Beaird Dermatology S C

Summary Statement of Deficiencies 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: D5217 Based on review of laboratory policies and procedures, laboratory proficiency testing records, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to perform bi-annual method accuracy evaluations for microscopic Potassium Hydroxide (KOH) wet mount testing from 2023 to the date of survey, 09/24/2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "General Laboratory Policies", which stated, under section titled "7.Proficiency Testing", "This laboratory will enroll in formal proficiency testing appropriate to the test menu and treat all proficiency test challenge specimens the same as patient specimens." 2. Review of laboratory PT records found no documented KOH proficiency testing or bi-annual method accuracy evaluations. 3. Interview with the TS on 09/24/2025, at 9:48 am, confirmed that the laboratory was not enrolled in proficiency testing nor did the laboratory have any documented bi- annual method accuracy evaluations for KOH testing. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: A Based on review of the laboratory's quality assessment policies and procedures, review of quality assurance records, review of proficiency testing (PT) records, and interview with the technical supervisor (TS), the laboratory failed to follow the written quality assurance policy for monitoring, assessing, and correcting problems related to PT from 2023 to the date of survey, 09/24/25. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Quality Assurance Program", stated the following: "Twice yearly review by the laboratory director or designee will be conducted for quality assurance. This will cover the quality assessment program for procedures used in this laboratory. The checklists are used to evaluate general laboratory systems, Pre-analytical systems, analytic systems, and post-analytic systems. Any discrepancy found in the checklist will be documented as a lab error form and kept I the manual for two years ... Error reporting Anytime and every time an error occurs, an error form must be filled out." 2.Review documents titled "Quality assurance (QA) annual review" signed by the laboratory director /designee on 3/21/25 and 3/15/24 did not identify issues related to PT and did not have documented

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 review of the laboratory's policies and procedures manuals, Laboratory Personnel Report (Form CMS 209), personnel records, and interview with the practice manager; the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency as specified in the personnel requirements is subpart M. Findings include: 1. Review of the laboratory's policies and procedures manuals revealed that the laboratory had 4 separate procedures manuals that included Potassium Hydroxide (KOH) ; a MOHS procedure from "Got MOHS"; the laboratory's own written procedures manual; and the Clinical Laboratory Improvement Amendments for Dermatology from the American Academy of Dermatology (AAD). The AAD's procedure even included a section that listed each positions responsibilities and duties, as well as for documenting the training and competency of laboratory personnel, which were not completed by the laboratory. 2. Review of Form CMS 209 revealed that the names of personnel were listed for the following positions in the laboratory: a. Laboratory Director b. Clinical Consultant (X2; with one of them being the laboratory director). c. Technical Supervisor d. General Supervisor e. Testing Personnel 3. Review of 9 personnel records revealed that there was no documentation to show that personnel listed on Form CMS 209 were assigned to their specific positions in the laboratory, nor what their duties or responsibilities were for 9 of 9 records reviewed. Also, there was no documentation to show training of personnel and their competency assessed for 9 of 9 personnel records reviewed. 4. At 10:00 AM on 09/24/18, the practice manager confirmed the surveyor's 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 3 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)