Summary:
Summary Statement of Deficiencies D0000 Excellence Medical Labs was found to NOT be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a initial survey on February 3, 2025. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain hematology quality control records between January 18, 2025 and January 30, 2025. Findings include: Review of the laboratory document titled "Daily Laboratory Specimen Log" showed a "Complete Blood Count" was ordered on approximately 24 patients between January 18th, 2025 and January 30, 2025. The laboratory was unable to show quality control documentation for each day of patient testing. Two patients were tested on 1/18/25; Eights patients were tested on 1/22/25; Six patients on 1/27/25; Six patients on 1/29/25; and two patients were tested on 1/30/25. The interview on 2/3/25 at 12:55pm with Testing Person A confirmed the records were missing. 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 --