Southwest Skin Laboratory Pllc

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 humidity records for review from 2022, 2023 and 2024, review of the manufacturer's specifications for the Avantik QS12 Cryostat, Sakura Tissue-Tek Prisma Automated Slide Stainer, Sakura Tissue-Tek VIP Vacuum Infiltration Processor, Roche Ventana Benchmark Ultra and Roche Ventana Benchmark Special Stains, and interview with the testing personnel (TP-2), the laboratory failed to monitor and document the humidity of the room where the above instrumentation is utilized. Findings include: 1. The laboratory utilizes the Avantik QS12 Cryostat and the Sakura Tissue-Tek Prisma Automated Slide Stainer in conjunction with Mohs testing under the subspecialty of Histopathology with a reported annual test volume of 2880. 2. The manufacturer's specifications for the Avantik QS12 Cryostat reviewed during the survey listed an operating relative humidity range of 0%-60%. 3. The manufacturer's specifications for the Sakura Tissue-Tek Prisma Automated Slide Stainer and the Sakura Tissue-Tek VIP Vacuum Infiltration Processor reviewed during the survey listed an operating relative humidity range of 30%-85%. 4. The manufacturer's specifications for the Roche Ventana Benchmark Ultra reviewed during the survey listed an operating relative humidity range of 10%-90%. 5. The manufacturer's specifications for the Roche Ventana Benchmark Special Stains reviewed during the survey listed an operating relative humidity range of 20%-80%. 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 -- 6. On the survey date of 3/28/2024, no documentation was provided for review to indicate the laboratory monitored and documented the humidity of the room where the above instrumentation is utilized on each day of patient testing during 2022, 2023 and 2024 through the date of the survey. 7. The TP-2 interviewed on 3/28/2024 at 12:00 PM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's pathology test reports for Biopsy interpretations performed in 2019, 2020 and 2021 and interview with the facility personnel, the laboratory failed to include the gross description on three out of three test reports reviewed during the survey. Findings include: 1. The laboratory performs Biopsy interpretations, including the gross description, under the sub-specialty of Histopathology, with an approximate annual test volume of 4,757. 2. During the survey conducted on February 25, 2022, three out of three pathology test reports reviewed [SW19-0970 from 6/9/19, SW20-1181 from 8/7/20 and SW21-0255 from 2/3 /21] failed to include the gross description. 3. The gross description (including weighing, measuring, describing color, specific orientation for diagnostic interpretation, and other characteristics of the tissue) must be included on the pathology test report. 4. The facility personnel confirmed that the biopsy test reports reviewed during the survey failed to include the gross description as described above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- 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 to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of testing personnel competency evaluation documentation and interview with the facility personnel, it was determined that the technical supervisor failed to evaluate and document the performance of one testing personnel at least annually. Findings include: 1. During the survey conducted on February 25, 2022, no documentation of an annual competency assessment from 2019, 2020 and 2021 was presented for review for one testing personnel who performs the gross description on patient specimens. 2. The facility personnel confirmed that no annual competency evaluation was performed during 2019, 2020 and 2021 for the testing personnel indicated above. -- 2 of 2 --