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Standard Operational Procedure for administration of intravenous iodinated contrast medium by Radiographers Title of SOP: Standard Operational Procedure for administration of intravenous iodinated contrast medium by Radiographers Dates: April 2012 Issue Date: Purpose and Background (ie Policy Statement and Background): Background Injection of intravenous (IV) Iodinated contrast medium is used routinely in CT scanning for opacification of vascular structures and organs, allowing improved visualisation of anatomy and some pathologies. Injection is via a cannula (inserted as per department SOP) and may be A hand injection ( usually a bolus of 50ml) Via the pressure injector (usually 100-150ml) Though adverse reactions are generally mild and self limiting more severe life threatening reactions can occur. The individual administering the pharmaceutical must be aware of risk factors in order to minimize adverse reactions and should they occur, know how to promptly recognise and manage them. Side Effects Reactions are infrequent and may be mechanical or physiological. Mechanical: Extravasation of contrast may occur with either method of delivery of IV contrast but may have more serious sequela when the pressure injector is used, due to the pressure, volume of contrast and remote operation of the system. Air Embolism is a rare complication. Physiological Anaphylactoid – more common in patients with history of previous contrast reaction and asthma, though anxiety and fear have an effect. Anaphylactoid reactions usually occur within 20 minutes of the injection but may occur with a delay of some hours and are independent of the dose administered. Symptoms classified in three groups: Mild – skin rash, itching, nasal discharge, nausea, vomiting Moderate – persistence of mild symptom, facial or laryngeal oedema, bronchospasm, dyspnoea, tachycardia or bradycardia. Severe – Life threatening arrhythmias, hypotension, overt bronchospasm, laryngeal pulmonary oedema, seizure, syncope, death. Nonanaphylctoid Reactions Result from the ability of the contrast media to upset homeostasis of the body. Larger volumes and route of administration affect the risk. Symptoms: Warmth, metallic taste, nausea, vomiting, bradycardia, hypotension, vasovagal reactions, neuropathy and delayed reactions. Contrast induced nephropathy (CIN) Acute renal failure which occurs within 48 hours of administration of iodinated contrast, which is not attributable to other causes. Risk is increased in patients with with pre-existing renal dysfunction and those with concurrent conditions and medications which may affect renal function. To minimise side effects and optimise patient care Radiographers administering intravenous contrast must adhere to the following standard operational procedure. Scope (i.e. organisational responsibility) Vital functions affected by this SOP: This document applies to all Radiographers when administering IV iodinated contrast during CT examinations. Escalations (if you require any further clarification re the process outlined please contact): CT Lead Radiographer Senior Radiographer of the day Clinical Lead in Radiology Author: Angela Smith CT Lead Radiographer Section 2: Operating Procedure 1. The radiographer must have completed a recognised IV cannulation course and completed the departmental record of practical training. (Appendix 2) 2. The radiographer must be up to date with the Trust mandatory training in resuscitation. 3. A Patient Group Directive (PGD) for each contrast agent/drug to be injected must be signed by the Radiographer following appropriate training. Optiray 300 mg iodine/ml (active ingredient ioversol) Visipaque 270mg/ml (active ingredient iodixanol) Niopam 300mg/ml ( active ingredient iopamidol) 4. The Radiographer must complete the departmental training for the use of the power injector 5. Between the hours of 9am – 5pm Monday to Friday a Radiologist must be in the department when delegation of this duty occurs, to provide advice and cover in the event of an adverse reaction. 6. Between the hours of 5pm and 9am Monday to Friday, and 5pm on Friday until 9am on Monday all inpatients referred for a contrast CT must be accompanied by a member of staff from the referring ward/team. In the event of a suspected evolving adverse reaction medical staff from A/E department will provide support. Advice on the appropriateness of IV contrast in high risk patients must be sought from the on-call Radiologist. 7. Radiographers must only administer injections to adults (16 years and above). 8. The pharmaceutical and its dose should be given by the radiographer in accordance with established departmental protocols, or as individually advised by the supervising Radiologist. 9. The Safety Questionnaire for Outpatients Undergoing CT Scanning or the Checklist for inpatient CT scans must be completed: (Appendix 1) 10. To minimise the risk of CIN all patients must be well hydrated prior to administration of iodinated contrast. Out patients – all out patients attending for Iodinated contrast CT examinations will be advised to drink 500ml water over the hour proceeding their CT appointment. Information is also given to hydrate ( 1 litre of water over 24 hours) after the scan. On arrival at the department a further 500ml water is given to support hydration. On completion of the scan the Radiographer must reiterate the post scan hydration advice. Drink 1 litre of water over the next 4-6 hours. Inpatients – if eGFR is between 30-60 inpatients must be hydrated prior to CT. The clinicians must assess individually and ensure that hydration is optimised. The following regime is a recommendation only. IV hydration – Normal saline at 100ml/hour for 4 hours prior to the CT study and for 12 hours after the study at the same rate. Oral hydration – 500ml of fluid 2-4 hours prior to the CT study and 2.5L over the 24 hours following. 11. If the patient reports a history of severe allergic reaction to any substance, the supervising Radiologist must be consulted before proceeding. 12. If the patient has poorly controlled asthma, which has required recent hospitalisation consult the supervising Radiologist before proceeding. 13. If the patient is known to suffer from any of the conditions stated on the Safety Questionnaire consult the supervising Radiologist before proceeding. 14. Check renal function on all inpatients and outpatients known to have a renal problem. 15. Renal Function parameters and iodinated contrast: eGFR greater than 60 – proceed with iodinated contrast eGFR between 30-60 – implement hydration policy ( see 13 above) eGFR below 30 – discuss with Radiologist before proceeding 16. Emergency Drugs must always be available in the room 17. A second member of staff must be available to assist whilst an injection is taking place: To observe the injection site for extravasations To assist if an emergency situation arises 18. If extravasation occurs: Abort the injection immediately Assess the pulse distal to the injection site Manage small extravasations by removing the cannula, elevating the limb and applying a cold compress. Larger volumes (50ml +) inform the supervising Radiologist. 19. If a patient has an adverse reaction, however mild, one member of staff must stay with the patient whilst the second informs the supervising Radiologist. 20. Any adverse reaction must be documented on CRIS and for inpatients, in the notes. 21. Type/quantity and batch number of all injection must be checked by two members of staff 22. Following injection with iodinated contrast the patient must not be left unsupervised for 5 minutes and must remain in the department for at least 20 minutes. The patient must be advised to stay within the hospital for 1 hour following the injection and not to drive for 1 hour following the injection. 23. Patients who are deemed to be higher risk should remain in the department for at least 30 minutes post injection. 24. Saline may be injected by the Radiographer to check and maintain patency of the cannula 25. ALL DOCUMENTATION MUST BE COMPLETED ON THE APPROVED FORM AND SCANNED INTO THE PATIENTS’ FILE ON CRIS Appendix 1 Safety Questionnaire for Patients Undergoing CT Scanning Your doctor has asked us to perform a CT Scan. This involves the use of x-rays and an intravenous injection of contrast (dye). It is important that you complete the following information prior to your scan. Please hand the completed form to the CT Radiographer at the time of your appointment. Name Date of Birth Checklist – Do you suffer from any of the following: Have you had x-ray contrast before? Severe allergies Asthma (which has required you to be bought into hospital in the last 12 months) Diabetes which is treated with Metformin Kidney problems Hepatic disease Myeloma Hyperthyroidism / treatment with radioactive iodine Phaeochromocytoma Anuria (Unable to pass urine) High or low blood pressure Congestive heart failure Myasthenia Gravis Yes No Comment eGFR…….. Date……….. Female Patients Only Are you pregnant or breast feeding? When was the first day of your last period? By signing below you acknowledge that your personal details are correct and that you have answered the questions to the best of your knowledge. Signed: Date: Staff Only Bowel Preparation Yes No Contraindications Comments Quantity Batch Expiry Bladder emptied prior to scan Yes No CT Urogram Contraindications Furosimide CTC Buscopan Initial An appropriately qualified member of staff must sign to confirm that they have followed the correct identification procedure, as per IR(ME)R and checked all appropriate contraindications to comply with Macclesfield District General Hospital Patient Group Directives. Signed: Cannulation Record Inserted at ……………………………hrs Date: by…………………………. Position………………………….Guage………………. Attempts…………………………………………………………………….. Removed at………………………….hrs by………………………….. Aseptic Technique…………......... Checklist for Inpatient CT Scans These checks MUST be completed when Intravenous Iodinated Contrast is required Patient ID Date/ Time of Scan Renal Function: eGFR ml/min: Date of result: If this patient’s eGFR is <= 60 ml/min then your patient is at significant increased risk of CONTRAST INDUCED NEPHROPATHY (CIN). CIN is associated with much higher subsequent patient morbidity and death. Optimal hydration if eGFR < 60 ml/min is indicated to minimise risk. ONE of the following IV or ORAL hydration regimes are suggested for eGFR 30-60 ml/min. Patients with eGFR <30 ml/min should be discussed with a Radiologist Oral hydration – 500ml of fluid 2-4 hours prior to the CT study and 2.5L over the 24 hours following. yes no IV hydration – Normal saline at 100ml/hour for 4 hours prior to the CT study and for 12 hours after the study at the same rate. yes no Please indicate an alternate regime or clinical urgency preventing pre-scan hydration as follows: Is there a history of: Any known allergies Asthma (requiring recent hospital admission) Myeloma Myasthenia Gravis Pheochromocytoma Glaucoma Cardiac arrhythmia Urinary Retention Metformin Therapy Does the patient require barrier nursing? Has information been given to the patient regarding their scan Has the patient been prepared according to the protocol overleaf Female Patients LMP yes yes yes yes yes yes yes yes yes no no no no no no no no no yes yes no no yes no Name and designation of person completing the checklist: => Signature Date and Time Section 4: Standing Operating Procedure (SOP) Back Up Information Document Change History: Replacing Existing Policy Approval Record: Committee/Group Date Radiology Departmental Meeting Roles and Responsibilities: It is the responsibility of the CT Lead Radiographer to make this policy available to all staff working in the CT Suite. It is the responsibility of all staff working in the CT department to familiarise themselves with this policy and to implement it where appropriate Measuring Performance: Audit: After 12 months Definitions: None References: Contrast –Induced Nephropathy T Gleeson, S Bulugahapituija 2004 American Journal of Roentgenology Iodinated Contrast Media and their adverse reactions. J Sing. A Daftary 2008 Journal of Nuclear Medicine Technology Vol36.2.69-74 Optiray 300 Technical Leaflet. Malinckrodt Medical Imaging. Ireland RCR (2005) Standards for Iodinated Contrast Agent Administration to Adult Patients Visipaque 270 Technical Leaflet . GE Healthcare. England Niopam 300 Technical Leaflet Bracco England Review Date: July 2014 Policy Title: Standard Operational Procedure for connecting InPatients to the pressure injector prior to contrast enhanced CT scan Directorate: SBU Name of person/s auditing / authoring policy: Sara Rathmill. Service Development Manager Radiology Policy Content: For each of the following check whether the policy under consideration is sensitive to people of a different age, ethnicity, gender, disability, religion or belief, and sexual orientation? The checklist below will help you to identify any strengths and weaknesses of the policy and to check whether it is compliant with equality legislation. 1. Check for DIRECT discrimination against any minority group of PATIENTS: Action Question: Does the policy contain any statements which Response required may disadvantage people from the following groups? Yes 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 Age? Gender (Male, Female and Transsexual)? Learning Difficulties / Disability or Cognitive Impairment? Mental Health Need? Sensory Impairment? Physical Disability? Race or Ethnicity? Religious Belief? Sexual Orientation? No x x x x x x x x x Yes No Resource implication Yes x x X X x X X X X No x x X x X X X X x 2. Check for DIRECT discrimination against any minority group relating to EMPLOYEES: Action Resource Question: Does the policy contain any statements which Response required implication may disadvantage employees or potential employees from Yes No Yes No Yes No any of the following groups? x x x Age? 2.0 x X X 2.1 Gender (Male, Female and Transsexual)? X X X 2.2 Learning Difficulties / Disability or Cognitive Impairment? X X X 2.3 Mental Health Need? X X X 2.4 Sensory Impairment? X X X 2.5 Physical Disability? X X X 2.6 Race or Ethnicity? X X X 2.7 Religious Belief? x x x 2.8 Sexual Orientation? TOTAL NUMBER OF ITEMS ANSWERED ‘YES’ INDICATING DIRECT DISCRIMINATION = 0 3. Check for INDIRECT discrimination against any minority group of PATIENTS: Question: Does the policy contain any conditions or requirements which are applied equally to everyone, but disadvantage particular people because they cannot comply due to: 3.0 Age? 3.1 Gender (Male, Female and Transsexual)? 3.2 Learning Difficulties / Disability or Cognitive Impairment? 3.3 Mental Health Need? 3.4 Sensory Impairment? 3.5 Physical Disability? 3.6 Race or Ethnicity? 3.7 Religious, Spiritual belief (including other belief)? 3.8 Sexual Orientation? Response Yes No Action required Yes No x X X X X X X X x Resource implication Yes x X X X X X X X x No x X X X X X X X x 4. Check for INDIRECT discrimination against any minority group relating to EMPLOYEES: Action Resource Question: Does the policy contain any statements which Response required implication may disadvantage employees or potential employees from Yes No Yes No Yes No any of the following groups? X X X Age? 4.0 X X X 4.1 Gender (Male, Female and Transsexual)? X X X 4.2 Learning Difficulties / Disability or Cognitive Impairment? X X X 4.3 Mental Health Need? X X X 4.4 Sensory Impairment? X X X 4.5 Physical Disability? X X X 4.6 Race or Ethnicity? X X X 4.7 Religious, Spiritual belief (including other belief)? x x x 4.8 Sexual Orientation? TOTAL NUMBER OF ITEMS ANSWERED ‘YES’ INDICATING INDIRECT DISCRIMINATION = 0 Signatures of authors / auditors: Date:11/7/2011 Equality and Human Rights Compliance / Percentage Calculation Number of ‘Yes’ answers for DIRECT discrimination. (A) 0 Number of ‘Yes’ for INDIRECT discrimination. (B)0 Total answers for POLICY CONTENTS discrimination. (A+B)0 Percentage content non compliant = 100) 0 (Divide a+b by 36 x