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Dr. Anne PostulkaChristchurch, NZ, June 2015

Not only for Google: Why does speed matter?

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Who am I and where do I come from?

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Who else is there?

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For Google

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Speed matters – also in MedTech

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• Definition of speed

• Objectives of speed

• Feasibility of speed

• Benefits of speed

• What does it take

Content

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09:00 10:00 11:00 12:00 13:00 14:00 15:00 16:00 17:00 18:00

Reception Assemble Batch Set up Run assay

Tran

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Samples received after 15:00 processed next working day –> TTR minimum 23h plus transport time

Reception Assemble Batch Set up Run assay

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Speed? Let’s talk TAT

TAT: Is it real?

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• Speed is TAT, but above all total time-to-result (TTR)

What does speed mean – for IVDs?

Recommended: the DIY pathway (speed) analysis

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• Definition of speed

• Objectives of speed

• Feasibility of speed

• Benefits of speed

• What does it take

Content

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Reducing TTR = Increasing Medical Value

TIME TO RESULT

Medical Value: Time to Result is crucial

ME

DIC

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0 12 hrs 1 day 2 days

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«Better, sooner, more convenient: Increasing youth

friendliness of Family Planning Services in New Zealand »

Ms Rose Stewart, National Nursing Advisor, New Zealand

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Potential Patient Impact• Delayed or Wrong Diagnosis• Misuse or Overuse of Antibiotics• Cross-infection• Increased Length of Stay

Potential Economic Impact• Unnecessary Antibiotics Expense• Isolation Expenses• Blocked Bed Expenses

Economic and Medical Cost of Delayed Diagnosis

Time to Test Results Costs Money and LivesTime to Test Results Costs Money and Lives

Articles that look at time to result as crucial to maximizing diagnostic value:1. Lance R. Peterson, M.D., Donna M. Hacek, M.T. (A.S.C.P.), Ari Robicsek, M.D., Case Study: An MRSA

Intervention at Evanston Northwestern Healthcare, printed in The Joint Commission Journal on Quality and Patient Safety Volume 33 Number 12, December 2007

2. Lance R. Peterson, M.D., Rapid Diagnosis of Community-Acquired MRSA, printed in Clinical Updates in Infectious Diseases, Volume Issue 3, October 2008

3. Eli N. Perencevich, MD, MS et al., SHEA Guideline: Raising Standards While Watching the Bottom Line: Making a Business Case for Infection Control, Infection Control and Hospital Epidemiology, Volume 28, Number 10, October 2007

TIME TO TEST RESULT

2 HOURS 24 HOURS 48 HOURS 72 HOURS

CEPHEID PCR

EXPENSE

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Meet the Needs of Patients and Physicians

Short TAT, short TTR, actionable results

‒ Improve access to and value of testing

‒ Avoid disruption of carer-to-patient-interaction

‒ Personalize care (Chris Price, UK)

‒ Patient-centered, outcomes focused medicine

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• Definition of speed

• Objectives of speed

• Feasibility of speed

• Benefits of speed

• What does it take

Content

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Reliable, reproducible results anytime, any place

Integrated Platform and Test

1 2 3

Total Hands-On Time <1 Minute

Insert Cartridge and Start Assay

Insert Swab into Elution Reagent Vial and Break at Score

Vortex and Dispense Sample into Port S

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Random Access 24/7 – the Alternative

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Modules

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• In 8 hours: 50-100 real-time results

• Daily capacity ~250 results with 8 modules used 24/7

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Feasibility of speed = near-patient

MRSA Group B StrepInfluenzaCT/NGC.difficileNorovirusTuberculosis…

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Bringing diagnostics closer to patients

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• Definition of speed

• Objectives of speed

• Feasibility of speed

• Benefits of speed

• What does it take

Content

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Medical and Economic Benefits of Speed

• Speed = short TTR = timely diagnosis‒ Does it make a difference for patients?

• Where is the evidence?

• And hey: What does it cost?

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Evidence? An example.

Introduction of the first random access PCR test for the diagnosis of C.difficile Infection.

Objective of project:

Answer 2 questions.

1. Do rapid results make a difference for patients (outcomes)?

2. How does the impact translate into costs (or gains) for the hospital?

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“Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile” 1/2

Study design‒ Prospective interventional study‒ 2 acute care hospitals in Swansea, Wales, UK ‒ More than 1,000 consecutive patients enrolled from March to Sept. 2011

ResultsTime to reportable result for Xpert C. difficile was on average 1.53h:

‒ 21h faster than reference method for positive samples

‒ 45h faster for negative samples

Length of stay‒ PCR positive patients were discharged ~4.88 days earlier &‒ PCR neg. patients ~7.03 days earlier compared to reference method.

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“Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile” 2/2

• Micro-costing results: ‒ Testing cost per sample was £36.18 for PCR, £7.53 for CCNA positive, and

£8.78 for CCNA-negative samples

• With routine use of real-time PCR on all patients in one year would potentially save 38,247 bed days in ABMUHB.

• Cost of extended LOS has been identified as main cost driver in CDI.

• Extrapolation: Investing 80 NZD in rapid PCR could provide:‒ Clinically useful result within 1-2 hours ‒ Reduced LOS‒ Cost-savings 740 NZD/day; 1,640 NZD per patient

• Conclusion (authors)‒ A rapid molecular test for C. difficile in an acute hospital setting produced

quick results that led to a decrease in LOS compared to historic CCNA control patients. This could result in considerable savings through reduced excess inpatient days.

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Bode, NL and D

Lonneke G.M. Bode, M.D., Jan A.J.W. Kluytmans, M.D., Ph.D., Heiman F.L. Wertheim, M.D., Ph.D.,Diana Bogaers, I.C.P., Christina M.J.E. Vandenbroucke-Grauls, M.D., Ph.D., Robert Roosendaal, Ph.D.,Annet Troelstra, M.D., Ph.D., Adrienne T.A. Box, B.A.Sc., Andreas Voss, M.D., Ph.D., Ingeborg van der Tweel, Ph.D.,Alex van Belkum, Ph.D., Henri A. Verbrugh, M.D., Ph.D., and Margreet C. Vos, M.D., Ph.D.

ConclusionsThe number of surgical-site S. aureus infections acquired in the hospital can be reducedby rapid screening and decolonizing of nasal carriers of S. aureus on admission.

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Bode et al, NEJM: Conclusions

• HAI: ‒ “The results of our trial provide solid evidence of the preventive effect of

S. aureus decolonization and a good estimate of the size of this effect: the risk of hospital-associated S. aureus infections was reduced by nearly 60% (3,4% vs. 7,7%))”.

• LOS: ‒ “The mean duration of hospitalization was significantly shorter in the

mupirocin-chlorhexidine group than the placebo group (12.2 vs. 14.0 days)”

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Benefits of Speed: Summary

• The value of rapid results – Is it worth it ‒ Does it make a difference for patients?‒ Does it cost more (ROI)?

• Fast (and precise) results mean‒ Optimal patient management and therapy‒ Avoiding useless and/or harmful interventions‒ Reducing transmission for infectious diseases and HAIs ‒ Improving Antimicrobial Stewardship‒ Positively impact overall disease burden with reducing LOS,

related (total) costs, isolation days, expensive cleaning etc.pp

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• Definition of speed

• Objectives of speed

• Feasibility of speed

• Benefits of speed

• What does it take

Content

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• Put the patient in the center

• Change the patient’s journey

• Plan new pathway and process

• Transform communication

• Manage and lead change

What does it take? Change management!

Because it’s the right thing to do.

“Ärmel aufkrempeln, zupacken, aufbauen”

Roll up your sleeves, get a good grip, go!

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Speed matters: For patients and their doctors.

Take-home message

And for Joe, too!

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Thank you.