A7: Good scientific and clinical practice

Question 1

the principles of good practice in scientific and clinical settings

Answer 1

1. using standard operating procedures SOPs
2. Effectively managing calibration and maintenance of equipment and work areas
3. appropriately storing products, materials and equipment
4. effectively managing stock

Question 2

in the work environment you aim to achieve:

Answer 2

1. consistency
2. predictability
3. reproducibility
4. reliability

Question 3

What is an SOP?

Answer 3

Standard operating procedure are set steps or instructions in a sequence that are designed to standardise the approach to the process or acction, so that everyone learns to do it the same way.

Question 4

How are SOPs used in the workplace?

Answer 4

1. receiving goods, booking them into stock and informing the accounts department that the invoice can be paid
2. cleaning a room in a healthcare facility or a microbiology lab
3. producing a batch of a pharmaceutical ingredient
4. analysing that batch to make sure it meets standards of purity, activity and safety

Question 5

Why are SOPs important for everyone to follow?

Answer 5

1. maintaining health and safety
2. enabling consistency of approach
3. meeting any legal or organisational requirements
4. upholding professional standards
5. demonstrating compliance for audit purposes

ensure that processes can be followed consistently, as not following may lead to legal consequences or someone may be injured as a result

Question 6

examples of how SOPs might be required for organisation or legal reasons

Answer 6

1. cleaning staff writing their initials on a chart to show that regular scheduled cleaning has been carried out
2. following government requirements for storing and issuing controlled drugs in a hospital or care homes
3. storing and disposing of hazardous waste
4. carrying out clinical trials of new medicines or therapies
5. obtaining regulatory approval for new medicines, medical devices or treatments

Question 7

Why you should ensure SOPs are up-to-date

Answer 7

1. methods may have been changed
2. equipment or processes may have been updated
3. regulations may have changed
4. roles and responsibilities may have evolved

Question 8

How to make sure you use the latest version of an SOP

Answer 8

1. controlling the production and distribution of SOPs so that old versions are returned or destroyed when new versions are introduced
2. maintaining a central desposit that can be accessed but not removed or downloaded
3. maintaining a central index or database so that version numbers of SOPs in use can be checked to ensure they are the most up to date

Question 9

risks to health and safety

Answer 9

1. spread of infection
2. production of toxic/dangerous by-products
3. invalid results
4. inefficient working practices

Question 10

potential impacts of not maintaining, cleaning and servicing equipment

Answer 10

1. risks to health and safety: increased risk of injury and spread of infection
2. invalid results: contamination or cross-contamination
3. reduced function of equipment

Question 11

why is it important to calibrate and test equipment to ensure it is fit for use

Answer 11

1. ensuring accuracy of measurements
2. prolonging the life of equipment
3. meeting legal requirements

Question 12

define ‘accuracy’

Answer 12

measurements that are close to the true value

Question 13

define ‘precise’

Answer 13

measurements that are close to each other, but they may be inaccurate

Question 14

define ‘calibration’

Answer 14

the process of comparing measurements, usually against a reference standard

Question 15

define ‘reference standard’

Answer 15

something of known size, mass, concentration, etc. that we can use to calibrate equipment or methods

Question 16

how to escalate concerns if equipment is not correctly calibrated/unsuitable for intended use

Answer 16

1. taking the equipment out of action
2. labelling the equipment as being out of use, if appropriate
3. reporting concerns to the relevant person, in line with organisational policies and procedures
4. recording concerns according to organisational procedures

Question 17

Why is it important to order and manage stock

Answer 17

1. ensuring sufficient supply of required consumable and materials
2. ensuring that materials are used before their expiry date
3. reducing the costs of excess stock
4. improving efficiency and productivity
5. ensuring safety of stock

Question 18

define ‘consumables’

Answer 18

items that are used and then disposed of. they are mostly single-use but might be re-used in some circumstances

Question 19

define ‘materials’

Answer 19

include items such as ingredients or components used in the manufacture of a product

Question 20

The potential consequences of incorrectly storing products, materials and equipment

Answer 20

1. cross-contamination
2. breakdown of limited stability products
3. products exceeding expiry dates
4. loss of samples or degradation of reagents not stored at the correct temperatures (-20c, -4c, 4c, or room temp)
5. risks to health and safety
6. stock is difficult to locate
7. financial loss

Question 21

stock rotation means…

Answer 21

using the oldest batch first