Title

Conduct a baseline assessment of the laboratory

Why

Before planning for the implementation of a quality management system, it is helpful to conduct an assessment to understand the baseline situation of the laboratory. The assessment will provide information on where some elements of a quality management system may be already in place and functioning, or may reveal where there are gaps that need to be addressed. That is, the strengths and weaknesses of the laboratory can be objectively identified and appropriate action taken. Such an assessment can be of great assistance when planning for the implementation of a quality management system.

What

An example Laboratory Assessment Tool, as developed by WHO, is provided here. This Laboratory Assessment Tool offers guidance to assess laboratories and national laboratory systems. The target audience is any stakeholder performing laboratory assessments including national health authorities, multilateral agencies, Non-Governmental Organizations (NGOs) and laboratory managers. The main document describes a general process for assessing laboratories and is accompanied by two questionnaires, one to help assess national laboratory systems (Annex 1) and the second for use by individual laboratories (Annex 2). Assessors can use the questionnaires as they are, or can customize the available materials to meet local requirements and better fit the assessment context.

 

The questionnaires are provided in PDF that can easily be printed, and also as Excel files that enable automatic calculations of module indicators when answering to questions. In Excel format, the questionnaires are available in four languages: English, French, Spanish and Russian. The language can be changed during use.

How & who

Laboratory Manager

  1. Build and prepare the assessment team.
    An assessment team should be assembled from appropriate personnel. The assessment can be carried out by:
    • Laboratory specialists (representatives from public health, hospital, clinical, private or academic laboratories, etc.)
    • Staff from the Ministry of Health
    • WHO country office staff
    • Public health specialists, epidemiologists
    • Disease control programme officers (e.g. HIV, tuberculosis, malaria national control programmes)
    • non-governmental organizations

    The roles and responsibilities of each team member should be clearly stated in the Terms of Reference document, and a team leader should be designated.

 

Assessment Team:

  1. Review the LAT and adapt if necessary.
    The assessment team should review the Laboratory Assessment Tool/System Questionnaire and the Laboratory Assessment Tool/Facility Questionnaire and adjust them according to the local structure and needs. The team should ultimately agree on the assessment questionnaire(s) to be used and familiarize themselves with the questions.
  2. Collect documents for review.
    Key documents such as regulations, guidelines, and manuals should be collected as much as possible in advance. A non-exhaustive list of useful documents to gather is provided in the Laboratory Assessment Tool (see pages 17-19).
  3. Plan for meetings, interviews and field visits.
    The assessment team should create a planning agenda for the assessment process, clearly stating the deadline dates, the expected outcomes/deliverables and identifying the persons responsible for each task. Requests for interviews, meetings and documents should be sent ahead of time. Translations and interpretations, if needed, must be planned for.
  4. Conduct the assessment.
    The assessment should be conducted using the previously agreed-upon questionnaire. If necessary, the members of the assessment team can separate into smaller groups to cover different technical or geographical areas.
  5. Prepare the assessment report.
    Ideally, a draft report could be drafted during the assessment mission and shared across the team before the final day. The assessment team should agree on the report content (main recommendations) as well as the format, length and dissemination process. This report, together with the findings of the assessment, should be used to help plan the process to implement the quality management system.
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This activity belongs to the QSE Assessment

 

ISO15189:2007:
ISO15189:2012:
ISO15190:2003:

LQSI tool version: 1.0

LQSI tool version: 1.0