The Disparity in Global Laboratory Standards The global approach to medical laboratory competence, as overseen by the International Laboratory Accreditation Cooperation (ILAC) and regional bodies, is currently facing scrutiny. Many countries achieve ISO 15189 accreditation without employing formally educated medical specialists. The standard’s use of the term “competent person” is broad, leading to variable interpretations and applications worldwide.
The Unequal Weights of Competence In certain regions, only qualified medical professionals like MDs or post-MBBS diploma holders are authorized to sign off on test results and provide expert interpretation. Conversely, in numerous countries, this pivotal role is filled by medical technologists, who may lack comprehensive professional expertise. This discrepancy raises questions about the equivalence of laboratory competence when the presence of medical specialists is not uniform.
Pre-Analytical Oversights and the Risk of Inequality The lack of medical specialists can lead to the neglect of pre-analytical conditions, patient history, and clinical correlation, which are crucial for accurate diagnostics. There exists an inherent inequity between laboratories with medical specialists and those operated solely by medical technologists, directly impacting the reliability of lab results.
Assessor Expertise: A Question of Adequacy It has been observed that accreditation bodies sometimes deploy medical technologists or even non-medical personnel to assess laboratories. This practice casts doubt on the assessors’ ability to thoroughly evaluate laboratory competence as per the nuanced ISO 15189:2022 criteria.
Inconsistencies in Medical Specialization Even in jurisdictions where a medical specialist’s involvement is mandated, it is not uncommon for a general pathologist to interpret results outside their specific field, such as in biochemistry or microbiology. This practice, sanctioned by regional cooperation and ILAC policy, further complicates the dependability of laboratory data.
The Consequences of Commercialization The silent endorsement by ILAC and regional cooperatives of such practices suggests a tilt towards commercialization, where the expansion of accreditation scope is encouraged, possibly at the expense of technical competence. The lack of specific, uniform criteria for medical laboratory personnel’s competence and the broad allowance for various interpretations of “competent person” raise critical concerns.
The Call for Uniformity and Reliability There is a pressing need for ILAC to establish and enforce specific criteria for the competence of laboratory personnel. Without such uniformity, the global equivalence of laboratory accreditation is compromised, potentially diminishing the reliability of medical test data.
Local Regulations and Their Impact on Laboratory Competence
The landscape of medical laboratory accreditation is shaped by a myriad of local regulations that govern safety protocols, infection control measures, facility conditions, internal quality control, manpower competence, and medical device regulations. These regulations, while intended to ensure the safe and effective operation of medical laboratories, can sometimes vary greatly from one region to another. This lack of uniformity may lead to inconsistencies in the competence of laboratories to deliver reliable test results.
For instance, a laboratory in one country may follow stringent safety and infection control protocols in line with high international standards, while another may adhere to less rigorous local standards. The disparity in accommodation conditions, such as the laboratory’s physical infrastructure, can also impact the quality of test results. Laboratories with state-of-the-art facilities are likely to produce more reliable results than those operating in suboptimal conditions.
The Role of Medical Device Regulations
Medical device regulation is another critical factor. Laboratories that use well-regulated, state-of-the-art equipment are at an advantage compared to those with outdated or poorly maintained devices, often due to lax local regulations.
The Need for Harmonized Regional Cooperation
Regional cooperation monitored by ILAC needs to establish equal minimum specific criteria for laboratory competence to prevent the quality of test results from being compromised. For instance, if one lab uses an advanced PCR machine for pathogen detection while another uses an older model due to less stringent local medical device regulations, the accuracy of test results can vary significantly, which is a cause for concern.
Conclusion: The Imperative for Uniform Standards
In summary, the effectiveness of medical laboratory services hinges on harmonized, stringent standards and regulations that span all aspects of laboratory operation. ILAC and regional cooperation bodies are called upon to standardize these criteria to ensure that the quality of test results is consistent, reliable, and comparable on an international scale. Without such uniformity, the very essence of quality assurance in medical laboratory testing is at risk.
About the Author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories and hospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairman of IOL ( An ILAC stakeholder organisation), Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at director@iaqmconsultants.com and contact information are available on his websites,https://www.quality-pathshala.com and https://www.sambhuchakraborty.com , or via WhatsApp at +919830051583