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Criteria for Selecting a Performance

Evaluation Site
Created 2003-06-01 02:00
[1]

Published: June 2003

Find more content on: Feature Articles [2], Regulation and Compliance [3]

Criteria for Selecting a Performance Evaluation Site

IVD DIRECTIVE

I. Facilities
Return to
Article:

Organizing
• The working environment must be made safe for staff and study
participants. performance
• Sufficient and appropriate equipment, materials, and reagents must be evaluation to
used. meet IVD

Directive
II. Quality Policy
requirements
• Policies, procedures, and laboratory methods must be documented. [5]
• Internal and external quality assurance procedures and systems should
be documented and evaluated.
• Quality systems should cover preanalytical, analytical, and postanalytical phases of
sample analysis or examination.

III. Study organization and administration

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Criteria for Selecting a Performance Evaluation Site Page 2 of 2

• A well-constructed staffing structure should be established in advance.

• Accountability and job responsibilities for each employee should be clearly
designated and documented.

IV. Staff qualifications

• Sufficient numbers of staff should be available to administer the evaluation.

• Staff should have received appropriate education and training, along with provisions
for continuing education and an assurance of staff competencies.
• Staff performing testing should have received postsecondary education in
appropriate scientific disciplines and training in laboratory procedures.
• Laboratory directors should have graduate degrees in medicine or science, as well
as specialized postgraduate education and training in clinical laboratory work.

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Feature Articles Regulation and Compliance

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[5] http://www.ivdtechnology.com/ivdt/archive/03/06/008.html

http://www.ivdtechnology.com/print/380 1/10/2011