exercise serenlookback report v5 · exercise seren would not have been possible without the help of...

Technical Report of a Blood-Borne Virus Look-Back Exercise related to a

body piercing and tattooing studio in Newport, South Wales

Exercise Seren

My thanks to everyone who helped particularly Heather Lewis who chaired the Outbreak Central Team. Ceri Harris Health Protection Nurse, Kelly Lee Environmental Health Officer, Newport City Council, Mererid Bowley who chaired the Co‐ordinating Hub. Peter Carr and Zoe Couzens who directed helpline groups, Wendy Warren who directed clinical response, Richard Griffiths, Tracey Deacon, Claire Griffiths and Yasmin Smith who helped with preparation of this report and the communications teams from ABUHB, PHW and Newport City Council. The ABUHB team won a National Social Media Award for their work on Exercise Seren. Lisa Chichester directed laboratory work, Nicola Morgan, Daniel Grenyer, Sharon Lord and Cynthia Henderson provided essential guidance on clinical systems, database, booking helpline and medical records. Malorie Perry and colleagues at PHW helped with analysis.

All the many contributors who made this response successful are listed in the acknowledgements, in alphabetical order.

Publication Details

Title: The Technical Report of a Blood‐Borne Virus Look‐Back Exercise related to a body piercing and tattooing studio in Newport, South Wales

Publisher: Aneurin Bevan University Health Board Date: 26th July 2016 ISBN 978‐0‐992932978

© 2016 Aneurin Bevan University Health Board [NHS Trust]

Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context.

Acknowledgements to Aneurin Bevan University Health Board to be stated

Copyright in the typographical arrangement, design and layout belongs to Aneurin Bevan University Health Board

Aneurin Bevan University health Board is the operational name of Aneurin Bevan Local Health Board

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Acknowledgements I would like to acknowledge and thank the following colleagues for the help and support received during Exercise Seren

Maireen Awan Len Hayward Heeam Nassa Rebecca Jane Bamber Jane Helmich Karen Newman Sarah Barnes Cynthia Henderson Joanne Oatley Samantha Bellanato Ashley‐Jade Hitchman Mark O'Neill Richard Bevan Lesley Elizabeth Hobbs Daniel Owens Mandeep Bhogal Amy Hodge Irene Parker Susan Born Richard Howells Holly Parsons Jacqueline Bowen Joanne Hughes Gareth Pembridge Mererid Bowley Isobel James Malorie Perry Kimberley Cann Dr Rachel Jones Claire Peters Peter Carr Helen Jones Jane Phillips Lisa Chichester Teresa Jones Lyn PopePope Samantha Clarke Sue Kearney Maryann Porter Patricia Cole Kelly Lee Karen Potter Vicky Coleman Heather Lewis Angela Powell Olivia Collins Kate Lewis Deborah Prigg Zoe Couzens Kayleigh Lewis Chris Pritchard Leah Crook Avril Lidstone Sam Ray Marion Daniels Sharon Lord Sian Redwood Claire Davidson Sherril Lovell Chris Slape Tracey Deacon Marion Lyons Lin Slater Drew Evans Michael Mallett Josie Smith Jon Evans Andrew Malon Yasmin Smith Sarah Evans Rebecca Mansfield Rosie Sullivan Sian Evans Brendon Mason Liam Taylor Rachael Gibbon Christopher Mason Sarah Taylor Zoe Gibson Amanda Maughan Daniel Thomas Diane Godwin Jo McCarthy Jane Thomas Daniel Grenyer Denise McColl Jemma Thomas Jane Eleanor Haines Jemma McHale Miranda Thrift Gavin Hardcastle Ceri Milton Phillipa Toft Lisa Harries Shanine Mitchell Leanne McCracken Ceri Harris Karrina Mitchell Denise Weaver Pamela Harris Murton Lorraine Morgan Roger White Nicola Hathway Nicola Morgan Claire Williams Debra Hawkins Samuel Morgan Julian Hayman Camilla Morgan

Exercise Seren would not have been possible without the help of each individual listed. Dr Gillian Richardson Executive Director of Public Health Aneurin Bevan University Health Board

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Contents Acknowledgements ............................................................................................................ 2

Contents ............................................................................................................................. 3

Tables and Graphs .............................................................................................................. 5

Appendices ......................................................................................................................... 6

Executive Summary ............................................................................................................ 7

Recommendations: ............................................................................................................. 8

Glossary of Terms and Abbreviations ................................................................................. 9

1. Introduction .................................................................................................................. 10

1.1 Background ............................................................................................................ 10

1.2 Skin Infections ........................................................................................................ 10

1.3 Blood‐borne viruses ............................................................................................... 11

1.4 Initial alert .............................................................................................................. 13

1.5 Aims and Objectives of the Incident Management Team (IMT) ........................... 15

1.6 IMT Subgroups ....................................................................................................... 16

2. Database Subgroup ....................................................................................................... 16

2.1 Patient Identification Exercise .................................................................................... 17

2.2 GP Validation .............................................................................................................. 18

2.3 Social Services ............................................................................................................. 18

2.4 Data Security ............................................................................................................... 18

2.5 Patient Administration System (Myrddin) .................................................................. 19

3. Communications ........................................................................................................... 19

3.1 Objectives ................................................................................................................... 19

3.2 Holding press statement ............................................................................................. 19

3.3 Communication with the tattoo and body piercing business owners ....................... 19

3.4 Communication with members of the public ............................................................. 19

3.4.1 Public Announcement of look‐back exercise‐ ‘Going Live’ ..................................... 19

3.4.2 Websites .................................................................................................................. 21

3.4.3 Social Media ............................................................................................................. 21

3.5 ABUHB Employees ...................................................................................................... 22

3.6 PHW Employees .......................................................................................................... 22

3.7 Welsh Government ..................................................................................................... 22

3.8 Communications to Each Client Category and GPs .................................................... 23

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3.9 CHC ............................................................................................................................. 24

3.10 GPs ............................................................................................................................ 24

4. PHW Helpline ................................................................................................................ 24

4.1 PHW Helpline Operating Hours .................................................................................. 25

4.2. Staff Training .............................................................................................................. 25

4.3 Calls Received by PHW Helpline and NHS direct ........................................................ 25

4.4 Referrals from PHW helpline to the ABUHB Appointment Line ................................ 26

4.5 PHW Helpline Staffing ................................................................................................ 26

5. ABUHB Appointment Line ............................................................................................ 27

5.2 Activity ........................................................................................................................ 28

6. Testing ........................................................................................................................... 28

6.1 Testing Model ............................................................................................................. 28

6.2 Staffing ........................................................................................................................ 28

6.3 Clinic venues ............................................................................................................... 29

6.4 Phlebotomy ................................................................................................................ 29

6.5. Clinic Dates and Times ............................................................................................... 29

6.6 Clinic Activity and Follow up ....................................................................................... 30

6.7 ‘Did Not Attend’ clinic analysis ................................................................................... 31

6.8 Hepatitis B follow up testing ...................................................................................... 31

7. Results ........................................................................................................................... 32

7. Communication of Results ............................................................................................ 33

7.1 Informing of negative samples ................................................................................... 33

7.2 Informing clients of reactive or positive samples ...................................................... 34

7.3 Informing GP of results ............................................................................................... 34

7.4 Out of area results ...................................................................................................... 34

7.5 Vulnerable Clients ....................................................................................................... 34

7.6 Recording on Patient Record ...................................................................................... 34

8. Storage .......................................................................................................................... 34

8.1 Samples ....................................................................................................................... 34

8.2 Proformas ................................................................................................................... 35

9. Support Infrastructure .................................................................................................. 35

9.1 Hub functions ............................................................................................................. 35

9.2 Situational Reporting .................................................................................................. 35

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9.3 Project Manager ......................................................................................................... 35

10. Costs ............................................................................................................................ 36

11. Learning Points ........................................................................................................... 36

12. Recommendations ...................................................................................................... 37

Tables and Graphs Tables

Table 1 Admitted cases with Pseudomonas Aeruginosa infection post piercing

Table 2 Details of previous complaints Table 3 Final allocations from both cohorts Table 4 Communication methods by client group Table 5 PHW Helpline staffing Table 6 Nurse‐led outpatient clinics at RGH Table 7 Number of identified and eligible clients for BBV testing Table 8 Number of identified and eligible clients for BBV (as at 3/3/16) Table 9 Number of clients tested by location (as at 03/03/16)

Table 10 Difference between age reported at time of procedure and true age at that time

Table 11 Summary of Exercise Seren costs

Graphs

Graph 1 Number of calls received by PHW Helpline, by date

Graph 2 Referrals from PHW Helpline to Health Board Appointment Line, by date

Graph 3 ABUHB Appointment Line Activity Graph 4 Number of appointments booked where client did not attend Graph 5 Age and sex distribution of cohort

Graph 6 Percentage of individuals attending for a BBV screen reporting a body piercing at an intimate site (nipples and/or genitals) by age group

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Appendices Appendix 1 Patient Identification Flow Diagram Appendix 2 Holding Press Statement Appendix 3 Press Release 06/05/2015 Appendix 4 Press Release 14/05/2015 Appendix 5 Press Release 22/05/2015 Appendix 6 Press Release 26/05/2015 Appendix 7 Hepatitis B factsheet Appendix 8 Hepatitis C factsheet Appendix 9 HIV factsheet Appendix 10 Frequently Asked Questions Appendix 11 Easy Read ‘Frequently Asked Questions Appendix 12 Reporting Template to Welsh Government Appendix 13 Initial letter to Parent/Guardian for clients who are under 16 Appendix 14 Initial letter to clients aged 16 ‐ 17 Appendix 15 Initial letter to clients aged 18+ Appendix 16 Reminder letters to Parent/Guardian of clients who are under 16 Appendix 17 Reminder letters to clients aged 16 and over Appendix 18 DNA letter for clients aged under 16 Appendix 19 DNA letter for clients aged 16 and over Appendix 20 Local Enhanced Service Appendix 21 Clinic Proforma Appendix 22 Action Card for Phlebotomist Appendix 23 PHW Screening Criteria and Flowchart Appendix 24 NHS Direct Algorithm for clients aged under 18 Appendix 25 NHS Direct Algorithm for clients aged 18 and over Appendix 26 Public Health Wales referral form to the ABUHB Appointment Line Appendix 27 ABUHB Appointment Line Appendix 28 Testing Strategy for SEREN Incident Appendix 29 Action Card for Receptionist Appendix 30 Action Card for Clinician Appendix 31 Action Card for Paediatric Nurse Appendix 32 Action Card for Clinic Controller Appendix 33 Follow Up Hepatitis B letter Appendix 34 Final letter for clients aged under 16 Appendix 35 Final letter for clients aged 16 and over Appendix 36 Positive Antigen Proforma Appendix 37 Situational Report Appendix 38 Project Manager Job Description and Person Specification

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Executive Summary In November 2014, Gwent Health Protection Team were notified of several cases of serious Pseudomonas Aeruginosa infection in individuals, who had undergone body piercing. The alert was raised by a junior doctor working in the Ear, Nose and Throat (ENT) specialty at the Royal Gwent Hospital, Newport, South Wales.

Patients had been admitted with severe post‐piercing infections needing surgery, and in some cases, reconstruction.

All cases had their body piercing carried out at the same tattoo and piercing premises, 83 Commercial Street, Newport City Centre, and there were no other common factors linking the cases.

Following a Prohibition Notice (PN) on piercing at the premises, the Local Authority (LA) investigated consent forms for those who had been pierced at the premises. Further visits led to a PN on the tattooing element of the business and the consent forms of clients who had been tattooed at the premises were also seized.

As part of investigations it emerged that the company had been operating out of a previous location in the same street under several alternative names. This led to further consent forms from the previous location being retrieved and included in investigations.

Poor hygiene practices were identified at the studio and culture of the contents of a water bath grew Pseudomonas Aeruginosa. Because there had been known Pseudomonas transmission from the studio to individuals, it was felt there was therefore a risk that that blood‐borne virus transmission could also occur.

Following discussions between Public Health Wales, Aneurin Bevan University Health Board and the UK Advisory Panel on blood‐borne viruses (UKAP), a look‐back exercise was undertaken to offer testing to clients for Hepatitis B, Hepatitis C and HIV.

After extensive investigation, planning and preparation, ‘Exercise Seren’ look back was announced to the public on the 6th May 2015.

The consent forms retrieved from both premises indicated 691 clients were eligible for BBV testing. Seven of these lived outside of Wales, so letters were sent to GPs/individuals where details were able to be traced. This meant 684 clients were invited to have BBV testing locally at nurse‐led clinics. Six of these informed us that they had changed their mind following completion of consent form and had not gone ahead with a procedure, meaning only 678 clients were eligible for local follow up. Of this 678 clients, 507 attended for BBV testing (75% uptake rate).

Following public appeal and comprehensive media coverage a further 334 clients came forward for testing.

By 3rd March 2016, 841 clients had been tested via a variety of different routes.

10 nurse led clinics were held evenings and weekends, and tested 727 patients; GPs tested 45 patients and 69 patients were tested in sexual health clinics.

The total cost of the look‐back exercise was estimated to be £240,159 (£85,237 in additional costs and £154,922 in notional opportunity costs).

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Recommendations:

1. Education of young people about risks of tattooing and piercing including blood borne viruses and bacterial infections should be supported nationally.

2. There is a need for improved regulatory powers for the enforcement of hygiene measures in body piercing/tattooing premises. There are better safeguards in place with regard to buying a sandwich than having potentially harmful procedures such as tongue piercing currently.

3. All premises performing body piercing/tattooing should keep detailed client lists and consent forms with address and contact numbers.

4. Intimate piercing should only be performed over the age of 16 where documented proof of age is demonstrated.

5. The piercing/tattooing of intimate areas can be considered a safeguarding issue, if the client is not of age or is vulnerable in other ways and it is recommended that these procedures are carried out by a same sex practitioner preferably in the presence of a client advocate.

6. All tattooing and body piercing practitioners should have DBS checks completed and undergo safeguarding training.

7. Registration/licensing to perform tattooing/piercing should be on an individual basis of competency based on understanding of infection control, safeguarding legislation, technical aspects and practical skills, similar to other forms of minor surgery e.g. cosmetic. The current situation, whereby anyone with no training can open for trading with no quality assurance, is unacceptable particularly with ever invasive procedures e.g. tongue piercing, body modification.

8. Substantiated complaints against an individual should revoke licence until a period of retraining and reaccreditation fulfilled.

9. Local authorities should have shared databases of licensed practitioners and those whose licence has been revoked.

10. There should be awareness‐raising among GPs and ENT doctors so that if anyone presents with infection following piercing/tattooing they alert the local Health Protection team urgently.

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Glossary of Terms and Abbreviations

ABUHB Aneurin Bevan University Health Board

BBV Blood‐borne Virus

CHC Community Health Council

Cohort 1 Known clients who had a tattoo or body piercing at 83 Commercial Street, Newport between February 2014 and January 2015.

Cohort 2 Known clients who had a tattoo or body piercing at 92 Commercial Street, Newport between May 2013 and February 2014.

CWS Clinical Work Station‐ A digital hospital patient records system which is integrated between primary and secondary care on which laboratory test results may be viewed.

DBS Disclosure Barring Service

DNA Did Not Attend

ENT Ear, Nose and Throat

EHO Environmental Health Officer

GP(s) General Practitioner(s)

HIV Human Immunodeficiency Virus

HPT Health Protection Team

LA Local Authority

LES Local Enhanced Service‐ Schemes agreed by Health Boards in response to local needs and priorities, sometimes adopting national service specifications.

Myrddin A hospital based patient administration system

NHSDW National Health Service Direct Wales

PHW Public Health Wales

PN Prohibition Notice

Proforma The form used by clinicians or GPs to ascertain personal information and potential risk factors.

RGH Royal Gwent Hospital, Newport

SitRep Situational Reporting Form

UHW University Hospital of Wales

UKAP United Kingdom Advisory Panel for Health Care Workers infected with Blood‐borne viruses.

WDS Welsh Demographic Service

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1. Introduction

This is the technical report on behalf of the multi‐agency Incident Management Team (IMT) in relation to a look back exercise named ‘Exercise Seren’. This was set up following the notification of a cluster of Pseudomonas Aeruginosa infections associated with having procedures at a Newport‐based tattoo and body piercing premises. Since it had been established that there had been bacterial infection as a result of procedures at the premises and that there were concerns regarding infection control practices, a theoretical risk of transmission of other organisms such as blood‐borne viruses existed. Following discussion with the Medical Director of the UK Advisory Panel for BBVs, a decision was therefore made to offer testing for Hepatitis B, C and HIV to clients of the premises. The primary focus of this report is to provide the details about the management of this incident by all the partners involved as well as details on:

• The background to the incident • The planning for the look‐back exercise • Pathways of care for affected clients • Clinical and laboratory processes • Co‐ordination of the look back functions at the coordinating Hub • Any recommendations for future similar look back exercises

The majority of potential clients lived within the ABUHB geographical areas and Exercise Seren Outbreak Control Team involved representatives from a number of bodies including;

• Aneurin Bevan University Health Board (ABUHB) • Public Health Wales (PHW) • Newport City Council • NHS Direct Wales • Gwent Community Health Council (CHC)

The look‐back was named ‘Exercise Seren’ during the investigation phase and therefore preserved confidentiality before implementation and ‘go live’.

1.1 Background

Tattooing and body piercing procedures have become increasingly popular in the United Kingdom (UK) in the last decade. The range of tattooing and body piercing procedures has also increased. There are known and well reported health risks which can be attributed to these procedures. Poor infection control may result in localised skin infections at the site of the tattoo or piercing. There may also be a risk of transmission of blood‐borne viruses, such as Hepatitis B, Hepatitis C or HIV, which can have serious and long term health consequences.

1.2 Skin Infections

Various organisms have been associated with body piercing and tattooing. Pseudomonas infections are caused by strains of bacteria found widely in the environment; the most common type causing infections in humans is called Pseudomonas Aeruginosa. Serious Pseudomonas infections usually occur in people in hospital or those with weakened immune

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systems. However, healthy people can also develop serious infections from Pseudomonas Aeruginosa, although this is more unusual. Pseudomonas Aeruginosa can be spread on the hands of those undertaking procedures such as body piercing or by equipment that gets contaminated and is subsequently not properly cleaned and sterilised. Infection can be prevented with careful attention to routine infection control practices, especially hand hygiene and environmental and instrument cleaning. Other conditions documented as being associated with body piercing and tattooing include mycobacterial and fungal infections. These may also be prevented by attention to infection control.

1.3 Blood‐borne viruses

Blood‐borne viruses (BBVs) can be carried in the blood stream and can spread through an infected person’s blood or other bodily fluid coming into contact with another individual’s blood or bodily fluid. This can occur when there is cross contamination after tattooing and body piercing equipment used on a person with a BBV comes into contact with another person. The most common BBVs are Hepatitis C, Hepatitis B and Human Immunodeficiency Virus (HIV). The prevalence of chronic Hepatitis C in the UK is approximately 4 in every 1,000 people with around 3 people in every 1,000 having chronic Hepatitis B. The prevalence of HIV in the UK is estimated to be 1 in every 1,000. There are a variety of symptoms associated with BBVs. The symptoms of acute Hepatitis B can include:

• Jaundice (yellowing of the skin, whites of the eyes, and under the fingernails) • Dark urine and/or pale stool, diarrhoea • Fatigue • Fever • Abdominal pain • Nausea and loss of appetite • Joint pain

If a patient’s immune system is not able to clear acute Hepatitis B infection within six months, they are termed as having ‘chronic’ Hepatitis B. Not everyone with acute Hepatitis B experiences symptoms. Symptoms of chronic Hepatitis B can include those typically seen in acute disease; however these can be mild to moderate and may fluctuate. Other symptoms can occur, particularly in people who have had chronic Hepatitis B for many years. These include rashes, hives, urticaria, arthritis and polyneuropathy (burning/tingling in the arms and legs) In relation to Hepatitis C only around one in every three or four people will have any symptoms during the first six months of acute Hepatitis C infection. If symptoms do develop, they usually occur a few weeks after infection. Symptoms may include:

• a high temperature of 38°C (100.4°F) or above • fatigue • loss of appetite • abdominal pains • feeling nauseous and/or vomiting

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Around one in every five people who experience symptoms will also have jaundice due to abnormal liver functioning. In around one in every four people infected with Hepatitis C, the immune system clears the virus within a few months and the person will have no further symptoms. In remaining cases, the virus may persist for many years as chronic Hepatitis C infection. Symptoms of (chronic) Hepatitis C can vary widely. In some people, symptoms may be barely noticeable. In others, they can have a significant impact on quality of life. Symptoms can also disappear for long periods of time and then return. Some of the most common problems experienced by people with chronic Hepatitis C include:

• extreme fatigue • joint and muscle aches and pains • feeling nauseous • abdominal pain, indigestion or bloating • itchy skin • mood swings • depression or anxiety • problems with short‐term memory, concentration and completing complex mental

tasks

Hepatitis B is preventable by immunisation. There is no vaccine for Hepatitis C but modern therapies mean a significant proportion of patients are now treatable with up to 90% cured (especially if identified early). Both infections can eventually cause the liver to become scarred (cirrhosis). Longer term five percent of those with cirrhosis will unfortunately go on to develop cancer of the liver.

Those who have HIV infection may experience flu‐like symptoms two to six weeks after being infected. These symptoms disappear after about two weeks following which HIV may not cause any symptoms for many years. However, the virus continues to replicate and causes progressive damage to the immune system, leading to vulnerability to infections and specific cancers. Blood tests can check for current infection or historic exposure to HIV, Hepatitis B or Hepatitis C viruses. Exercise Seren used a two‐staged approach to testing. An initial screening blood test (analysed by Architect assay) gave either a negative or ‘reactive’ result. Any marker that was reactive on initial screening had confirmatory tests performed on the primary sample. If the blood test was confirmed as ‘reactive’, this required a further patient sample to confirm initial blood sample, and also to determine whether infective agent was as a result of a recent or previous exposure. The follow up blood samples were processed at the neighbouring hospital using a combination of EIA and PCR methods. If a PCR test proved to be positive, the patient was informed by a Specialist Nurse in clinic and given follow up appointment at the Liver clinic. Therapeutic pathways were then commenced. For acute Hepatitis B infection there is no specific treatment, but rest is advised and medication for symptom control may be given. Advice with regard to diet and reducing alcohol consumption is usually given. For Hepatitis C, effective treatments exist and in up to 80% of cases modern drug therapies may clear the infection before liver fibrosis, cirrhosis and further complications can occur. There is no known cure for HIV but antiretroviral therapies can

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stabilise the disease and immune system and enable most people who have HIV infection to live a long and healthy life. Legislation and Enforcement Local Authorities (LA), Environmental Health Departments, are responsible for enforcing legislation in body piercing/ tattooing premises in Wales. The LA officers will usually inspect the premises before a certificate of registration is issued; however, there is no set timescale for the LA to routinely conduct follow up inspections on these premises. Both the person undertaking the piercing and the premises itself must be registered with the LA. The LA alone does not have the power to revoke a premises registration, only a Court can do this following a successful prosecution. Conversely, if a person or premises is found to be not complying with local byelaws made under the Local Government Act 1982, providing the LA has adopted the byelaws, they can instigate legal proceedings. If found guilty of an offence, the Court may order the suspension or cancellation of the premises or the person’s registration to carry on the practice of skin piercing/tattooing. However this would be applicable in that particular LA only. The National Local Authority (LA) Enforcement Code set out the risk based approach to targeting health and safety interventions and is to be followed by LA regulators. Alongside the Code, the Health and Safety Executive publish a list of higher risk activities falling into specific LA enforced sectors which are suitable for targeting proactive inspection by LA, but this does not currently including body piercing or tattooing. There is a voluntary Code of Conduct for tattooists but, at the time of writing, not for body piercers. The Public Health Bill was brought before Welsh Government in the summer of 2015. Exercise Seren helped to inform the content of the Bill and the need for improved regulation as the IMT Chair kept Welsh Government officials informed of the issues that arose and the Director of Public Health gave evidence to the cross party Committee examining the issue.

1.4 Initial alert

In November 2014, Gwent Health Protection Team were notified by an Ear, Nose and Throat (ENT) junior doctor at the Royal Gwent Hospital, Newport, South Wales, of several cases of Pseudomonas Aeruginosa infection in individuals, who had undergone body piercing. Patients had been admitted as in‐patients with severe post‐piercing infections, some needing surgery and reconstruction. All cases had their body piercing carried out at the same premises at 83 Commercial Street, Newport City Centre and there were no other common factors that linked the cases. The tattoo and body piercing studio at 83 Commercial Street had traded under the names of Blue Voodoo, Sun Tattoo Studio and Flesh Wound at various stages in the past. Details of cases are described in Table 1 below.

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Table 1: Admitted cases with Pseudomonas Aeruginosa infection post piercing

Case Date of piercing Date of symptom onset

Date of admission to Royal Gwent Hospital

Case 1 20/10/2014 approx Unknown 27/10/2014 & 31/10/2014 Case 2 18/10/2014 24/10/2014 31/10/2014 Case 3 27/10/2014 29/10/2014 11/11/2014 Case 4 13/11/2014 approx 21/11/2014 28/11/2014

On 17th November 2014, the Health Protection Team notified the relevant Local Authority, Newport City Council.

On 1st December the LA visited the premises and were informed that cosmetic piercing was no longer undertaken at the premises and the last piercing was completed approximately a week earlier. The LA visited the premises again on 10th December. They found deficiencies in the infection control procedures at the premises, confusion regarding correct dilution of the cleaning chemical in use as an environmental cleaner. Furthermore, fluid in two ultrasonic baths in use at the premises was only changed every few days, there were no written procedures for the correct use of the ultrasonic baths and no record of them having been serviced. The purpose of the ultrasonic baths was to clean equipment such as clamps and used jewellery prior to these being put into the autoclave for sterilising. However the process described by at least one client was that sterile jewellery was dipped into the ultrasonic bath (thereby potentially contaminating) prior to being placed in the new piercing site. The LA took environmental swabs and samples during their visit.

On 15th December results were received by the Local Authority which confirmed that Pseudomonas Aeruginosa had been isolated from the two ultrasonic baths in use at the premises and from the wash hand basin in the treatment area.

On 17th December the LA met with Public Health Wales (PHW) local Health Protection Team to discuss the premises and results.

On 18th December a Prohibition Notice (PN) was served on the owners of the premises prohibiting any body piercing from taking place at the premises until effective infection control measures were put in place.

All client records for the piercing side of the combined business were taken for investigation

On 2nd February during a preliminary incident meeting the LA advised that the PN was still in place. The LA were concerned that was inadequate sterilisation at the premises as although there was an autoclave on site, it was not effective for use with the ‘wrapped’ products that the premises were using.

In addition to visiting the premises, the LA also checked the complaint history of the premises and found two related complaints to the LA detailing post piercing infections. See Table 2 below.

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Table 2: Details of previous complaints

Case Date of piercing

Date of symptom onset Details of complaint

Complainant 1 10/05/2014 14/05/2014 Skin infection following nipple

piercing. (Organism Unknown)

Complainant 2 04/08/2014 11/08/2014

Infection following upper ear and auricle piercing.

Pseudomonas Aeruginosa isolated 20/8/14

On the 5th February 2015 the LA returned to the premises to check on the tattooing side of the studio. They found used needles in a glass jar, that the owner claimed he was returning to the supplier. The premises were using silicone grips which were not suitable for sterilisation in the autoclave, so the owner was cleaning with an alcohol wipe. It was unclear how long the silicone grips had been in use. There was also a tattoo gun present with a needle still attached and a pot of Vaseline with a used single use spatula in it. The owner advised the LA Environmental Health Officers that used tattoo needles were being put into the ultrasonic baths a practice that had not come to light on previous visits. These were the same baths in which jewellery used for piercing was being dipped, meaning that tattooing and piercing sides of the business were not separate for infection control purposes.

The LA EHO’s reported that on each visit to 83 Commercial Street, practices and equipment used appeared to have changed.

The LA requested all client consent forms for the tattooing element of the premise and were given records from January 2014 to January 2015 however it was felt that possibly only September 2014 seemed to be complete, with fewer tattoos listed for the other months and some months seeming to have none.

On 5th and 25th February the LA formally requested any other client records that had not already been provided. No other records were provided by the premises.

1.5 Aims and Objectives of the Incident Management Team (IMT)

A preliminary ‘Incident Management Team’ meeting was arranged by PHW Local Health Protection team for the 2nd February to scope the incident. A second IMT with wider invited membership including ABUHB was convened by the Health Protection Team on the 10th February 2015. The response to the incident was codenamed ‘Exercise Seren’.

The aims and objectives agreed by IMT were:

• To identify the clients at risk/possibly exposed by having had any procedure at the studio under any name (all registered to same owner)

• To offer blood‐borne virus testing for clients who had a procedure at the premises • To ensure a helpline was established with appropriately trained staff to offer advice to

clients • To ensure an appointment booking line was available • To offer nurse led appointments and counselling to all clients or an appointment with

their GP if preferred

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• To ensure adequate laboratory support to analyse the results was in place. • To implement a comprehensive communications plan to support clients, GPs, the wider

health community and the general public. • To write a full report for the Aneurin Bevan University Health Board, Public Health

Wales, Newport Council and the Welsh Government. • To ensure that client’s best interests were at the centre of every decision made.

1.6 IMT Subgroups

In order to progress this complex response, five subgroups were set up. These subgroups were:

• Database and Information Governance • Communications • Help and Advice line (PHW) • Appointment Line (ABUHB) • Testing, Laboratory and Clinics

2. Database Subgroup

An electronic database was constructed to provide a systematic repository of information about all of the individuals who had been identified as having had procedures done at the premises of interest. All of the known clients were entered into a database and details were stored on a number of aspects e.g. demographics, whether or not client had come forward for testing, which BBVs they were tested for (clients had the option of which viruses to be screened for) additional risk factors and the results. Those who did not elect to take up testing were sent a letter reminding them about the potential for BBV transmission and restating the offer for opportunities for them to get tested in the future. Communication to the client’s GP also took place.

The anonymised database may enable further analysis of risk factors for BBVs amongst a cohort of young people who have frequented tattoo and piercing businesses.

The original database was constructed from details on consent forms from the tattoo and body piercing studios at 83 Commercial Street obtained by the LA.

As investigations continued it appeared that the same company had previously operated under different names at 92 Commercial Street, Newport. Initially there was no indication that there were any concerns regarding poor hygiene issues at this earlier location. However, further investigation revealed a complaint had been received regarding possible infection, so consent forms for this premise were also requested in order that clients could be included in the look‐back exercise.

Clients whose consent forms were from 83 Commercial Street were named as ‘Cohort 1’. Those clients whose consent forms were from 92 Commercial Street were named as ‘Cohort 2’

This original list of clients was passed to PHW from the LA to enable PHW to validate client details which were often incomplete or inaccurate. PHW matched the client details with the Welsh Demographic Service (WDS) system and added NHS numbers where possible. Discrepancies in age stated on consent forms and recorded on WDS were highlighted. This

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information was passed to ABUHB where the database was checked against the Myrddin electronic health record system.

2.1 Patient Identification Exercise

See Appendix 1 for flowchart.

In order to fulfil information governance requirements and to ensure clients of the premises were correctly identified, since some dates of birth etc seemed incorrect; ‘Green’ and ‘Red’ lists were created. The ‘Green’ list referred to those clients where ABUHB, PHW and the LA were confident that the original consent form correctly corresponded to the person the Exercise was about to contact. The ‘Red’ list referred to those clients who had a written consent form, but whose details were not able to be matched during the validation process, so were unable to be contacted. There was also an ‘Amber’ list which referred to clients where it was fairly sure that the validation process had identified the correct person but due to key differences e.g. date of birth, further detailed work was needed to determine whether the client went on to the ‘Green’ or ‘Red’ list. The fields which were checked were forename, surname, address and date of birth (DOB). Where three of the four of these fields were matched to WDS, the below rules were considered for the client to be included:

• Where DOB was not a full match but both the day and month were, this was considered a match on DOB.

• Where DOB did not match but the DOB given allowed the client to be considered over 16 years of age at the date of attendance, this was considered a match on DOB.

• Where the forename or surname was not a match but highly likely to be a spelling mistake e.g. where the sound was similar but the spelling different, particularly where the name was not common, this was considered a match on name.

• Where the surname did not match WDS or Myrddin or both, the surname history was checked using WDS to determine whether the client had changed their name from the surname given, if this was the case this was considered a match on surname.

• Where the address did not match WDS or Myrddin or both, the address history was checked using WDS to determine whether the client had previously lived at the address given or the address found by Myrddin, if this was the case this was considered a match on address.

• WDS was considered to be more up to date than Myrddin where the two differed. • Where no address was given by the client, this could not be matched and was

categorised Red

There were cases where, following further information, a previously allocated ‘Amber’ or ‘Red’ client became ‘Green’.

As previously unknown clients came forward through the PHW Advice Helpline or walked into clinic (sometimes with a client who was known about), they were added to the green list.

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Table 3: Final allocations from both cohorts

List Allocation Cohort 1 Cohort 2 Total Green 414 107 521

Green (previously Amber) 135 31 166 Green (previously Red) 4 0 4

Total Green 553 138 691 Red 101 34 135

Red (previously Amber) 25 31 56 Total Red 126 65 191

882

A total of 691 Green list clients were thus able to be followed up, and a total of 191 Red list clients could not be approached due to information governance concerns on the accuracy of details. The team needed to be able to identify individuals by name for testing and appointments, however for the purpose of data analysis anonymity was preferred so a unique identifier was allocated, with records for linking kept separately. Following allocation to the ‘Green’ list, the unique reference number was allocated to each client. In this exercise, the CRN number from the Myrddin system was used.

2.2 GP Validation

GP validation was performed on all Green list clients to ascertain the most up to date address for individuals, recognising the serious implications of sending a letter to the wrong address, which could cause unnecessary distress to individuals, involve informing the Information Governance officer with the possibility of a substantial fine. A list of clients who were to be offered testing was sent securely to their practice so that could notify us of any inaccurate data or vulnerable patients. This information was sent out approximately a week before the ‘go live’ date where press announcement and patient communications were to be launched. An incorrect address may occur as there is a time delay to update the central WDS database after a Practice has uploaded patient information. This also enabled a check on whether there was any reason why a client should not be contacted (e.g. death, bereavement, terminal illness, current severe or unstable mental illness).

2.3 Social Services

Social Services were made aware of this investigation and looked through the list to ensure any clients in their care or in receipt of services were noted (e.g. looked after children, clients with learning disabilities or mental illness) so that they could have their letter delivered by their key worker if appropriate to minimise distress.

2.4 Data Security

All files relating to Exercise Seren were kept on the shared X drive which was only accessible to relevant staff. All documents with sensitive information on this shared drive were password protected to strengthen information governance systems.

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2.5 Patient Administration System (Myrddin)

The Myrddin system was used by the appointment line and in testing and counselling clinics. This enabled generation of patient letters directly from the database. The final valid database was uploaded in two parts. On the 27th April 2015 cohort 1 was uploaded shortly followed by cohort 2 on the 11th May 2015. Subsequent clients who were identified following the public ‘call out’ communication were uploaded on an ad hoc basis.

3. Communications The Communications subgroup was chaired the Director of Public Health. The aim of the subgroup was to manage all internal and external communications including press and media correspondence. Materials developed included patient letters, FAQ sheets, GP letters, clinic proformas and helpline messages.

3.1 Objectives

The objectives of the subgroup were:

• To inform the clients, public, NHS and Newport LA staff and local and national media of the issues, to explain the context and the actions being taken.

• To reassure and offer guidance to clients and members of the public • To plan and coordinate communication activity for all stakeholders including Newport

City Council, Aneurin Bevan University Health Board, Public Health Wales, General Practitioners and NHS Direct Wales, working closely with all organisations communications teams proactively and reactively.

• To inform Welsh Government and media of progress with Exercise Seren

3.2 Holding press statement Although all correspondence and Exercise Seren related material was to be treated as strictly confidential, it was acknowledged that it may become public knowledge prior to the ‘go‐live’ date. Therefore, a holding press statement was prepared in readiness. See Appendix 2.

3.3 Communication with the tattoo and body piercing business owners In addition to the numerous visits to the premises by Newport City Council Environmental Health Officers, the chair of the IMT visited the owners of the company to communicate with them that the look back exercise was going to occur and to advise on the timings. The owners were also made aware that the premises were going to be named in the media and since one person lived above premises, advice was given regarding the possible need to relocate depending on media reaction. The offer of testing the owners for BBVs was made verbally and followed up by letter.

3.4 Communication with members of the public 3.4.1 Public Announcement of look‐back exercise‐ ‘Going Live’

The ‘go‐live’ date was planned in consultation with colleagues in the Welsh Government for Wednesday 6th May 2015.

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This date was determined at early IMT meetings based on the estimated time required to ensure that there was an effective response in place. This was based on the complexity of the preparation required, included data cleansing to ensure accuracy when contacting clients, establishing a testing model and ensuring that all information and communications materials to clients, professionals and stakeholders was effectively prepared. This date also meant that many young people of late school age would be able to access weekend clinics on the 8th, 9th and 10th May before GCSEs, AS and A level examinations which began the following week. It was acknowledged that this was the day prior to the General Election but following advice it was determined that this should not be a reason to prevent the look back exercise and that delay would mean clashes with examination timetables. Letters were sent first class on Tuesday 5th May; so on the day of the press conference, most letters were arriving at households. Attention was also paid to dates of birth in order to ensure that letters did not arrive on a client’s birthday, as the potential to cause significant distress was recognised. The first clinics were arranged for the evening of Friday 8th May. The ‘Go Live’ day consisted of extensive media communications which were initiated by a press conference and attended by a variety of broadcasters including BBC Wales, ITV Wales and The Argus newspaper. The expert panel consisted of

• Director of Public Health (Chair) • Head of Planning‐ Civil Contingencies for ABUHB • Consultant in Health Protection • Regional Epidemiologist • Newport City Council Strategic Director

At the beginning of the press conference, a press statement was read out by the chair of the panel; journalists were provided with a briefing pack and given time to read this through. Journalists were then invited to participate in an open ‘Question and Answer’ session with the panel members before any ‘one‐to‐one’ media interviews commenced. There was a Welsh speaker and Welsh translations of the press release available for the Welsh speaking broadcasters. See Appendix 3 for the first press release and Appendices 4, 5 and 6 for further press releases. The press briefing pack included the first press release as well as:

• Hepatitis B Factsheet (Appendix 7) • Hepatitis C Factsheet (Appendix 8) • HIV Factsheet (Appendix 9) • Frequently Asked Questions (Appendix 10)

Through this press conference the public were informed about the nature of the incident and how ABUHB and partners were dealing with the incident e.g. that the letters would be arriving over the next few days. A public Call‐out was made for any clients had a tattoo or body piercing procedure at these two premises under any of their names, between the specified dates, but had not received a letter

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by Friday 8th May. These clients were asked to call the PHW Helpline, for which the number was provided. This was necessary as it was felt client lists were incomplete. Clients receiving letters were advised to call a separate clinic booking line number which was not made available to the general public. PHW Helpline was able to transfer any caller who satisfied the criteria for being included for testing (client of premises at either address between specified dates) to the booking line so that appointments could be arranged for clients not yet known to the look‐back Hub. Communications continued on a daily basis throughout the ‘Go Live’ phase, until final clinics were held on 30th May. Social media coverage continued after this date on the ABUHB and PHW websites and social media accounts.

3.4.2 Websites

As part of the communications strategy a dedicated webpage was established (http://www.wales.nhs.uk/sitesplus/866/page/80604). This webpage contained the relevant factsheets on the BBVs tested for, a ‘Frequently Asked Question’ and corresponding ‘Easy Read’ document, provided details about the premises, background information, the PHW helpline telephone number, press updates and Welsh versions. A total of 15,638 hits to the website, over the initial month period were recorded. See Appendices 7 to 11.

3.4.3 Social Media

In recognition that our predominant age range was between 16 to 25 years a social media strategy was imperative to the success of reaching clients who were unknown to the exercise since we did not have their client record or they were on the ‘red list’ with insufficient data to follow up, but did meet the criteria for BBV testing. The Communications team ensured that an officer kept a watching brief on social media both in and out of office hours. Facebook posts saw:

• Reach – 19,209 • Clicks – 1,677 • Shares/Likes/Comments – 717

During the first week ABUHB tweets earned 51,112 impressions. For comparison, in the previous week to the look‐back exercise their tweets earned 9,875 impressions. The value of social media was evidenced by the example of a Scottish lady who was not known to the look‐back exercise but saw the story through her Twitter account and felt she was at risk. The lady contacted the ABUHB Communications team who ascertained her relevant details, confirming her suspicions. Details were then passed to the Hub which contacted her GP in Scotland and arranged for BBV testing.

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3.5 ABUHB Employees

A week prior to the ‘go‐live’ date, a briefing was sent to all involved staff, which contained all the information which had been sent out to clients, the press release and action cards for their roles. All materials were marked as strictly confidential. On a wider staff basis, a briefing on the ABUHB intranet site was launched on the ‘go‐live’ date and was updated when new briefings were issued. The Board and Executive Team were briefed throughout.

3.6 PHW Employees

The PHW employees who were part of exercise Seren had the same briefing as ABUHB employees. Wider PHW employees were kept informed via their internal intranet page and their Board and Executive Team were briefed throughout.

3.7 Welsh Government

The Welsh Government was updated on a weekly basis. Information included;

• How the planning of the exercise was progressing. • Key decisions such as the inclusion of the second premises. • Figures on how many clients had been tested. • The number of calls the PHW Helpline and ABUHB Appointment line had received. • Any results available.

An example of the reporting template to Welsh Government is shown in Appendix 12.

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3.8 Communications to Each Client Category and GPs

A decision was made to split the known clients into several different categories and contact them as follows; Table 4: Communication methods by client group

Client Group Contacted via Testing routes offered Rationale

Under 16 Letters to their parents/guardian See Appendix 12

Specialist outpatient clinics, GP, GUM Clinic (e.g. Cordell Centre

It was arranged that Paediatric nurses were

available at every specialist clinic.

16 and 17 Letters to clients See Appendix 13

Specialist outpatient clinics, GP, GUM Clinic (e.g. Cordell Centre

Specialist nurses were present at every outpatient

clinic. If preferred GUM appointments are

anonymous.

Over 18 Letters to clients See Appendix 14

Specialist outpatient clinics, GP, GUM Clinic (e.g. Cordell Centre)

Recognising specialist outpatient clinics may not be a chosen venue or

feasible for all, clients were also offered appropriate

treatment in Primary Care or GUM Clinic settings.

Vulnerable Patients

Social Services checked lists

initially to ensure clients they knew of were identified. Clients often had

their letters delivered by key

workers.


Recognition that these clients needed ease of access to a variety of

settings regardless of age.

Out of ABUHB Area‐ but in South

Wales

Contacted in the same way as those who came from

ABUHB.


Specialist clinics in reasonably close proximity, but Primary Care available

locally.

Out of Area ‐ outside of South Wales

Contact made with client’s GP who

then made contact with client. PHW made contact with client’s local health protection team.

Clients were advised to visit their GP

Significant travel distances precluded specialist

outpatient patient clinics.

As well as receiving letters, the known clients received the ‘Frequently Asked Questions (FAQs)’. See Appendix 10.

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After the initial letters had been sent, a further reminder letter was sent on the 13th May. This reminder letter was for clients who were on the database but had not yet made an appointment or been seen in any alternative setting offered to them. See Appendices 16 and 17. If a client ‘Did not Attend (DNA)’ their clinic slot then an automatic letter was generated via Myrddin. See Appendices 18 and 19.

3.9 CHC

Throughout the creation of the letters and the FAQ pack process, the CHC were actively involved to ensure that the communications were as appropriate and clear as possible. CHC also assisted with preparation of materials for awareness raising of the risks of tattooing/piercing

3.10 GPs

GP’s were sent briefing packs and materials before ‘go–live’ and throughout the exercise and could contact the Hub with any queries or problems. They were offered a Local Enhanced Service (LES) which would enable them to claim £35 per client (who was aged 17 or over) whom they tested in their practice. See Appendix 20. The GP packs were put together to ensure that all GPs and their teams were aware of the exercise. Packs were sent to all ABUHB GPs in case clients may self present at their practice. Packs were also sent to out of area GPs where a patient who had been identified lived outside of ABUHB boundaries. The GP Pack included;

• The first press release (Appendix 3) • A Seren Proforma (Appendix 21) • An action card for Phlebotomist (Appendix 22) • A copy of the of LES (Appendix 20) • FAQs (Appendices 10 and 11) • Hepatitis B, C and HIV factsheet (Appendices 7, 8 and 9)

GPs were also sent a letter at the end of the exercise explaining their clients’ results or informing of any who did not attend.

4. PHW Helpline

Due to the volume of ‘Red’ (unidentifiable) and totally unknown clients, in order to protect the appointment line from being overloaded with calls, this number was only shared with letter recipients who when telephoning were to give their unique reference number to access their appointment. A PHW Helpline was set up to advise and receive calls from further potential clients. It was considered that for the piercing and tattooing business to have been viable, there may probably have been more clients than those with paper consent forms. Clients who met the criteria of having had procedures at the premises (either address) within the relevant timescales had their details passed to the Health Board appointment line. A number of appointments daily could be booked by PHW helpline directly for eligible clients. Appendix 23 outlines criteria.

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A further reason for the helpline was that as BBVs can be very emotive and many clients were young, it was helpful for individuals to be able to discuss concerns with Public Health professionals.

4.1 PHW Helpline Operating Hours

The helpline ran from the 6th May and continued to the 29th May. The opening hours were planned to mirror the ABUHB appointment line (see following section).

4.2. Staff Training

A few days prior to the exercise ‘going‐live’ PHW provided training regarding safeguarding issues, BBVs and an explanation of the processes for their helpline. The safeguarding information was provided by a PHW safeguarding nurse and provided some relevant scenarios for the helpline staff. The BBV information was provided by a Specialist Nurse and mirrored the information provided by the specialist nurses in ABUHB for the clinics.

4.3 Calls Received by PHW Helpline and NHS direct

There was an initial peak of calls to the PHW helpline as media communications reached the wider public. This is illustrated by the table below: Graph 1: Number of calls received by PHW Helpline, by date

In order to ensure that all telephone advice routes were available, PHW worked with NHS Direct (Wales) to formulate an algorithm to direct callers to the right service and correct advice. ‘Worried well’ were directed to NHS direct. See Appendices 24 and 25.

0

20

40

60

80

100

120

140

Num

ber o

f Calls re

ceived

Date

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4.4 Referrals from PHW helpline to the ABUHB Appointment Line

Graph 2: Referrals from PHW Helpline to Health Board Appointment Line, by date

As is shown by Graph 1 and Graph 2, the initial high numbers of calls were similar for both helplines. There were some surges of demand after the initial few days on two further dates; the 11th and 13th May. The 11th May was the date of a second press release and the 13th May was the date reminder letters arrived for known clients. 4.5 PHW Helpline Staffing

In order to match demand with capacity, previous look back exercise data call volumes were examined, recognising there may be a variance due to the nature of this exercise. Appendix 27 shows how capacity was subsequently utilised as the helpline was flexed up or flexed down, depending on demand.

0

20

40

60

80

100

120

140

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f Referrals se

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Table 5: PHW Helpline staffing

Date Revised staffing as appropriate to meet demand

Number of Calls

Number of Emails

6th May 2015 8 on phone lines and 1 responding to emails from appointment line 126 20

7th May 2015 8 on phone lines and 1 responding to emails from appointment line 96 10

8th May 2015 7 on phone lines and responding to emails 65 1

9th May 2015 Initially 5 then reduced to 3 after 2hrs then to 2 at approx 2pm 9 0

10th May 2015 2 on phone lines and responding to emails 6 0 11th May 2015 5 on phone lines and responding to emails 26 1 12th May 2015 4 on phone lines and responding to emails 17 0

13th May 2015 7 overall available to be used for the day but only 3 at any one time 29 0

14th May 2015 5 overall available to be used but only 3 at any one time 9 0

15th May 2015 4 staff took calls 11 0

18th May 2015 3 took calls 9 0



21st May 2015 3 took calls 3 0

22nd May 2015 1 took calls 3 0

26th May 2015 2 took calls and 2 Health Protection (HP) staff available 6 0

27th May 2015 2 took calls and 2 HP staff available 3 0

28th May 2015 1 took calls and 2 HP staff available 2 0

29th May 2015 no calls although 2 HP staff available 0 0

5. ABUHB Appointment Line

The dedicated appointment line was set up for those who had received letters or been referred by PHW. The appointment line number was included on the client’s letter. Appointment slots at a specialist nurse clinic set up for Exercise Seren were offered with patient choice of slots. In order to match demand with capacity, previous look back exercises call volumes were examined, recognising there may be a variance due to the nature of this exercise. Appendix 28 shows how capacity was subsequently utilised as the helpline was flexed up or down, depending on demand.

Although the total number of hours worked was 847.5 only 312 hours were claimed as overtime. Therefore, the booking of the appointments was mainly done within normal working hours with opportunity costs for the booking centre.

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19. The highest numbers of clinicians were used in the initial clinics as demand was harder to predict. Once these initial clinics had passed and there could be analysis on the demand coming through the telephone lines, staffing levels corresponded to this demand. The clinics aimed to see one client per clinician every thirty minutes, enabling clients to have enough time to ask questions, for the patient proforma to be completed and for the client to make an informed decision about having the blood tests prior to these being conducted. Roles within the clinics were:

• Clinic Controller • Receptionists • Nurses including a Paediatric Nurse • Phlebotomists

There was an action card developed for each role. See Appendices 28 to 31.

6.3 Clinic venues

As the body piercing and tattooing studio was in Newport it seemed appropriate to base the clinics in that area. Initially it was planned via IMT for under 18 year olds to be seen in specialist nurse clinics in Royal Gwent Hospital (RGH) and the over 18’s to be seen by their GP. Following a Local Medical Council (LMC) meeting a £35 fee was agreed to be paid to GPs per client seen, however after cost effectiveness analysis it was determined that opening clinic appointments to everyone would be more cost effective, whilst also leaving the option of attending their GP if client preferred. Clinic nurses had specific expertise and training in BBV, proforma completion could be checked, blood tests taken and batched for processing and economies of scale achieved. The eventual saving by inviting the clients aged 18 to clinics was £3, 406. The majority of clients were seen in the clinics, with a small number going to their GP Practice or GU Medicine (usually the Cordell centre in Newport).

6.4 Phlebotomy

Phlebotomy was undertaken by phlebotomists or paediatric phlebotomists with the appropriate skills were present at the clinics. All blood forms were marked with ‘SEREN’ to ensure the laboratory was able to link the samples to the look‐back exercise process when reporting results.

6.5. Clinic Dates and Times

Table 8 below shows the dates and times where appointments were available in the specialist outpatient clinics at RGH.

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Table 6: Nurse‐led outpatient clinics at RGH

Date Appointment Times 8th May 2015 6:00pm ‐ 8:30pm 9th May 2015 9:30am ‐ 6:00pm 10th May 2015 10:00am ‐ 4:30pm 13th May 2015 6:00pm ‐ 8:30pm 15th May 2015 6:00pm ‐ 8:30pm 16th May 2015 9:30am ‐ 6:00pm 17th May 2015 10:00am ‐ 4:30pm 20th May 2015 6:00pm ‐ 8:30pm 27th May 2015 6:00pm ‐ 8:30pm 30th May 2015 9:30am – 12:00pm

6.6 Clinic Activity and Follow up Table 7: Number of identified and eligible clients for BBV testing

Number Number of clients identified through client records 691 ‐ Of which number living outside of Wales 7 Total number of clients living in Wales invited for testing 684

Table 8: Number of identified and eligible clients for BBV (as at 3/3/16)

Invited Self presenting TOTAL Total number invited for testing 684 ‐ Of which, number informing us that they had not had a procedure e.g. changed their mind after filling in the consent form at the premises

6

Total number of invited eligible clients 678 Number of clients presenting for testing 507 334 841 ‐ Percentage of total (invited and self presenting) tested 60% 40% Number of clients invited but who had not presented for testing despite 2 reminders 171 ‐ Percentage of invited eligible clients not presenting for testing 25%

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Table 9: Number of clients tested by location (as at 03/03/16)

Invited Self‐presenting Total ABUHB Specialist Nurse Clinic (08/05/15 – 30/06/15) 447 280 727

GP practice 22 23 45 Sexual Health Clinic 38 31 69 Total number tested 507 334 841 Total number of invited eligible clients 678 ‐ Percentage invited who were tested 75%

6.7 ‘Did Not Attend’ clinic analysis

Graph 4: Number of appointments booked where client did not attend

6.8 Hepatitis B follow up testing

Guidance on testing for Hep B states that 6 months should have elapsed between exposure and testing. However it was felt by IMT that the one sample screening should still be offered to clients who were not yet 6 months from exposure so that Hep C and HIV could be tested for and reassurance given Following the clinics 168 clients were sent a letter which offered a further screening test for Hepatitis B to confirm status 6 months post exposure. These clients were offered this further test as there had not been 6 months between their time of potential exposure and undertaking their Hepatitis B test. This further test was carried out by their GP or as part of their GMS service or by GUM Clinics (e.g. Cordell Centre) according to client preference. See Appendix 32.

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7. Results

The majority of clients were young people below the age of 25 years, with some below the age of 13 years. Graph 5: Age and sex distribution of cohort

Differences between the age the client stated at the time of procedure and their true age at that time were highlighted. This revealed disparity, which was maximal in those of true age 14 and 15 years. In this group, 33% of 14 year olds and 48% of 15 year olds inflated their ages by two years and one year respectively. This was possibly in order to have procedures undertaken without obtaining parental consent.

Table 10: Difference between age reported at time of procedure and true age at that time

Analysis of all individuals attending for testing, who reported a body piercing at an intimate site (nipples and/or genitals), revealed that several young people below the age of 16 years had

Female Male

350 250 150 50 50 150 250 350

Under 13 yrs

13 yrs

14 yrs

15 yrs

16 yrs

17 yrs

18-25 yrs

25 yrs and over

Reported age greater than true age Exact match Reported age less than true age

>2 years 1‐2 years <1 year <1 year 1‐2 years > 2 years

<13 0% 6% 38% 56% 0% 0% 0% 13 10% 10% 10% 70% 0% 0% 0% 14 13% 33% 8% 38% 4% 0% 4% 15 6% 15% 48% 29% 2% 0% 0% 16 8% 6% 12% 73% 1% 0% 0% 17 0% 29% 16% 52% 0% 3% 0% 18‐25 1% 0% 3% 96% 0% 0% 0% >25 0% 0% 0% 97% 0% 0% 3%

Total 4% 12% 17% 65% 1% 1% 1%

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experienced this. This raises concerns about safeguarding aspects of body piercing, which have been reported through Newport City Council Social Services.

Graph 6: Percentage of individuals attending for a BBV screen reporting a body piercing at an intimate site (nipples and/or genitals) by age group

Positive BBV results following all testing steps were:

Hepatitis B 5 clients (of whom 1 was surface antigen positive)

Hepatitis C 3 clients

HIV 0 clients (1 reactive initially, later found to be a false positive)

All clients who were found to have had BBV exposure had other risk factors, so that a link with the body piercing parlour could not be established. Zero typing was not possible due to the majority of clients having cleared virus.

7. Communication of Results

7.1 Informing of negative samples

To inform patients of a negative result, the hub generated a standard letter which was sent to either themselves, their parent/guardian if under 16 years, or by hand via their case manager for vulnerable patients. See Appendices 33 and 34. In the client proforma it enquired how the patient would like their results to be feedback to them; some patients requested a text result which was facilitated by the Hub or GU Medicine clinic.

0 5 10 15 20 25 30

Under 13 yrs

13 yrs

14 yrs

15 yrs

16 yrs

17 yrs

18‐25 yrs

25 yrs and over

%

age

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7.2 Informing clients of reactive or positive samples

Once the sample had been confirmed to be reactive, a BBV nurse was asked to contact the client by phone and invited them in for further testing. At this appointment an additional proforma was completed which further explored their risk factors. See Appendix 35. Once the final results for these patients were obtained the specialist nurse informed the patient of the findings, inviting them in if positive before disclosing result.

7.3 Informing GP of results

Clients were asked to give consent for their GP to be made aware of their results. If so, a letter was generated to GP from the Hub.

7.4 Out of area results

For results processing, all out of area clients were treated in the same manner as ABUHB patients. Many of them lived in neighbouring health board areas and attended the special clinics. For others who were tested via their GP, their GP and Laboratory were asked to forward results to the Hub.

7.5 Vulnerable Clients

To inform vulnerable clients of a negative result, the letters in Appendices 33 and 34 were sent or where appropriate, delivered via their key worker. In relation to a reactive result, the BBV nurses would have contacted the client or their key worker.

7.6 Recording on Patient Record

It was agreed that clients who got tested at GU Medicine clinics were a separate cohort who had deliberately chosen this anonymous route and their involvement in Seren should not be recorded on Myrddin/CWS. GUM should therefore hold results for future reference. For Clients tested at Specialist Outpatient Clinics or by GPs a clinical alert was placed on Clinical Work Station for each client (excluding those who expressed that they did not wish their GP to be informed): “BBV screened as part of Newport tattoo/piercing look‐back exercise (Exercise Seren) May 2015. Contact Head of Health Records for further information.” For clients who did not want their GP to be informed, their proforma was scanned and held with the hard copy Health Records.

8. Storage

8.1 Samples

All blood samples were stored at Nevill Hall Hospital laboratory following testing. There is a large freezer purchased for a previous look back exercise which has been utilised. During consultation clients were advised that their blood would be stored.

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8.2 Proformas

Proformas with risk factor details were not placed in the patient’s hard record. Health Records scanned all proformas, transferred to the anonymous database and any identifiable data was removed for this purpose.

9. Support Infrastructure

9.1 Hub functions

The hub was situated in ABUHB headquarters The objectives of the hub were:

• To coordinate the ‘go‐live’ operational phase of Exercise Seren. • To coordinate all activity, respond to queries relating to Seren operational phase. • To receive results from laboratory and process all clinic results, including informing

patients and GPs. • To maintain a situation report throughout the operational phase for Welsh Government

and other stakeholders.

There were two dedicated email addresses set up for the exercise, one generic for queries and proformas and a second address for the laboratories to send results to. Three phone lines were also assigned to the hub.

9.1.1 Microbiology Lab Processing

The lab staff performed the Seren testing out of core hours and during weekends to ensure Seren patients had fast turnaround times.

9.1.2 Reporting

The microbiology data was gathered every day using national LIMS IT system, and checked against the patient request forms. The microbiology staff transposed this data into encrypted Excel spreadsheet and emailed Hub with results on a daily basis.

9.2 Situational Reporting

The situational reporting (SitReps) were done on a daily basis for the purpose of:

• Internal monitoring of daily activity to inform operational planning of clinics/appointment line.

• External reporting.

See Appendix 36.

9.3 Project Manager

The exercise had a designated project manager. This role had a defined job role and was useful in ensuring that there was a designated person who oversaw the entire project and updated the project plan. The Job Description is in Appendix 37.

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10. Costs

Table 11: Summary of Exercise Seren costs

Component Costs Actual costs

Estimated Opportunity

Costs

Total of Actual & Opportunity

Costs

£ £ £

Aneurin Bevan University Health Board (Non‐acute)

48,106 46,056 94,163

Acute A&E/Inpatient 30,976 30,976

Newport City Council 3,597 3,597

Local PH Team Hub 43,518 43,518

PHW Helpline 6,155 11,133 17,289

PHW (other) 8,717 8,717

Outbreak Control Meetings 41,900 41,900

Totals 85,237 154,922 240,159

11. Learning Points

As part of the creation of this technical report, the chairs of subgroups were asked to collect learning points and recommendations from their colleagues. The learning points were:

1. GPs were instructed to fill out the proformas and return them via the designated email address. However, some practices returned the proformas with the blood samples and some did not fill out the proformas at all. Therefore, an added hub function was to ring these clients and fill out the proforma over the phone. It was not always possible for the hub to contact the client and led to a small number of clients having test results but not aligned proforma.

2. Appointment line staff were very respectful of confidentiality during the whole process especially with reference to the teenagers who didn’t want their parents to know they were coming. DNA letters went out to all DNA’s causing some parents to call in saying they weren’t aware of an appointment their child had. This may have occurred due to under 16s who called into the PHW Helpline, met the criteria for the appointment line, and booked an appointment but subsequently DNAd. Therefore, a DNA letter would have been generated which due to their age would have been addressed to their parents who may not have been aware of their child originally calling in to the PHW Helpline.

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3. ABUHB commissioned a DNA text appointment reminder service from an external provider who is used already in Orthopaedics. However it was stopped within two days of the appointment line being operational after it was found that the information related to mobile phone contacts in the database wasn’t robust. The learning from this is that the additional service of text reminders, whilst anticipated to be enhanced level of service for the clients, can be problematic. The IMT are content that they responded immediately to concerns and limited any negative impact from the failure.

4. All sub‐groups need dedicated secretarial support. 5. Aspects which worked really well were; the positive team culture within all aspects of

the exercise, all the subgroups were highly solution focussed, the heads of the subgroups encouraged innovation, there was good communication between those involved and there was a positive patient centred attitude displayed within the RGH outpatient clinics.

6. As ABUHB had undertaken a look‐back previously the team were able to draw on this experience which enabled Exercise Seren to be more effective and quickly determine how to meet the needs of this client group.

7. Communication utilising social media proved to be especially positive in the situation and would be used again. The Communications Team won a national social media award for their work on Exercise Seren.

12. Recommendations

1. Education of young people about risks of tattooing and piercing including blood borne viruses and bacterial infections should be supported nationally.

2. There is a need for improved regulatory powers for the enforcement of hygiene measures in body piercing/tattooing premises. There are better safeguards in place with regard to buying a sandwich than having potentially harmful procedures such as tongue piercing currently.

3. All premises performing body piercing/tattooing should keep detailed client lists and consent forms with address and contact numbers.

4. Intimate piercing should only be performed over the age of 16 where documented proof of age is demonstrated.

5. The piercing/tattooing of intimate areas can be considered a safeguarding issue, if the client is not of age or is vulnerable in other ways and it is recommended that these procedures are carried out by a same sex practitioner preferably in the presence of a client advocate.

6. All tattooing and body piercing practitioners should have DBS checks completed and undergo safeguarding training.

7. Registration/licensing to perform tattooing/piercing should be on an individual basis of competency based on understanding of infection control, safeguarding legislation, technical aspects and practical skills, similar to other forms of minor surgery e.g. cosmetic. The current situation, whereby anyone with no training can open for trading with no quality assurance, is unacceptable particularly with ever invasive procedures e.g. tongue piercing, body modification.

8. Substantiated complaints against an individual should revoke licence until a period of retraining and reaccreditation fulfilled.

9. Local authorities should have shared databases of licensed practitioners and those whose licence has been revoked.

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10. There should be awareness‐raising among GPs and ENT doctors so that if anyone presents with infection following piercing/tattooing they alert the local Health Protection team urgently.

Press Releases During Exercise

Publication Details

Title: The Technical Report of a Blood-Borne Virus Look-Back Exercise related to a body piercing and tattooing studio in Newport, South Wales

Publisher: Aneurin Bevan University Health Board

Date: 26th July 2016

ISBN 978-0-992932978

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