Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the Director of Laboratory Services, the laboratory failed to be constructed, arranged, and maintained to ensure the space necessary for conducting all phases of testing processes. This deficient practice had the potential to affect 3,706,530 patients tested under the specialties of Microbiology, Chemistry, Hematology, Diagnostic Immunology, and Immunohematology from 01/01/2022 through 12/04/2023. Findings Include: 1. The inspector directly observed the laboratory on 12/04/2023 at 1:00 PM and found the laboratory was located in a 972 square foot room. 2. The laboratory contained two Roche Cobas 6000s, one Sysmex DI-60, 18 benchtop testing instruments, one Sure- Grip EX 45 gallon flammable cabinet, one 12 gallon flammable cabinet, four Thermo TSX single door refrigerators, one Thermo TSX single door freezer, one Thermo Revco single door freezer, two Thermo Revco double door refrigerators, one under cabinet Thermo refrigerator, two sinks, a closed system molecular preparation hood, a blood bank preparation hood, one floor model water filtration system, and a small specimen accessioning area. 3. The Director of Laboratory Services stated the laboratory had been cited during previous accreditation inspections. The interview occurred on 01/26/2017 at 1:50 PM. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of