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, the laboratory failed to establish a written policy to assess the training and competency of testing personnel using the six competency assessment criteria, and failed to retain the competency performed on the Mohs technician for 2018. Findings: Review of the laboratory's procedure "Quality Assurance Program" in the section personnel noted "The histologist is evaluated annually for the performance of of her technical skills." The following six competency assessment criteria are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing: 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; 2. Monitoring the recording and reporting of test results; 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. Direct observations of performance of instrument maintenance and function checks; 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples 6. Assessment of problem solving skills. Competency assessment, which includes the six competency assessment criteria, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. Review of the "Employee Evaluation" form for 2019 showed that the Mohs Lab Technician was evaluated for punctuality, attitude, adherence to duties, cleanliness, and ability to perform lab duties. No evaluation for 2018 was available for review. During an interview on 3/11/19 at 2:22 PM, the Mohs Technician stated that she was unable to find her 2018 employee 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 -- evaluation. During an interview on 3/11/19 at 3:45 PM, the Laboratory Director acknowledge the six competency assessment criteria were missing. 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)