Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2020013663, conducted on 08/25/20 to 08/26/20 at Niznik Lab Corp found that the laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The following conditions were cited: -D3000 - D6076 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). This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow Florida Department of Health (FDOH) guidelines for reportable diseases. Findings include: - Refer to D3009 During an interview on 08/26/2020 at 4:30 PM, the Chief Executive Officer confirmed that the laboratory failed to follow FDOH guidelines for reportable diseases. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to report to the Florida Department of Health (FDOH) positive results for reportable disease since 5 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 -- /2019 to 8/26/2020 for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis(CT). For Coronavirus 2019 (COVID-19), the laboratory failed to report to FDOH following COVID-19 special reporting requirements from June 5, 2020 to August 5, 2020. Findings include: -Review of FDOH reportable disease guidelines revealed timeframes and reportable diseases requirements for NG/CT, which are that the laboratory must report to the FDOH by next business day for positive results. -Review of FDOH Emergency Rule 64DER20-26 (64D-3.029) of April 10th 2020, revealed for COVID-19; the timeframe is immediately and had special reporting requirements. Results should be reported and accompanied by any testing conducted (positive and negative). For laboratories performing electronic laboratory reporting as described in subsection 64D-3.031 (5). F.A.C., all test results (positive and negative) are to be submitted, including screening test results (positive and negative). -Review of test menu revealed the laboratory is testing reportable diseases for: a) NG and CT since May 2019. - During year 2019: the laboratory had 14 positive cases: 3 NG ( 63637, 63982 and 64068) and 10 CT ( 63567, 63888, 63674, 63732, 63739, 63772, 63838, 63910, 64033, 64049) and 1 case with NG and CT (64118). -During year 2020: up until 8/27, they had 15 positive cases: 1 NG (64471), 12 CT (64202, 64150, 64188, 64322, 64388, 64550, 64551, 64624, 64731, 64700, 64703, 64739) and 2 NG and CT (64496 and 64655). The laboratory had no documentation that they reported these cases listed above to the FDOH. b) COVID-19. From 6/5/2020 to 8/5/2020 the laboratory tested 16600 cases. The case list is available on surveyor notes. -The laboratory reported 1 positive case (10070) to the Collier County by fax on 6/19/2020, they should have reported this case to Lee County which is the actual residency of the positive case, as per summary provided by the Chief executive Officer (CEO), and available on surveyor notes. -The laboratory contacted the FDOH by e-mail on June 23rd to request the setup of the Electronic Laboratory Reporting System (ELR). They received instruction to contact the FDOH ELR liaison to set up the system. In the e- mail, it was noted that "FDOH is requesting ALL COVID-19 (positive, negative, and inconclusive) laboratory results be submitted electronically. Once an electronic feed has been established and in production for COVID-19 testing, it is no longer necessary to report COVID-19 results via other means." -Review of their data submission showed one (1) unsuscessful attempt on 7/27/2020, the first data submission was done on 8/5/2020. -The laboratory could not provide documentation of submitted results by other means to FDOH before the ELR successful data transmission. During an interview on 08/2/2020 at 4:30 PM, the laboratory Chief Executive Office (CEO) provided a summary of the events that they faced during the process of set up of the ELR. He confirmed that the laboratory faxed one (1) case to Collier County, but he could not provide documentation that the laboratory sent reports for the remaining tests performed via other means until the laboratory had their ELR set up with the FDOH. 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 -- 2 of 4 -- 493.1253. (7) Control procedures. (8)