Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory staff, the laboratory did not establish written policies and procedures for assessing the testing personnel as defined in subpart M- CFR 493.1413(b)(8) through (9). Findings: 1. The laboratory's written procedure manual did not include all the required elements for evaluating the competency of the testing personnel and assuring that they maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to: direct observations of routine patient test performance, including patient preparation, if applicable; specimen handling, processing and testing; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills; and evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 2. The laboratory's "Training Checklist" form was used to perform competency assessments. The form had not been updated after the laboratory began using the Cell-Dyn Emerald for hematology testing and referred to the "QBC" analyzer used previously; and 3. The "Training Checklist" form did not include all 6 required elements for evaluating the competency of testing personnel. 4. A review of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- competency assessment records showed that 9 of 9 testing personnel reviewed had been evaluated using the outdated "Training Checklist." 5. During an interview on 1 /23/2020 at 12:15 PM, the laboratory staff confirmed that the policies and procedure manual did not include a written training program along with updated worksheets for the documentation of the training of the testing personnel and medical assistants who perform pre-analytical and analytical preparation. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)