Summary:
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 lack of temperature records for review and interview with the facility personnel, the laboratory failed to monitor and document the room temperature where dermatopathology reagents are utilized and stored and failed to monitor and document the temperature of the cryostat used in conjunction with Mohs testing during April and May 2020. Findings include: 1. The laboratory processes and interprets dermatopathology slides in conjunction with Mohs surgery, with an approximate annual test volume of 1,100. 2. No room temperature documentation was presented for review from April 2020 and May 2020 to indicate the laboratory monitored and documented the temperature of the room each day of patient testing, where dermatopathology reagents are utilized and stored. 3. No documentation was presented for review to indicate the laboratory monitored and documented the cryostat temperature each day of patient testing during April and May 2020. 4. The laboratory performed patient testing on 7 days during April and May 2020. 5. The facility personnel confirmed that the laboratory failed to monitor and document the cryostat temperature and the room temperature of the laboratory where reagents are stored and used for patient testing during April 2020 and May 2020. D5433 MAINTENANCE AND FUNCTION CHECKS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of microscope maintenance logs and interview with the facility personnel, the laboratory failed to perform and document the microscope maintenance as defined by policy during April and May 2020. Findings include: 1. The laboratory's log titled, "Daily Check for Mohs" indicates that the microscope should be cleaned each day of use. 2. No documentation was presented for review to indicate the laboratory performed the microscope maintenance as indicated above during April and May 2020. The microscope was used for patient testing on approximately 7 days during that time period. 3. The facility personnel confirmed that the laboratory failed to perform maintenance on the microscope as indicated in policy during the timeframe indicated above. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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 lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of staining materials used for patient testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 1,100. 2. No documentation of the Hematoxylin & Eosin (H & E) stain acceptability was presented for review for testing that occurred during April 2020 and May 2020. Approximately 30 patients were tested on 7 separate days during this time period. 3. The facility personnel confirmed that the laboratory failed to document the stain acceptability during the time period indicated above. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of Quality Control records for review, the laboratory director failed to ensure that quality control programs are maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5473 for findings. -- 3 of 3 --