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 was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2021 and 2022, and staff interview it was revealed the laboratory failed to ensure proficiency test samples were tested the same number of times as patient samples. The findings include: 1. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2021 (event 2 and 3) and 2022 (events 1 and 2) revealed the laboratory tested proficiency testing samples multiple times for 3 of 4 events. The dates and times were: a) 2021 event 2 Sample 6: tested: 08 /02/2021 15:53:52 (labeled as 1st Run) tested: 08/04/2021 15:11:09 (labeled as 2nd Run) Sample 7: tested: 08/02/2021 15:55:03 tested: 08/04/2021 15:12:20 Sample 8: tested: 08/02/2021 15:56:13 tested: 08/04/2021 15:13:30 Sample 9: tested: 08/02/2021 15:57:24 tested: 08/02/2021 15:14:40 Sample: 10 tested: 08/02/2021 15:58:34 tested: 08/04/2021 15:15:50 b) 2022 event 1 Sample 1: tested: 03/23/2022 16:07:26 (labeled as 1st Run) tested: 03/24/2022 13:35:53 (labeled as 2nd Run) Sample 2: tested: 03/23 /2022 16:08:36 tested: 03/24/2022 13:37:09 Sample 3: tested: 03/23/2022 16:09:46 tested: 03/24/2022 13:38:23 Sample 4: tested: 03/23/2022 16:10:57 tested: 03/24/2022 13:39:37 Sample 5: tested: 03/23/2022 16:12:09 tested: 03/24/2022 13:40:52 c) 2022 event 2 Sample 6: tested: 07/29/2022 16:03:11 tested: 07/29/2022 16:11:25 (labeled as 2nd) tested: 07/29/2022 16:19:15 Sample 7: \ tested: 07/29/2022 16:04:22 tested: 07 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 -- /29/2022 16:12:36 tested: 07/29/2022 16:20:25 Sample 8: tested: 07/29/2022 16:05:36 tested: 07/29/2022 16:13:45 tested: 07/29/2022 16:21:34 Sample 9: tested: 07/29/2022 16:06:48 tested: 07/29/2022 16:14:58 tested: 07/29/2022 16:22:46 Sample 10: tested: 07/29/2022 16:07:59 tested: 07/29/2022 16:16:08 tested: 07/29/2022 16:23:56 2. An interview with testing personnel number 2 (as listed on Form CMS 209) on 10/06 /2022 at 1000 hours in the laboratory revealed proficiency samples were tested multiple times to ensure they were tested using the quality control mode of the analyzer as required by the proficiency testing agency. This confirmed the findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient test records and staff interview, it was revealed the laboratory's quality assurance plan failed to identify that the correct collection time of samples was provided to the reference laboratory. The findings include: 1. A sampling of patient test records October 3 -5, 2022 revealed the laboratory collected complete blood count (CBC) samples at the following times: a) October 3, 2022 patient ID: 719690 collection time: 11:10 am b) October 3, 2022 patient ID: 795950 collection time: 01:42 pm c) October 3, 2022 patient ID: 22360 collection time: 02:23 pm d) October 4, 2022 patient ID: 708570 collection time: 08: 37 am e) October 5, 2022 patient ID: 752770 collection time: 04:31 pm 2. A review of the test requisitions for the identified samples to the reference lab used to confirm the CBC results revealed the reference lab was provided a collection time which was different: a) October 3, 2022 patient ID: 719690 reference lab collection time: 3:14 pm (4 hours 4 minutes later) b) October 3, 2022 patient ID: 795950 reference lab collection time: 3:06 pm (1 hour 24 minutes later) c) October 3, 2022 patient ID: 22360 reference lab collection time: 3:07 pm (54 minutes later) d) October 4, 2022 patient ID: 708570 reference lab collection time: 9:34 am (57 minutes later) e) October 5, 2022 patient ID: 752770 reference lab collection time: 5:16 pm (45 minutes later) 3. An interview with testing personnel number 2 (as listed on Form CMS 209) on 10/06/2022 at 1220 hours in the laboratory revealed the collection times for samples sent to a reference laboratory were defaulted to when the order for the sendout test was placed. This confirmed the findings. -- 2 of 2 --