Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted on 11/14/24 through 11/15/24 and standard level deficiencies were identified. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of procedure manuals, observations, and interview with the technical supervisor, it was found that the laboratory failed to follow their own written procedure for ensuring four of six observed Dengue IgM/PCR specimens were received within 48 hours. Findings included: 1. Review of the InBios DENV Detect IgM Capture ELISA and Dengue via PCR method stated, "Separated serum should remain at 20-25C for no longer than 8 hours. If assays are not completed within 8 hours, serum should be refrigerated at 2-8C. If assays are not completed within 48 hours, or separated serum is to be stored beyond 48 hours, serum should be frozen at or below -20C." 2. During a tour of the "Receiving" on 11/15/24 at 9:55 am, receiving of six aliquoted serum specimens were observed for Dengue IgM ELISA and PCR tests. The specimens were in a white Styrofoam box with a frozen cold pack. Four of the six test requisitions did not include the collection time to ensure the specimens were within the 48-hour stability per the procedure manual. Patient #1 date of collection 11/12/24, Patient #2 date of collection 11/13/24, Patient #3 date of collection 11/14/24, and Patient #4 date of collection 11/13/24. 3. During a tour of the 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 -- laboratory on 11/15/24 at 10:29 am, the six received aliquoted serum specimens were observed to be moved into "Refrigerator No. 1 Temp 2-8C, BSL-2 SAMPLES IN PROCESS." During an interview on 11/15/24 at 10:30 am, the technical supervisor stated the above specimen's stability at 2-8C is seven days and the above observed specimens would be stored there until PCR testing for Dengue on Monday (11/18/24). The laboratory did not ensure Arbovirus specimens were received and analyzed within 48 hours when stored at 2-8C as required in their written procedure. 4. During an interview on 11/15/24 at 11:30 am, the technical supervisor was asked whether the laboratory had performed studies for extending the stability (7 days at 2-8C) of Arbovirus specimens, she was unable to provide studies. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of the procedure manual, observation, review of test requisitions, and interview with the technical supervisor, it was found that the laboratory failed to ensure documentation of collection times for five of seven Dengue IgM specimens (defined stability: 48 hours at 2-8C). Findings included: 1. Review of the InBios DENV Detect IgM Capture ELISA and Dengue via PCR method stated, "Separated serum should remain at 20-25C for no longer than 8 hours. If assays are not completed within 8 hours, serum should be refrigerated at 2-8C. If assays are not completed within 48 hours, or separated serum is to be stored beyond 48 hours, serum should be frozen at or below -20C." 2. During a tour of the "Receiving" on 11/15/24 at 9:55 am, receiving of six aliquoted serum specimens were observed for Dengue IgM ELISA and PCR tests. The specimens were in a white Styrofoam box with a frozen cold pack. Four of the six test requisitions did not include the collection time to ensure the specimens were within the 48-hour stability per the procedure manual. Patient #1 date of collection 11/12/24, Patient #2 date of collection 11/13/24, Patient #3 date of collection 11/14/24, and Patient #4 date of collection 11/13/24. Review of a patient test report for patient #H00210068-01 included a date of collection 10/13/23, received 10/16/23, analyzed for IgM on 10/30/23, reported 10/31/23, and no collection time on the test requisition. 3. During an interview on 11/15/24 at 10:12 am, the technical supervisor stated collection times were not required and there was not a procedure manual supporting the lack of collection time. 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)