Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with testing personnel (TP 1), the laboratory failed to enroll in an approved proficiency testing (PT) program for high complexity respiratory syncytial virus (RSV), and influenza A / B testing from 12/10/2022 to the date of survey (07/06/2023). Affecting 10,767 tests performed. Finding Include: 1. Review of proficiency testing records found no documentation of the laboratory's enrollment in a Centers for Medicare & Medicaid Services (CMS) approved PT program for testing RSV and influenza A / B from 12/10/2022 to the date of survey (07/06/2023). a. Total number of RSV and influenza A / B tests performed from 12/10/2022 - 07/06/2023 = 10,767. 2. On 07/06 /2023 at 10:39 a.m., TP 1 confirmed the laboratory failed to enroll in PT for RSV and influenza A / B. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 testing personnel (TP 1); 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, interview with testing personnel (TP 1) and lack of documentation, 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, respiratory syncytial virus (RSV), and influenza A / B, for two of two testing years (2022 and 2023). Findings Include: 1. Review of the "iAMP COV/FLU/RSV Detection Kit (iAMP) Instructions for Use, QUALITY CONTROL, General Considerations" revealed the following: a. "Personnel must be familiar with the protocol and equipment/instruments used." b. "Maintain separate areas and dedicated equipment (e.g., pipettes, microcentrifuges) and supplies (e.g., microcentrifuge tubes, pipette tips, gowns and gloves) for assay reagent setup and handling of processed samples." c. "Workflow must always be from the clean area to the dirty area." d. "Wear clean disposable gowns and new, previously unworn, powder-free gloves during assay reagent setup and handing of processed samples. Change gloves whenever contamination is suspected." 2. Review of laboratory records and lack of documentation revealed the laboratory failed to record "iAMP CON/FLU/RSV Detection" assay training for TP 1. (See D6029). 3. On 07/06 /2023 at 11:12 a.m., direct observation of TP 1 performing the iAMP assay revealed the following: a. Preparation of extraction buffer reagent, the transfer of patient samples to the patient testing plates, and the addition of positive and negative control samples to the patient testing plates all performed in one biosafety cabinet ("LabMetrics, Serial # NA4FAT2012293"). b. Direct observation revealed the testing pipettes stored on a rack outside of the biosafety cabinet. c. Direct observation also revealed completed patient samples stored with new patient samples in one refrigerator. Surveyor observation also revealed the transport of initial patient samples through the amplification room containing thermal cycler ("analytikjena qTower3 -- 2 of 6 -- 84G - SN: 3107G-0578") for entry to the extraction room. 4. On 07/06/2023 at 11:12 a.m., an interview with TP 1 revealed, "lab coats are worn in the extraction room, not in the amplification room". D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the general supervisor (GS), the laboratory failed to maintain laboratory quality system assessment records for monitoring room temperatures, room humidity values, refrigerator temperatures, and freezer temperatures for two of two dates reviewed for SARS-CoV-2, respiratory syncytial virus (RSV), and influenza A / B testing in 2023. Affecting 19 patient samples. Findings Include: 1. Review of the laboratory's "Daily Temperature Checks" procedures revealed the following: a. "Each thermometer in use is checked to monitor reagent storage temperature daily." b. "Any out-of-range documentation must include