Using a quality management system to implement best practice standards for phlebotomy processes

Sept. 21, 2017

When errors occur during the collection and handling of blood specimens, significant and avoidable risks are posed to the patient and phlebotomist. The full implementation of global best practice standards in the laboratory is the best way to ensure that biologically representative specimens will be obtained, test results will be comparable from one facility to another, and patients and phlebotomists will not be injured during the procedure.1

Some complications of venipuncture procedures include, but are not limited to:

  • Accidental arterial puncture
  • Nerve injury
  • Hematoma
  • Iatrogenic anemia
  • Loss of specimen integrity (e.g., hemolysis).

Venipuncture complications can be effectively prevented or reduced by implementing a quality management system (QMS) in the venipuncture process.2 Additionally, the use of a QMS provides a framework to assist phlebotomists in following requirements from published standards and regulatory authorities.

The QMS is divided into 12 quality system essentials (QSEs). The QSEs are foundational building blocks that function effectively to support the laboratory’s path of workflow. The QSEs can be individualized to apply to the venipuncture process, and include the following:2

Organization: Management needs to actively support the establishment and maintenance of the QMS. This will be reflected in the quality policy and quality manual and includes appointing a quality manager with delegated authority to oversee compliance with the requirements of the QMS.

Customer focus: Feedback from customers should be solicited on a continual basis. Employees should be empowered to solicit customer input, and a mechanism should be in place to report feedback, handle dissatisfaction from customers, and take action to resolve complaints.

Facilities and safety: The physical environment for venipuncture procedures must reflect QMS requirements. Phlebotomists should perform venipuncture procedures in a clean, well-lit, quiet, and private environment. Facilities should be available to allow the phlebotomist to wash his/her hands between patients.

Personnel: An adequate number of qualified, well-trained, competent personnel must be available to perform and manage venipuncture processes. The necessary education, training, skills, experience, and, where applicable, certification and licensure for each job title related to venipuncture processes must be determined.

Purchasing and inventory: A process should be in place for qualifying suppliers, making selection decisions, and acquiring the supplies necessary for venipuncture procedures. Evaluation of safety equipment should include input from the end user (phlebotomist).

Equipment: Equipment used in collection and handling procedures such as centrifuges and refrigerators must be selected, used, and maintained in accordance with the QMS and the manufacturer’s instructions.

Process management: Current and any new or modified processes within the path of workflow for venipuncture that affect quality and productivity need to be identified and aligned with customer expectations and with regulatory and organizational requirements.

Documents and records: A system that manages both paper and electronic records must be in place to ensure that all patient records are created, identified, changed, reviewed, retained, stored, and maintained in a manner that meets the facility’s QMS requirements.

Information management: The facility must commit to confidentiality of patient-related information in accordance with regulatory and accreditation requirements.

Nonconforming event management: A nonconforming event (NCE) can happen during any deviation from approved phlebotomy procedures. Facilities need to put in place a program to manage and document NCE episodes, to investigate the cause, and to apply immediate remedial and corrective actions where appropriate.

Examples of phlebotomy-related NCEs in the preexamination phase include sample mislabeling; improper sample collection, handling, and transport practices; customer service incidents; safety infractions; and breaches of confidentiality.

Assessments: The venipuncture path of workflow should be regularly assessed by internal and external audit procedures to ensure that it continues to meet established QMS  requirements.

Continual improvement: The facility needs a defined strategy for continual improvement to ensure uniformity in its approach to sustain its QMS. Staff members have an important and ethical responsibility to submit suggestions for improvements, especially when the suggestion can lead to increased patient safety.

Phlebotomy is the most commonly performed invasive medical procedure in healthcare. Strict adherence to published standards is essential so that blood specimens are collected in a manner that prevents the occurrence of collection method–related erroneous test results and undesirable patient outcomes. Establishing a QMS can help improve and maintain the quality of care a patient receives from a facility.


  1. Collection of Diagnostic Venous Blood Specimens, 7th ed. CLSI standard GP41. Wayne, PA: Clinical and Laboratory Standards Institute; 2017;vii.
  2. Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition. CLSI document QMS01-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2011;13.
  3. Essential Elements of a Phlebotomy Training Program, 1st ed.CLSI guideline GP48. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.

Anne-Marie Martel, MT, is the Scientific Affairs Coordinator for Ordre professionnel des technologistes médicaux du Québec (OPTMQ), and was the Vice-Chairholder for the 7th edition of CLSI’s GP41—Collection of Diagnostic Venous Blood Specimens.