As part of our “Why” series of articles, we wanted to cover another question that we get often, and one that has been a hot topic of discussion in the forensic genetic genealogy community, about accreditation. What IS accreditation?
What are the benefits? Is it necessary? Here at Intermountain Forensics, we firmly believe that it is absolutely necessary. Accreditation makes us better at what we do, it adds to our transparency, and it is essential to our mission as an organization. We thought it might be useful to explain our rationale for dedicating so much time, money, and effort into pursuing accreditation for our massively parallel sequencing analysis workflow for SNPs, STRs, and YSTRs, in addition to our capillary electrophoresis-based (CE) analysis methods and body fluid identification.
What is accreditation?
Accreditation is a formal and independent review of your technical processes and management system structure, to ensure that it meets the requirements of a set of standards. The common standards that are relied on in the forensic community is ISO/IEC 17025. The most current version of those standards was published in 2017 and are the product of an international collaborative effort to establish the minimum requirements for a laboratory performing either testing or calibration. The standards address topics like reporting, technical record documentation and retention, and establishing test methods. There are also standards included that establish requirements for identifying and preventing issues, such as management review, performance monitoring, and internal audits. Additionally, because being accredited does not equate to being perfect, it also has standards on how to address corrective actions when nonconforming work, or work that does not conform to its procedure, occurs.
Accreditation should not be confused with certification. Accreditation is granted to an institution, business, or program. Certification is granted to an individual indicating that they have the required credentials and knowledge to practice disciplines, or for a product to say it meets certain specifications. While Intermountain Forensics is highly supportive of certification of its staff, and encourages pursuit of certification, accreditation is an achievement for the organization as a whole.
What does it mean to be accredited?
ISO/IEC 17025 is written in a language of shoulds and shalls and is not often the way we are used to discussing our actions, which can often make it tricky to interpret and apply. Additionally, the wording is vague enough to apply to many types of testing and calibration, instead of a specific scientific discipline. The standards do not tell you how to perform a test, what to do in response to nonconforming work, or even what nonconforming work is for a specific testing method! Instead, they give the requirements for the structure and leave it to your organization on how to apply that when building your quality management system. Think of how often you hear someone say “Trust me, I know what I’m doing.” Well…. How exactly do you know that you can trust them? You look at their behaviors, their conduct, how they do what they do, etc. Trust with an individual is built upon something other than their word. In knowing them, you can verify that they are doing things in a manner that is trustworthy to you. Accreditation is very similar to this. It is a transparent process that opens the doors of the organization to outside individuals to come in and look at how the organization operates. It fulfills the maxim of “trust but verify”.
A lab not being accredited does not mean they do not do quality work, just like being accredited does not mean your lab is infallible and mistakes cannot occur. What it means is that the organization actively assesses their risks and opportunities to prevent nonconformities (or errors) and has the structure in place to identify and deal with the errors when they could not be avoided. It requires active self-assessment but also requires transparency of allowing outside individuals to assess your organization on an administrative and technical level.
Letting the Vision and Mission Lead
Attaining accredited status was an essential element in the vision and mission of Intermountain Forensics. As affirmed in our mission statement “We will strive to ensure the full power of Forensic DNA will always be attainable, affordable, timely, transparent and of the highest possible quality.” Achieving this milestone for our capillary electrophoresis-based services (CE) was time consuming but not especially challenging. Accreditation for those methods is well established and has been expected and even required of a laboratory performing Forensic DNA analysis for decades. But… pursuing accreditation for our massively parallel sequencing services for STRs, YSTRs, and SNPs meant that we needed to blaze some new trails. The resources for completing validation studies, for completing proficiency tests, and even for training were not as readily available as for CE based analysis. It was a lot of hard work. Work that no one expected of us, but work that we felt needed to be done because we truly want to be an example of change in this field. We persevered, and now are the only lab to perform both targeted and whole genome sequencing accredited by the ANSI National Accreditation Board (ANAB) for ISO/IEC 17025:2017 and the AR3125 in Biology as well as Texas Forensic Science Commission Accreditation. We hope that one day there are as many accredited labs generating data using massively parallel sequencing as those using capillary electrophoresis. More labs accredited for these services will only benefit the community. Accreditation means consistency, transparency and ensuring quality…. And we offer our support to anyone who wants to walk down that path as well.