Evms Dermatology- Andrews Hall

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at EVMS Dermatology- Andrews Hall on September 26, 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 deficiency cited is 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 Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), mycology proficiency testing (PT) records, and an interview, the laboratory failed to verify testing personnel (TP) accuracy of Potassium Hydroxide (KOH) mycology microscopy for two (2) of 2 PT events in calendar year 2024 as noted on the date of the inspection, September 26, 2024. Findings include: 1. Review of the laboratory's CMS 209 personnel form revealed that four TP qualified to perform patient KOH microscopy examinations. (See Testing Personnel Code Sheet.) 2. Review of the laboratory's year to date 2024 American Proficiency Institute (API) Microscopy PT documentation, a total of 2 events, revealed the laboratory utilized PT to verify TP KOH microscopy accuracy. A review of the API PT reports revealed the laboratory failed accuracy verification year to date by receiving the following unsatisfactory scores: 2024 1st Event: 50% Unsatisfactory Scoring; failed for challenge KOH--02; 2024 2nd Event: 50% Unsatisfactory Scoring; failed for challenge KOH--03. The API report noted the laboratory as unsuccessful long term. 3. An interview with the practice manager, lab director, and TP on 9/26/24 at 11:30 AM confirmed the above 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 CLIA recertification survey was conducted at EVMS Dermatology- Andrews Hall on December 1, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspection also included a follow up offsite interview with the practice manager on 12/05/22. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulations: D6076 - 42 CFR. 493.1441 Condition: Laboratory Director. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) documentation, policies, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for one (1) of five (5) mycology microscopy PT events reviewed. *REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's American Proficiency Institute (API) mycology PT documentation (2021 Events 2-3, 2022 Events 1-3), a total of 5 events, revealed no LD or TP signed attestations for the 2021 Event 3. 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 4 -- inspector requested to review the LD and TP attestation documentation for the API PT event outlined above. No documentation was available for review. 2. Review of the laboratory's policies revealed a PT Quality Assurance protocol that stated, "Providers and laboratory director will sign attestations and will be reviewed for completion by the laboratory director, all attestations will be retained in PT binder". 3. An interview with the lab director, Mohs surgeon, practice manager, and histotech on 12/1/22 at approximately 4 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 policies, maintenance logs, lack of documentation, and interviews, the laboratory failed to retain documentation of maintenance for one (1) of 1 microscope utilized for patient Mohs histopathology testing in calendar year 2021 per an established protocol. Findings include: 1. During a facility tour at approximately 1:00 PM on 12/01/22, the inspector noted an Olympus Model BX43 Serial #2C40629 microscope in use in the histopathology MOHS specimen processing area. 2. Review of the policies and procedures revealed a quality assessment policy that outlined: "Microscopes 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 2021 equipment maintenance logs revealed no record for the Olympus microscope outlined above. The inspector requested to review maintenance records for calendar year 2021. No documentation was available. The practice manager stated on 12/01/22 at approximately 3:30 PM, "We have the maintenance record for the current year but will have to get with the secretary for previous records." 4. Interviews with the lab director, Mohs surgeon, practice manager, and histotech on 12/1/22 at approximately 4 PM and with the practice manager on 12/5/22 at approximately 4:30 PM confirmed the above findings D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of procedures, quality control (QC) records, patient logs, lack of documentation, and interviews the laboratory failed to document daily Hematoxylin -- 2 of 4 -- and Eosin (H&E) stain acceptability for eleven (11) of 11 months with six thousand seven hundred twelve (6,712) patient Mohs slides stained/ processed in calendar year 2022. Findings include: 1. Review of the laboratory's Mohs procedure manual revealed a policy (title: "QA/QC Forms") that stated, "Quality control forms are used to document results of Mohs clinical slides. Regular assessment of QC are used to monitor and evaluate procedures in the Mohs histology lab. Daily QC evaluation for routine H&E slides and special requests are signed by the Mohs surgeon who marks them as Satisfactory or Unsatisfactory." 2. Review of the available Mohs laboratory QC records revealed no documentation of daily H&E acceptability from January 3, 2022 up to the date of the survey on December 1, 2022. The inspector requested to review daily H&E QC documentation for the 11 months outlined above. No records for daily QC were available for review. The LD and histotech stated on 12/01/22 at approximately 3 PM "The daily stain QC check is done verbally, it has not been documented to date." 3. Review of the Mohs patient logs from January 2022 through November 2022 revealed 6,712 slides were processed/stained with H&E during the 11 months review timeframe. 4. Interviews with the lab director, Mohs surgeon, practice manager, and histotech on 12/1/22 at approximately 4 PM and with the practice manager on 12/5/22 at approximately 4:30 PM confirmed the above findings. 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 a review of policies,

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for EVMS Dermatology- Andrews Hall on January 21, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview and virtual record review conducted on 1/14/2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D5200 - 42 CFR. 493.1230 Condition: General Laboratory Systems. Specific deficiencies cited are as follows. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for seven (7) of 7 mycology microscopy PT events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) mycology PT documentation, a total of 7 events, revealed no LD or TP signed attestations for the following: 2018 3rd Event; 2019 Events 1-3; 2020 Events 1-3. The inspector requested to review the LD and TP 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 -- attestation documentation for the 7 PT events outlined above. No documentation was available for review. 2. In an interview with the practice manager on 1/21/21, at approximately 2:30 PM, the above findings were confirmed. 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 laboratory's Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report Form, mycology proficiency testing (PT) records, available PT

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at EVMS Dermatology- Andrews Hall on September 6, 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: 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 Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), mycology proficiency testing (PT) records, and an interview, the laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) mycology testing twice annually for the twenty-four (24) months reviewed.. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's CMS 209 personnel form revealed that two (2) testing personnel perform patient KOH microscopy examination. (See Testing Personnel Code Sheet.) 2. Review of the laboratory's American Proficiency Institute (API) mycology PT documentation, a total of six (6) events, revealed the laboratory utilizes PT to verify KOH accuracy twice annually. A review of the API reports revealed the laboratory failed twice annual accuracy verification from September 2016 to the date of the survey 9/6/18 by receiving the following scores: 2016 3rd Event: 50% Unsatisfactory Scoring; failed for KOH--06 2017 1st Event: 50% Unsatisfactory Scoring; failed for KOH--02 2017 3rd Event: No score/Not graded for KOH-05 and KOH-06 2018 2nd Event: 0% Unsatisfactory Scoring; failed for KOH-03 and KOH-04 3. In an interview with the practice manager at approximately 12:00 PM, it was confirmed that the laboratory, by receiving the scores outlined above, failed to successfully verify, twice annually, the accuracy of KOH testing in the twenty-four (24) months reviewed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records,