Texarkana Gastroenterology Consultants Pa

Summary Statement of Deficiencies D0000 The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on laboratory procedure, review of the CMS116, and confirmed in interview, the laboratory failed to perform a water rinse following disinfection of the FilmArray Pouch Loading station. The laboratory reported an estimated testing volume of 360 BioFire FilmArray Gastrointestinal panel tests, annually. 1. Review of the laboratory procedure titled 'FilmArray Gastrointestinal Panel' (FLM1-MKT-0071-02) Section 'Procedure', subsection 'Prepare Pouch' stated: "1. Thoroughly clean the work area and FilmArray Pouch Loading Station with freshly prepared 10% bleach (or suitable disinfectant) followed by a water rinse." 2. Review of the CMS116 section VII 'Non- Waived Testing' list and estimated annual test volume for the Microbiology specialty at approximately 360. 3. At 1350 hours on 12/1/2021, in the laboratory, the surveyor queried for the water used for the water rinse as listed in the procedure. The primary testing person stated that no water rinse was done after cleaning for the FilmArray Pouch Loading station. . D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on surveyor's observation and confirmed in interview, the laboratory failed to label aliquoted staining reagents with storage requirements, preparation, and expiration dates for ten of ten reagents used for the staining histopathology specimens. 1. Surveyor observed the partially labeled reagents in aliquoted containers, under a hood, for staining in the laboratory at 1400 hours on 12/1/2021: Xylene Alcohol Water Hematoxylin Eosin Bluing Clarifier Acetic Acid Alcian Blue Perodic Acid 2. In an interview at 1500 hours on 12/1/2021 in the laboratory, the primary testing person confirmed that the reagents were in use for histopathology staining, and that they were unaware each aliquoted container needed to be labeled with storage requirements, preparation, and expiration dates. . -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on review of laboratory policy for use of the BioFire FilmArray GI panel, the laboratory failed to document a change in procedure required by the manufacturer into lab policy; in addition this change showed no evidence of having been approved by the laboratory director. Findings: 1. On 03-05-2019, an Urgent Medical Device Recall notice was sent out to users of the BioFire FilmArray GI panel advising that, due to elevated rates of false positives using the system, positive Campylobacter and Cryptosporidium results should be confirmed by other methods before reporting. This was followed by another notice from the manufacturer on 03-13-2019, advising that positive results for Campylobacter and Cryptosporidium be confirmed by retesting with a new GI Panel pouch or an alternate assay, and that only results for confirmatory testing for those analytes should be reported. The notice affected panels with expiration dates of 10-23-2019 onward. 2. Review of laboratory policy showed no documentation reflecting addition of the notice or changes to policy reflecting the manufacturer's recommendations. 3. In an interview at the site on 06-05-2019, the laboratory technical consultant (CMS form 209) stated that testing personnel were aware of the notice, but it had yet to be addressed in laboratory policy. She further stated that since the time the notice was issued no patient specimens had tested positive for Campylobacter or Cryptosporidium. . D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on review of laboratory quality control documentation for 2018 and 2019 confimed by staff interview, the laboratory failed to perform controls at the required frequency when testing patient samples using the BioFire FilmArray Gastrointestinal (GI) panel. Findings: 1.Quality control records for 2018 and 2019 were reviewed. The laboratory was performing quality controls on the BioFire FilmArray GI panel according to manufacturer's recommendations; monthly and at lot change. According to materials provided the laboratory tests an average of 360 patient specimens a year using the system. 2. In an interview at the site on 06-05-2019, testing person 1 (CMS form 209) stated she was unaware of the regulatory requirement to perform controls on qualitative procedures at least once per day of patient testing if the laboratory has not developed an individual quality control plan (IQCP). . -- 2 of 2 --