Summary:
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 lack of training and competency assessment records, review of Standard Operating Procedures (SOPs), as well as interview with the Regional Practice Manager (RPM), the laboratory failed to follow written policies and procedures to assess employee competency. FINDINGS: 1. There was no documentation of training and competency assessment for the Mohs processing technicians. 2. This was contrary to instructions indicated in the Latham Dermatology Laboratory Management Quality Assurance (QA) manual training policies which specified documentation of staff training and competency assessments. 3. The RPM confirmed the findings on May 28, 2026, at approximately 3:30 P.M. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of SOPs and interview with the RPM, the laboratory failed to document approval and date of approval of the procedures by the current Laboratory Director (LD) before use. FINDINGS: 1. There was no documentation of LD review, approval, and date of approval for the Latham Dermatology Laboratory Management Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- QA binder laboratory's policies and procedures. 2. The RPM confirmed the findings on May 28, 2026, at approximately 3:30 P.M. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of thermometer calibration records and SOPs, as well as interview with the RPM, the laboratory failed to define a function check protocol that ensures instrument performance that is necessary for accurate and reliable test results and result reporting. FINDINGS: 1. There was no documentation of calibration for the Antonki digital thermometer hygrometer utilized for monitoring ambient room temperature and humidity in the Mohs processing laboratory. No serial or model number was available for the thermometer hygrometer. 2. The Latham Dermatology, PLLC SOPs did not include instructions for thermometer calibration and certificate retention. 3. The RPM confirmed the findings on May 28, 2026, at approximately 3: 30 P.M. D5781