Reporting of Deaths and Adverse Events Mandatory or Voluntary

1
Reporting ofDeaths and Adverse
EventsMandatory or Voluntary?

• Dr Heather Wellington
• 7 June, 2005

2
Overview of Presentation

• Concepts
• Current approaches to reporting
• Objectives of reporting
• Designing effective systems of compliance
• Conclusions

3
Concepts

• Man-da-tor-y
• 1. Required or commanded by authority obligatory
• Vol-un-tar-y
• 1. Done or undertaken of ones own free will

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Concepts

• Mandatory may, but does not necessarily, mean
  written in legislation for example, many
  health care accreditation systems in Australia
  are technically voluntary but are linked to
  funding or other incentives, making compliance a
  precondition to commercial survival
• Many voluntary systems are premised on either
  anonymity or confidentiality, and many mandatory
  systems are premised on disclosure, but
  mandatory is not necessarily synonymous with
  disclosure and voluntary is not necessarily
  synonymous with anonymity/confidentiality

5
Current approaches to reporting

• Suggestions for mandatory reporting generally
  attract strong reactions
• Groups are sharply split over whether health
  care organisations should be mandated to report
  serious or sentinel medical events to State
  agencies the split over mandatory reporting
  cuts to the core of the health care systems
  traditional reluctance to identify hospital
  procedures that contribute to serious medical
  errors. Patient safety experts say such
  reporting will force a change in the culture of
  finger-pointing that typically follows such
  events. Heath care providers, on the other hand,
  predict it would create new liability nightmares
  and drive voluntary efforts to admit and correct
  mistakes underground.
• Medscape, 2000

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Current approaches to reporting

• Coronial legislation mandates reporting
• Professional insurance coverage generally
  contingent on prompt reporting (effectively
  mandatory)
• All births (including stillbirths) must be
  reported to the CCOPMM (s162G Health Act 1958)
• Public health reporting requirements are
  generally mandated (cancer, infectious diseases)
• Victorian DHS requires hospitals to report
  sentinel events, but compliance is incomplete
• Device manufacturers and sponsors are required to
  report to the TGA adverse events associated with
  a medical device (IRIS Incident Report
  Investigation Scheme)
• Otherwise, reporting is largely voluntary e.g.
  APSF AIMS incident reporting, organisational
  safety and quality programs

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Objectives of reporting

• Reporting advocated for both accountability and
  improvement
• Reporting often advocated because the community
  has a right to know. Mandatory systems may be
  considered to have the potential to provide more
  transparent and complete information
• There is a continuing tension between the
  communitys right to know and the public
  interest in health care professionals
  participating in safety and quality programs,
  which is often said to be dependent on
  anonymity/confidentiality and, therefore, on
  voluntary rather than mandatory systems

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Objectives of reporting

• The purpose of mandatory reporting was
  essentially for accountability most people
  dont believe hospitals are held accountable, and
  that theres a tendency to cover things up.
• Lucien Leape MD re IOM study

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Objectives of reporting

• Some members of the medical profession
  maintain that such pressures public and
  parliamentary, to bring medical practice under
  closer scrutiny are to be resisted without
  argument and without compromise, and that we
  should have nothing to do with medical audit,
  quality control or whatever.
• McIntyre N, Popper K. The critical attitude in
  medicine the need for a new ethics. BMJ
  19832871921

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Objectives of reporting

• The rationale for anonymity/confidentiality
  (which often is associated with voluntary
  reporting systems) is based on
• Critical dependence on involvement of health care
  professionals for successful quality programs
• Medical culture that personalises error and seeks
  and expects perfection (i.e. denial of adverse
  events)
• Public and media attitudes to accountability that
  focus on blame
• Concern about data integrity and validity
• Concern about medico-legal consequences
• One view has been that improvement will only be
  achieved through genuine engagement of health
  care professionals, rather than through compulsion

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Objectives of reporting

• In South Australia
• 94.2 of survey respondents believed healthcare
  workers should report medical errors and
• Respondents were reluctant to accept healthcare
  worker anonymity (68 in favour of
  identification) (Evans, Berry et. al., 2004)
• In the USA
• The vast majority of consumers say that reporting
  of medical errors should be required and most say
  that this information should be released to the
  public (Kaiser Family Foundation, 2004)
• A majority of hospital managers object to state
  laws requiring major and minor errors to be
  reported (Weissman, 2005)

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Objectives of reporting

• Improvement purposes are based on potential to
  prevent further events
• To err is human but not to learn from our
  mistakes, and not to pass on what we learnt to
  others in order to prevent injury is
  unforgivable
• Mike Flood, TGA

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Objectives of reporting

• If all we do is create a big database in the sky
  to collect reports, all youre doing is counting
  mistakes, not improving patient safety and
  reducing medical errors. What we want is
  information in the hands of experts to understand
  what happened and to make the changes that are
  needed immediately.
• Carmela Coyle, American Hospitals Association
  (advocating local reporting and action)

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Objectives of reporting

• the Achilles heel of error-reporting
  systems the flawed notion that reporting
  alone is sufficient evidence that safety is
  improving. While there are certainly many
  pockets of success much work remains to create
  a system that effectively translates error into
  meaningful solutions.
• J Weisserman

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Objectives of reporting

• 69 of hospital leaders consider that mandatory
  systems that share information with the public
  discourage reporting
• 79 of hospital leaders consider that such
  systems encourage lawsuits
• Concern about lawsuits not shared as strongly by
  respondents from states that have such systems
  implemented 33 say no effect, or a positive
  effect
• Does familiarity breed acceptance??

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Objectives of reporting

• Will the information contribute to better
  outcomes/lower risk?
• Are communities likely to place a high value on
  accessibility to the information?
• Is access to the information likely to be
  important for public health?
• Are there likely to be any adverse consequences
  of mandating reporting (secrecy, disincentive or
  failure to disclose, cultural consequences etc)
• Are there alternative means of accessing the
  information?
• Are there alternative sources that could serve
  the same purpose?
• Is the information able to be interpreted?

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Designing effective regulatory systems

• The concept of responsive regulation
  encompasses diverse governance strategies to
  effect sustainable change
• Includes, e.g., consumer education and
  engagement, provider education and engagement,
  funding/financing strategies, information
  collection/feedback/disclosure, direct and
  indirect regulatory strategies
• The notion of responsive regulation requires
  the regulator to be armed with an escalating
  hierarchy of sanctions from which appropriate
  responses can be devised to address non-compliant
  conduct
• The ultimate sanction - corporate capital
  punishment - is rarely if ever used

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Conclusions

• Mandatory v voluntary needs to be
  distinguished from confidential/ anonymous v
  disclosed
• Proposals for mandatory reporting inevitably
  engender strong positions for and against
• Objectives of reporting systems are usually
  related to accountability and improvement
• Strong public desire for transparency and
  accountability
• Health care providers often have concerns about
  the way in which information will be used/abused
• Depending on the type of information that is
  required, mandating disclosure may not be the
  best approach