George C Borst Iii , Psc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 04/05/2023 and the facility was found not to be in substantial compliance with the laboratory requirements of 42 CFR, Part 493 with deficiencies cited. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on document review, facility policy review, and interview, it was determined the laboratory failed to perform semiannual competency evaluations of a new employee during their first year of employment for one (1) of two (2) testing personnel (TP) reviewed (TP#1). Findings included: A review of the "Laboratory Personnel Report (FORM CMS-209)," signed by the Laboratory Director and dated 03 /20/2023, revealed two (2) employees were listed as TP (TP #1 and TP #2). A review of TP #1's "Regional Endocrine and Diabetes Associates Laboratory Employee Competency," revealed TP #1 completed their initial competency evaluation on 11/29 /2021. Further review revealed TP #1 completed their annual competency evaluation on 12/07/2022. Review of the laboratory's policy titled "Standard Personnel Assessment," reviewed January 2022, did not specify when competency evaluations should be performed. During an interview on 04/05/2023 at 1:55 PM, TP #1 stated she was hired in November of 2021, after the laboratory's last recertification survey. During an interview on 04/05/2023 at 4:50 PM, TP #1 stated competency evaluations for new hires were performed on hire and then annually. 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 --

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 staff interview and record review on October 23, 2018, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Competency assessment was performed using zero (0) of six (6) methods of assessment for two (2) out of two (2) employees from October 27, 2016 through October 22, 2018. Findings include: Record review on October 23 revealed there was no documented competency assessments between October 27, 2016 and October 22, 2018, for two (2) employees that included the folowing: competency assessments failed to include direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples and problem solving skills. An interview with the staff on October 23, 2018 at 09:55 AM revealed the facility failed to have a system in place between October 27, 2016 and October 22, 2018 to ensure competency was performed using all six (6) mandated competency assessment requirements from October 27, 2016 and October 22, 2018. 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 --