Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Healthcare Colleagues Pa was found to be not in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 staff interview, the laboratory failed to document the laboratory room temperature, humidity, and temperature of the cryostat for 2 out of 17 days reviewed in August 2024 ,and 2 out of 16 days in September 2024. Findings include: Review of the document titled "Laboratory Environment Log" showed no documentation of laboratory temperature, humidity, or cryostat temperature on 8/6/24, 8/7/24, 9/4/24, and 9/12/24. During the interview with the Practice Manager on 11/6 /24 at 9:00am, it was confirmed the documentation was missing for room temperature, humidity, and cryostat temperature. 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 --