patient safety and compensation harm · 2019-07-20 · –is an incident which did not reach the...

PATIENT SAFETY AND

COMPENSATION

HARM

PROUDLY HOSTED BY THE

MDPCZ & HPAZ

DR. M R BILLA : REGISTRAR/CEO

ADV. F P KHUMALO : HOD LEGAL AND REGULATORY AFFAIRS

• CChallenges:

– Delivering safer and quality care in complex, pressurised and fast-moving healthcare

environments.

– In such environments, things can often go wrong.

– Patient Safety Incident Reporting and Learning Systems is used to identify patient

safety issues

• Cornerstone of patient safety strategies.

– By learning from these systems, errors can be corrected to

• prevent reoccurrence and

• ensure that patient safety,

• quality of care and health outcomes of patients are improved.

PATIENT SAFETY

• The impact of medico-legal litigations threatens the vision of Government of

– “Achieving a long and healthy life for all South Africans”

• WHO recommendation for Uniform National Reporting System of Adverse events

related to patient safety must be implemented

• National Department of Health (NDoH) developed the

– National Guideline for Patient Safety Incident Reporting and Learning System

• to guide the health system in dealing with patient safety incident reporting.

• Every health establishment should have a Patient Safety Incident Reporting and

Learning system as stipulated in this Guideline.

• Data from the system will be used to develop National action plans to improve

patient safety to ensure that all South Africans receive safe health care.

THE MINISTERIAL MEDICO- LEGAL COMMITTEE

• Lapses in patient safety are a major health care quality problem.

• These lapses in patient safety are referred to as patient safety incidents (PSI).

• PSI is an event or circumstance that could have resulted or did result in harm to a

patient as a result of the health care services provided, and not due to the underlying health condition.

• These are considered incidents.

– near miss,

– no harm incident or

– harmful incident (adverse event).

• A large majority of these lapses are the unintended results of highly complex and

imperfect health care delivery systems.

• Professional errors, at risk behaviour and reckless misconduct or negligent behaviour

contribute to patient safety incidents (PSI).

• All health-care professionals should report PSIs as soon as they become aware of it to

ensure that optimal learning take place.

Pharmaceuticals

PATIENT SAFETY INCIDENT

Competitor

Contoso Pharmaceuticals

IMPROVED PATIENT SAFETY

Competitor

Improved Patient Safety

Improved patient

satisfaction with health services

Reduction of avoidable mortality

Reduction of harm

encountered during care

Reduction in litigations

Reduced health care costs


REPORTING PATIENT SAFETY INCIDENTS

Competitor

• Report and record all patient safety incidents

• Report all incidents that resulted in serious harm or death (Severity

Assessment Code 1 incidents) within 24 hours to management or sub-

district/district and provincial office

• Commence and/or participate in the open disclosure process as

appropriate

• Participate in the investigation of incidents as required

• Finalise Severity Assessment Code 1 incident reports within sixty

working days

• Participate in the implementation of recommendations arising from

the investigation of incidents

• Encourage colleagues to report incidents that have been identified

– Use of reporting tool – to be discussed later


DEFINITION OF TERMS USED

Competitor

• Patient Safety:

– is the reduction of risk of unnecessary harm associated with

healthcare to an acceptable minimum.

• Near miss:

– is an incident which did not reach the patient.

• No harm incident:

– is an incident which reached a patient but no discernible harm

resulted.

• Harmful incident (adverse event):

– is an incident that results in harm to a patient that is related to

medical management, in contrast to disease complications or

underlying disease.


DEFINITION OF TERMS USED

Competitor

• Incident type:

– a descriptive term for a category made up of incidents of a

common nature, grouped because of shared, agreed

features

• Harm:

– implies impairment of structure or function of the body

and/or any deleterious effect arising there from, including

disease, injury, suffering, disability and death, and may be

physical, social or psychological.

• Degree of harm:

– is the severity and duration of any harm, and any treatment

implications, that result from an incident.


DEFINITION OF TERMS

Competitor

• Incident outcomes:

– all impacts upon a patient or an organisation wholly or partially attributable to

an incident

• Organisational outcome:

– the impact upon an organisation which is wholly or partially attributable to an

incident.

• Patient outcome:

– is the impact upon a patient which is wholly or partially attributable to an

incident

• Resulting actions:

– identify immediate or indirect action taken that relates to the patient or the

organization to improve the situation or prevent the reoccurrence of an incident.

• Minimal Information model:

– refers to a minimal common architecture for the core concepts considered tobe essential for information and comparison purposes of PSI reports

Pharmaceuticals

PRINCIPLES OF PATIENT SAFETY INCIDENT

Competitor

• Just Culture

• Confidential

• Timely

• Responsive

• Openness about failures

• Emphasis on learning

Pharmaceuticals

MARKERS OF NURSING CAREMarkers of Nursing Care

Pressure Ulcers

Patient Falls

Patient Safety

Pharmaceuticals

Competitor

PATIENT FALLS

o We have been tracking this for the last two years or so as a way ofmeasuring the quality of nursing care in the hospital.

o The plan is to focus more on the intrinsic factors, which I assume maybe

related to the clinical condition of the patient and the medication theyare taking.

o Appropriate measures need to be taken to prevent such falls. We will

develop new measures and protocols on how to prevent these falls. “

Inpatient falls are common and remain a great challenge for the NHS.

o Falls in hospital are the most commonly reported patient safety incidents,

with more than 240,000 reported in acute hospitals and mental healthtrusts in England and Wales every year (that is over 600 a day).”

PURPOSE OF THE PROJECT

o To do a retrospective study of the number of patient falls in the hospital

o To analyse the factors leading to patient falls in the hospital and group these into extrinsic and intrinsic factors

o To determine if these falls could have been prevented if appropriate measures were taken to prevent them, if any

o To develop strategies on how to prevent these patient falls

ls

OBJECTIVES OF STUDY

Pharmaceuticals

PRECAUTIONS TAKEN ?

Competitor

Precautions taken ?

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20

30

40

50

60

70

80

90

100

PRECAUTIONS TAKEN PRECAUTIONS NOT TAKEN

34

97

Precautions

Pharmaceuticals

FACTORS LEADING TO PATIENT FALLS

Competitor

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falls

Mechaism of the fall

Factors leading to Patient falls in the hospital

Pharmaceuticals

FACTORS LEADING TO PATIENT FALLS CONT….

Competitor

71

60

Intrinsic Extrinsic

Pharmaceuticals

PATIENT FALLS RELATIONSHIP TO DIAGNOSIS

Patient Falls Relationship to

Diagnosis

Pharmaceuticals

PATIENT FALLS RELATIONSHIP TO TREATMENT

Competitor

Pharmaceuticals

Competitor

Serious Adverse Event Reporting Tool

DrMS Reporting Form for Safety

Incident_php.htm

http://www.123contactform.com/form-

2440797/DrMS-Reporting-Form-For-Safety-

Incident

DrMS Reporting Form for Safety Incident_php.htm

DrMS Reporting Form for Safety Incident_php.htm

http://www.123contactform.com/form-2440797/DrMS-Reporting-Form-For-Safety-Incident

SOUTH AFRICAN LAW REFORM COMMISSION 2017

Competitor

Investigation into escalating medical claims

Pharmaceuticals

SOULS CLEOPAS VS PREMIER OF GAUTENG

Competitor

• The Minister of Justice and Correctional Services (the Minister) wrote to

the Chairperson of the SALRC on 16 January 2015.

• The Minister wrote the said letter in reaction to a request to the

Department of Justice and Constitutional Development (DOJCD) for

legislation to address the matters raised in the case of

– Souls Cleopas and the Premier of Gauteng unreported case

09/41967, Gauteng South High Court, April 2014 (Souls Cleopas case).

• The case was brought on the basis of negligent medical treatment that

the plaintiff had received from staff at Gauteng hospitals

• An official from the Office of the State Attorney: Johannesburg, requested

a meeting with the SALRC via the DOJCD on the increase in claims based

on medical negligence against the State.

• As a result of this meeting the SALRC agreed to look into :

– the manner in which compensation for medical malpractice is

determined and paid,

– the influence of the common law ―once and for all rule‖ on medico-

legal claims and

– lump sum payments as part of an investigation into medico-legal claims

against the state.

ESCALATING MEDICAL CLAIMS

Competitor

Pharmaceuticals

MEDICAL CLAIMS PAID OUT PER PROVINCE

Competitor

Province 2010/11 2011/12 2012/13 2013/14

Gauteng R 8 291 000.00 R 30 930 758.24 R 124 846 892.41 R 153 612 355.49

Eastern Cape R 10 260 049.00 R 25 336 038.35 R 44 743 495.84 R 49 513 108.93

Northern Cape R 6 810 428.00 R 705 000.00 R - R 7 107 000.00

KwaZulu Natal R 22 695 078.06 R 10 762 367.72 R 14 767 477.56 R 205 312 356.94

Western Cape R 9 210 000.00 R 15 860 000.00 R 11 710 000.00 R 15 680 000.00

Mahikeng R 12 550 000.00 R 753 602.57 R 7 899 232.50 R 698 940.17

Limpopo R 8 229 068.81 R 3 457 954.27 R 6 844 259.18 R 21 959 395.55

Free State R 256 081.57 R 988 604.43 R 327 192.00 R 673 373.00

Mpumalanga R 17 229 427.00 R 13 252 319.44 R 11 310 058.70 R 44 408 386.64

TOTAL R 95 531 132.44 R 102 046 645.02 R 222 448 608.19 R 498 964 916.72

• No legislation currently exists in South Africa to specifically address legal claims in the

medical field, which means that claims based on medical negligence are dealt with

under the common law.

• The escalation in medical negligence litigation, and in particular the increase in the

size of the damages sought and awarded, has become a major cause for concern in

the public and private health sectors.

• There is an urgent need to undertake reform of the law in order to regulate a system

that will become paralysed if no action is taken. It is crucial to cut down on litigationthat consumes time and money. Apart from the impact of medical litigation on the

public purse, the negative effect of such litigation on the rendering of health services inthe private sector must also be considered.

NEED FOR LAW REFORM

Competitor

• Regardless of the nature of the changes, legislation will be required to

effect such changes.

• Developing legislation in this field will aid in furthering the

implementation of broader government policy - Development Plan

(NDP) offers a long-term perspective

• Doctors turning to ―defensive medicine: Claassen & Verschoor

NEED FOR LAW REFORM

• The SALRC has called for inputs after it conducted an investigation into medico-legal

claims, especially claims against the state

• Its purpose is to initiate and stimulate debate, to seek proposals for reform and to serve as

a basis for further deliberation by the Commission

• The comment of any person on any issue contained in the issue paper or in respect of a

related issue which may need inclusion in the debate is sought.

• Such comment is of vital importance to the Commission, as it will assist in providing

direction with regard to the scope and focus of the investigation

• Respondents are requested to submit written comment, representations or requests to the

Commission by no later than 30 September 2017.

SOUTH AFRICAN LAW REFORM COMMISSION

PAPER

S

A media report on the summit commented that:

– The Minister of Health, addressing the summit, expressed his

concern that the lawsuit crisis that South Africa finds itself in

is ―what led to the collapse of the Australian health system15 years ago‖. He also referred to the ―US [that] had a

similar crisis in the 1970s and 1980s.‖

MEDICO-LEGAL SUMMIT OF MARCH 2015

Pharmaceuticals

MEDICAL MALPRACTICE WORKSHOP – MARCH

2017

Competitor

The Minister of Health reportedly made the following remarks at the summit:3

The nature of the crisis is that our country is experiencing a very sharp increase – actually an

explosion in medical malpractice litigation – which is not in keeping with generally known trends

of negligence or malpractice. … The cost of medical malpractice claims has skyrocketed and the

number of claims increased substantially. … [T]he crisis we are faced with is not a crisis of public

healthcare. It is a crisis faced by everybody in the healthcare profession – public and private.

Medical Malpractice Workshop of March 2017

Pharmaceuticals

COMPENSATION FOR HARM

Competitor

The golden tread in legislative framework establishing medical or health regulators of

different jurisdiction is that they exist to protect the public

• This public protection is achieved by ensuring that only competently educated and trained health practitioners are allowed to practice their profession;

• How do regulators satisfy themselves that a health practitioner is competently educated and trained?

• By setting the standards or get involved in setting the standards for education and training and monitor the implementation of such standards

THE ROLE OF A MEDICAL OR HEALTH REGULATOR IN

PATIENT SAFETY

Competitor

• By recognizing the qualifications for which the education standards have been set (entitling the holder thereof to practice);

• By ensuring that only registered/licensed persons are allowed to practice their profession in their respective jurisdiction;

• By setting and enforcing the standards for professional practice and professional conduct/ethical conduct;


PATIENT SAFETY CONT…

Pharmaceuticals



CompetitorWhat happens when standards for professional practice and

professional/ethical conduct are violated?

• Regulators take disciplinary actions against offending health practitioners and if found guilty health practitioners face disciplinary sanctions ranging from a caution to removal of a name from the register of health practitioners;

Pharmaceuticals



CompetitorAre disciplinary processes effective in dealing with medical

malpractice ?

• AMCOA member countries experience-let us have a brief discussion (5 minutes)

Pharmaceuticals

MEDICAL MALPRACTICE: A REGULATORY SLIPPERY

SLOPE

Competitor

Who should regulate medical malpractice?

• Is it the Department of health (seeing that often hospitals are facing civil litigation for compensation for harm);

• Is it the criminal justice system (seeing that health practitioners are facing criminal charges for culpable homicide- van Der Waldt case);

• Is it medical or health regulators (seeing that they set standard for professional practice and professional conduct);

Is there a medical malpractice crisis?

According to Masada (Masada ST.2004, Australia’s “Most Extreme Case”: A new

Alternative for US medical Malpractice Liability Reform, Pacific Rim Law & Policy

Journal, 163(2004)), medical malpractice crisis refers to a drastic surge in health care

providers’ liability insurance premiums that ultimately has encumbered patients

access to affordable health care.

• More than one-fourth of U.S. adults have experienced a medical error within the pasttwo years, despite the fact that the United States spends much more on health carethan any other country (Sage WM. 2003, Medical Liability and Patient Safety, HealthLaw 22:4);

• The Gauteng Department of Health and Social Development faced malpracticeclaims totalling R573 million in 2009 – 2010 (Pepper M, Slabbert MN.2011. Is South

Africa on the verge of a medical malpractice litigation storm?, June 2011, Vol. 4, No.

1 SAJBL)


SLOPE

Pharmaceuticals


SLOPE

Competitor


• In 2011 the Medical Protection Society (MPS) was assisting more than

895 members in South Africa who had ongoing negligence claims,

while there were more than 1 000 open files that were potential claims

awaiting assessment (Pepper supra);

• This represented an increase of nearly 550% compared with 10 years

ago; and the number of claims over R5 million had increased by 900%

in the past 5 years, with several topping the R30 million mark(Pepper

supra);

Pharmaceuticals


SLOPE


• The annual premium charged by the Medical Protection Society for

malpractice cover increased three-fold between 2008 and 2013, with

neurosurgery now classified as 'super high risk’.

• The annual premium (R250 900 for 2013) was second only to that for

obstetricians (R254 230) (Roytowski D, et al. 2014, Impressions of

defensive medical practice and medical litigation among South African

neurosurgeons, SAMJ, S. Afr. med. j. vol.104 n.11 Cape Town Nov. 2014)

• The scale of the problem is reflected in South Africa's highest-ever

medical damages settlement of R25 million in June 2013, to a patient

who had undergone neurosurgery (Roytowski D, et al supra)


What are the consequences of an increase in litigation?

According to Roytowski D, et al supra, the net result of increased litigation and increasedpremiums is thought to have amongst others, the following consequences where

medical practice is concerned:

a) A change in practice to more defensive behaviour, with the effect of increasingcosts to patients and funders, ultimately driving up healthcare inflation;

b) Limiting practice to patients and conditions that are thought to be 'lower risk'

rather than taking on complex or surgically demanding cases; and

c) Discouraging specialisation in high-risk disciplines and seeking activities withreduced liability risk, such as non-clinical legal, insurance or road accident fund

work.

als


SLOPE


What are other challenges of a delict/fault/tort based malpractice system?

litigation is often a lengthy process;

Other patient are not compensated because their injuries were not negligently caused;

Indigent patient do not afford litigation costs;

When compensation is finally made, up to 25% of the claim is paid to lawyers;

Health budgets in most cases do not include the cost of claims and litigation for medical

malpractice and thus funds appropriated for health services are depleted;


SLOPE

Pharmaceuticals

COMPENSATION FOR HARM: AN ALTERNATIVE TO

TRADITIONAL LITIGATION

CompetitorWhat are the alternatives to tradition litigation for compensation for harm?

• We have seen that at the centre of medical malpractice crisis is an

increase in litigation;

• there is consensus that where patients have suffered harm compensation

must be made;

• there is a view that compensation for harm should not always be an

outcome of costly litigation

Pharmaceuticals



Competitor

What are the alternatives to tradition litigation for compensation for harm?

• What if there was a system where an incident of medical malpractice would be investigated by a

multidisciplinary committee/task team (comprising of clinical experts, legal experts, health

economist/actuaries) and where a claim is found to be legitimate, compensation is awarded to a

victim without a need to go to court and prove fault- A ‘no fault liability’.

• In South Africa a National Health Litigation Authority Bill, was drafted in 2012 “To provide for the

establishment of the National Health Litigation Authority; to provide for appropriate redress for loss

or damage arising out of medical negligence from the public and private health establishment

and where applicable, provide for appropriate redress, including monitory compensation; and to

provide for matters connected therewith.”.

PWhat are the alternatives to tradition litigation for compensation for harm?

• National Health Litigation Authority Bill is still under consideration;

• In the UK, the Secretary of State for Health, signed Order (in 1995) establishing and

constituting the National Health Service Litigation Authority “to exercise on behalf of

the Secretary of State certain of his functions in connection with the establishment

and, subsequently, the administration of a scheme under section 21 of the National

Health Service and Community Care Act 1990 for meeting liabilities of health service

bodies to third parties for loss, damage or injury arising out of the exercise by those

bodies of their functions.



PWhat are the alternatives to tradition litigation for compensation for harm?

• In 1974 New Zealand replaced a delict/tort-based system for compensating

medical injuries with a government-funded compensation system which prohibited

medical malpractice litigation(Bismark M and Paterson R. 2006, No-Fault

Compensation In New Zealand: Harmonizing Injury Compensation, Provider

Accountability, And Patient Safety, HEALTH A F FA I R S, Vo l u m e 2 5 , Nu m b e r 1);

• In 2005 New Zealand expanded eligibility for compensation to all “treatment

injuries,” thus creating a true no-fault compensation system (Bismark supra);

• The benefit of the New Zealand system is that it offers more-timely compensation to

a greater number of injured patients and more-effective processes for complaintresolution and provider accountability (Bismark supra);



PHow does New Zealand claim process work?

The New Zealand’s Accident Compensation Corporation (ACC) system is one ofthe simplest in the world for patients to navigate, and although the eligibility criteria

have changed, the decision-making process remains much the same (Bismark

supra);

Claims are decided in the ACC’s national claims unit, based on information

provided by patients and their providers, and advice from independent clinical

advisers (Bismark supra);

Straightforward claims can be processed in weeks, with a statutory requirement fordecisions to be made within nine months (Bismark supra);

Historically, the ACC has accepted around 40 percent of all claims. Dissatisfied

claimants may request a review of the decision, and if this fails, they have a right of

court appeal (Bismark supra);



PHow is the ACC financed and what kind of entitlements are paid?

The ACC is financed through general taxation and an employer levy (Bismark supra);

A fixed award schedule means that claimants with similar disabilities receive similar compensation(Bismark supra);

Entitlements fall into four categories (Bismark supra):

(1) Treatment and rehabilitation includes the cost of pharmaceuticals, disability aids, child care, homemodifications, and vocational retraining. Most treatment costs are already covered by New Zealand’suniversal health care system.

(2) Compensation for loss of earnings includes weekly compensation of 80 percent of the claimant’searnings at the time of injury, up to a set maximum. (High earners can purchase additional first-partyincome protection insurance.)

(3) Lump-sum compensation—a onetime payment of up to US$70,000 to compensate for permanentimpairment resulting from an injury—is paid in addition to any other ACC entitlements.

(4) Support for dependents-takes the form of a funeral grant and a survivor’s grant paid to surviving spousesand children under age eighteen.



What are some of the benefits of a no fault system?

Reduction of barriers to compensation;

Reduction of costs (no litigation;

Increase in disclosure of errors as health practitioners would not be threatened by

litigation;

Reduce instances of practice of defensive medicine;

Encourage specialization in arrears considered high risk because of litigation;

Increased quality of care as cases are analysed for purposes of improvement and

not defence preparation;

Any other benefits?



THANK YOU

patient safety and compensation harm · 2019-07-20 · –is an incident which did not reach the...

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