Veracyte Labs Va

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at Haliodx, Inc on March 11, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with the laboratory conducted on February 18, 2021 with off-site record review of documentation on March 4, 5, and 10, 2021 and a follow-up phone conference on March 9, 2021. Specific deficiencies cited are as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. 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 the review of policy and procedures (P&P), lack of documentation and interviews, the laboratory failed to follow to established policy for performing calibration verification procedures every six months in the calendar year 2020 for seven (7) of 8 therapeutic drug monitoring (TDM) analytes assayed on the Dynex Ds2 platform. Findings include: 1. Review of the P&P "Metrology and Prevention Maintenance of the Dynex DS2" (updated 04/16/19) "4.8 Calibration Verification" revealed the following statement "4.8.1 Policy- Calibration verification is required for each assay under the following conditions: At least once every six months after initial assay verification". 2. Review of available calibration verification documents revealed the lab performed the procedures for all 8 TDM's on 07/08/20. The inspector requested to review additional calibration verification documentation performed in 2020 as defined by the established policy during an interview with the associated lab director on 03/11/21 at 3:50 PM. The lab was able to produce documents for the Vedolizamab analyte (performed on 02/07/20) and lacked documentation for the Adalimumab, Infliximab, Certolizumab, Golimumab, Ustekinumab, Inflectra and Renflexis analytes (7). Additional calibration verification procedures were not performed for the 7 specified analytes. 3. An interview with the lab director and associated lab director at 4:15 PM on 03/11/21 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Haliodx on May 21st and 22nd, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of polices, maintenance logs, field service engineer reports, patient test log, and interviews, the laboratory did not follow manufacturer's maintenance requirements for the Elga Purelab Ultra water purification system from April 26, 2019 to May 21, 2019 while processing and reporting one (1) immunoscore patient result during the lapse of maintenance. Findings include: 1. Review of the laboratory's Standard Operating Procedures (SOP) manual revealed a policy (title "Metrology and Preventative Maintenance of Distilled Water System, PCL03-004 V01) that included a manufacturer's maintenance chart that outlined replacement of POU Filter, LC182 Labpure S1, LC183 Labpure S1, LC184 Labpure S3, LC185 Labpure S4, and LC109 Ultra Micro Filter at a required frequency of every six (6) months. 2. Review of the available maintenance logs revealed the date of the water system installation as 10/26 /18. No record of 6 month filter replacement was recorded (review timeframe: October 2018 to the date of the survey on 5/21/19). The inspector requested to review 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 -- documentation of the filter replacements for the six month timeframe at 4/26/19. No records were available. The technical consultant (TS) stated, at approximately 3 PM on 5/21/19, "We did not realize that we could perform the six month filter replacements and called to request field service this week. He came in this morning and performed a preventative maintenance check." 3. Review of the Elga Purelab Ultra field service maintenance reports revealed a report (Report Number EB052119- 1) dated 5/21/19 by an Elga service provider engineer that stated, "When I arrived the final quality reading was bad. I confirmed with handheld that conductivity reading was 18.2 and replaced the line cell; rotated LC182." 4. Review of the immunoscore patient test logs revealed 1 patient (identifier number 20920030) was processed on 5 /13/19 during the one month lapse of the required filter replacement maintenance. 5. In an interview with the quality manager, TS, and laboratory owner at approximately 12:00 PM on 5/22/19, the above listed findings were confirmed. 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 a laboratory tour, review of procedures, manufacturer's package insert, validation records, and interviews, the laboratory failed to ensure that sixteen (16) packages of Roche Hematoxylin II stain, stored in the laboratory for use, were within the manufacturer's stated expiration dates. Findings include: 1. During a laboratory tour, at approximately 4:00 PM on 5/21/19, the inspector noted that 16 packages of Roche Ventana Hematoxylin II stain (Lot Number Y05952) had written receive dates of 11/30/18 and manufacturer stamped expiration dates of 4/18/19. The inspector opened two (2) of the 16 unopened packages and noted areas of stain precipitation in the containers. The laboratory inspector inquired if the the stain was currently used for patient testing. The general supervisor (GS) stated, "We used that lot number of stain for our validation and patient testing up to the expiration date and have not discarded it yet". The technical supervisor (TS) stated, "We plan to validate the use of the Ventana stain reagent kits beyond the expiration dates for experimental purposes." 2. Review of the laboratory's Standard Operating Procedures (SOP) manual revealed a policy (titled "Inventory Control for CLIA US Lab" Policy PCL08-003 R 02) that stated "All reagents must be stored according to manufacturer's recommendations (temperature, flammable, or reactivity restrictions) and all expired reagents must be discarded." 3. Review of the Roche Ventana Medical Systems Hematoxylin II stain package insert revealed storage and handling instructions that stated, "Do not use the reagent beyond the expiration date. The signs indicating instability of this product are precipitation of the reagent with clearing of the solution. At the first sign of instability of the reagent, contact Ventana."" 4. Review of the laboratory's validation study records revealed no quality plan validating use of Ventana Hematoxylin II reagent beyond the manufacturer's stated expiration dates. The inspector requested to review the validation of reagent use beyond expiration date. No record was available for review. 5. In an interview with the quality manager, TS, and laboratory owner at approximately 12:00 PM on 5/22/19, the above listed findings were confirmed. -- 2 of 2 --