Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/10/2019 found Jeffrey Marcus MD MMPH PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 cryostat manual review and staff interview, the laboratory failed to document room temperature and humidity requirement to ensure optimal operation for the Leica CM 150 cryostat for 2 out of 2 years reviewed. The findings include: A review of Leica CM 150 manual revealed a requirement for optimal operation, a range of room temperature below 22 C and Humidity must not exceed 60 %. A review of temperature logs for 2018 and 2019, revealed no documentation of room humidity and temperature. During an interview on 1:30 pm at 12/10/19, office manager confirmed that there was no documentation of the room temperature and humidity for the period of reference. 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 --