Genesiscare Usa Of Florida Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 27 - 29, 2023. Genesiscare USA of Florida LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report, competency evaluations, and proficiency testing (PT) records, and interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) in the specialty of Hematology for three of four (2022 1st, 2nd, 3rd and 2023 1st) events. Findings Included: Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 06/27/2023, listed three testing personnel (Testing Person A [TP-A], Testing Person B [TP-B] and Testing Person C [TP-C]). Review of the initial training records showed that TP-A's initial competency was dated 02/01/2021. Review of the initial training records showed that TP-B's initial competency was dated 09/14 /2021. Review of the initial training records showed that TP-C's initial competency was dated 11/01/2021. Review of the PT records from American Proficiency Institute showed the PT attestation forms were signed by TP-A as the "Person Performing Test" for the hematology PT for 2022 2nd, 3rd event, and 2023 1st event. On 06/29 /2023 at 9:52 AM, the Laboratory Consultant confirmed the lab had not rotated the performance of PT. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- 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 the application submitted to change the Laboratory Director and the procedure manual, and interview, the laboratory failed to provide documentation that showed the Laboratory Director approved, signed, and dated the procedure manual from 01/07/2022 to 06/29/2023. Findings: Review of the laboratory's Clinical Laboratory Improvement Amendments (CLIA) Application for Certification submitted on 01/10/2022, noted the laboratory changed laboratory directors to the Current Laboratory Director effective on 01/07/2022. Review of the procedure manual showed the Previous Laboratory Director approved, signed and dated the procedure manual on 11/11/2020. On 06/29/2023 at 10:30 AM, the Laboratory Consultant stated she was unable to located where the Current Laboratory Director had approved, signed and dated the procedure manual. D5781

Summary Statement of Deficiencies D0000 An initial certification survey conducted on 11-26-19, found the 21st Century Oncology LLC /DBA/ Florida Precision clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to receive a passing score of 80 percent for the White Blood Cell Differential analyte for the second event of American Proficiency Institute (API) in 2019 . Findings include : A review of the API proficiency testing record indicated the laboratory received a score of 16 percent for the White Blood Cell Differential analyte for the second event in June 30th , 2019 . On 11-26-19 at 12:00 pm , the testing person A and office consultant confirmed that laboratory had received a score of 16 percent for the White Blood Cell Differential analyte for the 2nd event in 2019 . 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 --