Summary:
Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual and interview with the Practice Administrator (AP), the laboratory failed to establish a written procedure for Biannual Assessment (BA) for Synovial Fluid Microscopy (SFM) test from 12/5/17 to the date of survey. The AP confirmed on 12/3/19 at 10:50 am that a BA procedure was not established for SFM. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor observation of the Accession Log (AL) and interview with the Practice Administrator (PA), the laboratory failed to maintain an Accession Log (AL) for Synovial Fluid Microscopy (SFM) test from 1/20/18 to the date of survey. The PA Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- confirmed on 12/3/19 at 10:15 am that the laboratory did not maintain an AL for SFM. -- 2 of 2 --