Summary:
Summary Statement of Deficiencies D0000 An initial certification survey conducted at SAWGRASS PEDIATRIC PARTNERS LLC from 10/23/2023 to 10/27/2023 found the clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and interview, the laboratory failed to read throat cultures (TC) at 24 hours per their policy for 14 out of 155 patients reported since 05/19/2023. Findings included: Review of the policy "DOCUMENTATION OF THROAT CULTURES" revealed that: "MD READS 24 HR AND IS ONLY DOCUMENTED IN LOG. MD TO READ 48 HR THROAT CULTURE, DOCUMENT IN LOG BOOK, ALSO ENTER RESULTS IN EHR." Review of "DAILY RAPID STREP/TC LOG" revealed the days and patients that results were not read at 24 hours, instead they were read at 48 hours: 05/19/2023: one patient 05/26/2023: six patients 07/23 /2023: seven patients During an interview on 10/23/2022 at 12:30 PM, the laboratory director confirmed that the laboratory failed to read 14 TC at 24 hours as per their policy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --