Summary:
Summary Statement of Deficiencies D0000 An Initial Certification survey was performed at Louisiana Internal Medicine & Pediatric Associates - CLIA # 19D2135111 on April 5, 2018. Louisiana Internal Medicine & Pediatric Associates was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing Moderate Complexity Testing, LABORATORY DIRECTOR 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 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to have a complete policy and procedure manual. Refer to D5403 2. The laboratory failed to use control material before reconstitution expiration date provided by the manufacturer for Total Bilirubin. Refer to D5415 3. The laboratory failed to have complete performance specification verification studies for three of three instruments reviewed. Refer to D5421 4. The laboratory failed to establish their own means and ranges for Quality Control (QC) material utilized for chemistry testing. Refer to D5469 5. The laboratory failed to follow established policies to monitor, assess, and correct quality issues in Analytic Systems. Refer to D5791 D5403 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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)