W9L13 - Lab Quality Management and Accreditation

Question 1

What is the primary role of pathology testing service?

Answer 1

To offer appropriate tests and produce accurate and precise results in a clear format within a meaningful time frame

Question 2

Core Quality Assessment Areas

Answer 2

Internal audits
Document control
Staff training/competency
Continuous improvement/corrective actions
Customer liaison/consultation
Management review/reporting
Clinical/POCT

Question 3

Internal Audits

Answer 3

Internal audit schedule which covers all aspects of ISO 15189
Types:
1. Vertical - all aspects of the process
2. Horizontal - look at one aspect across all different testing
3. Compliance - watch someone perform technique to make sure doing it correctly

Question 4

Document Control

Answer 4

All of the documents that cover all aspects of the work place
Ensures relevant/up to date documentation
Document requirements:
- reference ID
- owner
- manual
- title
- date

Question 5

Staff Training/Competency

Answer 5

Staff inductions
Training records created
Ongoing competency reviews
Continuous education - internal and external

Question 6

Continuous Improvement Corrective Actions

Answer 6

This is done through corrective action requests (CAR)

• applies to all areas/processes
• responsibility with all staff
• preventative measures
• finds root causes
• management review/follow up/feedback

Question 7

Customer Liaison

Answer 7

Feedback from patients, visitors, staff
- can be internal or external
Deals with:
- complaints
- compliments
- customer satisfaction
- notifications
- suggestions

Question 8

Management Review

Answer 8

Quality management reports (regular/annual)

• risk management
• safety
• meetings/committees
• key performance indicators

Question 9

Organisational vs Departmental Management Review

Answer 9

Organisational 
- staff training
- corrective actions
- complaints received
- pre analytical error rates
- pathology ordering
Departmental
- assay turnaround times (TATs)