Quality In Biomedical Sciences

Question 1

What is QMS

Answer 1

Quality managment system
Coordinated activities to direct and control an organisation with regard to quality

Question 2

What is quality?

Answer 2

Accuracy, reliability and timeliness’s of reported test results

Question 3

What can ineffective managment of quality lead to?..

Answer 3

Misdiagnosis of patients
Delay in treatment of patients
Incorrect treatment given to patients
Additional testing

Question 4

QMS vs QA vs QC

Answer 4

QMS is the overall system, QA is the part of the system that makes sure all requirements are met and QC is fulfilling the quality requirements

Question 5

Quality roles within the lab

Answer 5

Lab director
Quality manager
Departmental quality officer
Section leads
Everyone

Question 6

3 phases from sample collection to result interpretation

Answer 6

Pre analytical - samples collection, transport and receipt in the lab
Examination - producing the result
Post examination - reporting the result

Question 7

Standards for laboratories

Answer 7

ISO 15189:2022
Labs if they meet this standard can become UKAS accredited

Question 8

What does UKAS stand for?

Answer 8

United Kingdom accreditation service

Question 9

What legal requirements are there for blood banks and NI blood transfusion services? Who is the regulatory body for inspecting blood banks?

Answer 9

Blood safety and quality regulation 2005
MHRA

Question 10

Elements of the quality managment system

Answer 10

Personnel
Managment of documents
Lab facilities and environment
Equipment
Pre examination process
Examination process
Post examination process
Non-conformaties

Question 11

Documents in lab

Answer 11

SOPs
Policies
Kit inserts
Risk assessments
Templates and forms
COSHH

Question 12

What does the document control system Q-Pulse allows?

Answer 12

Save documents and records electronically
Assign owners to documents
Set review timescales
Electronically distribute documents to staff

Question 13

Examples of Facilities and environment under quality managment

Answer 13

Safe storage area for personal effects
Access restrictions
Storage for ppe
Showers and toilets
Access to drinking water

Question 14

Examination processes

Answer 14

Internal quality control
External quality assurance

Question 15

What is acceptable IQC?

Answer 15

A target mean is established for every analyse on the relevant IQC material
A result must be within 2SD of target mean to be acceptable
IQC can identify bias or imprecision

Question 16

Levy Jennings chart

Answer 16

Looks at target mean and individual IQC results. Compares each result to the target mean and how many SD the IQC results lie in

Question 17

Accuracy vs precision

Answer 17

Accuracy is the ability to produce results that reflect the true value. Precision relates to the ability to reproduce results.

Question 18

Potential causes of imprecision

Answer 18

Mechanical issue - inconsistent aspiration of reagents or sample. May be due to a damaged sample or reagent probe
Bubbles in reagent
Could be an issue with the IQC material itself - improper mixing or short sampling

Question 19

How does EQA work?

Answer 19

Labs register for EQA schemes for their tests. Lab samples are processed.
Compared to a reference value and other labs using stage same methods as this lab. Performance can be assessed over time.
Retrospective

Question 20

Analytical variation - what is it?

Answer 20

Taken from an EQA report.
Shows the variation that can exist when the same sample is analysed for the same test but on different instruments, different laboratories and using different methods.

Question 21

Post examination processes

Answer 21

Procedures in place for the release of results
Procedures in place for the storage, retention and disposal of clinical samples

Question 22

Pre examination process

Answer 22

Sample and request form documents
Transport

Question 23

What is an audit?

Answer 23

A systematic, independent and documented process for obtaining evidence and
evaluating objectively the extent to which audit criteria are fulfilled.

Question 24

Why are audits good?

Answer 24

Great way of confirming that we are doing what we say we do.
Compares practice to pre defined criteria eg SOPs
Help to identify errors or deficiencies in systems
Potential for improvement

Question 25

Internal audit

Answer 25

Self check carried out by lab staff Eg vertical, horizontal, examination, clinical audits

Question 26

External audit

Answer 26

Performed by persons external to the lab Eg UKAS, MHRA, health and safety exec

Question 27

Examination audit

Answer 27

Person selected Competency and knowledge of a particiular task assessed Documentation reviewed Equipment used reviewed Reagents tested

Question 28

Vertical audit

Answer 28

Follows one sample through every stage of particular process.

Question 29

Horizontal audit

Answer 29

Focuses on 1 aspect of the quality managment system or of examination process Eg management of reagents

Question 30

What is a non conformance?

Answer 30

Includes incidents that have happened when policies/procedures haven’t been followed

Question 31

How is a non conformance recorded?

Answer 31

Q pulse in CAPA module - corrective action preventative action

Question 33

What is recorded in a non conformity

Answer 33

What happened What you did immediately in response Investigation to root cause of incident Corrective action Follow up actions

Question 34

Benefits of recording a non conformance

Answer 34

Ensures stages are all completed. Can assign stages to relevant staff. Allows trending of incidents Allows photos to be attached as evidence

Question 35

Stages in recording a non conformance

Answer 35

Investigation Root cause Corrective Follow up

Question 36

Incident escalation - what is the model?

Answer 36

Swiss cheese model

Question 37

Swiss cheese model

Answer 37

Often incidents are the result of multiple failures/ mistakes that have occurred. The more failure or mistakes increase the impact that occurs.

Question 38

Contingency and emergency planning

Answer 38

Back up plans - incidents may always occur because control measures aren’t robust enough The lab produces contingency plans that cover losses.

Question 39

What might KPIs include

Answer 39

Targets for turnaround times For errors For completing CAPAs For completing audits

Question 40

What are key performance indicators?

Answer 40

Targets that the lab sets itself as goals.

Question 41

What are quality objectives ?

Answer 41

These are actions that the laboratory are taking to improve quality. The progress of these is monitored.