A Customers View

Karim Premji - Pathology IT Systems Manager

Background

• UKAS is currently managing the transition of all

CPA accredited laboratories to UKAS

accreditation to the internationally recognised

standard. See Medical Laboratory accreditation

(ISO 15189) for further information.

Assessor Quote.

“Any changes made to the LIMS, systems

connected to the LIMS and/or interfaces affecting

the functionality of the LIMS requires the

Verification and Validation (V&V) process to be

carried out to ensure that the LIMS functionality is

not affected or compromised.”

NPEx Changes.

• Changes made by NPEx (2018)

– NPEx Database Upgrade 11th April 2018

– NPEx Firewall Changes 5th May 2018

• Both changes are subject to V&V

UKAS & NUH Visit.

• UKAS assessor asked about NPEx usage.

• No V&V paperwork completed.

• Non-Conformance NC raised against the CHI

lab.

• Retrospective paperwork completed by NUH to

clear the NC.

• Paperwork submitted was very basic and was

just enough to clear the NC.

NPEx & UKAS

• NPEx single biggest provider of Electronic

Referrals ER.

• NPEx understands the need for controlled

change management.

• NPEx to work with NPEx Labs and Users to work

on quality and accreditation paperwork to V&V

the ER process.

• Initial conversation with NUH identified the

requirements and understand the process.

Proposed solution – requests

• ‘Special’ test code, routed to an NPEX virtual lab

• Whenever a validation is required, test is requested from LIMS

• NPEX generates a standard report against the request and returns

this to LIMS

• Easily automated

• Consistent across labs

• Can include a variety of results

LIMSVirtual

LIMS

VnV Request

Auto

Response

Proposed solution – results

• Not so easy to automate (result needs to be generated at Lab)

• Couple of ideas:1

– ‘Generate validation test request’ button in NPEx so lab can drive

a request into their LIMS from the NPEx virtual Lab

– Lab reports on this and gets to see result in NPEx (and print for

their validation report).

– Feels messy…

LIMSNPEx UI

1. Send Virtual Request

3. View/print Result

2. Generate Result

Proposed solution – results cont• Idea 2:

– NEQAS labs already have regular, consistent requests coming in from

NEQAS. These can be seen before and after the ‘change’ and used to

validate that nothing has changed

– Also feels not-quite-right – e.g. can’t be run on demand

NEQAS LIMS

Request

Change!

NEQAS LIMS

Request

Compare results before and after

UKAS Paperwork

• Change management diary.

• Verification and Validation (V&V).

• Document templates.

• Possible examples.

WinPath Request

WinPath Request on NPEx

WinPath Result from NPEx

Other NHS Request on NPEx

Other NHS Request on WinPath

Other NHS Result on WinPath

Other NHS Result on NPEx

Questions ?

• Shipping manifest?

• Time taken to complete paperwork?

• Consideration of other issues.