EBP4434115, 44589-1, INT- 44585-1, ALS-1010EBP44502320, and TWW-1046EBT4397955) had Autoimmune 30+ analytes testing performed on 02/03/2022 when reagent storage temperatures failed to be monitored. 5. Interview with TS 1 on 1-31-2023, at 2:45 p.m. confirmed 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 -- that the reagent storage temperatures were not monitored for the dates identified in February of 2022 due to a broken thermometer. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records, patient reports, and interview with technical supervisor (TS 1), the laboratory failed to provide written documentation of the statistical parameters established over time for the upper and lower control limits for three of six AMiDot Autoimmune analytes control lot numbers used for testing on one of one days in January 2023, impacting 17 patients tests results. Findings include: 1. Surveyor review of laboratory quality control procedure marked, "Establish Upper and Lower Control Sample Limits (Form P-100-69) revealed the following purpose and procedure, "When a new control lot is received, the sample is to be tested to determine control limits" and "run the new control over 8 separate days to obtain 8 replicates of each sample for all analytes." 2. Review of laboratory records revealed the laboratory failed to provide a record of the established statistical parameters for upper and lower control lot values for three of six AMiDot Autoimmune analytes control lot numbers (Z7_POS Z7121422, Z7_POS1 Z7121422, and Z7_POS2 Z7121422) utilized for patient testing on 01/20/2023. 3. Review of patient reports revealed the laboratory reported AMiDot Autoimmune 30+ analytes test results on 01 /20/2023, impacting 17 patients. 4. On 01/31/2023, at 1:48 p.m., technical supervisor 1 confirmed Findings 1 through 3. D5779

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of reagents; review of laboratory records and interview with Technical Supervisor #1, the laboratory failed to document all control procedures. Findings: 1. Quality Control reagents were in a kit that included positive and negative controls vials along with a Quality Control Certificate. 2. The manufacturer's lot number and "use by date" was included on the control vials. 3. Laboratory quality control records included a sticker titled, "Daily Control Kit." 4. The Daily Control Kit reads as follows: "Kit contains controls for use with AMiDot A/I testing. Kit will yield 4 runs. Remove kit from freezer and allow to thaw. Date and initial removal. Controls are prediluted. Run controls and return unused samples to freezer. Do not use past expiration date on vial." 5. A sticker for tracking and documenting the dates for the 4 runs of each kit is included with the documentation. 6. The lot number and use by date was not included in the documentation when the laboratory tracked the 4 runs of the quality control kits. 7 On 09/11/19 at 12:30 PM, the Technical Supervisor confirmed the surveyor's findings. 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 No Tags No deficiency details available. 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 --