SCHEDULE 2- THE SERVICES- A. SERVICE … · Hyperbaric Oxygen Therapy (HBOT) has been used for the treatment of decompression ... HBOT is targeted at a range of conditions and patient

1 NHS England D11/S/a

Gateway Reference 01367 © NHS Commissioning Board, 2013 The NHS Commissioning Board is now known as NHS England

D11/S/a NHS STANDARD CONTRACT FOR HYPERBARIC OXYGEN THERAPY (ALL AGES) SCHEDULE 2- THE SERVICES- A. SERVICE SPECIFICATIONS

Service Specification No. D11/S/a

Service Hyperbaric Oxygen Therapy (All Ages)

Commissioner Lead

Provider Lead

Period 12 months

Date of Review

1. Population Needs

1.1 National/local context and evidence base

National Context

Hyperbaric Oxygen Therapy (HBOT) has been used for the treatment of decompression illness for over 50 years. Since then, it has also been used for an increasing number of medical indications although, for many of these conditions, the theoretical basis for HBOT is unclear, and/or the evidence of efficacy and cost effectiveness is not well established or convincing. The term decompression illness includes decompression sickness and arterial gas embolism. The majority of cases of decompression illness arise from diving and other activities that involve exposure to raised environmental pressure followed by a return to normal atmospheric pressure. Between 200 and 300 cases present in England each year. A few cases arise solely from exposure to low pressure such as in an unpressurised aircraft. Cases to date have typically been otherwise healthy individuals in the age range between late adolescence and late middle age with a preponderance of males. The range of medical problems considered compatible with diving is gradually broadening. An increasing proportion of the diving population is in the seventh or eighth decade of life. The proportion of female divers is growing.



These factors mean that the age-gender profile, and the likelihood of significant pre-existing co-morbidities, within the population presenting with decompression illness will change in future. The geographical distribution of cases of decompression illness is determined by level of diving activity, and is concentrated around coastal areas and inland expanses of water. Airports provide a significant minority of cases which arise on flights back to England after a diving holiday abroad. A small number of cases of gas embolism arise from inadvertent introduction of gas into a patient’s circulation during a medical procedure. Decompression illness and gas embolism can leave casualties with significant disabilities and can sometimes be fatal. There is no other specific treatment for decompression illness or gas embolism. Evidence Base Most HBOT providers offer treatment for a range of other conditions approved by the Undersea and Hyperbaric Medical Society (http://membership.uhms.org/?page=indications) and / or the European Committee for Hyperbaric Medicine (http://www.echm.org/documents/ECHM%207th%20Consensus%20Conferenc e%20Lille%202004.pdf). NHS funding is informed by Health Technology Assessments (for example http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=9964e8a0- b1eb-46a6-949f-dbc3a57e2b64&version=-1) and NICE guidelines (for example http://www.nice.org.uk/nicemedia/live/13416/53556/53556.pdf). The areas in which research efforts are currently concentrated are treatment of diabetic foot ulcers and prevention or treatment of long-term complications of radiotherapy. There is an almost universal consensus supporting HBOT as standard care for decompression illness and gas embolism. HBOT providers are few in number. The main potential inequalities are the distances that an individual will need to travel for treatment and the variation in commissioning across the nation. The single national commissioning policy has addressed the latter source of inequality. It would be very difficult to address the former but the impact is minimised because providers are typically located close to areas where cases of decompression illness originate or where some other need has been identified.

2. Outcomes

2.1 NHS Outcomes Framework Domains & Indicators

Key Generic Outcome Measures

Compliance with national access and time to treatment targets

Un-planned re-admission to the unit

Elective care discharge to other than pre-treatment domicile



Contribution to and compliance with national audits and guidelines including:

NICE Guidelines NICE Improving Outcomes Guidance (IOG)

As proxy measures for outcome in HBOT, each provider shall:

Be a member in good standing of the British Hyperbaric Association (BHA)1.

Work in accordance with the BHA publication ‘Health and Safety for Therapeutic Hyperbaric Facilities. A Code of Practice’.

Be registered as a Hyperbaric Chamber Service with the Care Quality Commission.

Satisfy the requirements of a Category 1, 2 or 4 hyperbaric facility as defined by the Cox Report.

Operate under the clinical responsibility of a suitably qualified and experienced fully registered medical practitioner; the Medical Director of the HBOT unit as defined by the Cox Report.

Have robust clinical governance systems in place and conduct a rolling programme of clinical audits.

Have a formal agreement with an identified local hospital describing how the two organisations will co-operate in the treatment of patients requiring HBOT. The identified hospital must have support services appropriate to the category of chamber such as: emergency department, critical care, acute medical and surgical services, psychiatric services, ENT, pathology, x-ray and MRI services, paediatric services, access to a helicopter landing pad (or have other appropriate arrangements for the transfer of critically ill patients).

Key Service Outcomes for HBOT (please see Appendix One):

Patients will be treated by the service within the timescales agreed with the commissioning authority, recognising that, in some instances, in emergencies ‘time to treat’ patients may be prolonged due to factors entirely outside of a facility’s control.

Patients will receive a discharge letter on completion of treatment, onward referral if required and educational information at discharge.

Providers will have sufficient capacity to accept patients at the level agreed with the commissioning authority.

Feedback from patient experience outcome measures will be sought at least annually and will be acted upon as appropriate.

Whenever circumstances reasonably permit, patients will be fully informed about why they should receive HBOT and why it may be beneficial to them. This should include clear written information.

Mortality rates for each condition being treated shall not exceed the standardised mortality rates that would be expected if HBOT was not being administered.

Each provider will complete the quality dashboard with the required frequency and within the required timeframe. Any measure that is below the accepted standard will be addressed by the provider and all reasonable measures taken to rectify the shortcoming in future.

1 no pending or outstanding actions that BHA considers incompatible with membership.



Domain

1

Preventing people from dying prematurely

Domain

2

Enhancing quality of life for people with long-

term conditions

Domain

3

Helping people to recover from episodes of

ill-health or following injury

√

Domain

4

Ensuring people have a positive experience of

care

√

Domain

5

Treating and caring for people in safe

environment and protecting them from

avoidable harm

√

3. Scope

3.1 Aims and objectives of service

The service comprises the activity of a small number of discrete units which provide Hyperbaric Oxygen Therapy (HBOT) across England. For this document, HBOT is defined as delivery of oxygen inside a treatment chamber at a partial pressure greater than 100 Kilopascal (kPa). It is typically administered at a partial pressure substantially higher than 100 kPa and seldom at less than 220 kPa. Core objectives are:

To integrate with other hyperbaric units and medical emergency services for the benefit of the patient.

To provide staff who are suitably qualified and experienced to advise on hyperbaric medicine issues and to care for patients during HBOT.

To provide treatment in a safe environment this satisfies NHS and all other relevant standards and legislation.

To provide all necessary supportive treatment appropriate to the patient’s condition during hyperbaric treatment.

To provide a service from which patients can reasonably expect:

To have prompt 24 hour access to emergency HBOT for appropriate medical conditions through relevant referral channels.

To receive HBOT administered by appropriately trained personnel in facilities that are well maintained, comply with all relevant regulations and follow best practice.

To receive care suited to their medical condition.

To receive care that is integrated with care from other sources including their



general practitioner (GP), referring specialist and other healthcare professionals.

To be treated with respect and dignity with their own wishes being considered where possible and reasonable.

HBOT is targeted at a range of conditions and patient groups limited by the commissioning policy to those that most closely align with the principles of evidence based medicine.

3.2 Service description/care pathway

Service Delivery Principles: Hyperbaric Oxygen Therapy (HBOT) involves delivery of oxygen inside a treatment chamber at a partial pressure greater than 100 kPa. In certain circumstances divers require prolonged exposure to ambient pressure in excess of 100 kPa but the inspired partial pressure of oxygen is reduced to 50 kPa or less in order to avoid pulmonary toxicity. While this is, technically, not HBOT it is included in the scope of service as a necessary adjunct to HBOT. Resources: Components:

Hyperbaric centres are classified depending on the availability of medical facilities, suitability for different types of patients and whether they use mono- or multi-place chambers. There are both mono place and multi place chambers available across the UK.

Mono-place chambers are less costly and some are portable. They provide treatment for a single unaccompanied patient. They do not, however, allow access to the patient for assessment or intervention without cessation of treatment and depressurisation. As a result, they are inappropriate for some patients

Multi-place chambers allow an attendant or other health professional to deliver care directly to patients and to deal with emergencies immediately without interrupting hyperbaric treatment. In some circumstances, multiple patients may be treated simultaneously.

The service centres are not evenly distributed on a geographical basis, and they provide different services as defined by the Cox Report.

Cox Report categories:

Category 1: facilities should be capable of receiving patients in any diagnostic category who may require Advanced Life Support either immediately or during HBOT.

Category 2: facilities should be capable of receiving patients in any diagnostic category who are judged by the referring medical practitioner not to be likely to require Advanced Life Support during HBOT.

Category 3: facilities should be capable of receiving emergency referrals of divers and compressed air tunnel workers. These facilities should also be capable of providing



elective treatment of residual symptoms of decompression illness. Patients may be accepted, in the name of the Medical Director (whose role is defined in paragraph 24 of the Cox Report, 1994), even when no Hyperbaric Duty Doctor is available at the time of referral provided, in the view of the referring clinician, the patient’s condition demands immediate action. This does not obviate the need for discussion with the Hyperbaric Duty Doctor who should attend the patient as soon as is practicable.

Category 4: facilities should be capable of receiving elective and emergency referrals of patients in any diagnostic category who are judged by the referring medical practitioner, on the advice of the Hyperbaric Duty Doctor, not to be likely to require access during HBOT. Normally mono place chambers are not suitable for the immediate treatment of acute decompression illness.

With the foregoing classifications in mind the HBOT provider’s facility shall

Be a member in good standing of the British Hyperbaric Association (BHA).

Work in accordance with the BHA publication ‘Health and Safety for Therapeutic Hyperbaric Facilities. A Code of Practice.’

Be registered as a Hyperbaric Chamber Service with the Care Quality Commission (CQC).

Satisfy the requirements of a Category 1, 2 or 4 hyperbaric facility as defined by the Cox Report.

Operate under the clinical responsibility of a suitably qualified and experienced fully registered medical practitioner; the Medical Director as defined by the Cox Report

Have robust clinical governance systems in place and conduct a rolling programme of clinical audits.

Ensure that all decisions regarding HBOT will be undertaken by a Hyperbaric Physician who has specialist knowledge and experience of the use of HBOT. This medical practitioner will be responsible for HBOT until it stops or until the case is handed over to another hyperbaric physician with the requisite knowledge and experience.

Declare to the BHA whether they are registered with the Care Quality Commission to provide treatment to children.

Ensure that children treated at the unit have their care overseen by a paediatric consultant.

In addition, Cox Category 1 facilities shall: Declare to BHA whether they can accommodate ventilated patients on a continuous basis limited only by capacity of the host hospital critical care unit or if the capability is intermittent and to what extent that capability is predictable. Ensure that sedated, ventilated patients are overseen by trained anaesthetic / intensive care staff in or next to the chamber, as appropriate. Have a written agreement with their provider of medical cover that they will receive every reasonable level of support required, including the provision of trained professionals to assist with appropriate interventions if patients develop complications during treatment. Care Pathway



Referral NHS England commissions Hyperbaric Oxygen Therapy from providers registered as Hyperbaric Chamber Services with the Care Quality Commission for the indications in the D11/P/a Hyperbaric Oxygen Therapy Clinical Commissioning Policy. Referrals shall be made to chambers which are members in good standing of the British Hyperbaric Association. Patients may be referred to the appropriate Cox Category of facility by the following:

HM Coast Guard

British Hyperbaric Association advice line

An ambulance service

An emergency department

A registered medical practitioner

A patient directly accessing a provider. All referrals must be discussed and agreed with an appropriately trained UK General Medical Council (GMC) registered medical practitioner before the patient is accepted for hyperbaric treatment. Each provider must, therefore, provide a direct line of communication with such a medical practitioner during the hours of operation that it has agreed with the commissioning authority. For problems arising from reduction in ambient pressure (such as when diving), the medical practitioner must be trained to Level IIa / 2D (or equivalent). If hyperbaric oxygen therapy is to be used for conditions other than decompression illness or gas embolism, the medical practitioner must be trained to Level IIb / 2H (or equivalent). Emergency cases shall be transferred to the closest facility appropriate to their clinical requirements which, in some cases, will not be the facility closest to their location if it does not have the appropriate Cox Category. In order to avoid unnecessary delays, referring agencies shall be aware of the categorisation of chambers in their areas of responsibility. Transfer to a hyperbaric facility is typically by ambulance, by coastguard helicopter or by private vehicle. First aid for decompression illness is continuous high fraction inspired oxygen and this should be taken into account when planning the ambulance or helicopter transfer. Patients with suspected decompression illness should not take charge of a private vehicle used to transfer them to the hyperbaric facility. Assessment On arrival at the hyperbaric facility, the attending hyperbaric medical practitioner will interview and examine the diver to determine whether hyperbaric oxygen therapy is required. In some circumstances, the hyperbaric medical practitioner will attend the patient, for example in the Emergency Department, in order to ensure that all necessary non- hyperbaric interventions and investigations are complete prior to transfer or to avoid an unnecessary transfer altogether. If hyperbaric oxygen therapy is not required the patient will be discharged or referred to a more appropriate source of medical care, in which case funded activity is limited to the cost of the medical evaluation, mobilisation of the chamber



team and preparation of the chamber. As soon as it is established that hyperbaric oxygen therapy is required, that there is no contra-indication to the treatment and that all reasonably foreseeable medical requirements can be provided in the local chamber, the patient shall be treated. If the patient is more seriously ill than originally anticipated and medical requirements will exceed care available locally, transfer to a more capable hyperbaric facility will be necessary prior to treatment. 1. Treatment: Patients typically inhale oxygen or some other therapeutic gas mixture via a hood or a mask in a multi place chamber. Hyperbaric chamber pressures do not normally exceed 3 atmospheres absolute (ATA) when 100% oxygen is delivered to the patient(s). Standard treatment for decompression illness takes approximately 5 hours but many patients require longer treatment depending on severity of injury and response to treatment. For other conditions, an individual treatment session usually lasts up to 2 hours, although the total number of sessions required is highly variable. Depending on clinical condition and response to hyperbaric treatment, a patient will be discharged from the hyperbaric facility to:

The supporting hospital for observation and / or further care, or

a location other than a healthcare facility such as home or other accommodation. The patient might require further treatments in a hyperbaric facility, either as a readmission from the supporting hospital or as an outpatient. A transfer to another hyperbaric facility might be required in which case (with the consent of the patient, if reasonably possible) full clinical details will be passed to the receiving facility. Discharge, continuing care and rehabilitation

Patients will be assessed at appropriate intervals (such as in between HBO sessions and after the final HBO treatment) to establish whether they are fit to be discharged home or if

they require hospital admission. A discharge letter will be provided to the patient’s GP, with

copies to the patient and (if appropriate) referring specialist. The letter will recommend any further measures that might be necessary such as outpatient appointments, onward referral for further investigation, specialist opinion or input from other services such as physiotherapy. Specific discharge advice will be provided, tailored to the individual patient. This may include recommendations regarding a period of abstinence from diving, safety to return to activities such as driving or flying or other health related advice. Appropriate follow-up will also be defined.

Paediatrics: When treating children, the service will additionally follow the standards and

criteria outlined in Annex A Follow-up: It is the responsibility of the discharging hyperbaric facility to offer diving

casualties follow-up appointments to establish fitness to dive and to advise the patient’s



general practitioner of the appropriate investigations and / or specialist referrals required in more complex cases.

Audit, Governance, Quality Improvement

Each provider will have a nominated lead for clinical governance, audit and quality improvement. Providers will support routine collection of outcome data by clinical teams to demonstrate quality standards. The performance of HBOT units, including the measurement of effectiveness of care, compliance with national guidelines and standards will be audited, benchmarked against national norms and the results used to promote service development and improvements. Quality standards for HBOT have been established by the Faculty of Occupational Medicine in its report entitled ‘A Code of Good Working Practice for the Operation and Staffing of Hyperbaric Chambers for Therapeutic Purposes.’ and providers are expected to deliver care and have governance arrangements in line with those standards

Education and Training

All hyperbaric staff are to be educated and trained for their role(s) to a standard equivalent to that described in The Training and Education of Hyperbaric Unit Personnel. Report of a Working Party of the British Hyperbaric Association (available at http://www.marinerhosting.co.uk/bha/images/stories/publications/thetrainingandeducationofhyperbaricunitpersonnel.pdf).

For problems arising from reduction in ambient pressure (such as when diving), the treatment must be conducted under the supervision of a medical practitioner trained to Level IIa / 2D (or equivalent). If hyperbaric oxygen therapy is to be used for conditions other than decompression illness or gas embolism, the treatment must be conducted under the supervision of a medical practitioner trained to Level IIb / 2H (or equivalent). If the medical practitioner at the point of delivery of care does not have the necessary training, they must be supervised, to a level commensurate with their competence for independent practice, by a medical practitioner trained to Level IIa / 2D, Level IIb / 2H (or equivalents) as described above.

The Medical Director must be trained at least to Level IIa / 2D and Level IIb / 2H (or equivalents) and all who are newly appointed from 1 April 2014 must be eligible for appointment as a NHS consultant or general practitioner according to the General Medical Council’s List of Registered Medical Practitioners.

3.3 Population covered

The service outlined in this specification is for patients ordinarily resident in England*; or otherwise the commissioning responsibility of the NHS in England (as defined in Who

http://www.marinerhosting.co.uk/bha/images/stories/publications/thetrainingandeducationofhyperbaricunitpersonnel.pdf

http://www.marinerhosting.co.uk/bha/images/stories/publications/thetrainingandeducationofhyperbaricunitpersonnel.pdf



Pays?: Establishing the responsible commissioner and other Department of Health guidance relating to patients entitled to NHS care or exempt from charges). * Note: for the purposes of commissioning health services, this EXCLUDES patients who, whilst resident in England, are registered with a GP Practice in Wales, but INCLUDES patients resident in Wales who are registered with a GP Practice in England. The patients who will require access to this service are defined in the HBOT commissioning policy document and commissioning statement. Provision of services will be in line with the relevant equality & diversity policy to ensure care for all patients requiring HBOT. An equality impact screening template will require completion and those providing the service will be expected to implement any issues or recommendations that arise from this process. General Paediatric Care

When treating children, the Service will additionally follow the standards and criteria

outlined in the Specification for Children’s’ Services (attached as Annex 1 to this

Specification)

3.4 Any acceptance and exclusion criteria and thresholds

Acceptance Criteria

NHS England commissions Hyperbaric Oxygen therapy from providers registered as Hyperbaric Chamber Services with the Care Quality Commission. Other than in circumstances of exceptionality, the NHS will not normally make HBOT available to patients who are not defined in the commissioning policy document.

Exclusion Criteria

Since this specification requires hyperbaric oxygen therapy to be carried out under the direction of a suitably qualified and experienced medical practitioner it defines services that can be provided only by chambers registered with the Care Quality Commission. In view of this, NHS England does not commission activity from providers who are not registered as Hyperbaric Chamber Services with the Care Quality Commission as these are outside the scope of specialised commissioning.

3.5 Interdependencies with other services/providers

HBOT providers shall maintain close liaison with other HBOT providers and with many other services such as coastguard, fire service and ambulance service.



Co-located Services- to be provided on the same site

Cox Category 1 providers require immediate critical care services on site for critically-ill patients.

A medical emergency team or resuscitation team might be called in the event of an unexpected deterioration in a hospital based hyperbaric facility.

Interdependent services- required during the spell of care, but not necessarily co-located.

Each provider shall have a formal agreement with an identified local hospital describing how the two organisations will co-operate in the treatment of patients requiring HBOT. The identified hospital must have support services appropriate to the category of chamber such as: emergency department, critical care, acute medical and surgical services, psychiatric services, Ear Nose and Throat (ENT), pathology, x-ray and Magnetic resonance imaging (MRI) services, paediatric services, access to a helicopter landing pad (or have other appropriate arrangements for the transfer of critically ill patients). There is a requirement for medical equipment that is manufactured, modified or otherwise found suitable for use in the pressurised environment of a hyperbaric chamber. Units depend upon medical engineering companies or departments for the routine maintenance, calibration and repair of this equipment. Some examples are given below, Urgent requirements prior to treatment:

Subject to the advice of the responsible hyperbaric medical practitioner, many patients require evaluation of general medical status and co- morbidities, investigation and stabilisation in a local emergency department or an in-patient setting. The most common investigation of cases of decompression illness are chest x-ray to exclude pulmonary barotrauma and other abnormalities and blood tests to assess hydration, blood gases and metabolic status.

ENT assessment and myringotomy or insertion of grommets in patients who cannot ventilate their middle ears (sometimes in between or after HBOT).

ENT assessment of patients with clinical features that cannot be distinguished between inner ear barotrauma or audio-vestibular decompression illness (sometimes in between or after HBOT)

Immediately after, or in between, hyperbaric treatments:

Acute medical, surgical or other specialty inpatient admission.

Critical care admission for patients who remain critically ill

‘Hotel’ accommodation for patients who are self-caring.

Related Services- possibly required during stages of the patient’s care: Typically required in slower time after treatment but might occur prior to discharge home:



Respiratory, or even cardiothoracic surgical, assessment is required in patients in whom a lung problem has resulted in, or is a consequence of, a diving injury.

Cardiology assessment is required in a patient who has features suggestive of a right to left circulatory shunt. National Institute for Health and Clinical Excellence (NICE) recommends that clinicians wishing to undertake percutaneous closure of patent foramen ovale (PFO) for the secondary prevention of recurrent paradoxical embolism in divers should ensure that patients understand the uncertainty about the procedure's efficacy and the possibility of complications, and that they understand alternative options which may include modifying their diving practice to reduce the risk of gas bubble formation and that patient selection for this procedure should only be carried out by clinicians with specific expertise in decompression illness, in liaison with an interventional cardiologist.

Neurology / neurophysiological assessment, sometimes with MRI / computerised tomography (CT) imaging, is required for assessment of patients with atypical presentations of decompression illness or with neurological manifestations that do not resolve with HBOT.

Neuropsychologists are required to assess and to address residual defects in higher mental function.

Neuro rehabilitation resources, such as specialist physiotherapists, are required to assist with recovery in patients with residual neurological deficit

Psychiatric services are required in some cases where mental ill health has predisposed to, or has resulted from, the problem requiring HBOT.

The General Practitioner will play a pivotal role in organising and co-ordinating many of these services, especially if the patient lives a significant distance from the HBOT facility.

4. Applicable Service Standards

4.1 Applicable national standards e.g. NICE

HBOT providers shall comply with the following core standards: Acts / Regulations:

Health and Safety at Work etc Act 1974

The Diving at Work Regulations 1997 (when applicable)

Health and Social Care Act 2008

Care Quality Commission (Regulated Activities) Regulations 2010

Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.

Professional Guidance:

A Code of Good Working Practice for the Operation and Staffing of Hyperbaric Chambers for Therapeutic Purposes. Published by the Faculty of Occupational Medicine. (The Cox Report.) May 1994,ISBN 1 8732409 9 6

British Hyperbaric Association Guide to Fire Safety Standards for Hyperbaric Treatment Centres. ISBN 0 9527623 1 5



British Hyperbaric Association Guide to Electrical Standards for Hyperbaric Treatment Centres. ISBN 0 9527623 0 7

The Training and Education of Hyperbaric Unit Personnel. Report of a Working Party of the British Hyperbaric Association

The British Hyperbaric Association. Health & Safety for Therapeutic Hyperbaric Facilities. A Code of Practice. ISBN 0 9527623 2 3

The following Standards are recommended: National Standards:

BS EN 14931:2006. Pressure vessels for human occupancy (PVHO). Multi- place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing.

BS EN 16081:2011. Hyperbaric chambers. Specific requirements for fire extinguishing systems. Performance, installation and testing.

4.2 Applicable standards set out in Guidance and/or issued by a competent body (e.g. Royal Colleges)

Other Requirements

HBOT providers will supply activity data to the British Hyperbaric Association for the last calendar year by 31 March of the current year.

Professional Guidance

Educational and Training Standards for Physicians in Diving and Hyperbaric Medicine. Written by Joint Educational Subcommittee of the European Committee for Hyperbaric Medicine (ECHM) and the European Diving Technical Committee (EDTC). Approved by ECHM and EDTC on August/September 2011

Clinical Standards for Treatment of Decompression Illness. J. A. S. Ross. Engineering and Health in Compressed Air Work, pp 105-109. ISBN: 978-0-7277-3254-5.

5. Applicable quality requirements and CQUIN goals

5.1 Applicable quality requirements (See Schedule 4 Parts A-D)

HBOT providers will supply the following data to the NHS for each patient treated: personal

details (name, date of birth, gender, NHS number); provider’s case identifier (optional);

outcome of initial assessment; date of first treatment; date of last treatment; route of referral; geographic location of patient at time of referral (for emergency referrals); time from referral to treatment; NHS funding body; name of responsible commissioner; type of funding; emergency or elective care; whether medical notes were available at time of referral; indication for HBOT; medical history (brief summary of co morbidities); history of present referral; initial treatment table used; number of treatments including details of any



modifications to tables; outcome of treatment (include any objective measures used and all assessment points); invoiced cost. 5.2 Applicable CQUIN goals (See Schedule 4 Part E)

To be inserted following CQUIN schemes being agreed.

6. Location of Provider Premises The Provider’s Premises are located at:

1. Wirral; HYPERBARIC MEDICINE North West Emergency Recompression Unit. Address: Murrayfield Hospital, Holmwood Drive, Heswall, Wirral, CH61 1AU

2. Plymouth; Diving Diseases Research Centre (DDRC) DDRC Healthcare, Hyperbaric Medical Centre,

Tamar Science Park, Research Way, Plymouth, Devon, PL6 8BU UK

3. Poole; The Diver Clinic is a trading name for Atlantic Enterprise UK Ltd – “Poole Hyperbaric Centre”.

Address: 7 Parkstone Road Poole Dorset BH15 2NN

4. Reading; The Diver Clinic is a trading name for Atlantic Enterprise UK Ltd, Registered Office: 1 St. Stephens Road, Bournemouth BH2 6LA

5. Chichester; Chichester Hyperbaric Unit. Address: St Richard’s Hospital, Spitalfield Lane, Chichester,

West Sussex, PO19 6SE

6. London; St John's Wood: London Diving Chamber. Address; Hospital of St John & St Elizabeth, 60 Grove End Road, St Johns Wood,London, NW8 9NH

7. London;Whipps Cross; Whipps Cross University Hospital NHS-Trust Hyperbaric Unit. Address: London

Hyperbaric Medicine Ltd. Whipps Cross University Hospital NHS-Trust Leytonstone, London E11 1NR

8. Great Yarmouth; James Paget Hospital Hyperbaric Chamber. Address Lowestoft Road Gorleston Great

Yarmouth Norfolk NR31 6SG

9. Hull; North of England Medical Hyperbaric Unit. Address Spire Hospital Lowfield Road Anlaby Hull

HU10 7AZ

10. Rugby; Midlands Diving Chamber Ltd, 4 Admiral House, Cardinal Way, Wealdstone, MIDDLESEX HA3 5TE

7. Individual Service User Placement

N/A





Appendix One

Quality standards specific to the service using the following template:

Quality Requirement

Threshold Method of Measurement

Consequence of breach

Domain 1: Preventing people dying prematurely

Domain 2: Enhancing the quality of life of people with long-term conditions

Hyperbaric Oxygen Therapy must benefit the patient’s quality of life as measured by the EQ5D score

Change in EQ5D must not be any worse than expected for a matched population of patients that had not undergone hyperbaric oxygen therapy

Numerator - Differential between EQ5D score 3 months post treatment and score prior to first treatment for elective patients Denominator -Number of elective patients who have completed EQ5D questionnaires before and after treatment

General Conditions 8 General Condition 9

Domain 3: Helping people to recover from episodes of ill-health or following injury

Hyperbaric Oxygen Therapy must improve the chances of divers returning to pre-morbid functional state following treatment

Proportion making a recovery must not fall below expected for severity of disease on arrival.

Numerator - Number of divers returning to pre-morbid functional state (occupation and activities of daily living) following treatment and for severe neuro DCI at 6 months post treatment Denominator - Total number of divers treated


Domain 4: Ensuring that people have a positive experience of care

Percentage of patients who received adequate information about their treatment

Must exceed 90% Numerator - Number of patients who reported that quality of information provided was adequate Denominator - Number of patients who returned a completed patient feedback form


Domain 5: Treating and caring for people in a safe environment and protecting them from



Quality Requirement

Threshold Method of Measurement

Consequence of breach

avoidable harm

Hyperbaric Oxygen Therapy must not cause excess mortality

30 day mortality no greater than expected for a matched population of patients that had not undergone hyperbaric oxygen therapy

Numerator - Number of deaths within 30 days of any episode of HBOT treatment. Denominator - Total number of patients treated




ANNEX 1 TO SERVICE SPECIFICATION: PROVISION OF SERVICES TO CHILDREN

Scope

Aims and objectives of service This specification annex applies to all children’s services and outlines generic standards and outcomes that would be fundamental to all services. The generic aspects of care: The Care of Children in Hospital (HSC 1998/238) requires that:

Children are admitted to hospital only if the care they require cannot be as well provided at home, in a day clinic or on a day basis in hospital.

Children requiring admission to hospital are provided with a high standard of medical, nursing and therapeutic care to facilitate speedy recovery and minimize complications and mortality.

Families with children have easy access to hospital facilities for children without needing to travel significantly further than to other similar amenities.

Children are discharged from hospital as soon as socially and clinically appropriate and full support provided for subsequent home or day care.

Good child health care is shared with parents/carers and they are closely involved in the care of their children at all times unless, exceptionally, this is not in the best interest of the child; Accommodation is provided for them to remain with their children overnight if they so wish.

Service description/care pathway All paediatric specialised services have a component of primary, secondary, tertiary and even quaternary elements. The efficient and effective delivery of services requires children to receive their care as close to home as possible dependent on the phase of their disease. Services should therefore be organised and delivered through “integrated pathways of care” (National Service Framework for children, young people and maternity services (Department of Health & Department for Education and Skills, London 2004) Interdependencies with other



All services will comply with Commissioning Safe and Sustainable Specialised Paediatric Services: A Framework of Critical Inter-Dependencies – Department of Health. Imaging All services will be supported by a 3 tier imaging network (“Delivering quality imaging services for children‟ Department of Health, 13732 March 2010). Within the network:

It will be clearly defined which imaging test or interventional procedure can be performed and reported at each site.

Robust procedures will be in place for image transfer for review by a specialist radiologist, these will be supported by appropriate contractual and information governance arrangements

Robust arrangements will be in place for patient transfer if more complex imaging or intervention is required

Common standards, protocols and governance procedures will exist throughout the network.

All radiologists, and radiographers will have appropriate training, supervision and access to continuing professional development (CPD)

All equipment will be optimised for paediatric use and use specific paediatric software.

Specialist Paediatric Anaesthesia Wherever and whenever children undergo anaesthesia and surgery, their particular needs must be recognised and they should be managed in separate

facilities, and looked after by staff with appropriate experience and training.1 All UK anaesthetists undergo training which provides them with the competencies to care for older babies and children with relatively straightforward surgical conditions and without major co-morbidity. However those working in specialist centres must

have undergone additional (specialist) training2 and should maintain the

competencies so acquired3 *. These competencies include the care of very young/premature babies, the care of babies and children undergoing complex surgery and/or those with major/complex co-morbidity (including those already requiring intensive care supports). As well as providing an essential co-dependent service for surgery, specialist anaesthesia and sedation services may be required to facilitate radiological procedures and interventions (for example MRI scans and percutaneous nephrostomy) and medical interventions (for example joint injection and intrathecal chemotherapy), and for assistance with vascular access in babies and children



with complex needs such as intravenous feeding. Specialist acute pain services for babies and children are organised within existing departments of paediatric anaesthesia and include the provision of agreed (hospital wide) guidance for acute pain, the safe administration of complex analgesia regimes including epidural analgesia, and the daily input of specialist anaesthetists and acute pain nurses with expertise in paediatrics.

*The Safe and Sustainable reviews of paediatric cardiac and neuro- sciences in England have noted the need for additional training and maintenance of competencies by specialist anaesthetists in both fields of practice. References

1. Guidelines for the Provision of Anaesthetic Services (GPAS) Paediatric anaesthetic services. Royal College of Anaesthetists (RCoA) 2010 www.rcoa.ac.uk

2. Certificate of Completion of Training (CCT) in Anaesthesia 2010 3. CPD matrix level 3

Specialised Child and Adolescent Mental Health Services (CAMHS) The age profile of children and young people admitted to specialised CAMHS day/in-patient settings is different to the age profile for paediatric units in that it is predominantly adolescents who are admitted to specialised CAMHS in-patient settings, including over-16s. The average length of stay is longer for admissions to mental health units. Children and young people in specialised CAMHS day/in- patient settings generally participate in a structured programme of education and therapeutic activities during their admission. Taking account of the differences in patient profiles the principles and standards set out in this specification apply with modifications to the recommendations regarding the following:

Facilities and environment – essential Quality Network for In-patient CAMHS (QNIC) standards should apply (http://www.rcpsych.ac.uk/quality/quality,accreditationaudit/qnic1.aspx)

Staffing profiles and training - essential QNIC standards should apply.

The child/ young person’s family are allowed to visit at any time of day taking account of the child / young persons need to participate in therapeutic activities and education as well as any safeguarding concerns

Children and young people are offered appropriate education from the point of admission.

Parents/carers are involved in the child/young person’s care except where this is not in the best interests of the child / young person and in the case of young people who have the capacity to make their own decisions is subject to their consent.



Parents/carers who wish to stay overnight are provided with accessible accommodation unless there are safeguarding concerns or this is not in the best interests of the child/ young person.

Applicable national standards e.g. NICE, Royal College Children and young people must receive care, treatment and support by staff registered by the Nursing and Midwifery Council on the parts of their register that permit a nurse to work with children (Outcome 14h Essential Standards of Quality and Safety, Care Quality Commission, London 2010)

There must be at least two Registered Children’s Nurses (RCNs) on duty 24 hours a day in all hospital children’s departments and wards.

There must be a Registered Children’s Nurse available 24 hours a day to advise on the nursing of children in other departments (this post is included in the staff establishment of 2RCNs in total).

Accommodation, facilities and staffing must be appropriate to the needs of children and separate from those provided for adults. All facilities for children and young people must comply with the Hospital Build Notes HBN 23 Hospital Accommodation for Children and Young People NHS Estates, The Stationary Office 2004.

All staff who work with children and young people must be appropriately trained to

provide care, treatment and support for children, including Children’s Workforce Development Council Induction standards (Outcome 14b Essential Standards of Quality and Safety, Care Quality Commission, London 2010). Each hospital which admits inpatients must have appropriate medical cover at all times taking account of guidance from relevant expert or professional bodies (National Minimum Standards for Providers of Independent Healthcare, Department of Health, London 2002).”Facing the Future” Standards, Royal College of Paediatrics and Child Health. Staff must carry out sufficient levels of activity to maintain their competence in caring for children and young people, including in relation to specific anaesthetic and surgical procedures for children, taking account of guidance from relevant expert or professional bodies (Outcome 14g Essential Standards of Quality and Safety, Care Quality Commission, London 2010). Providers must have systems in place to gain and review consent from people who use services, and act on them (Outcome 2a Essential Standards of Quality and Safety, Care Quality Commission, London 2010). These must include specific arrangements for seeking valid consent from children while respecting their human rights and confidentiality and ensure that where the person using the service lacks capacity, best interest meetings are held with people who know and understand the person using the service. Staff should be able to show that they know how to



take appropriate consent from children, young people and those with learning disabilities (Outcome 2b) (Seeking Consent: working with children Department of Health, London 2001). Children and young people must only receive a service from a provider who takes steps to prevent abuse and does not tolerate any abusive practice should it occur (Outcome 7 Essential Standards of Quality and Safety, Care Quality Commission, London 2010 defines the standards and evidence required from providers in this regard). Providers minimise the risk and likelihood of abuse occurring by:

Ensuring that staff and people who use services understand the aspects of the safeguarding processes that are relevant to them.

Ensuring that staff understand the signs of abuse and raise this with the right person when those signs are noticed.

Ensuring that people who use services are aware of how to raise concerns of abuse.

Having effective means to monitor and review incidents, concerns and complaints that have the potential to become an abuse or safeguarding concern.

Having effective means of receiving and acting upon feedback from people who use services and any other person.

Taking action immediately to ensure that any abuse identified is stopped and suspected abuse is addressed by: having clear procedures followed in practice, monitored and reviewed

that take account of relevant legislation and guidance for the management of alleged abuse

separating the alleged abuser from the person who uses services and others who may be at risk or managing the risk by removing the opportunity for abuse to occur, where this is within the control of the provider

reporting the alleged abuse to the appropriate authority reviewing the person’s plan of care to ensure that they are properly

supported following the alleged abuse incident.

Using information from safeguarding concerns to identify non-compliance, or any risk of non-compliance, with the regulations and to decide what will be done to return to compliance.

Working collaboratively with other services, teams, individuals and agencies in relation to all safeguarding matters and has safeguarding policies that link with local authority policies.

Participates in local safeguarding children boards where required and understand their responsibilities and the responsibilities of others in line with the Children Act 2004.

Having clear procedures followed in practice, monitored and reviewed in place about the use of restraint and safeguarding.

Taking into account relevant guidance set out in the Care Quality Commission’s Schedule of Applicable Publications



Ensuring that those working with children must wait for a full CRB disclosure before starting work.

Training and supervising staff in safeguarding to ensure they can demonstrate the competences listed in Outcome 7E of the Essential Standards of Quality and Safety, Care Quality Commission, London 2010

All children and young people who use services must be

Fully informed of their care, treatment and support.

Able to take part in decision making to the fullest extent that is possible.

Asked if they agree for their parents or guardians to be involved in decisions they need to make.

(Outcome 4I Essential Standards of Quality and Safety, Care Quality Commission, London 2010)

4. Key Service Outcomes

Evidence is increasing that implementation of the national Quality Criteria for Young People Friendly Services (Department of Health, London 2011) have the potential to greatly improve patient experience, leading to better health outcomes for young people and increasing socially responsible life-long use of the NHS. Implementation is also expected to contribute to improvements in health inequalities and public health outcomes e.g. reduced teenage pregnancy and Sexually Transmitted Infections (STIs) and increased smoking cessation. All providers delivering services to young people should be implementing the good practice guidance which delivers compliance with the quality criteria. Poorly planned transition from young people’s to adult-oriented health services can be associated with increased risk of non-adherence to treatment and loss to follow-up, which can have serious consequences. There are measurable adverse consequences in terms of morbidity and mortality as well as in social and educational outcomes. When children and young people who use paediatric services are moving to access adult services (for example, during transition for those with long term conditions), these should be organised so that:

All those involved in the care, treatment and support cooperate with the planning and provision to ensure that the services provided continue to be appropriate to the age and needs of the person who uses services.

The National Minimum Standards for Providers of Independent Healthcare, (Department of Health, London 2002) require the following standards:

A16.1 Children are seen in a separate out-patient area, or where the hospital does not have a separate outpatient area for children, they are seen promptly.

A16.3 Toys and/or books suitable to the child’s age are provided.

A16.8 There are segregated areas for the reception of children and adolescents into theatre and for recovery, to screen the children and



adolescents from adult Patients; the segregated areas contain all necessary equipment for the care of children.

A16.9 A parent is to be actively encouraged to stay at all times, with accommodation made available for the adult in the child’s room or close by.

A16.10 The child’s family is allowed to visit him/her at any time of the day, except where safeguarding procedures do not allow this

A16.13 When a child is in hospital for more than five days, play is managed and supervised by a qualified Hospital Play Specialist.

A16.14 Children are required to receive education when in hospital for more than five days; the Local Education Authority has an obligation to meet this need and is contacted if necessary.

A18.10 There are written procedures for the assessment of pain in children and the provision of appropriate control.

All hospital settings should meet the Standards for the Care of Critically Ill Children (Paediatric Intensive Care Society, London 2010). There should be age specific arrangements for meeting Regulation 14 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010. These require:

A choice of suitable and nutritious food and hydration, in sufficient quantities to meet service users’ needs;

Food and hydration that meet any reasonable requirements arising from a service user’s religious or cultural background

Support, where necessary, for the purposes of enabling service users to eat and drink sufficient amounts for their needs.

For the purposes of this regulation, “food and hydration” includes, where applicable, parenteral nutrition and the administration of dietary supplements where prescribed.

Providers must have access to facilities for infant feeding, including facilities to support breastfeeding (Outcome 5E, of the Essential Standards of Quality and Safety, Care Quality Commission, London 2010)

All paediatric patients should have access to appropriately trained paediatric trained dieticians, physiotherapists, occupational therapists, speech and language therapy, psychology, social work and CAMHS services within nationally defined access standards. All children and young people should have access to a professional who can undertake an assessment using the Common Assessment Framework and access support from social care, housing, education and other agencies as appropriate.

Ensure the medicines given are appropriate and person-centred by taking account of their age, weight and any learning disability

Ensure that staff handling medicines have the competency and skills needed



for children and young people’s medicines management

Ensure that wherever possible, age specific information is available for people about the medicines they are taking, including the risks, including information about the use of unlicensed medicine in paediatrics.

Many children with long term illnesses have a learning or physical disability. Providers should ensure that:

They are supported to have a health action plan

Facilities meet the appropriate requirements of the Disability Discrimination Act 1995

They meet the standards set out in Transition: getting it right for young people. Improving the transition of young people with long-term conditions from children's to adult health services. Department of Health, 2006, London





D11/S/a

Mark Glover

Change Notice for Published Specifications and Products

developed by Clinical Reference Groups (CRG)

Amendment to the Published Products

Product Name

Ref No

CRG Lead

Description of changes required

Describe what was stated in original document

Describe new text in the document

Section/Paragraph to which changes apply

Describe why document change required

Changes made by

Date change made

Put the previous year’s specification in the new specification template, this has created a new section that needed to be populated linked to the National Outcome Framework and domains.

Section 2 and appendix 1

To ensure consistency of specification formatting

CRG October 2013

Revise the wording of how HBOT units are identified, following the

Section 3.2 Further clarity CRG October 2013

Hyperbaric Oxygen Therapy



recent change by the Care Quality Commission (CQC) who have dropped the identification by levels and rather now simply say that units must be registered with the CQC

To ensure consistency of format across our specification through using common sub headings, ensuring words of scope and IR are included in the exclusion and acceptance area.

Section 3.4 and 6.0 To ensure consistency of specification formatting

CRG October 2013

Minor amendments for improved readability and clarity for example the education and research section.

Section 3.2 Further clarification CRG October 2013

New section for audit and governance.

Section 3.2 Further clarification CRG October 2013

Documents

SCHEDULE 2- THE SERVICES- A. SERVICE … · Hyperbaric Oxygen Therapy (HBOT) has been used for the treatment of decompression ... HBOT is targeted at a range of conditions and patient