Summary:
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 record review and staff interview, the laboratory failed to define and provide evidence of monitoring and documenting humidity requirements in the subspecialty of histopathology. Findings include: 1. Record review on 07/24/2023 of the laboratory maintenance records revealed lack of documentation of humidity levels in the laboratory area. 2. Record review on 07/24/2023 of the 'Tissue-Tek V.I.P. Vacuum Infiltration Processor' manual revealed a relative humidity of 0% to 85% (non- condensing). 3. Record review on 07/24/2023 of the 'Leica EG1160 Paraffin Embedding Center' manual revealed a relative humidity of 0% to 60% (non- condensing). 4. Record review on 07/24/2023 of the 'Leica CM 1510S' manual revealed a relative humidity of 0% to 60% (non-condensing). 5. Staff interview on 07 /24/2023 at 9:45 AM with the laboratory supervisor (LS) confirmed the above findings. The LS further commented that he/she was unaware of the humidity requirements. 6. The laboratory performs 8,809 tests annually in the subspecialty of histopathology. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) 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 -- (b) The postanalytic systems quality assessment must include a review of the effectiveness of