1. Lab Strengthening Efforts in the USAPI
Vasiti Uluiviti
PIHOA Regional Lab Coordinator
57th PIHOA Meeting: March 9th – 13th 2015
Palau

2. Overview of presentation
2015 4th PIHOA-AUL Lab Network Meeting – Overview of outcomes
Lab quality management systems (LQMS) in the USAPI
The USAPI medical laboratory workforce
The USAPI laboratory surveillance of infectious diseases
Guam Public Health Lab – Future expectations
PIHOA Regional Lab Initiative Progress Highlights:

3. 2015 4th PIHOA-AUL Lab Network Meeting – Overview of outcomes
Representation (~ 40 people)
USAPI Lab managers/supervisors
USAPI Hospital/public health lab administrators
CDC, APHL, WHO, SPC
US Naval Hospital, GMH, Guam Private labs, professional institutions (GMS, GMA, PBMA)
Stakeholders meeting – 2 days
GPHL Assessment Report (APHL)
Improving Level 1 (USAPI) testing capabilities
Expectations of Level 2 (GPHL) testing capabilities
4th AUL Meeting – 1 day
Election of new office bearers
Completion of the AUL strategic plan
Improve support of the PIHOA Reimbursable Fund (specimen transport)

4. Improving lab quality management systems in the USAPI

5. PIHOA Board Resolution # 48 – 03 (April 2010)
“Concerning Lab Strengthening among PIHOA Member States”
In support of:
World Health Organization (WHO) lab strengthening efforts through the Asian Pacific Strategy for Strengthening Health Laboratory Services, 2010 to 2015, which was endorsed by all Pacific countries and territories, including PIHOA member states, at the 60th Regional Committee Meeting of the Western Pacific Regional Office of the WHO in Hong Kong, China, September 2009;

6. Vision for the PIHOA Regional Lab Initiative: Laboratory quality improvement and standards in the FAS (FedSM, Palau, RMI)
Comply with Recognized Lab Standards
Goal:
By at least 2 labs in the freely-associated states of Palau, FedSM and RMI are accredited to a lab accrediting institution (ISO/CLIA- International/CAP-International)
Identify and rectify
deficiencies
Lab inspection
& assessments
Continuous lab improvements
Laboratory accreditation

7. does not guarantee an ERROR-FREE
LQMS vs No LQMS
Implementing
Quality Management
does not guarantee an ERROR-FREE
Laboratory
But it detects errors that may occur and prevents them from recurring

8. USAPI LQMS phases of improvement
Pre-accreditation audit Prepare for accreditation
Phase 4
2nd and 3rd LQMS re-assessments Recommended activities for improvement completed
Phase 3
Quality manual developed
Phase 2
LQMS training completed
Phase 1
1st LQMS assessment
Recommended activities for improvement completed
Phase 6 Accreditation completed
2017 – 2018???
This step wise approach is a stepping stone towards achieving accreditation requirements & desired standards
2010

9. Overview of LQMS activities completed in the USAPI

10. Regional EQA Program
Increased participation noticed - 4 laboratories reaching 100% in 2014
Inconsistent submission by some laboratories – no delegation/ QA officer. Lack of ownership -charge technicians/ staff
Room for improvements in 2015

11. USAPI TB Lab EQA
Blind slide re-checking
 100% participation
AFB Proficiency Panel
 100% participation

12. Improving the USAPI medical laboratory workforce

13. Vision for the USAPI Lab Workforce Development
Future lab workforce
Current lab workforce
Identify college
graduate
Acquire baseline
MLT qualifications
Certificate/PPTC Diploma
Bachelor in
Medical Lab Science
Licensure
Certification
Graduate studies

14. Vision for the USAPI Lab Workforce Development
Goal By 2020: 1. At least ONE (local) or more medical lab scientist employed in each USAPI lab 2. All USAPI lab staff to have acquired the minimum MLT/MLS qualification

15. Medical Lab Workforce - Statement of Need -
There is generally an essential and great need to increase the number of the medical lab workforce in each USAPI lab; increase the appropriate number with academic qualifications in MLS; and sustain these trained & qualified individuals with appropriate incentives. Why???
Workload in the each lab has generally increased over the years with the same number of people performing the tests.
The need to improve delivery of quality lab services, thus, ensuring quality patient care
Be able to perform much needed tests onsite with moderate – higher complexity levels

16. Overview of USAPI lab workload vs Number of lab staff
USAPI lab staff capacity

17. Lab Workload: Number of lab staff (ratio)
Q: IS THE RATIO ADEQUATE? DO WE NEED MORE LAB STAFF?
A: ??????
WHO WISN TOOL
- Workload Indicators of Staffing Need (WISN)

18. The WISN Tool
WISN is a tool and a method to adjust staffing levels to an optimal distribution across health facilities.
Analytical planning tool to:
Determine how many health workers are required to cope with actual workload in a given facility
Estimate staffing required to deliver expected services of a facility based on workload
Calculate workload and time required to accomplish tasks of individual staff categories
Compare staffing between health facilities and administrative areas

19. The WISN Tool Understand workload of staff at a given facility
Establish fair workload distribution among staff
Assess workload pressure on staff
Applicable to all personnel categories
Medical staff
Paramedical staff
Non-medical staff

20. Medical Lab Science Training Institutions
Fiji National University
Bachelors in Medical Lab Science (4 years)
Diploma in Clinical Lab Science (2 years)
Certificate in Phlebotomy (6 months)
Pacific Paramedical Training Center, NZ
Diploma in Medical Lab Technology (2 years) – WHO Pacific Open Health Learning Network (free)
Lab discipline courses (microbiology, hematology, biochemistry, blood bank, serology, lab quality management) – (onsite 3-months)
CDC
Online short courses in microbiology (free)
Other institutions
Philippines
Taiwan
Type of financial support
Scholarships (AusAid, WHO, Local govt, other govts)

21. Pacific Paramedical Training Center Wellington, NZ
Association of USAPI Labs (AUL) Recommendation
(Endorsed by the PIHOA Board in March 2014 – 54th PIHOA Meeting)
“PPTC Diploma in Medical Lab Science or equivalent as the minimum qualification to be acquired by all USAPI lab staff”

22. Status update: Pacific Paramedical Training Center (PPTC) graduates – Diploma in Medical Lab Technology (POHLN): 2006 – 2015

23. Status update: Fiji National University (Bachelors degree in Medical Lab Science)

24. Status update as of Jan 2015 Current number of USAPI lab staff vs % with MLS qualifications

25. Improving the USAPI laboratory surveillance of infectious diseases

26. Diagnostic Capabilities of Outbreak-prone Infections
Goal:
Enhance Level 2 lab capabilities/capacity at Guam Public Health Lab (GPHL)
Enhance microbiology diagnostic capabilities at Level 1 USAPI labs

27. Specimen referral for confirmatory testing in the USAPI
Influenza & Other diseases
GPHL/Hawaii State Lab/NRL – Australia/ Institut Pasteur, New Caledonia/CDC Labs
Ebola
CDC Lab, Atlanta
PIHOA shipping mechanism
Influenza specimen transport financially supported by SPC
Other specimens supported by USAPI
USAPI Laboratories
ASA
CNMI
GUA
CHK
PNI
KOS
YAP
PAL
MAJ
EBE

28. CDC Labs (Atlanta/Fort Collins, CO
CDC Labs (Puerto Rico)
Cairns

29. Specimen transport mechanism in the USAPI The PIHOA Shipping Mechanism
Replenishment of PIHOA Revolving Fund
Hawaii State Lab or
Diagnostic Lab Services (DLS)
CDC Labs, Atlanta
CCH/TNT charges PIHOA account
PIHOA
(PIHOA Revolving Fund)
PIHOA seeks reimbursement of shipping costs from institution concerned
Freight Forwarder
(Courier Corporation of Hawaii/TNT-Guam)
Airline Cargo charges PIHOA account
Communicates
PIHOA pays shipping invoices
Airline Cargo Station (United Airlines/Hawaiian Airlines)
USAPI Lab Shippers

30. IATA Infectious substances shipping training
Target: At least 3 certified shippers in each USAPI lab at all times
Training focused on most current version of the IATA Dangerous Goods Regulation (DGR) (Class/Division 6.2 Infectious substances)
PIHOA facilitates purchase of most current version of IATA DGR (bi- annually)
PIHOA conducts on-going infectious substance shipping training (certification & re-certification)
94 currently certified shippers in the USAPI (as of Dec 31st 2014)
Total # certified shippers in the USAPI labs (as of Dec 31st 2014) = 66
USAPI Lab
CERTIFIED
(* # lab certified shippers) 1
Guam
5 (*5) 2
RMI - Majuro
8 (*4)
RMI – Ebeye
5 (*4) 3
FSM - Yap
7 (*7)
FSM - Chuuk
7 (*4)
FSM – Pohnpei
10 (*4)
FSM - Kosrae
3 (*3) 4
CNMI – Saipan
12 (*4)
CNMI – Rota
2 (*0)
CNMI - Tinian 5
A Samoa
25(*25) 6
Palau
8 (*5)

31. Guam Public Health Lab (L2)
Proposed future algorithm for the regional influenza testing in the USAPI at GPHL
CDC Influenza Lab (L4)
1. Conduct reference testing for HSLD
Guam Public Health Lab – Expectations as a Level 2 Reference Lab for the Northern Pacific
Hawaii State Lab (L3)
. Conduct PCR and viral culture on all VTMs received.
. Report PCR and viral culture results to GPHL.
. Refer all positive viral cultures to CDC reference lab.
. Pack and ship specimens (as a batch) with dry ice to CDC reference lab.
Guam Public Health Lab (L2)
. Store VTMs at -70oC.
. Conduct PCR testing on VTM specimens
. Report PCR test results to USAPI labs.
. Refer all positive and negative VTMs to HSLD.
. Pack and ship specimens (as a batch) with dry ice to HSLD.
. Report HSLD lab results to USAPI labs.
Other USAPI Labs (L1)
. Perform Influenza Rapid Test (IFA/Test kit).
. Document test results.
. Refer 2 specimens to GPHL (1 nasopharyngeal swab in alcohol & 1 nasopharyngeal swab in VTM.
. Pack and ship specimens to GPHL with gel ice packs.

32. GPHL Microbiology Skill-up Enhancement Training
Goal: Strengthen Level 2 reference lab testing of infectious diseases at GPHL
Objectives:
Conduct microbiology skill-up training at GPHL between 2015 – 2016
2015
Phase 1 (1st Q)– Microbiology skills
Phase 2 (2nd Q) – Microbiology skills
Phase 3 (3rd Q) – Lab surveillance/Antibiotic resistance patterns
Phase 4 (4th Q) – Food microbiology
2016
Phase 5 (1st Q) – Water microbiology
Phase 6 (2nd Q) – Bacterial agents of bioterrorism
Types of assistance:
SPC  Financial & Training delivery/co-facilitation
PIHOA  Training delivery/co-facilitation

33. USAPI Microbiology Skill-up Enhancement Training (if or when funding is available)
Goal:
Strengthen Level 1 lab surveillance of infectious diseases
Enhance Level 1 diagnostic microbiology testing capabilities and infection control
Objectives:
Conduct microbiology skill-up training in the USAPI labs
Incorporate lab infection control training modules

34. Challenges

35. MAJOR CHALLENGES FACED IN LQMS IMPLEMENTATION THROUGHOUT THE PACIFIC REGION INCLUDING THE USAPI
Lack of Quality Culture.
Lack of priority or urgency for Laboratory issues. Inadequate resources and infrastructure.
Lack of Quality champions.
Poor and ineffective management.
Lack of support by Ministries of health
Accuracy, reliability, timeliness of lab services are questionable.
Weak area of Human resources and capacity.
No urgency in LQMS implementation.
Little incentive for staff, small salaries, 2nd jobs, little recruitment.
Isolated and remote islands.
No Lab Information systems (LIS) generally.
No formal qualification internationally recognised. PPTC/FSM
Inadequate transport and referral to Reference Labs.
Lack of Quality Culture.
This unfortunately remains a reality in selected countries throughout the Pacific.
Staff are undervalued, not compensated for the work that they do, no incentive to do better. Often there is no desire to change. Why do it differently if it means more work and no rewards. What are the consequences if the work is done badly.
Lack of priority or urgency for Laboratory issues, inadequate resources and infrastructure.
Prolonged TAT, Lack of equipment, staff, inadequacies in procurement, facilities, education and training etc
Lack of Quality champions.
Poor and ineffective management.
Lack of support by Ministries of health
Inadequate resources and infrastructure.
Weak area of Human resources and capacity.
No urgency in LQMS implementation.

36. Major challenges vs Suggested Solutions
Slow progress in the implementation of LQMS recommended activities for improvement in USAPI labs (especially with the FAS). U
npaid shipping invoices – slow replenishment of the PIHOA Reimbursable Fund.
Suggested solutions
Appointment of a Lab Quality Officer in each USAPI Lab
Injection of $2,000 - $3,000 into the PIHOA Reimbursable Fund by each USAPI Lab

37. PIHOA Regional Lab Initiative Progress Highlights: 2005 - 2015
Survival of the PIHOA Lab Initiative (on-going funding by APHL/CDC, ASTHO, DLS-TB Program)
Effective use of the PIHOA Reimbursable Fund
Successful use of the PIHOA Shipping Mechanism
Shipping
Continuous re-certification of shippers: 25 (2006) vs 94 (2015)
Successful specimen transport

38. PIHOA Regional Lab Initiative Progress Highlights: 2005 - 2015
TB Lab Network
Active USAPI TB Lab Network
USAPI TB Lab EQA -100% participation
AUL
Active Association of USAPI Labs (AUL)
LQMS
LQMS activity implementation
LQMS improvements noted but slow

39. PIHOA Regional Lab Initiative Progress Highlights: 2005 - 2015
Medical lab workforce
Continuous professional development of lab staff
GPHL
GPHL improvements with the ‘BT suite’
Increased testing capabilities (Genexpert Influenza, Genepert Chlamydia & Gonorrhea, PCR Influenza typing (H1, H3, H5, H7), Leptospirosis, Measles/Rubella)
Dengue PCR: soon in late 2015

40. Chuuk, FedSM: Nov – Dec 2014

41. Chuuk, FedSM: Nov – Dec 2014

42. Thank you!!! Questions???