Introduction
Diagnostic laboratories are healthcare facilities that perform tests on biological specimens to help clinicians diagnose, treat, and monitor patients. Authoritative medical literature recognizes laboratory testing as an integral component of clinical decision-making across healthcare settings. While laboratories are essential to emergency care, only certain aspects of their role—such as quality standards, testing processes, error risks, and accreditation frameworks—are supported by high-quality evidence. This article presents what is verified, clearly distinguishes what lacks strong evidence, and avoids assumptions beyond the available data.
What Diagnostic Laboratories Do
Clinical laboratories provide a wide range of laboratory procedures that assist clinicians in diagnosing, treating, and managing patients. Testing is performed on biological specimens such as blood, urine, or tissue, and results are used for diagnosis, monitoring response to therapy, screening, and disease surveillance.
Laboratory professionals are trained to perform, analyze, and report test results, and laboratories often operate in close coordination with clinicians to ensure timely communication of findings.
How Laboratory Testing Works
Laboratory testing follows three recognized phases:
- Pre-analytical phase – specimen collection, labeling, handling, and transport
- Analytical phase – actual testing and analysis of the specimen
- Post-analytical phase – reporting and communication of results
High-quality evidence shows that more than 60–70% of laboratory errors occur during the pre-analytical phase, highlighting the importance of standardized procedures, staff training, and quality controls throughout the testing workflow.
Certification, Accreditation, and Quality Standards
Accreditation frameworks exist to promote quality and competence in medical laboratories. A widely recognized international standard is ISO 15189, which defines requirements for quality management and technical competence in medical laboratories.
Accreditation standards address:
- Quality management systems
- Risk management across all testing phases
- Documentation and standard operating procedures
- Professional competence and ethical conduct
- International standards for laboratory quality and competence exist.
- Accreditation frameworks emphasize accuracy, reliability, risk management, and ethical practice.
- Direct proof that certification alone reduces diagnostic errors in emergency care.
- Evidence that certification independently improves emergency outcomes or turnaround times.
Patient Safety, Public Health, and Ethics
Clinical laboratories contribute to:
- Disease screening and surveillance
- Monitoring public and global health programs
- Supporting outbreak detection through laboratory data
- Maintaining biosafety and confidentiality standards
Laboratory professionals are required to maintain patient confidentiality, adhere to ethical codes of conduct, and follow biosafety guidelines when handling biological materials.
Technology and Automation in Laboratories
Modern clinical laboratories increasingly use automation and laboratory information systems. High-quality evidence shows that automation:
- Improves ordering, testing, and reporting processes
- Increases productivity
- Improves accuracy and precision of test results
- Automation enhances efficiency and quality in laboratory operations.
- That certification specifically ensures safe or effective implementation of new technologies.
Emergency Care: What Is Known and What Is Not
Laboratory testing is routinely used in emergency departments to support clinical evaluation.
However:
There is no high-quality evidence directly proving that laboratory certification alone improves emergency-specific outcomes, turnaround times, or diagnostic accuracy under time pressure.
The importance of laboratories in emergencies is inferred from their general clinical role, not from certification-specific outcome data.
When to See a Doctor
Authoritative public health sources recommend immediate medical evaluation—often in an emergency setting—for symptoms such as:
- Chest pain
- Difficulty breathing
- Sudden changes in consciousness
- Signs of severe infection or high fever
Emergency clinicians determine which laboratory tests are necessary and how urgently they are required.
Frequently Asked Questions
Why are diagnostic laboratories important?
They provide test results that help clinicians diagnose, treat, and monitor patients. This role is well established in medical literature.
What standards do accredited laboratories follow?
Accredited laboratories may follow international standards such as ISO 15189, which focus on quality management and technical competence.
Do certified laboratories reduce diagnostic errors?
There is no high-quality evidence showing that certification alone reduces diagnostic errors, although quality management systems aim to minimize risk.
Are certified laboratories safer than non-certified laboratories?
There is no high-quality evidence directly comparing safety outcomes between certified and non-certified laboratories.
What is a diagnostic laboratory?
A healthcare facility that performs laboratory tests on patient specimens to support diagnosis, treatment, and monitoring.
What is laboratory diagnosis?
The use of laboratory test results to identify diseases or health conditions and guide clinical care.
How can I find a qualified laboratory?
There is no high-quality evidence supporting a single method for identifying laboratory quality beyond recognized accreditation standards.
Are emergency lab tests faster in certified laboratories?
There is no high-quality evidence supporting this.
Do laboratory errors happen often?
Yes. High-quality evidence shows most laboratory errors occur before analysis, during specimen collection and handling.
APA Reference List
Bayot, M. L., Lopes, J. E., Zubair, M., & Naidoo, P. (2024, January 26). Clinical laboratory. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK535358/
Centers for Disease Control and Prevention. (2024, October 24). About heart attack symptoms, risk, and recovery. https://www.cdc.gov/heart-disease/about/heart-attack.html
Hawkins, R. (2012). Managing the pre- and post-analytical phases of the total testing process. Annals of Laboratory Medicine, 32(1), 5–16. https://doi.org/10.3343/alm.2012.32.1.5
International Organization for Standardization. (2022). ISO 15189:2022 Medical laboratories — Requirements for quality and competence. https://www.iso.org/standard/76677.html
MedlinePlus. (2024, September 4). When to use the emergency room—adult. https://medlineplus.gov/ency/patientinstructions/000593.htm
MedlinePlus. (2025, January 8). Recognizing medical emergencies. https://medlineplus.gov/ency/article/001927.htm
World Health Organization. (2018, November). Executive summary: World Health Organization model list of essential in vitro diagnostics (EDL), first edition (2018). https://cdn.who.int/media/docs/default-source/in-vitro-diagnostics/edl/first-meeting/edlexecutive-summary_nov2018.pdf?sfvrsn=eee95e46_5