Abstract

IntroductionAn observational study was conducted using a structured observation scheme to assess compliance with the local phlebotomy guideline, to identify necessary focus items, and to investigate whether adherence to the phlebotomy guideline improved.Materials and methodsThe questionnaire from the EFLM Working Group for the Preanalytical Phase was adapted to local procedures. A pilot study of three months duration was conducted. Based on this, corrective actions were implemented and a follow-up study was conducted. All phlebotomists at the Department of Clinical Biochemistry and Pharmacology were observed. Three blood collections by each phlebotomist were observed at each session conducted at the phlebotomy ward and the hospital wards, respectively. Error frequencies were calculated for the phlebotomy ward and the hospital wards and for the two study phases.ResultsA total of 126 blood drawings by 39 phlebotomists were observed in the pilot study, while 84 blood drawings by 34 phlebotomists were observed in the follow-up study. In the pilot study, the three major error items were hand hygiene (42% error), mixing of samples (22%), and order of draw (21%). Minor significant differences were found between the two settings. After focus on the major aspects, the follow-up study showed significant improvement for all three items at both settings (P < 0.01, P < 0.01, and P = 0.01, respectively).ConclusionContinuous quality control of the phlebotomy procedure revealed a number of items not conducted in compliance with the local phlebotomy guideline. It supported significant improvements in the adherence to the recommended phlebotomy procedures and facilitated documentation of the phlebotomy quality.

Highlights

  • An observational study was conducted using a structured observation scheme to assess compliance with the local phlebotomy guideline, to identify necessary focus items, and to investigate whether adherence to the phlebotomy guideline improved

  • A total of 126 blood drawings by 39 phlebotomists were observed in the pilot study, while 84 blood drawings by 34 phlebotomists were observed in the follow-up study

  • Continuous quality control of the phlebotomy procedure revealed a number of items not conducted in compliance with the local phlebotomy guideline

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Summary

Introduction

An observational study was conducted using a structured observation scheme to assess compliance with the local phlebotomy guideline, to identify necessary focus items, and to investigate whether adherence to the phlebotomy guideline improved. The ongoing vast automation of the laboratories certainly helps in this matter, but preanalytical errors remain a challenge, and studies have reported that up to 75% of laboratory errors occur in the preanalytical phase, where the blood sampling procedure is a pivotal area [2,3,4]. Recent reports on the un-harmonised training in European countries of the personnel performing phlebotomy and the lack of adherence to guidelines by the Clinical and Laboratory Standards Institute (CLSI) and the International Organization for Standardization (ISO) is alarming [5,6,7,8]. Efforts are made to improve this, e.g. an expansion of the pre-examination procedures section in the revised international standard ISO 15189:2012, where laboratories are required to include a number of activities, e.g. collection and pre-collection activities, specific instructions for patient preparation, and sample transportation [7].

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