Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/29/2024 found the DERMATOLOGY GROUP OF FLORIDA PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to label the Bio-Optica Manual Stainer to identify what reagents were in use for the Hematoxylin and Eosin (H&E) stain. Findings included: On 01/29/2024 at 10:45 AM a Bio-Optica Manual Stainer sat on the counter with unlabeled containers to identify what reagents were in use for the H&E stain. During an interview with the Risk Manager on 01/29/2024 at 12:00 PM, she confirmed that the containers in the stainer were not labeled with the reagent in use. 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. 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 record review and staff interview, the Technical Consultant (TC) failed to perform initial and six months Potassium Hydroxide (KOH) competency for one out of two Testing Personnel (TP) in 2022/2023. Findings included: -Review of FORM- 209 (01/2021) signed and dated by the Laboratory Director (LD) on 01/04/2024, revealed that the LD, Clinical Consultant (CC), TC and TP#B were the same person and he was the only person listed performing KOH test. -Review of MYCOLOGY- VIROLOGY-SCABIES PREP LOG FOR YEARS 2022 AND 2023 revealed that there was a second TP (TP#C) performing KOH test. Review of personnel records revealed that the TP#C had no initial competency evaluation signed by the TC before patient testing on 10/28/2022 and no six months competency during 2023, that he also performed testing. During an interview on 01/29/2024 at 11:30 AM, the Risk Manager confirmed that the TC failed to perform initial and six month competencies for TP#C. -- 2 of 2 --