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Research Laboratory  

by Daniel Watch and Deepa Tolat Perkins + Will

Within This Page

Building attributes, emerging issues, relevant codes and standards, additional resources.

Research Laboratories are workplaces for the conduct of scientific research. This WBDG Building Type page will summarize the key architectural, engineering, operational, safety, and sustainability considerations for the design of Research Laboratories.

The authors recognize that in the 21st century clients are pushing project design teams to create research laboratories that are responsive to current and future needs, that encourage interaction among scientists from various disciplines, that help recruit and retain qualified scientists, and that facilitates partnerships and development. As such, a separate WBDG Resource Page on Trends in Lab Design has been developed to elaborate on this emerging model of laboratory design.

A. Architectural Considerations

Over the past 30 years, architects, engineers, facility managers, and researchers have refined the design of typical wet and dry labs to a very high level. The following identifies the best solutions in designing a typical lab.

Lab Planning Module

The laboratory module is the key unit in any lab facility. When designed correctly, a lab module will fully coordinate all the architectural and engineering systems. A well-designed modular plan will provide the following benefits:

Flexibility —The lab module, as Jonas Salk explained, should "encourage change" within the building. Research is changing all the time, and buildings must allow for reasonable change. Many private research companies make physical changes to an average of 25% of their labs each year. Most academic institutions annually change the layout of 5 to 10% of their labs. See also WBDG Productive—Design for the Changing Workplace .

• Expansion —The use of lab planning modules allows the building to adapt easily to needed expansions or contractions without sacrificing facility functionality.

A common laboratory module has a width of approximately 10 ft. 6 in. but will vary in depth from 20–30 ft. The depth is based on the size necessary for the lab and the cost-effectiveness of the structural system. The 10 ft. 6 in. dimension is based on two rows of casework and equipment (each row 2 ft. 6 in. deep) on each wall, a 5 ft. aisle, and 6 in. for the wall thickness that separates one lab from another. The 5 ft. aisle width should be considered a minimum because of the requirements of the Americans with Disabilities Act (ADA) .

Two-Directional Lab Module —Another level of flexibility can be achieved by designing a lab module that works in both directions. This allows the casework to be organized in either direction. This concept is more flexible than the basic lab module concept but may require more space. The use of a two-directional grid is beneficial to accommodate different lengths of run for casework. The casework may have to be moved to create a different type or size of workstation.

Three-Dimensional Lab Module —The three-dimensional lab module planning concept combines the basic lab module or a two-directional lab module with any lab corridor arrangement for each floor of a building. This means that a three-dimensional lab module can have a single-corridor arrangement on one floor, a two-corridor layout on another, and so on. To create a three-dimensional lab module:

• A basic or two-directional lab module must be defined.
• All vertical risers must be fully coordinated. (Vertical risers include fire stairs, elevators, restrooms, and shafts for utilities.)
• The mechanical, electrical, and plumbing systems must be coordinated in the ceiling to work with the multiple corridor arrangements.

Lab Planning Concepts

The relationship of the labs, offices, and corridor will have a significant impact on the image and operations of the building. See also WBDG Functional—Account for Functional Needs .

Do the end users want a view from their labs to the exterior, or will the labs be located on the interior, with wall space used for casework and equipment?

Some researchers do not want or cannot have natural light in their research spaces. Special instruments and equipment, such as nuclear magnetic resonance (NMR) apparatus, electron microscopes, and lasers cannot function properly in natural light. Natural daylight is not desired in vivarium facilities or in some support spaces, so these are located in the interior of the building.

Zoning the building between lab and non-lab spaces will reduce costs. Labs require 100% outside air while non-lab spaces can be designed with re-circulated air, like an office building .

Adjacencies with corridors can be organized with a single, two corridor (racetrack), or a three corridor scheme. There are number of variations to organize each type. Illustrated below are three ways to organize a single corridor scheme:

Single corridor lab design with labs and office adjacent to each other.

Single corridor lab design with offices clustered together at the end and in the middle.

Single corridor lab design with office clusters accessing main labs directly.

• Open labs vs. closed labs. An increasing number of research institutions are creating "open" labs to support team-based work. The open lab concept is significantly different from that of the "closed" lab of the past, which was based on accommodating the individual principle investigator. In open labs, researchers share not only the space itself but also equipment, bench space, and support staff. The open lab format facilitates communication between scientists and makes the lab more easily adaptable for future needs. A wide variety of labs—from wet biology and chemistry labs, to engineering labs, to dry computer science facilities—are now being designed as open labs.

Flexibility

In today's lab, the ability to expand, reconfigure, and permit multiple uses has become a key concern. The following should be considered to achieve this:

Flexible Lab Interiors

Equipment zones—These should be created in the initial design to accommodate equipment, fixed, or movable casework at a later date.

Generic labs

Mobile casework—This can be comprised of mobile tables and mobile base cabinets. It allows researchers to configure and fit out the lab based on their needs as opposed to adjusting to pre-determined fixed casework.

Mobile casework

Mobile base cabinet Photo Credit: Kewaunee Scientific Corp.

Flexible partitions—These can be taken down and put back up in another location, allowing lab spaces to be configured in a variety of sizes.

Overhead service carriers—These are hung from the ceiling. They can have utilities like piping, electric, data, light fixtures, and snorkel exhausts. They afford maximum flexibility as services are lifted off the floor, allowing free floor space to be configured as needed.

Flexible Engineering Systems

Lab designed with overhead connects and disconnects allow for flexibility and fast hook up of equipment.

Labs should have easy connects/disconnects at walls and ceilings to allow for fast and affordable hook up of equipment. See also WBDG Productive—Integrate Technological Tools .

The Engineering systems should be designed such that fume hoods can be added or removed.

Space should be allowed in the utility corridors, ceilings, and vertical chases for future HVAC, plumbing, and electric needs.

Building Systems Distribution Concepts

Interstitial space.

An interstitial space is a separate floor located above each lab floor. All services and utilities are located here where they drop down to service the lab below. This system has a high initial cost but it allows the building to accommodate change very easily without interrupting the labs.

Conventional design vs. interstitial design Image Credit: Zimmer, Gunsul, Frasca Partnership

Service Corridor

Lab spaces adjoin a centrally located corridor where all utility services are located. Maintenance personnel are afforded constant access to main ducts, shutoff valves, and electric panel boxes without having to enter the lab. This service corridor can be doubled up as an equipment/utility corridor where common lab equipment like autoclaves, freezer rooms, etc. can be located.

B. Engineering Considerations

Typically, more than 50% of the construction cost of a laboratory building is attributed to engineering systems. Hence, the close coordination of these ensures a flexible and successfully operating lab facility. The following engineering issues are discussed here: structural systems, mechanical systems, electrical systems, and piping systems. See also WBDG Functional—Ensure Appropriate Product/Systems Integration .

Structural Systems

Once the basic lab module is determined, the structural grid should be evaluated. In most cases, the structural grid equals 2 basic lab modules. If the typical module is 10 ft. 6 in. x 30 ft., the structural grid would be 21 ft. x 30 ft. A good rule of thumb is to add the two dimensions of the structural grid; if the sum equals a number in the low 50's, then the structural grid would be efficient and cost-effective.

Typical lab structural grid.

Key design issues to consider in evaluating a structural system include:

• Framing depth and effect on floor-to-floor height;
• Ability to coordinate framing with lab modules;
• Ability to create penetrations for lab services in the initial design as well as over the life of the building;
• Potential for vertical or horizontal expansion;
• Vibration criteria; and

Mechanical Systems

The location of main vertical supply/exhaust shafts as well as horizontal ductwork is very crucial in designing a flexible lab. Key issues to consider include: efficiency and flexibility, modular design, initial costs , long-term operational costs , building height and massing , and design image .

The various design options for the mechanical systems are illustrated below:

Shafts in the middle of the building

Shafts at the end of the building

Exhaust at end and supply in the middle

Multiple internal shafts

Shafts on the exterior

See also WBDG High Performance HVAC .

Electrical Systems

Three types of power are generally used for most laboratory projects:

Normal power circuits are connected to the utility supply only, without any backup system. Loads that are typically on normal power include some HVAC equipment, general lighting, and most lab equipment.

Emergency power is created with generators that will back up equipment such as refrigerators, freezers, fume hoods, biological safety cabinets, emergency lighting, exhaust fans, animal facilities, and environmental rooms. Examples of safe and efficient emergency power equipment include distributed energy resources (DER) , microturbines , and fuel cells .

An uninterruptible power supply (UPS) is used for data recording, certain computers, microprocessor-controlled equipment, and possibly the vivarium area. The UPS can be either a central unit or a portable system, such as distributed energy resources (DER) , microturbines , fuel cells , and building integrated photovoltaics (BIPV) .

See also WBDG Productive—Assure Reliable Systems and Spaces .

The following should be considered:

• Load estimation
• Site distribution
• Power quality
• Management of electrical cable trays/panel boxes
• User expectations
• Illumination levels
• Lighting distribution-indirect, direct, combination
• Luminaire location and orientation-lighting parallel to casework and lighting perpendicular to casework
• Telephone and data systems

Piping Systems

There are several key design goals to strive for in designing laboratory piping systems:

• Provide a flexible design that allows for easy renovation and modifications.
• Provide appropriate plumbing systems for each laboratory based on the lab programming.
• Provide systems that minimize energy usage .
• Provide equipment arrangements that minimize downtime in the event of a failure.
• Locate shutoff valves where they are accessible and easily understood.
• Accomplish all of the preceding goals within the construction budget.

C. Operations and Maintenance

Cost savings.

The following cost saving items can be considered without compromising quality and flexibility:

• Separate lab and non-lab zones.
• Try to design with standard building components instead of customized components. See also WBDG Functional—Ensure Appropriate Product/Systems Integration .
• Identify at least three manufacturers of each material or piece of equipment specified to ensure competitive bidding for the work.
• Locate fume hoods on upper floors to minimize ductwork and the cost of moving air through the building.
• Evaluate whether process piping should be handled centrally or locally. In many cases it is more cost-effective to locate gases, in cylinders, at the source in the lab instead of centrally.
• Create equipment zones to minimize the amount of casework necessary in the initial construction.
• Provide space for equipment (e.g., ice machine) that also can be shared with other labs in the entry alcove to the lab. Shared amenities can be more efficient and cost-effective.
• Consider designating instrument rooms as cross-corridors, saving space as well as encouraging researchers to share equipment.
• Design easy-to-maintain, energy-efficient building systems. Expose mechanical, plumbing, and electrical systems for easy maintenance access from the lab.
• Locate all mechanical equipment centrally, either on a lower level of the building or on the penthouse level.
• Stack vertical elements above each other without requiring transfers from floor to floor. Such elements include columns, stairs, mechanical closets, and restrooms.

D. Lab and Personnel Safety and Security

Protecting human health and life is paramount, and safety must always be the first concern in laboratory building design. Security-protecting a facility from unauthorized access-is also of critical importance. Today, research facility designers must work within the dense regulatory environment in order to create safe and productive lab spaces. The WBDG Resource Page on Security and Safety in Laboratories addresses all these related concerns, including:

• Laboratory classifications: dependent on the amount and type of chemicals in the lab;
• Containment devices: fume hoods and bio-safety cabinets;
• Levels of bio-safety containment as a design principle;
• Radiation safety;
• Employee safety: showers, eyewashes, other protective measures; and
• Emergency power.

See also WBDG Secure / Safe Branch , Threat/Vulnerability Assessments and Risk Analysis , Balancing Security/Safety and Sustainability Objectives , Air Decontamination , and Electrical Safety .

E. Sustainability Considerations

The typical laboratory uses far more energy and water per square foot than the typical office building due to intensive ventilation requirements and other health and safety concerns. Therefore, designers should strive to create sustainable , high performance, and low-energy laboratories that will:

• Minimize overall environmental impacts;
• Protect occupant safety ; and
• Optimize whole building efficiency on a life-cycle basis.

For more specific guidance, see WBDG Sustainable Laboratory Design ; EPA and DOE's Laboratories for the 21st Century (Labs21) , a voluntary program dedicated to improving the environmental performance of U.S. laboratories; WBDG Sustainable Branch and Balancing Security/Safety and Sustainability Objectives .

F. Three Laboratory Sectors

There are three research laboratory sectors. They are academic laboratories, government laboratories, and private sector laboratories.

• Academic labs are primarily teaching facilities but also include some research labs that engage in public interest or profit generating research.
• Government labs include those run by federal agencies and those operated by state government do research in the public interest.
• Design of labs for the private sector , run by corporations, is usually driven by the need to enhance the research operation's profit making potential.

G. Example Design and Construction Criteria

For GSA, the unit costs for this building type are based on the construction quality and design features in the following table   . This information is based on GSA's benchmark interpretation and could be different for other owners.

LEED® Application Guide for Laboratory Facilities (LEED-AGL)—Because research facilities present a unique challenge for energy efficiency and sustainable design, the U.S. Green Building Council (USGBC) has formed the LEED-AGL Committee to develop a guide that helps project teams apply LEED credits in the design and construction of laboratory facilities. See also the WBDG Resource Page Using LEED on Laboratory Projects .

The following agencies and organizations have developed codes and standards affecting the design of research laboratories. Note that the codes and standards are minimum requirements. Architects, engineers, and consultants should consider exceeding the applicable requirements whenever possible.

• 29 CFR 1910.1450: OSHA "Occupational Exposures to Hazardous Chemicals in Laboratories"
• ANSI/ASSE/AIHA Z9.5 Laboratory Ventilation
• ANSI/ISEA Z358.1 Emergency Eyewash and Shower Equipment
• Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Standards
• Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition , Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health.
• GSA PBS-P100 Facilities Standards for the Public Buildings Service
• Guidelines for the Laboratory Use of Chemical Carcinogens , Pub. No. 81-2385. National Institutes of Health
• NIH Design Requirements Manual , National Institutes of Health
• NFPA 30 Flammable and Combustible Liquids Code
• NFPA 45 Fire Protection for Laboratories using Chemical
• Unified Facilities Guide Specifications (UFGS) —organized by MasterFormat™ divisions, are for use in specifying construction for the military services. Several UFGS exist for safety-related topics.

Publications

• Building Type Basics for Research Laboratories , 2nd Edition by Daniel Watch. New York: John Wiley & Sons, Inc., 2008. ISBN# 978-0-470-16333-7.
• CRC Handbook of Laboratory Safety , 5th ed. by A. Keith Furr. CRC Press, 2000.
• Design and Planning of Research and Clinical Laboratory Facilities by Leonard Mayer. New York, NY: John Wiley & Sons, Inc., 1995.
• Design for Research: Principals of Laboratory Architecture by Susan Braybrooke. New York, NY: John Wiley & Sons, Inc., 1993.
• Guidelines for Laboratory Design: Health and Safety Considerations , 4th Edition by Louis J. DiBerardinis, et al. New York, NY: John Wiley & Sons, Inc., 2013.
• Guidelines for Planning and Design of Biomedical Research Laboratory Facilities by The American Institute of Architects, Center for Advanced Technology Facilities Design. Washington, DC: The American Institute of Architects, 1999.
• Handbook of Facilities Planning, Vol. 1: Laboratory Facilities by T. Ruys. New York, NY: Van Nostrand Reinhold, 1990.
• Laboratories, A Briefing and Design Guide by Walter Hain. London, UK: E & FN Spon, 1995.
• Laboratory by Earl Walls Associates, May 2000.
• Laboratory Design from the Editors of R&D Magazine.
• Laboratory Design, Construction, and Renovation: Participants, Process, and Product by National Research Council, Committee on Design, Construction, and Renovation of Laboratory Facilities. Washington, DC: National Academy Press, 2000.
• Planning Academic Research Facilities: A Guidebook by National Science Foundation. Washington, DC: National Science Foundation, 1992.
• Research and Development in Industry: 1995-96 by National Science Foundation, Division of Science Resources Studies. Arlington, VA: National Science Foundation, 1998.
• Science and Engineering Research Facilities at Colleges and Universities by National Science Foundation, Division of Science Resources Studies. Arlington, VA, 1998.
• Laboratories for the 21st Century (Labs21) —Sponsored by the U.S. Environmental Protection Agency and the U.S. Department of Energy, Labs21 is a voluntary program dedicated to improving the environmental performance of U.S. laboratories.

WBDG Participating Agencies

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Scientific Research & Analysis Laboratory

Image Caption: Dr. Rosie Grayburn (right) and graduate student Yan Ling Choi examine the elemental composition of the pigments on “Helen’s Scrapbook House” using non-destructive X-ray fluorescence  analysis.

Winterthur’s state-of-the-art Scientific Research & Analysis Laboratory is a research and teaching facility housed in the Department of Conservation. Scientific analysis of objects is carried out to answer questions about their condition, technology of manufacture, and history. Answers to these questions are critical for formulating appropriate conservation treatments. 

One of only 18 similar museum labs in the country, the SRAL is equipped with instruments for materials characterization, with a focus on elemental and molecular analysis of cultural heritage materials. The laboratory also has portable equipment that can be used for scientific investigations in the Winterthur Museum and other heritage collections. Many types of analysis can be done non-destructively without taking a sample. In other cases, technology has advanced so that only a tiny sample is necessary.

The laboratory employs two conservation scientists who work closely with Winterthur curators and conservators, academic staff at the University of Delaware,  Winterthur research fellows ,  research students , and students in the University of Delaware doctoral Program in Preservation Studies, the Winterthur/University of Delaware Program in Art Conservation, and Winterthur Program in American Material Culture. Amazing  volunteers  with extensive backgrounds in science aid in the work of the lab. The lab staff also teaches concepts about the interface of art and science to museum visitors of all ages. 

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Fostering creative research in modern electromagnetics, communications, and antennas...

• Attract the best and most motivated students.
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• Published over 40 books and book chapters, and over 1100 papers.
• Over 100 Ph.D./M.S. students graduated.
• Pioneered new designs and techniques.
• Won over 50 awards.
• Featured on the cover-page of 20 magazine issues .
• Presidency of IEEE AP society and URSI-USNC.
• Editorship of several journals and special issues.
• Hosted over 20 postdoctoral and visiting scholars.

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DRI’s Organic Analytical Laboratory (OAL) is led by Dr. Andrey Khlystov and provides high quality, cost-effective collection and analysis of trace organic contaminants and hazardous pollutants in ambient air and other environmental samples (soil, water, etc.). The Laboratory also performs source characterization for volatile organics and organic particulates. DRI’s OAL provides a full range of sampling, laboratory analysis, data management, and quality assurance services including custom research methods development.

The Laboratory is equipped with state-of-the-art instrumentation and is staffed by world leaders in data collection and analysis. The laboratory also designs and fabricates air samplers to meet varying project needs using components time-tested for reliability, durability, and cleanliness.

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• v.73(2); 2023 Sep
• PMC10493209

Quality analysis of the clinical laboratory literature and its effectiveness on clinical quality improvement: a systematic review

Ahmed shabbir chaudhry.

1 Department of Medical Quality and Safety Science, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

2 Department of Intensive Care Medicine, Osaka Women’s and Children’s Hospital, 840 Murodo-cho, Izumi, Osaka 594-1101, Japan

Etsuko Nakagami-Yamaguchi

3 Department of Medical Quality and Safety Science, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

Associated Data

Quality improvement in clinical laboratories is crucial to ensure accurate and reliable test results. With increasing awareness of the potential adverse effects of errors in laboratory practice on patient outcomes, the need for continual improvement of laboratory services cannot be overemphasized. A literature search was conducted on PubMed and a web of science core collection between October and February 2021 to evaluate the scientific literature quality of clinical laboratory quality improvement; only peer-reviewed articles written in English that met quality improvement criteria were included. A structured template was used to extract data, and the papers were rated on a scale of 0–16 using the Quality Improvement Minimum Quality Criteria Set (QI-MQCS). Out of 776 studies, 726 were evaluated for clinical laboratory literature quality analysis. Studies were analyzed according to the quality improvement and control methods and interventions, such as training, education, task force, and observation. Results showed that the average score of QI-MQCS for quality improvement papers from 1981–2000 was 2.5, while from 2001–2020, it was 6.8, indicating continuous high-quality improvement in the clinical laboratory sector. However, there is still room to establish a proper system to judge the quality of clinical laboratory literature and improve accreditation programs within the sector.

Introduction

The robustness of the healthcare system relies upon the clinical laboratory because all the clinical decisions taken on patients by physicians mainly depend upon the clinical lab reports. ( 1 , 2 ) About 70–75% of medical diagnoses are obtained via clinical laboratory reports, making laboratory service quality directly impact healthcare quality. ( 3 , 4 ) Laboratory findings should be precise as possible, also at the same instance; all laboratory operations must be reliable with timely reporting resulting in a beneficial clinical setting. ( 5 ) Negligence during laboratory operations, including processing, assessing, and reporting, can cause severe consequences, including complications, lack of adequate treatment, and delay in correct and timely diagnosis, leading to unnecessary treatment and diagnostic testing. ( 6 – 8 ) A clinical laboratory is a complex set of cultures that include several activity steps, and many people make it unique and saucerful. The comprehensive set of these complex operations occurring during a testing process is called the path of the workflow. ( 9 ) The workflow path in a clinical laboratory initializes with the patient and finishes with reporting and comprehending the results. In any clinical lab setting, it is presumed that mistakes will be made in this process due to the high volume of samples, the limited number of staff, and the different steps implicated in the testing process. ( 10 , 11 ) Errors at any stage of the total testing process (TTP) can result in inaccurate laboratory outcomes. To guarantee the quality of the results, a reliable method for determining errors within the TTP is required. ( 12 )

Significance of quality in the medical laboratory

The term “quality” in the healthcare context has been properly defined by the Institute of Medicine (IOM). ( 13 ) It defines “quality of care as the extent to which health services for individuals and populations increase the probability of desired health outcomes and conform with current professional knowledge.” More recently, quality has been characterized as “doing the right things for the right people, at the right time and doing them right the first time.” In recent years, quality may entail different domains; there appears to be a consensus emerging that quality involves safety, effectiveness, appropriateness, responsiveness or patient-centered care, equity or access, and efficiency.

Importance of standardization

In the context of laboratory medicine, high-quality diagnostic testing (such as for patient safety) is often achieved through the application of standardized processes. Standardization helps to guarantee the accuracy and reproducibility of test outcomes and their appropriate application to the correct patient and also helps to ensure that the results are accurate. The accreditation agencies guarantee crucial points for standardization in laboratory medicine. There are several authorized CLIA accreditation agencies like the College of American Pathologists (CAP), Joint Commission (JCIA), Accreditation Commission for Health Care, Inc (ACHC), and American Association for Laboratory Accreditation, accreditation, which significantly influences quality improvement (QI) in medical laboratory. However, the international organization of standardization ISO is a non-governmental organization that offers a general framework for all procedural sections up to reporting results. Over the years, the establishment and maturity of each agency have brought significant improvement in the medical laboratory sector. The most crucial accreditation is ISO 15189 among all others because ISO 15189 fixates more on laboratory management systems and processes, e.g., The ISO 15189 standard includes requirements linked to the entire testing process, including pre-examination (i.e., pre-analytics), examination (i.e., analytics), and post-examination (i.e., post-analytics). These requirements include developing and implementing standard operating procedures, validation processes, staff training, internal and external quality control (EQC) measures, laboratory setup, and other aspects. In contrast, the other CLIA-approved laboratory accreditation program concentrates more on technical procedures implicated in testing, e.g., policy statement, certification standards, archive standards, and adequate laboratory testing.

The originality of this study

Several systematic analyses have been published on the quality and management of clinical laboratories, but none focus particularly on the overall QI of medical laboratories ( Supplemental Table 1 * ). This leaves a dent in our understanding of QI in clinical laboratory settings. ( 14 , 15 ) Regardless of the number of QIs in a medical laboratory context, the high-quality collective QI systematic review is insufficient, which limits our understating of this field and requires further advancement of QI reporting in the clinical laboratory.

Purpose of the study

This study sought to comprehensively review and evaluate published literature on QI in clinical laboratories. The goal was to provide researchers and professionals with a thorough overview of the present knowledge on quality control (QC) and improvement in medical laboratories. Furthermore, the study sought to determine areas for potential future research and developments in the field of QI in this setting.

Materials and Methods

Study design.

A systematic review is a technique for objectively summarizing prior research through a systematic and replicable process. ( 16 ) This review followed a three-stage design suggested by Tranfield et al. 2003. ( 16 , 17 ) During the planning stage, the choice of databases and keywords and the inclusion and exclusion criteria for selecting contextual articles were identified. The preferred reporting items for systematic reviews and Meta-analyses flow chart (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) was employed to illustrate selecting articles for inclusion in the final sample.

Data source

To guarantee comprehensive coverage of the literature, multiple databases were applied in the bibliometric analysis. ( 18 , 19 ) In this research, the Web of Science (WOS) core collection and PubMed were chosen for their significance to management and medical research. Three keywords were used to determine relevant articles: “quality control” in any of its forms, terms linked to quality processes such as “quality systems,” “quality improvement,” or “quality management,” and “clinical laboratory” to narrow the focus to the healthcare sector using different databases and these keywords helped to guarantee a comprehensive search of the literature on QC and improvement in clinical laboratories. ( 20 )

Study selection

The present analysis specializes in clinical laboratory QC and improvement research published between 1981 and 2021. To be added, the publication must be a research article and be written in English, with at least a title and summary available. Conference proceedings, letters, notes, reviews, editorials, summaries, and other types of publications were removed from the analysis.

Data processing

Before undertaking the study, we standardized the data to enhance the conformity of the results. We standardized the spelling of the author’s names and the formatting of journal affiliations and other data. We also revised to ensure that citations for each article were not counted multiple times when using both databases. Two authors worked independently to mitigate the risk of errors. Only articles that both reviewers agreed upon were included in the review, as displayed in Fig. 1 .

PRISMA (preferred reporting items for systematic reviews and meta-analyses)

Quality assessment of literature extracted

The QI Minimum Quality Criteria Set (QI-MQCS) (16) was used to assess this study. The QI-MQCS is employed in the evaluation of QI interventions in healthcare. The QI-MQCS comprises 16 operational and psychometrically dimensions being assessed to present a reliable and accurate assessment of different QI intervention evaluations. Two of the three reviewers in our study individually reviewed the publications. We allocated a score of 1 to each domain with the minimal criterion and a score of 0 to each area that was not satisfied; hence, each article was allocated a score between 0 and 16. The full review committee handled any score disagreements until a consensus was agreed upon. Although the QI-MQCS does not have a set threshold at which the quality of the articles is determined acceptable, “high quality” was defined in this study as a score between 14 and 16. ( 21 )

A total of 776 results were collected from PubMed and WOS bibliographic databases. Of these, 50 were duplicates, and 726 were screened based on their titles and abstracts. After an additional assessment, 224 of the remaining articles were deemed eligible for the QI study, and 53 met the inclusion criteria, as depicted in Fig. 1 . The selected papers were classified into QI ( n  = 19) and QC ( n  = 33), as presented in Table 1 . Most QI studies were performed in university hospital laboratories ( n  = 34), while some of the QC studies were conducted in general community hospital laboratories ( n  = 9). There was a great difference in the types of errors detected in these two categories of examinations. Preanalytical errors ( n  = 12) were the most prevalent in the QI studies. In contrast, analytical errors ( n  = 28) were the most prevalent error in QC studies.

Table 1.

Characteristics of selected papers

QI in the clinical laboratory focuses on preserving quality standards. The 19 extracted papers on QI were classified based on their themes, goals, methods, and interventions. The major theme among these papers was the improvement of clinical quality standards lab practice and training in the laboratory ( n  = 8), followed by the improvement of problems in the reception area ( n  = 5), the improvement of TTP ( n  = 4), the management of preanalytical errors ( n  = 4), and the evaluation and evolution of quality indicators ( n  = 2). Accreditation ( n  = 6) was the most prevalent method employed in these QI approaches. In contrast, training and education ( n  = 17) were the most common interventions employed to achieve these goals, as highlighted in Table 2 .

Table 2.

Characteristics of quality improvement papers

PDSA, plan, do, study, act; DMAIC, define, measure, analyze, improve, control; TQM, total quality management.

The retrieved papers were classified based on their objectives, goals, and methods to examine the QC characteristics in the clinical laboratory. The core QC analytical processes in these papers included performance evaluation ( n  = 10), QC assessment ( n  = 7), improvement of laboratory practices ( n  = 3), improvement of quality through the use of the sigma metric ( n  = 8), and the QC criteria for susceptibility testing ( n  = 7). These processes highlighted the objectives of QC standards in the clinical laboratory. They were implemented using various methods, including accreditation ( n  = 22), six sigma ( n  = 12), QC practices ( n  = 4), statistical approaches ( n  = 4), external quality assessment (EQA) ( n  = 2), and EQC ( n  = 1), as expressed in Table 3 .

Table 3.

Characteristics of quality control papers

EQA, external quality assessment; EQC, external quality control; POC, point of care; EBV, Epstein-Barr virus; IQC, internal quality control.

In this systematic review, we evaluated the present state of QI interventions, the frequency of errors in clinical laboratories, and the prevalence of issues in QI reporting by systematically examining QI articles in clinical laboratory contexts. As the number of QI publications in healthcare has elevated, so is the number of QI publications in clinical laboratories. ( 22 ) Laboratory errors can occur at any stage of the TTP and can promote increased healthcare costs, decreased patient satisfaction, delayed diagnosis, misdiagnosis, and adverse risks to patient health. ( 23 ) Despite the increasing automation of laboratory diagnostics, our research discovered that laboratories remain a source of errors that can influence patient care decisions.

Distribution of errors among QI and QC papers

Overall, errors in the preanalytical and postanalytical phases are more prevalent, accounting for most errors. ( 24 ) Errors within the analytical stage are generally fewer. ( 25 , 26 ) Our findings indicate that the frequency of errors within the analytical phase has declined in recent years. We categorized the papers into QI and QC to identify the prevalence of errors in each setting. Our findings revealed that preanalytical errors were most predominant in QI papers, comprising 12 out of 19 papers.

In contrast, analytical errors were mostly observed in QC papers, comprising 28 out of 33 papers, as presented in Table 1 . This disparity may be due to the focus of the papers in each category. QI papers often address training, education on safety teams, and other interventions that involve direct human interaction, such as phlebotomy, which may elucidate the higher prevalence of preanalytical errors in these papers. However, QC papers often assess methods or processes for improvement, such as six sigma, accreditation, QC practices, statistical approaches, and other related methods, which involve more analysis in the context.

GCLP is a potential source for QI

To prevent errors, the clinical laboratory must be accurate and precise in its testing. A quality assurance system based on GCLP guidelines can help with this, but it necessitates the commitment of both management and technical staff. A study executed by Horace Gumba et al. ( 27 ) has revealed that improving the workflow, increasing patient satisfaction, evaluating performance, and improving the test-treatment process can all contribute to QI in the clinical laboratory. Implementing GCLP guidelines also requires effective management, a solid foundation of best practices and a focus on quality culture, and training and education. Another study by Horace Gumba et al. 2018 ( 28 ) indicated that on-site training and education have been found to enhance the implementation of quality management systems considerably. Our previously reported data linked to QI supplement these ideas and propose that writing standard operating procedures, improving documentation practices, implementing GCLP guidelines, conducting improvement projects, and providing training on quality indicators can all be efficient interventions for improving the quality in the clinical laboratory, as expressed in Table 2 .

Performance evaluation

Performance evaluation in clinical laboratories is crucial for guaranteeing test results’ accuracy, precision, and reproducibility. This is typically accomplished through QC materials. These materials, which have prominent values, are used to validate the performance of the laboratory’s test systems. QC materials can be classified into internal and external types. Internal quality control (IQC) materials are used for consistent monitoring of the laboratory’s test systems, while EQC materials are used for comparison to those of other laboratories. A study was carried out by Loh et al. , ( 29 ) analyzed several methods used to assess clinical laboratories’ performance, including QC materials and inter-laboratory comparisons. The study highlighted the importance of constant improvement in the QC of clinical laboratories. Our QC paper intentionally highlights this concept in Table 3 .

Importance of accreditation in clinical laboratory

Accreditation of clinical laboratories is essential for promoting the quality of clinical laboratory practices. Our findings in Table 3 highlight the significance of accreditation in clinical laboratories, which conforms with the findings of research by Alkhenizan et al. ( 30 ) One of the main restrictions to implementing accreditation programs is the skepticism of healthcare professionals, particularly physicians, concerning the impact of accreditation on the quality of healthcare services. ( 31 , 32 ) In healthcare, QI activities are often promoted as part of a total quality management (TQM) strategy, including Kaizen/QI activities in nursing care, medical quality, logistics, administrative work, and patient services. In clinical laboratories, however, the influencing force behind the QI is often linked to accreditation, as it presents formal recognition and certification from a regulatory body that the laboratory is competent and operates effectively. ( 33 )

Influence of accreditation in QI and QC studies

To assess the trend of QI in clinical laboratories, we analyzed papers from 1981 to 2021 and made some intriguing findings. There was relatively minimal research on QI or control from the 1980s to 2000s, possibly due to insufficient quality infrastructure, barriers to globalization, and limited access to modern knowledge. Data categorization revealed that QI and QC trends increased considerably after 2000, suggesting a significant improvement in the laboratory sector. Several possible explanations abound for this trend, including increased awareness of the importance of quality healthcare and developing quality management systems. The most substantial factor is the establishment of accreditation agencies such as ISO 15189 and CAP. CAP and ISO 15189 have greatly impacted the clinical laboratory sector through several initiatives and guidelines. ( 34 ) CAP has had multiple changes from 1994 to 2020, including implementing training and unannounced inspection programs for pathology laboratories, establishing a multiyear initiative to promote the pathology specialty, and introducing CAP 15189 as a voluntary program. ISO 15189 was first published in 2003, offering information on the medical laboratory sector and outlining guidelines for sample procedures, results interpretation, reasonable turnaround times, patient sample collection, and the role of the laboratory in training and educating healthcare staff. It was revised in 2007 to conform with ISO/IEC 17205. A third edition was published in 2012, as depicted in Table 4 , which revised the prior layout and added a section on laboratory information management. ( 35 ) The effects of these changes on QI in clinical laboratories can be seen in our results in Fig. 2 from 2000 onwards, indicating a clear QI trend in medical laboratories.

Number of QI and QC papers per 5 years from 1981–2020. QC papers were the most published from 2001, indicating the gradual change of quality in clinical laboratory settings.

Table 4.

Introduction of accreditation agencies for the improvement of clinical laboratory

QI-MQCS as a psychometrically tool for quality publication

To determine the QI of clinical laboratory literature, we used the 16 domains of QI-MQCS. ( 21 ) Each paper was evaluated on these domains and scored on a scale of 0 to 16, with a score of 1 given if at least one reason was outlined. The QI papers generally followed the most domains. These papers were then classified by year of publication, and the average QI-MQCS score was determined. A substantial difference in QI-MQCS scores was detected in articles published between 2000 and 2020, as depicted in Fig. 3 . This disparity may be due to the implementation of laboratory QI standards and the accreditation of clinical laboratory facilities, which have been previously outlined.

This figure illustrates the scoring pattern of QI-MQCS concerning years of publication. The average score of QI-MQCS from 1981–2000 is 2.5, whereas, from 2001–2020, it is 6.8, which reveals the high quality of continuous enhancement in the clinical laboratory sector.

Limitations and strengths

One of the strengths of this analysis is its thorough analysis of all QI-related clinical laboratory papers. The clinical laboratory field is extensive and includes various subfields, but to our knowledge, only 12 reviews have previously addressed QI in the clinical laboratory. This research is the first to thoroughly evaluate all QI-related clinical laboratory papers in one review. There are some limitations to this research. Firstly, the lack of reporting or evaluation of clinical laboratory studies using QI-MQCS limits our comprehension of the QI process. Second, we assessed and scored all papers based on the 16 domains of QI-MQCS, even though some domains may not have been significant to medical laboratories ( Supplemental Table 2 * ). For example, spread (7%), sustainability (3%), penetration (3%), adherence/fidelity (7%), organizational readiness (11%), and intervention description (11%). This is because clinical laboratories do not typically entail delivering interventions or implementing evidence-based interventions in practice and do not usually require the analysis of performance measurements or process systems or developing connections between people.

The major function of the clinical laboratory is to offer diagnostic support to physicians, which can aid in the treatment process and contribute to further progress. However, the QI-MQCS was developed to help stakeholders determine high-quality studies in their field. QI techniques are diverse and distinct from clinical interventions, and the QI-MQCS is a psychometrically tested tool for evaluating the QI-specific characteristics of QI publications. This analysis has possible bias as it did not include other significant databases like Embase and EBSCOhost and only included articles in English.

This study investigated the trend and scope of QI and QC papers in clinical laboratory practice. Our findings revealed that the trend of QI and QC increased markedly after 2000, possibly due to the implementation of laboratory QI standards and the accreditation of clinical laboratory facilities. Our study emphasizes the importance of compliance with good clinical laboratory practice standards and the potential for collaboration between accredited and non-accredited organizations to enhance the quality management system and influence consistent improvement in the clinical laboratory sector.

Author Contributions

This research paper is the culmination of a joint effort between the author, the co-author YI, and the supervisor EN-Y. The study was conceptualized and designed through collaborative discussions between the author and the supervisor. The data collection process was a collaborative effort with significant contributions from YI, who provided valuable data visualization and analysis guidance. The supervisor was crucial in developing and refining the research framework, offering valuable insights that improved study conceptualization. The co-authors reviewed and revised the manuscript and provided critical feedback on presenting findings, including figures and tables.

Acknowledgments

We extend our heartfelt gratitude to the following colleagues for their invaluable contributions and support: Dr. Kaoru Nakatani, Mr. Nozomi Kamamemoto, Ms. Tomoko Honjo, and Mr. Atsushi Tokuwame. Additionally, we would like to acknowledge all those who have been a source of inspiration and motivation throughout the research process.

Abbreviations

Conflict of interest.

No potential conflicts of interest were disclosed.

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