using a quality management system as an accreditation tool

www.angliacancernetwork.nhs.uk

1

www.suffolkpct.nhs.uk 1

Using a Quality Management System as an accreditation

tool

Anne Emmett Quality Assurance ManagerAnglia Cancer Network

JACIE


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



3


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


4


• Will a QMS mean you will pass JACIE?

• No!• Will a QMS help you pass

JACIE?• Yes!



5


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?


http://www.jacie.org/portal/jacie/welcome


6


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


7


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


8


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


9


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


10


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


11


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?



12


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


13


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.


14


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


15


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


16


• 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



17


And essential documentsB5.1 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?



18


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


19


…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?



20


• 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



21


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



22


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…….


23


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?



24


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


25


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


26


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


27


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


28


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


29


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



30


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…..



31


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…...



32


• 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!



33


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


using a quality management system as an accreditation tool

Health & Medicine