Clarity Genetics Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 02/01/2021 found that the Clarity Genetics LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 interview with laboratory personnel, the laboratory was not in compliance with state requirement that testing personnel is required to have a Florida License. Finding include: -Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 01/30/2021 revealed that there was 1 testing person (TP). -Review of Personnel files revealed that the TP had no Florida License as Medical Technologist. During an interview on 02/01/2021 at 10:00 am with TP, he confirmed that he has no Florida License as Medical Technologist. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory test report failed to list the correct laboratory director, for 4 out of 4 patients report reviewed from January of 2021. Findings Include: Review of the final report for patient 1 (CLARGX-03321), 2 (CLARGX-03328), 3 (CLARGX-03326) AND 4 (CLARGX-03329), showed that the reports failed to have the correct laboratory director. During an interview on 02/01 /2021 at 11:30 am, with laboratory manager, he confirmed that the reports of reference failed to include the correct laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with general supervisor (GS), the laboratory failed to perform the six months competency assessment for 1 out of 1 testing personnel (TP) for 2017 year. Findings include: Review of employee competency policy revealed that the requirement for the 6th month evaluation in the first year of employment was missing. Review of employee documentation showed that the laboratory failed to have documentation of the 6th month evaluation on testing person for the year 2017. During an interview on 12/03/2018 at 10:30 AM, with the GS, he confirmed that the competency assessment policy missed the requirement for the 6th month assessment during 1st year of employment and that there was no six months competency assessment documented for the period of reference for TP. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --