Dyson Dermatology, Pllc

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of final test result information for Mohs maintained in the Electronic Health Record (EHR), review of established policies and procedures and interview with the facility personnel on 10/09/25 at 11:27 AM, the laboratory failed to accurately report Mohs test results in the patient's EHR for one out of two patient records reviewed during the survey. Findings include: 1. Specimen information and the final test result for Mohs is manually transcribed by laboratory personnel into the patient's EHR. 2. The laboratory's established policy titled, "Documentation for Mohs Surgery in the Electronic Health Record EMA", states, "All documentation is double- checked by the lab technician, who ensures the Mohs Flow Chart is uploaded to the patient's chart and that all information in the visit note is accurate and precise prior to note finalization." 3. One out of two Mohs cases reviewed (# M25-009) failed to include the correct accession number in the patient's EHR. The EHR record listed the accession number as M24-009, and the Mohs log, patient slides and Mohs map listed the the accession number as M25-009. 4. The laboratory failed to follow their established policy indicated above to ensure the visit note for Mohs case# M25-009 was accurate and precise prior to note finalization. 5. The facility personnel interviewed on 10/09/25 at 11:27 AM confirmed the Mohs accession number listed in 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 -- the EHR for case# M25-009 was incorrect and confirmed that the laboratory failed to follow their established policy to ensure the accuracy of manually transcribed test information. 6. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 4,342. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on lack of initial training documentation for 2 out of 2 testing personnel (TP-2 and TP-3) and interview with facility personnel on 10/09/25 at 10:55 AM, the laboratory director failed to ensure that all testing personnel receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. No initial training documentation was presented for review for 2 out of 2 testing personnel (TP-2 and TP- 3) who perform the gross examination of dermatopathology specimens in the specialty of Pathology. 2. The facility personnel interviewed on 10/09/25 at 10:55 AM confirmed the laboratory failed to provide documentation of initial training for the two testing personnel indicated above. 3. The laboratory began performing the gross examination of dermatopathology specimens on 3/03/25 and reports an annual test volume of 4,296. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on personnel record review and review of laboratory policies and procedures on 10/09/25 at 11:00 AM, the laboratory director failed to establish policies and procedures for monitoring and assessing the competency of 2 out of 2 testing personnel who conduct testing in the subspecialty of histopathology. Findings include: 1. The laboratory employs two testing personnel who perform the gross examination of dermatopathology specimens. 2. The laboratory director failed to establish policies and procedures to monitor individuals who perform the gross examination of dermatopathology specimens, to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 3. The facility personnel interviewed on 10/09/25 at 11:00 AM acknowledged the laboratory director failed to establish policies and procedures to assess the competency of testing personnel who -- 2 of 3 -- perform the gross examination of dermatopathology specimens. 4. The laboratory performs 4,296 tests annually in the specialty of Histopathology. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of documentation of semiannual competency evaluations for 2 out of 2 testing personnel and interview with facility personnel on 10/09/25 at 10:26 AM, the technical supervisor failed to evaluate and document the performance of individuals responsible for the gross examination of dermatopathology specimens at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. No evidence of a semiannual competency evaluation was presented for review for two out of two testing personnel (TP-2 and TP-3) who perform the gross examination of dermatopathology specimens. 2. The facility personnel interviewed on 10/09/25 at 10:26 AM confirmed the technical supervisor failed to perform and document semiannual competency evaluations for the 2 testing personnel indicated above. 3. The laboratory began performing the gross examination of dermatopathology specimens on 3/03/25 with a reported annual test volume of 4,296. -- 3 of 3 --

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 Advantik QS11 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 QS11 Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology with an annual test volume of 492. 2. The manufacturer's specifications for the Advantik QS11 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 2022 through 2024 (through the survey date of 8/27/2024). 4. The facility personnel interviewed on 8/27/2024 at 8:40 AM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the patients' Mohs map, review of patient slides, review of the electronic test report, review of the laboratory's Mohs log and interview with the facility personnel, the laboratory failed to follow established procedures to ensure positive identification of patient's dermatopathology specimens throughout the test reporting process. Findings include: 1. The laboratory performs Mohs testing under the sub-specialty of histopathology, with an approximate annual test volume of 564. It is the practice of the laboratory to assign a unique case number to each patient's Mohs specimen. The unique case number is included on the laboratory's Mohs log, the patient's Mohs map, the patient slide(s) and the patient's electronic test report. 2. Review of the Mohs map and electronic test report for patient B.M. from testing performed on 3/04/2022 indicated the Mohs case number as "M22-065". The Mohs log and Mohs slides for this patient indicated the Mohs case number as "M22-066". 3. Facility personnel interviewed during the survey confirmed that the Mohs map and the electronic test report indicated above listed the incorrect case number. The facility personnel acknowledged that the unique case number for this patient, tested on 3/04 /2022 was M22-066. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) documentation, review of electronic test records and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified with electronic test reports. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 564. 2. The laboratory utilizes an electronic medical record (EMR) system to document the Mohs test procedure and Mohs test results. The test information is manually transcribed by laboratory personnel into the EMR. In addition, the laboratory manually documents the Mohs log, the Mohs map and patients' slides. 3. No QA documentation was provided for review during the survey to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified with dermatopathology test results which are manually entered into the EMR, in addition to the patient's case information documented on all Mohs test records including the Mohs log, Mohs map, patient slides and electronic test reports. 4. The laboratory failed to enter (manually transcribe) the correct Mohs case number in the EMR for one patient record reviewed during the survey, and failed to manually scribe the correct Mohs case number on the Mohs map. See D5203 for findings. 5. The facility personnel confirmed that the laboratory failed to establish QA policies and procedures to monitor, assess and correct problems identified with the postanalytic systems, specifically test report information which is manually scribed (Mohs log, Mohs map, and patients' slides) and manually entered into the EMR (electronic test report). -- 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 accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2017 and 2018. Findings include: 2. No documentation was presented for review during the survey to indicate that the laboratory verified the accuracy of Mohs testing at least twice annually during 2017 and 2018. 3. No documentation was presented for review during the survey to indicate that the laboratory verified the accuracy of Biopsy interpretation at least twice annually during 2017 and 2018. 4. The facility personnel presented a policy that indicated accuracy checks were to be performed twice a year (10 total per year) by outside dermatologists. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of room temperature and cryostat temperatures for the year 2019 up to the day of the survey and interview with the facility personnel, the laboratory failed 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 -- to provide