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Workplace-Based, Accreditation-Focused
Laboratory Mentorship:
An Effective Way to Improve Laboratory Quality
Towards WHO-AFRO Stepwise Laboratory Accreditation
Success Story
I-TECH Ethiopia
February 2015
This project was made possible by the International Training and Education Center for Health (I-TECH) with funding from
Cooperative Agreement U91HA06801-06-00 with the US Department of Health and Human Services, Health Resources
and Services Administration (HRSA), through the US President’s Emergency Plan for AIDS Relief (PEFAR). The contents
and conclusions do not necessarily reflect the views of I-TECH, HRSA or the US government and are the sole
responsibility of the author.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 1
Quality laboratory services ensuring that results are accurate, reliable, reproducible, and rapid enough to
be useful is crucial to improved health outcomes and moreover are key to improving global health and
reaching Millennium Development Goals. —WHO
Prepared by
Wubshet Mamo, DVM, MVSc, PhD, Clinical Associate Professor
Cell phone: (251) 911 821 624
E-mail: wubshetmam@yahoo.com
Skype: Wubshet.mamo1
Addis Ababa,
Ethiopia
February, 2015
Workplace-Based, Accreditation-Focused Laboratory Mentorship 2
TABLE OF CONTENTS
ACRONYMS AND ABBREVIATIONS................................................................................................................3
INTRODUCTION.............................................................................................................................................4
OBJECTIVES ...................................................................................................................................................5
IMPLEMENTATION........................................................................................................................................6
Accreditation-Focused Mentorship..........................................................................................................6
Quality-Improvement Projects.................................................................................................................7
Supportive Site Visits................................................................................................................................7
Progress Evaluations.................................................................................................................................7
RESULTS ........................................................................................................................................................9
Overall Performance.................................................................................................................................9
The First National SLMTA Program (June 2010 – October 2011).............................................................9
Internal Audits ..........................................................................................................................................9
External (National) Audits.........................................................................................................................9
The Second National SLMTA Program (January 2011 – May 2012) .......................................................10
Internal Audits ........................................................................................................................................10
External (National) Audits.......................................................................................................................10
CHALLENGES ...............................................................................................................................................11
LESSONS LEARNED......................................................................................................................................12
CONCLUSIONS AND RECOMMENDATIONS.................................................................................................14
REFERENCES................................................................................................................................................16
Workplace-Based, Accreditation-Focused Laboratory Mentorship 3
ACRONYMS AND ABBREVIATIONS
EPHI Ethiopian Public Health Institute
EQA External Quality Assessment
FMOH Federal Ministry of Health
ISO International Organization for Standardization
I‐TECH International Training and Education Center on Health
IQC Internal Quality Control
QMS Quality-Management System(s)
RHB Regional Health Bureau
SLIPTA Stepwise Laboratory (Quality) Improvement Process Towards Accreditation
SLMTA Strengthening Laboratory Management towards Accreditation
WHO World Health Organization
WHO-AFRO World Health Organization Regional Office for Africa
Workplace-Based, Accreditation-Focused Laboratory Mentorship 4
INTRODUCTION
A strong health service delivery system requires a strong laboratory service system. Therefore,
expanding the breadth of laboratory services accessible to clients, and ensuring that results are
accurate, reliable, reproducible, and obtained rapidly enough to be useful, is crucial to
achieving improved health outcomes.
The World Health Organization (WHO) recognizes quality laboratory services as key to
improving global health and reaching Millennium Development Goals. Therefore, under its
authority to set standards for building institutional capacity, the World Health Organization
Regional Office for Africa (WHO-AFRO) has established the Stepwise Laboratory (Quality)
Improvement Process Towards Accreditation (SLIPTA) program to strengthen lab systems.
SLIPTA is a framework for improving quality of public health laboratories in developing
countries, in order for them to achieve ISO 15189 standards (1, 2). It is a systemic approach, a
process that enables labs to develop and document their ability to detect, identify, and
promptly report all diseases of public health significance that may be present in clinical
specimens.
Until recently, the majority of Ethiopian public health laboratories delivered suboptimal service,
and were thus not in a position to contribute to a quality health care system. Many labs
performed poorly, hindered by dilapidated infrastructure, and poor development and
implementation of quality-management systems (QMS), with inadequate participation in
external quality assessment (EQA) programs. The culture of QMS has been uncommon in
Ethiopian labs; as such, there is a need to build this culture.
However, in recent years, under the leadership of the Federal Ministry of Health (FMOH), via
the Ethiopian Public Health Institute (EPHI), and through the concerted efforts of international
and local partners, public health laboratories in Ethiopia have begun to implement national and
international QMS to provide quality lab services by adapting the WHO-AFRO SLIPTA programs.
Since June 2007, I-TECH Ethiopia has partnered with the FMOH through the EPHI, regional
health bureaus (RHBs) and local partners to provide the support needed to strengthen the
national laboratory system in the three northern regions of Ethiopia: Amhara, Tigray, and Afar.
The I-TECH lab program has focused on three major areas of support—upgrading infrastructure,
building up professional skills, improving labs and preparing them to earn accreditation. I-TECH
implemented the program through its field lab support programs.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 5
In 2010, a National Laboratory Strategic Plan was developed in Ethiopia to strengthen
laboratory QMS and prepare laboratories to earn accreditation (3, 4). As a result, the
Strengthening Laboratory Management Towards Accreditation (SLMTA) program was initiated.
Between 2010 and 2012, a total of 45 labs were enrolled in the program, to help them facilitate
improvements in quality and accelerate preparations for stepwise accreditation (3).
The first national SLMTA program was implemented between June 2010 and October 2011; 24
public health laboratories in Ethiopia, of which five were supported by I-TECH, were enrolled
(5). Twenty-one labs, of which five were I-TECH-supported labs, participated in the second
program, implemented between January 2011 and May 2012.
The I-TECH Ethiopia laboratory team has implemented SLMTA, and its goals of meeting global
standards, to help these 10 labs from the three I-TECH-supported regions improve the quality
of their services through the five steps of the WHO-AFRO stepwise laboratory quality
improvement protocol. The stepwise approach acknowledges the current standing of each lab,
supports them with a series of evaluations to measure improvement, and both recognizes and
rewards their progress.
Following the National Laboratory Strategic Plan towards accreditation, I-TECH implemented a
workplace-based, accreditation-focused mentorship model, intended to provide an effective
means of accelerating the implementation of QMS to help labs prepare for accreditation. I-
TECH mentors were embedded in each lab enrolled in the SLMTA program for extended periods
of time, so they could develop in-depth understanding of lab operations, and provide day-to-
day assistance in implementing QMS and preparing for accreditation.
The workplace-based, accreditation-focused mentorship is an efficient tool in
implementing SLMTA that impacted every laboratory process; I believe that positive and
sustainable changes occurred at all levels in our laboratory. —Regional referral
laboratory manager
OBJECTIVES
 Strengthening the laboratory QMS in I-TECH-supported labs.
 Helping labs to improve quality of service, enabling them to assess both their own
quality and their competence in implementing the ISO15189 requirement through
WHO-AFRO’s SLIPTA program, and to pursue international accreditation.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 6
IMPLEMENTATION
Prior to initiation of the mentorship program, laboratory technicians were trained according to
SLMTA principles, applying the SLIPTA checklist and scoring system. This checklist sets out
quality and competency requirements, aimed at developing and raising the quality of lab
services to established national standards. The elements of this checklist are based on ISO
standard 15189:2007(E).
Accreditation-Focused Mentorship
I-TECH laboratory mentors (who had taken SLMTA “Training of Trainers” courses) participated
in the daily routines of each lab, providing 10 consecutive days of mentorship, with follow-up
site visits thereafter.
Ten I-TECH-supported laboratories were enrolled in the national SLMTA programs. During each
program, each lab received a total of 30 days of mentorship, spread out over three rounds, with
intervals of four weeks in between.
Figure 1. Providing on-the-job mentorship to laboratory professionals
To effectively implement SLMTA according to the 12 Quality Improvement Essentials,
laboratory staff were mentored on a continuing basis, the aim being to achieve international
standards for accreditation. Mentorship included support for implementing internal quality-
control (IQC) procedures and external quality assessments (EQAs). Mentors also monitored lab
performance using standardized checklists and tracked performance improvements.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 7
Quality-Improvement Projects
Quality-improvement projects were designed by each laboratory, based on common gaps
identified and addressed during the baseline audit. The projects were implemented by all staff,
monitored for effectiveness using the WHO-AFRO checklist and completed before the next exit
audit. Progress was monitored and reported by EPHI.
Supportive Site Visits
Supportive site visits were conducted by EPHI, regional referral laboratories and United States
(US) government partners, who monitored the progress of quality improvement projects using
checklists prepared for each specific project.
Progress Evaluations
National external audits conducted by the responsible accreditation authority (EPHI, in this
case) assessed the quality of each laboratory enrolled in the first and second national SLMTA
programs. This was done through a series of evaluations, using a comprehensive, standardized
SLIPTA checklist and scoring system. Each lab was awarded a rating of one to five stars, based
on performance. The audit checklist covered 12 quality-system components. Overall scores
were calculated as percentages of the maximum points possible. To provide benchmarks for
measuring progress, these scores were also defined with corresponding star levels (2):
 Zero stars: <137 points
 One star: 55%, or 138 points
 Two stars: 65%, or 161 points
 Three stars: 75%, or 186 points
 Four stars: 85%, or 212 points
 Five stars: 95%, or 237 points
Under this scoring system, laboratories that demonstrate outstanding performance by
achieving a five-star rating are entitled to enroll in an established international accreditation
scheme.
This five-step accreditation process is critical for improving quality so that labs will be able to
gradually receive credit for their improvements and eventually attain accreditation.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 8
Figure 2. WHO-AFRO Laboratory Accreditation scheme: A stepwise approach towards
quality improvement. (Gershy-Damet et al., 2010)
At the end of each mentoring period, mentors, mentees and lab managers worked together to
conduct exit audits to measure improvements in quality. (Exit audit results are also used to
establish baselines for the next round of mentorships.)
Differences between the baseline and exit audit scores were used to confirm improvements in
quality.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 9
RESULTS
Overall Performance
Improvement in overall performance was observed at all but one of the laboratories enrolled in
the two national SLMTA programs.
The First National SLMTA Program (June 2010 – October 2011)
Twenty-four public health laboratories in Ethiopia were enrolled in the first SLMTA program, of
which five were supported by I-TECH. I-TECH provided a total of 30 days of focused mentorship,
spread out over three rounds with intervals of eight weeks between each round. Audits were
conducted before (baseline) and after (exit) SLMTA implementation, using the SLIPTA checklist.
Internal Audits
The five I-TECH-supported laboratories enrolled in the first national SLMTA program scored 0
(<1) stars on the baseline audit. Following the three rounds of focused mentorship, all five labs
had improved their scores by one to three stars, according to the SLIPTA checklist and scores
(Table 1).
External (National) Audits
External audit results showed that one laboratory (at the University of Gondar Hospital) earned
a score of three stars; three labs earned two stars, and one laboratory earned one star.
According to the overall national evaluation of the SLIPTA results for laboratories participating
in the first program, the I-TECH-supported University of Gondar Hospital lab earned three stars,
making it the best of the 24 labs participating. The Axum Hospital laboratory came in second,
earning two stars.
Table 1. SLIPTA scores of laboratories enrolled in the first national SLMTA program.
I-TECH-
Supported
Laboratories1
Baseline (Internal)
Audit Result 2
(stars)
First Internal
Audit Result3
(stars (points))
Second Internal
Audit Result
(stars (points))
Third Internal
Audit Result
(stars (points))
National
(EPHI) Audit
Result(stars)
Axum HL 0 2 (170) 2 (178) 2 (173) 2
Gondar UHL 0 1 (144) 2 (170) 3 (210) 3
Bahir Dar RL 0 1 (146) 2 (172) 2 (170) 2
Dessie RL 0 1 (138) 2 (168) 2 (165) 1
Mekelle RL 0 1 (132) 1 (157) 2 (167) 2
1. HL: hospital laboratory. UHL: university hospital laboratory. RL: regional laboratory.
2. Audits conducted prior to mentorship intervention.
3. Internal audits conducted by I-TECH mentors.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 10
The Second National SLMTA Program (January 2011 – May 2012)
Twenty-one laboratories participated in the second program, of which five were I-TECH-
supported labs. Initially, all labs were at the zero-star level (i.e., with scores of <55%).
Internal Audits
Results showed that three of the I-TECH-supported laboratories (Dupti, Dessie, and Mekelle
Hospitals) improved their average SLIPTA scores by one to two stars. The Maychew Hospital lab
raised its score to three stars. On the other end of the scale, the Felege Hiwot Hospital lab
averaged zero stars.
External (National) Audits
Mirroring the internal audit results, the Maychew Hospital laboratory earned three stars; the
Dupti, Dessie, and Mekelle Hospital labs earned two stars; and the Felege Hiwot Hospital lab
earned zero stars (Table 2). The major contributor to Felege Hiwot’s score was the laboratory’s
poor infrastructure.
Table 2. SLIPTA scores of laboratories enrolled in the second national SLMTA program.
I-TECH-Supported
Laboratories1
Baseline (Internal)
Audit Result 2
(stars)
First Internal
Audit Result3
(stars (points))
Second Internal
Audit Result
(stars (points))
Third Internal
Audit Result
(stars (points))
National
(EPHI) Audit
Result(stars)
Dupti HL 0 2 (166) 2 (168) 2 (172) 2
Dessie HL 0 1 (154) 1 (157) 1 (159) 2
F/Hiwot HL 0 <1 (103) <1 (125) 1 (128) 0*
Maychew HL 0 1 (146) 2 (171) 3 (192) 3
Mekelle HL 0 1 (156) 2 (165) 2 (182) 2
1. HL: hospital laboratory.
2. Audits conducted prior to mentorship intervention.
3. Internal audits conducted by I-TECH mentors.
According to the overall national evaluation of the 21 laboratories participating in the second
program, the I-TECH-supported Maychew Hospital lab achieved the best score, being the first
among the 21 laboratories earning three stars. Maychew earned 208 out of 250 SLIPTA points
on the national exit audit of quality-system essentials. Another I-TECH-supported lab, at Dupti
Hospital, came in second.
The lack of improvement at Felege Hiwot hospital was related to a very poor infrastructure that
was not conducive to change. The Hospital administration and ITECH embarked on a laboratory
renovation project to improve the situation.
The focused mentorship and SLMTA implementation helped to engage hospital and senior
management, creating a strong commitment to ensure ownership and accountability of the
Workplace-Based, Accreditation-Focused Laboratory Mentorship 11
program, team spirit among lab staff and willingness to build a culture focused on quality and
problem solving.
CHALLENGES
 High turnover of laboratory staff, especially among staff trained in quality-management
and SLMTA procedures, and in biosafety, often caused inconsistency in the quality of
mentorship and delays in the SLMTA process.
 Lack of strong commitment and ownership of the accreditation process among facility
management, who tended to consider SLMTA and the WHO-AFRO SLIPTA as US
government partner programs. Moreover, the inability of facility management to
assume responsibility for the program made it difficult to address site-specific
deficiencies.
 Lack of a sense of urgency among stakeholders and responsible authorities (e.g., the
RHBs) to adequately implement the stepwise quality improvement process and assume
the costs of implementing and sustaining SLMTA.
 Changing poor laboratory habits has been a slow process, contributing to delays in
improvement:
 The program required more time and resources than the labs had anticipated.
 Maintenance of broken equipment was often delayed or not performed.
 Poor physical infrastructure at some of the labs impeded workflow and safety
procedures that, in turn, impeded the quality-improvement process.
The SLMTA program implementation and the routine laboratory service provision are not
integrated, and this disintegration resulted in a delay of SLMTA implementation,
consequently lowering SLIPTA scores. —Referral hospital laboratory manager
Workplace-Based, Accreditation-Focused Laboratory Mentorship 12
LESSONS LEARNED
Laboratory mentorship is a dynamic process, aimed at improving the diagnostic skills of lab
technicians, the quality of services provided, and patient care. Achieving international quality
standards (through accreditation) is a continuous process of improvement.
An accreditation-focused, workplace-based approach to mentorship was developed (adapted)
and implemented in I-TECH-supported laboratories, in collaboration with regional labs. I-TECH
has provided laboratory mentorship in many resource-limited countries, but the level of
mentorship provided by I-TECH Ethiopia is unique in its focus on accreditation through stepwise
quality improvements, helping to ensure that what is learned through training and mentoring is
actually implemented in the field.
This focused mentorship intervention is expected to guarantee that laboratory staff who have
benefited from mentoring will be confident, and capable of evaluating both the quality of their
own labs and their competence in implementing the ISO 15189 requirements through the
WHO-AFRO stepwise laboratory quality improvement protocols.
The stepwise approach recognizes that improvement takes time and often occurs in
increments—especially in resource-limited settings like Ethiopia.
External evaluation is the hallmark of accreditation, ensuring customers that laboratory services
meet acceptable quality and safety standards.
Embedding full-time mentors within the daily routines of laboratories over extended periods of
time enabled mentors to more fully understand the work culture, practices and people at those
labs, giving them enough time to foster positive changes.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 13
I-TECH mentor providing accreditation-focused mentorship to laboratory
technicians at Maychew Hospital
Involvement of facility management in the mentorship process is critical to the success of QMS
implementation, as the direct support of management is required in significant areas—e.g.,
funding for procurement of supplies, staffing, and challenges that may occur during the
mentoring process.
Unless management is fully committed to understand and support the process, whatever
efforts [are] made in implementing SLMTA towards WHO-AFRO/SLIPTA will never
succeed. —Regional referral laboratory manager
Sufficient engagement on the part of mentees is also critical, since it enables mentors to assist
with the smooth, uninterrupted implementation of SLMTA and shortens the amount of time
required for labs to function on their own.
Staff motivation was also noted as a key driver in SLMTA implementation.
The perception of SLMTA/WHO-AFRO/SLIPTA among laboratory quality-assurance officers and
facility managers is critical.
In general, improvement projects that were initiated and developed during SLMTA training
stimulated creativity, ownership and action among laboratory staff, and were great assets to
the quality-improvement programs.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 14
CONCLUSIONS AND RECOMMENDATIONS
The basic components of a laboratory QMS must be implemented at all levels of the laboratory
pyramid. I-TECH’s experience demonstrates that significant improvements in this system, which
will contribute to increased efficiency in both delivery and quality of service, can be achieved
through structured, workplace-based, accreditation-focused mentorship. The accreditation
focus of the mentorship program was shown to accelerate SLMTA implementation, enabling
labs to develop effective QMS that produced rapid and measurable change—as evidenced by
the jump from zero stars on the baseline audit to two and three stars on the exit audit.
Quality laboratory services have wide-reaching benefits for Ethiopia’s health care system
improvement goals. Increased access to effective, reliable diagnostic services will support
better patient care, improve the health care system and support achievement of Millennium
Development Goals.
The workplace-based, focused mentorships resulted in measurable improvement towards
preparation for the WHO-AFRO SLIPTA process in less than six months. The WHO-AFRO
stepwise quality improvement program uses internationally accepted standards, adapted to
local environments and scalable to meet lab complexity requirements. It also uses an
incremental, stepwise approach that is objectively measurable over time, employs a positive-
reinforcement approach to continuous quality improvement—and is affordable.
Accreditation also brings Ethiopia’s laboratories closer to the international community of
laboratory experts, allowing lab technicians and leaders to contribute to and learn from global
expertise on effective lab procedures, challenges and best practices.
Focused mentorship is also an effective means of 1) determining whether a laboratory is
providing accurate and reliable results; 2) determining whether the lab is well managed and
adhering to good lab practices; and 3) identifying areas for improvement.
It is recommended that the workplace-based, accreditation-focused mentorship be
incorporated into laboratory quality-management training programs such as SLMTA. This will
accelerate the quality-improvement process and the progress of labs towards achieving
accreditation.
The critical elements to be considered when setting up a long-term, sustainable and well-
structured mentorship program include: well-defined goals, sufficient length of on-site mentor
engagement, selection and training of mentors, a standard approach across laboratories, and
Workplace-Based, Accreditation-Focused Laboratory Mentorship 15
measurement of progress using standardized tools, well-structured reporting mechanisms, as
well as alignment of the program with overall national (FMOH) plans.
Given the results achieved during the two national SLMTA programs, it is clear that the focused
mentorship program played a key role in implementation of the SLMTA program, and must be
sustained. In addition, the regional laboratories must be empowered to oversee and follow-up
on the progress of SLMTA implementation.
Workplace-Based, Accreditation-Focused Laboratory Mentorship 16
REFERENCES
1. Gershy-Damet GM, Rotz P, Cross D, et al. The World Health Organization African Region
Laboratory Accreditation Process: Improving the quality of laboratory systems in the
African region. Am J Clin Pathol. 2010; 134(3):393–400.
2. World Health Organization’s Regional Office for Africa. WHO AFRO Stepwise Laboratory
Quality Improvement Process Towards Accreditation (SLIPTA) Checklist [document on the
Internet]. c2012 [cited 2014 May 31]. Available from:
http://www.afro.who.int/en/clusters-a-programmes/hss/blood-safety-laboratories-a-
health-technology/blt-highlights/3859-who-guide-for-the-stepwise-laboratory-
improvement-process-towards-accreditation-in-the-african-region-with-checklist.html
3. Ethiopian Health and Nutrition Research Institute. Five-Year, Balanced Scorecard-Based
Strategic Plan (2010–2015). Addis Ababa: EHNRI; 2010.
4. Ethiopia Ministry of Health. Master Plan for the Public Health Laboratory System in
Ethiopia 2009–2013. 2nd ed. Addis Ababa, Ethiopia: Federal Ministry of Health; 2009.
5. Hiwotu TM, Ayana G, Mulugeta A, et al. Laboratory System Strengthening and Quality
Improvement in Ethiopia. Afr J Lab Med. 2014;3(2), Art. #228, 6 pages.

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I-TECH-Success Story-Lab Mentorship

  • 1. Workplace-Based, Accreditation-Focused Laboratory Mentorship: An Effective Way to Improve Laboratory Quality Towards WHO-AFRO Stepwise Laboratory Accreditation Success Story I-TECH Ethiopia February 2015 This project was made possible by the International Training and Education Center for Health (I-TECH) with funding from Cooperative Agreement U91HA06801-06-00 with the US Department of Health and Human Services, Health Resources and Services Administration (HRSA), through the US President’s Emergency Plan for AIDS Relief (PEFAR). The contents and conclusions do not necessarily reflect the views of I-TECH, HRSA or the US government and are the sole responsibility of the author.
  • 2. Workplace-Based, Accreditation-Focused Laboratory Mentorship 1 Quality laboratory services ensuring that results are accurate, reliable, reproducible, and rapid enough to be useful is crucial to improved health outcomes and moreover are key to improving global health and reaching Millennium Development Goals. —WHO Prepared by Wubshet Mamo, DVM, MVSc, PhD, Clinical Associate Professor Cell phone: (251) 911 821 624 E-mail: wubshetmam@yahoo.com Skype: Wubshet.mamo1 Addis Ababa, Ethiopia February, 2015
  • 3. Workplace-Based, Accreditation-Focused Laboratory Mentorship 2 TABLE OF CONTENTS ACRONYMS AND ABBREVIATIONS................................................................................................................3 INTRODUCTION.............................................................................................................................................4 OBJECTIVES ...................................................................................................................................................5 IMPLEMENTATION........................................................................................................................................6 Accreditation-Focused Mentorship..........................................................................................................6 Quality-Improvement Projects.................................................................................................................7 Supportive Site Visits................................................................................................................................7 Progress Evaluations.................................................................................................................................7 RESULTS ........................................................................................................................................................9 Overall Performance.................................................................................................................................9 The First National SLMTA Program (June 2010 – October 2011).............................................................9 Internal Audits ..........................................................................................................................................9 External (National) Audits.........................................................................................................................9 The Second National SLMTA Program (January 2011 – May 2012) .......................................................10 Internal Audits ........................................................................................................................................10 External (National) Audits.......................................................................................................................10 CHALLENGES ...............................................................................................................................................11 LESSONS LEARNED......................................................................................................................................12 CONCLUSIONS AND RECOMMENDATIONS.................................................................................................14 REFERENCES................................................................................................................................................16
  • 4. Workplace-Based, Accreditation-Focused Laboratory Mentorship 3 ACRONYMS AND ABBREVIATIONS EPHI Ethiopian Public Health Institute EQA External Quality Assessment FMOH Federal Ministry of Health ISO International Organization for Standardization I‐TECH International Training and Education Center on Health IQC Internal Quality Control QMS Quality-Management System(s) RHB Regional Health Bureau SLIPTA Stepwise Laboratory (Quality) Improvement Process Towards Accreditation SLMTA Strengthening Laboratory Management towards Accreditation WHO World Health Organization WHO-AFRO World Health Organization Regional Office for Africa
  • 5. Workplace-Based, Accreditation-Focused Laboratory Mentorship 4 INTRODUCTION A strong health service delivery system requires a strong laboratory service system. Therefore, expanding the breadth of laboratory services accessible to clients, and ensuring that results are accurate, reliable, reproducible, and obtained rapidly enough to be useful, is crucial to achieving improved health outcomes. The World Health Organization (WHO) recognizes quality laboratory services as key to improving global health and reaching Millennium Development Goals. Therefore, under its authority to set standards for building institutional capacity, the World Health Organization Regional Office for Africa (WHO-AFRO) has established the Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program to strengthen lab systems. SLIPTA is a framework for improving quality of public health laboratories in developing countries, in order for them to achieve ISO 15189 standards (1, 2). It is a systemic approach, a process that enables labs to develop and document their ability to detect, identify, and promptly report all diseases of public health significance that may be present in clinical specimens. Until recently, the majority of Ethiopian public health laboratories delivered suboptimal service, and were thus not in a position to contribute to a quality health care system. Many labs performed poorly, hindered by dilapidated infrastructure, and poor development and implementation of quality-management systems (QMS), with inadequate participation in external quality assessment (EQA) programs. The culture of QMS has been uncommon in Ethiopian labs; as such, there is a need to build this culture. However, in recent years, under the leadership of the Federal Ministry of Health (FMOH), via the Ethiopian Public Health Institute (EPHI), and through the concerted efforts of international and local partners, public health laboratories in Ethiopia have begun to implement national and international QMS to provide quality lab services by adapting the WHO-AFRO SLIPTA programs. Since June 2007, I-TECH Ethiopia has partnered with the FMOH through the EPHI, regional health bureaus (RHBs) and local partners to provide the support needed to strengthen the national laboratory system in the three northern regions of Ethiopia: Amhara, Tigray, and Afar. The I-TECH lab program has focused on three major areas of support—upgrading infrastructure, building up professional skills, improving labs and preparing them to earn accreditation. I-TECH implemented the program through its field lab support programs.
  • 6. Workplace-Based, Accreditation-Focused Laboratory Mentorship 5 In 2010, a National Laboratory Strategic Plan was developed in Ethiopia to strengthen laboratory QMS and prepare laboratories to earn accreditation (3, 4). As a result, the Strengthening Laboratory Management Towards Accreditation (SLMTA) program was initiated. Between 2010 and 2012, a total of 45 labs were enrolled in the program, to help them facilitate improvements in quality and accelerate preparations for stepwise accreditation (3). The first national SLMTA program was implemented between June 2010 and October 2011; 24 public health laboratories in Ethiopia, of which five were supported by I-TECH, were enrolled (5). Twenty-one labs, of which five were I-TECH-supported labs, participated in the second program, implemented between January 2011 and May 2012. The I-TECH Ethiopia laboratory team has implemented SLMTA, and its goals of meeting global standards, to help these 10 labs from the three I-TECH-supported regions improve the quality of their services through the five steps of the WHO-AFRO stepwise laboratory quality improvement protocol. The stepwise approach acknowledges the current standing of each lab, supports them with a series of evaluations to measure improvement, and both recognizes and rewards their progress. Following the National Laboratory Strategic Plan towards accreditation, I-TECH implemented a workplace-based, accreditation-focused mentorship model, intended to provide an effective means of accelerating the implementation of QMS to help labs prepare for accreditation. I- TECH mentors were embedded in each lab enrolled in the SLMTA program for extended periods of time, so they could develop in-depth understanding of lab operations, and provide day-to- day assistance in implementing QMS and preparing for accreditation. The workplace-based, accreditation-focused mentorship is an efficient tool in implementing SLMTA that impacted every laboratory process; I believe that positive and sustainable changes occurred at all levels in our laboratory. —Regional referral laboratory manager OBJECTIVES  Strengthening the laboratory QMS in I-TECH-supported labs.  Helping labs to improve quality of service, enabling them to assess both their own quality and their competence in implementing the ISO15189 requirement through WHO-AFRO’s SLIPTA program, and to pursue international accreditation.
  • 7. Workplace-Based, Accreditation-Focused Laboratory Mentorship 6 IMPLEMENTATION Prior to initiation of the mentorship program, laboratory technicians were trained according to SLMTA principles, applying the SLIPTA checklist and scoring system. This checklist sets out quality and competency requirements, aimed at developing and raising the quality of lab services to established national standards. The elements of this checklist are based on ISO standard 15189:2007(E). Accreditation-Focused Mentorship I-TECH laboratory mentors (who had taken SLMTA “Training of Trainers” courses) participated in the daily routines of each lab, providing 10 consecutive days of mentorship, with follow-up site visits thereafter. Ten I-TECH-supported laboratories were enrolled in the national SLMTA programs. During each program, each lab received a total of 30 days of mentorship, spread out over three rounds, with intervals of four weeks in between. Figure 1. Providing on-the-job mentorship to laboratory professionals To effectively implement SLMTA according to the 12 Quality Improvement Essentials, laboratory staff were mentored on a continuing basis, the aim being to achieve international standards for accreditation. Mentorship included support for implementing internal quality- control (IQC) procedures and external quality assessments (EQAs). Mentors also monitored lab performance using standardized checklists and tracked performance improvements.
  • 8. Workplace-Based, Accreditation-Focused Laboratory Mentorship 7 Quality-Improvement Projects Quality-improvement projects were designed by each laboratory, based on common gaps identified and addressed during the baseline audit. The projects were implemented by all staff, monitored for effectiveness using the WHO-AFRO checklist and completed before the next exit audit. Progress was monitored and reported by EPHI. Supportive Site Visits Supportive site visits were conducted by EPHI, regional referral laboratories and United States (US) government partners, who monitored the progress of quality improvement projects using checklists prepared for each specific project. Progress Evaluations National external audits conducted by the responsible accreditation authority (EPHI, in this case) assessed the quality of each laboratory enrolled in the first and second national SLMTA programs. This was done through a series of evaluations, using a comprehensive, standardized SLIPTA checklist and scoring system. Each lab was awarded a rating of one to five stars, based on performance. The audit checklist covered 12 quality-system components. Overall scores were calculated as percentages of the maximum points possible. To provide benchmarks for measuring progress, these scores were also defined with corresponding star levels (2):  Zero stars: <137 points  One star: 55%, or 138 points  Two stars: 65%, or 161 points  Three stars: 75%, or 186 points  Four stars: 85%, or 212 points  Five stars: 95%, or 237 points Under this scoring system, laboratories that demonstrate outstanding performance by achieving a five-star rating are entitled to enroll in an established international accreditation scheme. This five-step accreditation process is critical for improving quality so that labs will be able to gradually receive credit for their improvements and eventually attain accreditation.
  • 9. Workplace-Based, Accreditation-Focused Laboratory Mentorship 8 Figure 2. WHO-AFRO Laboratory Accreditation scheme: A stepwise approach towards quality improvement. (Gershy-Damet et al., 2010) At the end of each mentoring period, mentors, mentees and lab managers worked together to conduct exit audits to measure improvements in quality. (Exit audit results are also used to establish baselines for the next round of mentorships.) Differences between the baseline and exit audit scores were used to confirm improvements in quality.
  • 10. Workplace-Based, Accreditation-Focused Laboratory Mentorship 9 RESULTS Overall Performance Improvement in overall performance was observed at all but one of the laboratories enrolled in the two national SLMTA programs. The First National SLMTA Program (June 2010 – October 2011) Twenty-four public health laboratories in Ethiopia were enrolled in the first SLMTA program, of which five were supported by I-TECH. I-TECH provided a total of 30 days of focused mentorship, spread out over three rounds with intervals of eight weeks between each round. Audits were conducted before (baseline) and after (exit) SLMTA implementation, using the SLIPTA checklist. Internal Audits The five I-TECH-supported laboratories enrolled in the first national SLMTA program scored 0 (<1) stars on the baseline audit. Following the three rounds of focused mentorship, all five labs had improved their scores by one to three stars, according to the SLIPTA checklist and scores (Table 1). External (National) Audits External audit results showed that one laboratory (at the University of Gondar Hospital) earned a score of three stars; three labs earned two stars, and one laboratory earned one star. According to the overall national evaluation of the SLIPTA results for laboratories participating in the first program, the I-TECH-supported University of Gondar Hospital lab earned three stars, making it the best of the 24 labs participating. The Axum Hospital laboratory came in second, earning two stars. Table 1. SLIPTA scores of laboratories enrolled in the first national SLMTA program. I-TECH- Supported Laboratories1 Baseline (Internal) Audit Result 2 (stars) First Internal Audit Result3 (stars (points)) Second Internal Audit Result (stars (points)) Third Internal Audit Result (stars (points)) National (EPHI) Audit Result(stars) Axum HL 0 2 (170) 2 (178) 2 (173) 2 Gondar UHL 0 1 (144) 2 (170) 3 (210) 3 Bahir Dar RL 0 1 (146) 2 (172) 2 (170) 2 Dessie RL 0 1 (138) 2 (168) 2 (165) 1 Mekelle RL 0 1 (132) 1 (157) 2 (167) 2 1. HL: hospital laboratory. UHL: university hospital laboratory. RL: regional laboratory. 2. Audits conducted prior to mentorship intervention. 3. Internal audits conducted by I-TECH mentors.
  • 11. Workplace-Based, Accreditation-Focused Laboratory Mentorship 10 The Second National SLMTA Program (January 2011 – May 2012) Twenty-one laboratories participated in the second program, of which five were I-TECH- supported labs. Initially, all labs were at the zero-star level (i.e., with scores of <55%). Internal Audits Results showed that three of the I-TECH-supported laboratories (Dupti, Dessie, and Mekelle Hospitals) improved their average SLIPTA scores by one to two stars. The Maychew Hospital lab raised its score to three stars. On the other end of the scale, the Felege Hiwot Hospital lab averaged zero stars. External (National) Audits Mirroring the internal audit results, the Maychew Hospital laboratory earned three stars; the Dupti, Dessie, and Mekelle Hospital labs earned two stars; and the Felege Hiwot Hospital lab earned zero stars (Table 2). The major contributor to Felege Hiwot’s score was the laboratory’s poor infrastructure. Table 2. SLIPTA scores of laboratories enrolled in the second national SLMTA program. I-TECH-Supported Laboratories1 Baseline (Internal) Audit Result 2 (stars) First Internal Audit Result3 (stars (points)) Second Internal Audit Result (stars (points)) Third Internal Audit Result (stars (points)) National (EPHI) Audit Result(stars) Dupti HL 0 2 (166) 2 (168) 2 (172) 2 Dessie HL 0 1 (154) 1 (157) 1 (159) 2 F/Hiwot HL 0 <1 (103) <1 (125) 1 (128) 0* Maychew HL 0 1 (146) 2 (171) 3 (192) 3 Mekelle HL 0 1 (156) 2 (165) 2 (182) 2 1. HL: hospital laboratory. 2. Audits conducted prior to mentorship intervention. 3. Internal audits conducted by I-TECH mentors. According to the overall national evaluation of the 21 laboratories participating in the second program, the I-TECH-supported Maychew Hospital lab achieved the best score, being the first among the 21 laboratories earning three stars. Maychew earned 208 out of 250 SLIPTA points on the national exit audit of quality-system essentials. Another I-TECH-supported lab, at Dupti Hospital, came in second. The lack of improvement at Felege Hiwot hospital was related to a very poor infrastructure that was not conducive to change. The Hospital administration and ITECH embarked on a laboratory renovation project to improve the situation. The focused mentorship and SLMTA implementation helped to engage hospital and senior management, creating a strong commitment to ensure ownership and accountability of the
  • 12. Workplace-Based, Accreditation-Focused Laboratory Mentorship 11 program, team spirit among lab staff and willingness to build a culture focused on quality and problem solving. CHALLENGES  High turnover of laboratory staff, especially among staff trained in quality-management and SLMTA procedures, and in biosafety, often caused inconsistency in the quality of mentorship and delays in the SLMTA process.  Lack of strong commitment and ownership of the accreditation process among facility management, who tended to consider SLMTA and the WHO-AFRO SLIPTA as US government partner programs. Moreover, the inability of facility management to assume responsibility for the program made it difficult to address site-specific deficiencies.  Lack of a sense of urgency among stakeholders and responsible authorities (e.g., the RHBs) to adequately implement the stepwise quality improvement process and assume the costs of implementing and sustaining SLMTA.  Changing poor laboratory habits has been a slow process, contributing to delays in improvement:  The program required more time and resources than the labs had anticipated.  Maintenance of broken equipment was often delayed or not performed.  Poor physical infrastructure at some of the labs impeded workflow and safety procedures that, in turn, impeded the quality-improvement process. The SLMTA program implementation and the routine laboratory service provision are not integrated, and this disintegration resulted in a delay of SLMTA implementation, consequently lowering SLIPTA scores. —Referral hospital laboratory manager
  • 13. Workplace-Based, Accreditation-Focused Laboratory Mentorship 12 LESSONS LEARNED Laboratory mentorship is a dynamic process, aimed at improving the diagnostic skills of lab technicians, the quality of services provided, and patient care. Achieving international quality standards (through accreditation) is a continuous process of improvement. An accreditation-focused, workplace-based approach to mentorship was developed (adapted) and implemented in I-TECH-supported laboratories, in collaboration with regional labs. I-TECH has provided laboratory mentorship in many resource-limited countries, but the level of mentorship provided by I-TECH Ethiopia is unique in its focus on accreditation through stepwise quality improvements, helping to ensure that what is learned through training and mentoring is actually implemented in the field. This focused mentorship intervention is expected to guarantee that laboratory staff who have benefited from mentoring will be confident, and capable of evaluating both the quality of their own labs and their competence in implementing the ISO 15189 requirements through the WHO-AFRO stepwise laboratory quality improvement protocols. The stepwise approach recognizes that improvement takes time and often occurs in increments—especially in resource-limited settings like Ethiopia. External evaluation is the hallmark of accreditation, ensuring customers that laboratory services meet acceptable quality and safety standards. Embedding full-time mentors within the daily routines of laboratories over extended periods of time enabled mentors to more fully understand the work culture, practices and people at those labs, giving them enough time to foster positive changes.
  • 14. Workplace-Based, Accreditation-Focused Laboratory Mentorship 13 I-TECH mentor providing accreditation-focused mentorship to laboratory technicians at Maychew Hospital Involvement of facility management in the mentorship process is critical to the success of QMS implementation, as the direct support of management is required in significant areas—e.g., funding for procurement of supplies, staffing, and challenges that may occur during the mentoring process. Unless management is fully committed to understand and support the process, whatever efforts [are] made in implementing SLMTA towards WHO-AFRO/SLIPTA will never succeed. —Regional referral laboratory manager Sufficient engagement on the part of mentees is also critical, since it enables mentors to assist with the smooth, uninterrupted implementation of SLMTA and shortens the amount of time required for labs to function on their own. Staff motivation was also noted as a key driver in SLMTA implementation. The perception of SLMTA/WHO-AFRO/SLIPTA among laboratory quality-assurance officers and facility managers is critical. In general, improvement projects that were initiated and developed during SLMTA training stimulated creativity, ownership and action among laboratory staff, and were great assets to the quality-improvement programs.
  • 15. Workplace-Based, Accreditation-Focused Laboratory Mentorship 14 CONCLUSIONS AND RECOMMENDATIONS The basic components of a laboratory QMS must be implemented at all levels of the laboratory pyramid. I-TECH’s experience demonstrates that significant improvements in this system, which will contribute to increased efficiency in both delivery and quality of service, can be achieved through structured, workplace-based, accreditation-focused mentorship. The accreditation focus of the mentorship program was shown to accelerate SLMTA implementation, enabling labs to develop effective QMS that produced rapid and measurable change—as evidenced by the jump from zero stars on the baseline audit to two and three stars on the exit audit. Quality laboratory services have wide-reaching benefits for Ethiopia’s health care system improvement goals. Increased access to effective, reliable diagnostic services will support better patient care, improve the health care system and support achievement of Millennium Development Goals. The workplace-based, focused mentorships resulted in measurable improvement towards preparation for the WHO-AFRO SLIPTA process in less than six months. The WHO-AFRO stepwise quality improvement program uses internationally accepted standards, adapted to local environments and scalable to meet lab complexity requirements. It also uses an incremental, stepwise approach that is objectively measurable over time, employs a positive- reinforcement approach to continuous quality improvement—and is affordable. Accreditation also brings Ethiopia’s laboratories closer to the international community of laboratory experts, allowing lab technicians and leaders to contribute to and learn from global expertise on effective lab procedures, challenges and best practices. Focused mentorship is also an effective means of 1) determining whether a laboratory is providing accurate and reliable results; 2) determining whether the lab is well managed and adhering to good lab practices; and 3) identifying areas for improvement. It is recommended that the workplace-based, accreditation-focused mentorship be incorporated into laboratory quality-management training programs such as SLMTA. This will accelerate the quality-improvement process and the progress of labs towards achieving accreditation. The critical elements to be considered when setting up a long-term, sustainable and well- structured mentorship program include: well-defined goals, sufficient length of on-site mentor engagement, selection and training of mentors, a standard approach across laboratories, and
  • 16. Workplace-Based, Accreditation-Focused Laboratory Mentorship 15 measurement of progress using standardized tools, well-structured reporting mechanisms, as well as alignment of the program with overall national (FMOH) plans. Given the results achieved during the two national SLMTA programs, it is clear that the focused mentorship program played a key role in implementation of the SLMTA program, and must be sustained. In addition, the regional laboratories must be empowered to oversee and follow-up on the progress of SLMTA implementation.
  • 17. Workplace-Based, Accreditation-Focused Laboratory Mentorship 16 REFERENCES 1. Gershy-Damet GM, Rotz P, Cross D, et al. The World Health Organization African Region Laboratory Accreditation Process: Improving the quality of laboratory systems in the African region. Am J Clin Pathol. 2010; 134(3):393–400. 2. World Health Organization’s Regional Office for Africa. WHO AFRO Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Checklist [document on the Internet]. c2012 [cited 2014 May 31]. Available from: http://www.afro.who.int/en/clusters-a-programmes/hss/blood-safety-laboratories-a- health-technology/blt-highlights/3859-who-guide-for-the-stepwise-laboratory- improvement-process-towards-accreditation-in-the-african-region-with-checklist.html 3. Ethiopian Health and Nutrition Research Institute. Five-Year, Balanced Scorecard-Based Strategic Plan (2010–2015). Addis Ababa: EHNRI; 2010. 4. Ethiopia Ministry of Health. Master Plan for the Public Health Laboratory System in Ethiopia 2009–2013. 2nd ed. Addis Ababa, Ethiopia: Federal Ministry of Health; 2009. 5. Hiwotu TM, Ayana G, Mulugeta A, et al. Laboratory System Strengthening and Quality Improvement in Ethiopia. Afr J Lab Med. 2014;3(2), Art. #228, 6 pages.