Risk management and medico-legal issues in reproductive healthcare

1. Risk management and medico-legal issues in reproductive healthcare Babatunde A. Gbolade Consultant Gynaecologist Director, Fertility Control Unit St James’s University Hospital Leeds

2. Risk management and medico-legal issuesin reproductive healthcare • Risk – The likelihood and consequence of something going wrong • Risk management - An approach to improving the quality of and safety of health care by identifying circumstances that put patients, staff and organisations at risk and acting to prevent or control those risks • Most commonly accepted definition is that of the joint Australia/New Zealand standard 4360:1999

3. Risk management and medico-legal issuesin reproductive healthcare “…a logical and systematic method of establishing the context, identifying, analysing, evaluating, treating, monitoring and the communication of risks associated with any activity, function or process in a way that will enable organisations to minimise losses and maximise opportunities. Risk management is as much about identifying opportunities as avoiding losses.”

4. Risk management and medico-legal issuesin reproductive healthcare • Input into risk management • FFPRHC evidence-based guidelines • RCOG evidence based guidelines • NICE Guidelines • WHO Medical eligibility Criteria • Clinical governance • Quality Assurance schemes (cervical screening, Colposcopy etc) • Legal sources (CNST, NHSLA, Defence Societies)

5. Risk management and medico-legal issuesin reproductive healthcare • Responsibility of all staff • Part of quality improvement programme • Individual roles and responsibilities need to be clearly understood • Ongoing training in quality improvement and risk management is important for all professionals working in this field • Need to strike a balance between overprotection that inhibits progress and innovation , and insufficient protection which can lead to unnecessary injury, loss or damage. • Care and safety of patients, staff and organisation should be of primary concern

6. Risk management in reproductive healthcare - Strategy • A structured approach to clinical risk management within a clinical governance framework that meets the needs of patients, staff and organisation • Risk management group with a multidisciplinary membership should be in place to provide strategic direction • A risk register should be established and systems should be in place to communicate effectively with all staff

7. Risk management in reproductive healthcare - Process

8. Risk management in reproductive healthcare – Risk identification • Formal processes should be in place using internal and external data to identify risks to delivery of safe, high quality service • Internal sources – • Incident reports • Near miss reports • Complaints • Claims • Patient satisfaction surveys • Staff surveys and consultations • Clinical audit • Risk assessment exercise in all clinical areas

9. Risk management in reproductive healthcare – Risk identification • External sources – • National Patient Safety Agency (NPSA) Alerts • Healthcare Commission reports • Medico-legal Defence Body data • Training, accreditation and acquisition of competencies mandatory for practice in the field (DFFP, MFFP, LOCs

10. Risk management in reproductive healthcare – Risk identification • Incident reports • Missed diagnosis (ectopic pregnancy, missed abortion) • Failed operations (TOP, Laparoscopic sterilization, vasectomy) • Omission of planned procedures (insertion/removal of IUD, Implanon) • Incorrect drug therapy • Omission • Wrong drug • Wrong dose • Wrong regimen

11. Risk management in reproductive healthcare – Risk analysis and evaluation • Establish the likelihood of an incident or risk and the consequences that follow • Assign a risk score for each risk or incident

12. Risk management in reproductive healthcare – Risk Treatment • Identify and consider range of options for dealing with the risk • Formulate and Action Plan to be implemented to reduce or eliminate the risk of similar incidents occurring again

13. Risk management in reproductive healthcare – Monitoring, Review and Feedback • Risks identified through earlier processes should be entered into a risk register. Escalation to different levels can take place based on present thresholds – • Risk management group should meet regularly to monitor and review incidents within the service • Regular dialog between protocol and risk management groups • Feedback through appropriate means to individuals and within the service • Communication to relevant external bodies (CNST, NPSA, MHRA)

14. Make the care of your patient your first concern; Treat every patient politely and considerately; Respect patients' dignity and privacy; Listen to patients and respect their views; Give patients information in a way they can understand Respect the rights of patients to be fully involved in decisions about their care; Respect and protect confidential information; Medico-Legal issues in reproductive healthcare The Duties Of A Doctor

15. Medico-Legal issues in reproductive healthcare Confidentiality • Patients have a right to confidentiality • Protection against improper or unintentional disclosure • Sharing of personal information • within the health care team, (unless patient objects). • with other organisations/agencies providing health /social care. • Data Protection Act

16. Medico-Legal issues in reproductive healthcare Disclosure • Disclosure without consent may be justified where failure to do so may expose the patient or others to risk or death or serious harm • Personal information may be disclosed in the public interest • E.G. Where a disclosure may assist in the prevention or detection of a serious crime. • If you believe a patient to be a victim of neglect or physical, sexual or emotional abuse

17. THE NATIONAL HEALTH SERVICE ACT 1977, The NHS Trusts and Primary Care Trusts (Sexually Transmitted Diseases) Directions 2000 Every NHS trust and Primary Care Trust shall take all necessary steps to secure that any information capable of identifying an individual obtained by any of their members or employees with respect to persons examined or treated for any sexually transmitted disease shall not be disclosed except- • for the purpose of communicating that information to a medical practitioner, or to a person employed under the direction of a medical practitioner in connection with the treatment of persons suffering from such disease or the prevention of the spread thereof, and • for the purpose of such treatment or prevention.

18. Medico-Legal issues in reproductive healthcare Consent • Agreement for a health professional to provide care • Patients can change their minds and withdraw consent at any time. • For consent to be valid patient must • Be competent to make decision • Have received sufficient information to make it • Not be acting under duress

19. Medico-Legal issues in reproductive healthcare Consent • Consent must be given voluntarily, not under • any form of duress • undue influence from healthprofessionals, family or friends. • You should: • give a balanced view of the options; • explain the need for informed consent. • you must declare any potential conflicts of interest

20. Medico-Legal issues in reproductive healthcare Types of Consent • Consent can be • written • oral • implied • A signature on a consent form does not itself prove the consent is valid • Beware of a patient's apparent compliance

21. Medico-Legal issues in reproductive healthcare Competence A patient will be competent if he or she can: • comprehend information, which has been presented to them in a clear way; • believe it; • retain it long enough to weigh it up and make a decision. Seek legal advice if in doubt. 

22. Medico-Legal issues in reproductive healthcare Who is competent? • Adults are always assumed to be competent unless demonstrated otherwise • A competent pregnant woman may refuse any treatment, even if this would be detrimental to the fetus. • Young people aged 16 and 17. • Younger children who understand fully what is involved in the proposed procedure

23. Medico-Legal issues in reproductive healthcareYoung People • The Children Act 1989 defines a young person as “a person who has not yet reached 18 years of age” • The age of consent in England Wales and Scotland is 16 and in Northern Ireland it is 17. • This applies to both hetero and homosexual sex

24. Medico-Legal issues in reproductive healthcare The Fraser Ruling • The young person understands the doctors advice • The doctor cannot persuade the young person to inform his/her parents and will not allow the doctor to inform his/her parents that the young person is seeking contraceptive advice • The young person is very likely to begin or continue having sexual intercourse with or without contraceptive treatment • Unless s/he receives contraceptive advice or treatment the young person’s mental or physical health or both are likely to suffer • The young person’s best interests require the doctor to give contraceptive advice or treatment or both without parental consent

25. Medico-Legal issues in reproductive healthcareThe Children Act • The best interests of the child are paramount • Duty of disclosure to Child Protection Services • With agreement if possible • The need of the young person for a confidential sexual health service vs. the need for protection from sexual abuse and exploitation • The law permits the disclosure of confidential information necessary to safeguard a young person. • Legal advice should be taken in doubtful cases

26. Medico-Legal issues in reproductive healthcare Child protection Issues • Risk of Sexually transmitted infections • Past and continuing sexual abuse/assault • Undiagnosed mental health problems including self-harm, eating disorders, alcohol and substance misuse • Risk of or involvement in prostitution/commercial sex work • Vulnerability of those living away from home/accommodated by the local authority • Vulnerability of disabled young people/ or those with learning difficulties irrespective of age

27. Medico-Legal issues in reproductive healthcare Child Protection issues • Be alert to the possibility of child abuse and neglect • Be aware of local area child protection committee procedures and protocols • Know the names of relevant named professionals • Be aware of your local under 16s guidelines • Be familiar with local procedures for checking the child protection register • Receive appropriate training to recognise and act on child welfare concerns

28. Write legibly Print your name Date and sign all entries Ensure that identifier is at the top of all continuation sheets together with the date. Keep contemporaneous complete, clear, accurate and appropriate record of all consultations including telephone consults Information should be factual- relevant clinical findings, decisions made, information drugs or other treatment prescribed; A copy of all letters should be retained in notes All correspondence and investigations should be filed in date order  Use the medical records as a source of information Medico-Legal issues in reproductive healthcare Record keeping