Authorization In Medical Laboratory Science: The Perspective Of ISO 15189:2022 And The Risks Of Undermining It

Authorization is a critical governance mechanism in medical laboratory science, ensuring that only qualified, competent, and formally approved personnel perform activities that influence the quality of laboratory examinations and patient outcomes. In ISO 15189:2022, authorization is positioned as a deliberate and documented management decision that links personnel competence to patient safety, accountability, and quality assurance. The standard moves beyond reliance on professional titles, hierarchy, or informal power structures and instead emphasizes evidence-based authorization grounded in demonstrated competence.

ISO 15189:2022 addresses authorization primarily under Clause 6, which outlines resource requirements, with particular emphasis on personnel. Clause 6.2 requires medical laboratories to define roles, responsibilities, and competence requirements for all staff whose work affects laboratory activities. Within this framework, authorization becomes the formal recognition by laboratory management that an individual is competent and permitted to perform specific tasks. This recognition must be explicit, documented, and traceable; it cannot be assumed or granted by implication.

Clause 6.2.2 establishes that authorization must be preceded by competence assessment based on education, training, skills, and experience. Authorization therefore represents the culmination of a structured evaluation process rather than an administrative convenience. The standard reinforces this principle in Clause 6.2.3, which requires laboratories to authorize personnel before they undertake specific activities that carry significant risk. These include the selection, development, modification, validation, and verification of examination methods; the review, release, and reporting of examination results; and access to and use of laboratory information systems, particularly where such access allows the entry, modification, or approval of patient data. By explicitly identifying these activities, ISO 15189:2022 underscores the importance of controlling who performs critical laboratory functions.

Authorization also serves as a foundation for accountability. When personnel are formally authorized, responsibility for decisions and outcomes can be clearly traced, which is essential for internal audits, external assessments, incident investigations, and management reviews. Clause 6.2.5 further reinforces this requirement by mandating the maintenance of personnel records that document competence, training, experience, and authorization decisions. These records provide objective evidence that authorization is justified and maintained over time.

Despite its central importance, authorization is often undermined in practice when it is “thrown to the dogs” for reasons of control, convenience, or political influence. In some laboratory settings, authorization decisions are overridden by managerial dominance, institutional politics, or non-professional interference, resulting in individuals performing critical tasks without formal authorization or demonstrated competence. Such practices directly conflict with the intent of ISO 15189:2022 and weaken the laboratory’s quality management system.

One of the major challenges arises when authorization is used as a tool of control rather than a quality safeguard. In such environments, authorization may be selectively granted or withdrawn to reward loyalty, suppress dissent, or consolidate power, rather than to ensure competence. This politicization of authorization erodes professional integrity and creates an unsafe culture where competence is secondary to influence. It also discourages objective competence assessment, as decisions become subjective and opaque.

Another challenge is the deliberate bypassing of authorization requirements under the guise of urgency, staffing shortages, or administrative expediency. While operational pressures are real, ISO 15189:2022 does not permit the suspension of authorization controls because the risks to patient safety remain unchanged. Allowing unauthorized personnel to validate methods, release results, or access laboratory information systems exposes laboratories to diagnostic errors, data integrity breaches, and loss of clinician confidence.

Political interference in authorization decisions also undermines accountability. When individuals perform tasks without formal authorization, responsibility becomes blurred, making it difficult to investigate errors or nonconformities. This weakens corrective and preventive action processes and compromises the effectiveness of audits and management reviews. Ultimately, the laboratory becomes vulnerable to repeated failures with no clear ownership of outcomes.

From a patient safety perspective, the consequences of abandoning authorization principles are profound. Medical laboratory results inform clinical decision-making, and errors introduced through unauthorized practice can lead to misdiagnosis, inappropriate treatment, delayed care, or patient harm. ISO 15189:2022 adopts a patient-centered and risk-based approach, and any dilution of authorization requirements directly contradicts this philosophy.

In conclusion, authorization under ISO 15189:2022 is not optional, negotiable, or subject to political convenience. It is a structured, evidence-based process that links competence, responsibility, and patient safety. Clauses 6.2.2, 6.2.3, and 6.2.5 collectively establish authorization as a cornerstone of professional practice and laboratory governance. When authorization is undermined for control or political reasons, laboratories compromise quality, erode accountability, and place patients at risk. Upholding robust authorization frameworks is therefore not only a requirement for accreditation but a professional and ethical obligation in medical laboratory science.

By: Dr. Solomon D.Y. Kwashie,
Medical Laboratory Scientist and General Secretary of the Ghana Association of Medical Laboratory Scientists

[email protected]