Validation of TEG5000 Functional Fibrinogen Reagent as Abnormal Quality Control Material for TEG 6s PlateletMapping

Graduation Date


Document Type

Master's Thesis

Degree Name

Master of Science

Department or Program

Clinical Laboratory Sciences

Department or Program Chair

Mary Sevigny, PhD

First Reader

Maria Theresa P. Ibanez, MBA, CLS

Second Reader

Maria C. DeSousa, JD, MPA, CLS


This capstone project covers the validation process of the Functional Fibrinogen reagent as an abnormal quality control material for platelet mapping using Thromboelastograph (TEG) 6s hemostatic analyzer at NorthBay Medical Center Clinical Laboratory. The Functional Fibrinogen reagent was manufactured for TEG 5000, model prior to 6s. This alternative will ensure that there will be no delay in the performance of periodic quality control due to the unavailability of quality control materials. It will also reduce laboratory expenses because Functional Fibrinogen reagent costs lower Col;ege of American Pathology proficiency samples which were used in the past as additional quality control materials for platelet mapping. A total of 21 samples from 10 screened, normal donors were collected in a six day period. The results correlated with the suggested manufacturer's abnormal quality control ranges and met the acceptable minimum criteria established by the Clinical and Laboratory Standards Institute EP28-A3C Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory Approved Guideline. The Functional Fibrinogen reagent passed the validation and testing personnel were trained on how to prepare the abnormal control sample. The Functional Fibrinogen QC material will resolve most of the quality control issues encountered since the analyzer was implemented, therefore it is beneficial to the laboratory.

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