QUALITY MANAGEMENT IN A LOCALPUBLIC HEALTH LABORATORY
DEBORAH K. SEVERSON, BS MT(ASCP)DIRECTOR, LABORATORY SERVICES
FAIRFAX COUNTY HEALTH DEPARTMENT LABORATORY703-246-3218
FAIRFAX COUNTY HEALTH DEPARTMENTFAIRFAX, VIRGINIA
Chaos to Q u a l i t y
OBJECTIVES
Provide an overview of Fairfax County Health Department Laboratory
Review strategies used in FCDHL to develop a more robust Quality
Management System
Review FCHDL’s development of Quality Assurance Manual
Provide examples of resources and tools used by FCHDL to organize and
streamline Quality Management Plan
FAIRFAX COUNTY HEALTH DEPARTMENT LABORATORY
FCHD lab is LPH performing over 200,000 clinical and environmental tests annually• Clinical
STD, TB, foodborne illness(enteric pathogens & parasites), HIV, Hepatitis B, QFT
• Drugs of Abuse Screening• Environmental Drinking Water• Rabies• Molecular testing for WNV, ZikaV in mosquito pools and Borrelia burgdorferi in
ticks
Multiple regulatory bodies; CLIA, EPA, VaDEQ
POPULATION SERVED
Population – 1.14 Million
Area – 390.97 sq. Miles
Median Age – 35.7
Foreign Born Population – 31.5%
Persons 5+ who speak a language other than English at home – 39.5%
PARTNERS AND STAKEHOLDERS
INTERNAL CLIENTS
•Five Health Department Clinics•Eight Fairfax County Agencies
EXTERNAL CLIENTS
•Neighboring jurisdictions•Hospitals•Local, Regional, State and National Parks•Universities•Private companies – Clarke (Mosquito
Testing)•Private Water System Operators•Private Homeowners•Dulles International Airport
F A I R F A X C O U N T Y H E A L T H D E P A R T M E N T S T A F F
P U B L I C H E A L T H T E C H N O L O G I S T S• Full-time - 9• Part-time - 3
L A B S U P E R V I S O R S - 2
L I S A D M I NI S T R A T O R - 1
A D M I N I S T R A T I V E A S S IS T A NT S• Admin IV – 1• Admin III – 2
C O U R I E R• Full-Time – 1• Part-Time – 2
FIRST STEPS
ASSESSCURRENT
QMS
IDENTIFY ROADBLOCKSTO EFFECTIVENESS AND
EFFICIENCY
• Organizational Structure• Many documents in many formats
in many places• Infrequent monitoring of overall
system• Limited staff involvement• Responsible persons
IDENTIFY RESOURCESAVAILABLE
• Monetary• Instructional
DESIGNING AND IMPLEMENTING A QUALITY MANAGEMENT SYSTEM
Realigning organizational
structure
Development of comprehensive
Quality Assurance
Manual
Assess and enhance inventory methods
Assess and enhance
document control
Promote Staff Involvement
ORGANIZATIONAL STRUCTURE
REALIGNMENT OF STAFF WITHIN ORGANIZATIONAL UNITS
CREATION OF CAREER LADDER FOR LABORATORY SCIENTISTS
•Attract and retain qualified laboratory scientists•Provide career path for staff•Increase morale, motivation, and quality
O R G A N I Z A T I O N A L S T R U C T U R E
FAIRFAX COUNTY HEALTH
DEPARTMENT LABORATORY
PROPOSED ORGANIZATION
CHART, MAY 2017
CREATING A COMPREHENSIVE QUALITY ASSURANCE MANUAL
CURRENT SYSTEMS IN PLACE
o Separate Manuals• Clinical QA Manual• Environmental QA Manual• Clinic QA Manual• Clinic Procedure Manuals• BSL3 Manual• Safety Manual• SOP Manuals
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CREATING A COMPREHENSIVE QUALITY ASSURANCE MANUAL
What resources are available?
• WHO/CLSI Quality Manual Template
• CLSI QMS25 “Handbook for Developing a Laboratory
Quality Manual”
• Ontario Laboratory Accreditation Division (OLA) Guidance
for Laboratory Quality Manuals
• APHL “How to Write a Laboratory Quality Manual”
Creating a Comprehensive Quality Assurance Manual
Assess current system
Determine QA Manual Structure
• Identify documents appearing in multiple manuals• Identify documents that are specific to lab areas• Identify Documents relevant to the entire lab
• Policies/Processes/Procedures• Requisitions/Forms• Position descriptions• Floor plans
• One all-encompassing manual• Individual manuals for each laboratory
discipline LABORATORY
MicroProcedures
forms
AdminProcedures
forms
RabiesProcedures
forms
One QA Manuals vs Multiple QA Manuals?
o Individual regulatory requirements
o Preferred format
o Overarching policies, processes, and
procedures in one place
o Environmentally preferable- less paper
o Easier to review and update one manual
vs multiple manuals
o Easier for staff to refer to one manual vs.
multiple
VS.
COMPREHENSIVE QUALITY ASSURANCE MANUAL
COMPONENTS OF QA MANUAL
QA
Manual
INTRODUCTION
LIST OFACRONYMS/
ABBREVIATIONS
TABLE OFCONTENTSDEFINITIONS
QSEs•Relevant to all
disciplines•Contain areas to
individual disciplines
•Differing regulatory requirements
COMPREHENSIVE QUALITY ASSURANCE MANUAL
QSE - Organization
QSE - Facilities and Safety
QSE - Equipment
QSE - Purchasing and Inventory
QSE - Process management
QSE - Assessments
QSE - Personnel
QSE - Customer Focus
QSE - Nonconforming Event Management
QSE - Continual Improvement
QSE - Documents and Records
QSE - Information Management
QSE STRUCTUREo QSE - Organization
o QSE - Personnel
o QSE - Equipment
o QSE - Facilities and Safety
o QSE - Purchasing and Inventory
o QSE - Information Management
o QSE - Documents and Records
o QSE - Nonconformance Management
o QSE - Assessments
o QSE - Process Improvements
o QSE - Customer Service
o QSE - Process Management
COMPREHENSIVE QUALITY ASSURANCE MANUAL
Work in progress
• Developing Supporting Documents
AppendicesPoliciesProcessesProceduresForms
INVENTORY SYSTEM
PURCHASED INVENTORY SYSTEM
MONITOR/TRACK INVENTORY
LOCATION
ITEMSSTOCK NUMBERSPRICING
FACILITATE PURCHASING
ALERTS FOR RE-ORDERING
TRACK LOT NUMBERS AND EXPIRATION DATES
TRACK VENDOR INFORMATION
DOCUMENT CONTROL
Purchased laboratory document control software
Document control
Equipment inventory and maintenance
Personnel
Competency assessment
Training and testing
Workflow development
PROMOTE STAFF INVOLVEMENT
Creation of teams to assess and monitor quality in the lab
Staff participation
Expected to serve on at least one team
Part of performance evaluation
Oversight provided by laboratory managersQuality
Assurance Team
Safety Team
WebsiteTeam
FCHD LABORATORY TEAMS
Developing internal audit checklists
Identify quality initiatives
Develop and provide staff training and quality improvement
Identify metrics to measure quality initiatives
FCHD LABORATORY TEAMS
Perform routine safety audits
Identify potential safety hazards
Identify and develop areas for staff safety training
Develop, maintain, and update division web pages, internal and external
SUMMARY
Quality Management is dependent on building a Quality Culture
Participation from all lab staff
• Scientists
• Administrative Assistants
• Couriers
Input from partners and stakeholders
• Customer Satisfaction Surveys
• Suggestion box
• LSIP Assessment
Never-ending
REFERENCES
o CLSI. Handbook for Developing a Laboratory Quality Manual. 1st ed. CLSI product QMS25. Wayne, PA:
Clinical and Laboratory Standards Institute; 2017
o OLA. Guidance for Laboratory Quality Manuals. Version 3. Quality Management Program – Laboratory
Services QMP-LS. Ontario, Canada; 2006
o APHL. How to Write a Quality Manual. Silver Spring, MD: Association of Public Health Laboratories;
2017
o WHO. Supplement to the Laboratory Quality Management System Training Toolkit, Module 16 –
Documents and records. 2013
