TBL 5 - CLINICAL GOVERANCE

Question 1

What is clinical governance?

Answer 1

Healthcare professionals required to have procedures in place to minimize risk and harm to patients. - this is clinical governance.
Clinical governance is about making sure that the right medicine is given the right person at the right time.
Requires written procedures are in place to make everyone understand what they should be doing and what their responsibilities.

Question 2

What does clinical governance require pharmacist to do (4 things)?

Answer 2

Requires pharmacist to:
- Consider what could go wrong
- Find methods of preventing errors
- Document the facts when something does go wrong
- Learn from any mistakes.

Question 3

What are examples of clinical governance?

Answer 3

• Audit
• Clinical effectiveness
• CPD
• Involving people who use you services
• Staff management
• Risk management (includes having an SOP in place)
• GDPR and data protection (includes confidentiality)

Question 4

Why would you conduct an audit?

Answer 4

By conducting an audit, you are helping to improve the quality of care that you provide to patients by reviewing what you are doing, learning from it and if required implementing changes.
Audit falls under quality improvement to allow us to provide the best possible care to patients.

Question 5

What are the main stages involved in an audit (11 things)?

Answer 5

Main stages involved in an audit are:
1) Selecting the area that you would like to audit
2) Agreeing the standards of best practising
3) Collecting the data
4) Analyzing the data against the standards
5) Providing feedback on the results obtained
6) Implementing agreed changes
7) Allowing time for the changes to be applied before re-auditing
8) Collecting data
9) Analyzing data
10) Providing feedback on the results obtained
11) Discussing whether the practice has improved.

Question 6

What is service evaluation?

Answer 6

Designed to determine how well service is working.
Important to establish if service is achieving the intended aims.

Question 7

What is the idea behind service evaluation?

Answer 7

Idea behind a service evaluation is to ensure that service supports evidence-based approach to practice delivery and to benefit the patients who are using the healthcare service,

Question 8

What is the outcome of service evaluation?

Answer 8

Outcome of service evaluation can aid decisions about the effectiveness of a service and what changes are required to improve the quality of care.

Question 9

How can you involve people who use the services at the pharmacy?

Answer 9

Involving people who use your services:
- Ensuring ppl are aware of services you offer within your pharmacy.
- Done via pharmacy practice leaflet and displaying notices within the pharmacy.

Question 10

How can pharmacy staff listen to ppl who use their services (3 things)?

Answer 10

Important that pharmacy staff listen to the ppl who use their services. Can be done through mechanisms like:
- Through feedback
- Through patient suggestions using questionnaires
- By using surveys

Pharmacy staff must also make sure that complaints from ppl are considered appropriately

Question 11

How do you manage staff (6 things)?

Answer 11

1)Each member of staff who joins a pharmacy team must have an induction when they start.
2) Must receive ongoing support with training and development to ensure that they are competent to carry out their role and continue to learn and develop.
3) Have clear procedures in place for managing poor staff performances.
4) Every pharmacy professional has a responsibility to raise concerns about individuals e.g. other staff members as well as actions or circumstances that could result in risks to patients.
5) Include circumstances where a staff member believes that the training they have received does not equip them appropriately to do their role.
6) GPhC has produced some guidance on raising concerns.

Question 12

What are the 5 categories of concerns that the GPhC will investigate?

Answer 12

1) Serious unprofessional or inappropriate behaviour
2) Dishonesty or fraud
3) Criminal conduct
4) Dispensing errors
5) Working under the influence of drugs or alcohol

Question 13

When raising concerns how does the public interest disclosure act (PIDA) 1998 protect whistle-blowers?

Answer 13

PIDA protects whistle-blowers from negative treatment or unfair dismissal if they have disclosed certain information in the public interest and pharmacy professionals have a duty to raise concerns under this act.

Question 14

What sort of disclosures are protected under the PIDA?

Answer 14

Disclosures which are protected under the PIDA are those in which in the reasonable belief of the person making the disclosure involves or is likely to involve in the future one or more of the following:
- The commission of a criminal offence
- Breach of a legal obligation
- A miscarriage of justice
- Danger to the health and safety of any individual
- Damage to the environment
Concealment of any of the above.

Question 15

When can a pharmacy professional disclose confidential info?

Answer 15

A pharmacy professional may disclose confidential information when it is considered to be in the public interest e.g. where info is required to prevent:
- A serious crime
- Serious harm to a person receiving care to a third party
- Serious risk to public health.

Question 16

What are the 12 things that SOP covers?

Answer 16

SOPs must cover at least:
1) Arrangements for safe and effective ordering, storage, preparation and disposal of medicines.
2) Supply of medicines
3) Medicine delivery outside the pharmacy.
4) Record keeping for all
6) The circumstances in which a non-pharmacist member of staff may give advice about medicinal products.
7) Identifying members of staff who are competent to perform specified tasks within the pharmacy.
8) Arrangements to apply if the responsible pharmacist is absent from the premises.
9) Steps to be taken when the responsible pharmacist is changed.
10) A complaints procedure
11) An incident procedure,
12) How changes to SOPs are communicated to all staff

Question 17

SOP is written procedure that details (5 things):

Answer 17

• What is to be done
  
  • When it should be done
  • Who should be doing it
  • Where it should be done
    
    • How it should be done

Question 18

What are the reasons for why we have SOPs (7 things)?

Answer 18

1) Help to ensure quality and consistency of service
2) Help to ensure that good practice is achieved
3) Help to ensure that the expertise of the team is fully utilized and define when it’s appropriate to delegate, depending on the abilities/qualification of the staff.
4) Provide an audit tool - a measurement of what should be happening
5) Assist with staff training and development
6) Used as an aide memoire when undertaking a task.
7) Used to help meet an employer’s health and safety obligations.

Question 19

What are the 7 principles of general data protection regulation (GDPR)?

Answer 19

1) Lawfulness, fairness and transparency
2) Purpose limitation
3) Data minimisation
4) Accuracy
5) Storage limitation
6) Integrity and confidentiality (security)
7) Accountability

Question 20

What do Caldicott principles apply to?

Answer 20

Caldicott principles apply all data collected for the provision of health and social care services where patients and service users can be identified and the expectation is that the data will be kept confidential.

Question 21

When NHS appointed a Caldicott guardian what are they responsible for?

Answer 21

Each NHS organisation has appointed Caldicott guardian, who is responsible for safeguarding patient info and ensuring good practices are implemented.

Question 22

What are the 8 Caldicott principles?

Answer 22

1) Justify the purpose for using confidential info
2) Use confidential info only when it’s necessary
3) Use the minimum necessary confidential info
4) Access to confidential info should be done on strict need-to-know basis
5) Everyone with access to confidential info should be aware of their responsibilities
6) Comply with law
7) The duty to share info for individual care is as important as the duty to protect patient confidentially
8) inform patient and service users about how their confidential info is used.

Question 23

What does confidential info include (5 things)?

Answer 23

1) Electronic and hard copy data
2) Personal details
3) Info about a person meds (prescribed and non-prescribed)
4) Other info about a persons medical history, treatment or care that could identify them.
5) Info that ppl share that is not strictly medical in nature, but the person disclosing it would expect to be kept confidential

Question 24

What does confidential info not include (3 things)?

Answer 24

1) anonymous info
2) peusodoymised info
3) info that is already legitimately in the public domain.

Question 25

4 circumstances when it may be appropriate for pharmacy professionals to disclose confidential information:

Answer 25

1) has the consent of the person under their care
2) has to disclose by law
3) should do so in the public interest, and/or
4) must do so in the vital interests of a person receiving treatment or care, for example if a patient needs immediate urgent medical attention

Question 26

What is a summary care record (SCR)?

Answer 26

Summary care record (SCR) is a secure, electronic patient record that contains key info from patients detailed GP records.

Question 27

When can the SCR be accessed?

Answer 27

Accessed in emergency and unplanned care scenarios.

Question 28

What does an SCR provide patients and who maintains the SCR?

Answer 28

SCRs provide healthcare staff treating patients with access to key clinical info
SCRs created and maintained by GP - read only view of patients key clinical info
Patients can choice if they have an SCR or not and can opt out.

Question 29

What does an SCR contains as a minimum (3 things)?

Answer 29

• Medicines: acute, current repeat and discontinued repeat items
• Allergies
• Adverse drug reactions.

Question 30

What is the main purpose of SCR?

Answer 30

Stated purpose of SCR is to improve the safety and quality of patient care by providing key clinical info to pharmacy professional when needed 24 hrs a day, 7 days a week.
Any addition info for example diagnoses, personal preferences or immunization the GP practice has added will also be visible.

Question 31

What are the common situations where SCR may be used in a community pharmacy (7 things)?

Answer 31

• Emergency supply
• Community pharmacist consultation service (CPCS) and NMS (New medicines service) service provision
• Private services
• Locally commissioned services such as emergency hormonal contraception
• Patient queries regarding current and/or discontinued medicines, or accessing info on allergies.
• Responding to symptoms over the counter where patients are taking additional medicines
• Establishing whether a prescription has been issued and finding lost prescription

Question 32

When can you access a patients SCR?

Answer 32

For routine SCR access require explicit consent or permission to view each time and to access an SCR, must have a legitimate relationship with the patient.

Question 33

When would it be inappropriate to access an SCR?

Answer 33

Would be inappropriate - could be judged to be breach of the GDPR to access your own SCR - ‘just to have a look’

Question 34

When would it be permissible to access a patients SCR without their permission (4 things)?

Answer 34

1) An emergency situation where patient is unconscious
2) Patients who are unable to speak English and SCR access is needed to provide appropriate care.
3) Patients who are confused and are unable to understand a question and access is required to address a safety issue.
4) Access for patients in care home settings

Question 35

How do you access an SCR (3 steps)?

Answer 35

1) Access to SCR via NHS spine.
2) To access SCR portal, need an NHS smartcard which been updated by the registration authority (RA) to allow SCR access.
3) Level of access only available for pharmacist and technicians and can only be granted once certain criteria and training have been met.

Question 36

What is a near miss?

Answer 36

potentially harmful errors are picked up before an item is given to a patient termed near misses.
Some picked up before the patient leaves the premises of a pharmacy, some are dealt when the patient is at home before the medication is taken.

Question 37

What is the national reporting and learning system (NRLS) and when was it set up?

Answer 37

• The national reporting and learning system (NRLS) is a central database of a patient safety incident reports.
• NRLS set up in 2003, culture of reporting incidents to improve safety in healthcare.
• All info submitted is analysed to identify hazards, risks and oppurtunites to continuously improve the safety of patient care.

Question 38

What is the aim of clinical governance?

Answer 38

Aim of clinical governance to learn from mistakes which we need to record all errors including near misses.

Question 39

With regards of dispensing errors the wrong dose can be sent out how can this occur (5 things)?

Answer 39

1) Not checking doses against the prescriptions, simply checking the dispensing label
2) Not checking the dose is appropriate in the BNF
3) Repeating the previous label on the patients record when the strength may have changed.
4) Selection error cus the drug packaging between different strengths is similar
5) transposition of labels - it is wrong if an ointment goes out labelled “Take ONE 5 mL spoonful ONCE daily at NIGHT” and a bottle of cough linctus goes out to a patient labelled as “Apply to the affected area ONCE daily at NIGHT”.

Question 40

With regards of dispensing errors missing items can be sent out how can this occur (3 things)?

Answer 40

1) sometimes there is a long “streamer” of labels hanging out of the computer printer and it is very easy, especially if the patient has more than one medicine, to lose or misplace one.
2) multiple prescriptions can get separated in the dispensing process
3) fridge items or controlled drugs which are specifically kept separately, but not reunited when the patient collects their medicine

Question 41

With regards of dispensing errors the wrong items can be sent out how can this occur (2 things)?

Answer 41

1) selection error because drugs have similar names
2) knowledge error because the person dispensing did not realise there was more than one formulation of the same drug

Question 42

With regards of dispensing errors the wrong quantity can be sent out how can this occur (3 things)?

Answer 42

1) multiple packs of the same medicine
2) different generics manufacturers having different pack sizes
3) split packs kept unmarked and returned to the shelves

Question 43

With regards of dispensing errors the date being expired can be sent out how can this occur (3 things)?

Answer 43

1) poor stock rotation
2) no date checking procedure for stock in the dispensary

Question 44

With regards of dispensing errors the wrong patient can be sent out how can this occur (2 things)?

Answer 44

1) leaving the patient’s name on the computer screen for the next prescription
2) patients with the same name and address or d.o.b. not checked

Question 45

What is the aim of the decimalisation of dispensing errors?

Answer 45

This was designed to prevent the automatic criminalization of inadvertent dispensing errors, provided that several criteria were met, thereby reducing the risk of prosecution and increasing the reporting of dispensing errors. The ultimate aim of this was of course to improve patient safety.

Question 46

The pharmacy (preparation and dispensing errors - hospital and other pharmacy services) order 2022…..

Answer 46

Came into effect on 1st December 2022 and extends existing defences to professionals working in hospitals and other pharmacy services e.g. in prisons and care homes.

Question 47

What Conditions must be met for defence to be applicable (6 things)?

Answer 47

1) Person who dispensed product was a registrant or acting under the supervision of a registrant.
2) Medicine must be supplied in the course of the provision of a relevant pharmacy service.
3) Registrant was acting in course of their profession
4) Med was a dispensed med
5)At the time it occurred defendant didn’t know that product had been adulterated/was not of the required nature or quantity.
6) Patient was promptly notified of the error, unless considered unnecessary

Question 48

Poor handwriting is a cause of a dispensing error why is that?

Answer 48

Poor handwriting:
1) Handwritten prescriptions in community are in the minority but still a major issue in hospitals.
2) Results fatal if wrong drug or dose given due to interpretation of the handwriting.
3) Good practise to contact prescriber to clarify what is required.

Question 49

A mental block is a cause of a dispensing error why is that?

Answer 49

1)Easy to confuse a pair of drugs on shelf or read something as you expect it to be but not as it really is.
2) Pairs of drugs commonly confused such as amiloride 5 mg and amlodipine 5 mg, atenolol 50 mg and atenolol 100 mg, and co-codamol 30/500 mg with co-codamol 8/500 mg

Question 50

Calculations are practical problems that can arise when dispensing?

Answer 50

Calculations:
Problem based on use of decimal points or a mixture of dosage units e.g. micrograms and mg.

Question 51

Dose forms are practical problems that can arise when dispensing (3 things)?

Answer 51

Dose forms:
1) In hospitals, injections can cause added problems since IM and IV injections may be different and interchangeable.
2) IV doses may be different to those given orally, especially for drugs which are metabolised by the liver.
3) Certain injections are only appropriate for particular routes of adminsteration, therefore need to label accordingly e.g. ‘for intramuscular use only’.

Question 52

Foreign bodies are practical problems that can arise when dispensing (3 things)?

Answer 52

1) Meds containing foreign bodies or dirt which cause harm to patient could cause supplier to be prosecuted under the medicines act.
2) Always store containers wither capped or inverted and check before use.
3)Be careful if you notice a broken container in a shrink wrap - ensure that none of the bits from this make their way into another container.

Question 53

Poor procedures are practical problems that can arise when dispensing (3 things)?

Answer 53

1) Too little space and too much clutter and untidiness are recipes for disaster.
2) Interruptions can create distractions and lead to errors.
3) If someone is in the middle of dispensing or checking a prescription wait until they have finished the task if you need to interrupt them.

Question 54

Unreasonable workloads are practical problems that can arise when dispensing (3 things)?

Answer 54

Unreasonable workloads:
1) Can be a cause of error for some but can concentrate the mind of others.
2) Essential to have sufficient time to perform dispensing checks
3) Staff who work less often in dispensary, frequently have higher error rates.

Question 55

How can Look-Alike, sound-alike (LASA) medications selection errors be reduced (4 things)?

Answer 55

1) Physical separation
2) Visual warning e.g. sign asking staff to triple check name/strength
3) Shelf edger’s e.g. signs on edge of meds shelves
4) Prompts on patient medication record (PMR) system to alert staff to whether the correct Item has been selected.

Question 56

What is a patient safety incident?

Answer 56

If dispensing error occurs an item reaches a patient the term for this is ‘patient safety incident’ regardless of whether there was any harm to the patient.

Question 57

What is the suggested procedure for dealing with a patient safety incident (5 things)?

Answer 57

1) Listen and find out the facts
2) Apologies to the patient- whether or not there is a mistake, they have had a cause for concern, so an apology, phrased correctly, can help with the situation
3) Stay calm when the patient is present
4) Take all complaints seriously
5) Work on the basis that the error is genuine, even if it proves not to be the case. Nobody should jump to conclusions without checking the facts very carefully.

Question 58

If an error had a occurred what should be the outcome?

Answer 58

If an error occurred pharmacist will need to assess the harm caused and report it.

Question 59

What is the National reporting and learning system (NRLS) degree of harm definition?

Answer 59

Degree of harm should be describe the actual level of harm a patient suffered as a direct result of patient safety incident.

Question 60

What is the definition of no harm?

Answer 60

A situation where no harm occurred either prevented patient safety or a no harm incident

Question 61

What is the definition of low harm?

Answer 61

Any unexpected or unintended incident that required extra observation or minor treatment and caused minimal harm to one or more persons.

Question 62

What is the definition of moderate harm?

Answer 62

Any unexpected or unintended incident that resulted in further treatment, possible surgical intervention, cancelling of treatment or transfer to another area and which caused short-term harm to one or more persons.

Question 63

What is the definition of severe harm?

Answer 63

Any unexpected or unintended incident that caused permanent or long-term harm to one or more persons.

Question 64

What is the definition of death?

Answer 64

Any unexpected or unintended event that caused the death of one or more persons.

Question 65

What replaces the national learning and reporting system (NLRS)?

Answer 65

learn from patient safety events (LFPSE) service, will replace the current National Learning & Reporting System (NLRS), and the Strategic Executive Information System (StEIS).

Question 66

Learn from patient safety events (LFPSE) will initially provide two main services:

Answer 66

1. it will allow organisations, staff and patients to record the details of patient safety incidents
2. it will allow providers to access data about recorded patient safety events

Question 67

How do you report an error as a pharmacist?

Answer 67

1) Pharmacist should record error, how it happened, who was involved and any actions taken.
2) Technician (if involved) should also sign the record.
3) Many pharmacies have a designated form to complete or on-line recording system and a copy of any records should be sent to the person responsible for clinical governance within the organisation such as pharmacy superintendent.
4) Record helpful should patient later decide to make a complaint.

Question 68

What should occur during an investigation?

Answer 68

1) Find out why incident occurred
2) Should be done by someone that was not involved in the incident and they should talk to those involved and look at the systems in place.
3)This should identify the contributing factors so that they can be dealt with.

Question 69

What type of plan can be made when an incident occur?

Answer 69

1) An action plan will then be developed with the purpose of preventing such an incident from recurring.
2) It may involve anything from changing procedures or providing staff training to increasing the staffing levels or changing the layout of the working environment.
3) Whatever the plan, it needs to detail when this should be completed, and by whom.

Question 70

When an incident occurs how does sharing occur?

Answer 70

1) individuals involved vital that they are told exactly what has happened.
2) Even if no further action is required it at least serves to sharpen their concentration and attention to procedural details.
3) Incident reports can be used to analyses trends of errors within your pharmacy and within your organisation.
4) Errors reported to the NRLS/NPSA help to monitor problems and provide national guidance to avoid similar repeated problems in the future. This is required as part of the NHS community pharmacy contract in England.
5) Reporting shows less incidents occur.

Question 71

What should be done if an error occurs within a pharmacy but does not reach the patient - an error known as a ‘near miss’?

Answer 71

The whole risk management process should still take place, but often in this case they will be analysed as a batch of incidents during an audit (survey) rather than after each individual incident.
It is recommended that pharmacies complete a near miss audit on a regular basis to identify any trends and to see if procedures can be changed or if training is required to reduce the incidence of near misses and potentially prevent an error in the future.

Question 72

What is a swiss cheese model and patient safety incidents?

Answer 72

The Swiss cheese model is a model of accident causation.
This was developed in the business and aviation industries to help reduce negative outcomes and produce better systems.
Also be applied to dispensing errors and patient safety incidents.