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Presented by: Keely Graham, Partner Lee & Lyons Lawyers Tel: (02) 8273 8000 Email: [email protected] Web: www.leeandlyons.com.au OPEN DISCLOSURE POLICY AND INCIDENT REPORTING IN RELATION TO A PATIENT IN CLINICAL DETERIORATION: A LAWYER’S PERSPECTIVE

Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

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Keely Graham, Partner, Lee & Lyons Lawyers delivered this presentation at the 2013 Managing the Deteriorating Patient conference. The management of patients in clinical deterioration has become a chief concern for Australian hospitals, with a patient’s potential for deterioration existing in every hospital ward and health service across the country. This annual event focusses on improving education for staff caring for these patients, and improving the policies and protocols in place to maintain patient safety. For more information, please visit the event website: www.healthcareconferences.com.au/deterioratingpatients

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Page 1: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Presented by: Keely Graham, Partner Lee & Lyons Lawyers Tel: (02) 8273 8000

Email: [email protected] Web: www.leeandlyons.com.au

OPEN DISCLOSURE POLICY AND INCIDENT REPORTING IN

RELATION TO A PATIENT IN CLINICAL DETERIORATION: A LAWYER’S PERSPECTIVE

Page 2: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

"We don't know whether Open Disclosure will result in more litigation or in less litigation... and we don't care".

OPEN DISCLOSURE

Page 3: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

OPEN DISCLOSURE

Open Disclosure Standard (Section1.1) Australian Open Disclosure Framework (Section 1.1)

1. An expression of regret 1. An apology or expression of regret, which should include the words ‘I am sorry’ or ‘we are sorry’. [The word “sorry” is mandatory].

2. A factual explanation of what happened

2. A factual explanation of what happened

3. No equivalent 3. An opportunity for the patient, their family and carer(s) to relate their experience

4. The potential consequences of the adverse event

4. A discussion of the potential consequences of the adverse event

5. The steps being taken to manage the adverse event and prevent recurrence.

5. An explanation of the steps being taken to manage the adverse event and prevent recurrence.

Page 4: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

1. APOLOGIES Theory: When an adverse outcome occurs some litigation or complaints will be avoided if someone with some empathy: 1. Acknowledges the issue saying something like “Things have not turned out as we had expected or hoped”; 2. Expresses empathy or regret saying something along the lines of “I am sorry this has happened”; 3. Asks if the person has anything to discuss; and 4. State only facts in response.

Page 5: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

The following will not be helpful:

1. “It was my fault”

2. “It was just one of those things”

3. “Think of your father as an old car. He has had his day and just could not have kept going”

4. “It was the resident/nurse’s fault”.

Page 6: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Tips from a lawyer’s perspective:

1. Record what was said.

2. Do not make an admission in your apology.

Page 7: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Legal Issues with an Apology

Page 8: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Dovuro v Wilkins (2003) CLR 317 Dovuro issued two statements: 1. “We apologise to canola growers and to industry personnel. This

situation should not have occurred”; and 2. “I’d like to stress at this stage that this does not excuse Dovuro in failing

in its duty of care to inform growers of the presence of these weed seeds”.

The High Court found that admissions by parties are of little value to the Court. Negligence is a finding at law which is for the Courts to decide based on the facts.

Page 9: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

However, some caution is needed as the apologies:

1. May have encouraged the Plaintiff to sue; and

2. In the absence of other evidence may help support a finding of facts consistent with negligence.

Page 10: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Apology Legislation

Legal protection for apologies has been introduced in all states.

Page 11: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

NSW:

S69(1) of the Civil Liability Act 2002 provides that an apology made by or on behalf of a person in connection with any matter alleged to have been caused by the person:

(a) does not constitute an express or implied admission of fault or liability by the person in connection with that matter, and

(b) is not relevant to the determination of fault or liability in connection with that matter.

s69(2) of the Act provides that evidence of an apology... is not admissible as evidence of the fault or liability of the person.

s68 provides an apology is “an expression of sympathy or regret, or of a general sense of compassion, in connection with any matter whether or not the apology admits or implies an admission of fault”.

Page 12: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Other Jurisdictions • Important differences relate to whether or not the protection

extends to statements which include words implying fault, or only to statements of regret which do not mention fault.

• Five jurisdictions (Qld, Vic, Tas, WA, the NT) explicitly exclude statements containing acknowledgements of fault or liability, and a sixth jurisdiction (SA) does so implicitly. In other words, the protections are lost if the apology includes a mea culpa statement.

• Another point of variation concerns the type of proceedings to which the shield applies. Tas and WA protect apologies from use in civil proceedings of any kind. NSW & ACT exclude certain types of civil liability claims. SA limits the protection to proceedings in tort. Qld, Vic and NT limit the protection to personal injury damages claims.

• Only the Victorian legislation explicitly covers medical board hearings.

Page 13: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Insurance Issues with Apologies

Standard Insurance Clause: “The Insured agrees not to admit liability, make any admission, offer any payment or assume any obligation in connection with any claim without the Insurer’s written consent”.

Issues:

1. Was there an admission or just an apology?

2. Even if there was an admission was the insurer prejudiced by this? (See s54 of the Insurance Contracts Act).

Page 14: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

2. A FACTUAL EXPLANATION OF WHAT HAPPENED?

• Clear, concise and purely factual.

• Do not pass blame.

OPEN DISCLOSURE

Page 15: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Tip: Delay full disclosure of facts until they are known and you have communicated with your insurer.

Page 16: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

3. PATIENT’S EXPERIENCE

• Important to lawyers so we can find out the patient’s likely version of events.

OPEN DISCLOSURE

Page 17: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

4. A DISCUSSION OF THE POTENTIAL CONSEQUENCES OF THE ADVERSE EVENT.

OPEN DISCLOSURE

Page 18: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

5. AN EXPLANATION OF THE STEPS BEING TAKEN TO MANAGE THE ADVERSE EVENT AND PREVENT RECURRENCE.

Try not to acknowledge that the event should or even could have been prevented. Instead talk abut how you could fix things going forward. For example, “we have carefully reviewed all the facts and believe we could prevent some future adverse outcomes by updating the protocols as follows. This may avoid some bad outcomes in the future”.

OPEN DISCLOSURE

Page 19: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

QUALIFIED PRIVILEGE Another potential difficulty with explaining what steps are being taken to prevent recurrence of a problem occurs where consideration of the issue and determination of steps to prevent any recurrences occurs through Quality Assurance Committees. Legislation generally provides qualified privilege protection to the work of health services bodies engaged in Quality Assurance work. Where Open Disclosure Step 5 of explaining steps being taken to prevent recurrence would entail revealing a Quality Assurance Committee’s findings: • There may be difficulties under some states’ laws to reveal the finding and

recommendation. • If you disclose the Quality Assurance Committee’s work you will lose

privilege and potentially be subject to significant penalties.

Page 20: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

State Legislation

Restrictions on release of information by members of QACs Restrictions on general use of information in legal settings

NSW Health Administration Act 1982

Committee members are “neither competent nor compellable” to produce documents, s 20H(1)(a) and (b)

Finding or recommendation re need for changes or improvements to a procedure or practice not admissible as evidence in any proceedings regarding whether procedure or practice was careless or inadequate, s 20I

Vic Health Services Act 1988

Committee members “shall not be required” to produce any document in their possession or control by reason of being committee members, s 139(4)

Information or documents prepared for purposes of a committee not admissible in any action or proceedings before any court, tribunal or board, s 139(5)

Qld Hospital and Health Boards Act 2011

As in NSW, s 84 As in NSW, s 87

SA Health Care Act 2008 As in Vic, s 66(3) No restrictions of this kind mentioned

WA Health Services (Quality Improvement) Act 1994

As in NSW, s 10(1) As in NSW. Plus: a document created by or at the request of a committee not subject to discovery and may not be used in evidence, s 10

Tas Health Act 1997 As in Vic, s 4(4) Evidence of any information or document relating to proceedings of committee not admissible, s 4(6)

NT Mental Health and Related Services Act 1998

As in NSW, s 149 As in NSW, s 148

ACT Health Act 1993 No restrictions of this kind mentioned Oral statement to a committee, document prepared solely for a committee and document prepared by a committee not admissible, s 47

Federal Health Insurance Act 1973

As in Vic, s 124Y(2) Person who obtains information in their role as committee member must not disclose that information “to another person or to a court”, s 124Y(1)

Restrictions by which qualified privilege laws protect QAC work

Page 21: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Don’t lie and cover it up.

Page 22: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Waiving fees or offering to cover the cost of future treatment involves insurance risks:

• “The insured agrees not to admit liability or settle any claim or loss, make an admission, offer any payment or assume any obligation in connection with any claim …. without our written consent”.

• If you want the insurer to cover it, contact them first and get their agreement.

• Clear documentation.

Page 23: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

INFORMED CONSENT REQUIRES OPEN DISCLOSURE

• Open disclosure is necessary in order to obtain informed consent.

• To be made aware of “material risks” inherent in a proposed treatment patients must have sufficient information given to them in such a way for them to understand and appreciate those risks and their consequences.

Rogers and Whittaker (1992) 175 CLR 479 McKellar v Blake (1998) (unreported, NSW District Court)

Page 24: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

THE IMPORTANCE OF GOOD RECORDS

Good records are particularly important in relation to a patient in clinical deterioration. 1. They enable proper treatment.

2. They are necessary for accurate open disclosure, incident

reporting and defence of any ultimate claim.

3. If facts are accurately and clearly recorded there is no downside in disclosing them to a patient and the open disclosure policy and legal view then largely align.

Page 25: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

GOOD RECORDS

Medbury v Camilleri unreported Supreme Court of New South Wales

• Patient ended up severely disabled after the onset of meningitis. • Dr Medbury performed a thorough examination to exclude a

serious diagnosis.

• The expert evidence indicated that based on the results of his examination and history taking, as recorded in his notes, there was no way that Dr Medbury could have diagnosed meningitis at the time of the consultation. Further, the Court found that Dr Medbury’s records indicated that he had given sufficient warning to the patient to return.

Page 26: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

BAD RECORDS

Coronial inquest into the death of Joshua Elliott, heard from 6 to 10 February 2012 in NSW. This is a sad case in which baby Joshua died at Sydney Children’s Hospital of massive pleural and pericardial collections due to CVC perforation following a number of conditions suffered by the baby. The mother and Joshua’s paediatric surgeon Dr Dilley agreed after detailed discussions that a PICC line should be inserted in Joshua and that only if that proved impossible, should a different option be tried. The mother and Dr Dilley agreed that if that happened a PCC would not be installed but instead a surgical central line would be installed due to the child’s age, size and history.

Page 27: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Dr Dilley received a telephone call from Dr Gupta at the Hospital two days later to discuss a proposed management plan for Joshua including gaining venous access. Dr Dilley informed Dr Gupta that he had not met Joshua let alone assessed him and noted that Dr Gupta’s management plan differed from the plan which Dr Dilley and Joshua’s paediatrician had devised. Dr Dilley said that he told Dr Gupta that a PICC was the preferable mode of gaining venous access and the boy’s mother was opposed to a PCC and that Dr Dilley would be happy to place a surgical central line in Joshua should a PICC line be impossible. Dr Gupta said that at no time did Dr Dilley specify that a PCC should not be inserted or that he should be invited to surgically install a line. A PCC line was attempted to be inserted and of course the worst case scenario occurred and baby Joshua died.

Page 28: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

If either doctor had kept a thorough note of the conversation: 1. We would be able to determine whose version of

events was correct and properly defend the doctor who was innocent; and

2. It would have been on the patient’s records and therefore the patient would probably not have died.

For care of patients and defence of health care providers, accurate, complete notes are so important.

Page 29: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

INCIDENT REPORTS Advantages: • Reporting incidents enables a review of errors, reduces

the chance of recurring errors. • Incident reports enable management to report the

incident or potential claim to insurers. If potential claims are not reported in the policy period - they may not be covered.

• Insurance policies usually have a requirement that potential claims be reported as soon as possible.

• The sooner lawyers become aware of a claim or potential claim, the sooner we can collate evidence.

Page 30: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Privacy framework

PRIVACY

To whom you disclose information in order to conduct open disclosure and in order to obtain informed consent?

Page 31: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Privacy framework

PRIVACY

PRIVACY FRAMEWORK

The National Open Disclosure Policy

Health Services Acts (States)

Privacy Act (Cth)

Common Law

Page 32: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

If the patient is sufficiently well to provide instructions you can disclose matters to the patient and anyone to whom they consent to the disclosure being made.

Page 33: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

If the patient is not sufficiently well to provide instructions or to understand disclosures the optimal situation is to have a patient indicate on or prior to admission to whom they wish disclosure to be made and any limits upon such disclosure.

Page 34: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

What happens if the patient cannot give instructions and has not nominated an available person for disclosure/consent?

• The Health Services Acts provide little guidance here as they require disclosure “to the next of kin or a near relative of the patient in accordance with the recognised customs of medical practice”.

Page 35: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

The Privacy Act requirements are clearer. They relevantly provide that personal information about an individual can be disclosed: • If the organisation reasonably believes that the disclosure is

necessary to lessen or prevent a serious or imminent threat to the individual’s life, health or safety or to public health and safety … or

• The organisation discloses the health information to a person

who is responsible for a patient and the disclosure is necessary to provide appropriate care or treatment or for compassionate reasons and the disclosure is not contrary to any express wish of the patient and the disclosure is reasonable and necessary in the circumstances.

Page 36: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Privacy Act amendments permit disclosure of health information if:

1. the organisation provides a health service to the patient; and

2. the recipient of the information is a responsible person for the patient; and

3. the patient is physically or legally incapable of giving consent to the disclosure; or physically cannot communicate consent to the disclosure; and

4. individual providing the health services for the organisation is satisfied that either:

- the disclosure is necessary to provide appropriate care or treatment of the patient; or

- the disclosure is made for compassionate reasons; and

5. the disclosure is not contrary to any wish:

- expressed by the patient before the patient became unable to give or communicate consent; and - of which the carer is aware, or could reasonably be expected to be aware; and

6. the disclosure is limited to the extent reasonable and necessary for a purpose mentioned in paragraph (4).

Page 37: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

The Open Disclosure Policy requirements have regard to the following:

1. A nominated contact person should be formally identified by the patient upon admission.

2. The only other category of people who are entitled to the patient’s information are persons with a pre-existing legal relationship, such as a parent, legal guardian or executor.

3. No nominated contact person? Use discretion (the requirements of the Privacy Act should be followed).

4. The duty is to the patient and not to their next of kin, friends, family or persons accompanying them for treatment.

Page 38: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Persons who breach the Privacy Act or other State-based health privacy legislation (such as the NSW and Victorian Health Records Acts) may find themselves the subject of claims for compensation.

Page 39: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Dunne v Victorian Aboriginal Health Service Co-operative [2012] VCAT 1770

GP asked a woman about her daughter (the complainant)’s recent stay in hospital. The woman replied that she and her daughter did not speak. The GP ended the conversation and walked away. A week later, the complainant attended the GP who advised of the conversation. The Complainant and her mother had been estranged for many years. She was allegedly “shocked” by the GPs audacity and suffered from post-traumatic stress disorder and depression as a result of the disclosure. A claim for compensation was brought against the GP’s employer, seeking ‘at least’ $50,000 in damages, training to its staff and a public apology. The complainant alleged the GP had breached the Health Records Act. The Tribunal found that disclosure that the daughter had been in hospital was a wrongful disclosure of confidential information. This case highlights the importance of obtaining the patient’s nominated contact person and of not assuming ‘standard’ relationships.

Page 40: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Amendments to the Privacy Act which come into force in March 2014 will make breaches of the Privacy Act and the Australian Privacy Principles subject to penalties of up to $340,000 for individuals and $1.7 million for organisations. Some insurance policies do not cover pecuniary penalties.

Page 41: Open Disclosure Policy and Incident Reporting in relation to a patient in clinical deterioration – A Lawyer’s Perspective

Questions?