1.1
Overview of laboratory quality
A medical laboratory plays a vital role in disease prevention and control. Medical
laboratories are responsible for providing a correct diagnosis of continuing or past
infections, thus Quality in clinical laboratory has a vast impact on disease diagnosis
and patient management. Providing accurate and reliable diagnosis rather than empirical
diagnosis counteracts resources wasting, worsening patient's health condition and
drug resistance. A study indicates that about 6% to 12% of laboratory errors direct the clients (patients)
at danger of incongruous care and expose them to adverse effects, and negative impact
on different dimensions of patient management been contributed by 26% to 30% of errors
(Fausta, 2011).
In consideration of the above-said roles of quality in the laboratory, the gapes of
status of public clinical laboratories and the ISO 15189 requirements for quality
and competence, Tanzania adopted the SLMTA program for laboratory quality improvement.
Its purpose was to strengthen laboratory management for immediate and measurable laboratory
transformation, where the External quality Assessment was among the major indicators
to measure the improvement. SLMT program involves three short sessions of training
laboratory personnel from selected laboratories in different Cohorts, followed by
mentorship session to the site of work (hands-on training) (SLMTA, 2008).
1.2
Approach to laboratory Quality improvement
In the past one decade, health care in Sub-Saharan Africa was paying attention to
communicable diseases particularly Tuberculosis (TB), Human immunodeficiency virus
(HIV) infections and AIDS, and malaria (Petti et al., 2006). The diagnosis confirmation and treatment and monitoring of these diseases were
to depend on Laboratory investigations, nevertheless, the utilization of laboratories
tests was undervalued and uncared (Andric & Massambu, 2006). Stakeholders had no trust
in the laboratory outputs, but also they fail to recognize that laboratory diagnosis
is of paramount to the prevention and treatment of diseases. Hence, the needs for
demanded devote in clinical laboratory services in Africa were highlighted (Petti et al., 2006).
Clinical/Medical laboratories are dependable for providing a correct diagnosis of
continuing or past infections for proper disease management (WHO, 2008), thus laboratory
quality assessment (LQA) in clinical laboratory become the stamina of laboratory performance
as quality has the vast impact on disease diagnosis and patient management (Jegede
et al., 2015). Implementation and /or strengthening of LQA programs give a country to recover
the trustworthiness of laboratory services and reproducibility of results (Jegede
et al., 2015).
The meetings of African laboratory network in Harare (2002) and that in Addis Ababa
(2006) followed by Maputo declaration, intended to strengthen clinical laboratory
systems for quality health services (The Maputo declaration, 2008). The International
Organization for Standardization (ISO, 2012 E) has suggested monitoring and evaluation
of quality management system (QMS) in a clinical laboratory as quality advancement
attempt for quality laboratory services. Following the WHO Regional Committee for
Africa resolutions (WHO-AFR/RC58/R2), several activities for capacity building by
the member countries has been implemented (WHO, 2008). In 2010 Tanzania through the
Ministry of Health and Social welfare (MoHSW) "by then" adopted SLMTA Program as an
option approach to train Laboratory managers and quality officers from 12 laboratories
(6 regional, and 6 districts laboratories) in cohort-1 as selected by the Country's
Laboratory Task Force and 18 (14 regional, 1 special, 2 faith-based and 1 private)
laboratories in Cohort-2 (Andric & Massambu, 2014), on LM and QMS, to generate assessable
improvements as per international clinical laboratory standards (SLMTA, 2008).
To improve laboratory services, a constant monitoring and assessments of the LQMS
are vital. Jegede in Nigeria also described the key measures for improving laboratory
services should sight on the total testing process, the use of quality indicators
to site improvement opportunities and estimate efficacy of specific interventions
thus to meet the LQMS main objectives- accurate and precise results in a timely manner
and meeting patient's needs and client satisfaction (Jegede et al. 2015). "The clinical
laboratory is the epicentre of the health care sector" (Chawla et al., 2010, par.
1). Empirical diagnosis is a carry out that waste resource and contributes to drug resistance
as well (World Health Organization, 2008).
1.3
Laboratory tests involved
Focusing on three (HIV rapid tests, Haemoglobin level estimation, and blood smear
for malaria parasites (B/S)) among many laboratory tests that are performed in the
laboratory facilities, the researcher tried to consider the popularized and commonly
performed laboratory investigations as per infrastructures settings in most areas
of Tanzania. A consequential effect of misdiagnoses of any one of the three has a
threatening implication.
There are many transmittable diseases imitate malaria, leads to elevated rates of
over-diagnosis and overtreatment of malaria disease. Microscopy, considered to be
the gold standard for the diagnosis of malaria, is usually available at district hospitals.
However, it has only 70–75% accuracy (Amexo et al., 20014). The technique depends
on well-maintained equipment, good quality reagents, well-trained laboratory personnel,
and good quality assessment and supervisory systems.
1.4
Consequences of misdiagnosis
The consequences of misdiagnosis of malaria are felt at individual, household, and
national levels. Non malarial cases are treating as malaria, thus masks fundamental
potential deadly conditions. Individuals incorrectly diagnosed with malaria are exposed
to unnecessary side effects of drugs, while the factual cause will not be identified
or treated. This situation is likely to lead to extended and worsening illness with
loss of income or productivity and repeated visits to health facilities (Amexo et
al., 20014).
HIV misdiagnosis occurs as an HIV-uninfected person is inaccurately diagnosed as infected
with HIV by the laboratory test used or vice versa. There are numerous factors that
can lead or contribute to HIV misdiagnosis. Deviation from standardized testing guidelines
or algorithms, users errors like improperly performing test procedures, incorrectly
interpreting laboratory test results, non-compliance to SOPs as well as clerical errors
(Kufa et al., 2017). False-positive (FP) rates as high as 10.3% upon retesting have
been found in a number of settings (Kufa et al., 2017). The penalties for HIV misdiagnosis
are serious.
An FP HIV test result leads to unnecessary treatment of HIV-uninfected person and
also exposure to stigmatization and as well as exposure to psychological trauma that
is associated with HIV infection and the loss of credibility of laboratory facility
and HIV testing programs. On the other hand, FN HIV test results signify missed opportunities
for enrolled in HIV care and treatment and of course, the risk of unintentionally
HIV transmitting to uninfected partners (Kufa et al., 2017). To lessen the risk of
HIV misdiagnoses, Tanzania use approved testing algorithms as well as the execution
of HIV rapid test quality assessment (QA) programs (NHLQTC). Key facets of these programs
comprise training, retraining and mentoring of testing staff, conducting external
and internal quality controls, proficiency testing (PT) and external quality assessments
(EQAs) (Kufa et al., 2017).
1.5
Review on Quality performance
If considering the pilot laboratories in the study that was done by Nevalainen to
represent American current situation of laboratory quality performance during the
year 2000, then it demonstrates that for about ten years of quality assurance programs
in America yet, there had been no significant improvement in laboratory quality performance
among public laboratories (Nevalainen et al., 2000). Nevalainen statement was trying
to justify that addition of quality assurance components is not direct proportional
to quality improvement when it comes to practical point of view. His statement was
as a response to what Hilborne stated 12 years before, when explained the expansion
of quality assurance components of clinical laboratory necessitated the passage of clinical
laboratory improvement Act of 1967, in which participation in proficiency testing
became mandatory. However, Hilborne pointed out that the assessment to ensure conformity
with established guideline and standard Operational procedures (SOPs) is one of the
major quality assurance activities (Hilborne et al., 1988). Even in Tanzania settings
the issue of frequent auditing programme to assess lab services delivery is important.
Agarwal et al (2012) in Nigeria conducted a study in diagnostic laboratories that received more
than 42000 samples for different lab tests. They found that, following sensitization
of laboratory staff on quality performance; most significant quality improvement was
in pre-and post-analytical phase, however, did not significantly have much impact
on the analytical phase (Agarwal et al., 2012). This is the point why the researcher
thought of including the main quality indicators (IQCs, EQA & TAT) found in the analytical
phase, where the laboratory personnel are directly involved in their daily professional
practices.
Ricos and colleagues suggested that 11% is a tolerable proportion of lab result that
may go beyond the agreed TAT Ricos et al (2004). Chawla and colleagues in their study
that was done in New Delhi, India observed the factors that contribute to prolonged
TAT includes delay in analytical phase, lost test request forms, specimens, and reports.
Timely reporting may enhance patient management and clients’ satisfaction like what
Valenstein et al said in their study (Chawla et al., 2010: Valenstein et al., 2003).
Using quality indicators to monitor the laboratory quality system improvement is very
valuable means in systematic and transparency controlling the total laboratory testing
process.
Manickam and Ankanagari (2015), evaluated quality system implementation in large and
small sized laboratories which did or did not have knowledge of quality system operation
for accreditation, they did as per WHO checklist per the standards requirements for
accreditation (ISO 15189:2012) and the general score was 43% for process quality controls/external
quality assurance (PT). They concluded that the score was due to lack of simultaneous
training to improve performance, negligence in evaluating personnel performance, etc
(Manickam & Ankanagari, 2015). However, this low scores result could also be contributed
by lack of consistence documentation of records by the lab personnel thus the auditors
could not see evidence of the practice, reluctance of laboratory staff and poor managerial
skills of administrators. But again, the WHO checklist that was used, to some of the
laboratories was naïve, in contrast to the customized SLIPTA checklist that were used
in this study is familiar to the study participants for about eight years.
Andric and Massambu (2014) in their article titled “One laboratory’s progress toward
accreditation in Tanzania.” Said about the improvement of quality implementation in
Tanzania, the 81% score (three-star rate) from a 36% (zero-star level) was said to
be a remarkable achievement by the Amana Hospital Laboratory among the 12 laboratories
involved in the SLMTA program in the first cohort. This achievement by the Amana laboratory
could be due to less reluctance of the lab personnel that may be caused by the short
interval auditing practice conducted during the program. And this fact evidenced by
the findings by Andric in the same study in which they observed that seven month post
the completion of the SLMTA program, the laboratory declined to 62% score (one star-level)
(Andric & Massambu, 2014).
Regardless of ten years of implementing QLMS, quality performance crossways the entirety
laboratory testing process is not adequately better in Tanzania. The findings from
the current study add to the body of knowledge for what SLMTA program has contributed
in improving quality performance of medical laboratories, especially for HIV rapid
tests, Hemoglobin level estimation and Blood smears for malaria diagnosis.
We hypothesized that the public medical laboratories which are under SLMTA program
have better EQA performance, as compared to those which are not in the program. Hence
we aimed to determine performance and participation of SLMTA and non-SLMTA public
laboratories in external quality assessment in Morogoro and Iringa region in Tanzania.