Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory verification studies, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions for performing the method comparison on the Sysmex XN-450 hematology analyzer. Findings were: 1. Review of the manufacturer's instructions XN- series XN-L Method Verification Manual (1251-LSS, Rev 2, Dec 2016) revealed "complete blood counts samples should be analyzed within 4 hours of collection and on both analyzers within 2 hours of each other." 2. Random review of the method comparison studies of the Sysmex XN-450 hematology analyzers revealed no documentation of the collection date and time. 3. Random review of the method comparison studies of the Sysmex XN-450 hematology analyzers revealed documentation that sample analysis was not within 2 hours of each analyzer for 9 of 10 samples reviewed. Patient ID 259304 sample analyzed 7/8/19 @ 10:19 hours (Sysmex XN-450) and 16:53 hours (2nd analyzer); elapsed time 6:34 Patient ID 261009 sample analyzed 7/8/19 @ 11:05 hours (Sysmex XN-450) and 16:54 hours Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (2nd analyzer); elapsed time 5:49 Patient ID 260727 sample analyzed 7/8/19 @ 12:07 hours (Sysmex XN-450) and 16:59 hours (2nd analyzer); elapsed time 4:52 Patient ID 49804 sample analyzed 7/8/19 @ 12:09 hours (Sysmex XN-450) and 17:09 hours (2nd analyzer); elapsed time 5:00 Patient ID 79373 sample analyzed 7/8/19 @ 11:02 hours (Sysmex XN-450) and 17:21 hours (2nd analyzer); elapsed time 6:19 Patient ID 249347 sample analyzed 7/8/19 @ 14:48 hours (Sysmex XN-450) and 17:24 hours (2nd analyzer); elapsed time 2:36 Patient ID 80767 sample analyzed 7/8/19 @ 11:24 hours (Sysmex XN-450) and 17:29 hours (2nd analyzer); elapsed time 6:05 Patient ID 68830 sample analyzed 7/9/19 @ 08:17 hours (Sysmex XN-450) and 11:49 hours (2nd analyzer); elapsed time 3:32 Patient ID 261187 sample analyzed 7/9/19 @ 09:48 hours (Sysmex XN-450) and 11:52 hours (2nd analyzer); elapsed time 2:04 4. An interview with the lab manager on 8/2/19 at 1315 hours in the laboratory confirmed the above findings. She was unaware of the time limits for the method comparison study. D5785