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Meeting the Challenges of Global

Laboratory Systems Development:

Human Resources Capacity

Development

Lucy A. Perrone, MSPH, PhD

Assistant Professor

Department of Global Health, University of Washington

Director, Certificate Program in Laboratory Leadership and Management

International Training and Education Center for Health (I-TECH)

perronel@uw.edu

• What are the big challenges for medical

laboratories globally?

• How can addressing HR improve lab

quality?

• Will you join us?

Key Questions

International

Training and

Education

Center for

Health

(I-TECH)

International

Clinical

Research

Center

(ICRC)

Health

Alliance

International

(HAI)

Institute for

Health

Metrics and

Evaluation

(IHME)

Center

for AIDS

Research

(CFAR)

Center for

Integrated

Health of

Women,

Adolescents,

and Children

(Global

WACh)

Improve laboratory governance,

quality and capacity towards:

• Evidence-based disease

diagnosis

• Patient care and treatment

• Timely disease detection and

surveillance

• Improved facility level biosafety

and national biosecurity

The Laboratory System

Strengthening Team’s Approach:

I N T E R N A T I O N A L T R A I N I N G & E D U C A T I O N C E N T E R F O R H E A L T H

Certificate Program in Laboratory Leadership and Management pre- service and educational programs

Laboratory QMS training and mentorship

QA of Diagnostic testingGovernment advocacy, policy

development and strategic planning

Program Management, Monitoring and Evaluation

Team Areas of Practice

Collaborators:• UBC POLQM• One World Accuracy (Laboratory External Quality Assurance Program)• I-ETCH SIGHT TEAM- Systems Innovation for Global health Technology (Informatics)

Development & Implementation• BloodWorks Northwest (Blood safety and supply) • Diagnostic Microbiology Development Program (TA in bacterial culture methods)

Delivering Quality through a Systems

Approach:

•Data and Lab

Management

•Safety

•Customer Service

Working on HIV rapid/POC testingprotocols

Training: HIV rapid testingon sample panels

Cote d’Ivoire, July, 2017

Clinicians stop utilizing testing

services

Syndromic clinical diagnosis prevails

Evidence-based clinical

practice suffers

Health policy suffers- no investment made in labs

Quality of

testing poor

The Cycle of Poor Testing

Quality:

Laboratories are an integral

part of the health system

Policy and Strategic Planning complex testing

Clinical Service Support

simple integrated testing

National Reference Laboratory

Regional Reference Laboratories

Referral Hospitals

Primary Hospital

Health Centers

Senior Health Scientists

Specialists

Senior Technologists

Program Officers

Doctors

Nurse Practitioners

Medical Assistants

Health data

•Appropriate National –Local organizational structures

•Laws and regulations

•Ability to lead and manage laboratories to national and international standards

•An Educated workforce

– Pre-service/in-service

•Professional Organizations

•Access to quality equipment/reagents

•Ability to manage and share information

Key Elements to Laboratory Quality and Capacity

Dec 16, 2011

SEARCH:

JUMP:

Students:

Program Directors:

Guide for Accredited Programs

Guide for Approved Programs

National Accrediting

Agency for Clinical

Laboratory Sciences

5600 N. River Rd.

Suite 720

Rosemont, IL 60018-

5119

847.939.3597

773.714.8880

773.714.8886 (FAX)

info@naacls.org

http://www.naacls.org

The National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) is committed to beingthe premier international agency for accreditation and approval of educational programs in the clinicallaboratory sciences and related health professions through the involvement of expert volunteers andits dedication to public service.

The Standards They Are a-Changin' An Overview of the Proposed NAACLS Standards NAACLS is pleased to offer this new workshop on Thursday, February 23, 2012 inSalt Lake City at CLEC. Early registration ends 1/15/12 and final registration ends2/10/12.

view workshops...

ASPA: Specialized & Professional Accreditation: WhatShould I Know?ASPA has created a video to help explain Accreditation.

Change to NAACLS Standard 7 A change to NAACLS Standard 7, adding item N, was adopted at the September23, 2011 Board of Directors meeting. Standard 7-N requires that students must beprovided with a clear, publically available, description of the program and itscontent and current publications, which must include at least one outcomesmeasure. To comply with the Standard, programs must disclose at least oneoutcomes measure in current publications (e.g., program brochures, studenthandbooks, policy manuals, catalogs, websites, etc...) available to students and/orapplicants of the program. (Effective for Self-Studies due September 1, 2012 or later)

Self-Study Template Available!NAACLS Programs undergoing the Accreditation process can now complete theirSelf-Studies using a pdf template. The Self-Study Template can be completedusing the free version of Adobe Reader. Simply download the file and follow theinstructions within. Completed Self-Studies can be submitted to NAACLS via flashdrive. Please note that you must save the file, not work on it online.

Guide to Accreditation for the DCLS The Guide to Accreditation for Doctoral Clinical Laboratory Science programs ison the web. If you have questions or comments, please send them here.

Program Revitalization: Strategies for Survival A task force chaired by Donna Spannaus-Martin has been charged to review andupdate the NAACLS Program Revitalization: Strategies for Survival document.Other task force members include Linda Ross, Debbie Wisenor, RandyVandervander, Fred Rodriguez (board liaison), and Gwen James-Oriaikhi (staffliaison).The Program Revitalization Task force would appreciate any ideas/strategies thatyou might have to include in the updated document. These can be sent directly toDonna Spannaus-Martin.

What are the challenges for

RLC’s?

People are at the Center of the

Health System Building Blocks

Systems thinking for health systems strengthening. WHO. 2009

What does this all mean for

RLC’s?

• Resource-limited countries

start at a disadvantage

towards achieving lab quality.

• Human Resources

development is a sustainable

way to improve lab quality/

• One of strongest influences

on lab quality lies with the

Lab Director and Managers.

Functioning

Laboratory System

Continuing education for current laboratory

staff cadres and management &

Mentorship

Training New

Laboratorians- Pre Service Education

(MLT BS)Graduate

Programs in Laboratory

Science and Public Health

Training and Education to Support

the Laboratory System

• Inadequate financial resources• Inadequate network support- Absent functional linkages

between labs• Difficulties assuring consistent quality of reagents and

equipment function• Procurement challenges• Limited HR capacity and high turnover of staff • Staff competency and work ethic• Infrastructure challenges like Inconsistent electricity and

poor water quality• Inadequate training in management of lab operations

Challenges for Lab Management

• Establish direction

• Align people

• Motivate and inspire

• Lead change

Expectations ofLeaders and Managers

• Planning and budgeting

• Organizing and staffing

• Improve processes

• Problem solve

Leaders Managers

WHO Stakeholders meeting on

Laboratory Leadership and

Management Needs12-13 May 2011, Lyon, France

Key Meetings on Laboratory Leadership

• Laboratory Supervisors

• Private and public sectors

• Global focus

• In-service education

• Blended learning

• Capstone/Laboratory

improvement Project

• Modular, customizable

• LMS with discussion board

• Mentored

I-TECH Certificate Program in

Laboratory Leadership and

Management

Core competency development

Hard Skills

• Understanding of quality

laboratory service

delivery requirements

• Advocating, partnership,

networking

• Visioning and planning

• Strategic thinking

• Policy development and

program planning

Soft Skills

• Understanding

organizational change

• Development of personal

leadership skills

• Developing and leading

teams

• Developing leadership

skills

• Understanding ethics and

leadership

Learning Goals

• Apply leadership traits and management skills

required for optimal laboratory performance and

inter-coordination with key stakeholders in the

public health community.

• Implement Quality Management System (QMS)

practices.

• Improve laboratory compliance and accountability

in line with local, national, and international laws

and regulations.

• Implement appropriate diagnostic methodologies

and technologies.

• Apply critical analyses to laboratory data and

communicate results and interpretations in an

impactful way.

Participants

• Mid-career senior manager or

director of a public health or

clinical laboratory.

• At least a Bachelor degree or

equivalent.

• >5 years of laboratory technical

experience.

• >2 years of laboratory supervisory

experience.

• Currently supervising >3 staff

• Comfortable daily computer user;

experienced using the Internet, e-

mail.

Program Mentors

• Senior level scientist with experience

in laboratory management.

• Graduate level degree (e.g.

Doctorate).

• Comfortable daily computer user;

experienced using the Internet, e-mail.

• >10 years of laboratory technical

experience,

• >5 years of laboratory supervisory

experience.

Key Program Elements

Audit Lab, Assess Gaps,

Develop Work Plan

Implement the Work PlanReassess Lab, Summarize, &

Present

Evaluate & Reflect

THE CAPSTONE PROJECT

An lab-specific, lab management team-based opportunity to:

Identify areas in their laboratory’s operations that need improvement.

Expand their leadership, management, analytical, and communication skills.

Implement principles of continuous quality improvement through ongoing cycles of assessment and interventions to address problems and gaps.

Focus on an area of particular interest to them in laboratory operations.

Completion Requirements

To receive a certificate, participants must pass all 5 courses

and complete the Capstone project.

MoH leadership support and

oversight

Financial support by the MoH and

US CDC

5-9 months of online training by

UW and UBC faculty and mentor

support

2 In-Person Workshop by UQ and UBC faculty

Laboratory Improvement Projects in 16 Referral and Reference

Laboratories

Mentorship by local and regional mentors (online and in-person)

Laboratory Quality

Improvement

towards ISO 15189

Program 2017-18

UW- UBC Collaboration

Functioning

Laboratory System

Continuing education for current laboratory

staff cadres and management &

Mentorship

Training New

Laboratorians- Pre Service Education

(MLT BS)Graduate

Programs in Laboratory

Science and Public Health

Training and Education to Support

the Laboratory System

Improving laboratory testing

quality and capacity using a

mentored laboratory quality

stepwise implementation (LQSI)

approach in Cambodia

Cambodia

• 25 Provinces, 159 districts

• Population (2015)= 15,578,000

• Lower-middle-income status country, GDP = $18 billion,

gross national income per capita = US$1,070, Poverty rate

= 17.7%, 90% of whom live in the countryside

• 32% of children <5 yro are stunted, 79% do not have

access to piped water supply and 58% do not have access

to improved sanitation.

• Literacy= 73.6%

• 70% of the population is under the age of 40 (2013)

• Limited health workforce

2015 data from the World Bank and WHO

IHR Capacity

Average laboratory general indicator

scores (WHO LAT-Facility level tool) ,

Public Health Laboratory Assessment

Report, Cambodia Ministry of Health, 2013

Laboratory Capacity is Insufficient

and Quality is PoorProficiency Testing Scores (2014)

# LaboratoryMicrobiology Biochemistry Hematology Serology

Part 1 Part 2 Part 3 Part 1 Part 2 Part 1 Part 2 Part 3 Part 1 Part 2 Part 3

40 100% 90% 100% N/A N/A N/A N/A N/A 100% 100% 97%

41 89% 88% 100% 46% 42% 81% 54% 83% 87% 86% 93%

42 100% 96% 100% 57% 46% 71% 63% 83% 88% 100% 100%

43 95% 81% 100% 48% 29% 0% 33% 67% 83% 100% 92%

44 100% 96% 92% 43% 53% 52% 52% 72% 86% 100% 90%

45 94% 88% 100% 36% 50% 54% 77% 89% 96% 96% 83%

46 85% 96% 92% N/A N/A N/A N/A N/A 97% 100% 93%

47 94% 96% 100% 36% 41% 40% 56% 72% 97% 92% 92%

48 84% 76% 96% 18% 38% 0% 0% 67% 96% 96% 96%

49 N/A N/A N/A 29% 41% 48% 44% 44% 96% 93% 90%

50 N/A N/A N/A 50% 40% 27% 46% 61% 100% 100% 100%

51 86% 85% 100% 44% 64% 65% 52% 94% 100% 93% 87%

52 N/A N/A N/A 39% 67% 60% 77% 83% 100% 100% 87%

53 N/A N/A N/A 28% 37% 27% 44% 50% 100% 97% 90%

54 N/A N/A N/A 38% 27% 46% 58% 83% 100% 80% 88%

55 N/A N/A N/A 23% 38% 50% 54% 39% 97% 97% 97%

56 N/A N/A N/A 71% 62% 21% 38% 83% 100% 100% 75%

57 N/A N/A N/A 10% 18% 48% 58% 67% 100% 100% 96%

58 N/A N/A N/A N/A N/A N/A N/A N/A 100% 96% 100%

Average for I-TECH labs 93% 45% 52% 94%

Average of Cambodian labs 93% 89% 98% 39% 43% 43% 50% 71% 96% 96% 92%

The Laboratory Quality Stepwise

Implementation (LQSI) Tool

Phase 1

Phase 2

Phase 3

Phase 4 104 178 129 54

Number of activities:

465 total

• Ministry’s of Health

• I-TECH LSS Staff

• Health Resources Services Administration (HRSA)

• Centers for Disease Control and Prevention (CDC)

– Global AIDS Program

– Global Disease Detection

• Department of Defense, Defense Threat Reduction Agency

• Department of State, Cooperative Bio-engagement Program

Acknowledgements

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