Susanne Norris Zanto, MPH, MLS, SM Montana Public Health Laboratory
PHL Role is changing Fewer mass screening tests Streptococcus infections in schools GC screening (Jembec plates) HIV ELISA
More confirmatory testing HIV Western Blot/ Acute Infection Testing
Unusual Antimicrobial Resistance Patterns Carbapenemase Producing Enterobacteriaceae
PHL Role is changing Healthcare associated infections Epidemiology based testing Pulsed Field Gel Electrophoresis (PFGE) Respiratory Viral surveillance (molecular) GC susceptibility testing
Outbreak Response Emerging or re-emerging pathogens Influenza pandemic, Measles, Mumps, E. coli O104
Regulations Verification studies FDA approved, Off-label, LDTs Availability of samples for verification studies
Proficiency testing Competency testing
Training Maintaining adequately trained professionals Shortage of Public Health Laboratorians
Limited Budgets Costs Labor and Non-Labor
Lack of state legislative support for public health
Advocate for increased funding Encourage PHL science as a profession Provide input on impact of proposed (and current) regulations
Use a public health laboratory systems approach
Regionalization for mutually agreeable activities and testing methodologies
Easy access to high quality, infrequently needed assays Reduces the impact of regulations
Not all laboratories need to do verification studies Fewer total specimens needed for verification studies
Not all laboratories need to do proficiency testing Not all laboratories need to maintain trained staff
Reduces both labor and non-labor costs Encourages continued collaboration – a public health laboratory system
Fear of loss of expertise / autonomy Jurisdictional barriers Funding/Cost Shifting
Who pays for the testing?
Will states accept federal dollars?
Transportation Reporting issues / ELR
Both order entry and result reporting
MOUs / MOAs / Contracted Services How binding are the agreements?
Do they need Attorney General review?
Newborn Screening 50 states + District of Columbia 32 states perform their own testing 19 states refer out all of their screening 3 states do a hybrid (some in-house, some referred) Minnesota, Montana, Utah
Many of the barriers have been addressed Reference: National Newborn Screening Information System, NNSGRC
TB Genotyping
Influenza Pyrosequencing
Influenza Characterization Regional Pulse Net Labs Calicinet
Again, barriers have been addressed
Montana North Dakota South Dakota Wyoming
We all share similar opportunities and similar challenges
Shared demographic statistics for MT, ND, SD, and WY Selected US Census Bureau Rankings
Category Resident Population American Indian Population
MT
ND
SD
WY
05 08 05 08 05
08
05
08
44 44 48 48 46
46
50
50
5
13
6
21
3
11
8
40
Resident Population, 65 Years and Older
10 10
4
7
7
8
34
37
Gross State Product
47 47 49 49 46
46
48
48
Average Annual Pay
50 49 47 47 49
41
42
26
Service a large geographical area
Sparsely populated areas, with several larger cities Small public health laboratory staff Limited budgets Fee for service
Electronic Laboratory Reporting (ELR)
Consistent laboratory leadership Provide classical reference laboratory
testing for clinical in-state laboratories
Opportunities to network with clinical laboratory colleagues
Test volumes are relatively manageable Willingness to share successes A “Can Do” attitude
Have been working together since 2006 on laboratory system improvement projects Realize the power of our partnership
How does the Northern Plains Consortium address the barriers to regionalization?
Fear of loss of expertise / autonomy
We still maintain subject matter expertise locally What tests are available and appropriate Specimen collection guidelines Interpretation of results
Jurisdictional Barriers
We have not encountered any – all contribute, all benefit
Funding/Cost Shifting
Reciprocal informal agreements Low volume tests Ability to charge (fee for service) if necessary
Transportation
Influenza Round Robin
Tested the ability to pack and ship influenza specimens between the 4 states, and maintain viability
Transportation
Influenza Round Robin
Tested the ability to pack and ship influenza specimens between the 4 states, and maintain viability
Courier Exercise
Tested the ability to transport specimens between the 4 state laboratories via ground transportation
MT
ND
SD
WY
Sheridan, WY
MT
ND
SD
WY
Reporting issues / ELR We currently fill out paper requisitions Results are faxed/mailed Results hand entered into LIS Reports generated just like in-house testing
MOUs / MOAs / Contracted Services Informal reciprocal agreements Testing services are requested, just like from our in-state clients
Shared Services - Activities
Exchange specimens for Comparison of Test Results (when no commercial PT is available) Educational Campaigns AST Training
Webinars Montana AST SME presented workshops in ND, SD
TB NAAT testing
4–state Webinar with expert speaker from WA state Print Campaign
Surveys of Clinical Laboratories AST, STD, C. difficile
Shared Services – Testing Methodologies
HIV Multi-Spot 16s Ribosomal bacterial identification Hantavirus Serology Certain IgM tests TB NAAT
WY, MT and ND pooled their grant funding Purchased a Cepheid GeneXpert
MT did the verification studies, will maintain proficiency, trained personnel, competency
MT is performing tests for WY, some for ND (& Idaho)
Shared Testing Services Template
Shared Testing Services Template
The Northern Plains Consortium is a state public health laboratory system on a regional level. Pooling resources for certain testing methods meets the needs of our states, our citizens and our public health partners.
Wave of the Future: an idea, product, or movement that is viewed as representing forces or a trend that will inevitably prevail
Public Health Laboratories are at a crossroads. The “R” word, some sort of regional testing model, is the wave of the future – public health laboratories will not be able to provide all the needed testing methodologies without looking for a systems approach.