As the title indicates, phlebotomy standards are not written in stone but are continuously under review and revised when deemed necessary. The latest Standards discussed below were established by the consensus of some of the most highly respected authorities in the healthcare industry. Those healthcare facilities that base their blood collection procedure manual(s) on these Standards can feel certain they are (1) providing their patients with a standardized phlebotomy experience, (2) maintaining sample quality, (3) preventing patient injury and that (4) the test results released by the laboratory accurately reflect the patient’s health status. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization.
The 7th Edition of Collection of Capillary Blood Specimens(GP42) was revised in 2020. This new edition:
- Has the content organized to reflect the incorporation of Quality Management System (QMS) principles.
- Conveys greater detail on patient identification, registration, and specimen labeling processes.
- Presents a revised protocol for identifying proper puncture sites.
- Provides greater guidance on patient positioning.
- Includes updated figures and references.
The CLSI Standard Accuracy in Patient and Sample Identification(GP33) was released in 2019. Features in the Second Edition include:
- Differences in requirements for patients with or without an ID band.
- Guidance on bar-code system implementation and user training.
- Validation of patient identification systems or programs and ongoing monitoring as a quality measure.
- System design consideration.
In 2017 CLSI released its 7th Edition of Collection of Diagnostic Venous Blood Specimens(GP41). This revised standard which was four years in the making features:
- A reader friendly design in full color with more images, tables, and graphic elements.
- Complete reorganization as a quality management systems document.
- Information on trace elements tubes in regard to the order of draw.
- Comprehensive sections on remedies for difficult collections.
- Changes to what constitutes acceptable venipuncture sites.
- Greater detail on patient ID and specimen labeling.
- 149 new mandatory requirements for the venipuncture procedure.
