New Dermatology Group Ltd

Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records, observation of retained slides in the laboratory, and interview with a testing personnel (staff A), the laboratory did not maintain slides in a manner that ensured their preservation; staff could not separate multiple stored slides from ten of 34 Mohs cases performed on two consecutive days of cases, January 31, 2025 and February 27, 2025. Findings include: 1. Review of the Mohs case log listed 19 cases on January 31, 2025 immediately followed by 15 cases on February 27, 2025. 2. Observation of retained slides in the laboratory on October 21, 2025, at 1:50 PM showed testing personnel could not separate slides from the following ten cases: 2a. Patient 1: The patient had a Mohs case on January 31, 2025. When testing personnel tried to separate the slides during the survey, two slides broke, and the remaining slides could not be separated. 2b. Patient 2: The patient had a Mohs case on February 27, 2025. All slides were stuck together and could not be separated to review individually. 2c. Patients 3 to 10: The eight patients had Mohs cases on February 27, 2025. All slides were stuck together and stuck to the slide box, and could not be separated to review individually. 3. Interview with staff A on October 21, 2025, at 1:50 PM confirmed the laboratory did not store the slides in a manner that ensured proper preservation to allow retrieval and review of individual slides. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, competency assessments, and interview with testing personnel, staff A, the laboratory did not follow their written policies for training and competency evaluation for two of two current testing personnel. Findings include: 1. Review of the "Mohs Competency Assessment and Review" procedure stated "Policy: All Mohs technicians are re-evaluated twice a year for competency." Further review stated "Individual technical competency of laboratory personnel is reassessed on a biannual basis by the Technical Supervisor". 2. Review of competency assessment records showed documentation of competency assessment for staff A and staff B January-June in 2021 and 2022 and July -December in 2021 and 2022. Further review showed no documentation of competency assessment for the first half of 2023. 4. Interview with staff A on September 26, 2023, at 9:25 AM confirmed the laboratory did not follow their written policies for competency assessment. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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. 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 surveyor review of testing personnel records and interview with staff A, the laboratory director did not ensure one of one testing personnel newly qualified to perform high complexity grossing of tissue specimens received the appropriate training for Mohs surgical grossing prior to performing on patient specimens. Findings include: 1. Review of personnel records for staff C showed documentation of additional university credits to qualify staff C as high complexity testing personnel as of June 27, 2023. 2. Review of competency assessment records for staff C showed competency assessment did not include grossing for 2021 and 2022. Further review showed the laboratorydirector did not document staff C had demonstrated the ability to perform tissue grossing procedures. 3. Interview with staff A and staff C on September 26, 2023, at 9:25 AM, confirmed staff C performed high complexity testing as of June 27, 2023. Further interview confirmed the laboratory director did not ensure documentation of appropriate training for staff C was performed prior to the high complexity testing being performed. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, laboratory records, and interview with testing personnel, staff A, testing personnel did not follow the procedure when documenting stain quality control for the hemotoxylin and eosin (H&E) stain for twelve of twelve patient testing days reviewed. Findings include: 1. Review of the "Mohs Staining Quality Control" procedure stated "The stain quality and specimen preparation is documented on the Mohs H&E Staining Quality Control Log." "The Mohs H&E staining Quality Control Log includes the following information: A. Surgery date B. Patient number C. Case number D. Stain acceptance- Y or N E. Slide /specimen preparation acceptable-Y or N F. Comments or corrections G. Technician initials H. Mohs surgeon signature" Further review stated "The Mohs surgeon signs the log each Mohs day". 2. Review of the "Mohs H&E Staining Quality Control Log" showed no documentation of the Mohs surgeon's signature for twelve patient testing days between January 2, 2023 and March 16, 2023. 3. Interview with staff A on September 26, 2023, at 9:50 AM confirmed testing personnel did not follow their procedure to document stain quality control by the Mohs surgeon. -- 2 of 2 --

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form 209 Laboratory Personnel Report, academic records, interview with testing personnel, and email correspondence with the laboratory director, one of three new testing personnel did not meet the qualification requirements for high complexity testing. Findings include: 1. One of three new testing personnel did not have documented education and training that met the qualification requirements of 493. 1489. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) 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 -- (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form 209 Laboratory Personnel Report, academic records, interview with testing personnel, and email correspondence with the laboratory director, one of three new testing personnel did not meet the qualification requirements for high complexity testing. Findings include: 1. Review of Form CMS-209 'Laboratory Personnel Report' signed by the laboratory director on October 18, 2021, showed six staff, including staff A, performed high complexity testing in the laboratory. Three of the identified testing personnel were not shown as testing personnel on the Form CMS-209 from the previous survey. 2. Review of academic qualifications for staff A, one of the newly identified testing personnel, did not show staff A had an acceptable degree or course -- 2 of 3 -- work to meet the qualification requirements for high complexity testing. 3. Interview with testing personnel (Staff B) on October 19, 2021 at 9:00 AM revealed staff A had performed high complexity testing at this laboratory during 2021. 4. In an email correspondence with the laboratory director on November 18, 2021 at 10:32 AM, the director stated, staff A "began training on the grossing procedure under direct supervision by me on January 4, 2021". -- 3 of 3 --

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of Mohs cases including review of the Mohs patient log, Mohs maps, patient test reports and observation of specimen slides, and interview with testing personnel, the laboratory director has not established a quality assurance program that identifies failures in accurate record keeping. Findings include: 1. Review of three Mohs cases revealed two of the three cases showed inconsistencies between information on the Mohs patient log, Mohs map, patient test report, or the specimen slides. Case 1: Observation of specimen slides on October 30, 2019 at 9:00 AM revealed a slide label that included the code "II 3 A". Review of the log showed the expected notation would have been "II 2 A". Case 2: Review of the Mohs patient log showed laboratory staff recorded that the surgery site was on the left side. Review of the patient report and Mohs map completed by the Mohs surgeon showed the surgery was on the right side. 2. Interview with testing personnel, staff A, on October 30, 2019 at 9:00 AM confirmed two of three cases reviewed had inconsistencies between records in the Mohs patient log, Mohs map, patient test report or the specimen slides. Staff A also confirmed the log was incorrect for Case 2. Further interview confirmed a quality assessment program to identify and correct failures in maintaining accurate records was not established. 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 --