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Assistantship Lecture Series 2021
Promoting Patient Safety in the NHS
after the Berwick Report
Professor Vinod Patel
FRCP FHEA MD MRCGP DRCOG RCPath ME
Clinical Skills and Diabetes
Hon Consultant in Diabetes and Endocrinology,
Acute Medicine, Medical Obstetrics
Ethical Principles
Beauchamp and Childress Approach:
Basically four prima facie ethical and moral principles plus a reflective concern
about their scope of application.
• Autonomy: the patient has the right to refuse or choose their treatment.
(Voluntas aegroti suprema lex.)
• Beneficience: a practitioner should act in the best interest of the patient.
(Salus aegroti suprema lex.)
• Non-maleficence: do no harm
(Primum non nocere)
• Justice: distribution of scarce health resources, and the decision of who gets
what treatment (fairness and equality). (iustitia)
Professional Skills Suite
1. Reducing Health Inequalities
2. Health Promotion
3. Patient Safety
4. Consent
5. Surgical Safety Checklist
6. Infectious Disease Notification
7. Death Certificates
8. Cremation Forms
9. Clinical Notes
10. Data interpretation: blood tests
11. Referral Letters
12. Clinical Discharge Summary
13. Clinical Audit
14. Chest X-rays
15. Care of the Dying Patient
16. Clinical Leadership Skills
All self-assessment unless in the
Portfolio Workbook
Swiss Cheese Model
Reason, 2000
•Why?
–Heavy workload
–Fatigue
–Stress
–Shift work
–Reliance on memory
–Reliance on vigilance
–Noise
–Distractions
–Unnatural workflow
Everyone Makes Mistakes
Examples please… or near misses
Watson, 2010
Novorapid 4U
Novorapid 4
Units
Medical Error
Death of Baby given 12.5 mg of digoxin rather than
12.5 micrograms- write as micrograms or MCG not ug
First Do no harm!
The Hippocratic Oath includes the promise
"to abstain from doing harm"
(Greek: ἐπὶ δηλήσει δὲ καὶ ἀδικίῃ εἴρξειν)
Primum non nocere: Latin phrase that means "first, do no harm."
Clinical Notes
Clinical Notes: Safety Tips
Referral Letter
Discharge letter
Patient Safety
Solutions
Surgical Safety Checklist
Ideas
Aviation has used the
“safety checklist” for at
least the last 75 years. It is
used every flight and is
multi-professional
Even when unavoidable
disaster strike, as in this
image, clear protocols based
on checklists were used for
safe evacuation
In the seminal paper, the multi-
professional use of the checklist in
8 different countries resulted in
significant reduction in mortality
(by 46%) and complications (by
36%)
Special Article
A Surgical Safety Checklist to Reduce Morbidity
and Mortality in a Global Population
Alex B. Haynes, M.D., M.P.H., Thomas G. Weiser, M.D., M.P.H., William R. Berry,
M.D., M.P.H., Stuart R. Lipsitz, Sc.D., Abdel-Hadi S. Breizat, M.D., Ph.D., E. Patchen
Dellinger, M.D., Teodoro Herbosa, M.D., Sudhir Joseph, M.S., Pascience L. Kibatala,
M.D., Marie Carmela M. Lapitan, M.D., Alan F. Merry, M.B., Ch.B., F.A.N.Z.C.A.,
F.R.C.A., Krishna Moorthy, M.D., F.R.C.S., Richard K. Reznick, M.D., M.Ed., Bryce
Taylor, M.D., Atul A. Gawande, M.D., M.P.H., for the Safe Surgery Saves Lives Study
Group
N Engl J Med
Volume 360(5):491-499
January 29, 2009
Study Overview
• In eight hospitals throughout the world, implementation of a 19-item
surgical safety checklist was associated with improved outcomes
• Use of the checklist may improve the safety of surgical procedures in
hospitals in various economic circumstances
Elements of the Surgical Safety Checklist
Haynes AB et al. N Engl J Med 2009;360:491-499
Surgical Safety Checklist
Characteristics of Participating Hospitals
Haynes AB et al. N Engl J Med 2009;360:491-499
Surgical Safety Policies in Place at Participating Hospitals before the Study
Haynes AB et al. N Engl J Med 2009;360:491-499
Characteristics of the Patients and Procedures before and after Checklist Implementation,
According to Site
Haynes AB et al. N Engl J Med 2009;360:491-499
Outcomes before and after Checklist Implementation, According to Site
Haynes AB et al. N Engl J Med 2009;360:491-499
Selected Process Measures before and after Checklist Implementation, According to Site
Haynes AB et al. N Engl J Med 2009;360:491-499
Conclusion
• Implementation of the checklist was associated with concomitant
reductions in the rates of death and complications among patients at
least 16 years of age who were undergoing noncardiac surgery in a
diverse group of hospitals
46%
reduction in Death!
36% reduction in
complication rates!
N Engl J Med 2009; 360:491-499
DOI: 10.1056/NEJMsa0810119
Patient safety Tips
• Patient identity, Site of surgery and antibiotic therapy are
still major correctable areas of avoidable complications:
• Ensure the patient has a wristband or equivalent to identify
them and are accompanied by all relevant documentation of
planned procedure prior to transfer to the operating theatre.
• When confirmation by the patient is not possible, carers or
significant others can support the process.
• Check notes very carefully for allergies in notes- do not rely on
a sedated patient.
Time-Out
• A team member in theatre is allocated responsibility for going
through all the steps described in the ‘time out’ phase.
– Introductions: The team members introduce themselves.
– Confirm Identity of patient and operation planned: The surgeon
and or anaesthetist verbally confirm identity of patient and the site of
the surgical procedure planned.
– Critical Event Review: The surgeon, anaesthetist and scrub nurse are
asked specific questions to determine if there are any critical events.
– Surgical site infection bundle is then carried out. This includes
checking if antibiotic prophylaxis is given, hair removal etc
– VTE Prophylaxis: The leading team member must then check if VTE
prophylaxis has been given or planned.
– Essential imaging available: Determine if any essential imaging such
as CT or x-ray has been seen and available.
Debriefing session:
• Ideally this should be conducted between all
members involved in the care of the patients at the
end of the operating session.
• It aims to evaluate the entire process to determine if
there were any problems with the ability to perform
the procedures or in the implementation of the
surgical safety checklist.
• Any deficiencies identified can be addressed in
subsequent sessions to improve the process.
Professionalism
• Communicate effectively and listen to others. Identify a team
member who will lead the process and is responsible for the
checks.
• Address any concerns or failures as a team.
• Conduct regular audit to determine compliance with NPSA
requirements and thereby improve clinical practice.
• A finite additional amount of time is likely to be needed and
this must be taken into account
Surgical Safety Checklist
Berwick Report on Patient Safety 2013
Francis Report 2013 and examined failings in care at Mid
Staffordshire NHS Foundation Trust 2005-9
The report makes 290 recommendations:
• openness, transparency and candour throughout the
healthcare system (including a statutory duty of candour),
fundamental standards for healthcare providers
• improved support for compassionate caring and committed
care and stronger healthcare leadership.
Berwick Report: The Problems in the NHS 1
• Patient safety problems exist throughout the NHS: Mid
Staffordshire tragedy most notorious… not unique.
• NHS staff are not to blame: Neither at Mid Staffordshire, nor
more widely. Not justifiable to blame the staff of the NHS or
label them as uncaring, unskilled, or culpable. Vast majority of
staff wish to do a good job, to reduce suffering and to be
proud of their work
• Incorrect priorities do damage: in the place of the prime
directive, “the needs of the patient come first”, goals of (a)
hitting targets and (b) reducing costs have taken centre stage.
Berwick Report: The Problems in the NHS 2
• Warning signals abounded and were not heeded:
Information on the deterioration of the quality of care at
Mid-Staffordshire was abundant.
• Responsibility is diffused and therefore not clearly
owned: Responsibility for oversight and remedy for quality
and safety concerns was diffused in the NHS in England
• Fear is toxic to both safety and improvement: a vicious
cycle of over-riding goals, misallocation of resources,
distracted attention, consequent failures and hazards,
reproach for goals not met, more misallocation. “Better
not to know” became the order of the day.
Berwick Report: The Problems in the NHS 3
• The most important single change in the NHS: a system
devoted to continual learning and improvement of
patient care, top to bottom and end to end.
• “we do not believe that the NHS is unsound in its core”:
achievements are enormous and its performance in many
dimensions has improved steadily over the past two
decades. Waiting times are shorter than 15 years ago, CVD
care and outcomes are far better, cancer care is improving
fast and healthcare-acquired infection rates have
plummeted.
Berwick Report Summary
Berwick Report
Summary
Berwick Report
Summary
GMC: What to expect from your doctor:
a guide for patients
Doctors must put patients' safety first and
make sure the care they provide is safe
and effective
Jeremy Hunt (r) visits University College hospital, prior to
his speech on the NHS. Photograph:
Three thousand patients a year – eight a day – die
because of lapses in safety in the NHS, where errors are
so common that people have become conditioned to the
thought of patient harm, the health secretary has said.
In a strongly worded attack on how the NHS treats
patients, Jeremy Hunt said appalling failures in care such
as those at Stafford Hospital and in the Morecambe Bay
scandal ……. showed that unacceptable medical practice
was tolerated………………………………..2013
Patient Safety in the NHS
Promoting Patient Safety in our
Assessments:
NHS Patient Safety: Levels of Harm
Patient Safety:
Levels of Harm
1. 30 failure to check drug expiry date,
allergies or contraindications
2. 10 failure to maintain sterile field
3. 7 issues with sharps handling/disposal
4. 8 issues with hand washing
5. 8 issue with driving advice
6. 7 issues with procedural inaccuracy
7. 3 issues with not checking patient ID
8. 2 issues with PPE
Patient Safety: Levels of Harm
Translate into OSCE Feedback as…?
1 No Harm A: Patient safety incident that had the
potential to cause harm, but was prevented-
‘near miss’
No Harm B: Patient safety incident that did
happen but no harm occurred
2 Low: Patient safety incident, unintended or
unexpected, required extra observation, minor
treatment or caused minimal harm
3 Moderate: Patient safety incident, unintended
or unexpected, required moderate increase in
treatment, possible surgical intervention,
cancelling of treatment, transfer to another
area, and caused significant but not permanent
harm.
4 Severe: Patient safety incident, unintended or
unexpected that appears to have resulted in
permanent harm
5 Death: Patient safety incident, unintended or
unexpected, that directly resulted in death
Patient Safety: Levels of Harm
Translate into OSCE Feedback as…?
1 No Harm A: Patient safety incident that had the
potential to cause harm, but was prevented-
‘near miss’
No Harm B: Patient safety incident that did
happen but no harm occurred
• failure to check drug expiry date, allergies
or contraindications
• failure to maintain sterile field
• issues with sharps handling/disposal
• issues with hand washing
• issue with driving advice
• ID Check
2 Low: Patient safety incident, unintended or
unexpected, required extra observation, minor
treatment or caused minimal harm
• IV Fluids run in too quickly, potential for HF
exacerbation
3 Moderate: Patient safety incident, unintended or
unexpected, required moderate increase in
treatment, possible surgical intervention,
cancelling of treatment, transfer to another area,
and caused significant but not permanent harm.
• Patient not cardioverted because of failure
to anti-coagulate
• Failure to stitch wound appropriately-
resulting in prolonged admission and scar
4 Severe: Patient safety incident, unintended or
unexpected that appears to have resulted in
permanent harm
• Beta-blockers given to patient with asthma-
brain damage
5 Death: Patient safety incident, unintended or
unexpected, that directly resulted in death
• Death due to overdose of insulin
Insulin
Safety
Initiative at
GEH
Human factors theory
• Aviation industry reduced fatalities from
crashes using
– Standard operating procedures
– Second opinions and teamwork
• Gaba (1994) CRM training in anaesthesia
• Standardisation of communication strategies
(Leonard 2004)
Leadership Checklist
• Build a safety culture
• Listen and support staff
• Integrate risk management activities
• Promote reporting
• Involve patients/clients, families and the public
• Learn and share safety lessons
• Implement solutions to prevent harm
Source: Charles Vincent, 2006
48
How can this be achieved?
"Never doubt that a small group of thoughtful,
concerned citizens can change the world. Indeed it
is the only thing that ever has.“
Margaret Mead
Changes in Culture, Not Just Structure
Politicians and some managers tend to get
preoccupied by structural change but the
Berwick approach emphasises changes in
culture and creating change through people as
much as policy and finance.
Concluding Remarks

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Patient safety assistantship Professor Vinod Patel

  • 1. Assistantship Lecture Series 2021 Promoting Patient Safety in the NHS after the Berwick Report Professor Vinod Patel FRCP FHEA MD MRCGP DRCOG RCPath ME Clinical Skills and Diabetes Hon Consultant in Diabetes and Endocrinology, Acute Medicine, Medical Obstetrics
  • 2. Ethical Principles Beauchamp and Childress Approach: Basically four prima facie ethical and moral principles plus a reflective concern about their scope of application. • Autonomy: the patient has the right to refuse or choose their treatment. (Voluntas aegroti suprema lex.) • Beneficience: a practitioner should act in the best interest of the patient. (Salus aegroti suprema lex.) • Non-maleficence: do no harm (Primum non nocere) • Justice: distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality). (iustitia)
  • 3. Professional Skills Suite 1. Reducing Health Inequalities 2. Health Promotion 3. Patient Safety 4. Consent 5. Surgical Safety Checklist 6. Infectious Disease Notification 7. Death Certificates 8. Cremation Forms 9. Clinical Notes 10. Data interpretation: blood tests 11. Referral Letters 12. Clinical Discharge Summary 13. Clinical Audit 14. Chest X-rays 15. Care of the Dying Patient 16. Clinical Leadership Skills All self-assessment unless in the Portfolio Workbook
  • 5. •Why? –Heavy workload –Fatigue –Stress –Shift work –Reliance on memory –Reliance on vigilance –Noise –Distractions –Unnatural workflow Everyone Makes Mistakes Examples please… or near misses Watson, 2010 Novorapid 4U Novorapid 4 Units
  • 6. Medical Error Death of Baby given 12.5 mg of digoxin rather than 12.5 micrograms- write as micrograms or MCG not ug
  • 7. First Do no harm! The Hippocratic Oath includes the promise "to abstain from doing harm" (Greek: ἐπὶ δηλήσει δὲ καὶ ἀδικίῃ εἴρξειν) Primum non nocere: Latin phrase that means "first, do no harm."
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  • 15. Surgical Safety Checklist Ideas Aviation has used the “safety checklist” for at least the last 75 years. It is used every flight and is multi-professional Even when unavoidable disaster strike, as in this image, clear protocols based on checklists were used for safe evacuation In the seminal paper, the multi- professional use of the checklist in 8 different countries resulted in significant reduction in mortality (by 46%) and complications (by 36%)
  • 16. Special Article A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population Alex B. Haynes, M.D., M.P.H., Thomas G. Weiser, M.D., M.P.H., William R. Berry, M.D., M.P.H., Stuart R. Lipsitz, Sc.D., Abdel-Hadi S. Breizat, M.D., Ph.D., E. Patchen Dellinger, M.D., Teodoro Herbosa, M.D., Sudhir Joseph, M.S., Pascience L. Kibatala, M.D., Marie Carmela M. Lapitan, M.D., Alan F. Merry, M.B., Ch.B., F.A.N.Z.C.A., F.R.C.A., Krishna Moorthy, M.D., F.R.C.S., Richard K. Reznick, M.D., M.Ed., Bryce Taylor, M.D., Atul A. Gawande, M.D., M.P.H., for the Safe Surgery Saves Lives Study Group N Engl J Med Volume 360(5):491-499 January 29, 2009
  • 17. Study Overview • In eight hospitals throughout the world, implementation of a 19-item surgical safety checklist was associated with improved outcomes • Use of the checklist may improve the safety of surgical procedures in hospitals in various economic circumstances
  • 18. Elements of the Surgical Safety Checklist Haynes AB et al. N Engl J Med 2009;360:491-499
  • 20. Characteristics of Participating Hospitals Haynes AB et al. N Engl J Med 2009;360:491-499
  • 21. Surgical Safety Policies in Place at Participating Hospitals before the Study Haynes AB et al. N Engl J Med 2009;360:491-499
  • 22. Characteristics of the Patients and Procedures before and after Checklist Implementation, According to Site Haynes AB et al. N Engl J Med 2009;360:491-499
  • 23. Outcomes before and after Checklist Implementation, According to Site Haynes AB et al. N Engl J Med 2009;360:491-499
  • 24. Selected Process Measures before and after Checklist Implementation, According to Site Haynes AB et al. N Engl J Med 2009;360:491-499
  • 25. Conclusion • Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals
  • 26. 46% reduction in Death! 36% reduction in complication rates! N Engl J Med 2009; 360:491-499 DOI: 10.1056/NEJMsa0810119
  • 27. Patient safety Tips • Patient identity, Site of surgery and antibiotic therapy are still major correctable areas of avoidable complications: • Ensure the patient has a wristband or equivalent to identify them and are accompanied by all relevant documentation of planned procedure prior to transfer to the operating theatre. • When confirmation by the patient is not possible, carers or significant others can support the process. • Check notes very carefully for allergies in notes- do not rely on a sedated patient.
  • 28. Time-Out • A team member in theatre is allocated responsibility for going through all the steps described in the ‘time out’ phase. – Introductions: The team members introduce themselves. – Confirm Identity of patient and operation planned: The surgeon and or anaesthetist verbally confirm identity of patient and the site of the surgical procedure planned. – Critical Event Review: The surgeon, anaesthetist and scrub nurse are asked specific questions to determine if there are any critical events. – Surgical site infection bundle is then carried out. This includes checking if antibiotic prophylaxis is given, hair removal etc – VTE Prophylaxis: The leading team member must then check if VTE prophylaxis has been given or planned. – Essential imaging available: Determine if any essential imaging such as CT or x-ray has been seen and available.
  • 29. Debriefing session: • Ideally this should be conducted between all members involved in the care of the patients at the end of the operating session. • It aims to evaluate the entire process to determine if there were any problems with the ability to perform the procedures or in the implementation of the surgical safety checklist. • Any deficiencies identified can be addressed in subsequent sessions to improve the process.
  • 30. Professionalism • Communicate effectively and listen to others. Identify a team member who will lead the process and is responsible for the checks. • Address any concerns or failures as a team. • Conduct regular audit to determine compliance with NPSA requirements and thereby improve clinical practice. • A finite additional amount of time is likely to be needed and this must be taken into account
  • 32. Berwick Report on Patient Safety 2013 Francis Report 2013 and examined failings in care at Mid Staffordshire NHS Foundation Trust 2005-9 The report makes 290 recommendations: • openness, transparency and candour throughout the healthcare system (including a statutory duty of candour), fundamental standards for healthcare providers • improved support for compassionate caring and committed care and stronger healthcare leadership.
  • 33. Berwick Report: The Problems in the NHS 1 • Patient safety problems exist throughout the NHS: Mid Staffordshire tragedy most notorious… not unique. • NHS staff are not to blame: Neither at Mid Staffordshire, nor more widely. Not justifiable to blame the staff of the NHS or label them as uncaring, unskilled, or culpable. Vast majority of staff wish to do a good job, to reduce suffering and to be proud of their work • Incorrect priorities do damage: in the place of the prime directive, “the needs of the patient come first”, goals of (a) hitting targets and (b) reducing costs have taken centre stage.
  • 34. Berwick Report: The Problems in the NHS 2 • Warning signals abounded and were not heeded: Information on the deterioration of the quality of care at Mid-Staffordshire was abundant. • Responsibility is diffused and therefore not clearly owned: Responsibility for oversight and remedy for quality and safety concerns was diffused in the NHS in England • Fear is toxic to both safety and improvement: a vicious cycle of over-riding goals, misallocation of resources, distracted attention, consequent failures and hazards, reproach for goals not met, more misallocation. “Better not to know” became the order of the day.
  • 35. Berwick Report: The Problems in the NHS 3 • The most important single change in the NHS: a system devoted to continual learning and improvement of patient care, top to bottom and end to end. • “we do not believe that the NHS is unsound in its core”: achievements are enormous and its performance in many dimensions has improved steadily over the past two decades. Waiting times are shorter than 15 years ago, CVD care and outcomes are far better, cancer care is improving fast and healthcare-acquired infection rates have plummeted.
  • 39. GMC: What to expect from your doctor: a guide for patients Doctors must put patients' safety first and make sure the care they provide is safe and effective
  • 40. Jeremy Hunt (r) visits University College hospital, prior to his speech on the NHS. Photograph: Three thousand patients a year – eight a day – die because of lapses in safety in the NHS, where errors are so common that people have become conditioned to the thought of patient harm, the health secretary has said. In a strongly worded attack on how the NHS treats patients, Jeremy Hunt said appalling failures in care such as those at Stafford Hospital and in the Morecambe Bay scandal ……. showed that unacceptable medical practice was tolerated………………………………..2013 Patient Safety in the NHS
  • 41. Promoting Patient Safety in our Assessments:
  • 42. NHS Patient Safety: Levels of Harm
  • 43. Patient Safety: Levels of Harm 1. 30 failure to check drug expiry date, allergies or contraindications 2. 10 failure to maintain sterile field 3. 7 issues with sharps handling/disposal 4. 8 issues with hand washing 5. 8 issue with driving advice 6. 7 issues with procedural inaccuracy 7. 3 issues with not checking patient ID 8. 2 issues with PPE
  • 44. Patient Safety: Levels of Harm Translate into OSCE Feedback as…? 1 No Harm A: Patient safety incident that had the potential to cause harm, but was prevented- ‘near miss’ No Harm B: Patient safety incident that did happen but no harm occurred 2 Low: Patient safety incident, unintended or unexpected, required extra observation, minor treatment or caused minimal harm 3 Moderate: Patient safety incident, unintended or unexpected, required moderate increase in treatment, possible surgical intervention, cancelling of treatment, transfer to another area, and caused significant but not permanent harm. 4 Severe: Patient safety incident, unintended or unexpected that appears to have resulted in permanent harm 5 Death: Patient safety incident, unintended or unexpected, that directly resulted in death
  • 45. Patient Safety: Levels of Harm Translate into OSCE Feedback as…? 1 No Harm A: Patient safety incident that had the potential to cause harm, but was prevented- ‘near miss’ No Harm B: Patient safety incident that did happen but no harm occurred • failure to check drug expiry date, allergies or contraindications • failure to maintain sterile field • issues with sharps handling/disposal • issues with hand washing • issue with driving advice • ID Check 2 Low: Patient safety incident, unintended or unexpected, required extra observation, minor treatment or caused minimal harm • IV Fluids run in too quickly, potential for HF exacerbation 3 Moderate: Patient safety incident, unintended or unexpected, required moderate increase in treatment, possible surgical intervention, cancelling of treatment, transfer to another area, and caused significant but not permanent harm. • Patient not cardioverted because of failure to anti-coagulate • Failure to stitch wound appropriately- resulting in prolonged admission and scar 4 Severe: Patient safety incident, unintended or unexpected that appears to have resulted in permanent harm • Beta-blockers given to patient with asthma- brain damage 5 Death: Patient safety incident, unintended or unexpected, that directly resulted in death • Death due to overdose of insulin
  • 47. Human factors theory • Aviation industry reduced fatalities from crashes using – Standard operating procedures – Second opinions and teamwork • Gaba (1994) CRM training in anaesthesia • Standardisation of communication strategies (Leonard 2004)
  • 48. Leadership Checklist • Build a safety culture • Listen and support staff • Integrate risk management activities • Promote reporting • Involve patients/clients, families and the public • Learn and share safety lessons • Implement solutions to prevent harm Source: Charles Vincent, 2006 48
  • 49. How can this be achieved? "Never doubt that a small group of thoughtful, concerned citizens can change the world. Indeed it is the only thing that ever has.“ Margaret Mead
  • 50. Changes in Culture, Not Just Structure Politicians and some managers tend to get preoccupied by structural change but the Berwick approach emphasises changes in culture and creating change through people as much as policy and finance. Concluding Remarks