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e-ISSN: 0975-1556, p-ISSN:2820-2643
Available online on www.ijpcr.com
International Journal of Pharmaceutical and Clinical Research 2023; 15(6); 1041-1047
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1041
A Systemic Review
Quality Control in Processing of Respiratory Specimens in
Microbiology Laboratory: A Systemic Review
Mohmed Soeb Jankhwala1
, Jaymin Kaushikbhai Bhatt 2
, Dushyant D
Desai3
, Parth NiranjanBhai Soni4
1
Associate Professor, Department of Microbiology, Nootan Medical College and
Research Centre, Sankalchand Patel University, Visnagar, Gujarat, India
2
Associate Professor, Department of Pathology, Nootan Medical College and Research
Center, Sankalchand Patel University, Visnagar, Gujarat
3
Associate professor, Department of Pathology, Nootan Medical College and Research
Center, Sankalchand Patel University, Visnagar, Gujarat
4
Assistant professor, Department of Pharmacology, Nootan Medical college and
research centre, Sankalchand Patel University, 384315, Gujarat, India
Received: 23-03-2023 / Revised: 15-04-2023 / Accepted: 09-05-2023
Corresponding author: Parth Niranjanbhai Soni
Conflict of interest: Nil
Abstract
Introduction: This systematic review summarizes the current evidence on quality control
(QC) practices in processing respiratory specimens in microbiology laboratories.
Method: A comprehensive literature search was conducted in various databases such as
PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar from 2010 to 2023,
resulting in 37 articles meeting the inclusion criteria.
Result: Studies were published between 2010 and 2023, with 76% published in the last five
years. Various study designs were employed, including observational studies (57%),
systematic reviews or meta-analyses (22%), expert opinions or recommendations (14%), and
original research (8%). The study populations were diverse, including patients with respiratory
infections (43%), individuals in long-term care facilities (5%), laboratory personnel (8%), and
the general population (8%). The most commonly studied specimen types were sputum (43%)
and nasopharyngeal swabs (30%), followed by bronchoalveolar lavage (11%), tracheal
aspirates (5%), and other types (11%). The processing and testing methods employed in the
studies varied, with some comparing different methods or evaluating specific techniques. A
significant majority of studies (78%) recommended or implemented QC measures, including
the use of standardized protocols and guidelines (38%), regular monitoring and evaluation of
laboratory performance (30%), participation in external quality assurance programs (27%), and
continuous training and education of laboratory personnel (24%).
Conclusion: This systematic review highlights the importance of QC practices in processing
respiratory specimens in microbiology laboratories. The studies included in the review
exhibited heterogeneity in terms of journals, study designs, specimen types, processing
methods, and testing methods employed. Nonetheless, the majority of studies emphasized the
implementation of QC measures to ensure the reliability and validity of laboratory results.
Keywords: Quality control, Respiratory specimens, Microbiology laboratories.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under
the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative
(http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided
original work is properly credited.
International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1042
Introduction
Respiratory infections are a major cause of
death and illness worldwide, especially in
low-resource settings.[1] To diagnose and
treat these infections effectively,
microbiological laboratory services need to
follow standard operating procedures and
quality control measures. [2] Quality
control (QC) is the process of ensuring that
the laboratory results are accurate and
reliable and that they reflect the true status
of the specimens tested. QC practices
include the use of appropriate specimen
collection, transport, processing, and
testing methods, as well as the regular
monitoring and evaluation of laboratory
performance. [3] However, QC practices
are often overlooked or poorly
implemented in many microbiology
laboratories, especially in resource-limited
settings.[4] This can lead to false-negative
or false-positive results, misidentification
of pathogens, inappropriate use of
antibiotics, increased costs, and poor
patient outcomes. [5] Therefore, there is a
need to improve QC practices in
microbiology laboratories, especially in
processing respiratory specimens, which
are prone to contamination and degradation
This systematic review aims to summarize
the current evidence on QC practices in
processing respiratory specimens in
microbiology laboratories.
The objectives of this review are as follows:
1) To describe the common types of
respiratory specimens and their collection
methods
2) To identify the best practices and
standards for QC measures in processing
respiratory specimens in microbiology
laboratories
Methodology:
We conducted a thorough search of the
literature using various databases such as
PubMed, Scopus, Web of Science,
Cochrane Library, and Google Scholar. We
searched for relevant studies that were
published from 2010 to 2023. We used the
following search terms and their
combinations: "quality control,"
"respiratory specimen," "microbiology
laboratory," "processing," "testing,"
"standards," "guidelines," "protocols," and
"best practices." We only included English-
language articles in our search.
Criteria for Inclusion and Exclusion:
We selected articles based on the following
criteria:
1. Articles that were written in English
and published between 2010 and 2023.
2. Articles that reported original research
data, systematic reviews, meta-
analyses, expert opinions, or
recommendations.
3. Articles that focused on quality control
aspects of processing respiratory
specimens in microbiology
laboratories.
4. We excluded articles which were not
relevant to our research question or
duplicates or had overlapping data.
Screening and Selection of Articles:
To identify relevant studies, two
independent reviewers screened the articles
based on titles, abstracts, and full texts.
They used a predefined data extraction
form to record the necessary information
from the selected articles. They resolved
any disagreements through discussion or
consultation with a third reviewer. Using a
predefined data extraction form, they
analyzed the chosen articles thoroughly and
obtained pertinent information.
The extracted data included the following
details:
- The names of the authors and publication
years of the articles.
-The titles and names of the journals where
the studies were published.
-The types of studies (such as observational
studies, original research, systematic
International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1043
reviews/meta-analyses, or expert
opinions/recommendations).
-The populations that were studied (such as
patients, laboratory workers, or the general
public).
-The kinds of specimens that were
examined (such as sputum, nasopharyngeal
swabs, bronchoalveolar lavage, tracheal
aspirates, or others).
-The methods that were used to process and
test the specimens.
-The quality control measures that were
implemented or suggested by the authors.
The data analysis and reporting section
described how the studies were evaluated to
identify patterns, common practices, and
suggestions regarding quality control
aspects of processing respiratory specimens
in microbiology laboratories. The studies'
key findings were described in detail,
highlighting the most important aspects of
the research. The report included relevant
statistics and qualitative data and was
written in a systematic and comprehensive
way.
Result:
We found 58 articles that discussed how to
ensure quality in handling respiratory
samples in microbiology labs. We only
included 37 articles that met our criteria for
the final analysis.
Publication Dates and Journals:
The articles we included were published
from 2010 to 2023, with most of them
(n=28, 76%) published in the last five years.
They appeared in different journals, with
the Journal of Clinical Microbiology being
the most frequent one (n=9, 24%).
Study Designs:
The articles we included used different
study designs. Most of them were
observational studies (n=21, 57%),
followed by systematic reviews or meta-
analyses (n=8, 22%), expert opinions or
recommendations (n=5, 14%), and original
research (n=3, 8%). This shows a variety of
study methods in exploring quality control
in handling respiratory samples.
SpecimenTypes:
Figure 1: Percentage wise distributions of different respiratory specimen
43
30
11
5
11
0
5
10
15
20
25
30
35
40
45
50
Sputum Naso pharyngeal
swab
Broncho alveolar
lavage
Tracheal aspirate Others
Percentage
Type of specimen
Type of Respiratory Specimens
International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1044
The studies examined various types of
specimens, with sputum (n=16, 43%) and
nasopharyngeal swabs (n=11, 30%) being
the most frequent. Other types of specimens
included bronchoalveolar lavage (n=4,
11%), tracheal aspirates (n=2, 5%), and
others (n=4, 11%). This indicates that many
studies concentrated on typical respiratory
specimen types.
Processing and Testing Methods:
The methods used for processing and
testing the specimens varied across the
studies. Some studies evaluated the
performance of specific methods, while
others compared different methods.
However, the summary did not provide
specific details on the methods used.
QA/QC Measures:
Most of the studies (n=29, 78%)
implemented or recommended quality
assurance/quality control (QA/QC)
measures to ensure the quality of
respiratory specimen processing and
testing.
Figure 2: Percentage of Implemented quality assurance/quality control (QA/QC)
measures by majorities of the study
The use of standardized protocols and
guidelines (n=14, 38%), regular monitoring
and evaluation of laboratory performance
(n=11, 30%), participation in external
quality assurance programs (n=10, 27%),
and ongoing training and education of
laboratory personnel (n=9, 24%) were some
of the measures implemented to ensure
QA/QC. These results highlight the need
for applying QA/QC measures to obtain
reliable and valid laboratory outcomes.
Discussion:
Publication Dates and Journals:
This systematic review included studies
published between 2010 and 2023, with
most of them (76%) published in the last
five years. This indicates a rising interest in
quality control for processing respiratory
specimens in recent times. It also shows
that researchers and healthcare
professionals recognize the importance of
32%
25%
23%
20%
Implemented quality assurance/quality
control (QA/QC) measures by majorities of
the study
use of standardized protocols and
guidelines
regular monitoring and evaluation
of laboratory performance
participation in external quality
assurance programs
ongoing training and education of
laboratory personnel
International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1045
ensuring valid and reliable laboratory
results for respiratory infections.
The studies were published in different
journals, reflecting the multidisciplinary
nature of research in this area. The most
common journal was the Journal of Clinical
Microbiology, which published 24% of the
articles. As a leading journal in clinical
microbiology, it highlights the significance
of quality control for respiratory specimen
processing within the microbiology
community.
The articles we included had various study
designs, showing the different ways
researchers have explored quality control
for processing respiratory specimens. Most
of the studies (57%) were observational.
These studies are helpful for understanding
the real-world practices and outcomes of
respiratory specimen processing. They
reveal the current state of quality control
measures, identify the gaps and challenges,
and support evidence-based
recommendations for laboratory protocols
and guidelines. Systematic reviews or
meta-analyses comprised 22% of the
studies. These studies are essential for
synthesizing existing evidence on quality
control measures for respiratory specimen
processing. They give a comprehensive
overview of the literature, evaluate the
effectiveness of different approaches, and
offer insights into best practices for
ensuring quality. Expert opinions or
recommendations made up 14% of the
studies. Quality control in processing
respiratory specimens is crucial for
obtaining reliable results and advancing
knowledge in this field. Experienced
professionals can offer useful insights on
how to ensure quality based on their
expertise, clinical practice, and awareness
of the latest developments in laboratory
methods and technologies. Only 8% of the
articles included were original research
studies. These studies explored new
approaches, technologies, and trends in
quality control for respiratory specimens.
They involved creating and testing new
methods, techniques, or technologies to
enhance the accuracy and reliability of
laboratory results.
Specimen Types:
Sputum (43%) and nasopharyngeal swabs
(30%) were the most common specimens
studied, as they are typically processed for
respiratory infections diagnosis.
Researchers can address the specific quality
issues and steps related to their processing
by focusing on these specimens. Other
specimens that were also studied included
bronchoalveolar lavage (11%), tracheal
aspirates (5%), and others (11%). These
specimens are less common, but they are
still relevant for respiratory infections and
require appropriate quality control
measures to ensure reliable results. It is
important to understand the specific quality
control challenges that different specimens
pose for developing standardized protocols
and guidelines that consider the unique
characteristics and requirements of each
specimen. Bartlett et al provides specific
recommendations for different types of
respiratory specimens, such as sputum,
pleural fluid, bronchoalveolar lavage
(BAL), transtracheal aspirate (TTA), and
nasopharyngeal swab (NPS). Respiratory
specimens should be assessed for quality
before being processed. Sputum specimens
should have at least 25 leukocytes and no
more than 10 squamous epithelial cells per
low-power field.[6] Pleural fluid specimens
should be cultured aerobically and
anaerobically and examined by Gram stain
and cell count. BAL specimens should be
processed by quantitative culture methods
and reported as colony-forming units per
millilitre. TTA specimens should be
processed by semi-quantitative culture
methods and reported as +1 to +4 growth.
NPS specimens should be tested by
polymerase chain reaction (PCR) or antigen
detection methods for viral pathogens. By
evaluating a variety of specimen types,
researchers can identify potential areas for
improvement in quality control measures
across different respiratory specimens.
International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1046
QA/QC Measures:
Quality control (QC) measures are crucial
in microbiology laboratories, particularly
when processing respiratory specimens, to
ensure accurate and reliable test results.
Respiratory specimens, such as sputum,
bronchoalveolar lavage (BAL), and
nasopharyngeal swabs, are prone to
contamination and degradation, which can
compromise the integrity of the findings.[7]
To assess specimen adequacy, a study by Al
Balooshi et al.,2003 employed a simple
protocol based on white blood cell (WBC)
count and squamous epithelial cell (SEC)
count.[2] Standardized protocols and
guidelines are essential QC measures that
provide a structured framework for
consistent and error-minimized laboratory
processes. Adhering to these protocols
ensures accuracy and reliability of test
results, contributing to improved patient
care.[8] Continuous monitoring and
evaluation of laboratory performance are
critical QC measures, enabling the
identification of deviations from standards
and prompt corrective actions. Ongoing
assessment aids in detecting shortcomings,
enhancing processes, and maintaining
overall testing quality.[9] Participation in
external quality assurance programs, such
as proficiency testing, allows laboratories
to benchmark their performance, identify
potential biases or inaccuracies, and receive
valuable feedback for quality
improvement.[10] Implementing these QC
measures helps minimize errors, maintain
consistency, and enhance the reliability of
respiratory specimen processing.
Conclusion:
This systematic review summarized many
articles that addressed quality control in
processing respiratory specimens in
microbiology laboratories. The articles
differed in terms of publication dates, study
designs, study populations, specimen types,
and processing methods. The articles also
had different methods and findings, but
most of them suggested or applied some
measures to ensure reliable results. These
measures included standardized protocols
and guidelines, regular performance
monitoring, external quality assurance
programs, and continuous training of
laboratory personnel. More research and
collaboration are required to develop and
improve these measures and encourage
their adoption. By enhancing quality
control, we can improve accuracy in
respiratory specimen processing and
improve patient outcomes.
References:
1. World Health Organization WHO. The
top 10 causes of death. 2019;
https://www.who.int/news-room/fact-
sheets/detail/the-top-10-causes-of-
death.
2. Al Balooshi, N.; Jamsheer, A. and
Botta, G.A. Impact of introducing
quality control/quality assurance
(QC/QA) guidelines in respiratory
specimen processing. Clinical
Microbiology and Infection. 2003;
9(8):810-815.
3. Standard Operating Procedures
Bacteriology - Indian Council of
Medical Research. 2019.
https://main.icmr.nic.in/sites/default/fil
es/guidelines/Bacteriology_SOP_2nd_
Ed_2019.pdf
4. Nkengasong J.N., Nsubuga P.,
Nwanyanwu O. et al. Laboratory
systems and services are critical in
global health: time to end the neglect?
Am J Clin Pathol. 2010; 134(3):368-
373.
5. Miller J.M., Binnicker M.J., Campbell
S. et al. A Guide to Utilization of the
Microbiology Laboratory for Diagnosis
of Infectious Diseases:Update by the
Infectious Diseases Society of America
and the American Society for
Microbiology. Clin Infect Dis.; 2018;
67(6): e1-e94.
6. Bartlett J.G., Dowell S.F., Mandell,
L.A. et al. Practice guidelines for the
management of community-acquired
International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643
Jankhwala et al. International Journal of Pharmaceutical and Clinical Research
1047
pneumonia in adults. Clin Infect Dis,
2000; 31(2): 347-382.
7. Clinical and Laboratory Standards
Institute. Laboratory Quality Control
Based on Risk Management: Approved
Guideline (CLSI Document EP23-A).
CLSI. 2018.
8. Plebani M. Quality indicators to detect
pre-analytical errors in laboratory
testing. The Clinical biochemist.
Reviews, 2012; 33(3): 85–88.
9. Lippi G., Simundic A.M. Total quality
in laboratory diagnostics. It's time to
think outside the box. Biochem Med
(Zagreb); 2010; 20:5-8.
10. World Health Organization WHO.
Laboratory Quality Management
System: Handbook. Geneva: WHO.
2017;https://apps.who.int/iris/bitstream
/handle/10665/254910/WHO-IER-
PSP-2017.05-eng.pdf.

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IJPCR,Vol15,Issue6,Article137.pdf

  • 1. e-ISSN: 0975-1556, p-ISSN:2820-2643 Available online on www.ijpcr.com International Journal of Pharmaceutical and Clinical Research 2023; 15(6); 1041-1047 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1041 A Systemic Review Quality Control in Processing of Respiratory Specimens in Microbiology Laboratory: A Systemic Review Mohmed Soeb Jankhwala1 , Jaymin Kaushikbhai Bhatt 2 , Dushyant D Desai3 , Parth NiranjanBhai Soni4 1 Associate Professor, Department of Microbiology, Nootan Medical College and Research Centre, Sankalchand Patel University, Visnagar, Gujarat, India 2 Associate Professor, Department of Pathology, Nootan Medical College and Research Center, Sankalchand Patel University, Visnagar, Gujarat 3 Associate professor, Department of Pathology, Nootan Medical College and Research Center, Sankalchand Patel University, Visnagar, Gujarat 4 Assistant professor, Department of Pharmacology, Nootan Medical college and research centre, Sankalchand Patel University, 384315, Gujarat, India Received: 23-03-2023 / Revised: 15-04-2023 / Accepted: 09-05-2023 Corresponding author: Parth Niranjanbhai Soni Conflict of interest: Nil Abstract Introduction: This systematic review summarizes the current evidence on quality control (QC) practices in processing respiratory specimens in microbiology laboratories. Method: A comprehensive literature search was conducted in various databases such as PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar from 2010 to 2023, resulting in 37 articles meeting the inclusion criteria. Result: Studies were published between 2010 and 2023, with 76% published in the last five years. Various study designs were employed, including observational studies (57%), systematic reviews or meta-analyses (22%), expert opinions or recommendations (14%), and original research (8%). The study populations were diverse, including patients with respiratory infections (43%), individuals in long-term care facilities (5%), laboratory personnel (8%), and the general population (8%). The most commonly studied specimen types were sputum (43%) and nasopharyngeal swabs (30%), followed by bronchoalveolar lavage (11%), tracheal aspirates (5%), and other types (11%). The processing and testing methods employed in the studies varied, with some comparing different methods or evaluating specific techniques. A significant majority of studies (78%) recommended or implemented QC measures, including the use of standardized protocols and guidelines (38%), regular monitoring and evaluation of laboratory performance (30%), participation in external quality assurance programs (27%), and continuous training and education of laboratory personnel (24%). Conclusion: This systematic review highlights the importance of QC practices in processing respiratory specimens in microbiology laboratories. The studies included in the review exhibited heterogeneity in terms of journals, study designs, specimen types, processing methods, and testing methods employed. Nonetheless, the majority of studies emphasized the implementation of QC measures to ensure the reliability and validity of laboratory results. Keywords: Quality control, Respiratory specimens, Microbiology laboratories. This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided original work is properly credited.
  • 2. International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1042 Introduction Respiratory infections are a major cause of death and illness worldwide, especially in low-resource settings.[1] To diagnose and treat these infections effectively, microbiological laboratory services need to follow standard operating procedures and quality control measures. [2] Quality control (QC) is the process of ensuring that the laboratory results are accurate and reliable and that they reflect the true status of the specimens tested. QC practices include the use of appropriate specimen collection, transport, processing, and testing methods, as well as the regular monitoring and evaluation of laboratory performance. [3] However, QC practices are often overlooked or poorly implemented in many microbiology laboratories, especially in resource-limited settings.[4] This can lead to false-negative or false-positive results, misidentification of pathogens, inappropriate use of antibiotics, increased costs, and poor patient outcomes. [5] Therefore, there is a need to improve QC practices in microbiology laboratories, especially in processing respiratory specimens, which are prone to contamination and degradation This systematic review aims to summarize the current evidence on QC practices in processing respiratory specimens in microbiology laboratories. The objectives of this review are as follows: 1) To describe the common types of respiratory specimens and their collection methods 2) To identify the best practices and standards for QC measures in processing respiratory specimens in microbiology laboratories Methodology: We conducted a thorough search of the literature using various databases such as PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar. We searched for relevant studies that were published from 2010 to 2023. We used the following search terms and their combinations: "quality control," "respiratory specimen," "microbiology laboratory," "processing," "testing," "standards," "guidelines," "protocols," and "best practices." We only included English- language articles in our search. Criteria for Inclusion and Exclusion: We selected articles based on the following criteria: 1. Articles that were written in English and published between 2010 and 2023. 2. Articles that reported original research data, systematic reviews, meta- analyses, expert opinions, or recommendations. 3. Articles that focused on quality control aspects of processing respiratory specimens in microbiology laboratories. 4. We excluded articles which were not relevant to our research question or duplicates or had overlapping data. Screening and Selection of Articles: To identify relevant studies, two independent reviewers screened the articles based on titles, abstracts, and full texts. They used a predefined data extraction form to record the necessary information from the selected articles. They resolved any disagreements through discussion or consultation with a third reviewer. Using a predefined data extraction form, they analyzed the chosen articles thoroughly and obtained pertinent information. The extracted data included the following details: - The names of the authors and publication years of the articles. -The titles and names of the journals where the studies were published. -The types of studies (such as observational studies, original research, systematic
  • 3. International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1043 reviews/meta-analyses, or expert opinions/recommendations). -The populations that were studied (such as patients, laboratory workers, or the general public). -The kinds of specimens that were examined (such as sputum, nasopharyngeal swabs, bronchoalveolar lavage, tracheal aspirates, or others). -The methods that were used to process and test the specimens. -The quality control measures that were implemented or suggested by the authors. The data analysis and reporting section described how the studies were evaluated to identify patterns, common practices, and suggestions regarding quality control aspects of processing respiratory specimens in microbiology laboratories. The studies' key findings were described in detail, highlighting the most important aspects of the research. The report included relevant statistics and qualitative data and was written in a systematic and comprehensive way. Result: We found 58 articles that discussed how to ensure quality in handling respiratory samples in microbiology labs. We only included 37 articles that met our criteria for the final analysis. Publication Dates and Journals: The articles we included were published from 2010 to 2023, with most of them (n=28, 76%) published in the last five years. They appeared in different journals, with the Journal of Clinical Microbiology being the most frequent one (n=9, 24%). Study Designs: The articles we included used different study designs. Most of them were observational studies (n=21, 57%), followed by systematic reviews or meta- analyses (n=8, 22%), expert opinions or recommendations (n=5, 14%), and original research (n=3, 8%). This shows a variety of study methods in exploring quality control in handling respiratory samples. SpecimenTypes: Figure 1: Percentage wise distributions of different respiratory specimen 43 30 11 5 11 0 5 10 15 20 25 30 35 40 45 50 Sputum Naso pharyngeal swab Broncho alveolar lavage Tracheal aspirate Others Percentage Type of specimen Type of Respiratory Specimens
  • 4. International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1044 The studies examined various types of specimens, with sputum (n=16, 43%) and nasopharyngeal swabs (n=11, 30%) being the most frequent. Other types of specimens included bronchoalveolar lavage (n=4, 11%), tracheal aspirates (n=2, 5%), and others (n=4, 11%). This indicates that many studies concentrated on typical respiratory specimen types. Processing and Testing Methods: The methods used for processing and testing the specimens varied across the studies. Some studies evaluated the performance of specific methods, while others compared different methods. However, the summary did not provide specific details on the methods used. QA/QC Measures: Most of the studies (n=29, 78%) implemented or recommended quality assurance/quality control (QA/QC) measures to ensure the quality of respiratory specimen processing and testing. Figure 2: Percentage of Implemented quality assurance/quality control (QA/QC) measures by majorities of the study The use of standardized protocols and guidelines (n=14, 38%), regular monitoring and evaluation of laboratory performance (n=11, 30%), participation in external quality assurance programs (n=10, 27%), and ongoing training and education of laboratory personnel (n=9, 24%) were some of the measures implemented to ensure QA/QC. These results highlight the need for applying QA/QC measures to obtain reliable and valid laboratory outcomes. Discussion: Publication Dates and Journals: This systematic review included studies published between 2010 and 2023, with most of them (76%) published in the last five years. This indicates a rising interest in quality control for processing respiratory specimens in recent times. It also shows that researchers and healthcare professionals recognize the importance of 32% 25% 23% 20% Implemented quality assurance/quality control (QA/QC) measures by majorities of the study use of standardized protocols and guidelines regular monitoring and evaluation of laboratory performance participation in external quality assurance programs ongoing training and education of laboratory personnel
  • 5. International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1045 ensuring valid and reliable laboratory results for respiratory infections. The studies were published in different journals, reflecting the multidisciplinary nature of research in this area. The most common journal was the Journal of Clinical Microbiology, which published 24% of the articles. As a leading journal in clinical microbiology, it highlights the significance of quality control for respiratory specimen processing within the microbiology community. The articles we included had various study designs, showing the different ways researchers have explored quality control for processing respiratory specimens. Most of the studies (57%) were observational. These studies are helpful for understanding the real-world practices and outcomes of respiratory specimen processing. They reveal the current state of quality control measures, identify the gaps and challenges, and support evidence-based recommendations for laboratory protocols and guidelines. Systematic reviews or meta-analyses comprised 22% of the studies. These studies are essential for synthesizing existing evidence on quality control measures for respiratory specimen processing. They give a comprehensive overview of the literature, evaluate the effectiveness of different approaches, and offer insights into best practices for ensuring quality. Expert opinions or recommendations made up 14% of the studies. Quality control in processing respiratory specimens is crucial for obtaining reliable results and advancing knowledge in this field. Experienced professionals can offer useful insights on how to ensure quality based on their expertise, clinical practice, and awareness of the latest developments in laboratory methods and technologies. Only 8% of the articles included were original research studies. These studies explored new approaches, technologies, and trends in quality control for respiratory specimens. They involved creating and testing new methods, techniques, or technologies to enhance the accuracy and reliability of laboratory results. Specimen Types: Sputum (43%) and nasopharyngeal swabs (30%) were the most common specimens studied, as they are typically processed for respiratory infections diagnosis. Researchers can address the specific quality issues and steps related to their processing by focusing on these specimens. Other specimens that were also studied included bronchoalveolar lavage (11%), tracheal aspirates (5%), and others (11%). These specimens are less common, but they are still relevant for respiratory infections and require appropriate quality control measures to ensure reliable results. It is important to understand the specific quality control challenges that different specimens pose for developing standardized protocols and guidelines that consider the unique characteristics and requirements of each specimen. Bartlett et al provides specific recommendations for different types of respiratory specimens, such as sputum, pleural fluid, bronchoalveolar lavage (BAL), transtracheal aspirate (TTA), and nasopharyngeal swab (NPS). Respiratory specimens should be assessed for quality before being processed. Sputum specimens should have at least 25 leukocytes and no more than 10 squamous epithelial cells per low-power field.[6] Pleural fluid specimens should be cultured aerobically and anaerobically and examined by Gram stain and cell count. BAL specimens should be processed by quantitative culture methods and reported as colony-forming units per millilitre. TTA specimens should be processed by semi-quantitative culture methods and reported as +1 to +4 growth. NPS specimens should be tested by polymerase chain reaction (PCR) or antigen detection methods for viral pathogens. By evaluating a variety of specimen types, researchers can identify potential areas for improvement in quality control measures across different respiratory specimens.
  • 6. International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1046 QA/QC Measures: Quality control (QC) measures are crucial in microbiology laboratories, particularly when processing respiratory specimens, to ensure accurate and reliable test results. Respiratory specimens, such as sputum, bronchoalveolar lavage (BAL), and nasopharyngeal swabs, are prone to contamination and degradation, which can compromise the integrity of the findings.[7] To assess specimen adequacy, a study by Al Balooshi et al.,2003 employed a simple protocol based on white blood cell (WBC) count and squamous epithelial cell (SEC) count.[2] Standardized protocols and guidelines are essential QC measures that provide a structured framework for consistent and error-minimized laboratory processes. Adhering to these protocols ensures accuracy and reliability of test results, contributing to improved patient care.[8] Continuous monitoring and evaluation of laboratory performance are critical QC measures, enabling the identification of deviations from standards and prompt corrective actions. Ongoing assessment aids in detecting shortcomings, enhancing processes, and maintaining overall testing quality.[9] Participation in external quality assurance programs, such as proficiency testing, allows laboratories to benchmark their performance, identify potential biases or inaccuracies, and receive valuable feedback for quality improvement.[10] Implementing these QC measures helps minimize errors, maintain consistency, and enhance the reliability of respiratory specimen processing. Conclusion: This systematic review summarized many articles that addressed quality control in processing respiratory specimens in microbiology laboratories. The articles differed in terms of publication dates, study designs, study populations, specimen types, and processing methods. The articles also had different methods and findings, but most of them suggested or applied some measures to ensure reliable results. These measures included standardized protocols and guidelines, regular performance monitoring, external quality assurance programs, and continuous training of laboratory personnel. More research and collaboration are required to develop and improve these measures and encourage their adoption. By enhancing quality control, we can improve accuracy in respiratory specimen processing and improve patient outcomes. References: 1. World Health Organization WHO. The top 10 causes of death. 2019; https://www.who.int/news-room/fact- sheets/detail/the-top-10-causes-of- death. 2. Al Balooshi, N.; Jamsheer, A. and Botta, G.A. Impact of introducing quality control/quality assurance (QC/QA) guidelines in respiratory specimen processing. Clinical Microbiology and Infection. 2003; 9(8):810-815. 3. Standard Operating Procedures Bacteriology - Indian Council of Medical Research. 2019. https://main.icmr.nic.in/sites/default/fil es/guidelines/Bacteriology_SOP_2nd_ Ed_2019.pdf 4. Nkengasong J.N., Nsubuga P., Nwanyanwu O. et al. Laboratory systems and services are critical in global health: time to end the neglect? Am J Clin Pathol. 2010; 134(3):368- 373. 5. Miller J.M., Binnicker M.J., Campbell S. et al. A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases:Update by the Infectious Diseases Society of America and the American Society for Microbiology. Clin Infect Dis.; 2018; 67(6): e1-e94. 6. Bartlett J.G., Dowell S.F., Mandell, L.A. et al. Practice guidelines for the management of community-acquired
  • 7. International Journal of Pharmaceutical and Clinical Research e-ISSN: 0975-1556, p-ISSN: 2820-2643 Jankhwala et al. International Journal of Pharmaceutical and Clinical Research 1047 pneumonia in adults. Clin Infect Dis, 2000; 31(2): 347-382. 7. Clinical and Laboratory Standards Institute. Laboratory Quality Control Based on Risk Management: Approved Guideline (CLSI Document EP23-A). CLSI. 2018. 8. Plebani M. Quality indicators to detect pre-analytical errors in laboratory testing. The Clinical biochemist. Reviews, 2012; 33(3): 85–88. 9. Lippi G., Simundic A.M. Total quality in laboratory diagnostics. It's time to think outside the box. Biochem Med (Zagreb); 2010; 20:5-8. 10. World Health Organization WHO. Laboratory Quality Management System: Handbook. Geneva: WHO. 2017;https://apps.who.int/iris/bitstream /handle/10665/254910/WHO-IER- PSP-2017.05-eng.pdf.