1. Intravenous Nursing New Zealand
Dr Cordelia Thomas
Associate Commissioner
5 April 2019

2. Topics HDC vision Complaint resolution role Complaint statistics
Informed consent
Right 7(4)
Emergency
Case study – blood products

3. Consumer Centred System
HDC Vision
Consumer Centred System
Engagement
Seamless Service
Culture
Transparency

4. HDC Approach
HDC contributes to the achievement of a safe consumer-centred system in a unique way:
Complaints resolution
Promote and protect consumer rights
Safety and quality improvement
Strengthen the system so that it continually improves
Public protection
Watchdog role

5. HDC’s complaint resolution role

6. Why complain? People complain to: receive information/explanation
receive an apology
be taken seriously
improve care quality
ensure accountability

7. What did people complain about ?
- surgery
Unexpected treatment outcome (53%)
Inadequate/inappropriate treatment (45%)
Missed/incorrect/delayed diagnosis (25%)
Disrespectful manner/attitude (24%)
Failure to communicate effectively with consumer (23%)
Inadequate information provided regarding treatment (19%)

8. HDC Complaints Processes
Initial review of complaint
No further action
s38
Refer to provider
s34(1)(d)
Refer to Advocacy
s37
Refer to registration authority
S34(1)(a)
Other
(eg s59(4), 61)
Get more information
s14
Investigation
s40

9. Refer to Director of Proceedings
Investigation
Investigate
Breach of Code
Recommendations
Refer to Director of Proceedings
Adverse comment
No breach

10. Complaint Statistics

11. Complaints per year

12. Individual providers – 2017/2018

13. Group providers – 2017/2018

14. Who decides? Competent person- consent for self- Child once 16 years
EPOA or welfare guardian
Right 7(4)
Guardian of incompetent child (under 18 years)
Spouse or whanau cannot consent on behalf of person over 18 years

15. Informed consent A process with three components:
Effective communication (Right 5)
Provision of information (Right 6)
Informed choice/consent (Right 7)

16. A competent person…
Where person has diminished competence, retains the right to make informed choices and give informed consent, to the extent appropriate to his or her level of competence (Right 7(3))

17. A competent person… Determining competence: - Clinical assessment
- Legal test – whether person understands the nature, purpose, effects and likely consequences of the proposed treatment or of refusing treatment

18. Right 7(4)
Provider may make decision to provide services to an incompetent consumer who has no one entitled to consent on their behalf if:
in the consumer’s best interests; and
reasonable steps taken to ascertain consumer’s views; and
services are either consistent with informed choice the consumer would have made OR provider has consulted with available people interested in the consumer’s welfare

19. Emergency
Right 7(1) Informed consent required unless an enactment, common law or Code provides otherwise
Common law exception- in cases of emergency or necessity
Medical emergency is acute injury or illness that poses an immediate risk to life or long-term health
Clinician may treat unconscious or incompetent patient – must act in patient’s best interests
BUT must respect prior refusal (e.g. refusal of blood products 11HDC00531)

20. Emergency? 15HDC01847
20 year old woman (Ms A) consulted a gynaecologist about endometriosis
Gynaecologist performed diagnostic laparoscopy
Found Ms A had stage 4 endometriosis and a “markedly thickened” left fallopian tube

21. Emergency? 15HDC01847
During 6 days following surgery Ms A increasingly unwell with abdominal pain, tachycardia and high temperature
Gynaecologist examined Ms A and arranged for further surgery the following day
Ms A understood that left fallopian tube might need to be removed
Consent form Ms A signed did not specify that both of her fallopian tubes might need to be removed
Possibility of right fallopian tube needing to be removed not discussed with Ms A

22. Emergency? 15HDC01847 WHAT DO YOU THINK? Left fallopian tube removed
Right fallopian tube swollen and had free pus coming out end
Gynaecologist said she did not consider allowing Ms A to wake up from the anaesthetic to discuss findings with her, because she considered it was an “emergency sort of situation”
Concerned that right fallopian tube would be a nidus for ongoing infection and sepsis, so Ms A might require further surgery acutely in the following few days
Further surgery to remove the tube would require another anaesthetic
In addition, if Ms A septic, might need treatment in ICU
WHAT DO YOU THINK?

23. Emergency? 15HDC01847
HDC’s expert advisor noted that there were other less invasive options that could reasonably have been taken
Considered that in the circumstances of the particular case- a young woman who had not yet had children- most gynaecologists would not have removed both fallopian tubes

24. Emergency? 15HDC01847
Commissioner stated: “Except for cases of emergency or necessity, all medical treatment should be preceded by the patient’s choice to undergo it. This choice is meaningless unless it is made on the basis of relevant information and advice. A medical practitioner has a duty to warn a patient of a material risk inherent in the proposed treatment. The risk that both fallopian tubes might be removed is clearly material to a 20-year-old making a decision to undergo surgery.”

25. Emergency? 15HDC01847 Commissioner concluded –
Not apparent that the removal of the right fallopian tube was an emergency
Gynaecologist made decisions with the best possible intentions, but Ms A had not given consent for removal of right fallopian tube
Gynaecologist should have discussed findings with Ms A before taking the action she did

26. Emergency? 15HDC01847 Commissioner stated:
“Once Ms A had recovered from the anaesthetic, the options for further treatment and risks of each option should have been discussed with her. Although Ms A may have required further surgery or intensive care treatment in the future, it is plainly unacceptable that the doctor removed Ms A’s right fallopian tube without her consent. It was her right to decide and she was deprived of that right.”

27. Case Study:
Use of blood products
11HDC00531

28. Use of blood products
Ms A seen by surgeon, Dr G, at surgical outpatients clinic at public hospital
Dr G confirmed diagnosis of symptomatic gallstones
Ms A was placed on the waiting list for an elective laparoscopic cholecystectomy   

29. Use of blood products
A month later, Ms A attended nurse-led pre-admission clinic
Recorded that Ms A stated she did not consent to the use of blood and blood products 
Ms A admitted for surgery
Dr C and anaesthetist Dr D met with Ms A to discuss operation and complete informed consent
When surgery commenced a short time later, Dr C unaware of Ms A's views about blood and blood products
Subject not raised during surgical "Time Out", when any issues of concern brought to the attention of the theatre team  

30. Use of blood products
Surgery commenced - difficulties with access and visibility and decided to convert to open surgery
Some bleeding during surgery, but not enough to cause concern
Ms A's gallbladder removed and operation ended at 11.15am
Ms A transferred to Recovery Unit at 11.25am 
Concerns about Ms A's condition from midday.
Initial measures taken unsuccessful, and thought Ms A probably bleeding internally
Dr C instructed that Ms A was to be given blood, at which point he was advised of her treatment refusal 

31. Use of blood products
Dr C decided further surgery needed to identify and address the cause of the bleeding.
Ms A, still partially sedated, restated that she would not accept blood.
Permission sought from Ms A's mother to override Ms A's directive. Mrs B said she could not do that  
Ms A returned to theatre -surgery commenced at 2.55pm
No obvious bleeding point identified
Dr C decided to pack liver bed and close abdomen, so Ms A could be transferred to a better equipped and staffed hospital
Arrangements were made to transfer Ms A by helicopter
By the time helicopter crew arrived was decided that transfer was inappropriate
Ms A's death confirmed at 6.59pm

32. Use of blood products Findings
Material information must be communicated to senior members of operating team before surgery.
Only senior person in the room who did not know that Ms A had declined blood products was surgeon.
Ms A's refusal of blood and blood products was information that anaesthetist and surgeon needed to know prior to surgery and in time for other plans and preparations to be made, should these have been necessary, following an appropriate discussion with Ms A
Arrangements and systems in place at hospital did not support the timely communication of this information. Ms A's refusal of blood and blood products should have been raised during the surgical "Time Out".
DHB breached Rights 4(1)   and 4(5)  of the Code

33. Use of blood products Findings contd
Dr C did not know about Ms A's refusal of blood and blood products until her condition began to deteriorate following first operation
Ms A's refusal of blood and blood products was documented in her clinical records, including in documents recently prepared for this surgery
Dr C did not read Ms A's notes sufficiently to obtain this information before commencing her surgery. This was a failure to provide services with reasonable care and skill and, accordingly, a breach of Right 4(1) 
Dr D decided that, given the surgery Ms A was to undergo and her particular risk profile, her refusal of blood and blood products was not sufficiently significant for him to need to communicate that issue to other members of team
Dr D did not discuss Ms A’s treatment refusal with Dr C preoperatively, and did not raise issue when Dr C converted to an open procedure
More likely than not that Dr D did not raise the issue during the surgical "Time Out"
Dr D failed to take reasonable steps to co-operate with his colleagues to ensure quality and continuity of services - breach of Right 4(5) of the Code  

34. Questions?
Any questions?