Quality

Question 1

What is validation?

Answer 1

• rigorous assessment process of e.g. a new assay
• usually involves significant change such as a new test
• defines characteristics of the new assay such as accuracy, limitations, behaviour of controls,
• is the test correct?

Question 2

What is verification?

Answer 2

• less rigorous process than validation
• may involve a commercial CE marked kit
• may involve comparing a kit to an existing method to find out if we can transfer over e.g. bisulphite conversion kit - might run 10 samples though just to check it works OK.
• more of a minor change

Question 3

Why are validation and verification important?

Answer 3

• evaluate performance of a test
• to give objective evidence that the method in question is accurate
• ultimately ensure the patient is getting the correct result

Question 4

What does robustness mean?

Answer 4

• can also be called ruggedness (this is actually more technically correct)
• it is the reproducibility of the assay under normal but variable conditions such as varying regents, varying equipment, varying users.
• a good laboratory assay needs to hold steady despite these variations to be usable in a diagnostic lab.
• robustness is actually an investigation into how the assay responds to deliberate changes such as halving the amount of a particular reagent that goes in, or deliberately setting the temperature too low and can help you learn how to troubleshoot the assay later down the line if things go wrong.

Question 5

What does repeatability mean?

Answer 5

• find out whether the assay can consistently produce the same results when the same sample is input multiple times
• known as within-run precision
• how much confidence can we have in this method
• all other parameters remain unaltered

Question 6

What is reproducibility?

Answer 6

• between run precision

- will the same sample produce the same result time after time

Question 7

What is sensitivity?

Answer 7

• ability of the assay to correctly identify all positive samples
• is it sensitive enough to detect every methylated patient?

Question 8

What is specificity?

Answer 8

• ability of the assay to correctly identify all the samples which are negative?
• e.g. do you get any false positives or is it highly specific?

Question 9

Why do we need to consider all these factors during a validation?

Answer 9

• objective evidence about assay performance
• evidence it is accurate
• evidence it is safe for use on patients
• right results for the patient every time

Question 10

What UKAS standard are we assessed against?

Answer 10

ISO 15189: 2012 - Requirements for quality and competence

Question 11

Why is UKAS accreditation important?

Answer 11

Demonstrates competence, impartiality and performance capability.
Gives users confidence that our service is high quality.
That the PATIENT will get the right test and the right result!

• regularly assesses the lab against international standards
• proves we have a solid system of continual quality improvement
• proves that all our staff are competent and trained appropriately
• lab is constantly striving to improve quality e.g. learning from incidents to improve our service.
• that the lab takes part in approved external quality assessment schemes

Question 12

What is registration? Why is it important?

Answer 12

It is a recognised standard across the UK and provides significant public protection from unprofessional or unethical behaviour.

It reassures patients, the public, users and employers that you are appropriately qualified, competent and safe to practice.

Question 13

Who is registration controlled by?

Answer 13

HCPC - Health and Care Professions Council

Question 14

What is the HCPC?

Answer 14

They protect the public by regulating several professions including Clinical Scientists

They do this by holding a register of professionals that can be searched online

They set the standards for education, training and practice which must be met in order to practice

Question 15

Who regulates the HCPC? State something they could do?

Answer 15

The Professional Standards Authority.

They could overturn a fitness to practice ruling if they felt it was too lenient and puts the public at risk.

Question 16

Where does the ACS come into this?

Answer 16

They are a HCPC approved assessor who can issue a Certificate of Attainment which allows an individual to apply for registration.

Question 17

Explain a role that the HCPC has in regulating Clinical Scientists?

Answer 17

They allow people to raise concerns - public, colleagues and even yourself (if for example you’ve received a police caution).

They will investigate the concern and if appropriate proceed to a hearing about the registrants fitness to practice.

This may result in the registrant being struck off the register, having special conditions placed against them or being suspended.

Question 18

How do the HCPC ensure that registrants are continuing their professional development (CPD) in line with the standards?

Answer 18

They randomly audit up to 2.5% of the registrants in a particular group at each renewal cycle.

Question 19

If you saw another scientist practicing badly, what could you do?

Answer 19

• could challenge them
• report concern to management, escalating this as you saw appropriate e.g. freedom of speech within trust
• if serious then could report a concern with the HCPC who are duty bound to investigate the matter if it meets their criteria.

Question 20

What are the CQC?

Answer 20

Regulator of health care in England inclu hospitals, dentists and GPs.

They come and inspect the hospital services in a similar way to how UKAS inspect us.

They provide each trust with an overall rating - LWH currently good.

Our UKAS accreditation certificate is submitted to CQC along with information about errors we’ve had and how we’ve tackled them.

Question 21

What is the Duty of Candour? In general what should happen?

Answer 21

It is a legal duty of a health organisation to be open and honest with patients when something goes wrong that has caused harm or has potential to cause harm.

Patient must be informed as soon as is practically possible after it is discovered. Patient should get an apology which should be followed up in writing along with details of what has happened.
Patient should be offered support and counselling and should be informed about the outcome of the investigation.

Question 22

What is the Francis report? Why is it relevant to me?

Answer 22

A public enquiry into the failings in care at Mid Staffordshire Foundation Trust in which there were over 1000 deaths due to poor care.
This poor care went on for 4 years and was missed by regulators.

Recommendations included:

• to introduce a Duty of Candour (applies to us)
• indirectly the friends and family test as was already in the pipeline (Salford, feedback tool that I took control of, had to show we had considered every comment for improvement by a patient/family member and the outcome was reported to the Trust)

Question 23

Why is health and safety important? What is it governed by?

Answer 23

In place to protect:

• the sample/patient
• the user
• your colleagues
• other stuff such as cleaners
• visitors.

Health and safety at work act 1974.

Question 24

What does the Health and Safety at Work Act state should be done?

Answer 24

COSHH
Risk Assessments

Training in things like fire safety, basic first aid etc.

Question 25

What is Information Governance? Who is allowed access to patient information?

Answer 25

Sets out the rules that an organisation needs to adhere to when they process or handle information, it could be personal info or corporate info e.g. patient, employee, financial, accounts.

Links to Freedom of Information act and Data Protection Act.

Exchange of confidential information is allowed between healthcare professionals as long as there is a requirement to need that info - should also use the minimum possible to do our job.

Question 26

What is the Freedom of Information Act?

Answer 26

Act that allows anyone to request information from a public sector organisation such as the NHS.

Requests have to be completed within a timeframe.

Can be used t request for example: how much money did your Trust spend on travel expenses during 2017-18.

Can’t be used to request sensitive information.

Question 27

What is the Data Protection Act 2018? Briefly, what does it cover?

Answer 27

Rules that govern the storage of personal information in files or on computers.

Can get fined (or worse) if a company doesn’t adhere to this act.

• employees have a legal right to access information held about them
• data must be accurate, not excessive, not kept for longer than necessary, must be collected lawfully, kept secure etc. (CALDICOTT principles)

Question 28

What is GDPR 2018?

Answer 28

General Data Protection Regulation - biggest shake up in a generation.

Modernisation of data protection laws that came into affect in May 2018

European directive to harmonise data protection - UK has written Data Protection Act 2018 using it.

Question 29

What was GDPR publicly ‘famous’ for?

Answer 29

Filling your email inbox with hundreds of ‘opt in’ emails!

Away from the NHS, GDPR brought in rules around consent - e.g. when signing up for something a pre-ticked box can’t be used as consent. A consumer has to OPT-IN. Companies also have to keep proof of this consent.

Question 30

Elaborate on one or more of those points…..

Answer 30

Implied consent or automatic consent is no longer allowed e.g. ‘untick’ box to opt out. Consent has to be an explicit OPT IN process and an organisation needs to prove they have it (and keep the proof).

A patient can opt out of allowing their information to be used for research and planning (known as secondary use). They can change this choice at any time. If they opt-out a patients information cannot be used for anything other than their individual care and treatment.

Genetic data has now been included as ‘sensitive’ data.

Question 30

State 4 things that are new about GDPR?

Answer 30

Consent must be PROVEN.

Patient can WITHDRAW their consent at any time.

Patient can withdraw consent from their data being used for RESEARCH and SERVICE PLANNING.

Sensitive data includes GENETIC information.

Question 31

What changes might the lab need to make in regard to GDPR? How might we achieve this?

Answer 31

We might need to prove we have consent to store DNA/cells/tissue. Consent forms currently completed by clinician - might have to request these copies are always sent with tests and kept on LIMS as proof of consent??
Or does this responsibility ultimately lie with requesting clinician?

New NGIS system might solve this.

Question 33

What is a Subject Access Request? What relevance might this have on the lab?

Answer 33

Patient can request to see all info that we hold about them.

Be careful what you write on patient files and contact logs as a patient may end up seeing it!

Question 34

What does CALDICOTT refer to?

Answer 34

7 principles which set out what an organisation should follow to ensure that information that is able to identify a patient is protected and is only used when it is appropriate.

Principles include:

• use of confidential information needs to be justified
• it must be absolutely necessary
• use the minimum necessary information
• access is on a strict need to know basis
• everyone who has access to the info should be fully aware of their responsibilities when using it
• the 7th principle which is the most recent addition is that the duty to share can be as important as the duty to protect confidentiality if it affects someone’s care.

Question 35

What is a CALDICOTT Guardian?

Answer 35

A nominated senior person who is responsible for protecting the confidentiality of patients health and care information.

Every Trust must have one.