Response to an event: Minding the patient & the Organisation an Australian Perspective P Scalliet M...

Response to an event: Minding the patient & the Organisation an Australian Perspective

P Scalliet

M Coffey

J Cunningham

C Hamilton

Topics Background, Definitions and Context The Incident The Patient

– Disclosure?– When?– What?– Where?– How?– Who?

The Organisation

Medical Errors Australian study revealed 18,000 annual deaths from medical

errors UK Department of Health Expert Group in June 2000 estimated

that over 850,000 incidents harm NHS patients In 2004, the Canadian Adverse Events Study found that adverse

events occurred in more than 7% of hospital admissions, and estimated that 9,000 to 24,000 Canadians die annually after an avoidable medical error.

WHO estimate that one in ten persons receiving health care will suffer preventable harm.

5,375 records Netherlands found 498 adverse events identified in the sample. Only 18 of the 498 (3.6%) records with references to adverse events were found in one or more of the four reporting systems that had been put in place. Christiaans-Dingelhoff

2011

The Case for Disclosure Ethical Requirement

– Patient Autonomy/ Therapeutic Relationship– Codes of Ethical Conduct

Nonmalfeasance, Beneficence, Informed Consent, Justice. US - JCAHO requirement

– As part of accreditation process– California SB1237 (2010) mandates >20% dose wrong site

or ptt errors are disclosed and reported. Hospital policy Legal risk management strategy (Uni Michigan reports 61% less

litigation costs)

Should you tell the patient?

Patients want full disclosure– Hypothetical error scenarios : Mild,

Moderate, Severe

Misconceptions– Change physicians– Litigation

Witman AB, Park DM, Hardin SB

Arch Intern Med. 1996;156:2565-2569

Disclosure – The Truth

Not often practised– Only ~50% of interns and residents who had made

medical mistakes informed their seniors– Less than 25% of them disclosed their mistakes to

the patient or familyWu AW, Folkman S, McPhee S, Lo B

JAMA 1991;265:2089-2094

Similar to breaking bad news Giving an apology / expressing regret

/explaining facts is not admitting liability

What is OD? ( from OD Review Allen et al 2008)

What is OD?

Function of OD

Barriers to OD

RT Errors

Rate of 0.6 events per patient (cf aviation)) 7.8% of these classified as high severity

events (>10 mm or 10% in dose) Most are near-misses. NY Times, Lisa Norris, Epinal, Adelaide Port

Macquarie etc

The Incident Type of error

– Dose or volume– Component: Dose / shielding /

isocentre / patient / field size / gantry angle / collimator angle / energy / bolus / wedge / . . .

Potential Consequences– Tumour Control Probability TCP– Normal Tissue Complication Probability

NTCP

The Error Can it be corrected?

– Type of error– Stage of treatment that error discovered– TCP / NTCP

Is recurrence of cancer ever an unanticipated outcome?

Similarly trained clinician could have made the same decision?

Error vs Uncertainty vs Deviation

How Radiation Oncologists Would Disclose Errors You evaluate and simulate a 31-y-old man with Hodgkins Lymphoma after 8

cycles of chemotherapy. His initial sites of disease were the left groin, bilateral external iliac nodes, and some low nodes in the paraortic chain. You design an inverted Y treatment field for him, which requires treatment at an extended source-skin distance of 110 cm, with 3060 cGy in 17 fractions.

The therapists realize at fraction 11 that he has been treated at source-axis distance (isocentrically). He has diarrhea and thrombocytopenia. He has been receiving 250 cGy per fraction at the volume of interest rather than 180 cGy and, as such, has reached 2750 cGy. You realize your colleague who initially checked the patient’s port film did not recognize the smaller volume of internal anatomy covered by the field than the

DRR demonstrated, as the isocenter was correct. You also checked a port film a week later and approved it. Chart rounds was not held in this interval. You review the treatment as delivered with dosimetry and find that all initially involved nodes were adequately covered with 1.5 cm margin.

What would you most likely say about what happened?

Evans IJROBP 2012

How Radiation Oncologists Would Disclose Errors Full disclosure option There was an error in your

treatment delivery which caused a higher daily dose to be delivered, causing you to complete your radiation ahead of schedule.

Partial disclosure option You received a higher dose per fraction of radiation than I had planned, causing you to complete your radiation ahead of schedule.

No disclosure option Given your side effects from the radiation, I feel you have reached an adequate dose, and can discontinue treatment without any compromise in your outcome.

Evans IJROBP 2012

How Radiation Oncologists Would Disclose Errors Full disclosure option The treatment set up field notes should

have been changed to reflect the treatment distance, and they were not. Your treatment field films showed this error, however, it went unrecognized. Our weekly quality assurance meeting was postponed due to a conflict during this time.

Partial disclosure option This occurred because of a miscommunication between myself and the dosimetrists who prepare the plan and therapists who deliver it.

No disclosure option I would not volunteer a cause of the error unless the patient asked me.

Evans IJROBP 2012

How Radiation Oncologists Would Disclose Errors Full disclosure option Full disclosure option

I am so sorry that you were harmed by this error.

Partial disclosure option I am sorry about what happened.

No disclosure option I would not volunteer that I was sorry or apologize.

Evans IJROBP 2012

Controversial Medical Impact

You are a radiation oncology attending practicing in a community hospital.

A physicist discovers that a dose calculation algorithm was affected by a keystroke error on a stereotactic radiation delivery system. This resulted in your patient’s solitary lung metastasis from colon cancer being underdosed by 25% during his SBRT.

The patient has since died of metastatic colon cancer. A chest CT performed weeks before he died showed new multifocal lung disease throughout, including progression of the underdosed treated metastasis. The error was not discovered until 2 mo after the patient’s death. After a careful review, this seems to be an isolated incident. What would your approach be? Assume that the error made no medical difference and that the University hospital down the road would have actually given the lower dose on protocol

Controversial Medical Impact

Full disclosure 1.7% I would tell his family that the physicist made an error resulting in a radiation underdose to his metastasis.

Partial disclosure 19.4% I would tell his family that his SBRT treatment was underdosed.

No disclosure 78.9% I would not contact his family regarding the error. If multiple patients were treated with an incorrect dose calculation

algorithm, how would this change your approach? Full disclosure 58% I would be more likely to disclose to all living or

deceased patients and families Partial disclosure 37.5% I would be more likely to disclose, but only to

living patients No disclosure 4.5% I would be less likely to disclose to all living or

deceased patients and families

ROSIS Incident (1)Found after treatment was completed

ROSIS Report Number 2

“a mistake in the report of the number of MU on the chart, not seen by the physicist who checked the chart at the beginning of treatment. The breast was treated with and without a wedge. Finally she rec'd 60Gy 4W, 5F/W instead of 45Gy. During treatment G1 erythema only” => Non-correctable

ROSIS Report Number 59 “8.46Gy instead of 8.0Gy was given for the first (and

only) fraction” => Non-correctable

ROSIS Incident (2)Found during treatment

ROSIS Report Number 101– “One field was treated at the wrong SSD

[105cm vs 100cm] for 5 fractions of a total 18. This mistake was correctable, and the monitor units were corrected for the error over the remaining fractions” => Correctable

ROSIS Incident (3) Found during treatment, wrong isocentre:

ROSIS Incident Report 22

“Head and neck treatment, involved two treatment areas - nose (60Gy/30fractions) and lower neck (46Gy/23fractions). 5 fields in total. The 3 nose fields were treated on the neck isocentre in error… Involved one fraction. Dose reconstruction was performed, and it was deemed partially correctable - one fraction added for nose area and one fraction subtracted for neck area. Dose ~4.4Gy to spine. No added overlap.”

ROSIS Incident (4) Found during treatment, wrong isocentre:

ROSIS Report 727“The patient . . . was planned for 3DCRT on mediastinal mass. In simulator tattoing two tattos were done on the skin, one central and one for aligning in lower position.

In CT acquisition the physician put metal marker on both. The physicist centered the beam on the lower tattoo (the alignment one)but didn't specify the shift in the setup note in R&V. The beam was centered on the upper tattoo with a difference of 10 cm . . . [18 fractions of 22 total] The doctor who discovered the error visited the patient for disphagia.

The correction consisted in making a new plan for giving dose to the missed lower volume.”

Disclosure in Radiotherapy

ROSIS Study in 2001– 22 incident report forms in use by radiotherapy

departments in Europe– 4 had section to document if the patient was

informed of the incident BSc Study in 2001

– 19 incident report forms in use by radiotherapy departments in Europe

– 7 had section to document if the patient was informed of the incident

Disclosure – What Patients Want To be told about incidents that affect them Acknowledgement of the distress caused Genuine expression of regret for distress Factual explanation of what happened Clear explanation of what will be done now A plan to correct / repair harm done

Australian Open Disclosure Standard &

UK National Patient Safety Agency (NPSA)

Draft Indicators

http://centreforhealthcom.org/100patients/wp-content/uploads/2010/02/evidence.pdf

‘100 Patient Stories Project’ Draft Indicators of Effective Open Disclosure Funded by the Australian Commission on Safety and

Quality in Health Care, Minimal standards or ‘indicators’ for Open Disclosure.

These indicators will enable Patients and families, clinicians as well as health

services to determine whether Open Disclosure is conducted in a way that is appropriate and satisfactory for everyone involved.

Centre for Health Communication UTS Sydney

Open Disclosure Research andIndicator Development. Feb 2010

SIGNALLING THE NEED FOR OPEN DISCLOSURE The first actions taken following an adverse

event ensure the physical, medical and psychological needs of the patient are

satisfied.

Australian Open Disclosure Standard 2010

SIGNALLING THE NEED FOR OPEN DISCLOSURE Staff involved in a clinical incident ensure it is

reported. Patients and families have access to a

service-internal complaints mechanism that activates OD.

As soon as is practical, (ie 1 day) the patient/family is approached with a request for OD.

Give OD BookletAustralian Open Disclosure Standard 2010

PREPARING FOR OPEN DISCLOSURE Family/Ptt Choice of location. Choice in staff attending. Choice in support person 2 contact persons with understanding of OD


DOING OPEN DISCLOSURE Explanation of roles. Explanation of incident Sincere expression of regret Ptt family express their questions feelings Consequences of incident explained Staff OD training and support Ex gratia payments Ptt family involved in corrective action Able to request further meetings Further support for ptt family if needed


PROVIDING FOLLOWUP

Schedule additional meetings Follow up additional information Allow Ptt/Family to contribute further to action All investigation/RCA etc reports are provided Changes to procedures are reported


Supporting the Patient

Psychological support– Invite support person to be at disclosure meeting– Support may be provided by friends and families, social

workers, religion– May need referral to counselling services– Give information on how to make a complaint

Financial Support– Early stage– Written Legal advice– Agreement with insurers

OD in the QA Cycle

Open Disclosure is integrated with an appropriate overarching framework of patient safety, encompassing clinical incident management and clinical governance.

All incidents reported and investigated.


ACHIEVING CLOSURE

The patient and/or family are provided with an assurance that their ongoing needs springing

from the incident will be provided for. The patient and/or family feels confident to

return to the hospital for future care. Verbal and/or written Report summarising the

Open Disclosure and RCI process at its completion. Plain language


ENSURING THERE IS APPROPRIATE DOCUMENTATION

OD documentation management process the

medical record, a record of the OD process, and incident investigation information.

Medical record is up-to date prior to the first meeting

Documentation is freely offered by the hospital, rather than FOI or legal action.Australian Open Disclosure Standard 2010

Litigation

Medical Errors Litigation Compensation

Patients’ Reasons for Litigating Accountability – wishing to see staff disciplined

and called to account Explanation – combination of wanting an

explanation and feeling ignored/neglected after the incident

Standards of Care – wanting to ensure that a similar incident did not happen again

Compensation – wanting compensation and an admission of negligence

Vincent C, Young M, Phillips A. Why do people sue doctors?

Lancet 1994;343:1609-1613

Australian Apology Laws The national Open Disclosure Standard includes an

“expression of regret” as an appropriate element of a disclosure, defining it as “an expression of sorrow for the harm experienced by the patient”.

All states and territories have “Apology Laws” — statutory provisions that protect statements of apology or regret made after “incidents” from subsequent use in various legal contexts.

These laws were not enacted with OD in mind; they apply to a much broader range of activities and predate the OD movement.

5 States explicitly do not protect a “mea culpa” type statement.

Studdert and Richardson MJA 2010

Jurisdictional Differences


Possible Law reform


Minding the organisation


Accepting Fallibility– Mistakes and failures are inevitable– Staff often feel personal guilt– Clear policies on how such incidents should be

managed –No Blame Culture–To Err is Human

Honesty and openness

At a professional level With patients At a public level Interactive dialogue Constructive criticism

No blame vs Blame culture

Media

Public outcry / condemnation

criticism

Litigation

RISK

OPENNESS

failure / inability to learn form experience

Potential risk of major incident

RISK

SECRECY

Honesty and openness

Overcoming the paternalistic approach to medical care– Deception at time of diagnosis– Treatment options– Prognosis

The culture of the doctor / professional always being right

Ownership of the incident

Doctor’s Liability and the Corporate Entity– Is the burden on the doctor to prove that a risk

was not foreseeable?• Is this an unrealistic expectation?• Is the contact person for the patient responsible for the

personnel actions and the equipment used?

Ownership of the incident


Establishing an environment where people feel supported and are encouraged to identify and report adverse events so that opportunities for systems improvement can be identified and acted on

Communication must be open and honest, immediate and acted upon

Ethical responsibility to maintain open communication even when things go wrong

Confidentiality QA Structure Meetings Documentation AV Tools Audit

Risk evaluation

Severity of injury Likelihood of recurrence Risk rating Probability of claim Contributory factors Systemic root causes Action taken or planned outcome

RESPONSE TO AN EVENT

Feedback Impementation of new policy Evaluation

Review of practice

Report to risk management team

Discussion with the patient

Decision on corrective action of required

Near Incident/low severity

Feedback Implementation of new policy Evaluation

Review of practice

Follow up

Consistency of approach

Support for staff if necessary

Meeting and open discussion with patient and support person

consider the necessity for external professionals

Identify the person who will communicate with the patient

Adverse Event

Evaluation of potential outcome and action level

Assessment of severity of event

Notification of responsible person/s

Incident form completed and signed

Initial Assessment

ADVERSE EVENT


Staff – A clear and consistent approach to open

communication to all concerned following an adverse event• What has happened• Why it happened• What action is being taken• What preventative measures are being put in

place

Staff support– Access to assistance, support and information

necessary for them to participate in open communication with the patient• Training and advice on management of adverse

events– Promote an environment that fosters peer support

and discourages blame– Prevent discrimination of staff who report incidents– Feedback and regular updates on the status of the

process– Provide support services for staff in these

situations– Focus on safety rather than blame


Staff protection (legal)– Acknowledge that there has been an incident – Express regret– Indicate investigation taking place– Provide feedback and contact details of a contact

person– Staff member should not state or agree that

they, another staff member or the institution are liable for the harm caused to the patient


Further Reading / Resources Australian Open Disclosure Standard (+ literature review)

www.safetyandquality.org Clinical Risk Management: enhancing patient safety. C

Vincent. 2nd Ed. BMJ Books; 2001 Vincent C, Young M, Phillips A. Why do people sue doctors?

A study of patients and relatives taking legal action. Lancet 1994;343:1609-1613

Melanie Hingorani, Tina Wong, Gilli Vafidis. Patients' and doctors' attitudes to amount of information given after unintended injury during treatment: cross sectional, questionnaire survey. BMJ 1999; 318: 640-641

UK National Patient Safety Agency www.npsa.nhs.uk/advice

Disclosure ASSIST Model, Cognitive Institute

– Designed for disclosing errors to patients– Acknowledge, Sorry, Story, Inquire, Solution, Travel

Models for breaking bad news– SPIKES : Setting up, Perception, Invitation, Knowledge,

Emotions, Strategy, and Summary UK National Patient Safety Agency

– “Being Open” e-learning tool & video-based training workshop www.npsa.nhs.uk/advice

Australian Council for Safety and Quality in Healthcare www.safetyandquality.org Aust Open Disclosure Project http://centreforhealthcom.org/100patients/wp-content/uploads/2010/02/evidence.pdf

http://www.safetyandquality.org/

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