Vivida Dermatology

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory manager, the laboratory failed to establish a written policy to assess personnel competency for mid-level practitioners who conducted (potassium hydroxide) KOH testing since the last survey on February 4, 2020. Findings include: 1. Review of laboratory policies and procedures revealed the laboratory failed to establish and perform competency assessment for two of two testing personnel who were mid-level practitioners conducting KOH testing. 2. On January 26, 2023 at approximately 10:00 AM, the laboratory director confirmed there was no competency assessment policy established or performed for mid-level practitioners conducting KOH testing. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on patient test records review and interview with staff, the laboratory failed to retain Mohs frozen section maps for at least 10 years that included the color designation of the specimen ink used to determine orientation of the specimenfor 1 of 4 Mohs maps reviewed (case # 19-0098). Findings include. 1. Patient test records for Mohs maps reviewed were scanned into the patient's chart in the electronic medical record. 2. Patient's electronic medical record of the Mohs frozen section specimen map for case 19/0098 for a 3 stage procedure was scanned into the record using black and white ink. The scanned map did not include the ink colors used to designate the specimen orientation in stages I, II, and III. and location of the residual tumor cells in stages I and II. 3. In an interview with staff on 02/04/2020 at approximately 2:30 P.M. staff stated the scans were made without a method to identify the specimen orientation for specimen 19-0036. 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. 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: Based on lack of quality control tissue, manufacturer's instructions review, and interview with staff, the laboratory failed to check Mart 1 immunohistochemical (IHC) stains for positive and negative antibody reactivity each time of use for 2 of 2 IHC stained specimen records reviewed for Mohs case #18-287. Findings include: 1. The laboratory did not have tissue specimens with known positive and negative reactivity for the Mart 1 antibody on 02/04/2020. 2. The Mart 1 IHC stain kit stated the positive control cells for the Kit included CaCl (Calcium Chloride) melanoma cells. 3. In an interview conducted on 02/04/2020 at approximately 2:30 P.M. staff stated their process was to view the positively stained cells in the patients tissue as documentation of the positive control and the negative control was to view the cells that did not stain differentially in the patient's tissue. It could not be determined how the laboratory verified the antibody reaction was specific for melanocytes versus non specific staining. -- 2 of 2 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the laboratory failed to establish the test performance characteristics for accuracy, precision, and analytical sensitivity and specificity for 3 of 3 immunohistochemical stains included in their test menu. Finding include: 1. The procedure manual contained procedures for performing Mart 1, CK 7 and CK 5/6 tests on Mohs surgery frozen tissue samples. 2. The laboratory lacked documentation of onsite validation studies for test accuracy, precision, sensitivity, and specificity performed with their reagents and personnel to determine test performance specifications. 3. In an interview on 09/26 /2018 at approximately 11:00 a.m. the director stated he was not aware that the laboratory needed to do their own validation studies to assure test reliability. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) 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 -- (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 laboratory testing records review, lack of documentation and interview with staff, the laboratory failed to document Hematoxylin and Eosin (H&E) stain quality adequacy each day of testing for 7 of 7 days of testing reviewed. Findings include: 1. Laboratory testing records document Histopathology testing including H&E staining on 07/18/2018, 05/23/2018, 06/25/2018, 07/23/2018, 08/20/2018, 09/12/2018, and 05 /09/2018. 2. The laboratory lacked documentation H&E stain quality had been evaluated for intended reactivity each day of testing. 3. Staff confirmed on 09/26/2018 at approximately 11:00 a.m. they had not been documenting H&E stain quality daily. 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 patient record review and interview with staff, the laboratory failed to document Mart 1 immunohistochemical (IHC) stains had been checked for positive and negative reactivity each time of use for 3 of 3 Mohs surgery test records reviewed that included the evaluation of Mart 1 staining in the test results. Findings include: 1. Patient records included documentation of Mart 1 stain performance for patient 18- 0014 on 05/23/2018, patient 18-0089 on 08/20/2018, and patient 18-0056 on 07/18 /2018. 2. Patient test records included a blank space for evaluation of stain adequacy for IHC stains. 3. All 3 records failed to include documentation the stain had been evaluated for positive and negative reactivity. 4. The director confirmed on 09/26 /2018 at approximately 11:00 a.m. Mart 1 stain adequacy had not been documented on the report or elsewhere in the laboratory. -- 2 of 2 --