Urological Associates Of Savannah, Pc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of 22 laboratory policies and procedures, laboratory records and interview the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure URINE CYTOLOGY WORKLOAD LIMIT, which stated: "To ensure compliance with regulatory requirements, there will be a time log placed by the microscope to be completed by the screener." 2. The Survey Team requested and the laboratory failed to provide records titled URINE CYTOLOGY SCREENER TIME LOG from 2022, 2023 and January 1, 2024 to the date of the survey in 2024 for one of one Technical Supervisors. Technical Supervisor includes: -Laboratory Director/Technical Supervisor 3. During an interview on February 13, 2024 at 3:15 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor and Laboratory Supervisor. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 16, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation by the surveyor during a tour of the laboratory, review of temperature requirements posted by the manufacturer on boxes of controls used in testing of testosterone, free PSA and total PSA levels on the Beckman Access 2 endocrinology analyzer, review of temperature logs for the freezer where controls are stored and staff interview, the laboratory failed to store controls at the temperature required by the manufacturer. Findings include: 1. Observation by the surveyor during a tour of the laboratory revealed BioRad Liquicheck Controls are stored in a frost free freezer. 2. Observation by the surveyor also revealed the storage temperature posted on the control vials by the manufacturer is negative 20 to negative 70 degrees centigrade. 3. Review of temperature logs for the freezer where controls are stored revealed the temperature is outside the acceptable range on 20 of 20 days in September 2018, 19 of 22 days in August 2018 and 10 of 21 days in May 2018. 4. Interview with technical consultant/laboratory supervisor (see CMS 209) in the 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 -- conference room at approximately 12:30 pm confirmed the manufacturer's acceptable temperature range is negative 20 to negative 70 degrees centigrade and the temperature of the freezer where controls are stored does not maintain the acceptable range. -- 2 of 2 --