Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on March 27, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: A review of the 2024 - 2026 Maintenance Records, 2024 - 2026 Personnel Records, 2024 - 2026 Proficiency Testing Records, 2024 - 2026 Quality Control Records, and 2024 - 2026 Temperature Records found that the Laboratory Director failed to ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services and identify failures in quality as they occur. THE FINDINGS INCLUDE: 1. A review of 2024 - 2026 Maintenance Records, 2024 - 2026 Personnel Records, 2024 - 2026 Proficiency Testing Records, 2024 - 2026 Quality Control Records, and 2024 - 2026 Temperature Records revealed that quality assurance records review was not performed. 2. An exit interview, with the HistoTech, on March 27, 2026, at 1:00pm confirmed that the Laboratory Director failed to ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and identify failures in quality as they occur. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) 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 -- (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: A review of 2024 - 2026 Maintenance Records and 2024 - 2026 Temperature/ Humidity Records confirmed that the Laboratory Director failed to ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. THE FINDINGS INCLUDE: 1. A review of 2024 - 2026 Maintenance Records confirmed maintenance documentation for the Ritter MII UltraClave was not available. 2. A review of 2024 - 2026 Maintenance Records revealed that the calibration, for the digital thermometer used for monitoring room temperature and humidity, was not completed after 10/01/2016. 3. A review of 2024 - 2026 Temperature/ Humidity Records revealed that the operating ranges for room temperature and humidity were not appropriate for the analyzers in use. The following were noted: a. Per the Temperature/ Humidity Logsheet the monitored temperature range was set as 32F - 122F (0C - 50C) and a monitored humidity range set as 20% - 90% 1. An Olympus BH-2 Microscope which has an operating temperature requirement of 0C - 40C (32F - 104F) with an operating relative humidity requirement of 30% - 90%. 2. A Lecia CryoCut 1800 which has an operating temperature requirement of 18C - 35C (64F - 95F) with an operating relative humidity requirement of 60%. 3. A ThermoScientific Linistain which has an operating temperature requirement of 5C - 40C (41F - 104F) with an operating humidity requirement of ? 80% up to 31C. 4. An exit interview, with HistoTech, on March 27, 2026, at 1:00pm, confirmed that the Laboratory Director failed to ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. -- 2 of 2 --