Lessons Learnt in Blood Processing

Bekki Ventre- Continuous Improvement Facilitator October 2019

One NHSBT

Our Core Purpose is to Save and Improve lives

About Me• Blood Manufacturing supervisor

• IVD’s Manufacturing supervisor

• Continuous Improvement Facilitator for Blood Supply

• Continuous Improvement Facilitator for (Diagnostic and Therapeutic Services) DTS

A consistent approach

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2019- Blood Supply Chain• Around 28,000 units of blood are collected every

week via a network of fixed sites and mobile blood collection teams.

• The blood is processed in three processing centres: Manchester, Filton and Colindale.

• The blood and associated blood products are then distributed via a network of fifteen stock holding units to over 250 NHS Trusts.

Manufacturing sites 2006

Key Challenges:• Poor estates• Fragmented• Inflexible• Cramped• Poor energy efficiency• Regulator requirements• Excess capacity• Falling Demand• Financial Environment

11 Blood Manufacturing sites

Back in 2008• Over the next 2 years 5 manufacturing sites were closed.

• Brentwood Blood Manufacturing site was due to close in 2009

• Manufacture had to be absorbed by the other 5 sites

• This created a ‘Burning Platform’ requiring significant operational changes

• Lean manufacturing was the agreed methodology to deliver the changes

• Identified a need to develop a culture of Continuous Improvement (CI)

What is Lean Manufacturing?

Value

Perfection

Value Stream

Flow

Pull

5 Key Principles

Eliminate Waste

Drive Quality

Improve Efficiency

People

Benefits Tool kit

6S

Standard Work

TAKT time

Visual Management

Lean cell

Action Taken• Established a comprehensive training program exposing

1,200 members of the team to lean thinking

• Established a team of facilitators- Lean experts

• Identified a network of CI champions across the departments

• Planned a series of change events

• A commercial partnership was established with the Lean consultancy, Simpler, to bring expert support and advice into the programme

2008 2009 2010 2011 2012 2013 2014 2015 2016Q1Q2Q3 Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3 Q4Q1Q2 Q3Q4Q1Q2Q3Q4 Q1Q2

2008/2009Price per unit of

blood £140

2015/2016 Price per unit of blood £120

2009Operational

Improvement Programme

commences at Filton

2012NHSBT wins HSJ award for Quality and Productivity

2014Strategy deployment National operations

2013SPS services

first event

20123 x planning

events In BD

2010Three large

production lines to individual pods

2015/2016 Planning assumptions

behind Manchester consolidation

201033% productivity improvement at

Filton 201511691 in

Manufacturingproductivity

Timeline of Change2016 Supply Chain Modernisation into Manchester

2010 Filton Flow Event

AfterBefore

Encouraged batch processing:• Centrifuge All• Press All• Label All

Less Work In Progress: • Initial standard work was 3 per

cell- driven down to 2• Units in the fridge more quickly• Removal of excess walking

Outcome

ManufacturingPer WTE/year5184- 20077248- 2010(+39.8%)

4000

4500

5000

5500

6000

6500

7000

7500

8000

8500

Apr-07 Aug-07 Dec-07 Apr-08 Aug-08 Dec-08 Apr-09 Aug-09 Dec-09 Apr-10 Aug-10 Dec-10

Manufacturing Productivity in SW

Uni

ts o

f blo

od m

anuf

actu

red

Date

Implementation of the CI programme 2009 Q3

Date

Effe

cted

uni

ts fo

r dis

card

Implementation of the CI programme 2009 Q3

15/06/2009 21/04/2013

Further Waste RemovalCapacity 3 people in a

pod2 people in a pod

Output per hour 54 48Output per person 18 24

Increase of 33%

Other Improvements made

Pre-weigh before

centrifugation

Packing of units Shadow Boards Supervisor

lights

8 hrs/day 11 hrs/day 8 mins/day67 mins/day

3 Blood Manufacturing sites

Manufacturing sites 2019

Deliverables

• Increased standardisation of practices and processes

• An increase of >70% in blood component manufacturing and testing productivity

• Release of over £10m a year back to NHS front-line patient care

• Reduction in absence of 10% saving £515K in overtime and agency costs

Lessons Learnt in the implementation of the Lean Program in Blood Supply

• Staff involvement in CI and top level leadership from the outset and beyond is critical

• Success should be celebrated in order to underpin cultural change and maintain morale

• Continued effort to sustain and re-enforce improvement is essential

• Clearly tracking benefits is fundamental to success and proves the case for continued investment

Lessons Learnt 1

Lessons Learnt 2• The Lean implementation process would have brought more of the

operational staff with it in the first instance to aid with engagement

• Use of consultants to guide and train staff on the new methodologies as well as aid in running RIE was crucial in ensuring success early on in implementation and proving that the methodology worked

• Providing foundation level Lean training earlier to operational staff working in a Lean environment would have helped embed Lean into the culture faster

• Lean champions have been crucial to the success of Lean implementation and organisational cultural change at their local NHSBT sites however on reflection this was at the detriment to the speed of cultural change at sites that did not have a local champion

• It is critical that the implementation of Lean felt very top-down and supported. Senior leaders had good buy-in and correct level of training

• Senior leaders must empower staff to come up with the improvements in the Rapid Improvement Events and support/enable the changes to be made

Lessons Learnt 3

Future Challenges for Blood Supply

Cellular and Molecular Therapies

• 17 clean rooms and close to 100 staff operating in a highly regulated

environment at eight locations

• Provision of cell collection services from NHSBT-managed clinics

• Donor/patient medical assessment and consent

• Donor/patient leucapheresis

• Donor/donation evaluation (flow cytometry)

• Collection in accordance to client protocols

• Packaging, shipping and chain of custody to processing/storage centre

• Processing of advanced cell therapies to client protocols in compliance with

UK regulations - selection/depletion/expansion/cryopreservation

• Receipt, storage, release and transport of cell therapy products to clinic

• HLA typing (NGS platform)

• Reporting and communications

Supporting ATIMPs

• A new facility at Bristol to more than double capacity for plasmid, viral vector

and protein manufacture

• A new Blood Centre at Barnsley with GMP capacity for Advanced Cell

Therapies

NHSBT - Future Growth

Case Study- International Blood Grouping Reference Laboratory (IBGRL) Molecular Diagnostics

From Research and Development to High Throughput

From R&D to launch • There are 100,000 births to Rh(D) negative pregnant women

each year in England / Wales

• A small number of D-negative women become allo-immunised to the D antigen and their babies are at risk of haemolytic disease of the fetus and new-born

Non-invasive fetal genotyping from maternal blood service was launched 2001 at NHSBT

NICE studies feasibility of a mass screening service 2002IBGRL continue to scale up

Fetal RHD genotyping

Pilot study in SW 2013-2015

Outcome of pilot success

NHSBT launch screening service 2015

NICE recommendation published Nov 2016

IBGRL started CI Journey 2017

Timeline

www.nice.org.uk/guidance/dg25

2015- 3,000 samples P.A 2019- 35,000 samples P.A

CI Journey

• Value Stream Analysis (VSA) was first held in 2017

• Referral rate at this time was 4,000 samples per annum

• VSA is a strategic look at the Value Stream end to end

• Created a foundation for improvement and a vision

• Target is 100,000 samples per annum

• Annual VSA’s are scheduled to review progress

Celebrating Successes• Sample volume increase from 3K to 35K samples in 4

years

• Accrediting body changed from CPA to UKAS (standard ISO 15189)

• Zero experience of CI to a Facility Assessment score of 71% within 3 years

• Staff team has doubled since 2015 with many staff cross-trained across all sections

• Turnaround times have remained stable despite the tenfold increase in sample volume

Sustaining

3.53

3.52.6

2.1 2.2 2.1 2.2 2.4

4.83.8 3.7 3.8

2.62.1 2.5 2.4 2

3.1 3.22.6

4.4

2.51.9

2.6 2.61.8

3.4 3.1589698

801 872

1075116211381202

1118

14121281

15401674

17741631

180417251736

20452065

1877

2565

220822782253

2539

2202

24692389

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Sam

ples

Rec

eive

d

Month

Fetal RHD Screening Activity: Samples received Vs Mean TAT Mean TAT FHTD Sample No

Final Thoughts

• High throughput manufacturing and Lean go hand in hand

• Lean drives quality across the Value Stream

• Embedding a Continuous Improvement Culture is key to success