Yale Dermatology-Branford

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 staff interview, the laboratory failed to establish competency assessment policy and procedures to assess competency for the regulatory responsibilities for the clinical consultant (CC) and Technical Consultant (TC) in the subspecialty of histopathology and mycology. Findings include: 1. Record review on 10/8/2025 of the laboratory's 'CLIA Testing Personnel' binder revealed lack of documentation of competency assessment for the regulatory positions of CC and TC. 2. Record review on 10/8/2025 of the laboratory's 'Quality Management System' manual revealed lack of an established competency assessment policy and procedure to assess competency for the regulatory positions of CC as well as TC and defining frequency of such assessments. 3. Staff interview on 10/8/2025 at 10:38 AM with the laboratory director confirmed the above findings. 4. The laboratory performs 400 moderate complexity tests in the subspecialty of mycology and 1200 high complexity tests in the subspecialty of histopathology annually. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- 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 record review and staff interview, the laboratory failed to follow their established policies and procedures and document the annual competency assessment for the testing personnel (TP) in the subspecialty of mycology. Findings include: 1. Record review on 10/8/2025 of the laboratory's 'CMS 209' form revealed 9 of 11 TP performing moderate testing in the laboratory. 2. Record review on 10/8/2025 of the laboratory's 'Quality Management System' manual revealed: 'Competency Evaluation of Personnel: A competency evaluation must be conducted for each test a person performs, with evaluation occurring six months after initial training and annually thereafter'. 3. Record review on 10/8/2025 of the laboratory's 'CLIA Testing Personnel' binder revealed lack of annual competency assessments for 6 of 9 moderate complexity TP for the year 2024 4. Staff interview on 10/8/2025 at 10:38 AM with the laboratory director confirmed the above findings. 5. The laboratory performs 400 moderate complexity tests annually in the subspecialty of mycology. -- 2 of 2 --

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 staff interview, the laboratory failed to establish competency assessment to assess their employees for the year of 2021 before patient testing is performed in the subspecialty of mycology. Findings include: 1. Record review on 03/17/2022 of the staff competency binder revealed lack of documentation for competency assessment for 10 of 10 testing personnel in 2021 for KOH fungal preparation. 2. Staff interview on 03/17/2022 at 9:32 AM with the Laboratory Director confirmed the following: a. The office was closed in 2020 due to COVID-19 pandemic. b. KOH fungal preparation was performed for 37 of 37 working days in the year of 2021 with no competency assessment documented. 3. The laboratory performs 350 tests annually in the subspecialty of mycology. 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) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)