Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 12, 2018. 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 policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings include: 1. SOP review revealed the laboratory failed to establish and follow written policies and procedures for performing testing personnel (TP) competencies using the six-procedure competency criteria. 2. An interview with the laboratory manager in a conference room on 7/12/18 at approximately 3 p.m confirmed the laboratory SOP did not contain the six-procedure TP competency policy and procedure. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as required. Findings include: 1. SOP review revealed the laboratory failed to establish and follow a quality assurance (QA) policy and procedure for the laboratory. 2. An interview with Staff #1 (CMS 209) in a conference room on 7/12/18 at approximately 3 p.m. confirmed the laboratory SOP did not contain a QA policy and procedure. 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)