Babcock Dermatology

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on March 25, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of 2024 - 2025 Personnel Records confirmed that the Laboratory Director failed to ensure that personnel were competent to perform test procedures. THE FINDINGS INCLUDE: 1. A review of 2024 - 2025 Personnel Records found 2 out of 5 personnel competencies were not completed. Competency documentation for HT1 and HT2 (identified on Form 209) was not available on the date of survey. 2. An exit interview, with the personnel, on March 25, 2026, at 12:45pm confirmed that the Laboratory Director failed to ensure that personnel were competent to perform test procedures performed at the laboratory. D6082 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)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: A review of 2024 - 2026 Temperature Records confirmed that the Laboratory Director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance. THE FINDINGS INCLUDE: 1. A review of 2024 - 2026 Temperature Records revealed temperature failures for the Cryostat without

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 23, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: A review of laboratory records and interview with the office manager and Testing Personnel (TP # 2, CMS 209) determined that the laboratory failed to provide annual Competency Assessment for all testing personnel. Findings include: 1. A review of testing personnel records revealed there was no competency evaluations for testing personal for 2016 and 2017. 2. The laboratory failed to have current written policy for semi-annual and annual competencies for testing personnel. 3. An interview with the office manager and TP # 2 (CMS 209) on March 23, 2018 at 12:50 PM in the review room confirmed that there was no current written policy in place and annual competencies were not performed for testing personnel. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 the review of laboratory maintenance records and interview with the office manager, the laboratory failed to calibrate the Horizon Model 642 Mini E centrifuge annually per manufacturer's recommendations. Findings include: 1. Observation during the laboratory tour revealed the LabCorp Horizon model 642 Mini E centrifuge was last calibrated on December 16, 2014. 2. An interview with the office manager on March 23, 2018 in the surveyor review room at approximately 12:55 PM, confirmed the centrifuge had not been calibrated since 12/16/2014. -- 2 of 2 --