Southwest Skin Specialists, Llc Dba

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 lack of established humidity criteria defined by the laboratory, review of the manufacturer's specifications for the analyzer, and interview with the facility personnel, the laboratory failed to define criteria for the humidity of the area where the Thermo Scientific HM525 NX cryostat is utilized. Findings include: 1. The laboratory utilizes the Thermo Scientific HM525 NX cryostat instrument to process patient tissue for analysis during the Mohs procedure. This testing is performed under the subspecialty of Histopathology with an annual test volume of 825. 2. The manufacturer's specifications for the Thermo Scientific HM525 NX cryostat reviewed during the survey listed an operating relative humidity range of 0% to 60%. 3. The laboratory failed to establish the humidity range for the room where the Thermo Scientific HM525 NX cryostat is utilized. 4. The facility personnel interviewed on 8 /25/26 at 10:00 AM confirmed the laboratory failed to define the humidity criteria for the area where the Thermo Scientific HM525 NX cryostat is utilized. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- (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 Mohs test reports maintained in the Electronic Health Record (EHR) and interview with the facility personnel, one out of three Mohs test reports reviewed in the EHR failed to list the correct number of Mohs stages performed. Findings include: 1. The laboratory reads and interprets slides in conjunction with the Mohs procedure in the subspecialty of Histopathology with an approximate annual test volume of 825. 2. It is the practice of the laboratory to maintain the Mohs test report (Mohs operative report and Mohs map) in an electronic record system. The total number of stages is documented on the test report (operative note) maintained in the EHR and on the Mohs map. 3. One out of three Mohs test reports (Patient #1: DOS; 4/17/25) reviewed in the EHR during the survey failed to list the correct number of stages. The Mohs log, Mohs map and slides indicated the case had four stages. The Mohs operative report maintained in the EHR stated, "Number of Stages: 6", however the operative report, Mohs log, and slides indicated the case was completed at 4 stages. 4. The facility personnel interviewed on 8/25/26 at 9:30 AM confirmed the Mohs operative report for the patient indicated above failed to list the correct number of stages performed. -- 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 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 --

Summary Statement of Deficiencies D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patients' electronic test reports and interview with the facility personnel, the laboratory failed to have two out of two pathology reports signed by the individual who performed the examination and made the diagnosis. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 238. The laboratory performs the Mohs procedure and performs frozen biopsy interpretation on patient specimens. It is the practice of the laboratory to record test results in the Electronic Medical Record (EMR). 2. Review of the electronic note for patient M17-147 on 11/27/17, indicated the pathology report failed to include the signature of the individual making the diagnosis. 3. Review of the electronic note for a frozen biopsy performed on 11/15/17 for patient, J.L., indicated the pathology report failed to include the signature of the individual making the diagnosis. 4. The facility personnel confirmed that the pathology reports indicated above were not signed by the individual who performed the examination and made the diagnosis. 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 --