Summary:
Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on staff interview and record review on 09/06/2018, the laboratory failed to perform calibration on the Cell-Dyn 1700 Hematology analyzer every six (6) months in accordance with the facility's standard operating procedure. Findings include: Calibration was not performed between December 8, 2017, through September 5, 2018. Testing personnel acknowledged in an interview on 09/06/2018 at 10:40AM that the laboratory failed to have a system in place to ensure calibration of the Cell- Dyn 1700 Hematology analyzer be performed and documented in accordance with facility's standard operation procedure between December 8, 2017, through September 5, 2018. 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 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 -- 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, the Technical Consultant failed to perform and document annual competency using the six (6) mandated competency assessment requirements for testing personnel. Competency assessment was performed using zero (0) of six (6) methods of assessment for three (3) out of three (3) employees from April 4, 2017, through September 5, 2018. Findings include: Record review on 09/06/2018 revealed there was no documented competency assessments between April 4, 2017 and September 5, 2018, for three (3) employees that included the following: 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 09/06/2018 at 9:02 AM revealed the facility failed to have a system in place between April 4 2017 and September 5, 2018, to ensure competency was performed using all six (6) mandated competency assessment requirements. -- 2 of 2 --