Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pensacola Pediatrics on 07/24/2024 to 08/01/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation, document review, and interview the laboratory failed to follow the written procedure to ensure positive identification and optimum integrity of a patient's specimen from the time of collection through completion of testing for specimens 3 of 3 urine culture and 7 of 7 throat cultures (patient #1-#10). Findings: During a tour of the laboratory on 7/24/2024 at 10:20 AM inoculated patient samples #1-#3 urine cultures and #4-#10 throat samples were labeled with patient first and last name and date samples set up. Review of the patient logs revealed there was no documentation of date of birth or urine specimen type. Review of the procedure manual for patient labeling for urine and throat cultures approved by the Lab Director 04/28/2020 stated urine cultures were to be labeled with name, date, provider, and if sample was clean catch, cath or bag specimen and throat cultures with patient name, chart number, and date. Testing Personnel #4 confirmed on 07/24/204 at 10:25 AM the laboratory was not following the written policies for ensuring patient identification from collection to completion of testing. 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 --