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 review of the laboratory procedure manual and interview with the Nurse Manager and Director of Clinical Services, the laboratory failed to establish procedures that monitor and assess the laboratory's pre-analytical, analytical and post- analytical quality assessment (QA) activities from November 2018 to the date of survey. Finding Include: 1. On the day of survey, 02/28/2019, the laboratory could not provide a QA policy that assess the laboratory's pre-analytical, analytical and post- analytical activities from November 2018 to February 2019. 2. The Nurse Manager confirmed on 02/28/2019 around 10:45 am, that a QA policy did not exist. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with the Nurse Manager and 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 -- Director of Clinical Services, the laboratory failed to perform quality control for microscopic urinalysis and microscopic synovial fluid examinations from 2018 to the date of survey. Findings Include: 1. On the day of survey, 02/28/2019, the laboratory could not provide documentation of quality control performed for microscopic urinalysis and microscopic synovial fluid examination performed from November 2018 to February 28th, 2019. 2. In 2018, 5 Microscopic Urinalysis patient samples were analyzed in November and 10 Microscopic Urinalysis specimen were analyzed in December. 3. In 2019, 9 Microscopic Urinalysis patient samples were analyzed in January and 12 Microscopic Urinalysis specimen were analyzed in February. 4. In 2019, 1 Synovial Fluid examination was analyzed in January 2019. 5. The Nurse manager confirmed the findings above on 02/28/2019 around 9:45 am -- 2 of 2 --