Standard Operating Procedure Disconnection of continuous infusional chemotherapy from Central Venous Access Devices (CVADs) in the Community

SH CP 192 Standard Operating Procedure Disconnection of continuous infusional chemotherapy from Central Venous Access Devices (CVADs) in the Community Version: 2 Summary: Keywords (minimum of 5): (To assist policy search engine) Target Audience: This Standard Operating Procedure states Southern Health Foundation Trust s position and expectation for all clinical teams with regards to the procedure for disconnection of continuous infusional chemotherapy for patients with CVADs chemotherapy, intravenous, cytotoxic drugs, disconnection, chemo, cyto All clinical teams who support patients Next Review Date: March 2021 Approved and ratified by: Patient Safety Group Date of meeting: 15 th February 2018 Date issued: Author: Sponsor: Steve Coopey Head of Clinical Development Juliet Wells Principal Pharmacist (North) Steve Mennear Medication Safety Officer Dr Abigail Barkham Integrated Services Matron Medical Director 1

Version Control Change Record Date Author Version Page Reason for Change April 16 J Wells 1 4 Summary flow chart added Aug 16 J Wells 1 To cover all kits as may vary with time 16/01/18 Reviewed no change Reviewers/contributors Name Position Version Reviewed & Date Dr Abigail Barkham Integrated Service Matron April 2015 Steve Coopey Head of Clinical Development June 2015, Aug 2016 Sue Hobbs Community Matron (Yew) April 2015 Juliet Wells Principal Pharmacist (North) June 2015, Aug 2016 Steve Mennear Medication Safety Officer June 2015, Aug 2016 Marie Corner Medical Device Adviser June 2015 Jacky Hunt Infection Control Nurse June 2015 Paula Deery Lead Chemotherapy Nurse (RSCH) June 2015 Jenny Nops Area Matron Winchester District and Enhanced Recovery +Support@Home January 2018 2

Contents Section Title Page Quick reference guide 4 1 Purpose of this Standard Operating Procedure (SOP) 5 2 Glossary of Terms 5 3 Background 6 4 Expectations 6 5 Who can disconnect Infusors? 6 6 Training requirements 6 7 Supporting References 6 SOP Guidance and Rationale 8 A1 Risk Assessment 10 A2 Clinical Competencies for Chemotherapy Disconnection 12 Levels of competency Rating Scale for the disconnection of 14 chemotherapy (PICC or CVC) A3 Healthcare Waste Collection Referral Form s Contacts Table 15 17 3

Standard Operating Procedure Disconnection of continuous infusional chemotherapy from Central Venous Access Devices (CVADs) in the Community Secondary Care ICS Registered Nurse competent in Chemotherapy CVAD disconnection IV therapy trained + assessed in practice, using the Clinical Competencies for the disconnection of continuous infusional chemotherapy assessed by another competent nurse or if already competent by self-assessment Not IV trained; attend SHFT IV Therapy training day & assessment in practice Complete full risk assessment for disconnection of chemotherapy (appendix 1) Patient s Home Preparation Discuss process with patient Obtain patient s consent Wash Hands (SH CP 12) Put on PPE & gloves Aseptic Preparation Equipment PPE & Nitrile Gloves Purple lidded (cytotoxic) waste bin with absorbent layer Chemo spill kit 0.9% sodium chloride flush & administration equipment + a prescription or PGD 109 Risk Assessment (Appendix 1) Disconnection Check that all the drug is delivered Check that there is no leakage Clamp Remove Infusor & attach red bung Flush (PGD 109) Purple Cytotoxic Waste bin Put Infusor in purple bin Inform patient Arrange collection by secondary care or local council collection (Appendix 3) Dispose of PPE Double bag label Wash hands Document 4

Disconnection of continuous infusional chemotherapy from Central Venous Access Devices (CVADs) in the Community 1. Purpose of the Standard Operating Procedure (SOP) This SOP sets out a Trust wide statement and vision on how Southern Health NHS Foundation Trust (SHFT) plans to support the process for disconnection of continuous infusional chemotherapy for patients referred to SHFT community care. This document provides guidance to managers and teams on how SHFT expects staff to carry out this procedure safely. Clinical evidence demonstrates that a robust assessment is imperative in order to plan and execute an excellent standard and quality of care. Sufficient evidence exists indicating that staff that come into contact with cytotoxic drugs are at potential risk of harm. Therefore a robust SOP will assist the mitigation of risk and harm to both patients and SHFT staff. 2. Glossary of Terms Central Venous Catheter (CVC) An intravenous device that allows access to a vein for the purposes of administering medications, where the distal tip of the device/catheter sits in the lower third of the superior vena cava. PICC A Peripherally Inserted Central Catheter (PICC) is a form of intravenous (IV) access device that can be used for a designated prolonged period of time e.g. 46 hours, 4 days, or 7 days. Skin tunnelled catheter (STC) This central venous catheter is inserted in secondary care and is used for long term access for IV therapy. These can have an external clamp (Hickman catheter) or internal valve (Groshong PICCs). Each type has its own management guidelines for flushing solutions and frequency for flushing. Implanted Ports An implanted vascular access device placed under the skin, made of two components: a reservoir with a self-sealing septum which is attached to a silicone catheter. It is a central venous catheter licensed for long term use and becoming more commonly used in cancer chemotherapy settings Chemotherapy Infusor A closed system elastomeric device that administers cytotoxic medication over a set time to the patient via a PICC or other type of CVC. Referred to as infusors. PPE Kit. Personal Protective Equipment which is intended to be worn or held by healthcare workers to promote personal and patient safety (nitrile gloves, aprons and eye protection). Nurse Throughout this document the term nurse refers to practitioners who are currently registered with the Nursing and Midwifery (NMC). 5

3. Background Chemotherapy treatments and administration has significantly changed within the community resulting in increased need for staff working in this environment to understand the implications of these changes for their practice. Chemotherapy infusors are lightweight, portable, disposable elastomeric infusion devices that allow administration of chemotherapy as a continuous infusion over several days thus enabling patients to be treated at home rather than in hospital. The chemotherapy is contained in a balloon reservoir inside a casing. As batteries are not used in the device, it does not make any noise. Patients will have their infusors initiated in secondary care by oncology specialist services. Disconnection of these devices pumps often falls upon the services of SHFT staff and requires the procedure to be undertaken in patient s homes or community clinics. 4. Expectations SHFT expects all nurses to complete a comprehensive holistic assessment within 24 hours of patient admission to the Integrated Community Team. This will: Help patients to realise their concerns are worthy of consideration and not unusual. Open the door to discussion and bring attention to sources of help that may not be required immediately but maybe needed at some point later. Allow patients and carers to discuss their concerns or issues at an early stage Enable realistic goals to be set. Enable safe and effective discharge planning through effective well-being planning Ensure that a robust risk assessment is in place for patient and staff safety. Ensure that correct equipment is in place for the management of this procedure. Ensure that cytotoxic waste is disposed of safely. It is expected that all Nurses must be competent to complete the disconnection of chemotherapy from a CVAD. 5. Who can disconnect Infusors? Only Nurses in Integrated Community Services that have been trained in IV therapy and have successfully completed assessment of competence in practice. 6. Training requirements All Nurses must complete the single IV therapy training day and be assessed in practice as competent to undertake the disconnection of continuous infusional chemotherapy from a CVAD. If already competent in IV therapy, the Nurse must complete the self-assessment of Competency to disconnect a continuous infusional chemotherapy infusor or be assessed by another competent Nurse. The training records are to be kept on the staff member s LEAD training record. 7. Supporting references CQC (2009) Essential Standards of Quality and Safety, London, CQC HPC (2008)Standards of Conduct, Performance and Ethics 6

NMC (2015) The Code: Professional standards of practice ad behaviour for nurses and midwives London NMC NMC (2008) Standards for Medicines Management NPSA (2007) Promoting Safer Use of Injectable Medicines SHFT SH CP137 Intravenous Therapy and Cannulation Policy SHFT SH CP1 Medicines Control, Administration and Prescribing Policy SHFT SH NCP Handling and Disposal of Healthcare Waste Policy SHFT SH CP14 Sharps and inoculation Management SHFT SH CP 12 Hand Hygiene Procedure SHFT PGD 109 Sodium Chloride 0.9% Injection http://www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm http://www.christie.nhs.uk/booklets/13.pdf Herman GD, Kenyon RJ (1987) Competency-Based Vocational Education. A Case Study, Shaftsbury, FEU, Blackmore Press, cited in Fearon, M. (1998) Assessment and measurement of competence in practice, Nursing Standard 12(22), pp43-47. 7

STANDARD OPERATING PROCEDURE Disconnection of Continuous Infusional Title Chemotherapy from a Central Venous Access device in the Community There is sufficient evidence that staff who come into contact with cytotoxic medication are potentially at risk of harm. Expert review suggests that efforts should focus on ensuring correct procedure in handling such medication. Risks fall into the following categories; 1. Local effect caused by direct contact with skin, eyes, mucous membrane e.g. dermatitis. 2. The systematic effects of inhaling or ingesting cytotoxic drug during contact. 3. Effects on the unborn child if pregnant The safe procedures regarding intravenous access to the patients should also be adhered to. Action 1. Read care plan / support plan and check prescription details ensuring the right patient / patient is identified. Check the name, NHS number or date of birth, prescriber s signature, approved medicine name, dose and frequency of administration, rate, diluent, date and route of administration. 2. Ensure that a full risk assessment of environment & patient/family, and staff safety is completed, before carrying out the procedure (Appendix 1) 3. Ensure that the following equipment is available; PPE Nitrile Gloves Purple lidded sharps bin (cytotoxic sharps) with absorbent layer Chemotherapy Spillage Kit 0.9% sodium chloride (saline) Flush and equipment to administer Prescription/PGD109 to administer 0.9% sodium chloride injection. 4. Explain procedure to the patient and ask for and record verbal consent 5. Wash own hands with soap and water or clean with alcohol sanitising foam if hands socially clean as per Hand Hygiene Procedure SHCP12 Thendon PPE equipment: Plastic Apron, Nitrile Gloves, Eye Protection Rationale 1. Plan will explicitly identify care required. Chemotherapy disconnection should only be undertaken with the written directions of the secondary care provider through referral process. 2. This will ensure that the home environment is clean and calm for the task being undertaken. If not a more suitable community environment may be required to be sourced such as a clinic or community hospital. 3. To ensure that time is not wasted and procedure goes smoothly. To prevent infection. 4. To inform the patient and obtain evidence of informed consent. 5. To prevent cross infection and contamination from chemotherapy by following the Trust Infection Prevention and Control Policy and Hand Hygiene Procedure (SH CP 12) 6. Prepare the equipment for aseptic procedure 6. To minimise risk of infection 8

7. Before starting the disconnection procedure, ensure the complete delivery of the drug has occurred and there are no signs of leakage. If this is not the case contact initiating hospital centre for advice 8. Clamp off the infusor prior to disconnection 9. Remove the infusor from the CVAD. Attach the red bung to end of infusor line clamp and dispose of it in the designated purple lidded sharps bin provided from secondary care for collection by local council 10. Flush the CVAD with 0.9% sodium chloride injection 11. Ensure all PPE equipment is disposed of by placing in in a clinical waste bag. Only double bag if it has been contaminated by cytotoxic drugs and label clearly Cytotoxic Waste. Contact local council for collection (see Appendix 3. Clean hands. 7. To minimise risk of exposure to staff and patient. To ensure the patient has received their treatment. 8. To prevent the spillage of cytotoxic medication on removal. 9. Ensuring safe storage and disposal in that area 10. Ensuring correct care of the Intravenous Access Device according to Therapy and Peripheral Cannulation Policy SHCP 137. 11. Ensuring the safe disposal of waste potentially contaminated by cytotoxic drugs 12. Inform the patient to (a) return the waste bin back to secondary care, or (b) store safely until local collection. The bin will need to be sealed and labelled whilst awaiting disposal. 13. Record the details of the administration in the appropriate documentation 12. This will enable the waste to be disposed of and stored safely and that it is returned to the administering location or collected by the local 13. To prevent duplication of treatment and adherence to policy guidelines 9

APPENDIX 1 Risk Assessment for Disconnection of Chemotherapy from a CVAD A risk assessment must be fully completed by the Registered Nurse before the procedure of chemotherapy disconnection and line flushing is undertaken. If the answer is no to any of these questions an alternative strategy is required. Patient Name NHS Number D.O.B: 1 Patient Yes / No 1.1 An assessment and individualised care record has been completed by a registered practitioner. 1.2 The patient has no family or informal carers able to complete this procedure, who have had the appropriate training 1.3 The patient s physical condition requires the procedure to take place in the community 2 Registered Practitioner 2.1 The Registered Nurse (s) has completed training to undertake this role and has been assessed as competent. 2.2 Following training, the Registered Nurse accepts responsibility to perform the procedure of disconnecting continuous infusional chemotherapy from a CVAD management of a chemotherapy disconnection to the standard required by SHFT 2.3 Pregnant staff or those planning their pregnancy should be advised of the potential risk associated with handling chemotherapeutic/cytotoxic agents and given the opportunity to refrain from completing this task 3 Task Yes / No 3.1 Environmental risks have been identified, assessed, minimised and documented 3.2 The patient has been referred with required equipment and there is access to Personal Protective Equipment 3.3 There is an appropriate chemotherapy spill kit available 10

3.4 There are suitable storage facilities in the patient s home for securing waste including a purple-lidded sharps bin containing and absorbant to contain any cytotoxic liquid, which might leak from the device. 3.5 There are suitable disposal & collection facilities for medication waste (return to secondary care or collection) All aspects of the risk assessment have been completed and control measures achieved To be completed by Registered Nurse: Name Designation Signature Date 11

APPENDIX 2 - Clinical competencies for the Disconnection of Continuous Infusional Chemotherapy from a CVAD Name: Role: Base: Date initial intravenous therapy training completed: Date aseptic e-assessment completed: Competency Statement: The participant demonstrates clinical knowledge and skill in chemotherapy disconnection. Assessment in practice must be by a Registered Nurse who can demonstrate competence at level 4 or above. Performance criteria Assessment method Level achieved Date 1. Demonstrates safe knowledge in disconnecting IV chemotherapy. a) Identify the correct venous Questioning / access device appropriate for cytotoxic therapy. b) List three complications of Questioning / cytotoxic therapy c) Describe and demonstrate the precautions taken when handling cytotoxic medicines d) Demonstrate knowledge / practice on how to manage a cytotoxic spillage e) Describe and demonstrate precautions which should be taken by a pregnant or breast feeding woman in relation to cytotoxic therapy f) Demonstrate correct documentation following procedure/removal. Questioning / Questioning / Questioning / Questioning/ 2. Demonstrates safe practice in disconnecting chemotherapy a) Demonstrate safe knowledge Questioning / and practice of the equipment and preparation required for disconnection of chemotherapy including; patient preparation and comfort, and selection of correct equipment. b) Demonstrates knowledge and practice of safe removal of a chemotherapy infusor Assessment of patient and medical condition. Awareness of risks associated Questioning / Assessor 12

with removal. Appropriate use of PPE. Correct disposal of equipment. Ensuring patient comfort and safety. c) Demonstrate correct use of aseptic technique during the procedure, identifying key parts and key sites d) Demonstrate appropriate equipment preparation. e) Demonstrate correct removal technique f) Demonstrate correct disposal of waste and sharps. g) Demonstrate correct documentation following removal. Date all elements of Competency Tool completed Name Signature Status Date For Assessor I confirm that I have assessed the above named Registered Nurse and that he/she has demonstrated an overall competence in chemotherapy disconnection at level Assessor Signature Status Date Review Competent Registered Assessor Comments Dates: Yes / No Nurse Signature signature 13

Levels of competency Rating Scale for the disconnection of chemotherapy (PICC or CVC) Novice Level of achievement Cannot perform this activity satisfactorily to the level required in order to participate in the clinical environment Can perform this activity but not without constant supervision and assistance Can perform this activity with a basic understanding of theory and practice principles, but requires some supervision and assistance Level 0 1 2 Competent Practitioner Can perform this activity with understanding of theory and practice principles without assistance and/or direct supervision Can perform this activity with understanding of theory and practice principles without assistance and/or direct supervision, at an appropriate pace and adhering to evidence based practice At this level competence will have been maintained for at least 6 months and/or is used frequently (2-3 times /week) The practitioner will demonstrate confidence and proficiency and show fluency and dexterity in practice This is the minimum level required to be able to assess practitioners as competent Can perform this activity with understanding of theory and practice principles without assistance and/or direct supervision, at an appropriate pace and adhering to evidence based practice. At this level the practitioner will be able to adapt knowledge and skill to special/ novel situations where there may be increased levels of complexity and/or risk 3 4 5 Expert Can perform this activity with understanding of theory and practice principles without assistance and/or direct supervision, at an appropriate pace and adhering to evidence based practice. Demonstrate initiative and adaptability to special problem situations, and can lead others in performing this activity At this level the practitioner is able to co-ordinate, lead and assess others who are assessing competence. Ideally they will have a teaching and /or mentor qualification 6 Adapted from: Herman GD, Kenyon RJ (1987) Competency-Based Vocational Education. A Case Study, Shaftsbury, FEU, Blackmore Press, cited in Fearon, M. (1998) Assessment and measurement of competence in practice, Nursing Standard 12(22), pp43-47. 14

HEALTHCARE WASTE COLLECTION REFERRAL FORM APPENDIX 3 - Waste Management Sections to be completed by a Healthcare Professional Strictly Confidential PATIENT S DETAILS Patient s Name Patient s Address (Including Postcode) Patient s Telephone Number HEALTHCARE ASSESSMENT OF INTENDED WASTE RESULTING FROM TREATMENT Tick category YELLOW SHARPS BOX YELLOW SHARPS BOX PURPLE LID ORANGE SACK OFFENSIVE Infectious sharps contaminated with medicines Infectious sharps contaminated with cytotoxic / cytostatic products Infectious waste that can be treated Waste that is not infectious and does not require specialist treatment or disposal HEALTHCARE PROFESSIONAL DETAILS (To include Healthcare Professional; Name, contact number, address, fax or email - stamp may be used) Declaration to be completed by PATIENT if PATIENT is submitting referral form to Local Authority Only waste as described above should be presented by the Patient under this referral Print Name Signature Date Once complete Healthcare Professional or Patient to send form to Local Authority collection service (details on reverse of form) 15

HEALTHCARE WASTE COLLECTION REFERRAL FORM Local Authority Reference Number Property type and Pick up location Additional information for Hampshire Local Authority use only Likely frequency and duration of requirement (e.g. weekly, on request) Sharps Box collection service (tick requirement) Deliver sharps box Collect and replace box Collect only no replacement Sack collection service (tick requirement) Deliver sacks Collect and replace sacks Collect only no replacement 16

HEALTHCARE WASTE COLLECTION REFERRAL FORM Local Authority Department Contact Postal Address Southampton City Eastleigh Borough New Forest District Test Valley Borough Business Support Direct Services Waste Management Clinical Waste Services Fax Number Email address Regulatory Services, Civic Centre, Southampton. SO14 7LY 02380-833005 02380-833079 healthcare.waste@southampton.gcsx.gov.uk Hedge End Depot, Botley Road, Hedge End, Southampton, SO30 2RA 02380-688440 02380-688382 healthcare.waste@eastleigh.gcsx.gov.uk Marsh Lane Depot, Marsh Lane, Lymington, Hampshire, SO41 9BX 02380-285000 02380-285052 healthcarewaste@nfdc.gcsx.gov.uk Unit 37 Macadam Way, West Portway, Andover, Hampshire, SP10 3XW Telephone Number 01264-368393 01264-353603 Healthcare Professional use only esldgcsx@testvalley.gcsx.gov.uk eslegcsx@testvalley.gcsx.gov.uk Winchester City East Hampshire District Portsmouth City Havant Borough Gosport Borough Fareham Borough Basingstoke & Deane Borough Joint waste client team Waste Collection team Customer Services Administration team Administration team Joint waste client team East Hampshire District, Penns Place, Petersfield, GU31 4EX dross@winchester.gcsx.gov.uk healthcarewaste@easthants.gcsx.gov.uk Street Environment, Portsmouth City, Civic Offices, Guildhall Square, Portsmouth, PO1 2NE 02392-834092 02392-841561 healthcare.waste@portsmouthcc.gcsx.gov.uk Havant Borough, Southmoor Offices and Depot, 2 Penner Road, Havant, Hampshire, PO9 1QH 02392-446010 02392-498031 healthcare.waste@havant.gcsx.gov.uk Streetscene, Community Customer service unit, Gosport Borough, Town Hall, High Street, Gosport, PO12 1EB Civic Offices, Civic Way, Fareham, PO16 1AZ Hart District, Civic Offices, Harlington Way, Fleet, Hampshire, GU51 4AE 01730-234307 01730-234291 Please phone before use 0800-0198598 n/a healthcare.waste@gosport.gcsx.gov.uk 01329-236100 01329-550468 healthcarewaste@fareham.gcsx.gov.uk 01256-622122 01252-774408 clinical.waste@hart.gcsx.gov.uk Hart District Rushmoor Borough Contracts Team RBC Healthcare Waste, Offices, Farnborough Road, Farnborough, Hampshire, GU14 7JU 01252-398399 01252-398694 Healthcare.waste@rushmoor.gcsx.gov.uk 17