Clinical Product Management Policy
The Trust strives to ensure equality of opportunity for all, both as a major employer and as a provider of
health care services. This Clinical Product Management policy has therefore been equality impact
assessed by the [insert authorising committee name] to ensure fairness and consistency for all those
covered by it, regardless of their individual differences, and the results are shown in Appendix A.
Policy Number:
[Click here and type]
Version:
2.0
Authorisation Committee:
Policy Approval Group
Date of Authorisation:
[Format dd-mmm-yyyyy]
Name and Job Title of author:
Fiona Burton, Head of Clinical Products
Name of responsible committee or
individual:
a) Patient Safety Committee
Executive Director Sponsor
Steve Bolam
Key individuals and/or Committees
consulted during drafting:
Clinical Management Board
And Chairs of:
Medical Devices Management
Committee
New and Novel Procedures and Policy
Committee
Date issued:
[Format dd-mmm-yyyyy]
Review date:
[Format dd-mmm-yyyyy]
Target audience:
All Trust Staff
Equality Impact Assessments
completed:
5th September 2013
Policy Checklist completed:
Number of pages:
19
Document History:
Version
Date
1.
04/03/2010
2.
5 September 2013
Review date
September 2016
Clinical Product Management Committee
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Comments
Changes to terms of reference updated,
New Products approval included
Terms of Reference v.2 Sep 2013
Contents
1.
Policy Statement ................................................................................................................................ 2
2.
Definitions .......................................................................................................................................... 4
3.
Scope ................................................................................................................................................. 6
4.
Aims and Outcomes ........................................................................................................................... 6
5.
Purpose .............................................................................................................................................. 6
6.
Related Trust Policies ........................................................................................................................ 6
7.
Monitoring effectiveness and compliance .......................................................................................... 7
8.
References ......................................................................................................................................... 7
Appendix A: ................................................................................................................................................... 9
Appendix B: ................................................................................................................................................. 11
Appendix C:................................................................................................................................................. 14
Appendix D:................................................................................................................................................. 15
Appendix E: ................................................................................................................................................. 18
Appendix F:………………………………………….………………………………………………….....……….19
Executive Summary
St Georges Healthcare NHS Trust Clinical Product Management (CPM) endeavours to provide
leadership to the procurement process through practical application and critical thinking derived from
an extensive background of clinical experience. Utilisation of CPM processes encourages a balance
of optimal clinical outcomes and supply governance while striving to deliver objective evidenced based
clinical analysis through research, multidisciplinary collaboration and data which includes function,
cost, utilisation, impact on infection control, and patient outcomes.
CPM will be achieved through the appropriate distribution of governance roles which will ensure the
oversight of clinical product choice, product evaluation and quality control. This will include the
management of Trust relationships with suppliers to ensure the most favourable strategic alliances
with vendors and the oversight of the introduction of new products.
The structure of St Georges NHS Trusts CPM organisation will include a Clinical Product Management
Committee that is accountable to the Trusts Patient Safety Committee. The CPMC will oversee three
product review teams to include: a) Medicine, cardiac & Cardio-thoracic; b) Surgery, Theatres and, c)
Anaesthetics; Children & Women, Clinical Imaging, Therapies and Diagnostics. These product review
teams will include multidisciplinary staff and consultant end-users to evaluate and make
recommendations on products. Business cases presented to the CPMC for authorisation will include a
review of clinical evidence based research, patient safety cost/ benefit analysis and product evaluation
and trials as appropriate. The CPMC will have an integrated relationship with the Medical Devices
Management Committee and Procurement Sourcing and Contracting.
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Terms of Reference v.2 Sep 2013
1.
Policy Statement
To achieve its vision, the Trusts Clinical Product Management organisation will:
1
2
3
4
5
6
7
8
9
Serve as gatekeepers of new products for each facility and system-wide in collaboration with
Procurement leadership as needed.
Drive contract compliance by identifying non-contract products and determining clinically
equivalent contract supplies.
Review product substitutions and conversions to determine clinical equivalency and the ability to
meet clinical needs.
Develop cross department review groups to standardise like products across services when
products have applications throughout the organisation.
Determine product quality concerns/issues are valid clinical concerns or product defects.
Provide Senior Leadership with Procurement focused clinical support required to optimize and
reduce the cost of providing optimal patient care.
Provide clinical expertise regarding product safety, efficacy, and use.
Evaluate product related safety concerns and collaborate actively with clinical teams, Risk
department and Consultant Leadership to identify supply related issues.
Provide a point of contact for suppliers wishing to build business between themselves and St
Georges Healthcare NHS Trust.
The Clinical Product Management Structure will include a Clinical Product Management Committee
(CPMC) with oversight of three Product Review Groups.
1.1
The CPMC
Membership
Core members:

Medical Director (Chair)
Procurement Manager
Head of Clinical Products
 Assistance director of finance
 Senior Nurse: DDN
 Senior Finance representative
 Senior Medical Physics Representative.
 Senior Education Representative
 Infection Control
Co opted members / Sub groups (as required)
Any key personnel the group feels should be invited


Roles & Responsibilities





Review and approve new product (as defined by policy) requests and determine whether trials
and/or evaluations are required.
Review new product requests.
Review and approve product conversions.
Review results of all trials followed by selection of the most cost effective, clinically sound product.
Serve as sole authority to evaluate and make recommendations for clinical supplies and products.
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Terms of Reference v.2 Sep 2013

Establish investigation and where feasible, standardise when two or more products are used to
perform the same function promoting selection of the most cost effective product alternative.
 Review product usage so its economic impact can be identified.
 Validate that benchmarking and/or literature reviews are completed prior to product selection and
reviews performed using evidenced based practice.
 Utilise established Product Review Teams to assist in the evaluation of products and the building
of business cases.
 Identify current practice and policies and procedures impacted by the potential change.
 Recommend education and communication to support product implementation.
 Consider impact to revenue and expenses.
 Provide that the Clinical Product Management process is maintained.
 Can not delegate responsibilities.
In the event that decisions are challenged the proposer will be given the opportunity to present the
alternative case at the next meeting of the CPMC. The committee’s decision after this will be final.
Full terms of reference are provided in Appendix B
1.2
Divisional Product Review Teams
The divisional product review teams will be responsible for driving forward product related review or
change projects where initiated by CPMC.
Team Leadership and Standing Members
Teams will be co-lead and facilitated by a Clinical Procurement Manager, Procurement Sourcing and
Contract Manager and a representative from the service line represented (i.e. a consultant or Head of
Nursing).
Teams
Product Review Team
Medicine and cardiac
 Divisional Chair (Chair)
 Clinical Product Specialist
 Care Group Leads or Consultant resource
 Heads of Nursing
 Business Manager – This may be deputised by a GM
 Divisional Procurement Manager
 Ancillary Department Managers, as required
 Ad hoc subject matter experts and end users
Product Review Team
Surgery, Theatre & Anaesthetics and neurology
 Divisional Chair (Chair)
 Clinical Product Specialist
 Care Group Leads or Consultant resource
 Heads of Nursing
 Business Manager – This may be deputised by a GM
 Divisional Procurement Manager
 Ancillary Department Managers, as required
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Terms of Reference v.2 Sep 2013

Ad hoc subject matter experts and end users
Product Review Team Clinical Imaging, Therapies and Diagnostics
 Divisional Chair (Chair)
 Clinical Product Specialist
 Care Group Leads or Consultant resource
 Heads of Nursing
 Business Manager – This may be deputised by a GM
 Divisional Procurement Manager
 Ancillary Department Managers, as required
 Ad hoc subject matter experts and end users
Full terms of reference can be found in Appendix C
2.
Definitions
2.1
Medical Device:
'medical device' means any instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software necessary for its proper application intended by the
manufacturer to be used for human beings for the purpose of:
 Diagnosis, prevention, monitoring, treatment or alleviation of disease,
 Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
 Investigation, replacement or modification of the anatomy or of a physiological process,
 Control of conception,
 and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function by
such means. (European Union, 1993)
2.2
Medical Consumable:
A ‘Medical Consumable’ is any medical device that has an in use life-span of less than 6 months.
2.3
Single Use Consumable
A ‘Single Use Consumable’ is a consumable manufactured to be disposed after one use with one
patient. (MHRA, 2006)
2.4
Single Patient Use
This indicates that a medical consumable can only be used with one patient; however this can be on
more than one occasion. (MHRA, 2006)
2.5
Systemness
Systemness takes into consideration whether the product or device has applications throughout the
organisation.
Examples: Can this product be used within all Trust divisions & specialties? Does it support a need at
multiple sites?
2.6
Quality
Quality is a composite criterion emphasising performance, which includes the item's durability,
reliability, integrity, and maintains or enhances care delivery.
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Terms of Reference v.2 Sep 2013
Example: How durable is a pair of gloves during normal use? How often do the gloves tear? Does the
product impact the quality of care?
2.7
Effectiveness
Effectiveness describes how well an item meets its intended purpose or required need.
Examples: Do the gloves meet their intended function? How well do the gloves protect your hands?
Do the gloves allow for sufficient tactile response (feeling)? Does the product meet the needed
capacity?
2.8
Cost
Cost includes the actual direct cost of the product, the cost relative to improved clinical outcomes and
the financial impact of the acquisition on revenue in alignment with product utilisation and includes
frequency of use and appropriateness of the device/ product to level of care needed.
Examples: Is the product reimbursable or revenue generating and what is the impact on the overall
cost per case?
2.9
Standardisation
Standardisation is the ability to compress products into a standard or pre-determined set to minimise
variety, reduce variability and increase interchange ability.
Examples: Can we use these gloves throughout the system? Can this item fill multiple needs or
replace multiple different products?
2.10
Utilisation
Utilisation includes evaluating the current trends and the manner and frequency for which a product
will be used as well as the capacity of the product to meet the need.
Examples: How is it used? How often will this product be used? Does it fill the intended need?
2.11
Research
Consider the impact of using the product, system compatibility, and best practice outcomes integrating
clinical expertise with the best available external evidence. Conduct data analysis, case study and
literature research to assess impact for system as a whole.
Examples: Can the product be used with existing equipment? Does it support clinical practice? What
are the national/regional trends?
2.12
Education/Training
Consider education and training requirements. Consider impact on current Policies and Procedures
and/or order sets.
Examples: Does the item require any special training for use? Does this item require training for
compliance with regulatory requirements? Who will be responsible for providing training? Does the
use of this item require special credentialing?
2.13
Safety / Infection Control / Waste Management
The item will comply with all hospital MHRA, NPSA and any other governmental
regulations/requirements as well as consider CQC indicators, and NICE recommendations.
Examples: Is there an increased risk of injury. (i.e., sharps injury or back injury)? If the item is
disposable, does it have any special disposal requirements? If the item is reusable, does it require
any special reprocessing? Is the product invasive? Does the product come into contact with nonintact skin or mucous membrane?
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Terms of Reference v.2 Sep 2013
2.14
Clinical impact / Risk
Assess the impact of a new or substituted product on the provision of safe patient care including any
factors that may affect the risk of error or adverse or unplanned events.
Examples: How will this affect patient care? What is the risk of use to the patient and staff? Does this
need to be referred to the MHRA or NPSA?
2.15
Packaging and Space
Optimal packaging will have minimal waste, an ease of opening, and ease of storage.
Examples: Is the item packaged as desired? Does the item require any special tools or methods for
storage or opening its packaging? Does packaging and storage impact utilisation? Is there
unnecessary waste with the packaging?
3.
Scope
This policy will apply to all staff within St Georges Healthcare NHS Trust. The policy applies to all
medical devices and their manufacturer and suppliers. This policy will be compliant with the
Procurement Policy within St Georges Healthcare NHS Trust. This policy will apply to all procurement
of clinical products to be used within St Georges Healthcare NHS Trust. This includes items that are
funded via charitable organisations.
For clarification this includes products for Laboratories such as reagents, nutrition & medical
equipment. The CPMC will not oversee the procurement of items Furniture such as chairs and other
non clinical items that will be managed by the non-clinical procurement team.
4.
Aims and Outcomes
The aims and objectives of this policy are to provide a structure to support effective governance of
Clinical Product selection and use. This will embed within the organisation a culture of clinical
oversight and engagement with end users. The increased engagement and oversight is structured to
ensure that consideration is given to systemness, quality, effectiveness, cost, standardisation,
utilisation, clinical risk, education, infection control, waste management and, packaging and space.
5.
Purpose
Ensuring high quality clinical and financial governance to all procurement activity within St Georges
NHS Trust is a necessary element to ensure the highest quality of treatment and care to our service
users.
St Georges Healthcare NHS Trust recognises that good governance regarding the choice of clinical
products we procure, and the availability of unsolicited or unselected products impact on our patients’
outcome and experience.
6.
Related Trust Policies
Medical Devices - Management and Use of
Medical Devices - Training policy
Infection Control Policy
Decontamination Policy
Glove Policy for Clinical Use
Safe use and disposal of Sharps, Sharps Injury and Splash
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Terms of Reference v.2 Sep 2013
Medicines Management Policy
Analysing and Learning Policy
Central Alerting System (CAS) Alerts Policy
Governance and Risk Management Strategy and Framework
Serious Untoward Incident Policy
Health and Safety Policy
Control of Substances Hazardous to Health Policy
Latex Policy
Lifting Operations and Lifting Equipment
Personal Protective Equipment (PPE)
Workplace (Health, Safety and Welfare) Policy
Standing Orders, Standing Financial Instructions and Scheme of Delegation
Procurement Procedures
7.
Monitoring effectiveness and compliance
7.1
Process for Monitoring Compliance and Effectiveness
The Procurement Nurse will produce a monthly report of KPI’s to be presented at the CPMC, this will
be communicated as an attachment to the minutes of each months first CPMC meeting.
7.2
Standards/Key Performance Indicators
Benchmark for Medical devices/consumable related incident reports
CPMC to review all S.U.I.’s that involve medical devices/consumables.
A standard for product / supplier variance
A standard for % of supplies (both cost and lines) received through NHS Supply Chain.
A measure of audit of clinical satisfaction / maybe an audit schedule (qualitative)
8.
References
European Union (1993), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices,
Official Journal L 169 , 12/07/1993 P. 0001 – 0043
MHRA (2006), Device Bulletin Single-use Medical Devices: Implications and consequences of Reuse
DB2006(04)
Clinical Product Management Committee
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Terms of Reference v.2 Sep 2013
Appendix A:
EQUALITY AND IMPACT ASSESSMENT TEMPLATE
Policy or Service Name:
Clinical Product Management Policy
Lead or EIA and contact
details:
Fiona Burton ext 0768
Date completed:
5th September 2013
STEPS/ACTIONS
OUTCOMES/KEY FINDINGS
Step 1
Briefly describe the key
objectives and outcomes
of Policy
The Clinical Management Policy sets the organisational strategy
and structure for effective oversight of Clinical Product
introduction or change.
This document has been approved by the Procurement
Transformation Programme board and is being presented to
CMB for approval as a working Draft.
Step 2
Screening the policy or
service for relevance to
diversity
 age
 gender
 disability
 race
 language
 religion or belief
 sexuality
 human rights
If there is no relevance
process stops here.
Step 3
Assessing the impact
that a proposed policy or
service is likely to have
on diversity.
The policy is intended to be non-discriminating as it
encompasses products for all service users and service
providers. It is the intention to engage with all members of clinical
staff in service delivery.
- A clause within the product review groups TOR states that
consideration must be given if a product choice unequally
affects a section of our client base.
- Where a product range is used for one section of our
client population a rationale will need to be made within
any business case for change. For example, should a hip
replacement joint be chosen on the basis of price,
consideration must be given regarding the life expectancy
of that joint to ensure younger clients are not
disadvantaged.
- The nature of this policy will make decisions more transparent
than is currently the case.
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Terms of Reference v.2 Sep 2013
Step 4
Consulting with groups
who are likely to be
affected and identifying
remedial action (state
which groups were
consulted)
-
Procurement Transformation Steering Committee
Procurement Transformation Programme Board
Clinical Management Board
-
KPI indicators include
o Benchmark for Medical devices/consumable
related incident reports
o CPMC to review all S.U.I.’s that involve medical
devices/consumables.
o A standard for product / supplier variance
o A standard for % of supplies (both cost and lines)
received through NHS Supply Chain.
o A measure of audit of clinical satisfaction / maybe
an audit schedule (qualitative)
Step 5
Proposed changes,
improvements to make
to the policy or service in
order for it to promote
equality and diversity
Step 6
Resource Implications
Step 7
Monitoring
Arrangements
This is not optional. All
decisions must include
monitoring arrangement
to ensure that the policy
or service is executed
appropriately and has
the desired results when
implemented
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Terms of Reference v.2 Sep 2013
Clinical Product Management Committee (CPMC)
Terms of reference
1. Authority
1.1
The Clinical Product Management Committee is constituted as part of the Core Trust Clinical
Procurement Policy.
2. Aim /Objective of group
2.1
The main focus of CDPG will be to manage change in clinical procurement activities. To
achieve greater value for money whilst ensuring quality and best practice are adhered to by
reviewing clinical procurement opportunities, and manage product evaluations centrally using
structured guidelines.
-
To help define and implement standardisation and quality.
-
Review and respond to any guidelines / practice changes.
-
Allocate product reviews most appropriate.
-
To help identify savings ideas and schemes.
-
Develop an actions log to track ideas to real savings.
-
To ensure all real savings are documented.
3. Membership
3.1
The membership of CPMC will be as follows

Medical Director (Chair)

Head Clinical Procurement

Medical devices co-ordinator

Assistant Director of finance / procurement

Head of Nursing Intensive Care

Risk Assurance Manager

Deputy finance director

Procurement data analysis

Infection Control
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Terms of Reference v.2 Sep 2013
3.2
Nominated deputies for the above members may attend on behalf of the member.
3.3
Other interested parties may be invited to attend meetings as and when required.
4. Frequency
Alternative Month commencing 12June 2013 – to be reviewed after 4 months.
4.1
4.2
Additional meetings will occur by exception and can be requested by any member for
consideration of the Chair.
5.
Reporting and assurance
5.1
CPMC will produce a monthly meeting/action notes. These will be available via the Trust
intranet.
5.2
A list of approved projects and standardised products will be
view via the Trust intranet.
maintained and available to
6. Roles and Responsibilities
The Clinical Development, Innovation and Procurement Group will consider all requests for
development of clinical services, innovation in products or procedures and specific
procurement of new clinical products.
6.1
CPMC will provide a forum to:

Consider and approve / decline clinical business cases for the development of new clinical
services, new clinical procedures and new equipment/products. Cases to include clinical
evidence, any co-dependencies (research, teaching and education), patient safety,
alternative options, activity & income forecast, funding and value for money.
Note – no service or procedure can commence, nor products/equipment ordered
without prior approval of the Business Cases by CPMC

Carry out a high level clinical review of capital business cases prior to consideration by the
Investment Viability Group / the Medical Equipment Procurement Group.

Review and revise the Protocol for Restricted Access of Medical Representatives.
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Terms of Reference v.2 Sep 2013

Inform and direct the clinical work plan of the Procurement Department, including the
development of projects that impact on care pathways and review demand/protocols.

Each Division must send a representative and that the representative must be authorised to
make binding decisions regarding products and services.

Each representative promised to engage with their colleagues and to ensure that clinical
trials are completed on time and to the appropriate standard.
7. Outputs
7.1
The following will be outputs from the Clinical Procurement Group:

Two Monthly report to include a summary of all the themes detailed in 6.1

Where relevant, papers for further discussion or endorsement by the Trust Board, Trust
Management Executive, Investment Viability Group and so forth.
A summary highlight report to be accessed on the Trust intranet.
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Terms of Reference v.2 Sep 2013
Appendix C – Committee structure
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Appendix D:
Product Review Teams



Medicine, cardiac & Cardio-thoracic
Surgery, Theatres and, Anaesthetics
Children & Women, Clinical Imaging, Therapies and Diagnostics
Terms of Reference
Purpose
The purpose of the team is to build business cases and recommendations regarding
conversions, new product requests and standardisations based upon the policy for the Clinical
Product Management Process.
Team Responsibilities
 Receive proposals for investigation from:
– Clinical Product Management Committee
– Clinicians
– Nurse Leaders
– Sourcing Managers
– All Trust staff

Review proposals and prioritise with consideration of:
– Clinical need
– Patient Safety
– Organisational function
– Financial impact

Build a business case for change. This should:
– Understand specification required
– Review of available products that meet specification
– Review product usage so its economic impact can be presented.
– Validate that benchmarking and/or literature reviews are completed prior to product
selection and reviews performed using evidenced based practice.
– Enlist experts and/or end-users as sub-committee’s as necessary to assist in the
evaluation and presentation of products.
– Identify current practice and policies and procedures impacted by the potential change.
– Recommend education and communication to support product implementation.
– Consider impact to revenue and expenses.
– Give consideration to impact on equality & diversity where a case can be made that a
section of our client base may be unequally affected by the product choice.

Present business case and recommendations to CPMC.
Seek CPMC decision making and advice where prioritisation is not clear or decisions
disputed.

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Terms of Reference v.2 Sep 2013
Product Review Teams



Medicine, cardiac & Cardio-thoracic
Surgery, Theatres and, Anaesthetics
Children & Women, Clinical Imaging, Therapies and Diagnostics
Team Leadership and Standing Members
Teams will be co-lead and facilitated by a Clinical Procurement Manager, Procurement
Sourcing and Contract Manager and a representative from the service line represented (i.e. a
consultant or Head of Nursing).
Standing team members for each Product Review Team are non-voting and include one
representative from each of the areas below:
 Infection Control
 Clinical Risk
 Nursing Education
 Decision Support
 Procurement Sourcing/Contracting Representative
 Procurement Manager
Teams
Product Review Team
Medicine, Cardiac, Cardio-thoracic








Divisional Chair (Chair)
Clinical Product Specialist
Care Group Leads or Consultant resource
Heads of Nursing
Business Manager – This may be deputised by a GM
Divisional Procurement Manager
Ancillary Department Managers, as required
Ad hoc subject matter experts and end users
Product Review Team
Surgery, Theatres and, Anaesthetics








Divisional Chair (Chair)
Clinical Product Specialist
Care Group Leads or Consultant resource
Heads of Nursing
Business Manager – This may be deputised by a GM
Divisional Procurement Manager
Ancillary Department Managers, as required
Ad hoc subject matter experts and end users
Product Review Team
Children & Women, Clinical Imaging, Therapies and Diagnostics






Divisional Chair (Chair)
Clinical Product Specialist
Care Group Leads or Consultant resource
Heads of Nursing
Business Manager – This may be deputised by a GM
Divisional Procurement Manager
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Terms of Reference v.2 Sep 2013


Ancillary Department Managers, as required
Ad hoc subject matter experts and end users
Meeting parameters
 The teams will meet once a month.
Recruitment of Sub Groups
A list of current products / product ranges being evaluated should be available to all St Georges
Hospital staff so that they can express an interest.
Where the product is mainly used by nurses, all Heads of Nursing, Specialist Nurses and
Matrons should receive an invitation to express an interest by e-mail.
Where the product is used by Clinicians, all Clinical leads should receive an invitation to
express an interest by e-mail.
The Product Review Team is responsible for ensuring any product related sub group should be
made up of a representative sample of the product users.
Conduct of Meetings
The meeting will follow the following format:
 Apologies
 Matters Arising
 Review current projects
– Refer complete projects to CPMC for final decision to implement
– Review ongoing projects timelines and milestones
– Recommend action where necessary
– Prioritise resources within projects as per CPMC decisions
 Consider New projects
– Allocate project lead
– Recruit service level team members
– Set time line & Milestones
 Refer any irresolvable issues to CPMC Any other business
 Date & Time of next meeting.
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Terms of Reference v.2 Sep 2013
Appendix
E:
New / Alternative Product Application Form (v0.1)
Instructions: i.e. complete all relevant fields; boxes will expand as you type…
Section 1: Product Outline
Item #
Description
Annual Qty. Used
Price
Subtotal
Section 2: Product Details
Trust wide impact assessed - Please attach evidence
Current delivery:
Financial Impact Assessed - Please attach evidence
VAT:
Clinical Evidence Explored and Attached
Trust wide usage:
Impact on Clinical practice / outcomes assessed
- Evidence attached
Decontamination / sterilization impact assessed
- Evidence attached
Education & Training Implications considered
- Evidence attached
Annual Trust wide cost:
Trust wide impact assessed - Please attach evidence
Section 3: Please describe why this product or product range should be explored.
Section 4: Proposer Details
Proposer:
Phone #:
Position:
Date:
Department:
Clinical Product Management Committee
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Signature:
Terms of Reference v.2 Sep 2013
/
/
Appendix F:
Clinical Product Management Committee
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Terms of Reference v.2 Sep 2013
Appendix G:
Checklist for the Review and Approval of Procedural Documents
To be completed and attached to any document submitted to the Policy Ratification Group for ratification.
Yes/No/
Title of document being reviewed
1.
2.
Unsure
Title
Is the title clear and unambiguous?
Yes
Is it clear whether the document is a guideline, policy,
protocol or standard?
Yes
4.
5.
6.
Title unchanged
Rationale
Are reasons for development of the document stated?
3.
Comments
Yes
Policy review
Is the method described in brief?
Yes
Unchanged
Are individuals involved in the development identified?
Yes
Amendments only as an
update
Do you feel a reasonable attempt has been made to
ensure relevant expertise has been used?
Yes
Unchanged
Is there evidence of consultation with stakeholders and
users?
Yes
Clinical procurement
group approved changes
to terms of reference
Is the objective of the document clear?
Yes
Unchanged
Is the target population clear and unambiguous?
Yes
Unchanged
Are the intended outcomes described?
Yes
Unchanged
Are the statements clear and unambiguous?
Yes
Unchanged
Is the type of evidence to support the document
identified explicitly?
Yes
Unchanged
Are key references cited?
Yes
Unchanged
Are the references cited in full?
Yes
Unchanged
Are local/organisational supporting documents
referenced?
Yes
Unchanged
Does the document identify which committee/group will
approve it?
Yes
Unchanged
If appropriate, have human resources/staff side
committees (or equivalent) approved the document?
No
Development Process
Content
Evidence Base
Approval
Clinical Product Management Committee
Page 21 of 21
Terms of Reference v.2 Sep 2013
7.
Dissemination and Implementation
Is there an outline/plan to identify how this will
be done?
Does the plan include the necessary
training/support to ensure compliance?
8.
9.
10.
11.
Yes
Procurement homepage and
through the CPMC group
Unsure
Document Control
Does the document identify where it will be
held?
Unsure
Have archiving arrangements for superseded
documents been addressed?
Unsure
Process for Monitoring Compliance
Are there measurable standards or KPIs to
support monitoring compliance of the
document?
Yes
Is there a plan to review or audit compliance
with the document?
Yes
CPMC group
Review Date
Is the review date identified?
Yes
Is the frequency of review identified? If so, is it
acceptable?
Yes
Overall Responsibility for the Document
Is it clear who will be responsible for
coordinating the dissemination, implementation
and review of the documentation?
Clinical Product Management Committee
Page 21 of 21
Yes
Terms of Reference v.2 Sep 2013