Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: Based on record review of Competency Assessment, a lack of documentation, and interview with the Histology Tech (HT), the Technical Supervisor (TS) failed to ensure that testing personnel (TP) were evaluated for competency to perform high complexity testing in 2021 for the subspecialty of histopathology. Findings Include: 1. Record review on 6/03/2022 of the laboratory's 'Frozen Section Quality Assurance Proficiency Record' for TP 2021 competency assessment revealed the following: a. 1 of 3 TP did not have documented competency assessment for 2021. b. Competency assessment slides for TP1(W10-20 SoCo) were given to the TS for peer review on 4 /01/2021. c. The TS did not document review of the slides until 2/10/2022. d. Upon review of W10-20 SoCo slides, the TS noted, "+ Margin". 2. Record Review on 6/3 /2022 of the medical record of W10-20 SoCo revealed a note titled 'Telephone Encounter' dated 2/10/2022 stating the following: a. "On peer review of a Mohs case that I performed on 11/5/20 for a recurrent BCC on the L cheek, it was found that there was a very subtle small focus of residual infiltrating BCC at the 8-9 O'clock margin." b. "I requested that the pt come in for additional Mohs to ensure clearance of the tumor ..." 3. Staff interview with the HT on 6/03/2022 at 11:00 AM confirmed the above findings. 4. The laboratory performs 1,284 tests annually in the subspecialty of histology. 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 --