901 Venipuncture

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) To ensure the proper and safe collection of blood samples for laboratory testing in individuals two years of age and older.

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Procedures

1. Training

In Ohio, under proper supervision, personnel can draw blood from individuals regardless of previous experience or education. Drawing blood and handling specimens does not require a license in Ohio. CTRU staff will receive training in phlebotomy techniques and perform at least 3 successful venipunctures under supervision before performing this procedure unsupervised. Staff must also complete the Ohio University (OHIO) Bloodborne Pathogens Training before attempting phlebotomy, and annual refresher training as required by the OU Environmental Health and Safety Office.

2. Safety

The Principal Investigator (PI) or delegated study staff are responsible for performing proper and safe venipuncture. Venipuncture and documentation will be performed as specified by the study protocol. If the study protocol does not specify particular requirements, then the PI or delegated study staff will follow the procedure below.

Personal protective equipment is required. Identification of the participant and assessment for allergies is assumed throughout.

Special considerations for a child:

• Good communication is a must.
• Positive body language (cheerful/relaxed).
• Soft voice.
• Eye to eye contact.
• Listen.
• Demonstrate sensitivity to child’s wishes.
• Involve child with procedure if age appropriate.
• Be honest.

Challenges: Age-specific behavior should be considered prior to collection:

• Psychological:
  • Fear of strangers.
  • Limited language use.
  • Fear of pain.
  • Separation anxiety.

3. Preparation: Assemble Supplies

• Chux or other drape to cover work surface
• Needles, 19-23 gauge, multi-sample or wing-tipped (butterfly) (Note: gauge depends on many factors, including size of vein and protocol)
• Single use, needle holder for evacuated system
• Single-use tourniquet
• Alcohol prep pads
• Gauze pads
• Adhesive band aids or cotton balls and tape if an allergy exists.
• Disposable latex-free gloves
• Blood collection tubes
• Sharps container
• Cavi-wipes or other disinfectant for clean-up

4. Other Supplies As Needed:

• Blood collection tube labels
• Laboratory requisition
• Biohazard bags (for transport of collection tubes)
• Centrifuge
• Pipettes (for drawing off serum and plasma)
• Plastic transfer tubes (for serum and plasma)

5. Preparing for Venipuncture

• After assembling equipment, ensure all information for sample processing has been reviewed and needed supplies are on hand (e.g., dry ice, coolers for sample transfer, centrifuges, availability of refrigerators/freezers, shipping materials, etc.).
• Greet the individual and introduce yourself.
• Identify the individual.
• Verify diet restrictions and time requirements.
• Position the individual comfortably.
• Explain the procedure as needed.
• Assemble supplies. Check expiration dates on collection tubes, put on gloves, apply tourniquet and palpate venipuncture site for vein before cleansing.
• Select the venipuncture site. The most frequently used veins are the superficial veins located in the forearm and hand. Commonly used are the median cubital vein and cephalic vein. Other veins in the anterior surface of the forearm, as well as on the back of the hand are acceptable sites. Lower extremities, legs, feet, ankles and the underside of wrist are not acceptable. Venipunctures should not be performed on the side in which a mastectomy has been performed.
• Remove tourniquet.
• If palpation and/or visualization is difficult, consider the following actions:
  • Consult with another phlebotomist, if available.
  • Use a vascular visualization device, if available.
  • Use a heating pad to warm the extremity if not contraindicated.
  • Have subject drink water to increase hydration if not contraindicated (i.e. fasting).

6. Performing Venipuncture (Evacuated System)

• Open alcohol pad, gauze pad, and organize supplies on protected work surface.
• Apply tourniquet.
• Put on protective gloves.
• Special considerations for children: If required, have an assistant hold child. The assistant places one hand, palm up, under the child’s elbow. The other hand is placed palm down on the child’s wrist. The assistant’s fingers should be placed in such a manner as to allow the child to squeeze the fingers.
• Cleanse venipuncture site with friction using an alcohol pad and allow to dry (residual alcohol may cause hemolysis of specimen as well as a stinging sensation when skin is punctured).
• After inspecting the needle for hooks/barbs, anchor the vein 1 to 2 inches below venipuncture side and, with the bevel of the needle directed up, perform venipuncture (approximately at a 15-30 degree angle).
• Holding the needle steady, push collection tube into vacutainer needle and allow the tube to fill. Once filled, remove the tube. If multiple tubes are required, insert each tube using the correct order of draw. Mix tubes with additives immediately by gently inverting them 4-5 times. Do not shake tubes vigorously.
• Remind participants not to pump their hand during venipuncture.
  • NOTE: Recommended order of draw
    1. Blood Culture tube
    2. Blue (Citrate)
    3. Serum tube with or without gel (Red, Gold or SST)
    4. Green (Heparin)
    5. Lavender (EDTA)
    6. Gray (Oxalate/Fluoride)
• Release tourniquet. Take care that the tourniquet is not applied for longer than 1 minute.
• Fold gauze into quarters (to act as a pressure bandage) and place over venipuncture site.
• Remove needle by withdrawing slowly. Safely dispose of needle immediately in appropriate sharps container to prevent accidental needle stick injury.
• Apply pressure to venipuncture site until bleeding has stopped.
• Apply band aid. Note: Some individuals may be allergic to adhesives on band aids. Always ask before applying band aid. 
• Special considerations for a child: Give rewards and praise.

7. Procedural Notes

• Blood samples should not be drawn from an arm receiving IV fluids.
• Exercise care not to "hunt" for the vein. Minimal redirection of the needle may be attempted but if unsuccessful in finding the vein, the needle should be withdrawn and another attempt made or a more experienced phlebotomist consulted.
• Do not perform venipuncture on the arm on the side on which a mastectomy has been performed.
• Do not collect samples from an area with a hematoma.
• Avoid scar tissue and areas with extensive burns.
• Do not obtain samples from edematous extremities (arms or hands).
• Do not obtain samples from thrombosed veins.
• Do not obtain samples from a cannula or fistula.

8. Potential Complications

• Pre-fainting Symptoms (increased nervousness, increased respiration, a slow and weak pulse, pallor, mild sweating, nausea, vomiting)
  • Treatment:
    1. Stop procedure.
    2. Immediately remove tourniquet and needle.
    3. Speak calmly and have individual lower head and breathe slowly and deeply, or may elevate feet.
    4. Take vital signs (blood pressure, pulse, respiratory rate, oxygen saturation).
    5. Apply cool compress to the head.
    6. Offer juice or water.
    7. Provide a basin and issues if nausea/vomiting is present.
    8. Notify CTRU Medical Director and PI.
• Fainting (Syncope)
  • Treatment:
    1. Follow CTRU protocol for loss of consciousness (Appendix B). Prevent or brake fall.
    2. Call for help. Loosen clothing.
    3. Take vital signs (blood pressure, pulse, respiratory rate, oxygen saturation). Do not allow individual to leave until fully recovered.
    4. Notify CTRU Medical Director and PI.
• Convulsions
  • Treatment:
    1. Follow CTRU protocol for seizures (Appendix A).
    2. Help individual to floor.
    3. Prevent individual from injuring himself/herself.
    4. Loosen tight clothing, such as a scarf, necktie, or belt.
    5. Call for help.
    6. Take vital signs (blood pressure, pulse, respiratory rate, oxygen saturation).
    7. Notify CTRU Medical Director and PI.
• Hematomas (swelling due to ruptured blood vessels, bruising will occur)
  • Treatment:
    1. Stop procedure.
    2. Immediately remove tourniquet and needle.
    3. Apply pressure to venipuncture site until bleeding has stopped.
    4. Cold packs can be applied to reduce bruising and pain.
    5. Notify CTRU Medical Director and PI.
• Excessive bleeding after venipuncture (may be seen in individuals on anticoagulant therapy, medications containing aspirin, or individuals with low platelet counts)
  • Treatment:
    1. Prepare to apply pressure on venipuncture site for longer periods of time.
    2. Do not leave individual until bleeding has stopped.

9. Inability to Collect Sample

• If a staff member is unable to successfully obtain samples, another trained staff member may attempt venipuncture. However, this is ultimately at the discretion of the individual. If samples cannot be obtained, document and notify the PI. Rescheduling the blood draw will be done at the discretion of the PI and participant.
• Special considerations for a child: Attempt only two venipunctures on a child. After two unsuccessful attempts, document and inform CTRU Medical Director and PI.

10. Specimen Labeling

• Complete laboratory requisition per study lab manual.
• Label each specimen tube as required per study lab manual (e.g., Study, Subject ID#, Subject Initials, Date of Collection, and Time of Collection).
• Prepare specimens for shipment per study lab manual.

11. Clean-up

• Clean area with Cavi-wipes or other disinfectant.

12. Suggested Informed Consent Language

During the study, your blood samples will be obtained by an experienced nurse or trained study staff. This will involve inserting a needle into a vein in your arm and withdrawing the blood. You may experience minor discomfort or bruising at the site where the blood is drawn. You may feel lightheaded or faint. There is a small risk of infection. The amount of blood drawn will be approximately (enter amount).

References: CLSI 2017 Standards. Collection of Diagnostic Venous Blood Specimens; Seventh Edition, April 2017

Davis, Bonnie K., Phlebotomy: A Client-Based Approach. 1997

Attachments: None

Appendices: Appendix A- Emergency Protocol for Seizures

Appendix B- Loss of Consciousness Protocol

Approver: Director, CTRU and Clinical Partnerships