All Flashcards
What is the sensitivity of an assay and how is it calculated?
The proportion of positive results correctly identified by a test, calculated as follows:
= True positives / (True positives + False negatives) x 100%
What is the specificity of an assay and how is it calculated?
The proportion of negative results correctly identified by a test, calculated as follows:
= True negatives / (True negatives + False positives) x 100%
What is the accuracy of an assay and how is it calculated?
How often a test gives the correct result (either positive or negative), calculated as follows:
= True results / (True results + False results) x 100%
What is the positive predictive value and how is it calculated?
The positive predictive value is a measure of the chance that a positive result is correct and is calculated as follows:
True positives / (True positives + False Positives )
What is the negative predictive value and how is it calculated?
The negative predictive value is a measure of the chance that a negative result is correct and is calculated as follows:
True negatives / (True negatives + False negatives )
What is clinical governance?
Clinical governance is a systematic approach to maintaining and improving the quality of patient care within a health system.
What are the three key attributes in clinical governance?
- Recognisably high standards of care.
- Transparent responsibility and accountability for those standards.
- Constant dynamic of improvement.
What are the components of clinical governance?
- Clinical audit – review of clinical performance, refining clinical practice as a result and then measuring performance against agreed standards.
- Clinical effectiveness – a measure of the extent to which a particular intervention works.
- Education and training – continuing professional development (CPD).
- Risk management – risks to patients, practitioners and the organisation need to be considered and balanced.
- Openness – processes which are open to public scrutiny, while respecting individual patients and practitioner confidentiality, and which can be openly justified, are an essential part of quality assurance.
- Research and development – techniques such as critical appraisal of the literature, project management and the development of guidelines, protocols and implementation strategies are all tools for promoting the implementation of research practice.
- Clinical information and information technology – committed to the development and use of information to improve care and service users’ experience.
- Patient and public involvement – services should be seamless and patient centred.
- Staffing and staff management – committed to the management and direction of staff.
What is risk management and how can risks be minimised?
Risk is defined as the potential that a chosen action, inaction or activity will lead to an undesirable outcome.
Risk management is about minimizing these risks
By:
Identifying what can and does go wrong during care
Understanding the factors that influence this
Learning lessons from any adverse events
Ensuring action is taken to prevent recurrence
Putting systems in place to reduce risks
What are the different types of incidents?
Adverse incident reporting allows refinement/redesign of processes based on actual experience. There are several categories listed below:
Adverse Incident - When an event occurs that causes harm to any person or damage to or loss of any property or assets of the Trust or any individual and may damage the reputation of the Trust.
Patient Safety Incident - Any unintended or unexpected incident(s) that could have or did lead to harm for one or more persons receiving NHS funded healthcare.
‘No Harm’ Incident - Any unexpected or unintended incident which ran to completion but no harm, damage or loss occurred.
‘Prevented’ Incident - Any incident that had the potential to cause harm but was prevented from occurring, resulting in no harm, damage or loss.
If a complaint is received, who should be notified?
The authority for addressing complaints lies with the Head of Department and therefore wherever possible, all complaints must be referred in the first instance to the Head of Department. In the absence of the Head of Department, the responsibility passes to the most senior member of staff available.
What measures should be undertaken to try and resolve a complaint?
Staff should aim to resolve the complaint informally wherever possible:
- Listen to the complainant and acknowledge their complaint;
- Express regret for any inconvenience caused;
- Clarify the details of the complaint;
- Offer an explanation if appropriate;
- Thank the complainant for raising the complaint and refer him/her to the Trust complaints procedure.
All complaints are recorded as an incident on the QMS
What should be included in the incident report?
- The nature of the complaint;
- Result of investigations of the complaint;
- Corrective or preventative action taken;
- Person discharging the complaint.
What should happen if a complaint cannot be resolved informally?
If a complaint cannot be settled informally with the Department, it should be explained to the complainant that they may make a formal complaint, in accordance with Trust Complaints Policy and Procedure.
What should the lab have in place in relation to ethical conduct?
a) There is no involvement in any activities that would diminish confidence in the laboratory competence, impartiality, judgement or operational integrity.
b) Management and personnel are free from any undue commercial, financial or other pressures and influences that may adversely affect the quality of their work.
c) Where potential conflicts in competing interests may exist, they shall be openly and appropriately declared
d) There are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements.
e) Confidentiality of information is maintained.
If a patient phoned the lab, can you give them a result and why?
Results should not be communicated to the patient without the opportunity for adequate genetic counselling. All results are confidential unless disclosure is authorised wherein the results may be reported to other parties with the patient’s consent or as required by law.
What does ISO stipulate about data protection?
The laboratory should ensure that all information is stored safely and that there are reasonable safeguards against loss, unauthorised access, tampering and other misuse.
What does ISO stipulate about informed consent?
ISO states that all procedures should be carried out with the informed consent of the patient. The standards also state that using patient samples for purposes other than those requested should only occur if the samples are rendered anonymous or have been pooled.
What are the different types of incidental findings?
1) actionable (whether immediately or remotely)
2) clinically relevant, but not actionable
3) of uncertain significance.
What considerations should be made when reporting and incidental finding?
- Is it clinically relevant
- Is the disease or risk clearly proven
- Would reporting the finding lead to a better clinical outcome (e.g. are treatments available)
- Has the patient given informed consented for this test
- Patient autonomy- Is there an option for the patient to opt-out for receiving feedback from incidental findings
- Would withholding the information open the department to litigation
- Is it ethical to withhold the information
What is the human tissue act?
The Human Tissue Act came into force on 1st September 2006 establishing Informed consent as the fundamental principle underpinning the lawful removal, storage and use of human tissue and organs.
What are the 8 principles of the 1998 data protection act?
The act protects individual rights regarding the use of, and access to, their personal data.
The 8 core principles are:
1, Information must be processed fairly and lawfully.
2, Information collected must be processed for limited purposes.
3, Information collected must be adequate, relevant and not excessive.
4, Information collected must be accurate and up to date.
5, Information must not be held for longer than is necessary.
6, Information must be processed in accordance with the individual’s rights.
7, Information must be kept secure
8, Information should not be transferred outside the European Economic Area unless adequate levels of protection exist.
What is ‘Duty of Candour’
Every healthcare professional must be open and honest with patients. Healthcare professionals must:
- Tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong.
- Apologise to the patient (or, where appropriate, the patient’s advocate, carer or family)
- Offer an appropriate remedy or support to put matters right (if possible)
- Explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family) the short and long term effects of what has happened.
What is the main role of NICE?
Producing evidence based guidance and advice for health, public health and social care practitioners.
Developing quality standards and performance metrics for those providing and commissioning health, public health and social care services.
Providing a range of informational services for commissioners, practitioners and managers across the spectrum of health and social care.
What does NICE stand for?
National Institute for Health and Care Excellence
What are the NHS values?
- Working together for the patients
- Everyone should be treated with respect and dignity
- Commitment to quality of care
- Compassion
- Improve lives
- Everyone counts
What are the principles which guide the NHS?
- The NHS provides a comprehensive service to all
- Access to NHS services is based on clinical need and not an individuals ability to pay
- The NHS aspires to the highest standards of excellence and professionalism
- The patient will be at the heart of everything the NHS does
- The NHS works across organisational boundaries and in partnership with other organisations in the interest of patients, local communities and the wider population.
- The NHS is committed to providing best value for taxpayers’ money and the most effective, fair and sustainable use of finite resources.
- The NHS is accountable to the public, communities and patients that it serves.
What is patient centered care?
Patient centered care is when health and social care professionals work collaboratively to with patients. It is coordinated and tailored to the needs of the individual and insures individuals are treated with care, dignity and respect.
What are the four principles of patient centered care?
- Affording and individual dignity, compassion and respect.
- Offering coordinated care, support or treatment.
- Offering personalised care, support or treatment.
- Supporting individuals to recognise, develop and develop strengths and abilities to live a healthy and fulfilling life.
It is important that healthcare professionals and the patient work together to.. ?
- Understand what is important to the person
- Make decisions about their care and treatment
- Identify and achieve their goals
Healthcare professionals must play a role in helping a patient develop the knowledge in order to fully participate in the partnership.
What is emotional intelligence?
Being aware of and managing our emotions and involves
- Self awareness
- Self management
- Social awareness
- Relationship management
Why is it important to give and receive feedback?
Giving feedback is important to make sure people are performing
Receiving feedback is important for personal development as it helps maximise out potential and raise awareness of our strengths and areas for improvement
What should be included in feedback?
Feedback should be about delivering a message that allows the individual receiving it to understand how they are performing within their environment and where that performance can be improved for themselves, the team and the organisation.
