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The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices

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For a clinical study in the European research network on better diagnosis for neglected infectious diseases (NIDIAG) project (Better Diagnosis of Neglected Infectious Diseases: www.nidiag.org), we developed Standard Operating Procedures (SOPs), which we implemented in a basically equipped laboratory in a 380-bed rural hospital (“Hopital General de Reference Mosango”) in the Kwilu province in the Democratic Republic of the Congo (DRC). The study aimed to improve the early diagnosis of severe and treatable infections among patients with neurological disorders and took place over a 20-month period (14/09/2012–24/05/2014) (ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT01589289","term_id":"NCT01589289"}}NCT01589289). The set of 50 SOPs (S1 Appendix), all in French, include procedures related to the inclusion and clinical management of patients with neurological disorders (n = 4), diagnostic testing (n = 33), data collection and management (n = 5), and quality assurance (n = 8).
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SYMPOSIUM
The Art of Writing and Implementing
Standard Operating Procedures (SOPs) for
Laboratories in Low-Resource Settings:
Review of Guidelines and Best Practices
Barbara Barbe
´
1
*, Kristien Verdonck
1
, Deby Mukendi
2
, Veerle Lejon
1,3
, Jean-Roger Lilo
Kalo
2
, Emilie Alirol
4
, Philippe Gillet
1
, Ninon Horie
´
4
, Raffaella Ravinetto
1,5
,
Emmanuel Bottieau
1
, Cedric Yansouni
6
, Andrea S. Winkler
7,8
, Harry van Loen
1
,
Marleen Boelaert
1
, Pascal Lutumba
2,9
, Jan Jacobs
1,10
1Institute of Tropical Medicine, Antwerp, Belgium, 2Institut National de Recherche Biome
´dicale, Kinshasa,
Democratic Republic of the Congo, 3Institut de Recherche pour le De
´veloppement, Montpellier, France,
4Geneva University Hospitals, Geneva, Switzerland, 5Department of Pharmaceutical and
Pharmacological Sciences, KU Leuven, Leuven, Belgium, 6JD MacLean Centre for Tropical Diseases,
McGill University Health Centre, Montreal, Canada, 7Department of Neurology, Technical University of
Munich, Munich, Germany, 8Centre for Global Health, University of Oslo, Oslo, Norway, 9Universite
´de
Kinshasa, Kinshasa, Democratic Republic of the Congo, 10 Department of Microbiology and Immunology,
KU Leuven, Leuven, Belgium
*bbarbe@itg.be
For a clinical study in the European research network on better diagnosis for neglected infec-
tious diseases (NIDIAG) project (Better Diagnosis of Neglected Infectious Diseases: www.
nidiag.org), we developed Standard Operating Procedures (SOPs), which we implemented in a
basically equipped laboratory in a 380-bed rural hospital (“Hôpital Général de Référence
Mosango”) in the Kwilu province in the Democratic Republic of the Congo (DRC). The study
aimed to improve the early diagnosis of severe and treatable infections among patients with
neurological disorders and took place over a 20-month period (14/09/2012–24/05/2014) (Clin-
icalTrials.gov Identifier: NCT01589289). The set of 50 SOPs (S1 Appendix), all in French,
include procedures related to the inclusion and clinical management of patients with neurolog-
ical disorders (n = 4), diagnostictesting (n = 33), data collection and management (n = 5), and
quality assurance (n = 8).
In this symposium paper, we (i) review current standards and guidelines about writing and
implementing laboratory SOPs, (ii) discuss best practices for writing and implementing labora-
tory SOPs in low-resource settings, and (iii) share some lessons learned in the NIDIAG study
in the DRC. This paper targets clinical investigators of Neglected Tropical Diseases (NTDs),
but also laboratory managers involved in routine patient care and policy makers developing
national laboratory regulations in low-resource settings.
Why are SOPs important?
SOPs are written step-by-step instructionson how to carryout procedures correctly. SOPs are
meant to ensure consistency, accuracy, and quality of data [1]. SOPs harmonize laboratory
practices, reduce user errors, and can be used as training tools. Moreover, they help ensure
compliance to the study protocol, regulations, and international standards. SOPs are the main
building blocks of a laboratory quality assurance framework and are, as such, embedded in the
PLOS Neglected Tropical Diseases | DOI:10.1371/journal.pntd.0005053 November 3, 2016 1 / 12
a11111
OPEN ACCESS
Citation: Barbe
´B, Verdonck K, Mukendi D, Lejon V,
Lilo Kalo J-R, Alirol E, et al. (2016) The Art of
Writing and Implementing Standard Operating
Procedures (SOPs) for Laboratories in Low-
Resource Settings: Review of Guidelines and Best
Practices. PLoS Negl Trop Dis 10(11): e0005053.
doi:10.1371/journal.pntd.0005053
Editor: Patricia V. Aguilar, University of Texas
Medical Branch, UNITED STATES
Published: November 3, 2016
Copyright: ©2016 Barbe
´et al. This is an open
access article distributed under the terms of the
Creative Commons Attribution License, which
permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Funding: This work is part of the NIDIAG European
research network (Collaborative Project) supported
by the European Union’s Seventh Framework
Programme for research, technological
development and demonstration under grant
agreement no 260260. The funders had no role in
study design, data collection and analysis, decision
to publish, or preparation of the manuscript.
Competing Interests: The authors have declared
that no competing interests exist.
Quality Management System (QMS), which defines and rules the quality organization and
management of a laboratory service.
By their nature and objective, SOPs connect to all other building blocks of the QMS, such as
organization and personnel, equipment,procurement, process control, biosafety, and correc-
tive and preventive actions. Within a laboratory QMS, SOPs (or procedures) are considered as
documents together with policies, processes, and forms [2]. SOPs are subject to version control
(e.g., versionnumber and date), review and approval, distribution and implementation, update
and revision, and archiving of superseded versions. Training of staff on SOPs (with competence
assessment) is an essential QMS requirement and connects the SOPs to the “organization and
personnel” building block [2].
How to write and implement SOPs?
We reviewed QMS documents (identified through an unstructured internet search) that
address SOP development. We also searched for evidence about legibility, readability, and
comprehensibility of other written documents (i.e., package leaflets of medicines and medical
devices). S2 Appendix gives the scope and content of the assessed documents.
A well-conceived template of the SOP assures completeness and
comprehension
QMS standards and guidance documents vary in scope and level of detail about SOP content,
formatting, and version control (Table 1). The Clinical and Laboratory Standards Institute
(CLSI) QMS02-A6 guideline, the World Health Organization (WHO) Laboratory QMS hand-
book, and the Strengthening Laboratory Management Toward Accreditation (SLMTA) provide
the most extensive information [13]. They highlight the importance of a logical and consistent
structure and promote the use of a template in order to assure completeness and comprehen-
sion [12]. Table 2 describes the SOP template recommended by CLSI QMS02-A6. It com-
prises 17 sections and is, therefore, comprehensive but long. Of note, none of the SOP
templates recommended by the assessed QMS documents include a separate section about
waste management.
The art of SOP writing: Legibility, readability, and comprehensibility
Apart from the QMS documents in Table 1, we aggregated additional guidelines for clarity of
writing, mostly about writing for patients and health care workers (Table 3). Legibility is
defined as the easewith which a reader can recognizethe characters and words in a text. It is
mainly determined by typography (e.g., font and point size). Readability measures the com-
plexity of words and sentence structure (e.g., numbers of syllables in a word, difficulty of
words, and sentence length). Comprehensibility (also referred to as “comprehension”) refers to
whether or not a reader understands the intended meaning of a text and is able to draw the cor-
rect conclusions. [10]
The guidelines we assessed give different recommendations on legibility. There is no agree-
ment on font types (with or without serifs) or font sizes: a minimum type size of nine points
(font “Times New Roman, not narrowed) with space between the lines of at least 3 mm (for
package leaflets) versus type sizes of 10–14 points (for laboratory documents, user manuals,
and medical device labeling) have been recommended [2,1113]. As for design and layout,
emphasis is put on the proper use of white space, headers and templates, and bulleted or num-
bered lists. Graphics are promotedif they are clear, simple, precise, and depictedat appropriate
size and resolution. Drawings are preferred over pictures [12,14]. Box 1 lists the basic principles
of SOP writing.
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Table 1. Overview of laboratory QMS standards and guidance documents and the information they include about writing and implementing SOPs.
Name Title Edition Category Document
type
Job
aids
SOP
topics
SOP
content
Formatting
and layout
Readability Language Use of
graphics
Document
control
Review/
approval
Availability/
distribution
Pretesting Training Implementation Ref
ISO
17025:2005
General
requirements for the
competence of
testing and
calibration
laboratories
2nd Nonclinical International
standard
a
+
b
+ − − + + + +[4]
ISO
15189:2012
Medical laboratories
—Requirements for
quality and
competence
3rd Clinical International
standard
+/
c
+ + +/+/− − +++[5]
JCI 2010 Accreditation
standards for
clinical laboratories
2nd Clinical International
standard and
guideline
+ + +/− − +/+/ +[6]
WHO GCLP
2009
Good clinical
laboratory practice
(GCLP)
1st Clinical International
standard
+ − − +/+/++[7]
CLSI
QMS01-A4
2011
QMS: A model for
laboratory services
4rd Clinical International
guideline
+− − + ++
d
++ + +[8]
CLSI
QMS02-A6
2013
QMS: Development
and management of
laboratory
documents
6th Nonclinical International
guideline
++ ++ ++ +/− − ++ ++ + + + [2]
WHO LQMS
handbook
2011
Laboratory QMS
handbook
1st Clinical International
guideline
++ + +/ − − ++ + + + +/[1]
SLMTA 2009 SLMTA 1st Clinical International
guideline
+/− − + +/+/+/− − + +/++ +/[3]
CLSI, Clinical and Laboratory Standards Institute; ISO, International Organization for Standardization; JCI, Joint Commission International; (L)QMS, (Laboratory) Quality
Management System; SLMTA, Strengthening Laboratory Management Toward Accreditation; SOP, Standard Operating Procedure; WHO, World Health Organization. Categories
are “clinical” (in context of patient care) and “nonclinical” (laboratory work not related to patient care, clinical research). Document types are categorized according to Datema et al. [9].
S2 Appendix gives the scope and content of the documents and their organizations.
a
” Not mentioned
b
“+” Detailed
c
“+/” Mentioned but not detailed
d
“++” Extensively detailed
doi:10.1371/journal.pntd.0005053.t001
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Testing for readability
Readability can be assessed by formulas and is expressed as the grade level (years of formal edu-
cation) needed to easily read the text [10]. Examples are the Simple Measure of Gobbledygook
grading (McLaughlin 1969) and the Flesch–Kincaid grade level. Some readability formulas are
part of text processing programs such as Microsoft Office Word 2010. Recommended grade
levels are a maximum of 6th grade for patient education material [15,16]. The United States
Food and Drug Administration (FDA) guidelinesrecommend 6th or 7th grade [12] up to a
maximum of 8th grade level [13] to reach most of the population of the United States. It should
be noted that theserecommendations are meant for documents written for patients and that
the audience targeted by laboratory SOPs is different. Most laboratory staff have a good educa-
tion level and are trained in understanding technical documents. None of the QMS documents
recommend readability testing of SOPs, and to our knowledge, it is rarely practiced for SOPs.
Furthermore, the reading level of a text does not reflect its comprehensibility as reading formu-
las do not take into account the content or the organization of a text.
Assessing comprehensibility of SOPs through pretesting
To enhance its comprehensibility, each SOP should be pretested and adapted before finaliza-
tion. Pretesting is the systematic and formal gathering of user reactions after reading a docu-
ment and is a prerequisite to distribution,training, and implementation [1113]. The
European Commissionguideline explains the concept of usertesting, discusses the testing of
multiple language versions, and describes a method for pretesting package leaflets [11]. The
FDA guidelines discuss different methods for pretesting such as focus group interviews, indi-
vidual in-depth interviews, questionnaire surveys, and operator performance studies [1213].
Of note, none of the QMS documents cites nor recommends pretesting, except for CLSI
Table 2. SOP template with section headings according to CLSI guideline QMS02-A6 2013 [2].
1 Purpose
2 Scope/applicability
3 Reagents/media
4 Supplies/materials
5 Equipment
6 Safety precautions
7 Sample requirements
8 Quality control
9 Procedure
Qualitative method: Quantitative method:
10 - Expected results - Calculations
11 - Interpretation - Reference interval
12 - Critical values - Critical values
13 - Results reporting - Results reporting
14 - Method performance specifications - Method limitations
15 References
16 Related documents (forms, job aids)
17 Attachments/appendices
CLSI, Clinical and Laboratory Standards Institute; QMS, Quality Management System; SOP, Standard
Operating Procedure.
doi:10.1371/journal.pntd.0005053.t002
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Table 3. Overview of guidance on legibility and readability of labeling and instructions for use of medicinal products and medical devices.
Name Title Edition Required
contents
Formatting
and lay-out
Readability Language Use of
symbols/
graphics
Document
control
Review/
approval
process
Availability/
distribution
Pretesting Training Implementation Ref
ENTR/
F/2/SF/
jr(2009)
D/869
Guideline on the
readability of the
labeling and package
leaflet of medicinal
products for human use
2nd
a
++
b
++ +
c
+− − ++ [11]
FDA
1993
"Write it right"—
Recommendations for
developing user
instruction manuals for
medical devices used in
home health care
1st ++ ++ ++ − − + ++ [12]
FDA
2001
Guidance on medical
device patient labeling;
Final guidance for
industry and FDA
reviewers
1st + ++ ++ ++ − − ++ [13]
FDA, United States Food and Drug Administration.
a
” Not mentioned
b
“++” Extensively detailed
c
“+” Detailed
doi:10.1371/journal.pntd.0005053.t003
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guideline QMS02-A6. This guideline mentions document verification as part of the review pro-
cess (see below), which can be considered as a form of pretesting [2].
Writing, review and approval of SOPs: Who does what?
An SOP should be written by a person who knows the procedure [2] and, if possible, by the
staff that will follow the instructions. The review process should also involve people outside of
the writing process, to ensure that the SOP can be used by persons that are not familiar with
the topic. CLSI recommends several rounds of reviews by different laboratory staff, focusing on
different aspects per review round. CLSI also recommends document verification to ensure
that by following the procedure the correct end result is obtained. This can be done, for exam-
ple, by asking the laboratory staff who were not involved in writing and reviewing to perform
the procedure exactly as is written in the SOP [2]. Apart from the review process during the
SOP development, revisions are required on a regular basis (e.g., annual or biannual review),
while updates may occur at any time, when needed.
Finally, the SOP is approved by the laboratory management, e.g., by circulating a signature
page together with the SOP or by an electronic sign-off. SOP approval ensures that the content
of the SOP is known to the managers and that they approve the use of the SOP by the staff.
SOP approval also allows coordinated and timely implementation of the SOP on-site. An
approval procedure should be established, specifying the individuals involved (by their posi-
tions or functions) and the order in which approvals are given. [2]
Box 1. Basic principles on the art of SOP writing
Use a unique and meaningful title
Write in simple language: simple words with a maximum three syllables, sentences
with a maximum of 25 words, avoid formal language
Choose legible font and font size (e.g., Arial, 11 point type)
Use SOP templates
Do not use more than two levels of headings
Use active voice, use “you”
Turn any list into a bulleted or numbered list
Put instructions in a logical order
Be precise, use concrete examples
Put warnings/precautions before the action
First put the instruction, then the reasoning
Stress important information (capitals, bold, colour)
Avoid abbreviations and acronyms
Use drawings and place them next to corresponding text
Drawings are preferred over pictures
Think about resolution, color, and size
Use job aids
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SOP management
A controlled document master list should be kept by a dedicated document manager, specify-
ing the SOP names and identification numbers, the versions in use, and the effective dates and
locations of controlled copies. Copiesof SOPs need to be clearly labelledas approved and cur-
rent versions, while out-of-date versions must be removed from site. The SOP master file con-
tains the current and previous versions of the SOP and serves as the source for generating
working copies of current SOPs as well as a historic record, which is useful for audit and
inspection purposes. Obsolete versions should be clearly labeled as such, e.g., by means of a
notation or stamp. All SOPs need to be stored in a manner that prevents loss, damage, or unau-
thorized access and should promote easy retrieval. The retention duration of SOPs is defined
by regulations, accreditation requirements, study protocol requirements, and the sponsor’s
quality system [2].
Training of involved laboratory staff
Training takes place after approval and before distribution and implementation of the SOP.
Group training can be effective, if it allows time for discussion, questions, and answers. Individ-
ual hands-on training is recommended for more challenging or unfamiliar techniques and for
new laboratory staff. Training records (e.g., sign-in sheets) must be kept either in the SOP mas-
ter file or a group training file, but also in the individual’s training file [2].
On-site accessibility and visibility of SOPs and job aids
SOPs must be available where used [2]. For swift retrieval, consulting, and use, SOPs related to
laboratory work must be visible and accessible close to the bench rather than in a cupboard in
the quality manager’s office. A controlled copy of the original SOPs can be displayed (marked
as “copy”).
As to accessibility and visibility, so-called job aids are a valuable adjunct. Job aids are
instructions, lists, or quick reference materials derived from the main document and are used
when the full procedureis not needed at the time the task is performed [2]. They are designed
for direct use at the testing site and are meant to supplement but not replace SOPs [1]. Clear
job aids improved health workers performance during malaria rapid diagnostic tests (RDTs)
[1719]. Job aids are also subject to document control and can be included or referred to in the
“related documents” section of the SOP template [2]. Job aids should be posted in a place that
is clearly visible from the work space [1] (e.g., on the wall or on a dedicated display system/doc-
ument holder).
What are best practices for writing and implementing laboratory
SOPs in low-resource settings?
In low-resource settings, specific factors that may interfere with writing and understanding of
SOPs should be anticipated and addressed.
Language and terminology
Most laboratory staff in low-resource settings are not native English (or French) speakers and
are often not expert in the particular domain of care or research; therefore, their literacy level
may be lower than anticipated. This language barrier is often not overcome by simple transla-
tion into the locallanguage, as words in different languages are not always identical in meaning
and function [20]. In addition, producing a high-quality translation is labor intensive [21].
Web-based translation machines may be inaccurate: as an example, Google Translate only had
PLOS Neglected Tropical Diseases | DOI:10.1371/journal.pntd.0005053 November 3, 2016 7 / 12
an accuracy of 57.7% for the translation of common medical statements to 26 languages [22].
Apart from interlanguage differences, there is also the issue of terminology. For instance, the
“buffer” used for RDTs is also called “blood lysis buffer, “clearing buffer, “assay (or sample)
diluent, or “reagent, and the “specimen transfer device” may be named “tube, “straw, or
“pipette” [2324].
In this context, extra care should be taken to adhere to the aforementioned requirements of
legibility, readability, and comprehensibility of the SOP and to consistently use simple terms
and words. Graphics should be used to simplify the overall message, with preference for draw-
ings [12,14].
Cultural background
Concepts and symbols can be interpreted differently in different cultures [20,25]. A person’s
perception of a symbol varies across cultures [25] but also depends on training, educational
level, and professional experience[26]. Furthermore, even if quality systems have become a
dominant feature in industrial societies, this is not always the case elsewhere. In particular, a
QMS cannot hinge solely on written instructions in an environment with a strong oral culture.
Barriers to correct use and application of SOPs
Barriers to the correct application of SOPs include misunderstandings because of language or
jargon that’s too technical, lack of familiarity with written guidelines, lack of belief that SOPs
will improve practice, and lack of motivation to change practice [27]. The number, length, and
complexity of SOPs can also be a barrier to writing and implementation, as well as the language
issues. In addition, presbyopia (i.e., loss of eye lens accommodation that results in an inability
to focus at near distances) tends to occur frequently and at an early age in Africa [28]; it may
pass unnoticed and may affect reading, particularly in low light conditions.
To overcome these barriers, ownership by and dialogue with local users is crucial in SOP
development and during periodic reviews. Moreover, it is the ethical principle of “collaborative
partnership to engage local researchers and to share the responsibilities within a study [29].
SOPs should be developed on-site to produce best practices in accordance with the available
resources [27]. Adequate budget and staff should be allocated to pretest the draft SOPs and to
implement them once finalized. A training period should be foreseen [2], and continuous sup-
port should be available. Regular exchange with the local users and supportive site visits are
indispensable for guaranteeing correct use of SOPs.
What did we learn about SOP writing and implementation during
the NIDIAG study on neurological disorders?
Outlines and examples of SOP writing
All SOPs were prepared in compliance with a “SOP-on-SOP” and were based on the NIDIAG
SOP template. Examples of NIDIAG SOPs are given as supporting information (S1 Appendix,
S1 and S2 Figs). The NIDIAG SOP template includes a standardized header, title box, and five
section headings: (i) Scope and application, (ii) Responsibilities, (iii) Procedures, (iv) Records
and archives, and (v) Document history. For clarity and simplicity, we opted for these five sec-
tions only, rather than for the full list of 17 sections recommended by CLSI (Table 2); we also
considered that these five sections were the most relevant at the time for all concerned SOPs
(also for those SOPs outside the laboratory domain). Of note, we explicitly added “safety pre-
cautions (at the beginning of the procedure and before each step whenever appropriate) and
“waste management” as separate headings.
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Training and implementation
During the prestudy phase, the feedback of the study site team helped to refineand adapt the
SOPs to the local setting. Oncefinalized, the SOPs were used for on-the-job training of all staff
involved during the on-site pilot of the study. The compilation and version management of the
SOPs were handled by the NIDIAG Good Clinical Practice (GCP) focal point, who ensured
availability of the most recent versions on the NIDIAG website, allowing for timely distribution
to all concerned individuals.
Feedback from the study site: Challenges and opportunities
With hindsight, setting up and using this extensive SOP system in the NIDIAG project
required more time and effort than anticipated. This is in line with the observations on QMS
implementation in low-resource settings recently compiled by Luman and coworkers [30]. The
large number of SOPs proved to be impractical, and it was difficult to comply with every single
one of them. By contrast, job aids were perceived to be very useful in day-to-day research prac-
tice. They were provided as a supplement to a number of SOPs and were displayed on the walls
in plastic covers (S3 Fig).
Timely review of SOPs proved to be challenging in ourstudy because of unforeseen events
(e.g., changed kit contents that had an effect on test procedures). Due to the difficult internet
and telephone communication with the remote site, some procedural changes could pass unno-
ticed. Because of the high number of SOPs, small errors slipped in, causing a series of (minor)
revisions, which complicated document control and on-site SOP management. Also, on-site
implementation of SOPs did not always happen in time.
Most QMS documents (e.g., CLIA regulations 2011 and CLSI guideline QMS01-A4 2011
[31,8]) have been developed for high-resource settings, hence anticipating fast-track documen-
tation and distribution systems (e.g., by using specific software systems). As these are not avail-
able in low-resource settings, one could reconsider some of the QMS requirements. For
instance, it could be allowed to adapt SOPs on-site, after discussionwith the study quality man-
ager and the sponsor, and the site quality manager’s sign-off. The compilation of small changes
could then be adapted at once during the planned periodic revisions of SOPs, resulting in offi-
cial new versions only at specific time points, thereby facilitating distribution and implementa-
tion of these new versions. The key learning points about SOP writing and implementation
during the NIDIAG study are summarized in Box 2.
Conclusion
The development of a setof SOPs is essential for the good conductof a clinical study, such as
the NIDIAG study on neurological disorders. SOPs should be based on a template and kept
simple and short, while still including the minimal essential information to perform the task
correctly. Efforts should be made to ensure their legibility, readability, and comprehensibility.
Graphics (preferably drawings) should be added to aid comprehension. When relevant, safety
precautions and waste management should be included as separate sections. The use of job
aids is recommended(e.g., displayed on the wall), as theyare often more practical than fully
detailed SOPs.
The users should be involved in SOP writing, and local development of SOPs—together
with the site team—is encouraged. The language barrier, differences in terminology, and the
user’s cultural background have to be taken into account. Pretesting of SOPs and staff training
need to take place before distribution and implementation of SOPs. Continuous support of
local staff and regular site visits are needed to ensure SOP compliance and to allow timely revi-
sions and implementation of SOPs.
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Supporting Information
S1 Appendix. SOP Manual—Neurological Syndrome. Set of 50 SOPs used for the NIDIAG
study on neurological disorders.
(PDF)
S2 Appendix. Overview of the laboratory QMS and other documents assessed for the writ-
ing and implementation of SOPs.
(PDF)
S1 Fig. Example of a NIDIAG SOP using the NIDIAG SOP template, indicating some
important characteristics.
(PDF)
S2 Fig. Extract of SOP-WP2-LAB-35-V2.0-11Apr2014 on how to perform the SD Bioline
Malaria Ag PF/Pan RDT (SD 05FK60), showing the interpretation section. Clear drawings,
Box 2. Key learning points
1. When writing SOPs, think about:
Layout: use a template with standardized sections, with a maximum of two levels of
headings, and bulleted or numbered lists (the latter for chronological steps)
Legibility and readability:use a clear font and font size,simple words, simple sen-
tences, add drawings
Comprehensibility: pretest SOPs before finalization
Use job aids and display them on/near the bench
2. When considering writing and implementing SOPs for a study in low-resource
settings:
Engage local staff to develop the SOPs
Think about the language of the SOP (English, French, local language)
Take extra care in adhering to requirements of legibility, readability, and
comprehensibility
Take cultural differences into account: different meaning of words, terms, and sym-
bols, the use of written documents in a settingwith a strong oral culture
Think about possible impaired vision of the user and low light conditions (e.g., use
larger print)
3. When implementing the SOPs:
Make sure SOPs are distributed in a timely fashion and are accessibleto all staff
involved
Provide training on SOPs for all users and other implicated staff
Plan periodic revisions and updating of SOPs in use
Provide continuous support and regular site visits
PLOS Neglected Tropical Diseases | DOI:10.1371/journal.pntd.0005053 November 3, 2016 10 / 12
a flowchart, and a decisiontable are used. The SOP is basedon the generic WHO job aid of a
malaria RDT (http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/generic_
PfPan_training_manual_web.pdf).
(TIF)
S3 Fig. Job aid on the specimen types to be collected during the study. This job aid repre-
sents a table summarizing the NIDIAG study specimen numbering information extracted from
SOP-WP6-DOC-02-V02.1-18Sep2012, and was put as its annex five. The job aid has a clear
title linking it to an approved SOP, thus making it subject to document control. Font type Cali-
bri, and type sizes of 18 and 24 points were used for table text and headers, respectively, allow-
ing the text to be easily read when printed out and posted on a wall. The “bold” font style was
appropriately used to highlight the column titles and abbreviations.
(TIF)
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... Standard operating procedures (SOPs) and job aids can help ensure uniformity for various procedures (inclusion and examination of study participants, collection and storage of specimens for the laboratory, laboratory assays, data management and quality assurance). 54 All guidance documents for data collection (field manual) should be developed with care so that they are legible, readable and comprehensible. 54 Generic templates are available for several types of SOPs. ...
... 54 All guidance documents for data collection (field manual) should be developed with care so that they are legible, readable and comprehensible. 54 Generic templates are available for several types of SOPs. 54 All data collection guidance tools should be available whenever and wherever the people involved in data collection need them. ...
... 54 Generic templates are available for several types of SOPs. 54 All data collection guidance tools should be available whenever and wherever the people involved in data collection need them. ...
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Over the past decade, two movements have profoundly changed the environment in which global health epidemiologists work: research integrity and research fairness. Both ought to be equally nurtured by global health epidemiologists who aim to produce high quality impactful research. Yet bridging between these two aspirations can lead to practical and ethical dilemmas. In the light of these reflections we have proposed the BRIDGE guidelines for the conduct of fair global health epidemiology, targeted at stakeholders involved in the commissioning, conduct, appraisal and publication of global health research. The guidelines follow the conduct of a study chronologically from the early stages of study preparation until the dissemination and communication of findings. They can be used as a checklist by research teams, funders and other stakeholders to ensure that a study is conducted in line with both research integrity and research fairness principles. In this paper we offer a detailed explanation for each item of the BRIDGE guidelines. We have focused on practical implementation issues, making this document most of interest to those who are actually conducting the epidemiological work.
... Lack of practice guidelines, standard operating procedures, protocols, check lists, and flow diagrams is a major challenge faced by clinical laboratories in countries with limited resources [1,2]. Even where protocols and standards are shared online by specialized international bodies, they are usually not developed to meet the specific needs of low resource settings and are often unavailable in all required languages [3]. Implementation of internet-downloaded guidelines is often delayed or mishandled by the local staff, mainly because of complicated algorithms, unclear terminology, unavailable material, or outdated knowledge of the documents' users [2,3]. ...
... Even where protocols and standards are shared online by specialized international bodies, they are usually not developed to meet the specific needs of low resource settings and are often unavailable in all required languages [3]. Implementation of internet-downloaded guidelines is often delayed or mishandled by the local staff, mainly because of complicated algorithms, unclear terminology, unavailable material, or outdated knowledge of the documents' users [2,3]. Guidelines for laboratory medicine routines shall accommodate up-to-date information and shall present sufficient procedural details without being difficult to read or understand [4]. ...
... A new sample should be requested. One type ≥ 100 One type ≥ 10 5 Mixed growth of two types, one is significant 3,4 Both ≥ 100 Both ≥ 10 5 Mixed growth of two types, both are significant 3,4 > two types Not important Not important Mixed growth of several types 4 1 Culturing 1 µL urine. 2 Cultures without growth shall be reported as "negative" or "no growth observed". 3 Sub-culture and perform antimicrobial susceptibility testing on every significant growth. ...
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Chapter
Standard Operating Procedures (SOPs) are a set of detailed written instructions that are followed to complete the prerequisite tasks in an orderly fashion. The aim of an SOP is to obtain consistent results, which comply with Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). In academic organizations, SOPs have been given less importance primarily due to evolutionary nature of protocols. Standardized procedures are written in workbooks or Journals and never recorded as an SOP. Moreover, research guides are not from the pharmaceutical industry thus, they often lack exposure to Quality concepts which is mandatory in a regulated industry. Finally, academic institutes are not highly regulated as they are considered to be the centers of excellence and are mainly non-clinical, and have not completely transitioned into the clinical setup. Research on developmental issues in the Pharmaceutical industries are carried out in R&D units. However, operating procedures in the laboratory are a part of the Quality Management System of the US FDA Code of Federal Regulations (CFR), Title 21, and other guidelines governed by the International Standards Organization (ISO), especially 9001. This chapter aims to introduce the concept of operationalization of SOPs in a PhD training program as we transition from research to a clinical environment. This is a prerequisite for future commercialization while meeting all the regulatory compliances. SOPs are now being incorporated into the system to ensure a risk-averse procedure, which is a part of the quality system, thus ensuring consistency of protocols to ascertain reliable results that form the basis of future diagnosis and treatment.
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Background Since its introduction in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has been implemented widely throughout Africa, as well as in the Caribbean, Central and South America, and Southeast Asia. Objective We compiled results from local, national and global studies to provide a broad view of the programme and identify directions for the future. The review consists of two companion papers; this paper focuses on content analysis, examining various thematic components of the SLMTA programme and future priorities. Methods A systematic literature search identified 28 published articles about implementing the SLMTA programme. Results for various components of the SLMTA programme were reviewed and summarised. Results Local and national studies provide substantial information on previous experiences with quality management systems; variations on SLMTA implementation; building human resource capacity for trainers, mentors and auditors; the benefits and effectiveness of various types of mentorship; the importance of management buy-in to ensure country ownership; the need to instill a culture of quality in the laboratory; success factors and challenges; and future directions for the programme. Conclusions Local, national and global results suggest that the SLMTA programme has been overwhelmingly successful in transforming laboratory quality management. There is an urgent need to move forward in four strategic directions: progression (continued improvement in SLMTA laboratories), saturation (additional laboratories within countries that have implemented SLMTA), expansion (implementation in additional countries), and extension (adapting SLMTA for implementation beyond the laboratory), to lead to transformation of overall health systems and patient care.
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Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications - US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved.
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Background The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. Objectives There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. Method We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services. Results Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Conclusion Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.
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Graphical symbols on in vitro diagnostics (IVD symbols) replace the need for text in different languages and are used on malaria rapid diagnostic tests (RDTs) marketed worldwide. The present study assessed the comprehension of IVD symbols labelled on malaria RDT kits among laboratory staff in four different countries. Participants (n = 293) in Belgium (n = 96), the Democratic Republic of the Congo (DRC, n = 87), Cambodia (n = 59) and Cuba (n = 51) were presented with an anonymous questionnaire with IVD symbols extracted from ISO 15223 and EN 980 presented as stand-alone symbols (n = 18) and in context (affixed on RDT packages, n = 16). Responses were open-ended and scored for correctness by local professionals. Presented as stand-alone, three and five IVD symbols were correctly scored for comprehension by 67% and 50% of participants; when contextually presented, five and seven symbols reached the 67% and 50% correct score respectively. 'Batch code' scored best (correctly scored by 71.3% of participants when presented as stand-alone), 'Authorized representative in the European Community' scored worst (1.4% correct). Another six IVD symbols were scored correctly by less than 10% of participants: 'Do not reuse', 'In vitro diagnostic medical device', 'Sufficient for', 'Date of manufacture', 'Authorised representative in EC', and 'Do not use if package is damaged'. Participants in Belgium and Cuba both scored six symbols above the 67% criterion, participants from DRC and Cambodia scored only two and one symbols above this criterion. Low correct scores were observed for safety-related IVD symbols, such as for 'Biological Risk' (42.7%) and 'Do not reuse' (10.9%). Comprehension of IVD symbols on RDTs among laboratory staff in four international settings was unsatisfactory. Administrative and outreach procedures should be undertaken to assure their acquaintance by end-users.
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