Chapter 1 - QA & Regulation of the Blood Industry & Safety Issues

Question 1

What is Canadian Blood Services responsible for?

Answer 1

Canadian Blood Services (CBS)

Responsible for donor recruitment, collection, processing, storage, testing and transportation of blood components and plasma fractionation products to hospitals for administration to recipients in need.

Question 2

Who regulates blood transfusions in Canada?

Answer 2

Regulated and Audited by Health Canada
Blood is a drug
Food and Drug Act (FDA) Canada:
- Enforces regulations to ensure the safety and efficacy of blood and blood components and reagents used or manufactured by blood establishments

Question 3

What QA responsibilities are there in blood transfusion?

Answer 3

QA responsibilities include:
Compliance
Review and approval of all SOPs
Specifications and validation protocols
Development, review, and approval of training programs
Investigation of product recalls, errors, and complaints
Coordination of internal quality auditing programs

Question 4

What is cGMPs?

Answer 4

Current Good Manufacturing Practices (cGMPs)

Question 5

What are the cGMPs?

Answer 5

cGMP are part of QA, but also legal requirements
What needs to be done

1. Writing and following Standard Operating Procedures (SOPs)
2. Record and document all work performed
3. Qualify personnel by training and educating
4. Design and build proper facilities and equipment
5. Maintain a housekeeping schedule for cleaning properly
6. Validate equipment, personnel, and processes
7. Perform preventative maintenance on facilities and equipment
8. Quality control
9. Audits performed to ensure all of these are done (accreditation)

Question 6

How do you make corrections on manual blood transfusion records?

Answer 6

Record date and initials of person making a correction (don’t record for someone else)
Single line for correction (do not obliterate error; must be able to read it)

Question 7

How is label control performed at the blood bank?

Answer 7

Blood banks have instituted label control programs to avoid mislabeling errors

It is the QA department’s responsibility to inspect and approve all labels

Question 8

What type of solution should be used for decontamination at a blood bank? How often?

Answer 8

Decontamination should occur daily or as needed, using
EPA-approved disinfectant
1:10 dilution of sodium hypochlorite (bleach)
(note CSMLS safety guidelines state 1:100 bleach for cleaning surfaces and 1:10 for spills

Question 9

Why are gamma irradiators used at the blood bank?

Answer 9

CBS use gamma irradiators for irradiation of blood components
Kills WBCs that may remain in blood components

Nuclear Regulatory Commission requires training for all personnel using irradiators

Employees are properly trained and monitored for exposure