Er Care Cfl Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 11/20/2024 to 12/9/2024. ER Care of CFL LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain the American proficiency institute (API) testing records for the 2nd event of Chemistry in 2023 and 2nd event of Hematology in 2024. Findings Included: Review of API proficiency testing record revealed no documentation of a proficiency testing packet for the 2nd event of Chemistry in 2023 and 2nd event of Hematology in 2024. Review of Record Retention Policy stated," Following is a listing of all records to be retained and the minimum period of time-proficiency testing - 2 years." On 11/20/2024 at 2:34 PM, the physician assistant confirmed proficiency testing was not maintained for the 2 years for the 2nd event of Chemistry in 2023 and 2nd event of Hematology in 2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interviews, the laboratory failed to document the daily 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 -- quality control maintenance, monthly maintenance, six month maintenance and calibration maintained to ensure it was completed for Mesonic M-series Hematology from October 2023 to November 2024. Findings Included: Review of Medonic M- Series Hematology Analyzer maintenance sheets revealed no written documentation of daily quality control maintenance, monthly maintenance, six month maintenance and calibration maintenance were filled in from Oct 2023 to November 2024 by testing personnel with dates. Review of Medonic M-Series Manual read," All maintenance should be documented (a maintenance log is recommended) and the documentation saved for a minimum of 2 years. Review of General maintenance policy signed by the laboratory director on 8/1/2023 read "instrument maintenance, function checks and

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on January 18, 2023. ER Care CFL LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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)