AMP: Geisinger Flu/RSV

FluWorks
Rapid influenza and RSV testing program
Geisinger Health Systems
Department of Laboratory Medicine
Donna M. Wolk, MHA, Ph.D., D(ABMM)
Raquel M. Martinez, Ph.D., D(ABMM)
Directors, Clinical and Molecular Microbiology
Lisa M. Scicchitano, B.S., MT(ASCP)
Technical Specialist, Molecular Microbiology
11/12/14
Heal • Teach • Discover • Serve
Relevant Disclosure
Cepheid research contract within last 3 years
Objectives
• Overview operational challenges to
healthcare facilities during a typical flu
season.
• Describe plans to assess the utility of a
rapid assay to mitigate patient bottlenecks
in Emergency Departments and clinics
during respiratory virus season and
increase transparency to the patient
record.
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Influenza
•
Seasonal influenza
• mortality/year = 36,000/year
• hospitalizations = 114,000/year
•
Since 2009, influenza
unexpectedly impacted healthy
young adults, pregnant women,
and those 35-45 yrs. old.
•
Complications can include
bacterial pneumonia, ear
infections, sinus infections,
dehydration, and worsening of
chronic medical conditions, such
as congestive heart failure,
asthma, or diabetes
|4
How low can we go? And does it matter?
In-Patient Respiratory Testing
RVPCR
|5
Challenges Remain for OP Respiratory Virus Diagnosis
Patients in Emergency Depts. (ED)
often present with respiratory
symptoms, which could be caused by
flu or other viruses.
ED bed/room management is
challenged with bottlenecks.
Antiviral and antimicrobial
stewardship is difficult.
Workforce shortages add to
challenges (peak throughput
requirements without peak workforce
capacity).
The Backdrop for FluWorks
• Geisinger Medical Laboratories (GML), 8 hospital integrated health service organization
• Serve > 2.6 million residents throughout 44 counties in central PA. |7
The Backdrop for FluWorks
• Current Flu/RSV assay for outpatients and non‐admitted Emergency Department (ED) patients, is tested in batch • Specimens are transported via courier at ~ 4 hour intervals • Average OP collect to result time (CTR) = 10 hr. (range ~ 1‐24 hours)
• No Antigens: OP testing performed only at the GML central laboratory
• For admissions and inpatients, a random access respiratory panel supports Infection Control and Prevention
• average CTR = 5.0 hrs, at 4 hospital sites
• pending random access implementations at 3 other sites |8
The Backdrop to FluWorks
HHS Press Office, February 3, 2014
HHS strengthens patients’ right to access laboratory reports: Access to
personal health information is a cornerstone of the Health Insurance Portability
and Accountability Act (HIPAA) Privacy Rule.
The final rule amends the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) regulations to allow laboratories to give a patient (or a
person designated by the patient, his or her “personal representative),
access to the patient’s completed test reports on the patient’s or
patient’s personal representative’s request.
Laboratory results can empower patients to track their health progress,
make decisions with their health care professionals, and adhere to
important treatment plans.
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Transparency Initiative: Patient Web Portal
NEJM, 370: Jan 2, 2014. and Ann Intern Med 2011. 155: 811-819
| 10
FluWorks: A Plan to unclog our EDs
and increase transparency …
FLuWorks Research Plan
Global Theme: Application and Benefits of Using Random Access Molecular
Technology for Patient Centered Care in an Integrated Healthcare System
2013-2014: Phase I, In house eval of Cepheid Flu/RSV RUO
Aim - To verify performance of Cepheid Flu/RSV RUO with
clinical specimens in a clinical laboratory setting
2014-2015 Phase II, Roll-out for Patient Testing
Patient centered care via FDA cleared test / consented enrollment with
rapid Dx in 6 hospitals supporting Rx de-escalation and antiviral
stewardhip.
Asses competency in POCT setting (4 CareWorks Clinics).
2015-2016 Phase III, Scalability:
Scale the FluWorks model to other facilities and clinics.
Assess impact of rapid results and prescriptions direct to patients and
pharmacy via MyGeisinger, the GHS patient portal.
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PHASE I
XPERT FLU/RSV* RUO METHOD
VERIFICATION (*PENDING FDA REVIEW)
Research Use ONLY
Spring 2014
AMP ID64/#4540
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Phase 1: Performance Characteristics
Xpert Flu/RSV Research Product
Verified according to CLIA ‘88 and STARD Guidelines
(STAndards for the Reporting of Diagnostic accuracy studies)
http://www.stard-statement.org/
Adapted from Cepheid
Cartridge Exploded View
Cartridge Body
(11 Fluid Chambers and
overmolded gasket)
Ports for
PCR tube
PCR
Tube
Valve body Ports
.
Syringe Barrel
.
Rotary Valve/Filter and
Ultrasonic Lysis or SPB
Region
Cap/Ultrasonic Interface
Cartridge Foot
Influenza Strain Coverage of Xpert Flu/RSV
• Conserved regions of multiple
viral segments
 redundancy between segments
 (>90%) strain coverage for each
segment (most 95-98%)
 protection from antigenic drifts due
to mutations and antigenic shifts due
to re-assortments
 detects multiple genetic copies to
improve detection
Adapted from Cepheid
RSV Target
•
Aids in isolation and treatment of
pediatric and geriatric patient
populations
•
Optimizes influenza therapy (usually
no Tamiflu or Relenza need be
prescribed)
•
Leverages RSV drugs in development
•
Utility in Emergency Department,
Pediatrics, Geriatrics
Adapted from Cepheid
Flu/RSV RUO: Experimental Design
Powered to
detect a 10%
difference with
alpha = 0.05
NP or aspirate
300 total samples;
178 clinical
samples
(NP, nasal, nares)
176 tested via
BioFire FilmArray
vs Xpert Flu/RSV
within 24 hrs.
174 tested with
Focus Dx (not
reported here)
2 QNS for Focus
Assay
QNS = quantity not sufficient for testing
4 Failed
Reactions/Total of
300 = 1.3%
2 QNS for retesting
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Flu/RSV Assay Performance
Positive % Agreement
Negative % Agreement
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Phase II:
GML FluWorks
Project
Key System Contacts for Assay Roll-out Pending FDA Review
Medical Centers
Geisinger Careworks®
Laboratory Information Systems
| 20
Phase II: Geisinger
Medical Center and
Careworks
GML FluWorks Project
Director, eHealth
DIRECTOR II - IT
Laboratory Analytics, GML
Pharmacy
Geisinger Careworks®
Laboratory Information
Systems
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Admitted/IP
Use Full
Respiratory Panel
Results in 55‐110 min.
Median 5 hrs. w transport
Patient w/
Influenza-like
illness
?Admission or
Out-patient
Results and Rx in 40‐63 min. from loading sample
GWV/GCMC ED
GML Hospital or ED Fast‐tracks
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Laboratory Speed and Accuracy
Drives Therapy, or De-escalation,
Transparency
and Engagement
Phase III: Extend to MyGeisinger
Test – to –Tamiflu
in less than an hour
Xpert
Flu/RSV
Phase III: Sample
Selection/Routing
Consented Samples
Age > 18 yr. or older
Phase I:
Pre-season
Verification
Phase III:
Pharmacies
GMC Bush
GWV
Weis Mkts.
II. GMC ED
Fast-track to
GMC 24/7 to
GMC Lab
CIDDR and Honest
Broker for Data
Analysis
Phase III: EPIC
and Text
Messages
w/ Laboratory
Results
II. GWV and
GCMC ED
II. CareWorks
Greys Wood
Hazleton
Bloomsburg
Danville
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Phase III: Retrospective Chart Review Planned
• In conjunction with Phase I of Pandemic Influenza Grant
• To determine…
• testing compliance with ILI symptoms and mitigate bias in
samples selected
• demographic characteristics of the data set
• symptoms, signs, clinical outcomes
• co-morbidities, exposures, risk Factors
• characterize specimen and laboratory data
Phase III: Clinical Assessment
Specific Aims:
– We expect FluWorks clinic will reduce ED wait times by at least
10%.
– We expect total healthcare cost/patient will be reduced by at
least 5%.
– We expect patient satisfaction will improve by at least 5%
(surveys common in ED at GHS, baseline is established).
– Example Metrics
•
•
•
•
•
•
Emergency Room (ER) wait time
ER antiviral prescriptions per day
ER antibacterial doses per day
Percent prevalence of influenza and sub-types
Influenza severity scale at triage
Satisfaction scale: patient, physician, nursing satisfaction
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FluWorks Team
Donna M. Wolk, MHA, Ph.D., D(ABMM)
System Director, Clinical Microbiology; Center Director / PI
Raquel M. Martinez, Ph.D., D(ABMM)
Director, Clinical Microbiology; CIDDR Center Director / PI
Diana R. Hernandez, Ph.D.
Laboratory Director
Ctr. for Infectious Disease Diagnostics and Research
Clinical Microbiology Specialists
*CIDDR Staff
Patti Fidelman, MS, MT(ASCP)
Ann Reichart, B.S., MT(ASCP)
Julie Riley, B.S., MT(ASCP)SM
Lisa Scicchitano, B.S., MT(ASCP)
Francis Tomashefski, B.S., MT(ASCP)
PJ Taylor, B.S., MT(ASCP)
Amada Styer, B.S.
Chad Varano, B.S.
Lisa Kreisher, R.N.
Jess Homanick, B.S.
Jacob Myers, A.S.
*Center for Infectious Disease
Diagnostics and Research
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Questions
Advancing diagnostics….saving lives

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