Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide evidence of required maintenance in the specialty of hematology. Findings include: 1 Record review of the Medonics instrument M Series Hematology Analyzer Serial number 26089 monthly maintenance logs for 2017 and 2018 on 5/8/18 revealed the following: a. Boule Cleaning Kit procedure is required every six months. b. The last documented procedure was 7/5/17. c. 2018 Documentation of the cleaning kit procedure performance was not available. 2. Staff interview with the technical consultant (TC) on 5/8/18 at 10:45 AM confirmed the above findings. TC stated he/she thought the cleaning kit procedure was performed but the testing personnel forgot to record the activity. 3. The laboratory performs 25 complete blood counts annually. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide evidence of documented competency assessment for all new testing personnel performing and 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 -- reporting tests in the specialty of hematology. Findings include: 1. Record review of 2017 and 2018 personnel competency records on 5/8/18 revealed semiannual documentation for 1 of 3 new testing personnel was not available. 2. Staff interview with the technical consultant on 5/8/18 at 11:40 AM confirmed the above findings. 3. The laboratory performs 25 complete blood counts annually. -- 2 of 2 --