Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Boca Raton Pediatric Associates on September 18, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have an incubator time policy and failed to record incubator enter and exit times for throat cultures and urine colony count from 6/24/25 to 9/13/25. Findings included: Review of Throat and Urine Culture Log Sheet revealed 93 patients were tested for throat cultures without incubation enter and exit times from 6/24/25 to 9/13/25. There were 15 patients tested for urine count colony without incubation enter and exit times from 6/24/25 to 9/12 /25. Review of Throat Culture-General Routine read, "The throat culture shall be placed in the incubator and shall be read by the physician 18-24 hours later. The results shall be recorded in the patient's chart and the laboratory logbook." Review of URICULT Urine CULTURE-PADDLES instructions for use read, "Place inoculated URICULT vial upright in incubator at 97 degrees Fahrenheit (F) +/- 4F (36 Celsius (C) +/-2 C) for 18 to 24 hours. Incubation should not exceed 24 hours. Incubation exceeding 24 hours may cause bacterial overgrowth resulting in difficult interpretation of colony counts and possibly misleading biochemical reactions." Review of incubation policy revealed there was no documentation of a policy for how to monitor 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 -- incubation enter and exit times for Throat Cultures and Urine Colony counts. On 9/18 /2025 at 4:38 PM, the Laboratory Director confirmed he was not monitoring enter and exit times of the incubator for throat cultures form and urine colony count. -- 2 of 2 --