Summary:
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 surveyor review of Biannual Assessment (BA) records and the CMS-209 provided during the survey and interview with Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice annually performed by all testing personnel from 4/20/21 to the date of the survey. The findings include: 1. The BA for Histopathology was not performed twice annually by Testing Personnel #2 (TP #2) designated on the CMS-209. 2. The OM confirmed on 9 /26/23 at 1:30 pm that TP #2 did not perform BA twice annually for Histopathology testing as stated above. 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 surveyor review of the Olympus BX40 and Leica DME Microscopes 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 -- Instruction Manuals (IM's) and interview with the Office Manager (OM), the laboratory failed to document the room temperature and humidity per the IM's requirements in the pathologist's office on days of slide reading from 4/20/21 to the date of the survey. The findings include: 1. The surveyor observed requirements for room temperature, 50-104F/10-40C and humidity, 20-80%, in the IM's. 2. The OM confirmed on 9/26/23 at 1:00 pm that the pathologist's office room temperature and humidity were not documented on the days of slide reading. -- 2 of 2 --