Generic OSFA

Question 1

What are the Caldicott principles?

Answer 1

1. Justify the purpose for use of patient identifiable information
2. Only use patient identifiable information if absolutely necessary
3. Only use minimum necessary for purpose
4. Access should be restricted to “need to know” basis
5. Everyone with access should be aware of responsibilities
6. Everyone with access should understand and comply with data protection and security legislation
7. The duty to share can be as important as the duty to protect patient confidentiality
   Justify - Necessary - Minimum - Access - Responsibilities - Legislation - Share

Question 2

What are the principles in the Data Protection Act?

Answer 2

1. Fairly and Lawfully Processed
2. Processed for limited purposes
3. Adequate, relevant and not excessive
4. Accurate and up to date
5. Not kept for longer than necessary
6. Processed in accordance with right of data subject (can access information, request change)
7. Be protected (security measures)
8. Not be transferred outside the European Economic Area (EEA)

Question 3

What are the domains of Good Scientific Practice?

Answer 3

1. Professional Practice
2. Scientific Practice
3. Clinical Practice
4. Research, development and innovation
5. Clinical Leadership

Question 4

What does Professional Practice include (domain 1 of GSP)?

Answer 4

1. Professional Practice: Make patient priority, work within scope, keep skills and knowledge up to date, do not discriminate
2. Probity/moral principles: Inform regulatory bodies if necessary, be open and honest (duty of candour)
3. Working with colleagues: Communicate effectively in multi-disciplinary team, take advice, respect skills and contributions, participate in reviews of performance
4. Training and development of others: Training, supervision, support colleagues with difficulties, share information

Question 5

What does Scientific Practice include (domain 2 of GSP)?

Answer 5

1. Scientific Practice: Develop investigative strategies, undertake scientific investigations, provide clear reports, critically evaluate data and draw conclusions
2. Technical Practice: Provide technical advice, take part in audits, assess new technologies, identify and manage risk, apply good health and safety practice
3. Quality: Set, maintain, apply quality standards, make judgements on effectiveness of processes, participate in quality assurance programmes, maintain audit trail

Question 6

What does Clinical Practice include (domain 3 of GSP)?

Answer 6

1. Clinical Practice: Ensure consent, confidentiality, understand clinical consequence of decisions, maintain up to date knowledge, provide expert interpretation and clinical advice based on results, prioritise delivery of investigations, ensure audit is undertaken
2. Investigation and reporting: Plan and conduct procedures with professional skill, ensure safety
   Consent - Confidentiality - Consequence - Expert - Prioritise - Safety

Question 7

What does Research, Development and Innovation include (domain 4 of GSP)?

Answer 7

1. Critically appraise scientific literature, engage in evidence based practice, participate in audit, identify innovative approaches, participate in research
2. Develop, evaluate, validate and verify new procedures, implement new procedures, evaluate research, interpret data in clinical context, present data, support healthcare team

Question 8

What does Clinical Leadership include (domain 5 of GSP)?

Answer 8

1. Maintain responsibility when delegating, respect skills of colleagues, protect patients from risk and harm, treat colleagues fairly and with respect, ensure responsibilities are covered when absent
2. Ensure colleagues can raise concerns, review team performance, remedy poor performance, identify and take action to meet development needs of yourself and team
3. Act as an ambassador

Question 9

What are the key principles of the NHS constitution?

Answer 9

1. Comprehensive service (available to all)
2. Access is based on clinical need not ability to pay
3. High standards of excellence and professionalism ensures safe and effective care
4. The patient is at the heart of everything - individuals are supported to manage and promote their own health
5. NHS works across organisational boundaries
6. NHS provides best value for money (most effective, fair and sustainable use of resources)
7. NHS is accountable to the public and must be transparent and clear
   CAE-PAVA: Comprehensive, Access, Excellence, Patient-centred, Across boundaries, Value for money, Accountable to public

Question 10

What are the NHS values?

Answer 10

1. Working together for patients: Patient-centred care, speak up when things go wrong
2. Respect and dignity: Equality and diversity, transparency in what can and can’t be done
3. Commitment to quality of care: Encourage feedback for improvement
4. Compassion
5. Improving lives: Improve health and well-being, strive to excellence and professionalism
6. Everyone counts: Exclude nobody, some may need more help, do not waste resources
   PEQ-CIE: Patient-centered, Equality and diversity, Quality, Compassion, Improving lives, Everyone counts

Question 11

What are the different types of audits and their benefits?

Answer 11

Internal/external audit (e.g. accreditation body)

Vertical audit: Follows one sample through all steps of processing - is good for identifying where an error has occurred
Horizontal audit: Looks at one process (many samples) - can identify if outcomes of process fall within accepted range for a variety of samples
Examination audit: Observing a technique being done - tests if a SOP is being followed - can identify training needs or improvement needs to SOP

Evaluating user feedback
Evaluating staff suggestions

Benefit of audit: allow quality improvement to take place where it will be most helpful and will improve outcomes for patients

Question 12

How can you engage a colleague/patient with questioning styles?

Answer 12

TED: Tell me what… Explain to me… Describe to me…
5Wh’s: What, where, when, why, who, (how)…

These are open-ended questions.

Question 13

Which model can be used when presented with a task/situation?

Answer 13

STAR: Situation: Describe the situation. Task: What you have to do. Action: What actions you did/will do. Result: What result do you expect.

Question 14

How to manage a user complaint?

Answer 14

May be received by letter, email, phone, personal, social media, third party
Formal complaints: Resolution sought through Complaints Team (Trust) through formal investigation
Informal complaints: Redirect to Directorate General Manager, if relating to patient currently receiving treatment, then must be escalated to Complaints Team
Complainant’s personal details should remain limited to those, who need to know.
Statements from those involved are gathered.
A response is given out in writing.
Actions arising may be implementation and monitoring, audit, feedback to staff, supporting staff involved (counsellor/OWLS)

The Patient Advice and Liaison Service (PALS) offers confidential advice, support and information on health-related matters. They provide a point of contact for patients, their families and their carers

Question 15

Questions to ask when reviewing literature?

Answer 15

1. Did the study address a clearly focused issue?
2. Did the authors use an appropriate method to answer their question?
3. Case-control: Were the cases/controls recruited in an acceptable way? (Selection bias, were they representive? Non-responders?) RCT: Were patients randomised? Were everyone “blind” to treatment?
4. Case-control/RCT: Were groups treated equally? (Measurement, recall or classification bias)
5. Were groups comparable? (Genetics, environmental, socio-economic)
6. Confounding factors/bias?
7. Do we believe the results? (Have confidence limits been given?)
8. Are the results important? (Are benefits worth the harm?)

Question 16

How to react to an incident e.g. a person tripping?

Answer 16

1. Assess the environment
2. Ask what happened
3. Problem solving: Suggest appropriate solutions
4. Information gathering: Ask if a person is OK? Why is the wire there in the first place? What was nature of spillage? Can it be moved straight away? etc.
5. Informing Health and Safety manager or relevant person
6. Incident form
7. Root cause analysis
8. Do risk assessment

Question 17

What is validation and verification?

Answer 17

Validation: Are we building the right product? Is the process is capable of consistently delivering the required quality? Is the method fit for purpose? Does it have the right sensitivity and specificity?
ISO 15189:2012, validation is defined as “confirmation, through the provision of objective evidence that the requirements for a specific intended use or
application have been fulfilled”
Can be pre-purchasing stage.

Verification: Are we building the product right? Is the process is in reality consistently delivering the required quality? Describing the performance of the test. ISO 15189: 2012 defines “verification as the confirmation, through provision of objective evidence that specified requirements have been fulfilled”

Any new or changed process, equipment, facilities and systems must follow the change planning procedure. Risk and impact assessment must always be carried out for any change (assess consequences)

Question 18

What is the parameter to compare groups in case-control studies? Cross-sectional studies?

Answer 18

Case-control: Odds ratio
Cross-sectional: Risk ratio
proportion of disease in exposed/proportion of disease in unexposed

Question 19

What does the p-value depend on?

Answer 19

1. How big the difference is
2. Sample size
3. Variability of measurements
   Small study => Large p-value even if effect is large
   Large study => Small p-value even if effect is small (clinically irrelevant)

Question 20

What is the difference between bias and confounding?

Answer 20

Bias: Disease is not associated with exposure - the finding is wrong, problem with study design (e.g. selection bias, information bias)
Confounding: Disease is associated with exposure, but something else explains the association (but confounder is not causal) - e.g. if coal miners have lung cancer, but are also more likely to be smokers

Question 21

Which ways are there to deal with confounding?

Answer 21

Randomisation
Restriction
Analyse groups seperately
Multivariate analysis

Question 22

Give 3 examples of bias

Answer 22

Recall bias (more likely to recall something if affected)
Reporting bias (more likely to report exposure if affected)
Observer bias (probes more about exposure if know affected)
Use objective rather than self-reported measurements
Blind interviewer

Question 23

What does a p-value measure?

Answer 23

Probability that the observed effect happened by chance/probability that null hypothesis of no effect is true
Large p-value does not necessarily mean there is no effect - only that we can’t measure it with the sample size

Question 24

Give 3 examples of selection bias

Answer 24

Not from representative population (case/control studies)
Non-response (poor response amongst low SE-status)
Loss to follow-up (cohort studies, if drop-out is related to exposure)

Question 25

Calculate sensitivity and specificity, positive predictive value and negative predictive value

Answer 25

true disease - true well
test pos A B
test neg C D

true disease - true well
test pos TP FP
test neg FN TN

Sensitivity: A/(A+C) or TP/(TP+FN)
Specificity: D/(D+B) or TN/(TN+FP)

Positive Predictive value: A/(A+B) or TP/(TP+FP)
Negative Predictive value: D/(D+B) or (TN/(TN+FN)

A good test has minimal values in B and C (false positives and false negatives)

Question 26

How do you approach a colleague, who you are not line managing, about a problem?

Answer 26

1. Approach the colleague showing empathy - “Is there a problem?” “Is there anything at work I can help with?”
2. Suggest talking to their line manager about working hours or any issues they need support with.
3. Think about how to support the service delivery/team.

Question 27

An error has occured with a process - what do you do?

Answer 27

1. Immediate actions: Rectify/re-run, DATIX report, report to seniors
2. Long term actions: Root cause analysis, training, SOP review, worksheets that need investigation, potentially contacting clinicians
3. Mention patient safety
4. Incidents must be reported although patient result not affected
5. Potential causes of errors: Outdated SOP, SOP not routinely followed, not understanding need for following SOP, training issues, work load, proper equipment not present
6. Investigate sources of error, discussing with colleagues, reviewing training plans

Question 28

An error with quality control has happened

Answer 28

1. Recognise error, and importance to act and initiate relevant investigations
2. Gather information:
   Speak to member of staff
   Review batch records
   New controls in use?
   New staff trained?
   Review SOP.
   Root cause analysis
3. Re-run samples on same worksheet - patient safety
4. Report incident, DATIX
5. Communicate with senior staff

Question 29

What is required when making changes?

Answer 29

1. Follow change request procedure (Change Board reviews proposals)
2. Validation and verification
3. Risk assessment
4. Impact assessment (will new systems fit in existing structure, work in part of department? Which staff will be affected and do they need further training? Benefit vs cost?)
5. Document!
6. Implement (make SOPs and record templates, train staff, billing procedure, request form)
7. Review, maintain and improve
8. Inform users/stakeholders

Question 30

How would you develop a clinical audit?

Answer 30

1. Select topic of concern
2. Set standards/define criteria
3. Measure current practice
4. Implement change
5. Monitor/re-audit

Question 31

Explain Modernising Scientific Careers

Answer 31

Training programmes to develop healthcare science workforce - UK-wide
Enables better workforce planning, improves patient care by allowing quicker response to innovations
Practitioner: undergraduate level
Scientist: postgraduate, pre-registration
Higher Specialist: doctoral

Question 32

Name models for giving feedback, and describe them, including advantages and disadvantages.

Answer 32

• The “feedback sandwich”: Name what is positive, Name what to improve, Build up comfort and confidence. Advantage: Learner not discouraged. Disadvantage: May lose effectiveness over time
• Chronological feedback: Highlight what was good or needs improvement chronologically. Good for short feedback.
  Pendleton model: 1) Check that learner wants and is ready for feedback 2)-3) Learner Comments on assessment and states what was done well. 4) Facilitator states what was done well (reinforces positives) 5) Learner states what could be improved 6) Facilitator state how it could be improved 7) And action plan is made. Good for developing actions based on reflections, Rigid structure.
  AID (action-impact-development) model: Feedback on actions, not interpretations, intentions. What impact does action have (department, patient, public trust, NHS)? Development/desired behavior. Enhance performance and motivate. Enables reflections to view actions in larger context.

Question 33

Which barriers are there to effective feedback?

Answer 33

Generalised feedback not related to specific facts
Lack of advice on how to improve behaviour
A lack of respect for the source of feedback
Fear of upsetting colleagues
Fear of damaging professional relationships
Defensive behaviour/resistance when receiving feedback
Physical barriers: noise, or improper time, place or space
Personal agendas
Lack of confidence

Question 34

What do you do if your feedback is not accepted/acted on?

What should you do when receiving feedback?

Answer 34

Check that expectations are understood
Reiterate impact
Ask if there are hindrances to the expectations being met
Seek advice from senior or HR team

React: Manage emotional response, concentrate on on listening and understanding
Reflect: Keep an open mind, allow time for emotions to calm, ask questions to clarify
Respond: Thank for feedback, list reasons if not agreeing, suggest options and solutions, negotiate next steps, seek feedback on changes made
Know how and how often you would like feedback, how you would like to be supported, what you appreciate and/or would like changed

Question 35

What are important points to remember when giving feedback (any model)?

Answer 35

Don’t forget to feedback when things have gone well
Ask open-ended questions
Clarify agendas
Describe behaviour and its impact, rather than labelling the person
Be specific (describe expectations, situation, result)
Be prepared for an emotional reaction, (anger, rejection of feedback, tears) – stay calm, offer to have a break
Check understanding
Let the other person respond
Use active and reflective listening techniques
Be respectful
Remember to do action plan!

Question 36

What are 4 types of CPD activity required by the HCPC?

Answer 36

Work-based learning
Self-directed
Professional activity
Formal education

Question 37

What are the stages in Gibb’s reflective cycle?

Answer 37

Description
Feelings
Evaluation
Analysis
Conclusion
Action plan

Question 38

What are the stages in the Cambridge-Calgary model for taking patient history?

Answer 38

Initiate session
Gather information
Explaining and planning

Question 39

How would you calculate risk?

Answer 39

Likelihood x Consequence

Question 40

What are the pieces of legislation that allows reporting and recording of incidents?

Answer 40

Health and safety at work act 1974 - regulator: health and safety executive (HSE) - regulations include: CLP (classification of chemicals), COSHH (Control of Substances Hazardous to Health), Sharps disposal and injuries, electrical safety, fire safety, first aid provision, manual handling (lifting/carrying), PPE, work equipment, RIDDOR (Reporting of Injuries, Diseases and Dangerous Occurrences Regulations): Duty to report severe workplace accidents, diseases and near misses to HSE

The Health and Social Care Act 2008 - includes infection control - regulator: care quality comission (CQC) - regulations include: Cleanliness and security of premises and equipment; safe care and treatment, prevent avoidable risk/harm; Duty of candour

Question 41

How do we control hazardous substances at work so that they do not cause ill health?

Answer 41

Comply with Control of Substances Hazardous to Health (COSHH) Regulations 2002:

Risk assessment

Control measures: Use safer products; Use store minimum quantities; Have isolated storage areas; Separate flammable, corrosive, toxic chemicals, Enclose the process or extract emissions; Use PPE and other protective equipment; Training and SOPs; Hazard data sheets (COSHH documents on iPassport); Safe storage and disposal of waste; Actions in case of spillages
Control equipment can be e.g. ventilation

Monitor performance: E.g. measure air quality, do audits to ensure SOPs are being followed

Monitor exposure: Workplace Exposure Limits (WELs - published by HSE) should not be exceeded.

Continuously monitor and review

Train staff and have COSHH documents available for each substance indicating correct procedures for use, storage, disposal and actions to be taken in case of spillage and skin/eye contact

The laboratory is accredited by United Kingdom Accreditation Service (UKAS) according to ISO 15189: “Medical laboratories — Particular requirements for quality and competence” standards, which also cover health and safety in the workplace.

Question 42

Which actions can be taken to minimise spillages or leakage of samples to avoid infection risk?

Answer 42

Use absorbent paper to mop up and clean the area with Virkon.
In case of large spillages, isolate the area and inform a senior staff member. Use Virkon to disinfect and soak up the spillage with absorbent towels prior to mopping up.
Check vial for damage and secure lid to avoid further leaking.
Contaminated paperwork is kept contained while information is copied and then original is discarded through clinical waste line

Question 43

Which actions can be taken to minimise risk of sharps injuries?

Answer 43

Risk can come from microscope slides, needles, scalpels etc.

Never re-sheath sharp instruments.
Dispose of sharps in sharps bin.
Keep hospital waste secure until collection.
First aid provision: Training of first aider and having available first aid kits.
Encourage wound to bleed, wash under running water.
Notify manager of incident.
Complete incident form.
Report to Occupational Health for medical assessment.

Question 44

Which actions can be taken to minimise risk of splashes from samples on skin or mucous membrane (eyes/mouth) to avoid potential infection risk?

Answer 44

Using personal protective equipment (PPE), such as lab coats, gloves, safety spectacles.
Working in flow cabinets.
Wash contaminated skin with soap and plenty of water.
Eye washing stations.
Trained first aid officer.
Notify manager of incident.
Complete incident form.
Report to Occupational Health for medical assessment

Question 45

Which actions can be taken to minimise risk of transferring of pathogens through touch?

Answer 45

Do not come to work in case of:
• Chicken pox or shingles
• Severe upper respiratory tract infections
• For 48 hours after last diarrhoea or vomiting event
• Hand foot and mouth disease, rubella, streptococcus A, parvovirus, TB
• Hepatitis, HIV
All staff has documented immunity to Hepatitis B.
Follow hand washing policies.
Use flow cabinets for handling blood or body fluid samples.
Cover broken skin with waterproof bandage.
Do not handle computer keyboards, telephones, doorknobs etc. when wearing gloves.
Disinfect microscopes to avoid transfer of conjunctivitis or other eye infections.

Question 46

Which actions can be taken to minimise risk of exposure to fumes, dust or airborne pathogens

Answer 46

Working in safety cabinets:
• Exhaust air is HEPA-filtered to remove bacteria and viruses.
• CLASS I: Inward air flow - protects operator but not sample
• CLASS II: Inward flow of filtered air - protects both operator and sample
• CLASS III: Sealed units with air filtered on entry & exit – normally only used for class 4 pathogens
Monitor air quality.

Question 47

Which actions can be taken to minimise risk of harm from fire?

Answer 47

Install fire alarms, smoke extinguishers and smoke detectors.
Mandatory fire training for all staff.
Evacuation plan.
Appointment of fire wardens.
Keep fire exits clear.
Sign in/out book for visitors.

Question 48

Who is responsible for health and safety in the work space?

Answer 48

Everyone.

Employer is legally required to provide safe buildings, equipment, control measures and procedures for managing risks

Employee is responsible for being knowledgeable about health and safety procedures (attending mandatory training), take responsibility for own safety and that of colleagues, visitors and patients - everyone in the work space, reporting incidents or near misses

Question 49

What protects patients from harm?

Answer 49

Legal:
GDPR (general data protection regulation), before Data Protection Act - difference: Genetic data is classified as personal data, people have right to demand inaccurate information to be amended or have their records deleted (right to be forgotten).
Health and safety at work act 1974 (RIDDOR)
Health and social care act 2008 (duty of candour)
Freedom of information act: Have a duty to reply

As a clinical scientist: HCPC registration: Protected title, training uniform across country, continuously improve skills and knowledge
Competence assessment, only perform tasks that deemed competent to perform

NHS values: Patient-centred care, access based on need not ability to pay, high standards of excellence and quality, transparent about what we do

Lab: ISO 15189 accredited which means committing to continuous improvement. UKAS inspections, standard operating procedures (SOPs)
Internal and external quality control and assurance (EQA schemes). Control material used. Witness checks. Audit trails.
Incident reporting: DATIX.

Procedures for dealing with complaints, PALS services to advise about healthcare related issues, formal complaints are investigated and reported back in writing.