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WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010.

Cover of WHO Guidelines on Drawing Blood

WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy.

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Annex AMethods and evidence base

A1. Consultation with experts and scope of recommendations

In April 2008, the WHO Injection Safety programme – which is part of the Department of Essential Health Technologies (EHT) at WHO Headquarters in Geneva – convened a consultation on best practices for phlebotomy and blood collection. The consultation included special categories such as arterial blood sampling, capillary blood sampling and paediatric blood collection.

A working group was convened, comprising international experts and colleagues from WHO departments involved in infection control and safety of health-care practices.

The specific objectives of the consultation were to:

  • review the first draft of this document, which had been developed in response to clinical questions and a suggested scope developed by SIGN in consultation with other WHO experts and the Centres for Disease Control and Prevention;
  • identify critical steps in phlebotomy procedure as a basis for making recommendations.

The focus of the consultation was primarily on the needs of developing and transitional countries, in which injection safety programmes are not yet well developed or in which quality systems are lacking. The consultation identified the need for guidelines on best phlebotomy practices in policy and organizational issues, and in technical and scientific aspects of blood collection.

Recommendations of the working group

Content of guidelines

Guidelines should include information on the importance of:

  • safe practices in phlebotomy;
  • an uninterrupted supply of single-use devices in situations where safety-engineered devices are unaffordable;
  • training in phlebotomy, to avoid adverse effects to the patient and the health worker, and blood samples of poor quality.

Evidence base

Recommendations should be evidence based.

Consistency and flexibility

Recommendations should be designed to:

  • promote a consistent approach to ensuring phlebotomy safety and quality of blood drawn;
  • be sufficiently flexible to allow for variations in device selection and training curricula.

A2. Evidence base

An initial literature search was conducted by the guideline writer – Professor Mehtar (chair of the working group) – using PubMed, MedLine, the WHO library database and regional databases. Particular efforts were made to identify systematic literature reviews and evidence that related specifically to phlebotomy practices in developing countries.

The panel reviewed the draft guidelines and the evidence retrieved, and reached consensus on all but one of the recommendations. It found that further evidence was needed to determine the effect of “alcohol alone” versus “any skin disinfectant followed by alcohol for skin preparation” before blood collection for the purpose of blood transfusion. The panel commissioned a systematic review with evidence tables based on GRADE1 from the Cochrane group. The overall finding from the review, which is given in Annex J (1), was as follows:

In conclusion there is currently no evidence of a difference in either blood contamination or bacteraemia when donor skin is cleansed pre-venepuncture with a one-step alcohol based process or a two-step alcohol plus antiseptic process. This lack of evidence for a difference however results from a complete absence of research and therefore a real difference cannot be discounted. Until better evidence emerges, decisions about which mode of pre-blood donation skin cleansing to use are likely to be driven by convenience and cost.

This conclusion was circulated to the guideline development group, with a request for advice on the best recommendation to incorporate into the guideline. Additional infection control experts (see list of additional reviewers) were consulted by e-mail, in line with the WHO guideline development procedure which notes that, when evidence is lacking, a recommendation should be based on expert opinion as well as on convenience and cost. Consensus was reached by asking the experts to vote on the final recommendation.

The group was able to make a recommendation on best practice for skin disinfection in blood transfusion (see Section 4.2.1). Due to lack of evidence, the recommendation was based on expert opinion.

A3. Peer review and technical editing

Following the internal and external review and revision, an advanced draft of the document was sent to Dr Mary Catlin and Dr Michael Borg for a thorough peer review. The guideline was then submitted to the guideline development group and to additional experts who contributed to the development of the recommendation on skin disinfection before blood donation. The expert group amended the guidelines in light of the comments received and agreed.

The technical editing of this document was undertaken by Dr Hilary Cadman, under the technical guidance of Dr Selma Khamassi.

A4. Implementation and evaluation plans

The final phlebotomy guidelines will be translated into all United Nations languages, and printed for distribution in all six WHO Regional Offices and in many different countries. It will also be made available through the WHO Injection Safety Website. A CD-ROM containing the phlebotomy document, posters illustrating each of the practices described and a training package will be produced and translated. The document will also be adapted to local needs in some countries, although key steps and recommendations will be maintained.

Upon request, the WHO Injection Safety programme will provide technical support for adapting and implementing the guideline at regional and country levels.

The feasibility of recommended practices and the impact of the guideline on phlebotomy practices will be evaluated by the WHO Injection Safety programme, in collaboration with WHO Regional Offices. Feasibility and impact will be evaluated using the revised injection safety assessment tool C, developed by the WHO Injection Safety programme (2).

A5. Review and updating of the recommendations

The recommendations in this document are expected to remain valid for five years; that is, until 2014. The WHO Injection Safety programme will initiate a review of these recommendations at that time.

A6. Monitoring and evaluation of the implementation

The indicators listed in Chapter 9 should be used to monitor and evaluate the implementation of these guidelines.

Footnotes

1

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group is an informal collaboration that has developed a common, sensible and transparent approach to grading quality of evidence and strength of recommendations (http://www​.gradeworkinggroup.org).

Copyright © 2010, World Health Organization.

All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: tni.ohw@snoissimrep).

Bookshelf ID: NBK138663

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