Summary:
Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) 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. This STANDARD is not met as evidenced by: Based on a review of personnel records, Alabama County Health Department Laboratory Systems Policies and Procedures Manual, and an interview with Technical Consultant #2, the Technical Consultant failed to include direct observation of routine patient test performance required for moderate complexity testing evaluation of competency. This was noted from previous survey (11/20/2019) to current survey (04 /21/2022) for Vaginal Wet Preparations and Potassium Hydroxide (KOH) testing for a total of 161 Testing Personnel listed on the CMS 209 - Laboratory Personnel Report. The findings include: 1. A review of personnel records revealed the Competency Evaluation Checklist consisted a quiz which covered problem solving skills and assessment of test performance by identifying images for Vaginal Wet Preparations and KOH. This checklist did not include direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. 2. A review of Alabama County Health Department Laboratory Systems Policies and Procedures Manual revealed "...All phases of laboratory testing (preanalytic, analytic, and postanalytic) will be reviewed. Evaluation methods include direct observation, record review, and testing unknown specimens. 1. Direct observation - Personnel will be observed performing testing, QC, reporting, function checks, and maintenance to determine if written procedures are followed. 2. Record review - Quality control and maintenance records will be reviewed for accuracy and completeness. In addition, documentation of "out of control results" and