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. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory verification records, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions when performing the accuracy assessment with a correlation study for the Sysmex XS1000iC hematology analyzer. Findings were: 1. Review of the Sysmex XS- Series Implementation Manual (MKT-30-1009, November 2008) revealed "correlation is performed to determine equivalency of a new analyzer to the current analyzer or reference method...complete blood count (CBC) samples should be analyzed within 4 hours of collection and on both analyzers within 2 hours of each other." 2. Review of the laboratory verification records for the Sysmex XS1000iC hematology analyzer revealed a correlation study was performed on 01/30/17 and 01 /31/17. Random review of the correlation study data revealed 8 of 40 samples where 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 -- the laboratory documented the samples were analyzed greater than 4 hours of collection. Collection analyzed HMX Patient ID date time date time DL676440G 1/30 /17 11:18 1/31/17 15:16 elapsed time hours 27:58:00 DL721010G 1/30/17 17:04 1/31 /17 15:00 elapsed time hours 21:56 DL668983G 1/30/17 9:07 1/31/17 15:03 elapsed time hours 29:56:00 DL687171G 1/30/17 16:16 1/31/17 14:53 elapsed time hours 22: 37 DL693526G 1/30/17 16:05 1/31/17 15:15 elapsed time hours 23:10 DL698391G 1 /30/17 8:20 1/31/17 15:18 elapsed time hours 30:58:00 DL670797G 1/30/17 9:43 1/31 /17 15:24 elapsed time hours 29:41:00 DL675222G 1/30/17 10:55 1/31/17 15:26 elapsed time hours 28:31:00 Collection analyzed Sysmex Patient ID date time date time DL676440G 1/30/17 11:18 1/31/17 15:28 Elapsed time hours 28:10:00 DL721010G 1/30/17 17:04 1/31/17 15:19 Elapsed time hours 22:05 DL668983G 1/30 /17 9:07 1/31/17 15:21 Elapsed time hours 30:14:00 DL687171G 1/30/17 16:16 1/31 /17 15:25 Elapsed time hours 23:09 DL693526G 1/30/17 16:05 1/31/17 15:27 Elapsed time hours 23:22 DL698391G 1/30/17 8:20 1/31/17 15:29 Elapsed time hours 31:09: 00 DL670797G 1/30/17 9:43 1/31/17 15:31 Elapsed time hours 29:48:00 DL675222G 1/30/17 10:55 1/31/17 15:32 Elapsed time hours 28:47:00 3. Review of the laboratory verification records for the Sysmex XS1000iC hematology analyzer revealed a correlation study was performed on 01/30/17 and 01/31/17. Random review of the correlation study data revealed 9 of 40 samples where laboratory documented the samples were analyzed greater than 2 hours of analysis between analyzers. Hmx Sysmex Patient ID date time date time DL670420G 1/30/17 11:28 1/30/1714:19 Elapsed time hours 2:51 DL665635G 1/30/17 9:56 1/30/1714:21 Elapsed time hours 4: 25 DL665710G 1/30/17 9:33 1/30/1714:24 Elapsed time hours 4:51 DL664433G 1/30 /17 10:10 1/30/1714:25 Elapsed time hours 4:15 DL671838G 1/30/17 13:02 1/30 /1714:26 Elapsed time hours 1:24 DL667717G 1/30/17 11:26 1/30/1714:28 Elapsed time hours 3:02 DL670583G 1/30/17 11:46 1/30/1714:29 Elapsed time hours 2:43 DL670762G 1/30/17 11:33 1/30/1714:31 Elapsed time hours 2:58 DL760092G 1/30 /17 11:57 1/30/1714:32 Elapsed time hours 2:35 4. An interview with the technical consultant on 5/17/18 at 1050 hours in the office confirmed the above findings. She was unaware that there was a time limit of when the samples needed to be analyzed from collection or from each analyzer. -- 2 of 2 --