Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Florida Pediatric Group PA on April 30, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient test results reports and interview, the laboratory failed to identify the testing person who performed complete blood count (CBC) for 31 of 73 test results reports reviewed from January 2025, February 2025, and April 2025. Findings: Review of patients' CBC tests results reports revealed the identity of the testing personnel who performed the test was not indicated for the following patients: Patient 1 performed 01/07/2025 at 5:47 PM. Patient 2 performed 01/07/2025 at 12:21 PM. Patient 3 performed 01/08/2025 at 12:53 PM. Patient 4 performed 01/08/2025 at 3:09 PM Patient 5 performed 01/09/2025 at 5:03 PM Patient 6 performed 01/09/2025 at 10:29 PM Patient 7 performed 01/09/2025 at 12:01 PM Patient 8 performed 01/09 /2025 at 3:05 PM Patient 9 performed 01/09/2025 at 10:30 AM Patient 10 performed 01/10/2025 at 10:20 AM. Patient 11 performed 01/10/2025 at 2:30 PM. Patient 12 performed 01/16/2025 at 11:42 AM. Patient 13 performed 01/16/2025 at 4:26 PM. Patient 14 performed 01/16/2025 at 12:14 PM Patient 15 performed 01/16/2025 at 11: 04 AM Patient 16 performed 01/17/2025 at 3:55 PM Patient 17 performed 01/21/2025 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 -- at 10:44 AM Patient 26 performed 01/27/2025 at 2:59 PM Patient 28 performed 01/31 /2025 at 12:18 PM Patient 31 performed 02/06/2025 at 3:59 PM. Patient 32 performed 02/07/2025 at 11:10 AM. Patient 42 performed 02/26/2025 at 11:49 AM. Patient 43 performed 02/26/2025 at 10:22 AM Patient 48 performed 04/10/2025 at 4:08 PM Patient 50 performed 04/10/2025 at 2:12 PM Patient 51 performed 04/10/2025 at 1:59 PM Patient 53 performed 04/15/2025 at 9:05 AM Patient 54 performed 04/15/2025 at 9:04 AM Patient 55 performed 04/15/2025 at 9:02 AM Patient 56 performed 04/17 /2025 at 4:08 PM Patient 59 performed 04/18/2025 at 2:47 PM During an interview on 04/30/2025 at 11:05 AM, Testing Personnel A stated they record their initials on the instrument printout to indicate who ran the test. Testing Personnel A acknowledge some reports were missing the initials of the Testing Personnel who ran the test. -- 2 of 2 --