New River Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at New River Dermatology August 5-6, 2025 by the Virginia Department of Health's Office of Licensure and Certification. New River Dermatology was found not in compliance with applicable Standards and Condition under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Condition: D6076 - 42 CFR 493.1441 Condition: Laboratory Director. 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 review of procedures, proficiency testing logs, lack of documentation, and interviews, the laboratory failed to perform mohs histopathology accuracy checks by peer review twice annually per laboratory policy during twelve (12) of twenty (20) months reviewed (timeframe: December 20, 2023 to August 6, 2025). **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's procedures revealed a quality assurance policy for proficiency testing (titled "Proficiency Testing - Post Analytical"). The policy stated "Proficiency testing is done to ensure accurate interpretation of mohs slides by the mohs surgeon. For proficiency testing, two cases are selected for review by an outside dermatopathologist. This process is done twice a year." 2. Review of the laboratory's peer review records for the 20 months of review (12/20/23-8/5/25) revealed the following documentation: Peer review 2024- 2 cases dated 4/8/24; Peer review 2025- 3 cases dated 5/20/25; The inspector requested to review additional peer review verified in the 12 months of calendar year 2024. No additional records were available. 3. The inspector inquired as to the reason peer review cases were not pulled twice annually as outlined in the quality assurance policy. The mohs staff members stated on 8/5/25 at 3:30 PM, "We had a couple of 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 -- staff changes that occurred in 2024 that led to the lapse in pulling cases for peer review." 4. An interview with the mohs staff members on 8/5/25 at 3:30 PM and 8/6 /25 at 10 AM confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form, policies, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory director failed to identify PT quality assessment failures as they occurred when twice annual peer review assessment was not performed per policy in calendar year 2024 (a repeat deficiency). *Refer to D6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification (CMS 116) and Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the New River Dermatology on 12/19/23 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 the review of policy and procedures (P&P), peer review records, lack of documentation and interview, the laboratory failed to follow the established P&P for professional review for accuracy of at least two Mohs histological samples at the date of survey on 12/19/23. Findings include: 1. Review of the P&P revealed the policy "The professional review is performed to ensure accurate interpretation of Mohs frozen sections by the Mohs surgeon. Two random Mohs cases each year will be reviewed for slide interpretation accuracy. This will be done by a dermatopathologist. A Mohs Professional Quality Assurance Report shall be submitted with the comments of the Mohs surgeon and dermatopathologist and filed in the Quality assurance manual." 2. Review of available peer review records for the calendar year 2022 revealed four samples sent to a dermatopathologist for review. The date of review by the dermatpathologist was 01/23/23. The inspector inquired about the delay in the review of four cases for the calendar year 2022 with the clinical coordinator on 12/19 /23 at noon. The clinical coordinator stated, "I mailed the slides and forms to our dermatopathologist in November of 2022 and did not receive a timely response. We have had issues with getting the reports returned in a timely manner." The inspector requested to review the peer review records for the calendar year of 2023 or records pending review by the dermatopathologist. The clinical coordinator stated, "we have 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 -- not sent any slides or records for peer review as of today for our 2023 review." 3. An exit interview with the clinical coordinator on 12/19/23 at 12:30 confirmed the findings. 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 the review of daily quality control (QC) logs, patient testing logs for the Mohs histological samples, policy and procedure (P&P), lack of documentation, and interview, the lab failed to document the intended reactivity of the Hematoxylin and Eosin (H&E) stain on 07/21/22 and 08/25/23, reporting seven patients and one patient respectively. Record review beginning 01/01/22 up to date of survey on 12/19/23. Findings include: 1. Review of daily H&E Stain QC and patient testing logs for the Mohs histological samples revealed lack of documentation of intended reactivity of the H&E stain for the following: 07/21/22- seven patients reported, and 08/25/23- one patient reported. 2. Review of the P&P revealed the following statements, "Quality Assurance- the first case submitted to the Mohs lab which consists of NORMAL tissue will be stained for H&E and documented on the control sheet as the QA." 3. An exit interview with the clinical coordinator on 12/19/23 at 12:30 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the New River Dermatology on September 25, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report form (CMS 209), testing personnel (TP) records, lack of documentation, and an interview with the technical supervisor (TS), the TS failed to assess annual competency for one (1) of 1 TP in 2018. Findings include: 1. Review of the CMS Form 209: Laboratory Personnel Report revealed that the laboratory director serves as the TS and that there is 1 TP performing grossing of patient tissue samples in the laboratory. 2. Review of TP A records revealed a lack of documentation of an annual competency assessment in 2018 (See Testing Personnel Code Sheet.) 3. An interview with the TS at approximately 12:30 PM confirmed the findings. 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 --