Ameripath Florida Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/26/2022 found the AMERIPATH FLORIDA LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain stain process records for year 2021. Findings include: Review of laboratory's quality control documents revealed the laboratory failed to have the following records for year 2021: - Min/Max Humidity Monitoring Log. -Room temperature log. -Cryostat temperature. - Patient log. -Reagent Acceptability Worksheet. -Stain/Technical Quality. -Equipment maintenance. During an interview on 08/26/2022 at 10:30 AM, the General Supervisor confirmed that the laboratory failed to keep the documents of reference for year 2021. 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 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 9-9-2020 found that Ameripath Florida LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide documentation of their quality system assessment (QA) logs for the year 2019. Findings Included: A review of the QA logs revealed no documentation of QA logs for 2019. An interview on 9-9-2020 at 11:41 AM with the general supervisor B confirmed there was no QA logs for the year of 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 --