Commercialization and Credibility at a Crossroads Laboratory accreditation has traditionally signified a global recognition of a laboratory’s capacity to deliver accurate test results, crucial for patient safety and scientific reliability. However, with accreditation practices becoming increasingly commercialized, the credibility of these credentials is now under intense scrutiny. The global accreditation landscape is at a pivotal point where the authenticity of laboratory test reports is in question due to concerns about laboratories’ actual competence.
The Policy Quandary: One Nation, Multiple Accreditation Bodies In the absence of a ‘one nation, one accreditation body’ policy, the field has been thrown open to multiple players, including profit-driven entities. This shift from government-led accreditation bodies to private ones is raising serious questions. These organizations prioritize business growth over the stringent accreditation process, leading to a dilution of standards. Extravagant expenditures on conferences and travels are symptomatic of this shift toward commercialization.
Cross-Border Accreditation: Policy Breaches and Profit Motives Despite existing policies, accreditation bodies are expanding their services across borders, seeking additional revenue. Such actions ignore established ILAC cross-border policies and raise questions about the commitment to maintaining accreditation integrity, especially in regions like India, the Gulf countries, and Bangladesh.
Competency Under Fire: The Dilution of Standards in Accredited Labs The rush to commercialize has resulted in laboratories of dubious competency obtaining accreditation. This erosion in the stringency of the accreditation process is evident as some laboratories only appear competent during assessments, lacking a continuous commitment to quality.
The Rise of Profit-Driven Private Accreditation Bodies The entry of private, profit-oriented entities into the accreditation space has gone unchecked by ILAC. Such organizations, focused on financial gains, pose a threat to the objective and rigorous nature of the accreditation process.
Stakeholder Interests: The Commercialization of the Accreditation Ecosystem The current accreditation system sees stakeholders from both ILAC and APAC driven by commercial benefits. An increase in the number of accreditation bodies or accredited conformity assessment bodies benefits the accreditation community but raises concerns over the potential compromise of accreditation integrity.
Marketing Over Mission: The Aggressive Push for Global Accreditation Organizations like UNIDO and various trade bodies are promoting accreditation aggressively without a corresponding emphasis on ensuring quality. This trend towards marketing and promotion of accreditation risks prioritizing visibility over the delivery of quality services.
Governance Concerns: ILAC Board and Its Commercial Interests The ILAC board, mostly comprised of representatives from accreditation bodies, reflects a strong commercial orientation. Without external representation, the board’s decisions may lack the necessary balance to prevent commercial interests from overtaking quality considerations.
Lack of National Representation: The Missing Voices in Policy Making ILAC’s policy-making lacks representation from national standards bodies and governments, resulting in a policy void that fails to protect against the entry of private accreditation operators and preserve the integrity of the system.
Accreditation as a Market Commodity Accreditation bodies, traditionally gatekeepers of quality, are increasingly seen as prioritizing profit. This shift towards viewing accreditation as a commodity risks undermining the quality standards that are paramount for ensuring safety.
Feedback Fiasco: The Deficient Mechanisms for Quality Control The absence of a feedback mechanism from end users, such as patients relying on accredited laboratory services, is a glaring oversight. This lack of feedback compromises the ability to gauge the true effectiveness of accreditation bodies.
Technical Shortcomings: Inadequate Infrastructure and Assessor Expertise The technical shortcomings of accreditation bodies and their assessors are evident in their inability to fully grasp the operations of conformity assessment bodies, leading to inadequate assessments and a lack of accountability.
The Drive for Profit and Its Impact on Quality The commercial drive within the accreditation sector is leading to a race for certification, prioritizing market presence over quality enhancement, with accreditation bodies focusing on quantity rather than the quality of their evaluations.
Surveillance and Oversight: Inadequate Monitoring by ILAC and Regional Bodies The increase in accredited conformity assessment bodies is financially beneficial for regional cooperatives, but it fosters a commercial environment that may compromise the quality of accreditation due to insufficient oversight.
The Fallacy of Numbers: Revenue vs. Quality The focus on the growing number of accredited bodies and the corresponding revenue is misleading, as these figures do not reflect the actual quality of the accreditation process, a situation that calls for more rigorous monitoring.
The Need for Reform in Assessment and Accreditation There is an urgent need for ILAC and regional cooperatives to reassess and strengthen their accreditation criteria to ensure that only laboratories with the necessary competence and infrastructure are accredited.
The Challenge of Reform: Who Will Bell the CAT? The article concludes by highlighting the urgent need for reform in the accreditation process and calls for a collective dialogue among all stakeholders to address the commercialization that threatens the system’s integrity.
In summary, the commercialization of laboratory accreditation is a multifaceted issue that requires a concerted effort to address. The question of who will take responsibility to ‘bell the CAT’—a metaphor for initiating reform in a system where all parties have vested interests—is left open for the industry to answer.
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 organization), 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 info@sambhuchakraborty.com. Additional resources and contact information are available on his websites,https://www.quality-pathshala.com and https://www.sambhuchakraborty.com, or via WhatsApp at +919830051583
Very useful article for laboratory professionals