Credentialling and defining scope of clinical practice - Australian legal medical issues report


Credentialling and defining scope of clinical practice
'Credentialling refers to the formal process used to verify the qualifications,
experience and professional standing and other relevant professional attributes
of [health care professionals] for the purpose of forming a view about their
competence, performance and professional suitability to provide safe, high
quality health services within specific organisational environments. Defining the
scope of clinical practice follows on from credentialling and involves delineating
the extent of an [individual's] clinical practice within a particular organisation
based on the individual's credentials, competence, performance and
professional suitability, and the needs and capability of the organisation to
support the [health care professional's] scope of clinical practice'.92
Credentialling is an important risk management tool. It assists in ensuring that approval
granted by the hospital or health service to health care professionals to perform certain
procedures are within their experience and competence,

 therefore minimising the risk of
adverse events. Indeed the lessons learnt from various major inquiries into clinical governance
failures in acute hospitals, serve as a salutary reminder of the possible consequences of not
having effective systems in place for credentialling and defining the scope of practice of health
care professionals.
The concept that the hospital or health service may be liable for the conduct of its VMOs has
already been discussed. Further, it has been established, in the United States, that where a
patient is injured as a result of a doctor's incompetence, the hospital or health service can be
found liable for the negligent granting of privileges.93 We are of the view that particularly in the
implementation of the PCCM, in which registered nurses are taking on greater responsibilities,
an effective credentialling system should be implemented in respect of all health care
professionals, and not restricted to VMOs, to ensure a consistently high quality of patient care.94
The process of credentialling and defining the scope of clinical practice of health care
professionals should be carried out in accordance with principles of procedural fairness. The
process should be structured and routine, formalised and carefully documented. 

The process
has been recommended to include the appointment of a properly constituted committee with
carefully prepared terms of reference, the strict observation of confidentiality and the exposure
of all medical staff to the same process. It has also been recommended that regular

92 Australian Council for Safety and Quality in Health Care. Standard for Credentialling and Defining
the Scope of Clinical Practice. A national standard for credentialling and defining the scope of
clinical practice of medical practitioners, for use in public and private hospitals. July 2004. Available
93 Darling v Charleston Community Hospital 383 US 946 (1966). Liability is now limited somewhat
by US legislation which protects hospitals from liability in these circumstances provided there is
compliance with certain minimum standards of credentialling: Health Care Quality Improvement Act
1986, 42 USC 11101-11152
94 It has been suggested that in certain circumstances, a hospital could be directly liable if it failed to
provide properly qualified and competent medical staff: Wilsher v Essex Area Health Authority [1986]
All ER 801
applications ought to be made for the definition of scope of practice with a special review if
necessary if there are complaints or concerns about performance.95
Proper systems and policies ought to be put in place in respect of the process of credentialling
and defining scope of practice, in order to minimise the risk of litigation from disgruntled
practitioners who are denied rights and privileges resulting from the process.
The concept of credentialling has been endorsed by the Australian Competition Tribunal.96 It
said that:
'...The credentialling process not only involves an examination of the skills and
qualifications of the practitioner, but is directed to:

 (a) ensuring that practitioners with suitable experience are placed in
suitable positions within the hospital;
(b) ensuring that practitioners provide clinical services appropriate to the
particular role of the facility;
(c) ensuring that the hospital has available to it the necessary range of
clinical services including relevant specialities and sub-specialties to
perform its particular role; and
(d) facilitating the hospital's requirement to manage clinical and other
services to ensure their proper coordination and delivery to patients
in a clinically effective manner.'
Credentialling and defining scope of practice play an important role in assuring high quality care
and, therefore, in preventing adverse events. Yet the practical implementation of effective
credentialling and scope of practice systems is not without its problems, some of which can be
addressed by applying proper systems and policies to ensure the process is conducted fairly
and uniformly.
Open Disclosure
It has been suggested that if a patient is provided with a full and frank explanation and a sincere
apology when something has gone wrong, it is more likely that they will accept that a human
mistake has been made. Attempts to cover up mistakes are thought to increase the risk of
Open disclosure refers to the frank and open discussion of events that lead to harm to a person
while receiving health care. The essential elements of open disclosure include:
x frank discussion, which must be honest, open, and occur immediately;
x an acknowledgement that an adverse event has occurred;

 95 Appelbee L. Hospital Credentialling: Identifying and Managing the Risks. (2000 8 (1) JLM 112.
Citing LL Wilson. Credentialling of Hospital Medical Staff (1997) 17 J Qual Clin Practice 187 at 187
96 Re Australian Competition and Consumer Commission By Australian Association of Pathology
Practices Inc (2004) 206 ALR 271
97 Nisselle, P. Managing Risk in Medical Practice. JLM Vol 7. November 1999.
x an expression of regret;
x recognition of the reasonable expectations of the patient;
x a factual explanation of what happened;
x the provision of known clinical facts;
x discussion of the potential consequences and of ongoing care;

 x explanation of the steps being taken to manage the event;
x explanation of the measures being taken to prevent recurrence;
x an indication that an investigation is being, or will be undertaken to determine what
happened and to prevent recurrence, an agreement to provide feedback on the
investigation where possible.
Open disclosure, however, does not mean an admission of liability, even if an apology is made.
Health care professionals should be trained to speak openly and frankly with patients without
making an admission of liability. Open disclosure should never include any statement or
agreement as to who is liable for the harm caused. Just because an adverse event occurs
does not mean the test for negligence is satisfied.
The former Australian Council for Safety and Quality in Healthcare released an 'Open
Disclosure Standard': 'A National Standard for Open Communication in Public and Private
Hospitals, Following an Adverse Event in Health Care'.98 The purpose of the standard is to
promote a clear and consistent approach to the concept of open disclosure It has been
adopted and/or trialled by a number of health services in Victoria. Health care professionals
should ensure that they are familiar with the policy adopted by their health service with respect
to open disclosure.
Incident reporting
Any adverse event that occurs in the hospital or health service should be documented carefully
at the time it occurs and reported through the hospital's or health service's reporting systems.
Reporting assists hospitals and health services to review and remedy the causes of adverse
events, and enables them to comply with the notification requirements of their insurance policy. 

The DHS requires hospitals and health services to report 'Sentinel Events' within 3 working
days of the event occurring. The Sentinel Events which must be reported include:
x procedures involving wrong patient or body part;
x suicide in an inpatient unit;
x retained instruments or other material after surgery requiring re-operation or further
surgical procedure;

x intravascular gas embolism resulting in death or neurological damage;
x haemolytic blood transfusion reaction resulting from ABO incompatibility;
x medication error leading to the death of a patient reasonably believed to be due to
incorrect administration of drugs;
x maternal death or serious morbidity associated with labour or delivery;
x infant discharged to wrong family; and
x other catastrophic event.
Root cause analysis
One way of preventing the reoccurrence of adverse events is by root cause analysis ('RCA') on
high risk, high impact events, so that the factors which cause these events are identified. The
focus of RCA should be on the analysis of systems and processes, not individuals. The
outcomes of RCA can be used to decide what can be done to detect failures in the system, to
find solutions to address these failures and to prevent the same adverse incident from occurring
Further details on the RCA process can be found on the Victorian Government website.99 It is
vitally important that the RCA process is conducted and documented carefully to avoid
generating unnecessary medico-legal risk. Health care professionals should not conduct RCAs
unless they have received specific training. Key risk management strategies relating to
documentation of the RCAs include:
x remember – documentation may become available to the patient;
x restrict documentation to clinical facts which have been verified, as far as is possible,
as accurate;
x don’t attribute blame or make defamatory statements;
x don’t record opinions (other than expert opinion supported by evidence);
x maintain communication with the health service's insurer and seek legal opinion when
necessary; and
x investigation reports should not contain any identifying information.

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