Advancing excellence in laboratory medicine for better healthcare worldwide

C-CLM Glossary of Terms

Definitions of key terms are provided in the following list.

TERM

DEFINITION

SOURCE

 Accountability

As a leadership or staff quality it involves a demonstration of personal responsibility - Holding self and others accountable for outcomes that are in alignment with the direction of the organization.

 

 Accuracy

Has multiple definitions in laboratory medicine including:

  1. The degree of agreement between a measured value and the accepted reference value.
  2. The degree of correlation with the value achieved by the previous method.
  3. The degree of closeness of the determined value to the nominal or known true value under prescribed conditions. This is sometimes termed trueness.

1-3

 Accuracy of Measurement

Closeness of the agreement between the result of a measurement and a true value of the measurement.

3

 Adaptability

A leadership or staff quality involving open-mindedness to new ideas. It involves demonstrating flexibility when faced with changes in work expectations and environment; and responding to situations while maintaining a positive attitude.

 

 Clinical Laboratory

Typically refers to multiple rooms, in which medical laboratory examinations are performed. In the Clinical Laboratory, a variety of different test methods are used to measure different specimen components toward the purpose of diagnosis and management of disease in patients. For purposes of C-CLM the definition does not apply to laboratory based testing of nonmedical samples, laboratories performing point of care testing or direct to consumer testing.

 

 Communication

As it applies to good leadership practice, it involves practicing active listening supported with meaningful oral and written information.

 

 Competency

A characteristic and measurable pattern of knowledge, skill and ability, demonstrated through behaviors, which underlies and drives expected performance.

 

 Continuous Quality  Improvement (CQI)

According to Tindill and Steward (7) CQI can be described as:

 “A comprehensive management philosophy that focuses on continuous improvement by applying scientific methods to gain knowledge and control over variation in work processes.”

7

 Diversity

As it applies to leadership involves one who appreciates and leverages capabilities, insights, and ideas across a group of individuals diverse in culture, style, ability, and drive.

 

 External Awareness

As it applies to leadership, involves seeing things in multiple points of view. Keeps up to date with issues that affect responsibility.

 

 International Organization  for Standardization (ISO)

This is a worldwide federation of national standards bodies from 145 countries. ISO was established in 1947 as a non-governmental organization whose mission is to promote development of standards to facilitate the international exchange of goods and services, and to promote cooperation in the spheres of intellectual, scientific, technological, and economic activity. The product of this work is international agreements, which are published as international standards.

 

 Interpersonal Skills

Displays a consistent ability to build solid relationships of trust and respect inside and outside of the organization.

 

 Laboratory Professional

Laboratory medicine, an important medical discipline, relies on a teamwork of technicians, senior technicians and academic staff. Laboratory professionals spent most of their time in a Clinical Laboratory. In most countries, formal scientific and (para)medical training as regulated by the national government is required to be named a laboratory professional

 

 Leader

One who influences and guides others toward the accomplishment of goals.

 

 Leadership

In its application to the clinical laboratory, describes the position of one (or those) who drive results by aligning the vision, mission, and values to enhance the value of the laboratory. One operating in this position is able to enlist the willing cooperation of others, while tapping into their highest skills and abilities, to achieve desired results.

 

 Manager

One who is responsible for administering or controlling the operation of a service.

 

 Managing

As it applies to leadership, involves overseeing systems and processes, focusing on doing things correctly, and using resources wisely.

 

 Mentee

One who is in receipt of mentorship, also called protégé/ protégé of the mentor.

 

 Mentor

person who is perceived to have greater relevant knowledge, wisdom, or experience relative to the mentee

 

 Mentoring

The process for the informal transmission of knowledge, social capital, and the psychosocial support perceived by the mentee as relevant to work, career, or professional development; mentoring entails informal communication during a sustained period of time between the mentor and the protégé.

 

 Professionalism

As it applies to leadership, involves the projection of an image of maturity and integrity that creates credibility to patients, staff and third parties.

 

 Quality

Has many definitions but constitutes what is required to:

  • Become fit for a particular purpose
  • Satisfy certain specifications and requirements
  • Fulfill a required degree of dependability or consistency in performance
  • Meet the description as excellence in terms of properties relative to others.

 

 Quality Management System

According to QMP-LS (6) quality management system can be described as:

 

“A program developed to support efficient and effective, high quality and appropriate laboratory services (e.g. accurate and precise results, appropriate test selection, timely reporting, correct interpretation of results, clinical usefulness, appropriate recommendations for further tests).

 

Comprehensive and coordinated efforts (policies, processes and procedures) designed to meet quality objectives, to direct and control an organization with regard to quality.

 

Encompasses quality (management) system, quality assurance and quality control”.

6

 Results Oriented

As it applies to leadership, involves being passionate about achieving goals. A dedication to achieving all-win solutions to situations.

 

 Standard

As applied to components of professional practice, describes a guidance document describing the state of art in a specific discipline of practice or technical area, developed through expert consensus and provides requirements, specifications, guidelines or characteristics. When used consistently, a standard helps to ensure that materials, products, processes and services are fit for their purpose. The term can also be applied to a set of best practices that an organization agrees to adopt and to govern activity as an absolute requirement.  Standards do not usually have the force of law except.

 

 Team work

As it applies to effective leadership, involves organizing tasks, people, and resources in an optimal way by avoiding overload and idling.

 

 Trust

As it applies to an interpersonal work relationship, describes the knowledge that another will not take advantage of you. This, in effect, allows you to feel safe putting your self-esteem and position in that person’s hands.

 

 Values

As it applies to leadership, defines the basis for ethical conduct. It defines factors held in high regard by the leader and affects behaviors and actions. Values include the personal code of ethics. Leaders demonstrate a strong sense of integrity by working in accordance with their personal values.

 

 ISO 15189

 

It is an international standard, based on ISO/IEC 17025 and ISO 9001, that specifies requirements for competency and quality that are particular to medical laboratories.

 

ISO 15189 is designed specifically for clinical and medical laboratories and focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency. The International Organization for Standardization has released three versions of the standard. The first two were released in 2003 and 2007. In December 2012, the organization released a revised and updated version of the standard, ISO 15189:2012, which is often just referred as “ISO 15189”, without the version year.

4

 

 Validation

As applied to analytical process in a confirmation that the process (including method, reagents, analysis system) meet the requirements for specific intended use. This term is often used synonymously with evaluation. Validation only means confirmation of claims, whereas evaluation may also include setting claims by experimental work. However, in practice, both terms are used synonymously.

5

 Verification

As applied to analytical process and in contrast to validation, it involves confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. The definitions of both validation and verification are very similar. The difference lies in verification applying to testing characteristics that were previously determined as specifications that are characteristics of the test or testing device.

 

 Work Climate

Describes the prevailing workplace environment as experienced by employees within the workplace. It constitutes what it feels like to work in a place.

 

 

References:

1)    Eller, P. M. (Ed.). (1994). NIOSH manual of analytical methods (Vol. 94). Diane Publishing.

2)    Food and Drug Administration. (2007). Guidance for industry: bioanalytical method validation (2001). Available from: http://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf

3)    ISO. ISO 15189: Medical Laboratories—Particular Requirements for Quality and Competence. April 15, 2007

4)    ISO 15189 Medical laboratories – Requirements for quality and competence. Geneva, Switzerland: ISO; 2012.

5)    ISO/TS 22367Medical laboratories -- Reduction of error through risk management and continual improvement. ISO; 2008 

6)    Coffey, J., & Crawford, L. (2002). Guidance for laboratory: quality manuals. In Guidance for laboratory: quality manuals. OLA.

7)    Tindill, B. S. and Stewart, D. W. (1993) Integration of Total Quality and Quality Assurance. In Al-Assaf, A. F. and Schmele, J. A. (eds) The Textbook of Total Quality in Healthcare. St Lucie Press, Delray Beach, FL, pp. 209–220.

 

 
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