Dermatology Center Of Loudoun

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology Center of Loudoun on March 12, 2024 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 a review of the laboratory's policies and procedures, peer review records, and lack of documentation, the laboratory failed to follow their established policy for semi-annual proficiency testing (PT) peer reviews in calendar year 2022. The findings include: 1. Review of the laboratory's policies and procedures revealed a policy, "Proficiency Testing-Mohs Micrographic Surgery Skin Specimens", with the statements, "Semi-annually, the tech or risk manager will send pathology, the original slides, the surgical case number, and send it for a microscopic examination by a board- certified dermatopathologist." 2. Review of available PT peer review records for calendar year 2022 revealed PT peer review performed on 01/02/2022. No further documentation of 2022 PT peer review was observed. The surveyor requested to review additional PT peer review documentation for 2022. The laboratory provided no documentation for review. 3. In an exit interview with the practice manager and laboratory director on March 12, 2024, at approximately 11:00 AM, the above findings were confirmed. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on tour, review of maintenance records, laboratory policies and procedures, lack of documentation, and interview, the laboratory failed to follow their established policy of annual service/maintenance for one (1) of 1 microscope, 1 of 1 fume hood, and 1 of 1 cryostat utilized for Mohs surgery specimen processing in calendar year 2023. Findings include: 1. During a tour of the laboratory with the practice manager at 9:30 AM, the surveyor noted a Leica DM750 Microscope (Serial # C840342308SW0049), a G30 Fume Hood System (Serial # 11906973) and Leica CM1520 Cryostat (Serial # 1606) in use for Mohs surgery specimen processing. 2. A review of the laboratory's equipment maintenance records revealed the microscope, fume hood and cryostat annual service was performed by an Avantik vendor on 7/11 /2022 and 3/6/2024 respectively. The equipment records lacked documentation of the annual service for the above listed equipment for calendar year 2023. The surveyor requested to review the annual maintenance service documentation for calendar year 2023. The laboratory provided no documentation for review. 3. Review of the laboratory procedure manual revealed a laboratory policy with the statement "Preventative maintenance and grounding checks are done YEARLY." 4. In an exit interview with the practice manager and laboratory director on March 12, 2024, at approximately 11:00 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology Center of Loudoun on 07/12/22 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: 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 the review of policy and procedures (P&P), patient histology slides and Mohs surgery maps, and an interview with the lab director and office manager, the lab failed to follow the established P&P for patient labeling of Mohs histopathology slides for one of five random samples selected for review. Findings include: 1. Review of P&P "Slide Labeling" revealed the following statement: "Slides are to bel labeled with mohs log accession number, patient last name, number of stages will be marked with Roman numeral; stage I, II, III,etc." 2. Review of five random histology slides and corresponding Mohs surgery maps revealed that the last name of Patient A (21-157) was misspelled on all five slides (date of test 12/20/21). 3. An interview with the lab director and office manager on 07/12/22 at approximately 12:10 PM confirmed the findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the review of policy and procedures (P&P), patient histology slides, Mohs surgery maps, quality assurance (QA) records, lack of documentation, and an interview, the lab failed to follow the established P&P for performing and completing the monthly QA checklists four of twelve months in 2021, and completing a lab error form for one of five patients reviewed. Findings include: 1. Review of the P&P revealed the following QA statements, "Monthly the nurse or tech will check off the monthly Quality Assurance checklist. This will cover the quality assessment program for procedures used in this office. The checklist is used to evaluate general laboratory systems, pre-analytic systems, analytic systems and post-analytic systems." "Any discrepancies found in the checklist for the month will be documented on a lab error form and kept in the manual for 2 years." 2. Review of five random Mohs histology slides and corresponding Mohs surgery maps revealed that the last name of Patient A was misspelled (Refer to D5203). 3. Review of the available monthly QA checklists for the calendar year 2021 revealed lack of documentation of the completed checklists from 09/01/21 up to 12/31/21 (last completed document on 08/16/21). The inspector requested to review the checklists from 09/01/21 up to 12/31/21 and a lab error form that corresponding to the misspelled last name of Patient A on 12/20/21. The documents were not available for review. 4. An exit interview with the laboratory director and office manager on 07/12/22 at approximately 12:10 PM confirmed the findings. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), policy and procedures (P&P), testing personnel (TP) records, lack of documentation, and an interview, the lab director failed to follow the established policy of performing annual competency assessment for one of one TP in the calendar year 2021. Findings include: 1. Review of the CLIA CMS-209 form revealed one TP performing high complexity testing of the Mohs surgical histopathology slide examinations. 2. Review of the P&P revealed the following statements, "Personnel Assessment- CLIA guidelines require the semiannual assessment of personnel competency during the first year of test performance for moderate or high complexity testing. Thereafter, evaluation must be performed at least annually." 3. Review of TP A records revealed a semiannual competency on 10/02/20. The records lacked documentation of a competency assessment in the calendar year 2021. 4. An exit interview with the laboratory director and office manager on 07/12/22 at approximately 12:10 PM confirmed the findings. -- 2 of 2 --