Title

Write an SOP for Sample Collection

Why

When laboratory staff collects samples from patients themselves, it is important that they do this correctly, adhering to both the requirements of the laboratory to get a good quality sample, and to the requirements for correct treatment of the patient (such as protecting the patient’s privacy and safety).

What

Develop an SOP in which the protocols are described for collection of all types of samples the laboratory needs for its tests. These protocols should be aimed at laboratory staff collecting samples from the patients. They need to include elements such as:

  • Pre-collection:
    • Instructions for identification of the patient
    • Instructions to verify that the patient meets examination requirements
    • Instructions for correct treatment of the patient (with respect, friendly, and polite)
    • Instructions for information provision to the patient (what is going to happen, when can the patient expect the results and where can the patient get the results)
    • Instructions for protecting the privacy of the patient
    • Instructions for preparation of the patient (including provision of information to the patient on sample collection and laboratory testing)
    • Instructions for protecting patient safety
    • Instructions for protecting safety of the laboratory staff member
    • Guideline for completion of the Request Form, including identification of the person collecting the sample and the patient
  • Collection:
    • Instructions for correct collection of the sample, including reference to sample acceptance criteria to ensure collection of a good quality sample of sufficient volume
  • Post-collection:
    • Procedure for labeling of the sample
    • Requirements for correct and safe packaging of the sample
    • Instructions on sample transport (including time frame and temperature interval) and proper storage conditions if the sample is not transported directly after collection (background information is provided in the WHO Laboratory Quality Management System (LQMS) handbook document on sample transport in the right-hand column)
    • Instructions to safe disposal of materials used for collection of the sample


The Request Form developed in phase 1 must be included in this SOP as appendix.

How & who

Quality Officer:

  1. Read the background information of the WHO LQMS handbook on sample collection, preservation and transport to get insight into everything that needs to be taken into account for correct sample collection.
  2. Make an outline of the SOP. Be sure that the SOP is complete and covers all the aspects that need to be taken into account during sample collection, including above mentioned elements.
  3. Write the SOP in accordance with the protocol for writing a Procedure SOP in the Master SOP and use the template for a Procedure SOP attached to the Master SOP.
  4. When the SOP is ready determine at which locations copies of the SOP must be available and indicate this on the SOP (to facilitate efficient and correct replacement of all copies when a new version of the SOP is printed). The SOP must be coded as a Procedure SOP.
  5. Include the SOP in a Read and Understand List and identify the persons for which the SOP is relevant and who have to read and understand the SOP.
  6. Present the SOP to all staff members in a weekly staff meeting and explain which staff members have to read the SOP and sign of the Read and Understand List after reading.

Back to Roadmap Activity Overview
This activity belongs to the QSE Process Management
ISO15189:2007: 5.4.2 5.4.3
ISO15189:2012: 5.4.4.2 5.4.4.3 5.4.5
ISO15190:2003: