WOLFAP
World Lung Function Accreditation Project
Sept 2008
Draft Vers 3.3
Introduction
In January 2007 WOLFAP was inaugurated at the ARTP Conference in
Glasgow, Scotland by a group of experienced, senior lung function experts
who have high national and international profiles within their field. The key aim
of the meeting was to determine a way forward to produce an international
lung function assessment process that would become a benchmark
accreditation for all laboratories around the world. The success of WOLFAP
will ultimately be reflected by a high standard in the quality of lung function
measurements world-wide (see Appendix 1: Notes of WOLFAP Meeting).
The key outcomes of this meeting were;
1. Out of the three options brought to the meeting, the group agreed to
work up the Accreditation initiative (WOLFAP) first.
2. The Accreditation umbrella would cover training, competence,
standards and quality as the key priorities.
3. The accreditation model devised would be centred on the current
materials we have available from participating professional bodies
(especially TSANZ, AARC, ARTP).
4. The Accreditation process would be inclusive, performance based,
not prescriptive and approved by all interested stakeholders.
5. Any international examinations (ISDL or GLFDL) would be a minimum
level of training and not the sole training requirement for competent
practitioners.
6. This group will be driven by healthcare scientists, physiologists and
technologists and will consult with physician colleagues at the
appropriate stages.
Accreditation of respiratory function services is, at present, voluntary in a few
countries around the world. In 2006, Lung Function accreditation was made
mandatory by the Royal Australasian College of Physicians for all respiratory
departments within Australia and New Zealand that act as training sites for
Respiratory Physicians. The Thoracic Society of Australia and New Zealand
(TSANZ) have an established accreditation process to foster excellence in the
approach to assessment of respiratory function. There are separate
accreditation guidelines for adult and paediatric lung function laboratories and
sleep assessment laboratories. The Netherlands and the UK have outline
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accreditation schemes which are in development but most have not been
implemented.
The process seeks to define uniform minimum standards for services. The
process is aimed at assessing the service's organisation and administration,
staffing and direction, policies and procedures, staff development &
education, facilities & equipment, and quality assurance programmes. Its
general approach is influenced by programmes established by national
standards from participating countries.
The development of an internationally agreed accreditation process, based
on current international standards may be beneficial to those laboratories (or
countries) who have not had involvement in accreditation, i.e they will not
need to reinvent the wheel. Furthermore, by adopting accepted international
guidelines there will be more harmonisation as laboratories prepare their
applications for accreditation.
WOLFAP Process
The process for delivering WOLFAP includes several key steps;
1. Development of an agreed draft outline for the requirements of
WOLFAP lung function laboratory accreditation.
2. Preparing a self-assessment questionnaire to be sent to all lung
function organisations around the world to assess their compliance with
WOLFAP criteria.
3. Review the results of the questionnaire to ensure that the WOLFAP
standards are appropriate and achievable in all/most countries.
4. Publish the WOLFAP Accreditation document on websites (e.g.
SpireXpert) and engage all interested organisations (AARC, ANZSRS,
APSR, ARTP, TSANZ, ERS, ATS, etc.) to adopt the standards and
achieve world lung function accreditation standards.
The first phase of the process involves the development of this current
document. This document is using ideas from several professional bodies but
predominantly uses the TSANZ accreditation document. However, applying
the TSANZ standard to all countries of the world may require some
compromise in many of the TSANZ standards because the level of
sophistication of healthcare in many countries is not comparable to Australia
and New Zealand.
The second phase of the process will be to communicate and disperse the
draft WOLFAP document and process to medical and technical organisations
around the world and to obtain “buy in” from large respiratory professional
bodies (ATS, ERS, APSR, AARC, NBRC, etc.) as well as national
professional bodies and organisations too. This will in turn require the
expanding of the concept and principle of WOLFAP to drug companies,
clinical trials companies and leading decision makers in this area.
The third phase will involve using a detailed questionnaire which has been
designed to assess the laboratory's readiness for accreditation. Self
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Assessment is a key feature of this phase of the process. Ability to
satisfactorily respond to the questionnaire, guided by the Standards for
Accreditation detailed below, should indicate to the applicant service its likely
ability to comply with the requirements for accreditation.
The review of the accreditation document in the light of the “reality on the
ground”, from the responses to the questionnaires, will help shape the
relevance and usefulness of this accreditation initiative before its final
publication and we would hope foster adoption of this global minimum
standard.
Aim
To set a minimum acceptable standard(s) for accreditation of lung function
diagnostic services across the world. Acceptable standards will have to be
competence based rather than against qualifications. (Blonshine credentials
ref)
Whilst it may only be possible to have a minimum standard for all, there
should also be a higher standard appropriate for clinical trials and high quality
services where it is affordable/possible.
Overview
In setting a minimum standard for all, there has to be the realisation that not
all countries may have the infrastructure to deliver all/any of the desirables,
but for a safe, quality lung function service all the essentials should be met.
By having a basic standard (Level1) it is possible to allow for achievement of
competence centres for all. Future levels may be developed, but it is
important to set a minimum acceptable standard first.
WOLFAP accreditation will be modular to make it more inclusive so that
departments achieving what is possible are credited for their efforts.
The four key areas of training (T), competence (C), standards (S) and
quality (Q) are addressed in both essential and desirable indicators for
accreditation.
Essential Indicators for an Accredited Centre (these all need expanding
and given clear criteria and definitions)
1.
2.
3.
4.
5.
6.
7.
Trained Staff with on-going training/development programmes (T,C)
Standard Operating Procedures/Policies (evidence based) (C,S)
Equipment performing to international standards (Q,S)
Quality Assurance Programme to international standards(Q,S)
Infection control standards and policy (S)
Health & Safety Standards (C,S)
Reporting and interpretation of results using appropriate reference
equations and reporting formats (standardised residuals, range, etc.)
(Q,S)
8. Competence in spirometry, lung volumes and gas transfer
measurement (S,Q) .
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Desirable Indicators for an accredited centre
1. Key performance indicators (work output, efficiency etc.) (C,Q)
2. Service Programme & Preventative Maintenance (Q)
3. Facilities: working space, patient comfort and privacy, support
systems. (S,Q)
4. Administration (information, appointments, results) (Q,S)
5. Medical input where appropriate i.e. supervision/on call for
Bronchial challenge, exercise tests etc. (S,Q)
Accreditation Process
1. Accreditation Process
The accreditation process is described in terms of how to submit an
application, fees for accreditation, the structure and functions of
assessors and accreditation panels and process involved in site
visits.(Appendix 2)
2. Categories of Respiratory Function Assessment Service
The types of category and the level of service provided are listed in this
section (See section below)
3. Granting Accreditation /Re-accreditation of an Accredited Service
A detailed outline of the granting process is included in Appendix 3.
4. Confidentiality of Assessment Procedures
The importance of confidentiality is outlined in this section.
2. Categories of Respiratory Function Assessment Service
All accreditation will be determined by the local respiratory organisation which
has adopted the WOLFAP criteria for accreditation. The categories are
designed to be inclusive and to promote the development of best practice and
the highest possible standards in that centre.
Service categories
Whilst it would be preferable to provide accreditation for ‘spirometry only’ to
cover ”office spirometry” in primary care in the initial delivery of WOLFAP it
may only be possible to limit accreditation to “lung function labs” alone. The
accreditation of spirometry services should be developed from WOLFAP in
the long term.
Basic assessment of respiratory function including, as a minimum,
measurement of static lung volumes (total lung capacity, residual volume,
functional residual capacity and vital capacity); spirometry before and after
bronchodilator (maximum expiratory flow volume curves); carbon monoxide
gas transfer.
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For the purposes of accreditation a “service” is defined as a test that is
offered by trained and/or competent personnel to (exceptionally) at least 30
patients per year, but will mainly be delivered to at least 30 patients per
month.
Level 1 Accreditation
This would be the basic level of accreditation which would require at least the
first 7 of the10 essential indicators of accreditation to be achieved by that
centre. (This enables centres where there are financial constraints on services
to be given basic accreditation. They would be acceptable to bid for clinical
trials work in those basic tests)
3. Granting Accreditation
Granting of all accreditation will be by the local respiratory organisation which
has adopted the WOLFAP criteria on accreditation. In some cases this will be
a national professional body, but predominantly it will be the responsibility of
large respiratory bodies such as ARRC, ERS, APSR, etc.
For general guidance the recommended steps are considered in Appendix 3:
4. Confidentiality of Assessment Procedures
All the WOLFAP information and questionnaires will remain confidential and
will not be disclosed to third parties unless centres agree that it will be
necessary for publication or clarification WOLFAP Accreditation categories,
etc.
All accreditation processes run by local/national/international respiratory
organisations should remain confidential at all times.
Overview of the Accreditation
To acquire accreditation each lung function facility will need to achieve
acceptance in all of the following key criteria;
1. Appropriately trained staff (with qualifications where possible)
2. Complete departmental operating manual (The Policy manual and
Procedure manual, could be based on ATS/ERS standards)
3. Robust quality control procedures with evidence of regular checks.
4. Reliable and accurate lung function equipment with up-to-date
maintenance logs
Way forward by all WOLFAP Members
a. A Final Draft will be produced and put on professional body websites
(ARTI, ARTP, ANZSRS, TSANZ, NVLA, ERS, ATS etc.) for
consultation by 1st January 2009
b. Questionnaires to be prepared, agreed and circulated in a pilot to
WOLFAP members organisations by 15th November 2008.
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c. Questionnaires to be sent in digital format to professional bodies in
lung function and respiratory medicine by 1st January 2009.
d. Feedback from questionnaires will be received by 31st January 2009
e. Feedback from questionnaire to be used to modify the WOLFAP
document before producing the final version by 31st March 2009.
f. WOLFAP outcome to be presented to professional bodies (AARC,
ERS, APSR, etc. during 2009
g. Consideration of staff accreditation ISDL, GLFDL, etc. during 2009.
Considerations
1. Use the questionnaire step to conduct an “audit” of current quality of
lung function services which can be reviewed after the implementation
of department accreditation to show that accreditation drives up
standards and quality.
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APPENDIX 2
Process
(i) Applications for Accreditation should be received by an appointed
officer of the accrediting organisation.
(ii) The application should specify the category of respiratory function
assessment for which Accreditation is sought and a list of the
individual tests for which Accreditation is sought.
(iii) Accreditation should be granted only in relation to those
categories/tests for which application is made.
(iv) The professional body should respond to all applications by providing
applicant laboratories with Accreditation guidelines and the
application forms which seek information regarding the laboratory and
investigations/measurements that it performs ("the Accreditation
Package – available from respiratory society websites").
(v) Self assessment is a key feature of this phase of the process so that
each centre responds to the questions adequately. The laboratory
completes the forms and returns them to the professional body.
(vi) Copies of all correspondence should be sent to the Accreditation
Coordinator.
Fees
(vii) An "initial assessment fee” will be necessary (e.g. Aus$275; NZ $250;
UK £120, Euro 170, US$340) to cover the cost of the initial
assessment of submitted material.
(viii) A further fee (the "site visit" fee) should be charged if the application
is found to be acceptable, and a site visit is arranged (see below).
These fees, which are set to recover costs, should be determined by
the professional organisation and revised from time to time.
(ix) A current schedule of fees should be obtainable from the professional
organisation website.
Assessors & Assessment Panels
On receipt of the Accreditation fee and application forms the
Accreditation Coordinator should appoint an Assessment Panel and
its Chairperson.
(xi) The assessors will be recognized experts in the physiological and/or
technical aspects of respiratory function assessment and its
application to the diagnosis and management of respiratory disease.
(xii) The assessment panel should normally have three members, at
least one of whom should be from a city other than the one in which
the service undergoing accreditation is located. While individual
assessors need not necessarily be members of a professional body,
at least two members of the assessment panel should be. Where
practicable, two assessors should be respiratory scientist.
(xiii) The chairperson of the assessment panel should be responsible to
ensure that the documentation supplied by the applicant laboratory to
be reviewed by the Panel Members and seek supplementary
information where necessary.
(x)
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(xiv)
The result of the initial assessment should be given to the applicant
within eight weeks of receipt of the application.
(xv)
If the application is unacceptable the reasons for the decision
should be provided.
(xvi)
If the application is acceptable a site visit should be arranged at a
mutually convenient time (within two to three months of notice of
approval).
Site Visit
(xvii) The site visit is a critical step in the accreditation process. At
the site visit the veracity of answers provided in the application is
examined, and specific questions raised by these responses and by
inspection of the facilities addressed.
(xviii) The Chairperson of the Assessment Panel is responsible for the
review process including producing a report and recommendations
which should be forwarded to the Accreditation Coordinator.
The assessment process has two purposes:
(a) Advisory - to advise on ways in which perceived deficiencies of a Service
can be corrected.
(b) Evaluation - to establish whether a Service is competent and effective
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APPENDIX 3
1. To expedite the process an accreditation advisory panel is
empowered to act on behalf of the professional organisation and grant
Accreditation according to the recommendations of the Assessment
Panel.
2. The accreditation advisory panel should comprise a senior officer of
the professional body, the accreditation coordinator and the
assessment panel which assessed the particular laboratory.
3. The assessment panel may recommend that accreditation be
awarded unreservedly or subsequent to rectification of identified
deficiencies. In the latter case accreditation should be granted on
receipt of evidence that all suggested changes have been
implemented.
4. The application should lapse after 12 months from the date of issue
of the recommendations in the absence of such evidence. Rectification
should only apply where the panel considers that the changes are
relatively minor and can be implemented and verified without need for
a further site visit. (The process seeks "substantial compliance" with
the standards. It is recognised that local conditions may preclude
absolute compliance with every standard.)
5. A recommendation against Accreditation should normally be referred to
the senior tier of the professional body for confirmation before the
report is issued.
6. A Certificate of Accreditation should be issued once the
recommendation for accreditation is ratified by the accreditation
advisory panel or, where applicable, the professional executive. The
Certificate should be signed by the Chairman of the professional body
on behalf of the Society.
7. Accreditation is granted for a period of three years. and a centre
should notify the Accreditation organisation of any major changes from
their assessed state ( e.g. personnel, equipment or accommodation
changes)
Appeals
8. Where, in the opinion of a particular accreditation advisory panel, a
report is potentially contentious or there is disagreement over its
recommendations, the report should be referred to an appeal process
for comments and decision.
9. Laboratories that fail accreditation should be advised of the reasons for
the decision.
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10. If the laboratory wishes to challenge the decision it must do so in
writing to the accreditation appeals coordinator within 21 days of
receiving the decision stating the reasons for appeal.
11. The appeal should then be considered by a meeting of the
professional body executive to be convened within six weeks of receipt
of the appeal.
12. A recommendation against accreditation following appeal should be
confirmed before the report is issued. The accreditation coordinator
should advise the laboratory of the decision on the appeal and the
reasons for the decision.
13. A laboratory that fails accreditation may re-apply at any time that it
believes its standards have met those required for Accreditation.
14. The professional body should provide an Annual Report of success,
partial success and the number of failed applications to the
accreditation process and should display this on their website.
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