The Art of Writing and Implementing
Standard Operating Procedures (SOPs) for
Laboratories in Low-Resource Settings:
Review of Guidelines and Best Practices
*, Kristien Verdonck
, Deby Mukendi
, Veerle Lejon
, Jean-Roger Lilo
, Emilie Alirol
, Philippe Gillet
, Ninon Horie
, Raffaella Ravinetto
, Cedric Yansouni
, Andrea S. Winkler
, Harry van Loen
, Pascal Lutumba
, Jan Jacobs
1Institute of Tropical Medicine, Antwerp, Belgium, 2Institut National de Recherche Biome
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
Kinshasa, Kinshasa, Democratic Republic of the Congo, 10 Department of Microbiology and Immunology,
KU Leuven, Leuven, Belgium
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 . 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
´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.
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 . 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 .
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
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 [1–3]. 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 [1–2]. 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
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. 
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 [2,11–13]. 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
Readability Language Use of
Pretesting Training Implementation Ref
requirements for the
2nd Nonclinical International
+− − − − + + + −+−
3rd Clinical International
+ + −+/−+/− − +−+−+−
JCI 2010 Accreditation
2nd Clinical International
−+ + −+/− − − +/−+/− − − +−
1st Clinical International
−+− − − − − +/−+/−+−+−
QMS: A model for
4rd Clinical International
−+− − +− − ++
++ + −+−
and management of
6th Nonclinical International
+−+ ++ ++ +/− − ++ ++ + −+ + 
1st Clinical International
+−+ + +/− − − ++ + + −+ +/−
SLMTA 2009 SLMTA 1st Clinical International
+/− − + +/−+/−+/− − + +/−+−+ +/−
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. .
S2 Appendix gives the scope and content of the documents and their organizations.
“−” Not mentioned
“+/−” Mentioned but not detailed
“++” Extensively detailed
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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 . 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  up to a
maximum of 8th grade level  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 [11–13]. The
European Commissionguideline explains the concept of usertesting, discusses the testing of
multiple language versions, and describes a method for pretesting package leaflets . The
FDA guidelines discuss different methods for pretesting such as focus group interviews, indi-
vidual in-depth interviews, questionnaire surveys, and operator performance studies [12–13].
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 .
6 Safety precautions
7 Sample requirements
8 Quality control
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
16 Related documents (forms, job aids)
CLSI, Clinical and Laboratory Standards Institute; QMS, Quality Management System; SOP, Standard
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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
Readability Language Use of
Pretesting Training Implementation Ref
Guideline on the
readability of the
labeling and package
leaﬂet of medicinal
products for human use
+− − − ++ − − 
"Write it right"—
instruction manuals for
medical devices used in
home health care
1st −++ ++ −++ − − + ++ − − 
Guidance on medical
device patient labeling;
Final guidance for
industry and FDA
1st + ++ ++ −++ − − − ++ − − 
FDA, United States Food and Drug Administration.
“−” Not mentioned
“++” Extensively detailed
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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 .
Writing, review and approval of SOPs: Who does what?
An SOP should be written by a person who knows the procedure  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 . 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. 
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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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 .
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 .
On-site accessibility and visibility of SOPs and job aids
SOPs must be available where used . 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 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 . They are designed
for direct use at the testing site and are meant to supplement but not replace SOPs . Clear
job aids improved health workers’ performance during malaria rapid diagnostic tests (RDTs)
[17–19]. Job aids are also subject to document control and can be included or referred to in the
“related documents” section of the SOP template . Job aids should be posted in a place that
is clearly visible from the work space  (e.g., on the wall or on a dedicated display system/doc-
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 . In addition, producing a high-quality translation is labor intensive .
Web-based translation machines may be inaccurate: as an example, Google Translate only had
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an accuracy of 57.7% for the translation of common medical statements to 26 languages .
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
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-
Concepts and symbols can be interpreted differently in different cultures [20,25]. A person’s
perception of a symbol varies across cultures  but also depends on training, educational
level, and professional experience. 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 . 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 ; 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 .
SOPs should be developed on-site to produce best practices in accordance with the available
resources . Adequate budget and staff should be allocated to pretest the draft SOPs and to
implement them once finalized. A training period should be foreseen , 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 . 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.
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
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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S1 Appendix. SOP Manual—Neurological Syndrome. Set of 50 SOPs used for the NIDIAG
study on neurological disorders.
S2 Appendix. Overview of the laboratory QMS and other documents assessed for the writ-
ing and implementation of SOPs.
S1 Fig. Example of a NIDIAG SOP using the NIDIAG SOP template, indicating some
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
• 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
• 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
3. When implementing the SOPs:
• Make sure SOPs are distributed in a timely fashion and are accessibleto all staff
• 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
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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_
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.
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