Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as routine patient samples in the specialties of Chemistry and Hematology. Findings include: 1. Record review on 09/12/2023 of the laboratory's College of American Pathologists (CAP) 2022 PT records revealed: a. The attestation sheet for Urinalysis and Clinical Microscopy Event B contained the signatures of both Testing Personnel 1 (TP1) and Testing Personnel 2 (TP2). b. The Hematology and Automated Differential Event B attestation sheet contained both signatures of TP1 and TP2. 2. Record review on 09/12/2023 of the laboratory's CAP 2023 PT records revealed: a. The attestation sheets for Urinalysis and Clinical Microscopy Events A and B contained the signatures of both TP1 and TP2. b. The Hematology and Automated Differential Event A attestation sheet contained both signatures of TP1 and TP2. 3. Interview with TP1 on 09/12/2023 at 9:55 AM confirmed the above findings. TP1 stated, "We ask each other if they concur. We don't separate them or determine who is going to do which PT sample. I wouldn't be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- able to tell you who did what one. We don't do that with patients, only one of us reads patient samples." 4. The laboratory performs 314 Chemistry and 17,637 Hematology tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, record review, and staff interview, the laboratory failed to follow the approved "Confirmatory Test for Group A Strep from Plated Culture of TSA Blood Agar" procedure in the specialty of Microbiology. Findings include: 1. Surveyor observation on 09/12/2023 at 11:30 AM of the laboratory's incubator containing 2 patient culture plates for Group A Streptococcus confirmatory testing revealed: a. 2 of 2 plates were not streaked in a manner to obtain isolated colonies. b. 1 of 2 plates had been swept to obtain specimen for Sekisui Osom Strep A testing. 2. Record review on 09/12/2023 of the laboratory's "Confirmatory Test for Group A Strep from Plated Culture of TSA Blood Agar" procedure states, "Using a sterile swab select a beta hemolytic colony and perform the rapid test according to the manufacturer's instructions." 3. Record review on 09/12/2023 of the Sekisui Osom Strep A Test package insert states, "Lightly touch 1-3 suspect colonies (showing characteristic beta hemolysis) using a sterile swab. Do not sweep the plate." 4. Interview with Testing Personnel 1 on 09/12/2023 at 12:30 PM confirmed the above findings. 5. The laboratory performs 1,296 tests annually in the specialty of Microbiology. 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)