Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 2, 2018. Pathology Associates clinical laboratory had one deficiency found at the time of the visit. 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 record review and interview, it was determined that the laboratory did not document room temperature and humidity to assure optimal storage temperature for certain reagents and the cryostat machine for 2 years from August 2016 to 2018. Findings included: Review of the manufaturer's procedure indicated that the clearing solvent used for Histopath should be stored at a temperature between 15-30 degrees Celsius. The cryostat machine also requires humidity and room temperature for its optimal operation. There were no temperature and humidity logs available for documenting the temperature of the laboratory room. Interview on 08/02/18 at 1130 AM, testing person # 3 confirmed that the lab was not aware of the requirement to record humidity and room temperature and therefore it was not done and documented. 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 --