Washington Health System Lab - Ml

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of laboratory records, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature and humidity for 2 of 2 years to ensure reliable test system operation and test result reporting for instrumentation used to perform histopathology microscopic slide examinations from 01/09/2024 to the date of survey. Findings include: 1. The operating conditions listed in the instruction manual for the Olympus BX 46F microscope stated: "temperature: 5 C to 40C, humidity: 80%. RH max." 2. On the date of the survey, 01/15/2026 at 9:45 am, the laboratory could not provide documentation for monitoring room temperature and humidity to ensure operating conditions were met for 1 of 1 Olympus BX 46F microscope (s/n 7J40561) used to perform histopathology microscopic slide examinations for 2 of 2 years from 01/09/2024 to 01 /15/2026. 3. Review of the laboratory's test logs revealed the laboratory performed 1 histopathology microscopic slide examination from 01/09/2024 to 01/15/2026. 4. The LD confirmed the findings above on 01/15/2026 at 11:05 am. 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 --

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 a lack of documentation and interview with the laboratory director (LD), the laboratory failed to monitor and document the room humidity to ensure operating conditions were met for the histopathology testing from 02/17/2022 to the day of the survey. Findings Include: 1. On the day of the survey, 01/09/2024 at 11:21 am, a review of the Leica CM 1860 UV cryostat manufacturer's instructions revealed that all specifications related to temperature are valid only for an ambient temperature up to 22 C and for an air humidity lower than 60%. 2. The laboratory failed to provide documentation of humidity for the Leica CM 1860 UV cryostat for histopathology testing from 02/17/2022 to the day of the survey. 3. The LD confirmed the findings above on 01/09/2024 at 11:30 am. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated 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 -- to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a lack of documentation and interview with the laboratory director (LD), the Technical Supervisor (TS) (CMS 209 Personnel #1) failed to evaluate the annual competency assessment for 2 of 3 Testing Personnel (TP) who performed Microscopic Examinations, Grossing, Inking, and Mapping in histopathology laboratory in 2022 and 2023. Findings include: 1. On the day of survey, 01/09/2024 at 10:30 am, the laboratory could not provide competency assessment records for 2 of 3 TP (CMS 209 TP #2 and #3) for their testing responsibilities in histopathology laboratory in 2022 and 2023. 2. The laboratory's total estimated annual volume for histopathology testing was 40 (CMS 116). 3. The LD confirmed the findings above on 01/09/2024 at 11:30 am. -- 2 of 2 --