Accreditation requirements for phlebotomy services
Specimen collection is a foundational component of high-quality, safe diagnostic services. Improper specimen collection risks the integrity of the diagnostic service and may invalidate diagnostic test results and result in patient harm.
Specimen collection is a broad classification of medical procedures that range from non-invasive patient-led activities (e.g. mid-stream urine collection) to restricted medical procedures that may only be performed by select approved regulated medical professionals (e.g. lumbar punctures), and may be considered to include specimen processing and manipulation (e.g. centrifuged, specimen aliquoting or pre-treatment).
While specimen collection may be within the scope of practice of regulated health-care professionals, specimen processing and manipulation is not, and facilities engaged in such practices require DAP accreditation.
Key activities must be executed to ensure the preservation of specimen integrity through the pre-assessment phase. Failure to adhere to proper standards risks compromising specimen integrity and undermining reliability in diagnostic services, which can compromise patient safety.
To ensure adherence to best practices in all components of pre-analytical activities, the DAP Committee has established the following accreditation requirements for facilities performing phlebotomy services:
Accreditation is required if:
- Phlebotomy services are performed by
- unregulated health-care professionals, or
- regulated health-care professionals whose scope of practice does not include phlebotomy.
- Specimens are processed or otherwise manipulated (e.g. centrifuged, specimen aliquoting or pre-treatment) following phlebotomy services by allied health-care professionals or regulated health-care professionals regardless of approved scope of practice.
Accreditation is not required if:
- Phlebotomy services are performed by regulated health-care professionals whose scope of practice includes phlebotomy and specimens are not processed or otherwise manipulated prior to forwarding to an accredited diagnostic facility.