Sexual Health Services Standard Operating Procedure for the Prevention of Adverse Event during Intra Uterine Device / System Insertions.

Transcription

1 Sexual Health Services Standard Operating Procedure for the Prevention of Adverse Event during Intra Uterine Device / System Insertions. Reference No: G_CS_71 Version 1.1 Ratified by: F&HL Clinical Governance & Scrutiny Date ratified: 24 th November 2015 Name of originator / author: Helen Oliver & Dr Claire Brooking Name of responsible committee / Individual F&HL Clinical Governance and Scrutiny Committee Date issued: November 2017 Review date: May 2018 All Sexual Health Staff including clinicians Target audience: and practitioners Distributed via Website. Chair: Elaine Baylis QPM

2 Standard Operating Procedure (SOP) Prevention of Adverse Event during Intra Uterine Device / System Insertions Version Control Sheet Version 3 Section / Para / Appendix Version / Description of Amendments Date Author / Amended by 1 New Document H Oliver 1.1 Extension Agreed November 2017 Corporate Assurance Team Copyright 2017 Lincolnshire Community Health Services NHS Trust, All Rights Reserved. Not to be reproduced in whole or in part without the permission of the copyright owner 2 Chair: Elaine Baylis QPM

3 Standard Operating Procedure (SOP) Prevention of Adverse Event during Intra Uterine Device / System Insertions Contents i. Version control sheet ii. Procedural Document Statement iii. NHSLA Monitoring Template Section Page 1 Introduction 6 2 Background Information Definitions 6 3 Management 6 4 Training 9 5 Audit Auditable Outcomes 10 6 References 10 Appendix 1 Procedure 12 2 Referral Letter 13 3 Equality Analysis 14 4 NHLSA Monitoring Template 15 3 Chair: Elaine Baylis QPM

4 Standard Operating Procedure (SOP) Prevention of Adverse Event during Intra Uterine Device / System Insertions Procedural Document Statement Background Statement The purpose of this policy is to reduce risk associated with vasovagal or anaphylaxis episode, during the procedure of fitting an Intrauterine Contraception (IUC) This Standard Operating Procedure (SOP) offers best practice advice and guidance to ensure that processes minimise risks to individuals and the organisation (FHLS) particularly those concerning the management of vasovagal episodes. Responsibilities Training Compliance with the SOP will be the responsibility of all staff and managers responsible for the care of clients attending for an IUC insertion It is the responsibility of service managers and clinical leads to ensure that appropriate mechanisms are in place to support the implementation of this SOP including appropriate training and maintenance of competency. Dissemination Trust website / intranet, Via Service Managers. Clinic Leads, Sexual Health Staff and Mail. Resource implication Consultation This policy is underpinned by the Faculty of Sexual & Reproductive Healthcare ( FSRH) Clinical Guidance ( April 2015) and FSRH Service Standards for Resuscitation in Sexual and Reproductive Health Services ( 2013) As indicated within this SOP, consultation has taken place both formally and informally throughout its development. 4 Chair: Elaine Baylis QPM

5 1. Introduction This SOP has been produced in line with national guidelines which can be accessed via the FSRH website ( Staff utilising the SOP are encouraged to refer to this this website. The guidance within this document aims to give staff clear pathways regarding the management in the care of women attending for IUD / S insertion. Should staff feel that they are working outside of competence, they should contact Medical Consultants, Senior Nursing Staff within the main clinic sites for guidance and support. 2. Background Information 2.1Definitions IUD IUS IUC Intrauterine Device Intrauterine System Intrauterine Contraception IUC methods are Long Acting Reversible Contraceptives (LARC) with duration of use between three and ten years. The IUDs are non- hormonal and vary in size and shape, consisting of copper and plastic, with some types containing a core of silver or other noble metal, which helps to prevent corrosion. The IUD can be used for emergency contraception and is effective immediately following insertion. The IUS is a T shaped device with a core containing the progestogen; levonorgestrel. This device comes in a 52mg device which lasts five years and is also licensed for the management of heavy menstrual bleeding and endometrial protection during the use of hormone replacement therapy (HRT). A smaller device containing 13.5 mg of levonorgestrel is licensed for three years. The IUS is effective seven days following insertion. Guidance from the FSRH state that in very rare occurrences during the insertion of an IUC, a client can suffer a vasovagal reaction, bradycardia and other arrhythmias, or even more rarely anaphylaxis. (FSRH Clinical Effectiveness Unit April 2015). Vasovagal incidents usually resolve with simple resuscitation measures; rarely bradycardia persists and requires treatment with intravenous or intramuscular atropine. 5 Chair: Elaine Baylis QPM

6 This SOP has been written to give clinical staff guidance on how to manage a vasovagal or anaphylaxis episode, during the procedure of fitting an IUC. 3. Management The venue must be made aware that IUC procedures are being carried out (in the case of an emergency staff can direct Ambulance crews to the room) All venues where IUC are inserted should have emergency equipment readily available to include oxygen, defibrillator and emergency drugs. Examination couches should be provided which allow head tilt in an event of a patient suffering a vasovagal event. A named person should be responsible for maintaining all emergency equipment and drugs, which should be checked prior to any IUC insertion. A new stock of the existing emergency drugs should be ordered at least 1 month before the expiry date. Once the new supplies arrive the expired medicine should be disposed of as per the local SOP for Safe and Secure Handling of Medicines. A supply of Epinephrine (Adrenaline) and Diazepam rectal tubes should be available in all clinical areas where IUC are fitted. Epinephrine (Adrenaline) and Diazepam rectal tubes should be stored at room temperature and should not be subjected to extremes of temperature. The Healthcare professional (HCP) who is inserting the IUC, must have in-date Immediate Life Support training ( including training in insertion of an oropharyngeal airway) and ALWAYS have another HCP trained in Basic Life Support, assisting during the procedure to observe client and report any untoward symptoms. This chaperone should be trained, competent and confident to assist in medical emergencies. 6 Chair: Elaine Baylis QPM

7 Clinical staff who are undertaking insertion of any IUC must be qualified and updated as in Section 4: An individual client risk assessment should be completed prior to the procedure commencing. Taking a medical and drug history will help identify clients at particular risks and measures should be taken to minimise the risk before a problem arises. Modifying planned treatment, liaising with the clients General Practitioner or referral may be more appropriate (such as poorly controlled epilepsy or significant cardiac disease). Environmental factors which may help to reduce a vasovagal incident include; Working in a calm and organised manner Encouraging the woman to relax by 7-11 breathing Monitoring the pulse prior and during insertion of IUD/S The woman to remain in clinical observation in left lateral position following procedure Equipment to help minimise adverse effects and promote quick recovery must be available: Access to a phone A couch that can quickly allow for feet elevation above head An emergency box which includes Epinephrine (Adrenaline), Diazepam rectal tubes, needle and syringes Blood Pressure machine / sphygmomanometer Manual suction apparatus Pocket mask and one-way valve Oropharyngeal airways Oxygen with face mask reservoir and tubing Defibrillator Laminated emergency procedures and emergency telephone numbers chart Regular checks of emergency drugs (inline with LCHS policy) should be undertaken to ensure that emergency drugs are not passed their expiry date. Drugs should always be checked prior to the clinical session commencing. All staff should be aware of the precise location of the emergency drugs and equipment 7 Chair: Elaine Baylis QPM

8 Intrauterine contraceptive insertion as with any invasive procedure in a non-anaesthetised patient can trigger a vasovagal response. If, after basic resuscitation measures, a persistent bradycardia occurs, the treatment of choice would be to give intravenous (IV) Atropine. Due to rarity of occurrence and maintaining associated competences this treatment choice is not consistently available. It is advisable to provide and maintain good life support and a timely request for an ambulance. It is paramount that the call for an ambulance is not delayed. If the woman s condition causes concern or warrants any emergency medication Epinephrine (Adrenaline) or Diazepam the emergency services should be summoned without hesitation. Following use, arrangements must be made to replace the emergency drug box as soon as possible. Adhere to Organisation and national Adult Basic Life support practice as in managing any medical emergency. All action should be documented (electronically) in line with NMC /GMC guidelines and local policies and procedures. Only those who are trained and competent may give rapid IV Atropine as a single dose of 500 micrograms, followed by a saline flush. If there is no improvement in the client s condition a further dose may be given. The client usually responds quickly and effectively to the initial dose. For staff not trained to gain IV access a dose of IM Atropine may be given intramuscularly. This alternative route of administration is unlikely to cause significant harm but the increase in heart rate will be significantly slower than the IV route (FSRH 2013). A further dose (500 micrograms) may be given after 10 minutes if there is no improvement or further deterioration. In an emergency situation, Epinephrine (Adrenaline), is classified as a medicine which may be administered intramuscularly for the purpose of saving life in an emergency and, as such, are exempt from the need for a prescription or Patient Group Direction (Medicines Act 1968). Diazepam and Atropine do NOT have any such exemption from The Human Medicines 8 Chair: Elaine Baylis QPM

9 Regulations (2012) and cannot be given for the purpose of saving life in an emergency situation; all normal medicines control and prescription rules apply. Its inclusion in the emergency drug pack does not imply any relaxation of prescription or administration rules. A referral letter with details of treatments administered should be completed ready for transfer with client (Appendix 2). The Sexual Health Operational Manager should be notified of the incident and an electronic Datix incident should be completed as soon as possible. With consent, the client s General Practitioner should be informed of this event by letter. Team Leaders/ Manager should discuss a significant event with the individual s involved and provide any necessary support. Lessons learnt should be cascaded to the wider team. 4. Training Nominated staff will read and understand the SOP and be given sufficient local support to implement into their practice. All health professionals inserting any IUC whilst working for Lincolnshire Community Healthcare Services will hold the appropriate FSRH Letter of Competence in Intrauterine Techniques or have equivalent recognized competences and show evidence of recertification / reaccreditation. To ensure health professional are able to maintain competences they should be able to evidence At least two continuing professional development (CPD) credits relevant to IUC techniques Completion of e-srh module18 Other approved learning Annual Basic Life Support (BLS) training including AED Annual Immediate Life Support (ILS) training Annual Anaphylaxis update Annual evidence of at least 12 insertions with at least two different types of IUC 9 Chair: Elaine Baylis QPM

10 Additionally staff will be supported in clinical supervision sessions. It is individual staff responsibility to identify their own training needs via the appraisal system and request additional training and support from their line manager. 5 Audit Systems will be reviewed annually to ensure that they are meeting local service requirements and changes made based on best practice. Internal audits will be carried out regularly following auditable outcome measures as recommended by FSRH ( April 2015) ) and those required by commissioners. 5.1 Auditable outcome measures 1 The proportion of women who had a pelvic assessment either by bi- manual exanimation or ultrasound before insertion of IUC (auditable standard 97%) 2 An appropriately trained assistant should be present during insertion of IUC (auditable standard 97%) 6. References Adult Basic Life-support (BLS)[online]. Available at: British National Formulary No 68 Sept March 2015 Faculty of Sexual & Reproductive Healthcare. Statement on the management of persistent bradycardia during the fitting of intrauterine contraceptives [online]. Available at:. Faculty of Sexual & Reproductive Healthcare Service. Standards for Resuscitation in Sexual and Reproductive Health Services Jan 2013 [online]. Available at: 10 Chair: Elaine Baylis QPM

11 Faculty of Sexual & Reproductive Healthcare. Service Standards for sexual and reproductive healthcare.2013.[online]. Available at: Faculty of Sexual and Reproductive Healthcare clinical guidance. Intrauterine contraception, Clinical Effectiveness Unit April 2015 [online]. Available at: Murty J Do we really know how to respond to an unexpected event during the fitting of an intra-uterine contraceptive device? The Journal of Family Planning and Reproductive Health Care 27(3): The role of the Nurse in managing persistent bradycardia during intra-uterine contraceptive insertion by a nurse in sexual health services [online]. Available at: 11 Chair: Elaine Baylis QPM

12 Appendix 1 Procedure Unhurried, calm atmosphere, the assistant should monitor pulse rate during procedure and recognise early signs of vasovagal attack (Bradycardia Pallor Sweating Pale/clammy ) If persistent bradycardia of below 40 beats per minute 1 - abandon procedure if device partially inserted 2 - consider remove the IUD/S if already inserted. If convulsion or epilepsy occurs administer Diazepam 10mg by rectal tube and repeat if no response in 5 mins Leave client on couch, supine with head lowered and legs elevated. Reassure client Ensure open airway Record BP and pulse If at stage the client s condition deteriorates or they becomes unconscious, refer to your BLS guidelines ( in red emergency bag) If the client recovers 1- Ensure BP and pulse have returned to normal ( x2 recordings of 10 mins apart), 2- She has fully recovered before discharging from clinic Continue assessing and reassuring client. Phone for emergency services stating post-code and exact location Points to Remember Unhurried, calm, atmosphere Clear airway and follow BLS guidelines Avoid over treatment: keep simple Correct positioning should take priority over heroic procedures, lie client on left side Inadvisable use of drugs may do more harm than good. Don t panic 12 Chair: Elaine Baylis QPM

13 Appendix 2 Referral Letter following Medical Emergency Clinic Address Clinic Contact Number Client Name Address Contact Number Next of kin / other relation contacted Yes /No Medical emergency occurred following on at hrs. Record of care and medication given Care/ treatment/ medication Time BP Pulse Colour Respirations Responsive Yes / no Emergency services called at hrs arrived at hrs General condition of client on transfer Doctor / Nurse signature ( copy to GP) 13 Chair: Elaine Baylis QPM

14 Appendix 3: Equality Analysis Name of Policy/Procedure/Function* Standard Operating Procedure (SOP) Prevention of Adverse Event during Intra Uterine Device / System Insertions Date: Equality & Human rights Lead: Qurban Hussain Date: Director\General Manager: Sue Cousland Date: A. Briefly give an outline of the key objectives of the policy; what it s intended outcome is and who the intended beneficiaries are expected to be This standard operating provides a coordinated and standardised approach to the management of clients attending for IUD/S insertions B. Does the policy have an impact on patients, carers or staff, or the wider community that we have links with? Please give details C. Is there is any evidence that the policy\service relates to an area with known inequalities? Please give details D. Will/Does the implementation of the policy\service result in different impacts for protected characteristics? Disability Sexual Orientation No No Yes Sex X Only applicable to female clients Gender Reassignment Race Marriage/Civil Partnership Maternity/Pregnancy X Only applicable to non- pregnant women Age X Only applicable to those of childbearing years Religion or Belief x Carers x If you have answered Yes to any of the questions then you are required to carry out a full Equality Analysis which should be approved by the Equality and Human Rights Lead please go to section 2 The above named policy has been considered and does not require a full equality analysis Equality Analysis Carried out by: Helen Oliver Date: No x x x x x 14 Chair: Elaine Baylis QPM

15 Appendix 4: NHSLA Monitoring Template Minimum requirement to be monitored Process for monitoring e.g. audit Responsible individuals/ group/ committee Frequency of monitoring/audit Responsible individuals/ group/ committee (multidisciplinary) for review of results Responsible individuals/ group/ committee for development of action plan Responsible individuals/ group/ committee for monitoring of action plan Every 2 years Team Review Sexual Health Services Clinical Governance Group Annual Sexual Health Services Clinical Governance Group Sexual Health Services Clinical Governance Group Sexual Health Services Clinical Governance Group 15 Chair: Elaine Baylis QPM