Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/13/2024 found the SKIN AND CANCER ASSOCIATES LLP clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor (TS) failed to evaluate initial competency for three out of four testing personnel (TP) in 2024. Findings included: -Review of the FORM CMS-209 signed by the Laboratory Director (LD) on 05/13/2024 revealed that LD, Clinical Consultant (CC), TS, General Supervisor (GS) and Testing Person (TP) #A was the same person. The laboratory had four TP (TP#A, TP#B, TP#C and TP#D). -Review of personnel records revealed that there were no records of initial competency for TP#B, TPC and TP#D in 2024. - Review of patient records revealed that TP#B has performed tests for 208 patients since 02/06/2024, TP#C for 28 patients since 04/15/2024 and TP#D for 40 patients since 02/18/2024. During an interview on 05/13/202-4 at 11:45 AM with laboratory assistant, he confirmed that the TS failed to perform the initial competency for TP#B, TP#C and TP#D. 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 --