Appendix S1
Actions Following Adverse Clinical Incidents in Transplantation (6FNM9RG)
This is a web-based questionnaire study looking to see what actions are taken following an adverse clinical incident in a hospital.
The research is being conducted by the University Hospitals Coventry &
Warwickshire in collaboration with the University of Warwick.
What is involved?
There are 5 hypothetical clinical scenarios followed by 2 questions.
Please choose 1 appropriate response for the questions after reading through the scenarios. There is an optional third question for each scenario and space left for any additional comments you wish to add at the end. It is anticipated that each scenario would take 2–3 minutes to complete and therefore the total time to complete the questionnaire would between 10 and 15 minutes.
What are the benefits of participating in the study?
Though you may not directly benefit from this research, your responses based on your knowledge and expertise in a variety of clinical/patient care situations will help to inform future changes to the system.
A questionnaire looking to see if adequate actions are taken following adverse clinical incidents in transplantation.
Is the participation compulsory? Are there any risks involved in taking part?
Participation is completely voluntary. There are no anticipated risks in taking part in this study. It is a one-off self-completion questionnaire-based study, hence withdrawal from the study does not arise.
What will happen to the data?
Data will be completely anonymous, and all information will be securely stored following current recommended research governance guidelines. Participants will be allocated a unique identification code.
The results of the data will be used in presentations at conferences and in publications.
Thank you for reading this information sheet and for considering helping us with our research. We hope this information sheet provides you with enough information to help you decide if you want to take part in this study. However, should you have any further queries prior to taking part or if you need to get in touch at any time during or after the study, you are welcome to contact us.
Contact Details:
Dr Nithya S Krishnan
Consultant Transplant Nephrologist Renal Unit
UHCW NHS Trust
1. I confirm that I have read and understood the information given.
Yes No
2. I understand that my participation is voluntary and as it is a one–off questionnaire study, withdrawal is not possible.
Yes No
3. I am willing to participate in the study.
Yes No
4. Which of the below categories best reflects you?
Transplant Surgeon
Transplant Physician/ Nephrologist Paediatrician
Clinical Scientist Medical Student Renal Patient
Allied Health Professional Other
5. What is your ethnicity?
Caucasian Far East Asian Indo Asian African Latino
Middle Eastern Mixed
Other
6. What is your country of residence? – Answer required
7. What is your gender?
Female Male
8. What is your age?
20 to 29 30 to 39 40 to 49
50 to 59 60 or older
Scenario 1. Dr Mary Jones has been working in the Renal Transplantation department for 12 years. Throughout her tenure, she has risen rapidly through the ranks from house officer (intern) to registrar (resident) and finally consultant. Two years ago, she became the youngest director of a renal transplant center in the country.
Recently, her unit has started doing high-risk transplantation. This involves removing high level of donor-specific antibodies from the patient prior to transplantation. As Director, Dr Mary Jones makes a point of overseeing this program, personally seeing each patient and advising them on the risks, and reviewing each case regularly during the perioperative period and during later follow-up.
Recently, a 71-year-old patient with leukaemia, who had received a bone marrow transplant 8 years ago, was referred for high-risk transplantation. This patient had already been turned down by 2 other centers that do high-risk transplantation as the patient was assessed as being unsuitable for undergoing a major operation. Though several members of the transplant team stated at a multidisciplinary meeting that they were unhappy to proceed, Dr. Mary Jones persuaded her colleagues to go ahead with the transplant, stating that the risks were acceptable.
The patient underwent surgery, and everything went well for 3 days.
Unfortunately, the patient developed multiple problems and died.
1. How would you rate the clinical performance of Dr. Jones?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Dr. Jones
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 2. Professor Paul Hoffmann is a highly skilled surgeon, and because of this he became professor of renal transplantation within 12 years of graduating from medical school. In his post, he takes a personal responsibility for living kidney donor operations.
The unit recently changed its procedure for kidney removal from living donors from traditional open surgery to laparoscopic (keyhole) surgery carried out with the aid of a camera. To facilitate this change, professor Hoffmann arranged for an expert from a different hospital to visit his unit on a regular basis and train him in this new procedure.
When performing his first laparoscopic surgery alone, without the expert being present, he encountered difficulties with the instrument and had difficulty in stapling the blood vessels. The donor patient started to bleed torrentially. He immediately changed the keyhole procedure to a traditional open surgery method to stop the bleeding. The patient lost so much blood before the vessels could be clamped under direct vision that the donor experienced a period of about 30 seconds with no circulation. By the time professor Hoffmann had controlled the bleeding, the kidney had clotted off. Hence it was deemed unsuitable for transplantation or reimplantation and was therefore discarded.
The donor made a full recovery.
1. How would you rate the clinical performance of Prof. Hoffmann?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Prof. Hoffmann
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 3. Dr Marie Herbert is an experienced consultant transplant surgeon at 1 of the leading hospitals in the country. She had completed 15 years of training and has been in her consultant post for 5 years. She oversees the complete care of the patients admitted to her transplant ward.
Dr Herbert performed a kidney pancreas transplant on 42-year-old patient. The patient was recovering well but developed a nasty urine infection 5 days after transplantation. The infection did not respond to the usual antibiotic prescribed for this type of infection in the first 24 hours of treatment. Therefore, Dr Herbert asked for the results of laboratory testing to identify which antibiotics would be effective.
The results were made available to Dr Marie Herbert the next morning while she was on the transplant ward. Dr Herbert then prescribed an intravenous antibiotic (Co-amoxiclav, a penicillin-based antibiotic) to be given immediately.
Five minutes after receiving the drug, the patient started to develop a rash.
The rash rapidly got worse and the patient developed severe swelling of her lips and face, hoarseness of voice, and became short of breath. The patient was transferred to intensive care. The patient received very good care and was discharged home a week later.
Another doctor looked through the notes after the incident and observed that it was clearly recorded in the notes and on the prescription chart that the patient was allergic to penicillin and co-amoxiclav.
1. How would you rate the clinical performance of Dr. Herbert?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Dr. Herbert
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 4. Dr Stephen Davis has been practicing as a consultant transplant nephrologist for the last 2 years in a teaching hospital. When doing a 24-hour
“on-call,” he is responsible for the care of all patients on the transplant ward. In
the last 2 years, there have been 3 previous clinical incidents when he was on- call where there had been suboptimal patient care.
During his last on-call a 53-year-old patient had a deceased donor kidney transplant on a Thursday afternoon. This patient had been waiting for 12 years for his transplant. The operation was successful, and the kidney was working well. At 0100 on Saturday morning while Dr Stephen Davis was on-call, he received a phone call from the ward sister to inform him that the patient’s urine output was reducing and the blood pressure was dropping. Dr Davis was at home; the junior doctor on call in the hospital had no direct experience of kidney transplantation.
Dr Davis advised the nurse to give the patient intravenous fluids. At 0400, the nurse called him again reporting that the patient was not passing any urine at all. The nurse also informed Dr Davis that the patient’s blood pressure had dropped further and that the patient was now complaining of abdominal pain.
Dr Stephen Davis advised the nurse to give the patient painkillers, more intravenous fluids, and to continue to monitor.
At 0700, the nurse called to say that the patient’s condition was worsening and that the nurse was really worried about the patient. At this point, Dr Stephen Davis had only an hour to go before finishing his on-call and handing over to his colleague. Therefore, he told the nurse to manage the patient with more intravenous fluids and painkillers for the time being until he hands over the patient to his colleague.
Dr Stephen Davis’ colleague came to assess the patient at 0800. However, by that time the patient’s condition had deteriorated and an emergency call was put out for the cardiac arrest team. A diagnosis of massive bleeding from one of the blood vessels close to the transplant site was made.
The patient was resuscitated and rushed to theater where the bleeding was controlled and was then transferred to the intensive care unit. The kidney had delayed function (“gone to sleep”) and hence the patient had to be maintained on dialysis. However, the kidney function is now slowly improving, and the patient is on the road to recovery.
1. How would you rate the clinical performance of Dr Davis?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Dr Davis
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 5. Dr David Fisher is a clinical scientist and is the Director of the Tissue Typing laboratory in a teaching hospital. He had been recently appointed to the post after being awarded his PhD degree. He is responsible for all the test results produced by the laboratory. All test results for patients receiving a transplant have to be checked and authorized by him before they are released to the transplant team.
Three weeks ago, Dr Fisher had a call requesting an urgent blood test for a patient who was due to receive a transplant from a deceased donor. Dr Fisher requested the lab technician on duty to do the blood test to confirm matching and to rule out any antibodies in the patient’s blood that might cause rejection of the transplant. The lab technician on duty was very new and was therefore not familiar with the procedures.
Dr David Fisher checked and authorized the test result confirming that it was safe to proceed with transplant. The patient underwent transplant surgery, but the kidney appeared to not be functioning. The patient had a biopsy, which showed that there was severe rejection because of antibodies present in the patient against the donor kidney. The patient was given very powerful medications for treatment of rejection, and the kidney function started improving.
On investigating the cause of the transplant rejection, it became evident that the blood test carried out by the laboratory was based on an old sample sent a year ago and not the one provided on that day.
1. How would you rate the clinical performance of Dr Fisher?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Dr Fisher
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Are there any other comments you would like to add?
Free text
Thank you for taking the time to complete this survey.
Second version of the survey
Actions Following Adverse Clinical Incidents in Transplantation (2VRHY6R)
This is a web-based questionnaire study looking to see what actions are taken following an adverse clinical incident in a hospital.
The research is being conducted by the University Hospitals Coventry &
Warwickshire in collaboration with the University of Warwick.
What is involved?
There are 5 hypothetical clinical scenarios followed by 2 questions.
Please choose 1 appropriate response for the questions after reading through the scenarios. There is an optional third question for each scenario and space left for any additional comments you wish to add at the end. It is anticipated that each scenario will take 2–3 minutes to complete, and therefore the total time to complete the questionnaire would between 10 and 15 minutes.
What are the benefits of participating in the study?
Though you may not directly benefit from this research, your responses based on your knowledge and expertise in a variety of clinical/patient care situations will help to inform future changes to the system.
A questionnaire looking to see if adequate actions are taken following adverse clinical incidents in transplantation.
Is the participation compulsory? Are there any risks involved in taking part?
Participation is completely voluntary. There are no anticipated risks in taking part in this study. It is a one-off self-completion questionnaire-based study, hence withdrawal from the study does not arise.
What will happen to the data?
Data will be completely anonymous, and all information will be securely stored following current recommended research governance guidelines. Participants will be allocated a unique identification code.
The results of the data will be used in presentations at conferences and in publications.
Thank you for reading this information sheet and for considering helping us with our research. We hope this information sheet provides you with enough information to help you decide if you want to take part in this study. However, should you have any further queries prior to taking part or if you need to get in touch at any time during or after the study, you are welcome to contact us.
Contact Details:
Dr Nithya S Krishnan
Consultant Transplant Nephrologist Renal Unit
UHCW NHS Trust
1. I confirm that I have read and understood the information given.
Yes No
2. I understand that my participation is voluntary and as it is a one–off questionnaire study withdrawal is not possible.
Yes No
3. I am willing to participate in the study.
Yes No
4. Which of the below categories best reflects you?
Transplant Surgeon
Transplant Physician/ Nephrologist Paediatrician
Clinical Scientist Medical Student Renal Patient
Allied Health Professional Other
5. What is your ethnicity?
Caucasian Far East Asian Indo Asian African Latino
Middle Eastern Mixed
Other
6. What is your country of residence? – Answer required
7. What is your gender?
Female Male
8. What is your age?
20 to 29 30 to 39 40 to 49
50 to 59 60 or older
Scenario 1. Dr John Jones has been working in the renal transplantation department for 12 years. Throughout his tenure, he has risen rapidly through the ranks from house officer (intern) to registrar (resident) and finally consultant. Two years ago, he became the youngest director of a renal transplant center in the country.
Recently, his unit has started doing high-risk transplantation. This involves removing a high level of donor-specific antibodies from the patient prior to transplantation. As director, Dr John Jones makes a point of overseeing this program, personally seeing each patient and advising them on the risks, and reviewing each case regularly during the perioperative period and during later follow up.
Recently, a 71-year-old patient with leukaemia, who had received a bone marrow transplant 8 years ago, was referred for high-risk transplantation. This patient had already been turned down by 2 other centres that do high-risk transplantation as the patient was assessed as being unsuitable for undergoing a major operation. Though several members of the transplant team stated at a multidisciplinary meeting that they were unhappy to proceed, Dr John Jones persuaded his colleagues to go ahead with the transplant, stating the risks were acceptable.
The patient underwent surgery, and everything went well for 3 days.
Unfortunately, the patient developed multiple problems and died.
1. How would you rate the clinical performance of Dr Jones?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Dr Jones
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 2. Professor Sophie Hoffmann is a highly skilled surgeon, and because of this she became professor of renal transplantation within 12 years of graduating from medical school. In her post, she takes a personal responsibility for living kidney donor operations.
The unit recently changed its procedure for kidney removal from living donors from traditional open surgery to laparoscopic (keyhole) surgery carried out with the aid of a camera. To facilitate this change, professor Sophie Hoffmann arranged for an expert from a different hospital to visit her unit on a regular basis and train her in this new procedure.
When performing her first laparoscopic surgery alone, without the expert being present, she encountered difficulties with the instrument and had difficulty in stapling the blood vessels. The donor patient started to bleed torrentially. She immediately changed the keyhole procedure to a traditional open surgery method to stop the bleeding. The patient lost so much blood before the vessels could be clamped under direct vision that the donor experienced a period of about 30 seconds with no circulation. By the time professor Hoffmann had controlled the bleeding, the kidney had clotted off. Hence, it was deemed unsuitable for transplantation or reimplantation and was therefore discarded.
The donor made a full recovery.
1. How would you rate the clinical performance of Prof. Hoffmann?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Prof. Hoffmann
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 3. Dr Joseph Herbert is an experienced consultant transplant surgeon at 1 of the leading hospitals in the country. He had completed 15 years of training and has been in his consultant post for 5 years. He oversees the complete care of the patients admitted to his transplant ward.
Dr Herbert performed a kidney pancreas transplant on 42-year-old patient. The patient was recovering well but developed a nasty urine infection 5 days after transplantation. The infection did not respond to the usual antibiotic prescribed for this type of infection in the first 24 hours of treatment. Therefore, Dr Herbert asked for the results of laboratory testing to identify which antibiotics would be effective.
The results were made available to Dr Herbert the next morning while he was on the transplant ward. Dr Herbert then prescribed an intravenous antibiotic (co-amoxiclav, a penicillin-based antibiotic) to be given immediately. Five minutes after receiving the drug, the patient started to develop a rash.
The rash rapidly got worse and the patient developed severe swelling of her lips and face, hoarseness of voice, and became short of breath. The patient was transferred to intensive care. The patient received very good care and was discharged home a week later.
Another doctor looked through the notes after the incident and observed that it was clearly recorded in the notes and on the prescription chart that the patient was allergic to penicillin and co-amoxiclav.
1. How would you rate the clinical performance of Dr Herbert?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick 1)
No action
Informal word with Dr Herbert
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 4. Dr Susan Davis has been practising as a Consultant Transplant Nephrologist for the last 2 years in a teaching hospital. When doing a 24-hour
“on-call,” she is responsible for the care of all patients on the transplant ward.
In the last 2 years there have been 3 previous clinical incidents when she was on call where there had been suboptimal patient care.
During her last on call a 53-year-old patient had a deceased donor kidney transplant on a Thursday afternoon. This patient had been waiting for 12 years
for his transplant. The operation was successful,l and the kidney was working well. At 0100 on Saturday morning while Dr Davis was on-call, she received a phone call from the ward sister to inform her that the patient’s urine output was reducing and the blood pressure was dropping. Dr Davis was at home; the junior doctor on call in the hospital had no direct experience of kidney transplantation.
Dr Davis advised the nurse to give the patient intravenous fluids. At 0400 the nurse called her again reporting that the patient was not passing any urine at all. The nurse also informed Dr Davis that the patient’s blood pressure had dropped further and that the patient was now complaining of abdominal pain.
Dr Davis advised the nurse to give the patient painkillers, more intravenous fluids and to continue to monitor.
At 0700 the nurse called to say that the patient’s condition was worsening and that the nurse was really worried about the patient. At this point, Dr Davis had only an hour to go before finishing her on call and handing over to her colleague. Therefore, she told the nurse to manage the patient with more intravenous fluids and painkillers for the time being till she hands over the patient to her colleague.
Dr Davis’ colleague came to assess the patient at 0800. However, by that time the patient’s condition had deteriorated and an emergency call was put out for the cardiac arrest team. A diagnosis of massive bleeding from one of the blood vessels close to the transplant site was made.
The patient was resuscitated and rushed to theatre where the bleeding was controlled and was then transferred to the intensive care unit. The kidney had delayed function (“gone to sleep”) and hence the patient had to be maintained on dialysis. However, the kidney function is slowly improving now, and the patient is on the road to recovery.
1. How would you rate the clinical performance of Dr Davis?
Rating scale from 1 -10
2. If you were a member of the team what action would you take? (Please pick one)
No action
Informal word with Dr Davis
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Scenario 5. Dr Laura Fisher is a clinical scientist and is the director of the Tissue Typing laboratory in a teaching hospital. She had been recently appointed to the post after being awarded her PhD degree. She is responsible for all the test results produced by the laboratory. All test results for patients
receiving a transplant have to be checked and authorised by her before they are released to the transplant team.
Three weeks ago, Dr Fisher had a call requesting an urgent blood test for a patient who was due to receive a transplant from a deceased donor. Dr Fisher requested the lab technician on duty to do the blood test to confirm matching and to rule out any antibodies in the patient’s blood which might cause rejection of the transplant. The lab technician on duty was very new and therefore was not familiar with the procedures.
Dr Fisher checked and authorised the test result confirming that it was safe to proceed with transplant. The patient underwent transplant surgery, but the kidney appeared not to be functioning. The patient had a biopsy which showed that there was severe rejection due to antibodies present in the patient against the donor kidney. The patient was given very powerful medications for treatment of rejection and the kidney function started improving.
On investigating the cause of the transplant rejection, it became evident that the blood test carried out by the laboratory was based on an old sample sent a year ago and not the one provided on that day.
1. How would you rate the clinical performance of Dr Fisher?
Rating scale from 1–10
2. If you were a member of the team, what action would you take? (Please pick one)
No action
Informal word with Dr Fisher
Report in writing to the Departmental/ Medical Director Report to the National Regulatory body
3. Could you please explain the reasoning behind your decision (optional)?
Free text
Are there any other comments you would like to add?
Free text
Thank you for taking the time to complete this survey.