Summary:
Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on direct observation, laboratory documentation, and interview with the general supervisor (GS); the laboratory failed to meet the requirements of this condition. The laboratory failed to provide a unidirectional workflow for molecular amplification procedures to minimize contamination of patient specimens, equipment, instruments, reagents, materials, and supplies (Refer to D3005). D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation, manufacturers' package inserts (PI), laboratory records, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- and interview with the general supervisor (GS); the laboratory failed to maintain a uni- directional workflow for molecular amplification procedures to prevent potential cross-contamination in specimen processing, preparation, amplification, and detection for SARS-CoV-2 and Influenza A / B, and Respiratory syncytial virus (RSV) testing for one of one testing year (2022). Findings Include: 1. Review of the package inserts' warnings and precautions for the NTL Biotech Claro Series Multiplex Respiratory Assay (SMR) and the NTL Biotech Claro Series Covid -19 Direct Method Assay (CDM) revealed the following: a. "#7: The kit should be stored away from nucleic acid sources and PCR amplicons." b. "#8: To prevent contamination of the reaction mixture by previously amplified target sequences, maintain separate work areas, dedicated equipment." c. "#9: Different Laboratory coats should be worn pre- and post- PCR." d. "#10: The micropipettes used for pipetting PCR mixes and template nucleic acids should be separate. Filtered and nuclease-free pipette tips should be used." e. "#18: Amplified products should not be brought into the reaction setup area. To avoid false positives due to amplified material, the PCR completed reaction tubes should be disposed of before opening in the laboratory." 2. Direct observation on 03 /14/2023 at 8:45 a.m., of the GS demonstrating the testing procedures for NTL Biotech Claro Series Multiplex Respiratory Assay (SMR) and the NTL Biotech Claro Series Covid -19 Direct Method Assay (CDM) revealed the following: a. The SMR / CDM positive and negative control samples and the SMR / CDM assay kits were all stored in the same freezer. (Freezer - "am-1 MedLab"). b. The GS performed the testing process all within the same biological safety cabinet. The process demonstrated included the following; the preparation of extraction buffer reagent, the transfer of patient samples, and the addition of positive and negative control samples to the patient testing plates. (Biosafety cabinet, "Logic+ A2). c. The GS failed to change lab coats when transitioning from the pre to post polymerase chain reaction (PCR) phase of the testing process. d. The GS used the same set of pipettes for each process; the preparation of extraction buffer reagent, the transfer of patient samples, and the addition of positive and negative control samples to the patient testing plates. 3. On 03/14/2023 at 12:47 p.m., direct observation and interview with the GS revealed patient samples stored on one of one storage shelf located next to the thermal cycler ("qTower3 84G - Multiplex"): a. "to be processed" (minimum of 20 patient samples) b. "completed" (minimum of 22 patient samples) c. "positives/issues" (zero patient samples) 4. On 03/14/2023 at 12:47 p.m., an interview with the GS revealed that the laboratory does not perform wipe tests. 5. On 03/14/2023 at 12:48 p.m., the GS confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, laboratory records, lack of documentation, and interviews with the general supervisor (GS) and the laboratory director (LD); the laboratory failed to meet the requirements of this condition. The laboratory failed to establish, verify, and document the performance specifications for three of three -- 2 of 15 -- molecular biology assays utilized for patient testing and reporting of SARS-CoV-2 (COVID), Influenza A / B (FLU), and Respiratory syncytial virus (RSV) in 2022 and 2023. (Refer to D5421 and D5423). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)