Shenandoah Dermatology, Pc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Shenandoah Dermatology, PC on 06/04/24 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: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: 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 the review of policy and procedures (P&P), patient testing logs, histological tissue slides, lack of documentation, and interviews, the laboratory failed to document a positive and negative quality control (QC) reactivity for the immunohistochemical (IHC) Pan-Cytokeratin (Pan-Ck) and Mart-1/Melon-A stains for 47 of 47 dates reviewed, resulting 47 patients. Findings include: 1. Review of the P&P "Pan-Ck" and the "Mart-1/Melon-A" IHC stains" revealed the following statements, "one positive tissue control is needed for each set of tests. Known positive tissue controls should be utilized for monitoring correct performance of processed tissues and test reagents." "The same tissue used for positive control may be used for the negative control." 2. In interview with the general supervisor on 06/05/24 at 11:30 AM, they stated, "we process a positive and negative control slide with each use of the Pan-Ck and Mart-1 /Melon-A stains. The Mohs surgeon documents on the Mohs surgical map which stain was used, the result of the stain and that the case is negative or clear after the Mohs 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 -- surgery." The inspector requested to review documentation of positive and negative reactivity for each date of use for the Pan-Ck and Mart-1/Melon-A IHC stains. The documentation was not available for review. 3. Review of patient test logs, to include the Mohs surgical maps, revealed the following dates and accession numbers that lacked documentation of a positive and negative QC reactivity: 01/18/23 M23- 0085, 01/25/23 M23- 0122, 02/08/23 M23- 0188, 02/08/23 M23- 0190, 02/15/23 M23- 0220, 02/15/23 M23- 0224, 02/21/23 M23- 0244, 02/23/23 M23- 0264, 03/02/23 M23- 0300, 03/07/223 M23- 0311, 03/07/23 M23- 0318, 07/11/23 M23- 0828, 07/20 /23 M23- 0875, 08/22/23 M23- 1044, 09/07/23 M23-1116, 09/11/23 M23- 1133, 09/12 /23 M23- 1144, 09/18/23 M23- 1172, 10/04/23 M23- 1262, 10/12/23 M23- 1311, 10 /18/24 M23-1341, 10/23/23 M23- 1358, 10/25/23 M23- 1379, 10/30/23 M23- 1400, 11 /02/23 M23- 1429, 11/09/23 M23- 1472, 11/09/23 M23- 1476, 11/21/23 M23- 1543, 11/22/23 M23- 1646, 12/13/23 M23- 1665, and 12/20/23 M23- 1701. 01/09/24 M24- 0046, 01/15/24 M24- 0079, 01/22/24 M24- 0112, 01/30/24 M24- 0162, 02/15/24 M24- 0262, 03/06/24 M24- 0378, 03/11/24 M24- 0397, 03/25/24 M24- 0488, 03/26 /24 M24- 0499, 03/27/24 M24- 0510, 04/01/24 M24- 0532, 04/02/24 M24- 0549, 04 /03/24 M24- 0559, 04/24/24 M24- 0680, 04/30/24 M24- 0717, and 05/08/24 M24- 0770. The surveyor randomly selected 13 of the 47 IHC cases and requested to review the histology slides and confirmed that each case had a positive and negative QC slide. 4. An exit interview with the laboratory director and general supervisor on 06/04 /2024 at 12:50 confirmed the findings. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 the review of policy and procedures (P&P), patient testing logs, lack of documentation, and interviews, the laboratory director failed to document positive and negative quality control (QC) reactivity for the immunohistochemical (IHC) Pan- Cytokeratin (Pan-Ck) and Mart-1/Melon-A stains for 47of 47 dates reviewed, resulting 47 patients. Findings include: 1. Refer to D5601 for access number and date details. 2. In an exit interview with the laboratory director, who is also the Mohs surgeon, on 06/04/24 at 12:50, they stated, "we cut and stain a positive and negative QC slide to check the reactivity of the IHC stains each time we do the stains. I check for reactivity, but I do not document the review/results of the QC slides. We can certainly add that log sheet." -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at the Shenandoah Dermatology, PC on October 13, 2022 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 procedures, proficiency testing (PT) logs, quality assurance (QA) reports, lack of documentation, and an interview, the laboratory failed to perform Mohs micrographic histopathology testing accuracy checks twice annually per their policy in calendar year 2021 and up to the date of the inspection on October 13, 2022. Findings include: 1. Review of the laboratory's procedure manual revealed a PT policy for Mohs micrographic surgery skin specimens (titled: "Quality Assurance: Proficiency Testing"). The written policy outlined, "Randomly selected cases to be peer reviewed by an outside party laboratory for compliance diagnosis twice per year". 2. Review of the laboratory's PT documentation for calendar year 2021 up to the date of the inspection on 10/14/22 revealed documentation of Mohs micrographic split sample testing were sent out for peer review on 8/31/21 and 10/3/22. 3. Review of the available QA reports revealed no documentation of additional accuracy checks for Mohs micrographic histopathology testing. The inspector requested to review additional PT record documentation. No additional PT documentation was available for review. 4. An exit interview with the lead histotechnologist and laboratory director on 10/13/22 at approximately 3:30 PM confirmed the above findings. D6094 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 a review of procedures, proficiency testing (PT) records, Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, quality assurance (QA) reports, lack of documentation, and interviews, it was determined that the laboratory director's (LD) monthly and quarterly QA measures failed to: 1. identify lack of performance of Mohs micrographic histopathology accuracy checks twice annually per an approved QA proficiency testing policy in calendar year 2021 and up to the date of the inspection on October 13, 2022. Cross reference D5217. 2. identify the lack of training/semiannual competency evaluation documentation retention for one new histopathology testing personnel in calendar year 2021 and up the date of inspection on October 13, 2022. Cross reference D6127. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 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), laboratory personnel files, Quality Assurance (QA) reports, lack of documentation, and interviews, it was determined that the technical supervisor (TS) failed to retain documentation of semiannual competency evaluation for one new histopathology testing personnel ("TP A") in calendar year 2021 and up the date of inspection on October 13, 2022. (See Personnel Code Sheet.) Findings include: 1. Review of the CMS 209 form revealed that the laboratory director (LD) also performs the duties of TS and three testing personnel were identified as responsible for high complexity histopathology testing procedures during the review timeframe of January 2021 to 10/13/22. The lead histotechnologist identified "TP A" as having started employment in the laboratory as a new testing personnel processing/grossing/mapping patient tissue samples in June 2021. 2. Review of the laboratory personnel files revealed no training or competency assessments for TP A. The inspector requested to review training and competency assessments for TP A. The lead histotechnologist stated on 10/13/22 at approximately 2:00 PM, "The histotech worked here for a year but is no longer employed. A training check list and semiannual competency assessment were done but I do not have those records." 3. Review of the available QA reports revealed no mention/documentation of review of the training/competency assessments outlined above. 4. An exit interview with the lead histotechnologist and LD on 10/13/22 at approximately 3:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Initial on-site survey was conducted at Shenandoah Dermatology on January 14, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory was conducted on December 14, 2020 with virtual record review of documentation on January 12, 2021. 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 the laboratory's policy and procedures (P&P), daily patient testing log sheets, patient MOHS dermatologic maps and corresponding slides, and interview, the laboratory failed to follow the established P&P for patient labeling of MOHS histopathology tissue slides for eight (8) of 12 random samples selected for review. Dates of record review include June 15, 2020 up to date of survey on January 1, 2021. Findings include: 1. Review of the P&P "Laboratory Procedure Manual Histopathology- Central Virginia Skin Surgery Center Clinic MOHs Surgery" (signed by the lab director 06/08/20) revealed "3.4 Specimen Handling, Storage, Preservation and Identification" "3.4.6- Patient name, site, date, Mohs surgeon and laboratory technician is written on Mohs log, along with total number of slides processed." "3.4.9- Laboratory technician will label slides with Mohs number, layers and patient last name. Slides will be labeled permanently with Mohs number, patient last name, date, facility and Mohs layers." 2. Review of 12 random histology tissue slides, corresponding MOHS maps and daily patient testing log sheets revealed that on 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 -- October 16, 2020, 8 patient slides improperly labeled with the date of October 15, 2020 as the date of MOHS testing. In addition, the corresponding MOHS maps lacked the documentation of the laboratory technician that performed the processing of the samples (M20-393 to M20-400). 3. An interview with the histotechnologist on January 14, 2021 at approximately 11:00 AM confirmed the 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 the review of the laboratory's policy and procedures (P&P), daily patient testing log sheets, patient MOHS dermatologic maps and corresponding slides, and interview, the established P&P for reading results failed to identify the improperly dated slides and lack of laboratory technician identification on the MOHS maps for eight (8) of 12 random samples selected for review. Dates of record review include June 15, 2020 up to date of survey on January 1, 2021. Findings include: 1. Review of the P&P "Laboratory Procedure Manual Histopathology- Central Virginia Skin Surgery Center Clinic MOHs Surgery" (signed by the lab director 06/08/20) revealed "9.1 Reading Results- 4. When the case is completed, the Mohs map will be scanned or photographed and the laboratory technician will cross check and verify that all information is correct and completed on the operative/repair notes, Mohs map, patient photographs and Mohs patient log. When the QA is complete, the laboratory technician will sign the log sheet. 5. The preliminary report is reviewed by the Mohs surgeon and is verified that all the information is correct and the report is electronically signed and finalized." 2. Review of M20-393 to M20-400 histology tissue slides, corresponding MOHS maps, daily patient testing log sheets and reports revealed discrepancies. Refer to D5203. 3. An interview with the histotechnologist on January 14, 2021 at approximately 11:00 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Shenandoah Dermatology, PC on June 12, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirement. Specific deficiencies cited are as follows: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 the review of the Centers for Medicare and Medical Services Laboratory Personnel Report form (CMS 209), testing personnel competency assessment documents for calendar year 2017 and an interview with the clinical manager, the technical consultant failed to perform the annual competency assessments for four (4) of four (4) testing personnel in 2017. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director also performs the duties of technical consultant and that there were 4 testing personnel that were performing testing in 2017. 2. Review of the testing personnel competency assessment documents revealed that the technical consultant did not perform the annual competency assessment for 4 of 4 testing personnel in 2017. (See attached testing personnel code sheet) Testing Personnel A, Testing Personnel B, Testing Personnel C, Testing Personnel D. 3. In an interview with the clinical manager at approximately 10:30 AM, it was confirmed that the technical consultant failed to perform the annual competency assessments for the 4 personnel listed on the CMS 209 in 2017. 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 --