Lecture 10: QA in Bloodbanking

The primary regulatory agency overseeing blood safety

Food and Drug Administration (FDA)

The FDA ensures:

The safety and efficacy of blood, blood components & reagents used in blood banking

AABB (American Association of Blood Banks)

A professional organization that sets standards for blood banking and transfusion medicine

The AABB (American Association of Blood Banks) provides:

Voluntary accreditation, widely recognized for ensuring quality & safety in blood services

Facilities must have policies, processes & procedures to ensure proper documentation identification, review, approval, and retention

True

An audit trail is optional in bloodbanking labs

False, an audit trail must be maintained to recreate every step in the production and distribution of each unit of blood and its components

• Using correction fluid/whiteout when making a correction

• Use of pencil or nonpermanent ink

• Recording data for someone else

These are examples of:

Bad record keeping

If records are computerized, the computer system must:

Be able to trace original entries and identify the person making corrections

If records are computerized, the entries/data must have:

A reliable backup method

Major errors involving a donor or patient are reported to the:

FDA

Facilities should have procedures for inspecting and testing incoming materials from suppliers

True

Validation ensures:

That a specific process consistently produces a product that meets predetermined specifications

Surveys are created by accredited agencies (for proficiency testing), such as:

College of American Pathologists (CAP)

Label control programs are implemented to prevent:

Mislabelling errors

Who is responsible for inspecting & approving all labels to ensure accuracy and compliance?

The Quality Assurance (QA) department

Biologic Safety Cabinets

Use when handling potentially hazardous materials to minimize exposure

Decontamination should occur daily or as needed using:

• EPA-Approved disinfectants

• A 1:10 dilution of sodium hypochlorite (10% bleach)

In bloodbanking, gamma irradiators are used to:

Irradiate blood components to prevent transfusion-associated graft-versus-host disease (inactivates donor lymphocytes)

Mandates training for all personnel handling irradiators

Nuclear Regulatory Commission (NRC)

Biohazardous materials must be placed in:

Designated, leak-proof containers

Blood and blood components must be stored:

Separately from reagents & specimens to prevent contamination

How should specimens be transported within an institution?

In plastic bags to ensure safety and prevent leaks

Specimen shipping must comply with:

Department of Transportation (DOT) and the United States Postal Service (USPS) regulations

Who mandates employee education?

OSHA