Vietnam's military clinical laboratories
strengthen quality management towards
ISO 15189 – SLMTA pilot in the military
Supported by US DOD PEPFAR Vietnam
Presenter
Major Nguyen Quang Chien MD, Military Hospital 103, Military Medical University Vietnam
Contributing authors
1
Maj. General Vu Quoc Binh MD, PhD; Maj. General Dang Quoc Khanh MD, PhD; Senior Colonel Le Ngoc Anh MD, PhD
2
Trinh Thi Thanh Thuy MD, MPH; Phung Thi Phuong Mai MD; Ngo Manh Hung MSc ; 3 Nguyen Thi Minh Anh MSc;
4 Major
Nguyen Quang Chien MD, MSc
Affiliations
1
Military Medical Department, Ministry of National Defense, Vietnam
2
US DOD PEPFAR Vietnam, Office of Defense Cooperation, US Embassy Vietnam
3
US Armed Forces Research Institute of Medical Sciences (AFRIMS)
4 Military
Hospital 103, Military Medical University Vietnam
Disclosures
• The presenter has no financial relationships to disclose.
• This continuing education activity is managed and accredited by Professional
Education Services Group in cooperation with AMSUS.
• Neither PESG,AMSUS, nor any accrediting organization support or endorse
any product or service mentioned in this activity.
• PESG and AMSUS staff has no financial interest to disclose.
• Commercial support was not received for this activity.
Learning objectives
At the conclusion of this activity, the participant will be able to:
1. Understand the overview of program ‘Strengthening Laboratory
Management Toward Accreditation’ (SLMTA), and its initiation in the military
laboratory system in Vietnam including baseline assessment results.
2. Understand the overview of the SLMTA-required improvement projects
and the progresses made by the participating laboratories after one year of
program implementation including the lessons learned.
3. Learn of the recommendations on plans to assist the selected laboratories
to achieve ISO upon graduating from the program, and expand the program to
other military laboratories on a feasible roadmap using the military system's
own resources.
Presentation outline
1.
2.
3.
4.
5.
SLMTA – What is it?
SLMTA initiation in military lab system in Vietnam
Results from baseline assessment of selective labs
Improvement projects made towards ISO 15189
Way-forwards
SLMTA – What is it?
SLMTA stands for
STRENGTHENING LABORATORY MANAGEMENT TOWARD ACCREDITATION
SLMTA does what?
PROVIDE TASK-BASED TRAINING AND POST-TRAINING MENTORING FOR
LABS TO COMPLETE ALL QUALITY MANAGEMENT TASKS.
… so that labs can produce improvements that are immediate and
measurable, using labs’ own available (usually limited) resources
… each and every improvement made, and maintained, brings labs one
step closer to ISO 15189
guides steps towards ISO
SLMTA – What is it?
What bases are out there for SLMTA?
ISO 15189 for clinical and public health
laboratories
WHO AFRO’s Stepwise Laboratory Improvement
Process Toward Accreditation (SLIPTA)
 This SLIPTA checklist is used as SLMTA
backbone to guide and measure improvements
SLMTA – What is it?
The SLMTA standard process
Baseline assessment
Improvement
projects
Training
Workshop 1
Exit points
Improvement
projects
Training
Workshop 2
Improvement
projects
Training
Workshop 3
(3 months)
(3 months)
(3 months)
Site visits
Site visits
Site visits
-
Baseline points
=
SLMTA results
Exit
assessment
SLMTA – What is it?

How SLMTA measures improvements?
SLIPTA Checklist - the backbone
SLIPTA Score band: 0 – 258 Points
SLMTA Star band: 0 – 5 Stars
3-4 Star = High potential for continuing to ISO
5 Star = Very ready for ISO application



IMPORTANT:
SLMTA re-assessment every 02 years

0 – 142
< 55%
143 – 165
55 – 64%
166 – 191
65 – 74%
192 – 217
75 – 84%
218 – 243
85 – 94%
244 – 258
>95%
When: JULY 2009
SLMTA launching Where: Kigali, Rwanda
Why: To support WHO AFRO’s Stepwise Laboratory
Improvement Process Toward Accreditation (SLIPTA)
Attended by 120+ experts and policy makers from 12 African countries
9
SLMTA global roll-out
Yao K. et al, 2014, Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems, http://www.ajlmonline.org , doi:10.4102/ajlm.v3i2.262
SLMTA in Vietnam – since 2012
Background:
•Most labs in Vietnam are limited in human and technical
resources, equipment and facilities
•Before SLMTA, only few labs get ISO 15189 accreditation
•Rare mutual recognition of test results between labs, making
repeated testing on one same patient a must if the patient visits
another hospital.
 Costs patients time and money
 Costs society additional yet unnecessary health expenditures
•No official program in place that provides hands-on assistance to
and closely monitors labs’ adherence to MoH regulations on lab
quality management and assurance.
SLMTA in Vietnam – since 2012
Government agency: Ministry of Health (MoH)
Technical and funding agency: US CDC Vietnam
Round 1: 12 labs, all civilian
05/2012: Baseline assessment
06/2013: Exit assessment
Round 2: 14 labs, only 01 military lab
02/2014: Baseline Assessment
10/2015: Exit assessment
SLMTA for Tuberculosis Labs (06 labs): on-going, NO military lab
TOT/Mentors Training: 02/2012 and 05/2015
Auditors/Assessors Training: 08/2015
SLMTA in Vietnam’s military
SLMTA – A priority activity by Vietnam’s Ministry of Defense, backed by US
DOD PEPFAR Vietnam
Objectives:
•TA support to military labs to improve quality management capacity towards
accreditation
•TA support to build the military’s own capacity for sustained laboratory program
(trainers/mentors)
Coverage:
•7 labs in 4 leading military hospitals (HIV lab, blood transfusion lab, general lab)
•3 labs in military centers for hygiene and epidemiology (HIV lab, microbiology lab,
virology lab) .
SLMTA in Vietnam’s military
Coordination agency:
Vietnam’s Ministry of National Defense/Military Medical Department
Technical focal agency:
US Centers for Disease Control and Prevention Vietnam Office
US Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok,
Thailand
Coordination and funding agency:
US DOD PEPFAR Vietnam, Office of Defense Cooperation, US Embassy Hanoi,
Vietnam, via AFRIMS
SLMTA in Vietnam’s military
9/2014
Baseline assessment of 15 labs
Officially enrolled: 10 labs
1/2016
10/2014
Improvement
projects
Workshop 1
3/2015
Improvement
projects
7/2015
Improvement
projects
Workshop 3
Workshop 2
(5 months)
(4 months)
(5 months)
Site visits
Site visits
Site visits
Exit
assessment
of 10 labs
SLMTA in military – Baseline assessment results
All 15 labs at “ZERO STAR”
Average SLIPTA scores: 70.13 points
It’s a long way to reach ISO 15189!
SLMTA in military – Baseline assessment results
Weaknesses found in all areas of a quality management system.
Across all labs, the most outstanding areas for improvement,
include:
•Documents and Records, including importantly Standard Operating
Procedures (SOPs)
•Equipment preventative maintenance and calibration
•Internal quality control and external quality assurance
•Facilities and safety, including lab bio-safety
SLMTA in military – THE TRAINING WORKSHOPS
10/2014
Workshop 1
Team
work
SLMTA in military – THE TRAINING WORKSHOPS
3/2015
Workshop 2
Creative
trainer
SLMTA in military – THE TRAINING WORKSHOPS
7/2015
Workshop 3
and
creative
trainees
SLMTA in military – ON-SITE MENTORING
SLMTA in the Military - Improvement Projects
and Tasks
Important Messages
1… Improvement projects and tasks
are standardly designed for all
countries.
2… Labs start at very different
baseline point on each project/task
3… Most improvements can be
made using labs’ own, current
resources
Things To Do IMMEDIATELY
Nearly 40 important tasks are assigned to labs throughout the year,
after each training workshop,
Labs to execute these IMMEDIATELY.
Example tasks include:
• Floor plan and workflow
rearrangement
• Organizational chart
• Week/Month calendar work
planning
• Human resources documents and
records
• Staff training plan and records
• Work-station duty descriptions
• Quality indicators monitoring and
improvement
• Meeting minutes
• 5S + 1: Sorting/cleaning/arranging/
maintaining neatness etc.
• Temperature control and log chart
• Master document file list
• Quality handbook drafting
• And so many more …
Things Completed IMMEDIATELY
Workflow re-arranged at all labs: Based on logical analysis “spaghetti” mapping)
Military Institute for Hygiene and Epidemiology – AIDS Center
Things Completed IMMEDIATELY
Org-chart & duty assignment
All labs completed organizational charts to help effective
communication/collaboration and enforce reporting line
Daily duty assignment in place for clear accountability.
Central Military Hospital 108
Things Completed IMMEDIATELY
HR documents and records
All labs improved on human resources documents and records to help with HR
management and staff training/re-training/competency assessment planning.
Military Hospital 175 – Bio-Chemistry Lab
Things Completed IMMEDIATELY
Work areas duty description
All labs completed task: made clear which tasks in which work areas, which SOPs are to be
used there.
Central Military Hospital 108 – Immunology Lab
Things Completed IMMEDIATELY
Quality indicators monitoring
All labs started monitoring quality indicators (not the case before), including test TurnAround-Time, rate of rejected specimen, etc…
Meeting minute/Quality management progress minute
All labs started using meeting minutes routinely as records for quality management tasks.
Things Completed IMMEDIATELY
Clean and tidy work-space: 5S + 1
All labs maintained clean and tidy work space (much better than before project)
Military Institute for Hygiene and Epidemiology – AIDS Center
Things Completed IMMEDIATELY
… and many many other tasks have been completed.
Improvement project 1:
Analyze tests’ Turn-Around-Time (TAT), and shorten it
What is it:
• Aimed to return verified test results earlier and no later than policy required.
• Based on process mapping technique, labs to analyze TAT, and find ways to
shorten TAT if must be (or if need be).
Baseline status:
• All labs have long TAT (beyond desired/established timeframe).
• Benchmark not yet available at some labs for some tests
Current progress:
• 100% labs completed project on one test/procedure ONLY  TAT improved
significantly
• Work needed on a lot more tests.
Military Hospital 354
Project target: 90% of out-patient tests are returned within 80 minutes.
Pre-project: 82.5%
- No patient strict queuing
- Lab technical work areas are NOT arranged
one-way
Post-project: 91.8%
- Patients take numbers and queue
- One-way arrangement of technical
areas
Improvement project 1:
Analyze tests’ Turn-Around-Time (TAT), and shorten it
Main challenges:
• Changing ‘old’ practices of not documenting all time points especially when
involving other department staff;
• Work-flow arrangement within labs may not be optimum
• Availability of test results verifiers (on-duty doctors, particularly during night
shift).
• TAT project underway for selective tests only. Labs should roll out on all tests.
Improvement project 2:
Standard Operating Procedures (SOPs)
What is it:
• Aimed to issue all needed SOPs (technical and management SOPs) that reflect
labs' current resources, and ensure adherence to SOPs.
Baseline status:
• All labs do not have lab-issued SOPs in place. Few have some.
• Long-standing practice of doing things from memories/verbal instructions/
peer coaching.
Current progress:
• 9/10 labs completed at least 50% of SOPs required
• No lab has fully completed this task due to the sheer number of SOPs needed
• “SOPs atmosphere” spreading all over labs; attitude have changed dramatically.
Southern Preventive Medicine Center – HIV Lab
Project target: Complete and issue 50% of SOPs after 3 months (Achieved)
Improvement project 2:
Standard Operating Procedures (SOPs)
Main challenges:
• Labs vary in testing menu  vary in technical SOPs required.
• SOPs are all about “Write what you do!”
• A daunting task for all labs. Staff not familiar with writing SOPs  needs
training/assistance.
• Available time of staff to write
• And “Do what you write!”
• Adherence to SOPs is critical to ensure testing quality
• Availability of chief technician/QA manager to supervise adherence to
SOPs (well linked to staff competency assessment, Project 5)
Improvement project 3:
Lab facilities and safety
What is it:
• Labs to improve all aspects of their lab safety according to ISO standards.
Baseline status:
• Safety manual not available at all labs  to develop
• All safety aspects need improvement:
•
•
•
•
•
arrangement of lab sections,
access to sterilized vs non-sterilized areas,
sorting normal and medical waste,
fire and electricity safety equipment/device,
PPE, staff vaccination, etc…
Current progress:
• 100% labs completed improvements within reach. Other improvements
pending, including due to funding.
• This project proved among the most challenging
Military Hospital 103 – Blood Bank
Re-arranged/new safety notices
Military Hospital 103 – Blood Bank
Re-arranged/new safety notices
Military Hospital 103 – Blood Bank
Waste categorizing protocol, and respective bins
right down
Improvement project 3:
Lab facilities and safety
Main challenges:
• Change management, funding request, intra-lab and inter-department
coordination
• Most tasks can be completed with some internal re-arrangements, some
require supplies/funds but minimal including sending staff to bio-safety
training.
Improvement project 4:
Store/inventory management
What is it:
• Labs to improve all aspects of their store and inventory management practices
including importantly quality control of test kits/reagents
Baseline status:
• All labs have non-standardized store and inventory management practices,
various areas not meeting basic management principles.
• Example of most challenging areas:
• forecasting testing reagents supply and budget: labs may forecast, but can not
be on top of ordering and procurement process
• placing and tracking purchase orders, inventory stocktaking and consumption;
storage facilities: in charge of by procuring department
• reviewing suppliers including accredited and reliable suppliers: not possible,
may or may not happen at procuring department.
• etc.
Improvement project 4:
Store/inventory management
Current progress:
• 100% labs made improvement in areas within reach (storage, stocktaking
etc).
• Some areas suffer delays or are difficult (under management by other
departments, e.g. suppliers management, purchasing)
Main challenges:
• Changing old practices at labs
• Inter-department coordination for areas outside of labs’ scope
Military Hospital 103 – Bio-Chemistry Lab
Follow storage
standards;
List of items
attached.
Military Hospital 103 – Bio-Chemistry Lab
Refrigerator temperature log
in place post-project
Improvement project 5:
Staff competency assessment
What is it:
• Labs to develop roadmap and work-plan to perform regular assessment of
staff competency in their all areas of assignments.
• Assessment tasks include developing competency assessment SOP by,
question bank, assessment checklists (based on approved SOPs), and direct
observation of test demonstration.
Baseline status:
• All labs practice some sort of staff competency assessment annually, but not as
requirements by ISO.
• Must plan for staff assessment the way ISO required (more substantial
assessment)
Improvement project 5:
Staff competency assessment
Current progress:
• 2/10 labs have yet completed any steps.
• 8/10 labs issued staff competency assessment SOP and conducted assessment
on one or two technical protocols for which SOPs are available.
• Further SOPs and associated assessments to be completed.
Main challenges:
• Not all SOPs have been issued  task completion delayed;
• Some labs are yet to issue competency assessment SOP.
• Time availability to conduct assessment across the board
• Staff part-time in different areas including technical  large scope of
assessment required on any single staff
Improvement project 6:
Equipment management
What is it:
• Labs to improve all aspects of their equipment management including
importantly making available a plan for and regular conduct of equipment
preventative maintenance.
Baseline status:
• All labs rely on equipment suppliers and/or equipment departments on
preventative maintenance, repair and calibration. Very little or no self
maintenance in place.
• Very limited or no funding for regular maintenance; repair/replacement (by
equipment departments) take times (limited funds among the reasons).
Improvement project 6:
Equipment management
Current progress:
• All labs have been working on various related tasks:
• planning for equipment quality control
• requesting directorship for funding for regular conduct of preventative
maintenance and regular equipment/devices calibration, spare parts
availability,
• planning of actions on out-of-work or obsolete items including related
SOPs,
• etc.
• Some labs receive regular maintenance services provided by PEPFAR via
AFRIMS
Military Hospital 103 – Blood Bank
Equipment management SOP
Military Hospital 103 – Blood Bank
Numbering and tagging all equipment/device
Improvement project 6:
Equipment management
Main challenges:
• Preventative maintenance/calibration after end of vendors’ service period
rather costly
• In some sites: limited awareness by directorship/lab management of
equipment preventative maintenance towards general medical quality
•  Limited available funding;
•  “other priorities” tend to get funding
• Coordination with equipment departments challenging at times
• Using certified service providers not yet a practice in Vietnam
• Hospitals directorship and/or Ministry of Defense to provide further
directions
Improvement project 7:
Reduce rate of rejected specimens
What is it:
• Labs to monitor and find solutions to reduce rate of rejected specimens
received from clinical departments (for both in-patient and out-patient).
Baseline status:
• Most labs yet to issue specimen collection manual providing guidance and
standards. Training on standards to other departments not yet in place.
• At some sites, guidance in place but adherence not strictly re-enforced.
Military Hospital 103 – Blood Bank
Register Samples for Testing
Improvement project 7:
Reduce rate of rejected specimens
Current progress:
• Project assigned in August 2015. Guidance provided.
• Preparation for execution in progress.
• Survey information to include number and types of specimen rejected, for
which tests, from which department etc. (for both in-patient and out-patient).
Main challenges:
• Approve and issue Specimen Collection Manual
• Enforcing adherence to manual by all clinical departments essential to
success of project  intra-hospital collaboration critical.
Improvement project 8:
Client-satisfaction survey
What is it:
• Labs to conduct satisfaction survey on all their client categories: clinical
doctors, patients, others as appropriate.
Baseline status:
• Current practice: Complaints verbally informed to labs without records 
uncertain to trigger corrective actions and future improvement
• Complaint telephone hot-line currently available at some hospitals: Strict
actions NOT always certain.
Improvement project 8:
Client-satisfaction survey
Current progress:
• Project assigned in August 2015. Guidance provided.
• Preparation for execution in progress.
Main challenges:
• Serious partaking of all client categories critical for ultimately improving
overall hospital quality of services.
… for each and every improvement made,
labs take one step closer to ISO 15189.
… most improvements can be made using
labs’ own, current resources, and only if
all lab leaders and staff join in actions.
guides steps towards ISO
SLMTA – What is the biggest challenge???
… SLMTA/QMS is a new concept
compared to the established practices.
… Therefore, it will take time and efforts
to get realized
SLMTA in military – Common challenges and lessons learned
•
•
•
•
•
Lab space and facilities: Not all labs have decent and well-designed workspace in the first place  re-arranging/changes not easy
Lab workload: High, particularly at labs in big hospitals  SLMTA suffers
delays
Lab staffing: Under-staffing compared to workload at busy labs
Staff training: Not all staff are professionally trained to the tasks assigned
QMS staff: Few staff trained on quality management system and possess a
QMS mindset  it takes time to spread QMS out, and change the ‘old, inefficient’ practices
SLMTA in military – Common challenges and lessons learned
•
•
•
Intra-lab communication and coordination: Team-work and resultoriented attitude most critical, but need improvement
Inter-department coordination: Other departments are involved, and in
control for facilities, equipment management, procurement, and storage, etc.
 Coordination and collaboration with related departments essential.
Centrally-managed and funded mechanism: Complicated funds request
procedures, QMS-related requests may not be given the needed priority 
SLMTA suffers
SLMTA in military – Recommendations and way-ahead
•
•
•
•
•
•
Military Medical Department – MMD/MOD to issue policy and guidance in
facilitating SLMTA implementation that also address challenges (some
beyond labs’ authority).
SLMTA promotes improvements based on current, available resources  labs
to address all internal challenges observed
Exit assessment expectations: 2-3 labs scored at 3 STARS.
Recommend MMD to select some highest scored labs at exit for intensive
assistance towards ISO. Others may remain on a regular assistance plan to
build up SLMTA momentum and maintain improvements made.
MMD to facilitate QMS and SLMTA capacity building for more military staff,
particularly those trained as trainers. To use military own SLMTA trainers to
support system.
SLMTA expansion roadmap need be feasible, considering available expert
resources including military own resources.
Vietnam's military clinical laboratories strengthen
quality management towards ISO 15189
– SLMTA pilot in the military
Supported by PEPFAR via US Department of Defense
Contributing authors
1
Maj. General Vu Quoc Binh MD, PhD; Maj. General Dr. Dang Quoc Khanh MD, PhD; Senior Colonel Le Ngoc Anh MD, PhD
2
Trinh Thi Thanh Thuy MD, MPH; Phung Thi Phuong Mai MD; Ngo Manh Hung MSc ; 3 Nguyen Thi Minh Anh MSc;
4 Major
Nguyen Quang Chien MD, MSc
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