Atcg Laboratory

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's evaluation of proficiency testing performance documents and interview with the laboratory staff, it was determined that the laboratory at least twice annually failed to perform evaluation of proficiency testing performance by alternative peer reviews to verify the accuracy of SARS-CoV-2 PCR testing procedure which is not listed in the subpart I of 42 CFR part 493. The findings included: a. The laboratory performed SARS-CoV-2 PCR testing using ThermoFisher QuanStudio 12K Flex and reagents. b. The laboratory failed, at least twice annually, to perform evaluation of testing performance to verify the accuracy of SARS - CoV-2 PCR testing in 2020 and 2021. c. The laboratory performed evaluation of proficiency testing performance on 10/30/2020 by sending samples to a CLIA certified laboratory and received total of 75% correlation between this laboratory and the outside laboratory, which was not acceptable according to the CMS PT score of at least 80% being acceptable. d. The laboratory failed to perform evaluation of proficiency testing performance at least twice annually in 2021, the laboratory did it on 3/10/2021 and no more. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 review of the laboratory's policy and procedure for Proficiency Testing (MOL.22.QA04), the proficiency testing performance records, and interview with the laboratory staff, it was determined that the laboratory failed to establish written policy and procedure for SARS-CoV-2 PCR proficiency testing. The findings included: a. The laboratory performed SARS-CoV-2 PCR which is not listed in subpart I of 42 CFR part 493. b. The laboratory's Proficiency Testing (MOL @@.QA04 failed to state at least twice annually to verify and ensure the accuracy of the SARS-CoV-2 PCR testing procedure (see D-5217) D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's evaluation of proficiency testing performance records, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided. The findings included: a. The laboratory performed SARS-CoV-2 PCR testing and elected to verify the accuracy, at least twice annually, of the testing procedures by alternative peer review. b. The laboratory director failed to ensure the quality assessment programs were established and maintained to assure the quality of laboratory services provided, see D-5217 and D-5291 -- 2 of 2 --

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 observation and touring the laboratory facility and storage devices for reagents or supplies on 09/10/2020 at approximately 10:10 am, review of the laboratory's temperature recorded charts, and interview with the testing personnel, and the testing consultant, it was determined that the laboratory failed to monitor the temperatures daily, and failed to document when out of the acceptable temperature ranges, for the storage freezers and refrigerators. The findings included: a. The laboratory has established the acceptable temperature range for its freezer storing reagents between -15 to -25 oC. b. On September 10, 2020 at approximately 10:10 AM, while touring the laboratory facility, noted that the laboratory using digital temperature thermometers to monitor the condition of all its freezer and/or refrigerators. c. The digital thermometer equip with many functions, including modes of "Min" and "Max" in addition to current temperature inside and outside of the storage. d. Modes of "Min" and "Max" indicate the temperature condition inside the storage whenever the lowest or highest temperature condition ever reached, but does indicate when it happened. e. Observed the digital temperature device for a freezer located in "Warehouse", "Brand/Model "Frigidaire" FFFU17M1QWB", Freezer serial# "WB612246959" acceptable range -15 to -30 oC. f. Noticed a -2.9 oC when pushed to mode of Max and Min was -29.2 oC, where acceptable range was set -15 to 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 -- -25 oC g. Review of the "Freezer Temperature Log" for the year of 2020 from March thru September records, between May 12 thru June 17, no temperatures were recorded. h. Between June 18 and September 10, 2020, there were days other than Saturdays and Sundays, many days missed temperature records, as such on the dates, 06/30, 07/02, 07/03, 07/06, 07/07 etc. D5781