West Valley Dermatology

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Histotechnician, the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination for TP1 (testing Personnel). The laboratory performs approximately 274 histopathology slide examinations annually. Findings include: 1. Record review revealed that the laboratory failed to verify the accuracy, at least twice annually, of their test system for histopathology slide examination for TP1 since the last survey which was performed on 8/15/2023. 2. In an interview on 3/17/2025 at approximately 11:42 am, the Histotechnician confirmed the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination. 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 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 office manager, the laboratory failed to follow the laboratory's procedure to monitor and record room temperature and humidity. The laboratory performs approximately 326 histopathology tests annually. Findings include: 1. During laboratory record review, the laboratory failed to produce records of temperature and humidity readings. 2. Interview with office manager on 8 /15/2023 at 1:27 PM, confirmed the laboratory did not monitor or record the laboratory temperature or humidity since the last survey on 1/23/2021. 3. Review of 'Quality Control Program' procedure revealed the laboratory staff failed to follow their procedure as stated: 'Temperatures will be taken by an employee in the laboratory and recorded'. D5433 MAINTENANCE AND FUNCTION CHECKS 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 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 -- 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 record review and interview with the Laboratory Director, the laboratory failed to perform preventative maintenance for one of one microscopes since the last survey on 1/23/2021. Findings include: 1. Record review of the microscope maintenance records revealed lack of microscope maintenance documentation since the last survey performed on 1/23/2021. 2. Interview with the Laboratory Director on 8 /15/2023 at 1:35 PM, confirmed that the laboratory failed to perform preventative maintenance on one of one microscopes since the last survey on 1/23/2021. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on quality assessment records review, lack of documentation, and interview with the laboratory director, the laboratory failed to document they verified histopathology test accuracy at least twice annually for 1 of 2 years reviewed, 2020. The laboratory performed approximately 200 formalin fixed paraffin embedded biopsy diagnoses per year and 150 Mohs frozen section micrographic specimens per year. Findings include: 1. Twice annual test verification failed to include the dates the laboratory sent Mohs frozen section slide cases for review in 2020. Without the dates of verification, it could not be determined the laboratory performed test accuracy twice annually in 2020. 2. In an interview conducted on 01/23/2021 at approximately 9:50 A.M. the director confirmed the test accuracy failed to include the dates of review by a dermatopathology peer. 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 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 -- acceptability. This STANDARD is not met as evidenced by: Based on patient test reports review, lack of documentation and interview with the director, the laboratory report failed to include the Mohs Case number to associate the report with the slides and the Mohs map. Biopsy report for patient A included the incorrect slide number for the diagnosis of Squamous cell carcinoma from the right chin. Findings include: 1. Patient test reports for Mohs case number 140 performed on 12/03/2019 and Mohs case number 102 performed on 09/22/2020 failed to include the Mohs case number in the test report. The Mohs case number is the identification on the patient's slides associated with the report diagnosis. 2. Patient test report for Patient A formalin fix paraffin embedded biopsy of the Right chin include the diagnosis was made from side number 133. The actual slide number for Patient A, Right chin was 138. 3. In an interview with the director on 01/23/2021 at approximately 9:00 A.M. the director confirmed the case number was not included in the Mohs surgical reports for the diagnosis the Basal Cell Carcinoma tumors were removed and margins were clear and the test report for the right chin biopsy was due to a clerical error between the slide numbers assigned by the slide preparation facility and the laboratory patient log. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to verify potassium hydroxide (KOH) at least twice annually for 2 of 2 years of testing reviewed (August 2016 to August 2018). The number of KOH skin scrapings laboratory tested was not available. Findings include: 1. The laboratory failed to document they verified KOH test accuracy at least twice annually from August 2016 to August 2018. 2. In an interview with staff the laboratory on 08/17/2018 at approximately 10:30 A.M., staff stated they did not have a system to verify KOH testing accuracy at least twice annually in 2016 an 2017. THIS IS A REPEAT DEFICIENCY. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: 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 -- Based on lack of documentation and interview with staff, the laboratory failed to maintain records of potassium hydroxide (KOH) testing performed from August 2016 to August 2018. Findings include: In an interview conducted on 08/17/2018 at approximately 8:30 A.M. staff stated the laboratory did not perform KOH testing. Staff recalled at approximately 9:30 A.M. that KOH testing was performed on-site occasionally. Staff confirmed the laboratory did not maintain a record of the dates and the positive identification of the specimens examined for the presence or absence of fungal elements. -- 2 of 2 --