Mayer J Saad Md Pc

Summary Statement of Deficiencies 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 review of the laboratory's thermometer calibration procedure, observation of storage room thermometer, lack of 2021 thermometer calibration record for refrigerator #2 an interview with the technical consultant and testing person, the laboratory failed to maintained the laboratory's written calibration procedure. FINDINGS: 1. The laboratory's calibration procedure requires calibration of thermometers used for room, refrigerators and freezers annually. 2. The laboratory failed to maintain the procedure and perform a calibration on refrigerator #2 thermometer in 2021, no calibration records were available for review. 3. It was observed on 21/25/22 at 12:30 PM that the storage room thermometer was not a certified. 4. The technical consultant and testing person confirmed on 21/25/22 at approximately 12:00 PM, the laboratory failed to maintained the laboratory's written calibration procedure and implemented a certified thermometer for room temperature. D5785

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory records and interview with the laboratory director, the laboratory failed to verify the accuracy of the interpretation of UroVysion fluorescence in situ hybridization(FISH) images from urine specimen testing at least twice per year, in calendar year 2017. FINDINGS: The laboratory director confirmed, on November 7, 2018 at approximately 2:30 PM, the surveyor's review of laboratory records finding that the laboratory had failed to document the twice yearly verification for the FISH analysis in calendar year 2017. Approximately 50 patients' samples were tested and reported for FISH analysis in 2017. 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)