Position Paper by Medical Laboratories and Pathology Institutes: Toward a Reliable, Practical, and Effective Accreditation System

Position Paper by Medical Laboratories and Pathology Institutes:
Toward a Reliable, Practical, and Effective Accreditation System

Medical laboratories and pathology institutes are an indispensable part of modern, high-quality, patient-centered health care. In the field of in vitro diagnostics in particular, they form the foundation for precise diagnoses, personalized therapies, and innovative
care approaches. Quality assurance is essential in this context—and accreditation is a key tool for demonstrating this quality in a transparent and comparable manner.

The German Accreditation Body (DAkkS) plays a key role in ensuring a high standard of medical care. Its mission is to strengthen confidence in the professional competence of medical facilities through independent accreditation and to help improve professional competence for the benefit of patient care. This fundamental principle is expressly supported by the undersigned associations and professional societies.

At the same time, medical laboratories and pathology institutes have for some time been facing significant and growing challenges in the practical implementation of accreditation procedures. These challenges have now reached a level that is disconnected from patients and out of touch with reality—a situation that, in the view of professional associations and societies, is no longer acceptable and jeopardizes the reliability of healthcare provision and Germany’s position as a center for healthcare.

Current Accreditation Practices: More of an Obstacle Than a Help

What was intended as an important tool for quality assurance is increasingly perceived as a burden in its current form. For many institutions, accreditation procedures are becoming a hindrance to day-to-day operations. Instead of improving daily laboratory workflows and providing planning certainty, they create uncertainty, lead to financial pressure, and tie up already scarce personnel resources—which ultimately has a negative impact on the quality of patient care. This development runs counter to the policy goals of strengthening the healthcare sector in Germany, promoting innovation, and creating reliable framework conditions for service providers. Most recently, the Conference of Economic Ministers adopted and thereby underscored these goals at its meeting on November 28, 2025.

Key points of criticism from the perspective of medical laboratories and pathology institutes

1. Inadequate Communication and Long Processing Times
Numerous institutions report very long response times in ongoing accreditation procedures. In some cases, DAkkS does not provide feedback for months, or does so only after significant delays. This lack of reliability makes operational planning considerably more difficult and undermines the necessary
process reliability—even with respect to our customers, who cannot understand these delays.

2. Delays in Issuing Accreditation Certificates
In a number of cases, accreditation certificates are not issued until twelve to eighteen months after the conclusion of the process. This leads to legal and organizational uncertainties and has a negative impact on follow-up audits as well as on the public image of the affected institutions.

3. Excessive Bureaucracy and Documentation Requirements
The documentation burden associated with accreditation—which is far removed from day-to-day laboratory work—has increased significantly in recent years. This burden is often disproportionate to the actual improvement in quality. Instead of focusing on technical and medical content, formal and
system-related requirements dominate—requirements that do nothing to improve laboratory processes or patient care. This development contradicts the stated policy goals of reducing bureaucracy in the healthcare system.

4. Imbalance Between System and Subject- Matter Audits
The increasing focus on system audits—which are typically conducted by auditors from outside the relevant field—means that these audits now often require more time and resources than subject-matter audits. As a result, highly qualified medical staff are disproportionately tied up with formal
quality management requirements. This comes at the expense of patient care, research, and innovation.

5. Rising Costs and Financial Burdens
The costs of accreditation are rising steadily without providing any benefit to patient care. In addition to direct fees, there are significant indirect costs resulting from internal personnel expenses and external consulting services. Smaller and medium-sized facilities, in particular, are coming under increasing financial pressure as a result. For these institutions, accreditation is evolving from a quality assurance tool into a financial risk and placing an additional burden on our healthcare system. Limited financial resources should be used to safeguard and improve diagnostics, not for superfluous and useless documentation.

6. Loss of Professional Input and Transparency
The signatory associations and professional societies view the abolition of the former sector committees as a significant step backward. The structured, ongoing dialogue between DAkkS and the relevant medical specialties contributed significantly to professional acceptance and transparency. The current form of ad hoc involvement through a council of experts does not replace this dialogue.

Importance for Security of Supply and Germany as a Healthcare Hub

The problems described do not merely affect individual institutions; they have systemic repercussions. Delayed and inefficient accreditation procedures hinder innovation, dampen the willingness to invest, and, in the long term, jeopardize comprehensive, high-quality
health care. As a result, the DAkkS’s original, truly outstanding goals are now being completely undermined.

And they stand in direct contradiction to the goals set forth by policymakers—including in the context of the aforementioned resolutions of the Conference of Economic Ministers—to strengthen Germany as a hub for the healthcare industry. Reliable and economically viable framework conditions are a key prerequisite for a healthcare industry that is both resilient and innovative.

Reform Proposals for Constructive Further Development

The undersigned associations and professional societies expressly do not intend their criticism to be a blanket challenge to the accreditation or the work of DAkkS. Rather, the goal is the constructive further development of the system.

An effective accreditation system must

• be practical and proportionate,
• ensure transparent and predictable procedures,
• place greater emphasis on technical quality than on formal system requirements,
• be economically feasible,
• systematically involve the affected medical service providers and
• significantly benefit patient care.

The associations are therefore calling for:

1. A fundamental reform of accreditation practices, with a focus on efficiency, reliability, speed, and practical relevance.
2. Binding processing deadlines and transparent communication structures.
3. A significant reduction in bureaucratic and redundant documentation requirements.
4. A proper balance between system-level and subject-matter reviews, shifting away from an excessive focus on system-level reviews toward subject-matter reviews.
5. An economically viable accreditation framework, particularly for smaller institutions.
6. The institutionalized, binding, and participatory involvement of medical service providers and professional associations in the further development of accreditation procedures.

Quality assurance, patient safety, and innovation are shared goals of policymakers, accreditation bodies, and healthcare providers. However, these goals can only be achieved if accreditation is viewed as a supportive and reliable tool and is put into practice. The undersigned associations and professional societies, which represent laboratory diagnostics and pathological diagnostics in Germany, stand ready to contribute their technical expertise constructively to a timely reform process—in the interest of patients, the security of care, and Germany’s position as a strong healthcare hub.

Signatory Associations and Professional Societies
Professional Association of German Pathologists (BDP)
German Society of Pathology (DGP)
German Society for Neuropathology and Neuroanatomy (DGNN)
Professional Association of German Human Geneticists (BVDH)
German Society for Human Genetics (GFH)
Professional Association of German Laboratory Physicians (BDL)
Association of Accredited Medical Laboratories (ALM)
Professional Association of Physicians for Microbiology, Virology, and Infectious Disease Epidemiology (BÄMI)
German Society for Virology (Society of Virology , GfV)
German Society for Hygiene and Microbiology (DGHM)

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