Standard operating procedure

Premature Ovarian Insufficiency SOP

How [Organisation Name] identifies, investigates, and manages or refers patients under 40 with suspected premature ovarian insufficiency, a different clinical proposition from menopause at the expected age

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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Service model and competence
  • 6. Recognition and initial assessment
  • 7. Diagnosis
  • 8. Investigating the cause
  • 9. Patients needing a specialist pathway
  • 10. Hormone therapy
  • 11. Bone, cardiovascular and long-term health
  • 12. Fertility, contraception and psychological support
  • 13. Follow-up and annual review
  • 14. Safety netting and patient information
  • 15. Records
  • 16. Training and competence
  • 17. Monitoring and audit
  • 18. Related documents
  • 19. Review and version control
  • 20. Disclaimer

CQC fundamental standard

Regulation 9 (Person-centred care)
This document is written to evidence that standard. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

Legislation & standards it maps to

  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • European Society of Human Reproduction and Embryology (ESHRE), Evidence-based guideline: premature ovarian insufficiency (2024).
  • British Menopause Society consensus statements and Tools for Clinicians.
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including the sections on remote prescribing and on sharing information with a patient's general practitioner.
  • GMC, Remote consultations guidance and decision flowchart.
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, in particular Regulation 9 (Person-centred care), Regulation 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 13 (Safeguarding service users from abuse and improper treatment), Regulation 17 (Good governance) and Regulation 20 (Duty of candour).
  • Equality Act 2010.
  • UK General Data Protection Regulation and Data Protection Act 2018; Records Management Code of Practice (2023).
  • Care Quality Commission (CQC) assessment framework: the five key questions (safe, effective, caring, responsive and well-led) and the quality statements of the single assessment framework, and the sector-specific framework for primary care and community services when it replaces them.

Who it applies to

All clinical and administrative staff at [Organisation Name], including self-employed, sessional and locum clinicians, whether care is delivered in person or remotely

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

21-hydroxylase antibodies
Antibodies that attack the adrenal glands; a positive test signals a risk of Addison's disease.
Addison's disease (adrenal insufficiency)
A condition in which the adrenal glands do not make enough of certain hormones, which can cause a life-threatening adrenal crisis.
Amenorrhoea
The absence of periods.
Anti-Mullerian hormone (AMH)
A hormone that gives an indication of how many eggs remain in the ovaries.
British Menopause Society (BMS)
The United Kingdom specialist society for health professionals working in menopause care.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Combined hormonal contraception (CHC)
Contraception containing both an oestrogen and a progestogen, such as the combined pill, patch or ring.
Data Protection Act 2018 and UK General Data Protection Regulation (UK GDPR)
The laws governing how personal information, including health records, is collected, used and kept.
Dual-energy X-ray absorptiometry (DXA)
A low-dose X-ray scan that measures bone density.
Duty of candour
The legal duty to be open and honest with patients when something goes wrong that causes, or could cause, significant harm.
Early menopause
Menopause between the ages of 40 and 45.
Equality Act 2010
The law protecting people from discrimination, including on grounds of sex, gender reassignment and disability.
European Society of Human Reproduction and Embryology (ESHRE)
A European professional society that publishes evidence-based guidelines on reproductive medicine, including premature ovarian insufficiency.
FMR1 premutation
A change in the gene linked to fragile X syndrome that can cause premature ovarian insufficiency and can be passed on in families.
Follicle-stimulating hormone (FSH)
A hormone that rises in the blood when the ovaries are no longer working normally.
Fraser guidelines
Criteria used when deciding whether to give contraceptive advice or treatment to a person under 16 without parental involvement.
General Medical Council (GMC)
The body that registers and regulates doctors in the United Kingdom.
General Pharmaceutical Council (GPhC)
The body that registers and regulates pharmacists and pharmacy technicians in Great Britain.
General practitioner (GP)
The patient's family doctor.
Genetic counselling
A specialist appointment explaining a genetic result, what it means for the patient and relatives, and the choices available.
Gillick competence
Whether a person under 16 has enough understanding and maturity to consent to their own treatment.
Glycated haemoglobin (HbA1c)
A blood test showing average blood sugar over the previous two to three months.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards that registered providers must meet, enforced by the CQC.
Hormone replacement therapy (HRT)
Medicines that replace the oestrogen, and where needed progestogen, that the ovaries no longer make.
Iatrogenic
Caused by medical treatment, such as surgery, chemotherapy or radiotherapy.
International units per litre (IU/L)
The unit used to report FSH levels in the blood.
Karyotype
A test that looks at a person's chromosomes for changes in their number or structure.
Levonorgestrel intrauterine system (LNG-IUS)
A small device placed in the womb that releases progestogen; the 52 mg device can protect the womb lining during HRT.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom regulator of medicines and medical devices.
National Institute for Health and Care Excellence (NICE)
The body that publishes national evidence-based guidance on health and care in England.
NICE NG23
The NICE guideline Menopause: identification and management.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the United Kingdom.
Off-label
Use of a licensed medicine outside the terms of its licence, for example at a higher dose.
Oocyte donation
Fertility treatment using eggs donated by another person.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before the age of 40.
Progestogen
A hormone given with oestrogen to protect the lining of the womb.
Records Management Code of Practice (2023)
National guidance on how long health records are kept and how they are managed.
Single assessment framework
The framework the CQC uses to assess services, built around five key questions and quality statements.
Standard Operating Procedure (SOP)
A written step-by-step instruction for carrying out a task consistently and safely.
Summary of Product Characteristics (SmPC)
The approved document describing how a specific medicine should be used, including its licensed doses.
Thyroid-stimulating hormone (TSH)
A blood test used to check how well the thyroid gland is working.
Turner syndrome
A chromosomal condition affecting females, caused by a missing or altered X chromosome, which commonly causes POI and can affect the heart.
UK Medical Eligibility Criteria for Contraceptive Use (UKMEC)
National criteria used to judge whether a contraceptive method is safe for a person with particular health conditions.
Venous thromboembolism (VTE)
A blood clot in a vein, such as in the leg or lungs.

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