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: Through a review of the Operator's Manual for the Medonic M series hematology analyzer, a review of the calibration documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform calibration at least every 6 months, as required by the manufacturer. Survey findings include: A. In Section 7 of the Operator's Manual for the Medonic M series hematology analyzer, it states, "It is recommended to calibrate the instrument every 6 months." B. A review of the calibration documentation for 2020 through 2022 revealed calibrations were documented on 1/17/2020, 7/23/2020, 9/24/2020, 4/6/2021, and 11/11/2021. More than 6 months elapsed between calibrations on two of four occasions in 2020 and 2021. C. The technical consultant, as listed on the Form CMS-209, confirmed (4/26 /2022 11:15) the calibrations were not performed within six months on two occasions. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) 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 -- (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: Through a review of the CMS-209 form, a review of competency documentation for three of three testing personnel, and through interviews with laboratory staff, it was determined competency assessments were not performed using all required competency assessment criteria for two of three testing personnel. Survey findings include: A. A review of the CMS-209 form dated 4/25/2022 revealed three testing personnel listed as #4, #5, and #6 on the form. B. During a review of personnel competency assessments for the three testing personnel, it was determined the assessments for employee #5, dated 12/9/2020 and 12/21/2021, and the assessments for employee #6, dated 12/9/2020 and 3/11/2022, only included documentation of direct observation. There was no documentation of the required monitoring of recording and reporting test results, review of worksheets, quality control records, proficiency test results, and maintenance records, observation of instrument maintenance and function checks, testing of previously analyzed specimens, or proficiency testing samples, or documentation of assessment of problem solving skills. C. During an interview, at 10:15 a.m. on 4/26/2022, laboratory employee #3 (as listed on the form CMS-209) confirmed the only documentation of competency assessment for employees #5 and #6 was a documentation of direct observation of procedure. -- 2 of 2 --