Fairview Pathology

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation and interview with the Laboratory Director (LD), the laboratory failed to perform timer calibration checks as required by the manufacturer before the expiration date for 1 of 1 timer (s) in use. Findings include: 1. During a tour of the laboratory on 05/12/2025 at 12:20 pm, the surveyor observed a Traceable timer in use with an expiration date of 04/23/2023. 2. A record review of the laboratory procedure manual revealed the lack of a maintenance procedure for timer calibrations and/or replacement of timers prior to expiration date. 3. An interview on 05/12/2025 at 3:00 pm, with the LD confirmed the timer was not calibrated and/or replaced before the date of expiration. ***Repeat Deficiency from the 3/16/2023 and 08/21/2021 Survey*** 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform and document the timer calibration checks as required by the manufacturer before the expiration for 1 (Traceable timer) of 1 timer in use. Findings include: 1. During a tour of the laboratory on 3/16/2023 at 9:07 am, the surveyor observed a timer in the histopathology processing laboratory in use past the expiration date of 11/25/2021. 2. A record review of the procedure manual revealed no maintenance procedure for the frequency of timer calibrations and /or replacement prior to expiration date noted on the timer. 3. A record reviewed revealed a lack of documentation for the calibration of the timer and/or replacement by the expiration date noted on the timer. 4. A interview on 3/16/2023 at 12:15 pm, the LD confirmed the timer was not calibrated and/or replaced before their expiration. ***Repeat Deficiency from the 8/26/2021 survey*** 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with the Laboratory Director (LD), the laboratory failed to perform and document timer calibrations for 3 (Serial number (S/N) 151974019, S/N 151834685, and S/N 160145791) of 4 timers before their expiration dates. Findings include: 1. During a tour of the laboratory on 8/26 /2021 at 11:10 am, the surveyor observed the use of 3 of 4 timers in use past their expiration dates as follows: a. S/N 151974019 - expired 12/29/2017 b. S/N 151834685 - expired 11/05/2017 c. S/N 160145791 - expired 1/22/2018 2. An interview on 8/26 /2021 at 11:10 am, the LD confirmed the laboratory failed to perform and document timer calibrations or replace the timer. B. Based on record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform and document the weekly and monthly quality control for the eyewash maintenance for 24 months ( September - December 2019, February - December 2020, and January - August 2021) of 24 months reviewed. Findings include: 1. A record review of the "Eyewash Maintenance Chart" states the following 3 steps to be completed: a. "Activated the eyewash station weekly to flush out stagnant water and to check that the eyewash station operating properly (let run for a minimum of 30 seconds)." b. "Once a month check the temperature of the water coming from the eyewash station; verify that it is within the acceptable temperature range. If ouf of range report to maintenance for repairs." c. "Record date and your initials when testing is complete." 2. A record review of the "Eyewash Maintenance Chart" revealed the laboratory did not perform and document the maintenance of the eyewash station weekly and monthly as instructed as follows: a. September - December 2019 - lack of 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 -- weekly and monthly documentation b. February - December 2020 - lack of weekly and monthly documentation c. January - August 2021 - lack of monthly documentation d. No documentation of an acceptable temperature range for the water 3. An interview on 8/26/2021 at 10:20 am, the LD confirmed the eyewash quality control was not documented weekly and monthly as instructed. -- 2 of 2 --

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 interview with the Laboratory Director (LD), the laboratory failed to monitor and document humidity for 2 (August 2017 to August 2019) of 2 years. Findings include: 1. A review of the installation manual for the Leica ASP300S instrument stated the operating maximum relative humidity is "less than 80%." 2. A record review of the installation manual for the Hacker-Meisei coverslipper stated, "operational humidity range is 30% to 90%" 3. When requested, the LD was not able to provide documentation for humidity monitoring for August 2017 to August 2019. 4. During the interview on 8/26/19 at 10:37 am, the LD confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Laboratory Director (LD), the laboratory was using phosphomolybdic-phosphotungstic acid solution that exceeded the manufacturer's expiration date for the current lot in use. Findings include: 1. During a tour of the laboratory on 8/26/19 at 9:11 am, the surveyor observed one open bottle of phosphomolybdic-phosphotungstic acid solution, used in Masson's Trichrome staining, with the expiration date of 7/25/19. 2. A review of the laboratory's "Quality Assurance" procedure under the "Special Stains" section stated, "all stains and reagents are monitored to ensure that only stable chemicals are used in patient testing." 3. A review of the laboratory's log "Fairview Pathology Daily Total Numbers" revealed two patients were tested on 8/6/19 using the Trichrome method and the expired phosphomolybdic-phosphotungstic acid solution. 4. During the interview on 8/26/19 at 9:11 am with the LD confirmed the laboratory retained and used expired reagents. -- 2 of 2 --