Summary:
Summary Statement of Deficiencies D0000 An entrance conference was held 11/20/2019 with the Mohs Tech. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 11/20/2019, this facility was found NOT to be in compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1487 Testing Personnel High Complexity Testing An exit conference was held on 11/20/2019 with the Mohs Tech and Laboratory Manager. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. 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: I. Based on direct observation, manufacturer's instructions, temperature charts, and in interview with staff, the laboratory failed to define a temperature range for the room in which equipment and supplies were stored and have storage condition requirements for 12 of 12 months in 2018 and 10 of 10 months in 2019. Findings included: 1. During a tour of the Mohs laboratory on 11/20/2019 at 1:20 pm, Transystem Sterile Transport Swab COPAN swabs (quantity of 9; Lot #001B23, expiration date 08/31 /2020) were observed to be stored in the drawer and had a storage requirement of 5 - 25 degrees Celsius (C). The Mohs laboratory had 2 cryostats: Leica CM1510S Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- (cryostat #1) and Leica CM1520 (cryostat #2). Review of Leica operator's manual (manufacturer's instructions) stated, "4.1 Installation site requirements: The place of installation must meet the following requirements: Room temperature consistently 18C - 35C." 2. Review of temperature charts from 01/2018 through 10/2019 stated, "Temperature Range- 72." The laboratory did not define a temperature range to ensure all equipment and supplies stored in the Mohs laboratory were within the required temperatures. 3. During an interview on 11/20/2019 at 1:20 pm, the Mohs tech reviewed and confirmed the above findings. II. Based on direct observation, temperature charts, laboratory's procedure manual, and in interview with staff, the laboratory failed to define a consistent temperature range for the primarily used cryostat for 12 of 12 months in 2018 and 10 of 10 months in 2019. Findings included: 1. During a tour of the Mohs laboratory on 11/20/2019 at 1:20 pm, there were 2 cryostats: Leica CM1510S (cryostat #1) and Leica CM1520 (cryostat #2) observed. According to the Mohs tech on 11/20/2019 at 1:20 pm, she stated cryostat #2 is the one primarily used. 2. Review of the temperature charts from 01/2018 through 10 /2019 did not have a temperature range for the cryostat internal temperature, yet it was documented. 3. Review of the laboratory's procedure manual included 3 different policies with 3 different cryostat internal temperature ranges, as follows: "Equipment Quality Control-Cryostat ...2. Temperature range is -20*C to -30*C." "PURPOSE OF FROZEN SECTION: ...The temperature is kept within the recommended cutting range of -19C to -25C." "MOHS PROCEDURE: ...To begin a Moh's procedure the cryostat need to be turned to -20C to -25C." The laboratory did not ensure all of their policies were consistent and it was not known what temperature was the acceptable range. 4. During an interview on 11/20/2019 at 1:20 pm, the Mohs tech reviewed and confirmed the above findings. 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 review of the laboratory's procedure manual, manufacturer's instructions, and maintenance records, the laboratory failed to perform and document maintenance of the Tissue Processor as defined by the manufacturer and with at least the frequency specified by the manufacturer (weekly) for 23 weeks in 10/2018, 11/2018, 12/2018, 09 /2019, 10/2019, and 11/2019. Findings included: 1. Review of the laboratory's procedure for the processor maintenance stated, "7.2 Warm water flush performed weekly" followed by step-by-step instructions. 2. Review of the Sakura Tissue-Tek operators manual (manufacturer's instructions) stated, "WEEKLY MAINTENANCE: Reagent Exchange and Warm Water Flush" followed by detailed step-by-step instructions. 3. Review of a random sampling of Tissue Processor records from 10 /2018, 11/2018, 12/2018, 09/2019, 10/2019, and 11/2019 did not include documentation of the weekly "warm water flush" as defined in the procedure manual and operator's manual. 4. During the exit interview on 11/20/2019 at 2:50 pm, the laboratory manager stated the weekly warm water flush was performed on the Tissue Processor but had not been documented. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) -- 2 of 6 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, daily hematoxylin and eosin (H&E) quality control (QC) logsheets, test volume records, and in interview with staff, the laboratory failed to ensure documentation of H&E for intended reactivity to ensure predictable staining characteristics, each day of use for 61 of 61 days in 2018 and 61 of 61 days in 2019 (random sampling from 02/2018, 03/2018, 04/2018, 07 /2019, 08/2019, 10/2019). Findings included: 1. Review of the laboratory's procedure manual included "H&E Slide Staining" and did not include documentation of H&E intended reactivity to ensure predictable staining characteristics. 2. Review of the "Daily H&E QC Logsheets" from 02/2018, 03/2018, 04/2018, 07/2019, 08/2019, 10 /2019 included dates, "Tech Initials," Pathologist Initials, Acceptable Y/N, Comments, and