Richmond Dermatology Specialists, Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Richmond Dermatology Specialists, PC on November 13, 2023 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 and include the Condition under 42 CFR part 493 CLIA Regulation: D5200 -42 CFR. 493.1230 General Laboratory Systems. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services 116 form, procedures, proficiency testing records, lack of documentation, and interviews, the laboratory failed to retain documentation of twice annual accuracy verification for moderate complexity dermatological Potassium Hydroxide and high complexity histological pathology slide microscopy examinations during a recertification inspection's twenty-three months review timeframe (January 2022 to November 13, 2023). Cross Reference D5217. 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 116 form, procedures, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain documentation of twice annual accuracy verification for dermatological Potassium Hydroxide (KOH) and histological pathology slide microscopy examinations during the twenty-three (23) months review timeframe (January 2022 to November 13, 2023). Findings include: 1. Review of the CMS 116 form revealed that the lab director (LD) identified three testing personnel qualified to perform moderate complexity patient dermatological Potassium Hydroxide (KOH) microscopy examinations and one testing personnel qualified to perform high complexity histological pathology slide reading. 2. Review of the laboratory's procedure manual revealed a LD approved protocol "Proficiency Testing" that outlined PT/accuracy verification for the nonwaived testing procedures outlined above. 3. Review of the laboratory's PT binder revealed no accuracy verification documentation for the 23 months of review (timeframe January 2022 to 11/13/23). The inspector requested to review twice annual accuracy documentation for Potassium Hydroxide (KOH) and pathology slide microscopy examinations. The documentation was not available for review. 4. An exit interview with the LD, executive director, and clinical lead on 11/13/23 at 3:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Richmond Dermatology and Laser Specialists on September 12, 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: D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the policy and procedure (P&P) and an interview with the laboratory director, the laboratory failed to verify the accuracy of the Potassium Hydroxide (KOH) and dermatological Wet Preparation (Prep) microscopic examinations at least twice annually in the calendar year 2018 and 2019. (Repeat Deficiency and Cross Reference D5217.) 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. 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: **Repeat Deficiency** Based on a review of the policy and procedure (P&P) and an interview with the laboratory director, the laboratory failed to verify the accuracy of the Potassium Hydroxide (KOH) and dermatological Wet Preparation (Prep) microscopic examinations at least twice annually in the calendar year 2018 and 2019. Findings include: 1. Review of the P&P and interview with the laboratory director at approximately 10:00 AM revealed the laboratory performs dermatological Wet Prep and KOH microscopic slide examinations. The inspector requested to review the documentation of twice a year accuracy verification for the aforementioned tests. The documentation was not available for review. 2. An interview with the laboratory director at approximately 11:00 AM confirmed the findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)