QC

Question 1

why is quality management important?

Answer 1

• provide confident results to customer/patient

- corporate accreditation

Question 2

describe the 6 requrements for quality manager / system

1. NPAAC
2. ISO
3. NATA
4. RCPA
5. TGA
6. ACHS

Answer 2

1. NPAAC: National Pathology Accreditation Advisory Council: std & guideline
2. ISO: International stds. organisation: run by & meet & for food & water
3. NATA: National Assosiation of Testing Authorities > check for compliance
4. RCPA: Royal college of Pathologist of Australasia
5. TGA: Therapeutic Goods Administration > test donor material before give to patient
6. ACHS: Australasian Council of Health Care Services: like NATA

Question 3

7 Core QA areas

Answer 3

1. internal audits
2. Doc. control
3. Staff /training/competancy
4. COntinuous improvement /corrective actions
5. Customer Liasion / consultation
6. management t review / reporting
7. Point of care testing

Question 4

what’s the difference b/w control drift & control shift & reasons these would occrur

Answer 4

• Drift: results become worse overtime ie. move further from mean bc control / reagent deterioration, instrument/calibration
• Shift: suddenc change in control/s value bc operator change/error, instrument/kit failure, incorrect control

Question 5

coefficient variation (CV%) equation

Answer 5

CV% = SD / mean x 100

Question 6

control acceptable range requirements

Answer 6

• ≥20 runs
• inter & intra assay repeatability
• Different operators
• range +/- 2SD
• Good CV (<5%)

Question 7

3 types ofk internal QC materials

Answer 7

• **“in-house” samples / serum / blood
• *manufacturer / commercial QC: use QC from diff. manufacturer
• patient samples (pooled sera) / tissue: controls for that patient w/ rare cond

Question 8

internal QC essential considerations

Answer 8

• Storage / expirey / stability
• vol required
• infection control (minimise risk of handlers)
• reference range
• precision / accuracy / bias

Question 9

corrective action request (CAR)

Answer 9

• preventative measures
• root causes
• management review / follow up / feedback

Question 10

DATIX CIMS - clinical incident manageemtn

Answer 10

• is patient impacted = investigate what & why => how to prevent next time