Regulation of midwifery practice:

moving into the 21st century Prof Mary Chiarella

Obstetric Malpractice Conference

Melbourne June 2014.

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Content

•  Setting the scene •  History of midwifery regulation •  The regulation of midwifery in the new national

scheme – Continuing Professional Development – Eligible midwives – Safety & Quality Framework

•  Homebirth •  Strategic planning and evidence

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Midwifery Legislation & Regulation Midwifery regulation is the set of criteria and processes arising from the legislation that identifies who is a midwife and who is not, and describes the scope of midwifery practice. The scope of practice is those activities which midwives are educated, competent and authorised to perform. Registration is the legal right to practise and to use the title of midwife ICM “Framework for midwifery legislation and regulation”

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Global Standards for Midwifery Regulation

1.  Model of regulation 2.  Protection of title 3.  Governance 4.  Function

1.  Scope of Practice

2.  Pre-registration midwifery education

3.  Registration

4.  Continuing competence

5.  Complaints & discipline

6.  Code of conduct & ethics

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Background to the development of professional midwifery in Australia

›  First Diploma in Midwifery commenced at the Women’s Hospital in Melbourne in 1888, but only available as a P/G program for RNs

›  Midwives Registration Act 1915 (Vic) – made provision for the education and regulation of midwives

›  Nurses and midwives in all jurisdictions were later amalgamated into one regulatory framework, usually titled a Nurses’ Act

›  For many years, it was impossible in Australia to practise midwifery unless you were also a registered nurse

›  First direct entry midwifery program offered in 1997 at Flinders University South Australia (now 10 available)

›  The names of regulatory statutes started changing to Nurses and Midwives Acts from the mid-90s

›  Faculties started rebadging as Nursing and Midwifery faculties

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Background to the development of professional midwifery regulation in

Australia (cont)

•  First Doctor of Midwifery offered from 2000

•  First Chief Nurse changed her office title to the Nursing and Midwifery Office in 2003

•  Australian College of Midwives was part of the Australia Peak Nursing and Midwifery Forum auspiced by then (then) Australian Nursing and Midwifery Council

•  APNMF lobbied hard at the negotiations on the National Registration and Accreditation Scheme (NRAS) to have a separate midwifery register

•  This was achieved and with it the recognition that not all midwives were nurses

•  Still regarded as one profession for the purposes of much of the organisation of the scheme

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Midwifery in Australia NMBA registrant data March 2014

7

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

ACT NSW NT QLD SA TAS VIC WA No PPP

583

8846

534

6222

2240

644

7976

3024

209

91

687

54

528

455

13

940

318

72

Midwife

Nurse & Midwife

Who advises Health Ministers on this scheme?

›  AHMAC –Australian Health Ministers Advisory Committee (DGs) ›  NRAS sub-committee – advises AHMAC – mainly jurisdictional legal

reps but also some workforce – very influential in the early days of the scheme but completely invisible to the Boards

›  AHWPC –Australian Health Workforce Principal Committee ›  HPPPC – Health Policy Priorities Principal Committee ›  AgManCo –Agency Management Committee of AHPRA (really the

Board of the new NRAS scheme) ›  Why does it matter? Because these committees all examine various

aspects of the determinations of the Health Professional Boards – in our case the Nursing and Midwifery Board of Australia

›  SO ›  We need to know who they are and who will be looking at what.

Lots of people!!!!!!!!!!!

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Health Professions in the scheme to date…

July 2010 ! chiropractors ! dental care (including

dentists, dental hygienists, dental prosthetists & dental therapists),

! medical practitioners ! nurses and midwives ! optometrists ! osteopaths ! pharmacists ! physiotherapists ! podiatrists ! psychologists

July 2012

!  Aboriginal and Torres Strait Islander health

practitioners !  Chinese medicine

practitioners !  medical radiation

practitioners !  occupational

therapists

The regulation of midwifery in the new national regulation scheme

•  Two registers, one for nursing, one for midwifery •  Option to be non-practising •  Option to be on either or both •  Registration standards

– Criminal record check – PII – CPD (to be discussed further) – RoP – ELS

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Matters specific to midwifery already contained in the legislation

•  Midwife practitioners •  S.284 exemption for PII for homebirth midwifery

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Matters specific to midwifery that we addressed after the legislation was

introduced

•  Notation for eligible midwives •  Endorsement for eligible midwives •  The safety and quality framework (related to S.284) •  All these are currently under review

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CPD hours for midwives

Type of registration   Minimum hours   Total hours  

Midwife   20   20  

Registered nurse and midwife  

RN 20 Midwife 20   40  

Enrolled nurse and midwife  

EN 20 midwife 20   40  

Midwife practitioner endorsement  

Midwife 20 endorsement 10  

30  

Eligible midwife   Midwife 20 EM 20   40  

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CPD (cont)

•  In addition, an eligible midwife is also required to successfully complete a board-approved midwifery professional practice review (MPPR) every three (3) years to demonstrate competence in providing pregnancy, labour, birth and postnatal care to women and their infants across the continuum of midwifery care (currently under review).

•  If CPD activities are relevant to both nursing and midwifery professions, those activities may be counted as evidence for both nursing and midwifery CPD hours, provided they are relevant to your context of practice and improve and broaden your knowledge, expertise and competence.

•  The number of CPD hours that you are required to have is listed in the national board’s CPD registration standard published under the tab on the national board website

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What is an eligible midwife? •  Not a creation of the national regulatory scheme –provision for

registering midwives and midwife practitioners •  Developed by MSAG during the maternity reforms following the

Maternity Services Review •  MSAG determined that only “eligible midwives” would be eligible for

access to MBS and PBS •  It was agreed that NMBA should take ownership of this as there were

clearly regulatory issues emerging •  MSAG had deemed there had to be a set of criteria for eligibility •  These were being negotiated by other key stakeholders in Canberra

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So MORE key stakeholders to advise AHMC

•  Consumer groups

•  Midwifery groups

•  Obstetricians and GPs

•  Insurers

•  Industrial bodies

•  PLUS

•  All the other people who were already advising them earlier

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Legislative background to eligible midwives

•  2009-10 Budget measures announced new arrangements to enhance and expand the roles of nurse practitioners and midwives to allow them to take a greater role in providing quality health care.

•  Health Legislation Amendment (Midwives and Nurse Practitioners ) Act 2009 (Cth) was passed

•  The purpose of the Health Legislation Amendment (Midwives and Nurse Practitioners ) Act 2009 (Cth) is to amend the Health Insurance Act 1973 (Cth) and the National Health Act 1953 (Cth) to enable nurse practitioners and appropriately qualified and experienced midwives to request appropriate diagnostic imaging and pathology services for which Medicare benefits may be paid.

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Health Legislation Amendment (Midwives and Nurse Practitioners )

Act 2009 (Cth)

•  It will also allow these health professionals to prescribe certain medicines under the Pharmaceutical Benefits Scheme (PBS). The 2009-10 Budget measure also provides for the creation of new Medicare items, and referrals under the Medicare Benefits Schedule (MBS) from these health professionals to specialists/consultant physicians.

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Amended and new legislation

•  The Health Insurance Act 1973 (Cth) and the National Health Act 1953 (Cth) will be amended to provide access to the new arrangements.

•  Under the Health Insurance Act 1973 (Cth), a 'participating nurse practitioner ' or 'participating midwife' will be able to request or provide certain Medicare services.

•  Under the National Health Act 1953 (Cth), an 'authorised nurse practitioner ' or 'authorised midwife' will be authorised to prescribe certain PBS medicines.

•  Schedule 2 of the Act makes amendments to the Health Insurance Act 1973 (Cth), National Health Act 1953 (Cth), Medicare Australia Act 1973 and Medical Indemnity Act 2002 (Cth) which are consequential to, and commence at the same time as, the Midwife Professional Indemnity (Commonwealth Contribution) Scheme Act 2009 (Cth)

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Eligible midwives

•  Endorsement as an eligible midwife

•  Professional indemnity insurance arrangements in place or midwife meets the requirements for exemption

•  Safety and Quality framework for midwifery practice

•  PLUS

•  C’th requirements for collaborative arrangements

Now three NMBA regulatory elements to the registration provisions

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Endorsement as an eligible midwife

a)  Current general registration as a midwife in Australia with no restrictions on practice;

b)  Midwifery experience that constitutes the equivalent of 3 years full time post initial registration as a midwife;

c)  Current competence to provide pregnancy, labour, birth and post natal care to women and their infants;

d)  Successful completion of an approved professional practice review program for midwives working across the continuum of midwifery care;

To be entitled to endorsement as an eligible midwife, a midwife must be able to demonstrate all the following:

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Endorsement as an eligible midwife

e)  20 additional hours per year of continuing professional development relating to the continuum of midwifery care;

f)  Successful completion of:

– an accredited and approved program of study determined by the Board to develop midwives’ knowledge and skills in prescribing, or

– a program that is substantially equivalent to such an approved program of study, as determined by the Board.

:

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Safety and quality framework (S&QF)

•  The Health Ministers required that, in accordance with s. 284 of the National Law, a S&QF be put in place for privately practising midwives who were undertaking homebirth

•  NMBA was required initially to adopt the S&QF developed under the auspices of the (then) Victorian Minister for Health, but has just developed a S&QF that applies to all midwives

•  The original S&QF was based on four key principles, each of which requires evidence of compliance from the midwife. These principles are: consumer value, clinical performance and evaluation, clinical risk and professional development.

•  These principles reflect those articulated in the report on “Primary Maternity Services in Australia” (AHMAC 2008)

•  The S&QF currently out for consultation embraces these concepts and is also congruent with the NMBA regulatory framework

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Collaborative arrangements

•  Were introduced by the Federal government to ensure midwives are able to transfer care to a doctor when necessary

•  However they are not optional, they are compulsory

•  As the AMA explain "requirement for a collaborative arrangement with a medical practitioner puts in place an overarching quality framework to preserve patient safety and ensure that medical practitioners are not left out of the loop"

•  The legislation regarding collaborative arrangements includes:

•  The National Health (Collaborative arrangements for midwives) Determination 2010, and

•  The Health Insurance Amendment Regulations 2010 (No. 1).

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Collaborative arrangements

•  Collaborative arrangements make for an interesting concept

•  There is an absolute requirement for a midwife to collaborate with a doctor but no reciprocal requirement for a doctor to collaborate with a midwife

•  Thus collaboration doesn't necessarily describe the situation accurately

•  It seems more like an arranged and very one-sided marriage whereby if the midwife promises to "love, honour and obey" then the doctor promises (we hope) to love and honour but happily agrees to be obeyed

•  It seems odd that what is a completely professional expectation - namely that a midwife would refer to or work with a doctor if (s)he believed the patient to be high risk – becomes a matter of coercion that goes to the heart of access to MBS

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Add to the already complex mix the question of homebirth

•  …a valid and mainstream choice for women in many countries •  It provides many women with a satisfying and rewarding birth experience •  The right to have access to homebirth is now considered to be a fundamental

human right, according to the European Court of Human Rights in Strasbourg (Ternovszky v. Hungary (Application no. 67545/09) 14th December 2010)

•  In Australia PPMs cannot obtain PII to cover them for homebirth but all HCPs are required to have PII in order to practise their profession.

•  S.284 (discussed above in relation to the S&QF) provides an exemption for PPMs to be able to conduct homebirths without PII providing (inter alia) there is a S&QF in place

•  However PPMs do have to have PII to cover ante and post partum care, which means that, in order to access the government sponsored PII scheme, they have to meet the same criteria to be notated as eligible midwives

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How do we plan for the regulation of midwifery?

•  Good decisions are made on good information (Charlesworth M. 1989 Boyer Lectures)

•  Hard cases make bad law (Rolfe J. Winterbottom v Wright 1842)

•  Thus we need evidence •  Evidence of what works here, evidence of what can

work elsewhere, evidence of what is safe

My maxims

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NMBA strategic planning

•  PII - study commissioned by NMBA, completed by PwC •  SQF – out for consultation •  Supervision of PPM –study commissioned by NMBA, in

progress by PwC •  Midwifery Standards for Practice – RFT in place •  Registration standard for eligible midwives –out for

consultation

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The evidence –what is safe, what works elsewhere, what might work

here

•  National Institute for Clinical Excellence (UK) 2014 •  Intrapartum care: care of healthy women and their

babies during childbirth •  http://www.nice.org.uk/nicemedia/live/

13511/67644/67644.pdf

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Two key recommendations (p.10)

•  Advise low-risk multiparous women to plan to give birth at home or in a midwifery-led unit (freestanding or alongside). Explain that this is because the rate of interventions is lower and the outcome for the baby is no different compared with an obstetric unit.

•  Advise low-risk nulliparous women to plan to give birth in a midwifery-led unit (freestanding or alongside). Explain that this is because the rate of interventions is lower and the outcome for the baby is no different compared with an obstetric unit, but if they plan birth at home there is a small increase in the risk of an adverse outcome for the baby.

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The Birthplace UK study, 2011 (cohort of 65,000 women)

•  There were 250 primary outcome events and an overall weighted incidence of 4.3 per 1000 births (95% CI 3.3 to 5.5).

•  Overall, there were no significant differences in the adjusted odds of the primary outcome for any of the non-obstetric unit settings compared with obstetric units.

•  For nulliparous women, the odds of the primary outcome were higher for planned home births (adjusted odds ratio 1.75, 95% CI 1.07 to 2.86) but not for either midwifery unit setting.

•  For multiparous women, there were no significant differences in the incidence of the primary outcome by planned place of birth. “

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Continuity of care midwifery models

•  Caseload midwifery care versus standard maternity care for women of any risk: M@NGO, a randomised controlled trial

•  The Lancet, Volume 382, Issue 9906, Pages 1723 - 1732, 23 November 2013

Prof Sally K Tracy DMid, Donna Hartz PhD, Mark B Tracy FRACP, Jyai Allen BMid, Amanda Forti RM, Bev Hall MIPH, Jan White RM, Anne Lainchbury MMid, Helen Stapleton PhD, Michael Beckmann FRANZCOG, Andrew Bisits FRANZCOG, Prof Caroline Homer PhD, Prof Maralyn Foureur PhD, Prof Alec Welsh FRANZCOG, Prof Sue Kildea PhD

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Findings M@NGO study

•  Publicly insured women were screened at the participating hospitals between Dec 8, 2008, and May 31, 2011.

•  1748 pregnant women were randomly assigned, 871 to caseload and 877 to standard care. The proportion of caesarean sections did not differ between the groups (183 [21%] in the caseload group vs 204 [23%] in the standard care group;

•  The proportion of women who had elective caesarean sections (before onset of labour) differed significantly between caseload and standard care (69 [8%] vs 94 [11%];

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Findings (M@NGO study –cont)

•  Proportions of instrumental birth were similar (172 [20%] vs 171 [19%]; as were the proportions of unassisted vaginal births (487 [56%] vs 454 [52%]; and epidural use (314 [36%] vs 304 [35%].

•  Neonatal outcomes did not differ between the groups. T •  Total cost of care per woman was AUS$566·74 (95%

106·17—1027·30; less for caseload midwifery than for standard maternity care.

•  The results show that for women of any risk, caseload midwifery is safe and cost effective.

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The Lancet Midwifery Series

•  Launched  in  London  on  June  23,  2014,  is  a  collabora8on,  supported  by  The  Bill  and  Melinda  Gates  Founda8on,  that  advocates  for  developing  midwifery  services  at  scale.  

•  The  four  papers  in  the  series  look  at  the  impact  of  midwifery  and  health  systems  on  improving  maternal,  newborn  and  child  health  outcomes  in  low-­‐  and  middle-­‐income  countries.  An  interna8onal  team  of  35  researchers  in  midwifery  put  together  a  comprehensive  evidence  base  (god  enough  to  be  published  in  the  Lancet!).  

•  The  Lancet  series  papers  have  been  accompanied  by  a  huge  investment  in  iden8fying  the  state  of  play  in  73  high  burden  countries  in  "The  State  of  the  World's  Midwifery  2014:  A  Universal  Pathway.  Woman's  Right  to  Health"  report.  

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The  State  of  the  World's  Midwifery  2014:  A  Universal  Pathway.  Woman's  Right  to  Health"

•   Only  four  of  the  73  countries  in  the  report  have  a  midwifery  workforce  that  is  able  to  meet  the  need  for  sexual,  reproduc8ve,  maternal  and  newborn  health  services.    

•  Consequently,  many  women  and  babies  die  from  preventable  causes.    

•  A  woman  in  Sub-­‐Saharan  Africa  has  a  one-­‐in-­‐30  chance  of  dying  while  giving  birth.  In  the  developed  world,  the  chance  is  one-­‐in-­‐5,600.  

•  Experts  have  calculated  that  scaling  up  the  skilled  midwifery  workforce  would  prevent  close  to  two-­‐thirds  of  all  maternal  and  newborn  deaths,  saving  millions  of  lives  every  year.     36

The NMBA is adding to the evidence base

•  PII study •  Models of supervision study •  Midwifery standards for practice •  Data audits

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PII Study

•  The report was commissioned by NMBA to obtain information on the uptake and provision of PII internationally, the claims and complaints environment in relation to privately practising midwives (PPMs) providing homebirth and the potential barriers and enablers to PII for PPMs in Australia

•  They were specifically requested to model the issues and to identify considerations

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PII considerations

•  Specific registration of PPMs •  PPM Practice models –group practice, support,

supervision •  Nationally consistent risk assessment models and

frameworks for care •  Improved data collection •  Strengthened ties between industry and insurers •  Alternate insurance models •  Enhanced collaborative models to improve referral

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RFT on supervision models •  The scope of the project includes; •  International literature review on models of

supervision for midwives & other health professionals

•  Conduct interviews & focus groups with stakeholders

•  Analyse and assess models of supervision suitable for implementation in Australia

•  Recommendation of suitable & innovative models including cost and implementation strategy

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S&QF for midwives •  Currently out for consultation •  Now applicable to all midwives regardless of place

of practice •  However, specific requirements for PPMs providing

intrapartum care in the home to meet the provisions of S.284

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The elements of the SQF are as follows:

1. National competency standards 2. Scope of practice 3. Codes of professional conduct and ethics 4. Guide to professional boundaries 5. Recency of practice 6. Professional indemnity insurance

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Elements of the SQF (cont)

7. Continuing professional development 8. Decision making framework 9. Annual declaration 10. Audit of compliance with registration standards 11. Co-regulatory requirements of Medicare and the National Board* 12. Prescribing authority and compliance with state and territory legislation*

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Elements of the SQF (cont)

13. Collaborative arrangements* 14. Consultation and referral. 15. Guidelines for advertising of regulated health services 16. Mandatory reporting, and 17. Notification and management of performance, conduct or health matters, and 18. Clinical risk management.

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PII exemption

•  The National Law provides an exemption for PII to privately practising midwives providing intrapartum services in the home providing the following conditions are met. These conditions are outlined in section 284 of the National Law:

•  woman must give informed consent •  midwife must comply with any requirements set out

in a code or guideline approved by the Board included any reports to be provided, and

•  midwife must comply with the requirements relating to the safety and quality of the midwife’s practice.

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PII exemption (cont) •  The exemption to PII does not extend to any

antenatal and postnatal care that may be provided. PII for antenatal and postnatal care remains the responsibility of the privately practising midwife and continues to be part of the approved registration standard for PII.

•  To be considered eligible for PII exemption from the insurance requirement of the National Scheme, all PPMs who provide homebirth services are required to comply with this Board-approved Safety and quality framework (SQF) and to be able to demonstrate the requirements with supported evidence as outlined in the table below: 46

Evidentiary requirements to claim PII exemption under S.284

•  Privately practising midwives wishing to claim an exemption under S.284 will be identified at renewal and will be required to provide evidence that they meet the specifications identified. If they choose to be notated as an eligible midwife then there are evidentiary requirements that form part of the application for notation and ongoing compliance with the registration standard that will address these specifications in part.

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Evidentiary requirements to claim PII exemption under S.284 (cont)

•  In the event that a PPM does not yet meet, but is working towards the higher level criteria for notation as an eligible midwife, they must be practising under the supervision of an EM or medical practitioner. This is to occur until they attain the required competencies to be endorsed under the National Law as an eligible midwife.

•  A PPM who chooses / elects / decides not to practise with the notation as an EM, must be able to meet the S.284 evidentiary requirements outlined in Table 2 and provide annual evidence of compliance with those requirements. All PPMs who are not notated as EMs will be audited to ensure compliance with S.284 and policy requirements.

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Where to from here?

•  We believe we have proposed a robust framework for the protection of the public for PPMs wishing to provide antepartum care in the home.

•  The results of the midwifery supervision project will be critical to our next step.

•  We hope the work we are doing and the evidence emerging about homebirth will assist insurers to feel confident to provide PII and to obviate the need for S.284

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Regulation of scope of practice

•  What we cannot currently do is to protect the public against unregulated health workers who choose to assist with birth

•  Some jurisdictions are implementing restricted birthing practices legislation

•  We would prefer a regulated scope of practice in relation to ante-natal, intrapartum and post partum care to midwives, obstetricians and appropriately qualified General Practitioners

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The dilemma of the regulator

•  “Regulation touches the point between the public and the personal. Over regulation is seen as an interference in personal conduct; under regulation is seen as an abdication of public responsibility. When harm happens we blame ineffective regulation but when we are stopped from doing something risky we say regulation is excessive. The public, media and politicians often face both ways wanting more or less regulation depending on the moment and the mood”.

Harry Cayton, Chief Executive, Commission for Health Care Regulatory Excellence

Further Information

www.nursingmidwiferyboard.gov.au

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•  Brocklehurst P (2011) Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study BMJ 2011;343:d7400

•  National Institute for Clinical Excellence (UK) 2014 •  Intrapartum care: care of healthy women and their

babies during childbirth •  http://www.nice.org.uk/nicemedia/live/

13511/67644/67644.pdf •  Winterbottom v Wright (1842) 10 M&W 109

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