Summary:
Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory director's failure to monitor pre-analytic written orders (D5303); failure to effectively maintain analytic systems (D5400, D5401, D5411, and D5545);and failure to monitor post-analytic patient test reports (D5805) resulting in Immediate Jeopardy. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a lack of personnel records and a procedure manual and an interview with the Laboratory Director, the laboratory failed to assess the competencies on two of two testing persons performing moderate complexity testing (MCT) on the Activated Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Clotting Time (ACT) (Refer to D5209); the laboratory failed to document a quality assurance plan to ensure testing persons were qualified to perform MCT in coagulation (refer to D5293) resulting in Immediate Jeopardy. 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 the lack of a laboratory procedure manual and employee personnel records for 2018-2019, and interview with the laboratory director, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency resulting in Immediate Jeopardy. The findings include: 1) There was no laboratory procedure manual or procedure for the following six criteria to be included in the procedure and competency documentation: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2) There were no 2018-19 employee personnel records available for documentation of competency assessment for the six required criteria. 3) Interview on May 2, 2019 at 3:00 p.m. with the laboratory director, the laboratory did not have a testing personnel competency procedure that included the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of