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 review of the laboratory's Policy's and Procedures and interview with the laboratory technical consultant (TC) on 11/02/2020, the laboratory failed to establish policies and procedures to assess employee and consultant competency in accordance with 42 C.F.R. 493.1413(b)(8)(9). The findings include: 1. The laboratory personnel form (CMS-209) lists (26) testing personnel who are medical assistants or higher nursing degreed individuals. 2. The laboratory had no documentation of initial training or competency for the 12 new staff hired after the previous survey performed on 3/14/2018. 3. The laboratory had a check list sheet listed as semi-annual and annual competency. The competency form did not indicate or identify which of the six parameters listed in 42 C.F.R. 493.1413(b)(8) were used to determine competency for initial, semi-annual or annual competency. 4. The technical consultant confirmed by interview on 11/2/2020 that the laboratory does not have a policy or procedure for initial training and competency, semi-annual competency or annual competency which includes the six parameters that must be included in competency assessments in accordance with 42 C.F.R. 493.1413(b)(8). (i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; (ii) Monitoring the recording and reporting of test results; (iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; (iv) Direct observation of performance of instrument maintenance and function checks; (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and (vi) Assessment of problem Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- solving skills; 5. The laboratory has 26 testing personnel and reports performing 7900 patient specimens annually. 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)