Quality Assurance for Medical Translation

welocalize June 29, 2021

In 2010, Francisco Torres lost both his kidneys. Before his surgery at a hospital in California, he was given a consent form written in English. There were two problems, however. First, the form indicated the wrong kidney for removal. Second, Torres only spoke Spanish. Consequently, his good kidney was taken out. The hospital only realized its mistake afterwards and removed his diseased kidney as well. 

This is an often-cited classic case of an error in medical interpretation and translation. Unfortunately, the lack of translation or poor translation often leads to dire consequences. 

Value of QA for Medical Translation  

Medical translation covers a wide range of documentation. It includes informed consent forms, instructions for use, product manuals, medical examination reports, clinical trial results, and a lot more. 

The medical field has its own language. There are medical terms, abbreviations, neologisms, and synonyms that require specialized knowledge. Medical documents, wrongly translated, could compromise the quality of medical care. Translation errors in reports and results from clinical trials could lead to wrong diagnoses or recommendations. 

In medical translation, quality assurance, or QA, is therefore critical in detecting translation errors and inconsistencies. It’s highly valuable in improving accuracy and clarity in medical documents. 

Required Level of Quality  

All medical documents are vital. Instructions for use should be clear. Patient-reported outcomes must be accurate. Informed consent forms need to be understandable. Their translation requires the highest level of precision. There is just no room for error. 

Qualified translators are the only ones who can accomplish this level of quality in medical translation. While there are standards specific to medical translation, there are guidelines offered by the International Medical Interpreters Association (IMIA): 

Linguistic Proficiency 
  • Native or near-native, formal college level of language proficiency in the source and target languages 
  • Deep cultural knowledge in the source and target languages 
  • Ideally, has received instruction in translation theory and practice 
Medical Knowledge 
  • Fully understands the source text 
  • Expert on the terminology of the subject matter 
  • Can use specialized professional dictionaries and glossaries 
  • Can conduct terminology research to validate equivalents in the target language 
Professional Skills 
  • Proficient writing skills 
  • Analytical capabilities 

Rocío Txabarriaga, author of the IMIA Guide on Medical Translation, noted the real indicators of proficiency in translation. They are knowledge of the subject matter and knowledge of the relevant terminology. And they also include the ability to discern meaning in context and transfer it within the target language constraints, i.e., accurately, precisely, correctly, completely, and consistently. 

Medical Translation QA Process 

The process of medical translation QA involves designing control methods to detect errors, testing for readability and clarity, and verifying conventions and requirements regarding various text types and functions. 

There are several models for translation. The more stringent methods include multi-step translation and verification. These involve parallel forward translations, reconciliation of those forward translations, back translations, and reconciliation of those back translations. The translated text is then reviewed for final approval. 

While more complex review processes improve quality assurance, they also take a lot longer and cost more. They are also not foolproof, according to the IMIA. Back translations, which involve translating back from the target language to the original, “will most likely fail to indicate the target language contextual and usage nuances.” 

The IMIA recommends a more straightforward double verification process. First, once the translated text is ready, another professional will review and edit it. This editor is ideally someone who has more expertise, credentials, and experience in medical translation than the translator. Second, one or two proofreaders will proofread it. 

Roles of the Medical Translation Team 

The medical translation process is essential in ensuring that the translation work is rendered on time and within budget. The key, however, is the qualifications of the medical translation team. 

The medical translator should translate meaning for meaning, not word for word. The translator should self-edit before sending it to the QA process. According to the IMIA, the editor should check for punctuation, grammar, capitalization, semantic issues, syntactic issues, spacing, additions, omissions, orthographic accuracy, redundancies, cultural nuances, reading level, and general style correctness. The proofreader must check for capitalization, hyphenation, punctuation, spacing, and formatting. 

While there’s no certification specific to medical translators, those who are certified by the American Translators Association (ATA) can show evidence that they passed the rigorous test and abide by a code of ethics and standards of practice. 

Instead of, or in addition to using an in-house medical translation team, consider outsourcing to language service providers (LSPs) that specialize in medical translation. They can take on high-volume medical translation projects and multilingual requirements. They also have a stronger grasp of the varying translation requirements and regulations per country or region. 

When choosing vendors, consider the relevant ISO certifications they hold. This indicates their commitment to the highest standards of quality. ISO 13485:2016 applies to the quality management system (QMS) of companies that are in the medical device industry. An LSP with this certification is a great candidate for outsourcing translation work. 

A related ISO standard is ISO 9001:2015, which specifies requirements for a quality management standard for businesses in general. Specific to translation providers, meanwhile, is ISO 17100:2015, which provides requirements for things like processes, resources, and other things necessary to provide high-quality translations. 

Consequences of Translation Errors in Medical QA 

The quality standards for medical translation are higher than for other types of translation work. The stakes are higher. Translation errors can lead to costly litigation or regulatory penalties. They can cause bad publicity and damage reputations. 

The most serious consequence of poor translation puts the health of a patient at risk. It can be a matter of life or death. Mistranslated medical examination reports, instructions for use, or informed consent forms could lead to the wrong diagnosis, treatment, or dosage. 

Work With Welocalize Life Sciences 

Welocalize Life Sciences translates clinical, medical, healthcare, and regulatory documents to and from more than 250 languages. We are ISO 9001:2015, ISO/IEC 27001:2013, ISO 13485:2016, ISO 17100:2015, and ISO 18587:2017 certified. 

We have over 20 years of experience working with leading global pharmaceutical, biotechnology, medical device, and healthcare companies. Get in touch with us to discuss your medical translation requirements.