Mosaic Diagnostics, Llc

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the performance validation documents for the Luminex Flexmap 3D, performance validation documents for the GSD Bolt, patient test volumes, and interview, the laboratory failed to validate the reference intervals (normal values) for the 190 of 190 food IgG assays performed on the Luminex Flexmap 3D and failed to validate the reportable range and reference intervals (normal values) for the glyphosate assay performed on the GSD Bolt. Findings: 1. Review of the performance validation documents for the Luminex Flexmap 3D revealed no validation of normal values. 2. The Luminex Flexmap 3D was approved for the 190 food IgG assays by the laboratory director (LD) on 7/28/20. From 7/28/20 to 8/2/22, a volume of 8,571,280 patient test results have been reported. 3. Interview with Technical Supervisor (TS) #4 on 8/2/22 at 9:45 a.m. confirmed, the laboratory failed to validate the reference intervals (normal values) for the 190 of 190 food IgG assays performed on the Luminex Flexmap 3D were appropriate for the laboratory's patient population 4. Review of the performance validation documents for the GSD Bolt revealed no validation of the reportable range and reference intervals (normal values) for the 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 -- glyphosate assay. 5. The GSD Bolt was approved for the glyphosate assay by the LD on 6/21/21. From 6/21/21 to 4/20/22, a volume of 3,438 patient test results have been reported. 6. Interview with TS#1 on 8/2/22 at 2:40 p.m. confirmed the laboratory failed to validate the reportable range for the glyphosate assay and failed to validate that the reference intervals (normal values) for the glyphosate assay was appropriate for the laboratory's patient population as performed on the GSD Bolt . -- 2 of 2 --

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 upon direct observation during a tour of the laboratory with Technical Supervisor #4, review of manufacturer's reagent labels and staff interview, the laboratory failed to ensure that reagents and supplies in use were not expired. Findings were: 1. During a tour of the lab the surveyors observed the following expired reagents and supplies 1.5 K2Con aqueous, expired 4-13-11 with one month epiration date. 1.33 N KOH expired 10-10-11 Sulf 1 expired 4-5-2011 2. The above findings were confirmed by interview with TS#4 , at 1100 am on February 18, 2020 in the laboratory. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. 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 an absence of centrifuge records and interview with Technical Supervisor (TS) #4, the laboratory failed to define a function check protocol for the centifuges. Findings include: 1. No documentation was available for function checks of centrifuges for a 12 month period. 2. Interview with TS #4 on 02/18/2020 @1:30 pm confirmed the laboratory had no records of function checks for the centifuges and/or times on centifuges used in the laboratory for the past 12 months. Based on review of observation of 52 pipettes and interview with the TS#4, the laboratory failed to perform a function check on 6 out of 52 pipettes to verify the accuracy of the pipettes. Findings; 1. Observation of two of the Picus 5000 Sartarius 100-500 Ul pipettes, two of the Picus 5000 Satarius 0.5-10mL Pipettes, and VWR 100-1000 and VWR 20-200 pipettes located in the laboratory available for use showed no function checks for 2019. 2. Interview with the TS#4on February 18, 2020 at 1:35 PM confirmed, the laboratory failed to perform a function check to verify the accuracy of the volumes of 6 of 52 pipettes. -- 2 of 2 --