Summary:
Summary Statement of Deficiencies D0000 A Provider Performed Microscopy (PPM) Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 11, 2020. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to follow a policy and procedure to assess (TP) competency as required. Findings include: 1. Lack of TP competency documents revealed there was no annual competencies performed for the following TP(CMS 209) for 2018, 2019, and 2020 thus far: Staff #2, Staff #3. 3. An interview with the lab director in the staff breakroon on 2/11/2020 at approximately 12:40 p.m. confirmed there were no competency documents available at the time of survey for the aforementioned staff for 2018, 2019, and 2020 thus far. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP), lack of microscopic qualitative quality control (QC) documents, lack of maintenance records, and staff interview, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as required. Findings include: For details refer to D5403, D5433, D5435, and D5449 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)