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MIPS supports healthcare practitioners in openly disclosing adverse or unexpected healthcare outcomes. This process is fundamental to both patients and clinicians. It can assist practitioners in mitigating the risk of being the subject of legal and/or regulatory action in the aftermath of an adverse clinical event. 

Watch this video to learn more about open disclosure from a medico-legal perspective.

The open disclosure process.

At its core, open disclosure seeks to reduce adverse events and create a healthcare culture that is free from blame and focuses on developing organisational responsibility. By achieving this, healthcare organisation can:

• improve patient safety and quality of healthcare outcomes.
• increase trust and respect in the profession by the community.
• strengthen patient-clinician therapeutic relationships.
• support patients and families in recovering from adverse and harmful events.
• support practitioners who are involved in unintended adverse health outcomes. 

Healthcare organisations are encouraged to implement the Australian Open Disclosure Framework¹ alongside their own policies, risk mitigation guidelines, resources and relevant legislation requirements of insurance and/ or employment documents.

Benefits of open disclosure

Having open disclosure conversations is favorable for all parties affected by an adverse clinical event. 

For patients and their families:

• conveys respect to the patient and their families.
• provides reassurance that a proactive approach is being undertaken to prevent a future recurrence of a similar incident.
• increases trust in the doctor-patient therapeutic relationship.
• provides a conduit to assuage the consequences of a medical error. 

Similarly, healthcare practitioners benefit by:

• fostering a blame-free culture of learning from adverse events.
• reducing the likelihood of being the subject of regulatory and/or legal action.
• receiving adequate support to manage stress and guilt.
• fulfilling their moral and ethical duties to patients and the community.

For healthcare organisations:

• it provides a means to demonstrate transparency.
• it may reduce the likelihood of complaints and/or litigation. 

Watch the following video to learn more about the importance of honesty and transparency in open disclosure conversations.

The role of informed consent in mitigating negative outcomes from an adverse event

With the exception of emergency interventions, healthcare practitioners are bound to discuss the risks associated a clinical intervention, prior to the procedure taking place.  During this informed consent conversation, the likelihood of complications and the degree of certainty regarding a therapeutic outcome will be outlined. Well-articulated informed consent conversations should ensure the consent given by the patient is valid at law⁴. Thus, the following three criteria must be met:

• The patient must have capacity to make clinical treatment decisions.
• The consent must be free and voluntary.
• The consent must cover the act to be performed.

Legislation all Australian states recognise patients' right to autonomy and the duty on healthcare professionals to warn a patient about the material risks inherent in any clinical intervention. Accordingly:

"A risk is considered material if, in the circumstances of the particular case, a reasonable person in the position of the patient, if warned of the risk, would be likely to attach significance to it, or if a healthcare practitioner is, or should reasonably be, aware that the particular patient, if warned of the risk, would be likely to attach significance to it"

Therefore, when assessing how to inform a patient of a particular risk, there are three questions that will require consideration⁵:

• Would a reasonable person, in the position of the patient, be likely to attach significance to a specific risk?
• Are you aware, or should you be reasonably aware, that this particular patient would be likely to attach significance to that risk?
• Do you think the patient might change their mind if informed of the risk?

Informed consent discussions should include written acknowledgement from the patient that they have weighted the pros and cons of the intervention and have made an informed decision to proceed forward. Ensuring the informed consent process is carried out adequately, taking into consideration the views and needs of the patient, can go a significant way to mitigating the psychological and emotional affects that any future adverse event may have on a patient and their family. 

Open disclosure legislation

Legislation in Australia allows healthcare practitioners to acknowledge with adverse outcomes, without an admission of liability. This is achieved by:

• expressing regret or apologising for an adverse outcome;
• expressing sorrow or sympathy;
• reducing fees; or
• waiving fees entirely

In Australian jurisdictions, there is some protection for all professionals, not just doctors. For example, in NSW it is provided in Section 69 of the Civil Liability Act 2002 (NSW):

An apology made by or on behalf of a person in connection with any matter alleged to have been caused by the person:

• does not constitute an express or implied admission of fault or liability by the person in connection with that matter, and
• is not relevant to the determination of fault or liability in connection with a matter.

Evidence of an apology made by or on behalf of a person in connection with any matter alleged to have been caused by the person is not admissible in any civil proceedings as evidence of the fault or liability of the person in connection with that matter.

In Queensland, there is some similarity in The Civil Liability Act 2003 (QLD) where an apology which is an “expression of sympathy or regret, or of a general sense of benevolence or compassion, whether or not it admits or implies an admission of fault”, may be made without risk that it will be tendered in Court as evidence of fault or liability.

Medical and dental care, especially procedures or prescriptions, carry risks that a practitioner should make a patient aware of beforehand. If one of those risks eventuates, it’s wouldn’t be considered malpractice, it’s simply a known risk for which a patient should have provided their informed consent to accept. Saying sorry in these instances is simply a caring and dutiful way to treat your patients.

Saying sorry may also help you as a doctor to move on from an incident and feel better about your own conduct.

As a rule, we feel that saying the word ‘sorry’ carries the most weight compared to ‘I apologise’ or expressing ‘deep regret’. Additionally, try to use the personal pronoun “I” as this carries more weight than apologizing for the medical team or hospital, that is saying “we’re sorry” or “our apologies”. If you're a little lost for words, here's some of the ways we think you can say sorry:

• "I'm sorry we didn't get the outcome for which we were both hoping."
• "I apologise. It's not what I expected to happen."
• "I really regret what's happened. I'm sorry."
• "It's not what we expected or planned for. I hope you can accept my apology."

Apology and/or expressions of regret are key components of open disclosure, but also the most sensitive. ‘Saying sorry’ requires great care. The exact wording and phrasing of an apology (or expression of regret) will vary in each case. The following points should be considered.

• The words ‘I am sorry’ or ‘we are sorry’ should be included. It is preferred that, wherever possible, people directly involved in the adverse event also provide the apology or expression of regret.
• Sincerity is the key element for success. The effectiveness of an apology or expression of regret hinges on the way it is delivered, including the tone of voice, as well as non-verbal communication such as body language, gestures and facial expressions. These skills are often not innate and may need to be practised. Training and education in open disclosure should address this.

Challenges and potential solutions

While open disclosure offers promise to all stakeholders involved, there are challenges at each stage of the process. healthcare organisations and individiual practitioners should be aware of the potential pitfalls at each stage of the process and prepare contingency plans to prevent each from happening wherever possible. The following diagram highlights some of these challenges.

Diagram 1: Challenges at each stage of the open disclosure process. Image developed and modified from Holmes (2019)².

Your MIPS Indemnity Insurance Policy

Even though an apology may be appropriate, there are certain things you should not do in handling a complaint. This is set out in MIPS Members’ Indemnity Insurance Policy

27. Consent to settlement

27.1 You must:

a. not admit liability for a claim; and

b. not agree to settle a claim; unless you have our prior written consent.

27.2 We will not admit liability for, or settle, any claim against you without your prior consent.

27.3 If you refuse to consent to us making a settlement offer which we have recommended in respect of a claim, our liability in respect to that claim is limited to the amount of our recommended offer plus defence costs incurred to the date we recommended making the offer to you. 

You must contact MIPS in the event of a complaint, and you must not admit liability until this has been agreed with MIPS.

Conclusion

MIPS encourages healthcare practitioners to be transparent, empathetic and responsive to patients' needs following an adverse event. Engaging in an open disclosure dialogue is a valuable tool to resolve patients concerns, mitigate future legal and/or regulatory action and to foster high quality healthcare outcomes. 

As highlighted in this summary, there are several challenges to its successful implementation and roll out. MIPS members must contact MIPS in the event of a complaint, and you must not admit liability until this has been agreed with MIPS. Should members have any queries related to these issues they are advised to contact MIPS for advice on 1800 061 113.

Complete assessment questions!

References

¹Australian Commission on Safety and Quality in Health Care (ACSQHC). Australian Open Disclosure Framework.

http://www.safetyandquality.gov.au/wp-content/uploads/2013/03/Australian-Open-Disclosure-Framework-Feb-2014.pdf. 2013;

Canberra, Australia.

²Holmes, Bugeja, L., Ranson, D., Griffths, D., & Ibrahim, J. E. (2019). The potential for inadvertent adverse consequences of open disclosure in Australia: when good intentions cause further harm. Medicine, Science and the Law, 59(4), 265–274. https://doi.org/10.1177/0025802419872049

³ What is Open Disclosure? Clinical Excellence Commission Open Disclosure Handbook – Chapter 3. What is Open Disclosure? (nsw.gov.au)

⁴Medical Law in Queensland, Barry Nilsson Lawyers (2021). Course material, module 2 notes.

⁵Open Disclosure Position Paper, Royal Australasian College of Surgeons (2015). 

A patient’s health records are critical to all clinical encounters and almost all clinical negligence allegations. Accurate, up-to-date and clear health records are one of the most powerful tools when defending a medical negligence claim, complaint or investigation. 

If your healthcare is ever called into question, your records will be scrutinised and will form the basis of expert opinion that may determine the outcome of a claim. An independent medical expert will review the records with the goal of determining whether the clinical treatment you provided was appropriate according to the standard of care demanded by law, or whether a reasonable body of peer experts would have provided the same level of care¹. As such, medical records have significant evidentiary value.

In many medical negligence claims, records of treatment at other hospitals earlier or later than the impugned clinical intervention may also inform different aspects of a claim. On the other hand, they may relate to conditions not pertinent to a claim. A general practitioner’s (GP) health records are almost always highly relevant².

What is the expected standard of practice?

The Medical and Dental Board Codes of Conduct outline the principles underpinning high-quality healthcare practice in Australia. It defines the standards of ethical and professional conduct expected of healthcare practitioners by their peers and the community. Section 10.5 of the Code of Conduct outlines the standard expected of record-keeping practice.

Table 1: Good medical practice: a code of conduct for doctors in Australia (2020)³

The obligation to maintain accurate health records for the purposes of ongoing patient care is not only a professional duty, but also a legal one. 

Consider the case of Hughes v. Staunton, Collins, Daly⁴, involving three medical practitioners (a consultant neurologist and two GPs) alleged to incorrectly advising and prescribing an incorrect dose of a drug (Largactil) and failing to monitor its effects on a patient affected by Sub Acute Sclerosing Panencephalitis (SSPE).

There was also an allegation that the GPs had failed to keep appropriate health records. The court found Dr Collin's records to be substandard as they needed to contain more details for him to recall the patient's treatment. Shockingly, Dr Daly's records were non-existent.

Despite the fact that these issues had no bearing on liability and the prescription of the drug was found to be appropriate, the court stated that:

“The primary duty of a doctor is to treat the patient. Included in that will be the keeping of such records as are necessary for the continued treatment of the patient on a properly informed basis.”⁵ 

The case of Rhodes v. Spokes & Farbridge⁶ also highlights the relevance of ensuring health records are kept up-to-date and written accurately. The GP, Dr Spokes, did not keep detailed health records, and the ones he kept often contained personal comments about the patient. At trial, the court found the evidence of all the parties to be substandard and unreliable. In addition, it was evident that the passage of time from the events to the time of trial did not assist, and this fact negatively impacted Dr Farbridge’s accurate recall of the events that had taken place. Furthermore, the court made this significant observation:

“A doctor’s contemporaneous record of a consultation should form a reliable evidential base…I regret to say that Dr. Farbridge’s notes of the plaintiff’s attendances do not provide any such firm foundation. They are scanty in the extreme. He rarely recorded her complaints or symptoms; he rarely recorded any observation; usually he noted only the drug he prescribed. These brief entries were sometimes accompanied by a cryptic or occasionally even derogatory comment as to the genuineness of the plaintiff’s complaints.

The failure to take a proper note is not evidence of a doctor’s negligence or of the inadequacy of treatment. But a doctor who fails to keep an adequate note of a consultation lays himself open to a finding that his recollection is faulty and someone else’s is correct. After all, a patient has only to remember his or her own case, whereas the doctor has to remember one case out of hundreds which occupied his mind at the material time.”⁷

 This case highlights a common issue observed in medical negligence litigation - the time lag between when an alleged adverse incident occurs and when a complaint or claim is made can be very significant. As the court noted, there is a critical difference between a healthcare practitioner’s memory and that of a patient: the patient will only remember their case and the events that took place in one or a handful of encounters, whereas the doctor will have to recall one out of hundreds of patients at the time. Also, consider that when an allegation is made, and a doctor’s healthcare is called into question, a few years may have passed by, and they will have seen thousands more patients. Thus, their memory of the event in question would have deteriorated significantly. Commonly, a doctor in these circumstances will, in fact, not recall any of the events in question. Moreover, due to a long passage of time, "…

“either or both of the practitioner and patient may become polarised and perhaps mistaken in their recollection of what took place during their interaction.”⁸ 

In these circumstances, a well written recollection of events in the health records will be of upmost assistance in the defence of legal or regulatory proceedings.

Consider the case of O’Neill v Rawluk⁹, where the clinical intervention had been performed 12 years prior to the trial, the relevance and assistance of written records was noted by the court. Moriarty J stated:

“The unique experience of the plaintiff is likely to be more indelible than the recollection of one of many procedures undertaken by a busy neurological surgeon, with a clinical case load exceeding, on the defendant's own evidence, 350 patients per year. However, the defendant's practice of maintaining handwritten notes also gives a more reliable picture.”⁹

What should be included in the health records?

Health records include a wide variety of documents generated on, or on behalf of, all the health practitioners involved in patient care. This includes: 

• Clinical notes (electronic and handwritten).
• Correspondence between healthcare professionals regarding patient’s care.
• Laboratory reports.
• Imaging and radiology records.
• Data produced by monitoring equipment.
• Models & molds.
• Photographs.
• Video and audio recordings.
• Information given to patients.
• Medications & other management information.
• Informed consent discussions (including financial consent).

Correspondence and conversations between a practitioner and their indemnity provider and lawyers may not need to be included in a patient's health records. For example, advice given over the medicolegal advisory service could be recorded if this provides a reasonable justification for the actions taken. In fact, this is required by law if the nature of the conversation is not legal advice. However, correspondence about managing an actual claim or complaint should not be included in the health records. 

Who owns the records?

Generally, health records remain the property of the health service provider (practice or employer) who created the health record. However, the concept of legal ownership of records should not be conflated with the right of patients to access health information about them. The introduction of Commonwealth and state/territory privacy legislation, patients have a right to gain access (except in a limited number of situations) to all the information held about them.

How long should I store health records?

This varies between state and territory jurisdictions. However, in a number of states, health records should be kept for 7 years from when the patient was last seen or when any child patient turns 25 years of age, whichever occurs later. Records should only be retained beyond this period if it is suspected that a claim or complaint is likely to arise.

What are the consequences if a patient’s health records are lost or destroyed?

Recent case decisions in medical negligence serve as a welcomed reminder of the importance of proper record storage. 

Are audio and video recordings legal in Australia?

It may seem an easier way in this technologically savvy world we inhabit, to simply record information or other data about patients, either by audio or visual means. This is attractive as records are correct and comprehensive and may be utilised in the defence of any complaint. However, there are legalities surrounding such records and as a guide, as discussed below.

Audio records

The law surrounding audio recordings differ across each state and territory.

Things can be complicated if a person in one state or territory is speaking to someone in another state or territory – generally, it is the law of the state pertaining to the person who is doing the recording that applies.

Relevant legislation:

• NSW – Surveillance Devices Act 2007 (NSW)
• Victoria – Surveillance Devices Act 1999 (Vic)
• Queensland – Invasion of Privacy Act 1971 (Qld)
• South Australia – Listening & Surveillance Devices Act 1972 (SA)
• Western Australia – Surveillance Devices Act 1998 (WA)

The definition of a ‘listening device’ is wide. It generally includes anything used to overhear, record, monitor or listen to a private conversation, such as mobile phones or dictation devices. It does not include hearing aids or other similar devices.

A ‘private conversation’ is one where the parties may reasonably assume that they don’t want to be overheard by others or the circumstances indicate that either of the parties wanted it to be confined to the parties. 

If sensitive information is discussed, such as health information, this certainly constitutes a private conversation. It would be unusual for any conversation between a patient and a health practitioner not to be private.

Alteration of health records

It is not uncommon to realise after a record has been created that an error had been made in that record. In those circumstances, it is appropriate (and indeed preferable) that the record be corrected. However, there is a proper process for doing this. The original record should not be deleted. Instead, an addendum should be created that refers to the previous erroneous record, outlining why the record is erroneous, how and when this error was identified, any explanation of the error and then a clear statement that corrects the record. 

However, any inappropriate modification of health records e.g., for the purposes of misleading and changing the description of events that have taken place in a clinical intervention, will result in severe regulatory and legal action. Consider the case of Philp v. Ryan¹⁰, where Dr Ryan claimed he had altered the health records, after the commencement of legal proceedings, in order to reflect the accurate facts of what had happened according to his own recollection of events. Despite the fact he agreed it was inappropriate to make such an alteration, this event was only recognised at trial. In addressing this action, the trial judge conveyed he had:

“…absolutely no doubt that Mr Ryan acted quite improperly when he altered this clinical record.”

€50,000 in aggravated damages were awarded for this “grossly improper behaviour” of altering the health records. Furthermore, the Irish Supreme Court manifested a stronger opinion:

“This is an extremely serious finding against the first defendant. It is a finding that the first defendant deliberately and knowingly altered a document which he must have known would be used in court proceedings with the intention of, as the trial judge said, assisting his case, which in fact means with the intention of deceiving the court and of attempting to deprive the plaintiff of damages to which he has subsequently been found to be lawfully entitled. That matter is of itself extremely disturbing…”¹¹

In summary, health records cannot be retrospectively altered for any improper purpose. If a genuine mistake occurs, or where a further entry is required in the record on a retrospective basis, any mistake should be clearly struck through with a line and this should be signed/initialed and dated¹².

Privacy and confidentiality of health records

It goes without saying that a person’s medical records are confidential and normally not to be disclosed to anyone but his doctors. However, there are growing exceptions to the confidentiality of patient records. If you have any questions about disclosure of health information to third parties, you should contact the MIPS medicolegal advisory service. Relevantly to this module, in a personal injury action or a clinical negligence action he is taken to have waived his right to confidentiality so that the defendants are entitled to see all relevant records (and in most cases that will embrace all his records).

The Australian Privacy Principles (or APPs) are the cornerstone of the privacy protection framework in the Privacy Act 1988 (Privacy Act). They apply to any organisation or agency the Privacy Act covers.

There are 13 Australian Privacy Principles and they govern standards, rights and obligations around:

• the collection, use and disclosure of personal information.
• an organisation or agency’s governance and accountability.
• integrity and correction of personal information.
• the rights of individuals to access their personal information.

The Australian Privacy Principles are principles-based law. This gives an organisation or agency flexibility to tailor their personal information handling practices to their business models and the diverse needs of individuals. They are also technology neutral, which allows them to adapt to changing technologies.

Conclusion

In summary, accurate and contemporaneous health records are critical in ensuring high quality patient outcomes and defending healthcare practitioners against medical negligence allegations. Health records are:

”…important evidence in medical negligence claims, as those records are intended to ensure that patients are treated effectively and appropriately by providing relevant information to treating clinicians. The records, therefore, are likely to be the best evidence of crucial matters such as history, examination, investigations, referral, follow-up, diagnosis, treatment and advice/consent….”¹³ .

Remember:

• Health records should contain sufficient information that would enable another practitioner to appropriately takeover care of the patient.
• If it’s not documented, then it didn’t happen 
• Record any advice or warnings you routinely provide to patients.
• Never use derogatory and offensive comments, assume someone else (including the patient) may see the record.
• Use abbreviations with care, can be ambiguous or confusing.
• Don’t tamper with notes, new additions should be separately dated, timed and signed.
• If a mistake is made, correct it with a single strikethrough. Then sign and date the correction.
• Avoid cutting and pasting from previous records.
• Explain to the patient what you are doing, and involve them in their record.
  
  

Complete assessment questions!

References

¹Barry Nilsson Lawyers Medical Law Course (2021).

²Boyd, T., & Buchan, A. (2019). The medical records. In Clinical Negligence: A Practical Guide (pp. 559–587). Haywards Heath: Bloomsbury Professional. Retrieved March 1, 2023, from http://dx.doi.org.ezp-prod1.hul.harvard.edu/10.5040/9781526505361.chapter-021

³Medical Board of Australia. Good Medical Practice: A Code of Conduct for Doctors in Australia. 2020. Available at: Medical Board of Australia - Good medical practice: a code of conduct for doctors in Australia

⁴High Court, Unrep., Lynch J., 16/2/90.

⁵Fn 7 at p. 863.

⁶Rhodes v Spokes & Farbridge MLC 0640, [1996] 7 Med LR 135

⁷FN 20 at p. 139.

⁸Mills and Mulligan. Medical Law in Ireland (3rd Ed.) at p.55

⁹[2013] IEHC 461 at para. 42

¹⁰Philp v Ryan [2004] IESC 105, [2004] 

¹¹FN 28, at para 41, p. 255.

¹²Walsh, D. (2020) On the Record: Medico-Legal issues regarding medical records. Challenge Insurance Brokers Ltd.

¹³Jones,M (2021) Medical Negligence. Sweet & Maxwell, 6th Ed. (p. 1283).

This Educational Activity (EA) CPD task consists of Part A (Critical Reading section) and B (Critical Appraisal):

Part A – Critical reading section

From the standpoint of evidence-based medicine, critical reading is an instructional tool that develops healthcare professionals’ clinical competence by enhancing their metacognitive skills, self-efficacy and culturally situated perspectives.

In this pre-webinar activity, we invite you to read the article by Kelly, A. M. (2019). Medical experts and evaluations of the standard of care in medical litigation–strengths, weaknesses, and potential improvements. J. Law Med, 27, 455-71 and complete a critical appraisal assessment.

Link to PDF article below:

kelly-experts-27-jlm-455.pdf (dyzz9obi78pm5.cloudfront.net)

Once you've completed the reading, please continue to Part B Critical Appraisal.