Laboratory Competencies: Promoting
Sustainability
John Ridderhof, DrPH, HCLD (ABB)
Senior Advisor for Laboratory Integration
Division of Laboratory System/CSELS
ASCLS GA Annual Meeting
May 16, 2015
Marietta Georgia
Center for Surveillance, Epidemiology, and Laboratory Services
Office of the Director
CDC’s Role
“Public health laboratories are critically important to the health
of their communities and the entire nation. We must do all we
can to ensure that the public health laboratory system maintains
its capacity to address today’s health threats and those of the
future.”
– Dr. Frieden, A Practical Guide To Assessing and Planning
Implementation of Public Health Laboratory Service Changes, May
2012
CDC’s Laboratory Activities
Major Functions/Focal Areas
• Outbreak assistance
• Reference laboratory testing
• Management and inventory of
specimens
• Materials, reagents, equipment
• Research collaboration,
technology development,
transfer, and evaluation
• Quality assurance, standards,
guidelines, and proficiency
testing
CDC’s Laboratory Activities
Major Functions/Focal Areas
• Building infrastructure and laboratory capacity
•
Facilities design and
construction
•
Safety and security
•
Training and workforce
development
•
Laboratory information
management systems
• Policy and partnership
development, advocacy
• Strengthening public health testing capacity and integration
with clinical labs
CDC is the reference laboratory for the
country and the world
Infectious diseases
(pathogen reference,
diagnosis, research)
Environmental health
(genetics, nutrition,
chemicals, toxins)
Preparedness and
response
(bioterrorism,
outbreaks, disasters)
Occupational
safety and health
(workplace safety)
Lab standards
and science
(quality & laboratory
standardization)
Global health
(HIV, malaria, TB,
emerging/chronic
diseases)
Improving Emergency Response
More than 160 public health,
military, federal, food,
veterinary, and international
laboratories
Food safety in the United States
• Food-borne outbreaks are common and costly
– About 1,000 outbreaks/year
– 48M people/year get sick from eating contaminated food and 3,000 die
– Cost to society as high as $152B/year
• CDC’s role in food safety
– Identify and stop outbreaks
– Track trends in food-borne illness
and outbreaks
– Conduct applied research for better
diagnosis and prevention
– Track effectiveness of policies to
reduce infections
Newborn Screening Quality Assurance Program
Services provided





Filter paper evaluation
Reference materials
Quality control materials
Proficiency testing
Training, consultations,
network resources
Partners




Association of Public Health Laboratories (APHL)
73 domestic screening laboratories
Laboratories in 54 countries
400 plus screening laboratories worldwide
Emergency operations
•
•
Coordinates CDC’s
preparedness and emergency
response activities for public
health emergencies
Emergency Operations Center
monitors and coordinates
response activities during public
health emergencies
CDC Ebola Response
Clinical laboratories play a vital role in
Laboratory networks
160+ public health, military,
federal, food, veterinary, and
internatioal labs
Influenza-like illness
monitoring network
Tracking Multiple Drug
resistant TB
CDC measures 300+
environmental chemicals
in blood and urine
State Public Health Labs
How CDC helps states….








Reference testing
Methods development and transfer
Reagents
External quality assessment
Technical consultation
Domestic global networks (LRN, Pulsenet)
Guidelines and recommendations
Direct funding
APHL
Non-profit organization
More than 80 Staff
Growing membership
 ~800 members
 State and Local Public Health Labs
• Leadership, delegates
 State Environmental Laboratories
 Agricultural Laboratories
 Individual Members
Roles of Health Laboratories
Provide information for decision making
Clinical Labs
Public Health Labs
• Diagnostic testing
• Some diagnostic testing
• Some reference testing
• Reference testing
• Patient management
• Surveillance and monitoring
• Front line PH Response
• Information to Clinical labs
Individual health
Public health
Interdependent Network
National Laboratory System
Defining the
State Laboratory System, 2010
Definition: “An alliance of laboratories and
other partners within a state that supports
the ten essential public health services
under the aegis of the state public health
laboratory. The system members and
stakeholders operate in an interconnected
and interdependent way to facilitate
the exchange of information, optimize
laboratory services, and help control and
prevent disease and public health threats.”
Building State Laboratory Systems for
all Programs
MLS
Surveying Clinical Labs
Establishing linkages
Education
Proficiency Testing
MINNESOTA LABORATORY SYSTEM
A PUBLIC AND PRIVATE COLLABORATION
Ebola Funding: Enhanced Laboratory Biosafety and
Biosecurity Capacity
• To support public health departments and their clinical partners to
assess, develop and implement measures to improve laboratory and
biological safety practices for dealing with current and emerging
infectious diseases.
• Project Outcomes:
– More trained staff knowledgeable in working with infectious organisms and other
emerging pathogens of public health concern.
– Improved biosafety practices for handling/processing Ebola and other highly
infectious specimens at public health and clinical labs
– Better coordination of biosafety practices between public health labs and clinical
partners
– Labs better equipped to serve jurisdiction in the inactivation and disposal
Laboratory Efficiencies Initiative (LEI):
CDC Director’s initiative (2011) to sustain PHL services
“The LEI needs to accomplish what more than 100
individual labs cannot accomplish by working
alone.”
– Dr. Thomas Frieden
Collective Solutions to Improve
Effectiveness and Efficiency
•
•
•
•
•
•
Regional networks for shared services
Guidance for Policy and Practice
Informatics capacity development
Comprehensive data on PHL services
PHL workforce development - Competencies
Workflow efficiencies (Lean)
Laboratory Integration Unit
(LIU)/Division of Laboratory Systems
•
•
Mission: To maximize the effectiveness and sustainability of state and local
public health laboratory (PHL) testing services and capacity for surveillance
and health protection nationally.
Strategy: Promote coordinated CDC support for an integrated, national PHL
system
REGIONAL NETWORKS
WORKFORCE DEVELOPMENT
LABORATORY INFORMATICS
COMPREHENSIVE DATA ON PHL
TESTING SERVICES
Fund Regional Networks/Consortia
• Incentivize states to form consortia or regions to
promote test sharing and other activities (training, data
sharing)
• Provides infrastructure, enabling multiple programmatic
efforts to assure access to testing capacity in the states
• Northeast Environmental and Public Health Laboratory
Directors (NEEPHLD)
(NY, NJ, NH, MA, RI, CT,
others: ME, VT, New York City)
• Northern Plains Consortium
• 5 states (MT, ND, SD, WY, ID)
Expected Outcomes
• Sharing testing and training services, resources and
strategies
• Evidence/evaluation of cost effectiveness for
interstate test referral
• Logistical, legal, and financial requirements
• Develop scalable solution for interstate electronic
test order and results (ETOR)
• Enabling robust mechanisms that are flexible to
accommodate any testing
OVERVIEW
• Developed by informatics SMEs (CDC, PHLs) to assess
capabilities across the entire informatics enterprise
• The tool is intended for public health laboratories (PHLs) and is
generalizable to clinical laboratories
• Identify gaps in informatics capabilities through development
and use of a ‘gold standard’ for comparison
• Develop roadmap and steps for a PHL to benchmark and
measure progress in its informatics capacity over time
19 CAPABILITY AREAS
CA #1
CA #2
Laboratory Test Request and Sample
CA #11 Contract and Grant Management
receiving
Test Preparation, LIMS Processing, Test
Training, Education and Resource
CA #12
Results Recording and Verification
Management
CA #3
Report Preparation and Distribution
CA #13 Laboratory Certifications/Licensing
CA #4
Laboratory Test Scheduling
CA #14 Customer Relationship Management
CA #5
Prescheduled Testing
CA #15
CA #6
CA #7
Specimen and Sample Tracking/Chain
of Custody
Media, Reagents, Controls:
Manufacturing and Inventory
CA #16
CA #17
CA #8
Interoperability and Data Exchange
CA #18
CA #9
Statistical Analysis and Surveillance
CA #19
CA #10 Billing for Laboratory Services
Quality Control (QC) and Quality
Assurance (QA) Management
Laboratory Safety and Accident
Investigation
Laboratory Mutual Assistance/Disaster
Recovery
Core IT Services: Hardware, Software
and Services
Policies and Procedures, including
Budgeting and Funding
SAMPLE CAPABILITY AREA
DESIRED OUTCOMES – FOR PHLs
• Provides a peer-reviewed metric to seek improvements
• New Hampshire state PHL
– Conducted the assessment and used results for the laboratory’s
strategic plan and a capital budget request
Copy of downloadable Access file available online:
http://www.aphl.org/aphlprograms/lss/Laboratory-EfficienciesInitiative/Pages/Informatics.aspx
Consolidating Test Service Data for PHL
Directors
Public Health Laboratory System Database
(PHLSD)
• Manage and control
PHL’s own capacity data
• Create a nationwide test
service directory
• Information easily used
to meet the APHL survey
and CDC data requests
• Centralized location to
find laboratory
information
Test Information by Organism
PHLSD Linked to LOINC Codes
Main Data Tab
Personnel Data Tab
Regulatory Data Tab
Testing Data Tab
Equipment Data Tab
FEEDBACK
“I wish I had this tool during last
year’s hepatitis outbreak so I
could easily know who to contact
for assistance. A national test
database would allow us to view
methods and equipment utilized
by other public health
laboratories across the nation.
This feature will be quite
beneficial in surge events as
contact information will also be
included in the database.”
-Dr. Christine Bean, Laboratory Director,
New Hampshire Division of Public
Health Services, Department of Health
and Human Services
“It was critical that Iowa could
use the APHL Survey Resource
Center (SRC) to find other state
laboratories that could provide
surge testing services for
parasitology. The PHLSD
management database will be
an even greater improvement by
allowing us to immediately
identify states that provide the
specific microscopy tests for
Cyclospora and their testing
capacity.”
-Bonnie Rubin, Assoc. Director for
Administrative Service, State Hygienic
Laboratory at the University of Iowa
Workforce:
Public Health Laboratory* Competencies
 Laboratory workforce shortage is multifactorial
 Competencies are integral to any workforce development program,
supporting job descriptions, performance objectives and evaluations,
training and education programs, recruiting and orienting new staff,
etc
 In 2012, APHL and CDC formed a competencies partnership
o CSELS led
o Involvement across CDC’s scientific CIOs– governance, SME input
o Overall, >160 people worked to develop the competencies: CDC, APHL,
state/local PHLs, state environmental lab, federal and state agriculture labs,
clinical laboratories, academia
* Broadly defined to include governmental public health, environmental, and
agriculture labs
Previous Collaboration:
Biosafety Competencies
The lack of defined
workforce competencies
was identified as a
major gap in PHL
workforce development
Project Launch
• CDC/APHL Steering Committee to support
and guide project
• Oct 2012 kick-off meeting
– Guidance by competencies expert
– Present overview of competencies
– Working meeting to:
Define project scope, target audience
Prioritize stakeholder expectations
Establish criteria for writing comps
Determine comp structure, proficiency tiers
Develop list of draft comp domains
Workgroups and Teams
• Establishment of Domain teams to develop
competencies
– Facilitated conference calls
• Vetting
– Incl clinical lab reps and others not involved in
development
– Adjudication Process workgroup
• Lots of harmonization and quality control:
– Various workgroups to standardize language,
address gaps and overlaps, design the process
for adjudicating comments
Competency Structure and Rules for Writing
Bloom’s Taxonomy
Broad
statements
describing
the “what”,
not the “how”
observable and
measurable
No correlation to
any particular job
title or degree!
One verb only!
modifiers
Workgroups and Teams
• Lots of harmonization and quality control
– Development workgroup (strawman
documents)
– Synthesis workgroup (assess gaps/overlaps;
harmonize language)
– Harmonization of Domains workgroup and
small teams
– APHL and CDC project managers
Timeline:
March 2015
Additional quality
control and
polishing
Vetting
Aug. 2012
Schematic of Competency Domains for PHL
Professionals
Teams of subject matter experts developed general, cross-cutting technical, and specialized
competencies, with a quality management system as the foundation of every activity.
Example Competency (Draft)
I. Competency Domain: Quality Management System
Purpose statement: The competencies in Quality Management System (QMS) address the
knowledge, skills, and abilities required for developing a laboratory’s culture of quality. The essential
elements integrate operations, services, and infrastructure into a system that meets applicable
regulatory standards, professional guidelines, and customer requirements for ensuring and
maintaining quality and continually improving laboratory services.
Introduction (excerpt): QMS is a systematic approach for ensuring the consistent quality of the tests
performed, the products created, the data generated, and the results reported. Operating within a
quality system meets the needs and requirements of public health laboratories as well as the
expectations of partners, stakeholders, and users (internal and external customers)… Adhering to
quality standards for laboratory operations helps laboratories generate consistent, reliable, and
reproducible data and results…
Personnel management
•
•
•
•
Developing position descriptions
Defining job requirements/performance expectations
Establishing career ladders
Assessing individual staff performance
Example
Biosafety
Outreach
Officer
Position
Description
Training/Professional development
• Performing training needs assessments
• Designing training courses/curriculum, education
programs
• Refining professional development plans
Competency Assessment Tool
Competency Assessment Tool
Prepublication Use of PHL Competencies



Mapping recommended and required competencies for
biosafety training in response to laboratory incidents
Developing position descriptions for Bioinformatics
specialists as part of Advanced Molecular Detection (AMD)
Initiative
Identifying recommended competencies for the new CDC
Laboratory Leadership Service (LLS) Fellowship (modeled
after Epidemic Intelligence Service-EIS)
Organizational and system capacity




Assessing organizational capacity
Improving program development and management
Supporting quality improvement
Ensuring a sustainable PHL system
Competency Infinity Cycle
Infinity cycle courtesy of the International
Food Protection Training Institute (IFPTI).
Advocacy


Articulating the role of PHLs in the public health system
Standardization across the PHL system
Promotion
Summary
• Public health and clinical laboratories form networks to
support public health
• Sustainability is improved through shared solutions and
tools
• The PHL competencies provide value to personnel
management, training/professional development, and
organizational and system capacity
• The PHL competencies are universal for laboratory
practice
For more information please contact:
John Ridderhof, DrPH
Senior Advisor for Laboratory Integration
(OPHSS/CSELS)
THANK YOU
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.