Dan Tholen, MS

Laboratories must document their procedures — there is no way around it. Whether you must comply with Clinical Laboratory Improvement Amendments (CLIA) regulations or are seeking accreditation to International Organization for Standardization (ISO) 15189, you must write down what you do, including everything from telling your customers how to prepare specimens, through all the steps to reporting results and interpretations. The standards say what must be done and what the documented procedures must contain, but they do not say how to write them. This can be one of the most difficult steps in the accreditation process for many laboratories — just choosing a format can be frustrating, let alone distinguishing what is a procedure, as opposed to a policy, process, programme, or instruction. In this brief article, let me help make that less confusing, or at least give some assurance that you can do it.

Read the full article as originally published in the September 2007 issue of Medical Laboratory Observer. [ return to top ]