Blood Borne Virus Policy Haemodialysis Unit. Contents

Transcription

1 Blood Borne Virus Policy Haemodialysis Unit Classification: Policy Lead Author(s): Dr Francesco Rainone Renal Consultant Additional author(s): Dr P Evans, Dr A Jeans, Dr C Wijesekara, M Morris. Authors Division: Renal Unique ID: DDCHae01(16) Issue number: 1 Expiry Date: October 2018 Contents Section Page Explanation of terms and definitions 2 Who should read this document 2 Key points 2 What s new in this version 3 Background/ Scope 3 Standard Precautions 4 Dialysis Machines 4 Patient Segregation 5 Consent 5 BBV Surveillance 6 Immunisation 7 New BBV Infection 8 References and Supporting documents 9 Roles and Responsibilities 10 Appendix 1 Summarised table of infection control measures 11 2 Steps for standard precautions 12 3 BBV Surveillance 13 4 Risk Assessment 14 5 Algorithm for BBV testing following Dialysis away from Base 15 6 Hepatitis B Immunisation Protocol 16 Document control information (Published as separate document) Document Control Policy Implementation Plan Monitoring and Review Endorsement Equality analysis Page 1 of 16

2 Explanation of terms & Definitions ALT - Alanine aminotransferase AST - Aspartate aminotransferase BBV - Blood borne virus - Hepatitis B virus HBIG - Hepatitis B immunoglobulin Hep Bs Ag - Hepatitis B surface antigen Hep B Core Ab - Hepatitis B Core antibody Hep B DNA - Hepatitis B DNA Hep Bs Ab Hepatitis B Surface antibody HCV - Hepatitis C virus Hep C Ab - Hepatitis C antibody Hep C RNA - Hepatitis C RNA HIV - Human immune deficiency virus HIV Ab - Human immune deficiency virus antibody RRT - Renal replacement therapy Who should read this document? All clinical staff in the renal department. Key Messages 1) Standard precautions should be strictly adhered to at all times. 2) Patients with known infection require separate dialysis machines and should be segregated from the main unit. 3) Patients with known HCV and HIV infection do not require separate machines and do not require segregation. 4) All dialysis patients should be tested for and HCV. They do not require HIV testing unless considered high risk. 5) All patients should give verbal consent before BBV testing and this should be documented on EPR. 6) All patients requiring RRT should be immunised against infection. 7) If a patient has dialysed away from their base unit in the UK or abroad they should undergo a risk assessment on their return and may need enhanced surveillance. Page 2 of 16

3 What s New in this Version? This is the first iteration of this policy and is based on current guidelines and accepted best practice. Background & Scope In the 1960 s BBV infection was recognised as a significant risk to patients and staff on dialysis units. In 1972 the government published the Rosenheim report which included advice on the control of Hepatitis B on renal units. The main recommendations from this report consisted of what we now recognise as standard infection control precautions. The Department of Health published an updated report in 2002 which included recommendations regarding Hepatitis C and HIV. KDIGO published guidelines for the management of HCV in chronic kidney disease in Most recently the UK Renal Association published clinical practice guidelines for BBV infection in This policy is based in the main upon the Renal Association guidelines. Infection rates of BBV in dialysis units over the past 30 years have been low 1. However, with the ease of foreign travel and increased migration rates dialysis units must remain vigilant and ensure standards are maintained in order to avoid unnecessary BBV infection outbreaks. When referring to BBV infection the main risks are from, HCV and HIV. Other BBV infection outbreaks have been reported but the significance of these is uncertain. is more infectious than HCV and HIV but dialysis outbreaks of the latter two have been reported 1. The purpose of these guidelines is to maintain high standards of care and promote vigilance for the risk of BBV infection on the dialysis unit. By implementing this guidance we aim to ensure patient and staff safety remain our highest priority. Page 3 of 16

4 Policy/ Guidelines 1. Standard Precautions The most important method for avoiding transmission of BBVs is strict adherence to standard precautions. Local infection control guidelines should be followed regarding hand hygiene and aseptic non-touch technique. Hand washing should take place before and after each patient contact and after contact with blood or body fluids. Disposable gloves should be worn when working with blood or body fluids Disposable aprons and eye protection should be worn when splashing of blood or body fluids may occur, or if there is a risk of flying debris. Cuts/abrasions should be covered with waterproof plasters. Immediate and safe disposal of sharps into appropriate sharps bins. Never re-sheath needles Discard medicine vials after single use or, if for use with more than one patient, divided into multiple doses and distributed from a single area. Standard operating procedures should be followed for cleaning and disinfecting exposed surfaces and equipment. 2. Dialysis Machines Patients with known infection (or at high risk of infection) should use separate dialysis machines. A machine used for a infected can be used for other infected patients after undergoing heat and chemical disinfection between patients. A machine used for a infected patient can be used again for noninfected patients only after thorough decontamination. Any machines which are isolated must be clearly identified by the unit staff. Double isolators should be used on the blood lines when dialysing a patient. Staff should de-isolate the machine after referring to the specific instruction of the specific machine in use. If double isolators were omitted during any treatments or there is any other reason to believe that a machine has been internally contaminated, then these machines must be separately identified and sent immediately to the renal technician for de-isolation. The machine will also undergo external cleaning, heat disinfection and chemical disinfection. Gambro machines will be heat disinfected and chemically disinfected using Cleancart C (containing Citrate) or Cleancart A (containing sodium carbonate) depending on when the machine will next be used. Patients with known HCV or HIV infections do not require separate dialysis machines. Machines should undergo external cleaning, heat and chemical disinfection processes as per manufacturer guidelines between patients. External transducer protectors on blood circuit monitoring lines should be examined during and after dialysis by the healthcare worker responisble for the patient s dialysis session. If there is any evidence of breach by Page 4 of 16

5 blood or saline then the machine should be taken out of service and componants exposed to blood or body fluids replaced or decontaminated as per manufacturer s instructions. Dialysis machines should be cleaned between patients according to local standard operating procedures (Appendix 1; Appendix 2). 3. Patient Segregation (Segregation in this context means an area with a physical barriers such as walls or screens ensuring there is no possibility of traffic between infected and clean areas) Patients with known infection should be dialysed in an area segregated from the main unit. Healthcare workers dialysing patients with known infection should not dialyse patients without infection at the same time. Patients with known HCV infection or HIV infection do not need to be segregated from the main unit. However, more experienced healthcare workers (a healthcare worker not in training with minimum 6 months haemodialysis experience) should be allocated to perform the dialysis for these patients. 4. Consent All patients being tested for BBV infection should give verbal consent before the test is performed. Patients being tested for BBV infection should be offered counselling before testing. If they accept they should be referred to the Doctor responsible for their dialysis. Verbal consent can be taken by the healthcare worker proposing to take the blood for testing. This consent should be documented in the clinic letter if taken from clinic or as free text at the end of the dialysis flowsheet on EPR if taken on dialysis. If a patient refuses to give their consent to be tested for infection they should be segregated, unless known to be immune. If a patient is known to be immune and refuses to give their consent to be tested for HCV infection or HIV infection they do not require segregation but should be dialysed by an experienced Healthcare worker. The Doctor responsible for the patient s dialysis should be informed if the patient refuses to give consent to be tested for one or all BBV infections. Page 5 of 16

6 5. BBV Surveillance (Appendix 3) All patients starting haemodialysis should be tested for Hep Bs Ag, and known to be negative, before having dialysis on the main unit. Patients dialysing before the result of the Hep Bs Ag test is known should be dialysed in segregation from the main unit and the machine not used for another patient unless the result is known or the machine is decontaminated. Patients having regular dialysis and known to be immune to (Hep Bs Ab titre >10iu/mL) only need to be tested for Hep Bs Ag once a year. Non-responders (Hep Bs Ab titre <10iu/mL after a course of immunisation) should be tested for Hep Bs Ag every 3 months. Patients having regular dialysis should be tested for Hep C Ab every 6 months. Patients having regular dialysis do not require testing for HIV Ab unless they are considered high risk (See Table 1). Recently injected illicit drugs Has another BBV infection Unexplained abnormal ALT or AST Recently received a renal transplant or blood from a donor known to be infected with BBV Sexual partner with a BBV Table 1. Patients at high risk of a BBV (adapted from American Association for the Study of Liver Disease). Patients returning from dialysing outside the UK should have a BBV risk assessment for potential exposure (Appendix 4; Appendix 5). If BBV exposure is considered likely enhanced surveillance for BBV infection should be commenced. Patients should be segregated until known to be Hep Bs Ag negative or known to be immune. Patients at risk for new BBV infection (Table 1) should also undergo enhanced surveillance. The unit doctor in haemodialysis clinic should review their risk status. Enhanced surveillance consists of: Hep C Ab or Hep C RNA (if patient returning from intermediate or high risk countries) every 2 weeks for 3 months. Hep Bs Ag every 2 weeks for 3 months (unless known to be immune). If HIV infection is a possibility patients should be screened for HIV Ab every 2 weeks for 3 months. Patients undergoing regular dialysis with unexplained raised serum ALT or AST levels should be tested for Hep B DNA and Hep C RNA. Page 6 of 16

7 If a new BBV infection is identified in a dialysis unit all patients who may have been exposed should be tested for Hep B DNA and Hep C RNA. 6. Immunisation (Appendix 6) All patients requiring RRT should be immunised against. All patients who are likely to require RRT should be identified early and immunised against. Patients at high risk for should be tested for Hep B Core Ab and known to be negative before immunisation is commenced. The SRFT immunisation regimen currently recommends Fendrix 20µg injected intramuscularly at 0, 1, 2 and 6 months. Patients should be labelled a responder if Hep Bs Ab is >10iu/mL 8 weeks after completion of an immunisation course. Responders to immunisation should receive a booster dose if the annual Hep Bs Ab is <10iu/mL. Patients should be labelled non-responders if Hep Bs Ab is <10iu/mL 8 weeks after completion of a single immunisation course. Non-responders should receive no further immunisation with current preparations. Response status should be documented in the relevant section of the patient s dialysis clinic letters. Healthcare workers who have clinical contact with dialysis patients should be immunised against infection and be shown to be immune, or not have a infection. Healthcare workers not immune to infection should not dialyse patients with infection. Page 7 of 16

8 7. New BBV Infection Following identification of a previously unknown infection, enhanced surveillance (as described in Appendix 3) should be carried out on all patients with anti-hep Bs Ab titre between iu/ml over past year) and who had a dialysis session at the affected unit since the index patient s last negative test. Following identification of a previously unknown infection, patients with Hep Bs Ab titre between iu/ml over the past year, who have had a dialysis session since the index patient s last negative test, should be given a booster dose of vaccine. Following identification of a previously unknown infection, patients labelled as non-responders (Hep Bs Ab titre <10iu/mL), who have had a dialysis session since the index patient s last negative test, should be considered for HBIG after discussion with Microbiology. Following identification of a previously unknown HCV infection, enhanced surveillance (as described in Appendix 3) should be carried out in all patients who have had a dialysis session at the affected unit since the index patient s last negative test. Following identification of a previously unknown BBV expert Microbiology advice should be obtained to co-ordinate enhanced surveillance of at-risk dialysis patients and their carers and to arrange treatment of affected individual. Page 8 of 16

9 References and Supporting Documents 1. Geddes C, Lindley E and Duncan N. Blood Borne Virus Infection. Renal Association Clinical Practice Guideline, (accessed April 2016) 2. Department of Health. Good Practice Guidelines for Renal Dialysis/Transplantation units. Prevention and Control of Blood Borne Virus Infection ata/file/382207/good_practice_guidelines_renal_dialysis_transplantatio n.pdf (accessed April 2016) 3. Public Health England. Blood Borne Virus Testing in Dialysis Patients. UK Standards for Microbiology Investigations. V 10 Issue (accessed April 2016) 4. Department of Health. Good Practice Guidelines for Renal Dialysis/Transplantation units. Prevention and Control of Blood Borne Virus Infection. Addendum. Guidelines for dialysis away from base (DAFB) ata/file/382208/guidelines_dialysis_away_from_base.pdf (accessed April 2016) Page 9 of 16

10 Roles and responsibilities 1) Co-ordinator of each shift must ensure that all BBV patients are allocated in appropriate stations. 2) Co-ordinators of each shift must ensure that staff members are allocated to look after BBV patients in accordance with guidelines via safety huddle & daily goals. 3) BBV link nurses to keep the BBV database up to date (vaccination status and immunity status at least every 3 months). 4) Link nurses should inform the unit doctor of any BBV related issues and ideally they should meet on a regular basis in order to maintain surveillance. 5) Each nurse must enter the machine identification number on every dialysis flow sheet on EPR. 6) BBV link nurse to produce an annual summary of BBV database to infection control governance. Page 10 of 16

11 Appendices Appendix 1 SRFT Haemodialysis: Prevention and Control of Blood Borne Virus Infections Machine Segrega tion/ Isolatio n Period Bloods Taken and results checked Nursing All Disposa ble Equipm ent is Single Use Vaccina tion Machine Cleanin g AKI Own or pooled if screen tests have been negative in last month Yes Until Risk Assessmen t and screen bloods negative Hep Bs Ag Hep B core Ab Hep C Ab HIV if risk factors Standard Precautions Inspect Isolators (transducer s) Maintainanc e HD Holiday Pooled Own Pooled No immunisatio n Responder: 12 Monthly Hep Bs Ag, Hep Bs Ab All: 6 Monthly Hep C Ab (HIV if risk factors) Standard Precautions Inspect Isolators Isolation As per protocol (DAFB) As per protocol (DAFB) Standard Precautions Inspect Isolators Hep C Ab +ve, Hep C RNA - ve No immunisatio n Responder: 12 Monthly Hep Bs Ag, Hep Bs Ab 12 monthly Hep C RNA (HIV if risk factors) Standard Precautions Inspect Isolators Hep C RNA +ve Pooled Infection Risk No immunisatio n Responder: 12 Monthly Hep Bs Ag, Hep Bs Ab (HIV if risk factors) HCV monitoring per Hepatology/M icrobiology advice Standard Precautions Inspect Isolators Hep B sag +ve Barry Isolation monitoring per Hepatology /Microbiolo gy advice. 6 monthly Hep C Ab (HIV if risk factors) Standard Precautions Inspect Isolators Hep B Core Ab +ve Hep Bs Ag -ve Pooled No 3 monthly Hep Bs Ag 6 monthly Hep B DNA 6 Monthly Hep C Ab (HIV if risk factors) Standard Precautions Inspect Isolators Yes Yes Yes Yes Yes No No Yes EXTERNAL : Detergent & warm water. with 70% Isopropyl Alcohol INTERNAL: with Cleancart C EXTERNAL: Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C EXTERNAL : Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C EXTERNAL: Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C EXTERNAL: Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C EXTERNAL : Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C EXTERNAL : Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C HIV Ab +ve Pooled Infection Risk No immunisati on Responder: 12 Monthly Hep Bs Ag, Hep Bs Ab immunisatio n Non- Responder: 3 monthly Hep Bs Ag immunisatio n Non- Responder: 3 monthly Hep Bs Ag immunisatio n Non- Responder: 3 monthly Hep Bs Ag immunisati on Non- Responder: 3 monthly Hep Bs Ag 6 monthly Hep C Ab HIV monitoring as per GUM/Micro biology advice Standard Precautions Inspect Isolators EXTERNAL: Detergent & warm water. with 70% Isopropyl alcohol INTERNAL: with Cleancart C Page 11 of 16

12 Appendix 2 This document is under review as it is more than 5yrs old. Standard Operating Procedures for Cleaning Environment post Treatment Step Instruction 1 Wash hands with soap and water 2 Put on apron, visor and gloves 3 Strip machine and place lines in yellow clinical waste bag DO NOT CLEAN THE MACHINE UNTIL THE PATIENT HAS VACATED THE AREA 4 Strip bed and place in linen skip 5 Check curtains for any contamination, change as per SRFT ion Policy 6 Check floor for blood contamination clean with Haz Tab 10,000ppm chlorine solution as per SRFT ion policy 7 Dispose of clinical waste bag in clinical waste bin 8 Remove gloves, apron and visor 9 Wash hands with soap and water 10 Put on clean apron and gloves 11 Clean machine thoroughly with detergent filled cloth, this must include the top, bottom, back and underneath of main body of machine. 12 Spray machine with alcohol spray and leave it to evaporate 13 Clean table, chair/bed each with separate Chlor-clean filled cloth, clean from top to bottom and include the underneath surface of each piece of furniture 14 Clean Oxygen, suction and sharps bin with Chlorclean filled cloth 15 Dispose of cloths in orange clinical waste bag. Empty bucket, rinse with cold water and clean with Chlorclean prior to next use 16 Wash hands with soap and water 17 Gather equipment and linen for the next patient 18 Ensure that the surface is dry before the equipment and linen is used Date Time Sign Page 12 of 16

13 Appendix 3 BBV Surveillance BBV HCV HIV Hep Bs Ag Hep C Ab HIV Ab Blood Test Usual Surveillance Enhanced Surveillance Anti-HBs <10 Every 3 months Every 2 weeks for 3 months Anti-HBs Every 12 months Every 2 weeks for 3 months Anti-HBs >100 Every 12 months No increase in testing required Hep B Core Ab positive (any level of anti-hbs) Hep Bs Ag every 3 months DNA every 6 months No increase in testing required Every 6 months Every 2 weeks for 3 months Test for Hep C RNA if patient returns from intermediate or high-risk countries Does not need regular testing unless High Risk Every 2 weeks for 3 months Page 13 of 16

14 Appendix 4 Risk Assessment Following Dialysis away from Base Unit Page 14 of 16

15 Appendix 5 Algorithm for BBV testing following Dialysis away from Base Low Risk Countries: e.g. UK, Europe (except Eastern Europe), USA, Canada, Australia, New Zealand and Japan. Continue current testing as per guideline. Intermediate Risk Countries: e.g. Eastern Europe, Russia, South East Asia, South Africa, South America and Middle East. Undertake BBV risk assessment. If felt to be high risk commence enhanced surveillance. High Risk Countries: e.g. Indian subcontinent, Africa (except South Africa). Commence enhanced surveillance. Page 15 of 16

16 Appendix 6 Hepatitis B Immunisation Protocol Page 16 of 16