Clinical Laboratory

Article Author:
Marlon Bayot
Article Editor:
Steve Bhimji
Updated:
12/13/2018 11:03:39 AM
PubMed Link:
Clinical Laboratory

Definition/Introduction

Clinical laboratories are healthcare facilities providing a wide range of laboratory procedures, generating valuable and significant test results which aid the physicians in carrying out the diagnosis and management of patients. These laboratories are manned by medical technologists (clinical laboratory scientists) who are trained to perform simple and complex tests to sample specimens collected from its patients. Most of the clinical laboratories are situated within the hospital facilities both in public and private institutions.

In the past, the value of clinical laboratories as an integral part of the healthcare system was not well realized.[1] Throughout the time, more physicians have recognized the need of laboratory tests to confirm their diagnoses and to support the monitoring of their patients as to its response to therapy.[2] Aside from its known value to individual patients, the function of clinical laboratories was also used for screening and surveillance of diseases significant to public health. On a larger scale, program managers used some relevant tests as surrogate indicators to assess the progress of public, international and global health programs.

Laboratory networks were developed across countries and states to foster proper coordination and collaboration among clinical laboratories within the specified geographic areas.[3] Quality management systems within these laboratories have also become significant issues recently, including the standardization of laboratory services, strengthening of laboratory systems[4] and the development of new and rapid diagnostic tools. These issues are continually addressed by local and international health authorities and technical experts using the framework of a patient-centered approach.

Issues of Concern

Providing high-quality, diagnostic testing is the goal of all clinical laboratories. To attain this goal, several issues and problems are needed to be addressed which ultimately underline the need for improving laboratory capacity. Addressing human and financial resources, training and supervision, planning and budgeting, quality assurance, logistics and supply, biosafety and equipment management and other relevant laboratory aspects were found to be necessary to optimize laboratory services provided to patients.

In 2018, the World Health Organization developed and released the Essential Diagnostics List (EDL). This list was expected to be used to align the health community in bridging the gap to the accessibility and availability of high-quality testing of clinical laboratories, especially in resource-limited settings.[5] Using the EDL with essential medicines list (EML), authorities can now focus their efforts so that people can receive laboratory services they need the most.[6]

Accreditation for clinical laboratories became common recently with the emergence of international laboratory standards. Several guidelines for laboratories have been developed to regulate laboratory test procedures and maintain its quality.[7] An example of laboratory accreditation is the ISO 15189 provided by the International Organization for Standardization (ISO) which focuses on meeting the requirements for quality and competence of medical laboratories.[8]

The need for risk management in clinical laboratories was highlighted to maintain the accuracy and reliability of laboratory tests. The Clinical Laboratory Standards Institute (CLSI) developed a guideline to introduce the principles of risk management specifically in the clinical laboratory.[9] From risk assessment to risk analysis, evaluation and control down to the process of continuous quality improvement, the clinical laboratory should and must be able to minimize errors along its path of the workflow (i.e., pre-analytic, analytic and post-analytic phases). Such significant risks identified, for instance, in specimen collection and handling and the disposal of laboratory wastes must be taken into consideration by all clinical laboratories.

A laboratory information system is valuable in the management of results and other pertinent information regarding patients and their samples. The development of a laboratory information system started in the 1960s concentrating on data reduction-analogue-digital conversion and radioimmunoassay analysis. Recently, the focus has evolved into the aspects of digital histopathology and genomics, and issues about patients’ access to data, and a lot more.[10] In a rapidly changing environment for the modalities of patient record systems, there is a need for collaboration between clinical systems developers and laboratory-based informaticians to change and improve the existing technology to meet patient needs.

Clinical Significance

As the challenges faced by the clinical laboratories constantly arise, the most important value for each healthcare professional is the recognition its significance for the patient welfare. While patients and people in the community are not well aware of its role, the function and mandate of clinical laboratories remain the same: the provision of high-quality laboratory diagnostic tests. The development of newer diagnostic tests from its pipeline should not overestimate the need for improving existing laboratory services. Health authorities at the global level and stakeholders including clinicians, experts and other healthcare professionals at the local level must meet at both ends recognizing that the existence of clinical laboratories taking its hold within the most important clients of healthcare, its patients.[11][12]


References

[1] Kotlarz VR, Tracing our roots: origins of clinical laboratory science. Clinical laboratory science : journal of the American Society for Medical Technology. 1998 Jan-Feb     [PubMed PMID: 10177215]
[2] Delwiche FA, Mapping the literature of clinical laboratory science. Journal of the Medical Library Association : JMLA. 2003 Jul     [PubMed PMID: 12883564]
[3] Kirk CJ,Shult PA, Developing laboratory networks: a practical guide and application. Public health reports (Washington, D.C. : 1974). 2010 May-Jun     [PubMed PMID: 20518451]
[4] Alemnji GA,Zeh C,Yao K,Fonjungo PN, Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress. Tropical medicine     [PubMed PMID: 24506521]
[5] Schroeder LF,Guarner J,Amukele TK, Essential Diagnostics for the Use of World Health Organization Essential Medicines. Clinical chemistry. 2018 Aug     [PubMed PMID: 29871869]
[6] Velazquez Berumen A,Garner S,Hill SR,Swaminathan S, Making diagnostic tests as essential as medicines. BMJ global health. 2018     [PubMed PMID: 30116599]
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[9] Njoroge SW,Nichols JH, Risk management in the clinical laboratory. Annals of laboratory medicine. 2014 Jul     [PubMed PMID: 24982831]
[10] Jones RG,Johnson OA,Batstone G, Informatics and the clinical laboratory. The Clinical biochemist. Reviews. 2014 Aug     [PubMed PMID: 25336763]
[11] Nkengasong JN,Nsubuga P,Nwanyanwu O,Gershy-Damet GM,Roscigno G,Bulterys M,Schoub B,DeCock KM,Birx D, Laboratory systems and services are critical in global health: time to end the neglect? American journal of clinical pathology. 2010 Sep     [PubMed PMID: 20716791]
[12] Caliendo AM,Gilbert DN,Ginocchio CC,Hanson KE,May L,Quinn TC,Tenover FC,Alland D,Blaschke AJ,Bonomo RA,Carroll KC,Ferraro MJ,Hirschhorn LR,Joseph WP,Karchmer T,MacIntyre AT,Reller LB,Jackson AF, Better tests, better care: improved diagnostics for infectious diseases. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2013 Dec     [PubMed PMID: 24200831]