Dr Nick KendallClinical Psychologist

Pain Management and

Musculoskeletal Medicine

ACC

7:00 - 7:55 ACC Breakfast Session – Treatment Injury

Dr Peter JansenClinical Lead Treatment Injury

Accident Compensation

Corporation

New Zealand

Presenters:

Date:

Treatment Safety

8th June 2018

Peter Jansen, Clinical Lead Treatment Injury

Nick Kendall, Manager Treatment Safety

Chair: Peter Robinson, Chief Clinical Advisor, ACC

Agenda

Introduction

Dr Peter Robinson, Chief Clinical Advisor

Overview of Treatment Injury: What is It?

Dr Peter Jansen, Clinical Lead Treatment Injury

Treatment Safety: Preventing Injury caused by Treatment

Dr Nick Kendall, Manager Treatment Safety

Information on mesh-related claims

Dr Peter Robinson, Chief Clinical Advisor

Questions

Surgical MeshPeter Robinson

Surgical mesh-related claim insights

Let’s start at the beginning

When

What

Why

In 2014 the Health

Select Committee

received a public

petition

The petition raised

concerns about the

safety of surgical

mesh

Some patients had

developed severe

complications

following mesh

surgery

Analysis of surgical mesh-related claim data

(1 July 2005 to 30 June 2017)

We found that over…

163

113

194

14

106

170

50

POP & SUI repair

SUI repair

POP repair

Other hernia repair

Groin hernia repair

Ventral hernia repair

Other mesh surgery

Other mesh surgery

Hernia repair

POP and/or SUI repair

(6%)

(36%)

(58%)

Total

810

12years

810claims were assessed

79%were accepted for cover

$13mhas been paid out by ACC

POP: Pelvic Organ Prolapse

SUI: Stress Urinary Incontinence

Background to TI and CriteriaPeter Jansen

Medical Misadventure to Treatment injury

Change in legislation in 2005, with different criteria

Faster decisions on more claims, but still some uncertainty

Under medical misadventure...

60% of all claims were DECLINED for cover

17,500 decisions (approx.) were issued between 1992 to 2002

On average, it took 5 MONTHS to issue a

decision

Under treatment injury...

60% of all claims are ACCEPTED for cover

98,500 decisions (approx.) were issued

from 2007 to 2017

On average, it takes 30 DAYS to issue a

decision

What is treatment injury?

• Legislation change in 2005 from medical misadventure to treatment injury

• Personal injury that is caused by treatment (sections 32 and 33) from a registered health professional (section 6)

• Exclusions apply

• Personal Injury = actual bodily damage, not minor symptoms alone

Treatment: What’s included and what’s excluded?

Includes... Excludes...

Seeking treatment and receiving treatment Necessary part of treatment

Failure to diagnose or treat / failure to treat in

a timely manner

Ordinary consequence of treatment

Obtaining informed consent Withholding / delaying consent

Application of support systems Resource allocation

Equipment, device, prosthesis or tool failure Wear and tear of prosthesis or

supervening act

Ethics approved clinical trials not performed

for benefit of the manufacturer / distributor

Desired results not achieved

Claims process

Lodgement and initial consideration

Providers submit the claim, with relevant clinical records

Step 1 – is there a personal injury?

Step 2 – did that injury occur while seeking or receiving treatment by or at the direction of a RHP / RHPs?

• treatment injury includes personal injury from clinical trials if

• no written consent was obtained, or

• approved ethics committee approved the trial which is not for the benefit of the manufacturer or distributor

Step 3 – was the personal injury caused by the treatment? Taking into consideration:

• whether the client's underlying health condition(s) wholly or substantially caused the injury

• the client unreasonably withholding or delaying their consent to undergo treatment.

Step 4 – exclusions

• the injury a necessary part or ordinary consequence of treatment

• the injury caused solely by a resource allocation decision

• the treatment did not achieve the desired result

• implant or prosthesis failure due to wear and tear or an intervening act

• etc

Advice for the decision

• Further advice

• Internal or external medical advice as needed

• Objective, specialist advice taking all factors into account

• External advisors are contracted to ACC.

• Failure or Omission

• Claim is based on ‘failure’ then external clinical advice from a peer of the treatment provider is likely to be sought.

• Exclusions don’t apply where failure causes injury

• Complex Claims Panel

• Meets weekly

• Consider most complex claims and accidental death claims.

• Team leaders and medical advisers from TICA, representatives from legal and communications.

Risk of harm notifications

Reporting belief of risk of harm to the public

Section 284: Belief of risk of harm to the public

Public safety

• Statutory obligation to consider all claims

• Must report if reasonable belief of risk of harm to the public

Cover assessment

information only

• Information used to make a cover decision

• Can not seek additional information

Accepted and declined

claims assessed

• E.g. Medication omission without injury (declined claim)

• Trends and clusters

What do we consider?

Examples

Example 1

Liver failure

2 month old baby taken to public ED with 1 week of weight loss, fever, diarrhoea and vomiting causing dehydration.

Admitted to hospital for IV rehydration and other therapy.

Given 280mg of paracetamol in ED due to incorrect dose being charted – a dose of 80mg/kg instead of 10mg/kg.

On the following day abnormal liver function was noted.

Disclosure to parents of this overdose causing “acute liver failure”.

An ultrasound of the liver on the same day was normal liver and LFTs back in the normal range within 2 days.

The physical injury of acute liver failure has resolved.

What entitlements are available after discharge?

Example 2

Pressure injury

Patient admitted to ICU with acute neurological illness.

Resolved over 5 days with good recovery, and transferred to rehabilitation unit for a further 5 days.

Claim lodged for ‘friction blister’ to the right heel by rehabilitation unit staff.

ACC2152 from GP says the pressure injury to the right heel was caused by a failure to provide the appropriate preventive care. Hospital records provided show no evidence of assessment of risk for pressure injury nor any pressure injury prevention or treatment in ICU.

Wound located on day of admission to rehabilitation facility.

Exclusions don’t apply – failure.

ACC2184 says the patient had a high risk of developing a pressure area secondary to her health condition, underlying conditions and immobilisation in ICU. The risk of developing a pressure injury was not assessed and patient not provided with the appropriate preventive care.

Claim accepted grade 3 pressure injury caused by a failure to provide treatment.

Subsequently a district nursing care package was approved.

New request for motorised wheelchair due to immobility – neuropathy affecting right > left feet.

The heel wound is well healed.

Example 3

Disease progression

50 year-old presented to ED with severe new onset headaches.

CT performed to exclude vascular causes and was reported as normal.

Presented again 6 months later with 2-week history of increasing stridor. On direct examination a large mass obstructing the posterior pharynx was identified.

Collapse in ED with resuscitation

Emergency surgery was needed to protect the airway and biopsy the mass. Found to be XXX tumour, which was treated by wide excision and radiotherapy.

Blinded review of CT by three radiologists all identified the pharyngeal mass.

Expert advice that 6 month delay led to tumour growth, but no difference in treatment for the underlying tumour – the treatment plan would be the same if diagnosed earlier. Prognosis remains the same also.

Cover accepted for disease progression of tumour due to a failure to diagnose tumour with resulting obstruction of pharynx causing respiratory and cardiac arrest.

What if the treatment path was altered because of disease progression?

E.g. additional chemotherapy required or much greater excision?

What about recurrence?

Preventing Injury: Treatment SafetyNick Kendall

• National data

• Aggregate data for:

• 20 DHBs

• 38 NZPSHA facilities

• General Practice in 2019

www.acc.co.nz/treatmentsafety

A key role for ACC is to provide information to support treatment safety

Treatment Safety Initiatives

• NetworkZ surgical simulation training (formerly known as MORSim)

• Infection prevention

• Medication safety

• Pressure injuries

• Neonatal encephalopathy

Surgical Simulation Training

Safe surgery is important to ACC because the volume and

complexity of surgery increasing, greater risk factors in the

patient population. ‘Never Events’ include wrong-site surgery,

leaving items in patients, and major postoperative

complications.

Simulation training is well established in other sectors (e.g.

aviation) and is increasingly used in clinical training. More

effective teamwork and and communication have been shown

to reduce paient harm in operating rooms.

www.networkz.ac.nz

• “Train-the-trainer” approach to four cohorts of five DHBs

• Each DHB will have a state-of-the-art simulation suite and trainers

• At least 4,840 operating room staff will be trained

Multiple aspects to infection prevention

Infections

• Infections are the most frequent treatment injury claim.

• Most infection claims are low-cost, but a small minority have much

greater impact with higher cost and duration.

• Surgical site infections tend to be more expensive.

Surgical site infection (SSI)

Infections are the most frequent treatment injury claim.

Surgical site infection

• ACC funding to HQSC to support Surgical Site Infection

Improvement Programme (SSIIP).

• Target is deep/organ space and superficial SSIs for

Orthopaedics (only hip and knee replacement), and

Cardiac (coronary artery bypass graft, CABG).

Initiative interlocking with ICNet survelliance platform

Foetal Anti-Convulsant Syndrome (FACS)

We have developed FACS prevention documents with a team of 15 clinicians and consumers– one to inform health care professionalsand one to inform patientsabout the risks and benefits of anti-epileptic medicines

Foetal Anti-Convulsant Syndrome (FACS)

FACS is a cluster of various birth defects and developmental problems in infants exposed to anti-epileptic medicines in utero.

Taken for epilepsy, mood, and pain.

Sodium valproate has the greatest absolute risk.

Pressure injury prevention & management

6 auditable principleswww.acc.co.nz/treatmentsafety

40% of serious injury clients

with spinal cord injuries had

a Stage 3 or 4 pressure injury

within the last 3 years, cost ~

$42m.

1.2/100

0

NE case

Size of the problem

12.3

Claims

per

year

$3.9b

OCL$27m

moderate

serious

injury

223

ACC

Claims

$48m

severe

serious

injury

55 - 66% are

potentially

preventable

Human

Impact

Next steps could be

• Simulation training

• Support via “Maternity App”

Effective treatment

Cooling within 6 hours

to prevent neurological

damage … but need to

identify a potential case

How we are addressing it

Questions

He Patai