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

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: 2005 - 2015

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)

Improving lab quality management systems in the USAPI

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;

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 2018 - 2019 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

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

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

Overview of LQMS activities completed in the USAPI

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

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

Improving the USAPI medical laboratory workforce

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

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

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

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

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)

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

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

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)

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”

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

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

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

Improving the USAPI laboratory surveillance of infectious diseases

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

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

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

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

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)

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.

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

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

Challenges

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.

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

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

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

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

Chuuk, FedSM: Nov – Dec 2014

Chuuk, FedSM: Nov – Dec 2014

Thank you!!! Questions???