Three Rivers Hospital

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to have a procedure for use of Lipoclear (Refer to D5401) and failed to validate the use of Lipoclear reagent for removal of lipemia from patient samples for chemistry assays (Refer to D5421). 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017 proficiency testing performance evaluation reports, the laboratory's policy titled "Proficiency Testing", and interview with the laboratory supervisor the laboratory failed to follow quality assessment policy for evaluation of proficiency testing results in 2017. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing performance evaluation reports revealed the following: 2017 Immunology/Immunohematology 2nd event DAT-Anti-C3d-sample # DAT-03=Not Graded, no evaluation of non-graded result; 2017 Microbiology 2nd Event Group A Strep Antigen, sample # ST- 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 -- 09=Unacceptable, no