Atc Testing And Screening Services Llc

Summary Statement of Deficiencies D0000 An Initial/Complaint (LA 00057518) survey was performed at ATC Testing and Screening Services, LLC-CLIA ID 19D2191582 on April 1, 2021. ATC Testing and Screening Services, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1205: CONDITION: Virology 42 CFR 493.1443 CONDITION: Laboratories Performing High Complexity Testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories Performing High Complexity Testing, Technical Supervisor 42 CFR 493.1453 CONDITION: Laboratories Performing High Complexity Testing; Clinical Consultant 42 CFR 493.1459 CONDITION: Laboratories Performing High Complexity Testing; General Supervisor 42 CFR 493.1487 CONDITION: Laboratories Performing High Complexity Testing; Testing Personnel D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of the laboratory's policies, proficiency test records, and interview with personnel, the laboratory failed to maintain proficiency testing records for one (1) of one (1) event reviewed for COVID testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 28 -- for two (2) years. Findings: 1. Observation by surveyors on April 1, 2021 at 9:42 am during the laboratory tour revealed the laboratory utilizes the GeneFinder COVID-19 Plus Real AmpKit for COVID testing. 2. Review of the laboratory's policies revealed the laboratory did not have a proficiency testing policy. 3. Review of the laboratory's 2020 College of American Pathologists (CAP) records revealed the following documents were not maintained: COV 2-B 2020 SARS-CoV-2 Molecular: a) Attestation statement signed by testing personnel and Laboratory Director or designee b) Report form and raw data c) Evaluation/Results record provided by CAP 4. In interview on April 1, 2021 at 1:47 pm, the Technical Supervisor stated he did not have the identified proficiency testing documents. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of laboratory policies, and interview with personnel, the laboratory failed to establish and follow polices to minimize contamination during performance of the COVID testing procedure. Findings: 1. Observation by surveyors on April 1, 2021 at 9:42 am during the laboratory tour revealed the laboratory utilizes the GeneFinder COVID-19 Plus Real AmpKit for COVID testing. 2. Review of the GeneFinder's instructions for use under "Warnings and Precautions" and "Procedure"sections revealed the following: a) "Follow standard precautions. All patient specimens should be considered potentially infectious and handled accordingly." b) "All materials used in one area should remain in that area and should not be moved or used in other areas. After the assay procedures, the workbench and lab supplies should be cleaned and disinfected immediately." c) "All lab workbench and supplies should be cleaned and disinfected regularly using 75% Ethanol or UV light." d) "All pipette tips and centrifuge tubes in the assay should be DNase/RNase-free. The used centrifuge tubes and pipette tips should be discarded in waste bin with bleach and discarded after decontamination." e)" Clean and decontaminate all work surfaces, pipettes, centrifuges, and other equipment prior to use. Decontamination agents should be used including 10% bleach, 70% ethanol, and DNAZapTM solutions to minimize the risk of nucleic acid contamination." 3. In interview on April 1, 2021 at 9:42 am, the Technical Supervisor stated the laboratory previously used bleach to clean the workstation, however, it caused rusting of the metal tabletop. The Technical Supervisor stated the laboratory uses alcohol to clean the workstation. 4. Surveyors observed Testing Personnel 2 on April 1, 2021 at 10:00 am process two (2) patient samples for COVID testing without cleaning the workstation with alcohol prior to or after completion of patient testing. 5. Review of the laboratory's procedures revealed the laboratory did not include procedures including, but not limited to, agent used for cleaning/decontamination and frequency of performance. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous -- 2 of 28 -- materials. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of the laboratory's policies, manufacturer procedures, and interview with personnel, the laboratory failed to establish safety procedures for protection, handling, and disposal of biohazardous materials. Findings: 1. Observation by surveyors during the laboratory tour on April 1, 2021 at 9:42 am revealed the laboratory did not have any trash labeled biohazardous. Surveyors observed COVID patient samples labeled with patient name and date of birth in a large white plastic bucket on the floor. 2. In interview on April 1, 2021 at 9:42 am, the Technical Supervisor stated the samples observed in the bucket were old patient samples that needed to be discarded. The Technical Supervisor stated he opens the sample tubes and places them in a bucket located in his office that is filled with a 40 % bleach solution. The Technical Supervisor further stated he leaves the samples in the bleach solution for a few days then fishes them out and discards the patient sample tubes in the regular trash and the bleach solution down the drain. Surveyors observed uncapped samples and pipette tips in a bleach solution in a white plastic bucket with lid located in the Technical Supervisor's office. 3. Surveyors observed the laboratory receive two patient samples via FedEx Express on April 1, 2021 at 9:58 am. The samples were received in "Biohazard" bags inside of the FedEx package. Surveyors observed Testing Personnel 2 discard the empty "Biohazard" bags that contained the patient samples in a non-biohazard trash can and process the samples on open workstation. 4. In further interview on April 1, 2021 at 12:17 pm, the Technical Supervisor stated pipette tips used in the pre-lysis process are placed in bleach before being discarded into the regular trash. 5. Review of the GeneFinder's instructions for use under "Warnings and Precautions" section revealed the following: a) "Follow standard precautions. All patient specimens should be considered potentially infectious and handled accordingly." b) "Handle all specimens as if infectious using safe laboratory procedures. Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019-nCoV. Dispose of hazardous or biologically contaminated materials according to the practices of your institution." c) "Each step of operation, from specimen collection, storage and transportation, and laboratory testing, should be strictly conducted in line with relevant biosafety regulations and molecular laboratory management." d)" Following the amplification protocol, PCR plates should be placed into a sealable plastic bag for autoclaving and decontamination." 6. Review of the laboratory's procedures revealed the laboratory did not include safety procedures related to handling of biohazard materials to include, but not limited to personal protective equipment and safety equipment, spills and disposal of waste. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyors, review of laboratory's policies, patient test records, and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Virology. Findings: 1. The laboratory failed to maintain -- 3 of 28 -- proficiency testing records for one (1) of one (1) event reviewed for COVID testing for two (2) years. Refer to D2015. 2. The laboratory failed to establish and follow polices to minimize contamination during performance of the COVID testing procedure. Refer to D3003. 3. The laboratory failed to establish safety procedures for protection, handling and disposal of biohazardous materials. Refer to D3011. 4. The laboratory failed to have a system for handling complaints and problems reported to the laboratory. Refer to D5205. 5. The laboratory failed to have a system in place for identifying and documenting communication issues. Refer to D5207. 6. The laboratory failed to establish written policies and procedures to assess competency assessment policies for testing personnel. Refer to D5209 I. 7. The laboratory failed to establish written policies and procedures to assess competency of the Technical Supervisor. Refer to D5209 II. 8. The laboratory failed to ensure test requisitions included information as required for random selection of four (4) of four (4) patients reviewed. Refer to D5305. 9. The laboratory failed to ensure nasopharyngeal specimens for COVID testing met manufacturer's storage and transport requirements. Refer to D5311 I. 10. The laboratory failed to ensure the collection dates were accurate. Refer to D5311 II. 11. The laboratory failed to document the time samples were received for COVID testing for ten (10) of ten (10) patients reviewed. Refer to D5313. 12. the laboratory failed to ensure detailed written instructions for providers to maintain integrity of samples were established. Refer to D5317. 13. The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the preanalytic system. Refer to D5391. 14. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 15. The laboratory failed to establish complete policies and procedures. Refer to D5403. 16. The laboratory failed to monitor the room temperature where reagents and supplies are stored per manufacturer requirements. Refer to D5413 I. 17. the laboratory failed to monitor the temperature of the laboratory's freezer where reagents are stored per manufacturer requirements. Refer to D5413 II. 18. The laboratory failed to properly store COVID reagents per manufacturer requirements. Refer to D5413 III. 19. The laboratory failed to label reagent aliquots with required information. Refer to D5415. 20. The laboratory failed to have complete performance verification studies for COVID testing approved by the Laboratory Director. Refer to D5421. 21. The laboratory failed to establish maintenance protocols for equipment utilized for COVID testing. Refer to D5433. 22. The laboratory failed to establish