Bingham Dermatology Group

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 accuracy verification documentation for Mohs and interview with the testing personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2023 and 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Mohs testing at least twice annually during 2023 and 2024. 2. The testing personnel interviewed on 1/14/25 at 12:00 PM confirmed the laboratory failed to verify the accuracy of Mohs testing testing at least twice annually during 2023 and 2024. 3. The laboratory's reported annual test volume under the subspecialty of Histopathology is 700. 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of humidity records for review from 2023 and 2024, review of the manufacturer's specifications for the Advantik QS12 Cryostat and interview with the facility personnel, the laboratory failed to monitor and document the ambient humidity of the room where the cryostat is utilized. Findings include: 1. The laboratory utilizes the Advantik QS12 Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology with an annual test volume of 700. 2. The manufacturer's specifications for the Advantik QS12 Cryostat reviewed during the survey listed an operating relative humidity range of 0%-60%. 3. The laboratory failed to provide documention demonstrating the ambient humidity of the room where the cryostat is utilized was monitored and recorded on each day of patient testing from 2023 through 2024 (through the survey date of 1/14/2025). 4. The facility personnel interviewed on 1/14/2025 at 11:50 AM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of patient logs, direct observation of staining reagents and interview with the facility personnel, the laboratory utilized Xylene staining reagent past the expiration date indicated on the reagent label. Findings include: 1. Direct observation of the Xylene reagent used in the staining process of Mohs surgical slides revealed an expiration date of 10/07/2018. 2. The facility personnel confirmed that the expired reagent indicated above was being used in the slide staining process up to the day of the survey. 3. The number of patients tested using the expired Xylene reagent could not be determined at the time of the survey. 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 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 presented for review and interview with the facility personnel, the laboratory failed to verify the accuracy of Mohs surgery slide reading at least twice annually during 2016 and 2017. Findings include*: 1. The laboratory performs patient testing under the sub-specialty of Histopathology with an annual test volume of 780. 2. The laboratory presented accuracy checks performed by an outside lab in 2018 for Dermatopathology diagnostic assessment of Mohs slides from 2016 and 2017. There was no accuracy checks pertaining specifically to Mohs including number of stages and margins clear on a specific stage. There was only the pathology diagnostic assessment. 3. The slides from 2016 and 2017 were not sent out for accuracy assessment until 2018. 4. The facility personnel acknowledged that there was a misunderstanding pertaining to the accuracy checks. * This is a repeat deficiency from the survey performed on 03/24/2016. 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of room temperature logs for review and interview with the facility personnel, the laboratory failed to document the temperature of the room where slide staining reagents are stored for testing under the sub-specialty of Histopathology . Findings include*: 1. The laboratory presented a policy that indicated the criteria for the room temperature where slide staining reagents are stored (72 - 82 degrees F), but the room temperature log presented for review had no room temperatures documented. 2. The facility personnel confirmed that the laboratory was not documenting the room temperature as indicated above. * This is a repeat deficiency from the survey performed on 03/24/2016. -- 2 of 2 --