District Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at District Dermatology on June 15, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited 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 procedures, proficiency testing logs, and an interview, the laboratory failed to perform Mohs Micrographic skin specimen testing accuracy checks by peer review every six (6) months per their policy during calendar years 2020 and 2021 . Findings include: 1. Review of the laboratory's procedure manual revealed a policy for proficiency testing of Mohs micrographic surgery skin specimens ("Quality Control" page 4). The written policy stated "Every six months the director will randomly select a minimum of three cases that have been processed by the laboratory and forward those to a third party laboratory for compliance diagnosis. This will validate the original diagnosis and comply with CLIA for proficiency standard". 2. Review of the laboratory's proficiency documentation for calendar year 2020 up to the date of survey on 6/15/22 revealed the following documentation for Mohs micrographic split sample testing sent out for peer review on April 11, 2022: six cases from 2020 (accession numbers: 0020-003, 0020-0014, 0020- 039, 0020-044, 0020-049, 0020-068); six cases from 2021 (accession numbers: 0021- 012, 0021-039, 0021-080, 0021-132, 0021-166, 0021-228). The inspector requested to review peer review that was performed in 2020 and 2021. No documentation was available for review. The inspector inquired as to the reason the cases were not pulled every six months in 2020 and 2021 as outlined in the quality control policy. The 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 -- histotech stated on 6/15/22 at approximately 2:30 PM, "In April, we went back and pulled cases for each year and sent them out for peer review. The cases were not pulled every six months in 2020 or 2021." 3. An exit interview with the histotech on 6 /15/22 at approximately 4:00 PM confirmed the above findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 a tour, review of procedures, maintenance logs, lack of documentation, and interview, the laboratory failed to followed their established annual maintenance protocol for the microscope utilized in Mohs histopathology patient testing for two (2) of 2 years reviewed (2020 and 2021). Findings include: 1. During a facility tour at approximately 1:00 PM, the inspector noted an Olympus Model BX43F Serial #7C49531 microscope in the histopathology MOHS specimen processing area. 2. Review of the procedure manual revealed a policy ("Laboratory Microscope Maintenance Policy") that outlined: "The microscope will be inspected and serviced on at least a yearly basis by an independent microscope maintenance company or more often if needed due to performance issues." 3. A review of the laboratory's equipment maintenance logs (timeframe: 2020 to date of inspection on 6/15/22) revealed 1 record of annual maintenance completed by Alpha Omega Service, INC on 4/1/22. The inspector requested to review maintenance records for calendar year 2020 and 2021. No documentation was available. 4. An exit interview with the histotech at approximately 3:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at District Dermatology on January 15, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: 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 the review of the laboratory's Quality Assurance (QA) policy, quality assurance records, lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to follow their written QA policy for the review of their analytic test system in 2019. Findings include: 1. Review of the laboratory's QA policy revealed a "Chart Audit Policy" which stated: "To ensure proper log keeping, slide labeling, and Mohs map/flowsheet labeling,signing and completion, a minimum of 10 randomly selected cases will be audited annually by the laboratory director." 2. Review of the laboratory's QA records from January 1, 2019 until December 31, 2019 revealed a lack of documentation of the annual chart audit in 2019. The surveyor requested documentation of the annual chart audit in 2019. The laboratory provided no documentation of chart audit in 2019 to review. 3. In an exit interview with the LD at approximately 11:15 AM, the LD 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 --

Summary Statement of Deficiencies D0000 An announced initial CLIA survey was conducted at District Dermatology on October 9, 2018 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: 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 review of the policy and procedure manual, "QA Daily Chart for Frozen Sections", patient logs and interview, the laboratory failed to document intended reactivity for Hematoxylin and Eosin (H&E) stain for three (3) of five (5) days while reporting twelve (12) patients from June 7, 2018 to October 9, 2018. Findings include: 1. Review of the procedure manual revealed a policy, "Personnel and Duties", which states: "The Laboratory Technician is responsible for filling out all quality control and quality assurance logs on each day of surgery." 2. Review of the "QA Daily Chart for Frozen Sections" from June 7, 2018 to October 9, 2018 revealed H&E slide QC approved on 6/7/18 and 8/20/18. No other documentation of H&E slide QC was available for review. At approximately 12:15 PM, the surveyor asked the Lab Technician to explain how QC was performed for H&E slide staining. The Lab technician stated that he/she has a pre-cut slide he/she stains each day of patient testing. The slide is read for acceptability and documented on the "QA Daily Chart for Frozen Sections". 3. Review of the laboratory's patient logs revealed patient testing was performed as follows: 7/18/18 - 5 patients, 7/30/18 - 5 patients, 9/24/18 - 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 2 -- patients. 4. An interview with Lab Director at approximately 12:30 PM confirmed that the laboratory failed to document the acceptability of the H&E stain each day of patient testing. -- 2 of 2 --