Summary:
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's quality assessment process was ineffective when it failed to detect and correct problems with quality control limits and lot numbers in use for urine dipstick testing in 2017 and 2018. (Refer to D5293) D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of