Summary:
Summary Statement of Deficiencies D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based upon review of the laboratory's procedure manual and interview with TP (Testing Personnel) #1 on 1/9/24, TP#1 failed to follow the laboratory's procedure manual. Findings: Review of the laboratory's Neonatal Bili-Richert UNISTAT Bilirubinometer procedure states in "Specimen Collection, Preparation, and Storage" to "...Allow to clot for 10 minutes prior to centrifuging. Centrifuge 3 minutes in the STAT spin..." In interview at approximately 10:30 a.m., TP #1 stated that she routinely centrifuges bilirubin specimens for 7-10 minutes in the STAT spin centrifuge prior to patient 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 --