How an eQMS like Q-Pulse can help healthcare organisations attain JACIE accreditation

1. www.angliacancernetwork.nhs.uk1
www.suffolkpct.nhs.uk 1
Using a Quality
Management
System as an
accreditation
tool
Anne Emmett Quality Assurance Manager
Anglia Cancer Network
JACIE

2. www.suffolkpct.nhs.uk 2
Introduction
A QMS enables you manage and monitor
day to day activities relating to:
• Document Management
• Audit
• Corrective and preventative actions
• Training
• Assets
• Risks and incidents
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QMS for JACIE
• Assists in determining whether the right
thing is being done
– in advance of your inspection
• Cyclical process
– not ‘just’ for JACIE
• Collects routine data
– can be used evidentially
• Review of what is actually done
– can lead to process improvements

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• Will a QMS mean you will
pass JACIE?
• No!
• Will a QMS help you pass
JACIE?
• Yes!
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How can QPulse help
• Lets start with the first ‘Is there’ in the clinical
program check list of standards
B4.3.1 Is there a system to document the following for all
medical and nursing staff:
B4.3.1.1 Initial qualifications and training?
B4.3.1.2 Annual performance review?
B4.3.1.3 Provisions for continuing education?
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Training records
• This is covered by the people and training
modules
People will give you individual staff records
Training Courses will give you everyone who
has attended specific training courses

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You can use the system to search for
particular departments or particular staff
groups or specific training

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B4.3.1.1 Initial qualifications and training? - These are listed under a
event history for each staff member
B4.3.1.3 Provisions for continuing education? - These are
listed under a training plan for each staff member

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JACIE reviewers may also ask for
evidence of everyone who has
attended a training course, or who
is competent – particularly with
Intrathecal procedures. For this
you would select training courses
and then select category and show
the lists for the courses run

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This particular course is not
renewable, but a renewable
course would show renew by
dates, and there would be an
automatic reminder one month
before these are due

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This need for a training record
is rapidly followed by:
B4.4 Does the Quality Management Plan include, or summarize and
reference, policies and procedures for the following for critical
processes, policies, and procedures:
Development?
Approval?
Implementation?
Review?
Revision?
Archival?
B4.5 Does the Quality Management Plan include, or summarize and
reference, a system for document control, including a list of all
critical documents that shall adhere to the document control system
requirements?

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You can sort documents
by if they are Draft, Active,
Inactive or Obsolete. This
meets the requirement for
archiving of documents

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You can sort within
each status type
for specific groups
of documents
So when the JACIE
inspectors ask for
records of all your
Training
procedures… that
would be the type
you would search
for.

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Selecting an individual record in any of the
status types will show a complete history for
that document

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B4.4 Does the Quality Management Plan include, or
summarize and reference, policies and procedures for the following
for critical processes, policies, and procedures: Development?
Approval? Implementation? Review? Revision? Archival? – The full
record is available

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• B4.5 Does the Quality Management Plan include, or summarize and
reference, a system for document control, including a list of all
critical documents that shall adhere to the document control system
requirements?
• Put ALL your documents onto the database and then
you can ensure that all the critical ones are there.
• Ensure you have a policy for document control

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And essential documents
B5.1 Does the Clinical Program establish and maintain policies and procedures, in addition to those required in B4, addressing critical
aspects of operations and management including all elements required by these Standards?
Do the policies and procedures address at a minimum:
B5.1.1 Donor and recipient evaluation, selection, and treatment?
B5.1.2 Donor consent?
B5.1.3 Recipient consent?
B5.1.4 Donor and recipient confidentiality?
B5.1.5 Infection prevention and control?
B5.1.6 Administration of the preparative regimen?
B5.1.7 Administration of HPC and other cellular therapy products, including exceptional release?
B5.1.8 Blood product transfusion?
B5.1.9 Facility management and monitoring?
B5.1.10 Disposal of medical and biohazard waste?
B5.1.11 Emergency and disaster plan, including the Clinical Program response?
B5.2 Does the Clinical Program maintain a detailed Standard Operating Procedures Manual?
Does the Standard Operating Procedures Manual include:
B5.2.1 A procedure for preparation, approval, implementation, review, revision, and archival of all policies and procedures?
B5.2.2 A standardized format for policies and procedures, including worksheets, reports, and forms?
B5.2.3 A system of numbering and titling of individual procedures, policies, worksheets, and forms?

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B5.1 Does the Clinical
Program establish and
maintain policies and
procedures, in addition to
those required in B4,
addressing critical aspects of
operations and management
including all elements required
by these Standards? – you
can easily check from your list
of active documents that the
required documents are
present – with a recognisable
title.
You can even set
up your reference
codes to reflect the
JACIE standard
numbers

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…and yet more on
documents
B5.4 Are copies of the Standard Operating Procedures Manual readily
available to the facility staff at all times?
B5.5 Do all personnel in the facility follow the Standard Operating
Procedures related to their positions?
B5.6 Are new and revised policies and procedures reviewed by the
staff prior to implementation?
Is this review and associated training documented?
B5.7 Are archived policies and procedures, the inclusive dates of use,
and their historical sequence maintained for a minimum of ten
(10) years from archival or according to governmental or
institutional policy, whichever is longer?

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• B5.4 Are copies of the Standard Operating Procedures Manual
readily available to the facility staff at all times?
QPulse is a Networked solution and will work as a searchable database
in the same way as an Intranet or Sharepoint works as a central
repository.
Having this solution means staff are always looking at the most up to
date version
Access is via a shortcut icon which is put on everyone’s desktop in the
department

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B5.5 Do all personnel in the facility follow the Standard Operating
Procedures related to their positions?
B5.6 Are new and revised policies and procedures reviewed by the
staff prior to implementation?
Is this review and associated training documented?
QPulse will allow the set up a distribution list to notify all staff when
documents relevant to their area have been updated….. There is
also a feed back mechanism that will confirm they have read the
update
When documents with associated training are updated, the system will
automatically ask if a new training need has to be set up for the
revised document

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B5.7 Are archived policies and
procedures, the inclusive dates of use,
and their historical sequence
maintained for a minimum of ten (10)
years from archival or according to
governmental or institutional policy,
whichever is longer? The archive
process maintains records for as long
as you use the system…….

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Then there is audit
B4.8 Does the Quality Management Plan include, or summarize
and reference, policies, procedures, and a timetable for
conducting and reviewing audits of the Program's
activities to verify compliance with elements of the
Quality Management Program and operational policies
and procedures?
B4.8.1 Are audits conducted on a regular basis by an individual
with sufficient expertise to identify problems, but who is
not solely responsible for the process being audited?
B4.8.2 Are the results of audits used to recognize problems,
detect trends, and identify improvement opportunities?

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Audit takes two parts – a record of all the audits completed,
who completed the audit, who or where was audited, actions
raised, links to any reports, follow up
The second part – any actions raised are then automatically
loaded into the Corrective Actions and Preventative Actions
module

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B4.8.1 Are audits conducted on a regular basis
by an individual with sufficient expertise to identify
problems, but who is not solely responsible for the
process being audited? – the lead auditor name
can be checked against the relevant training
records, and their work location checked to avoid
any conflicts of interest

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B4.8.2 Are the results of audits used to
recognize problems, detect trends, and
identify improvement opportunities?-
Individual audit records will show problems
and identify improvement opportunities

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B4.8.2 Are the results of audits used to
recognize problems, detect trends, and identify
improvement opportunities? – actions and
opportunities are logged on the CAPA system.
Trends and types can be logged and reviewed

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B4.8.2 Are the
results of audits
used to recognize
problems, detect
trends, and identify
improvement
opportunities? –
there is a specific
trends analysis
section for CAPA –
with variable
analysis options

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• And the same issues are repeated in
sections
– C – Collection Facility, HPC Marrow
– C – Collection Facility, HPC Apheresis
– D - Processing

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And how will it help remember when all
these things need updating……..
Each month your QA
Manager can run workload
– and outstanding tasks for
the following month are
listed. Clicking on any link
will show full list.
A QMS can also be set up
to auto-email anyone with
an outstanding action…..

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And how will it help remember when all
these things need updating……..
Each time anyone logs on
and opens a module they
will also get a reminder of
any outstanding tasks…...

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• So will a QMS help you
get through JACIE?
That is for you to decide….
What it won’t do is take
away the work, it just
makes it easier to
manage!

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And finally remember JACIE is Just Another
Clinical Inspection Event – in other words an
AUDIT
• The best use of AUDIT as an acronym….
Alcohol Use Disorder Identification Test
Any Questions