Central Fabrication Accreditation: Has the Time Come?
May 2013 Issue
That depends on who you ask. In a year already awash with change as provisions of the Affordable Care Act move forward, the American Board for Certification in Orthotics, Prosthetics & Pedorthics' (ABC) plans to begin an option for central fabrication facilities to become accredited exclusively as such is drawing mixed reviews.
Says one industry leader, there is no middle road.
"It's either 'hell yes' or 'hell no,'" says Tony Wickman, CTPO, CEO of Freedom Fabrication, Havana, Florida, who contacted fabricators in the O&P industry to gauge how the idea was being received. Wickman says that he and others contacted every central fabricator in the United States that would be eligible for the new accreditation program-between 40 and 50 in all-and the response, literally, was almost half for it and half against it.
"The guys who rejected the idea pretty much unanimously just didn't think it would be of any benefit," he says. "Most said it would cost too much, take too much time, and increase their unbillable workload."
Wickman, however, says that he is in favor of the option. Ultimately, he says, "I think it is a good idea. I have felt that for many years this needed to be done. I am behind it 100 percent."
The program, expected to debut June 1, is in the final stages of preparation, according to Catherine Carter, ABC executive director. "Many ABC volunteers have been diligently working for almost two years on this project," she says. In addition, the association's board of directors "has spent many hours reviewing standards, eligibility criteria, and other aspects of the new program. Everything is finalized, approved, and ready to launch."
Stamp of Approval
The impetus behind the new accreditation program, Carter says, were requests from several central fabrication companies in the industry that asked ABC to explore the possibility of creating an accreditation program specifically designed for them. "They expressed a desire to be recognized by ABC as central fabrication facilities that meet the highest standards for quality control and best business practices."
Once the program launches, it will be up to the facilities to make sure they are eligible and in compliance, Carter explains. The central fabrication accreditation program includes 60 standards, which encompass the following areas:
- Organizational standards.
- Business records.
- Record keeping.
- Human resources.
- Warranty and recall.
- Safety and equipment.
- Quality assurance.
- Customer satisfaction.
With more than 14,000 certified individuals and more than 7,000 accredited facilities, ABC is well positioned to expand its existing facility accreditation program. ABC is recognized as a deemed authority for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) facility accreditation by the Centers for Medicare & Medicaid Services (CMS), the U.S. Department of Veterans Affairs (VA), and most major healthcare insurance providers and health maintenance organizations in the United States.
The timing, Carter says, is right for the type of program that ABC has designed because the O&P profession has seen a shift in recent years to more of a central fabrication model for O&P practice. "It makes sense to bring our expertise and knowledge to the fabrication side of the profession," she explains.
ABC views its central fabrication accreditation program as a move toward meeting the needs of patients by "creating standards that touch the entire spectrum of care, including the fabrication of the device that is the result of the O&P care that is delivered," Carter says.
Wickman agrees. As far as he is concerned, the most important reason behind the accreditation for central fabricators should be patient care. "My whole reasoning for being behind this thing is we owe it to our patients to do everything we can to protect them," he says. "That means we have to be able to apply some level of uniformity across the playing field."
Patients, he says, need to be assured that the facilities they go to for treatment or that produce the devices that help to increase function and mobility are safe. Patients should know that the employees who are making the devices are properly educated and meet certain standards that ensure safe and efficient products. "It's the same thing you would want and would investigate from a company that makes airplane parts," he says.
Those who are in favor of the move toward central fabrication accreditation also cite the industry's shift toward becoming more evidence-based as a motivating factor. Just as there needs to be consistent standards across which research and outcomes data are based, they argue, there also should be a consistent set of standards that central fabrication facilities must meet.
"I've said this a million times before, but I am just stunned at the lack of regulation in this industry," Wickman says. "You can't cut hair in the state of Florida without being licensed. We make things that people walk on, and if you don't do it properly, it will break. We've been in this vacuum for a long time, and I'm not sure how that happened."
And while the program was not sparked by increased regulatory scrutiny in the United States, ABC says that the accreditation is nonetheless a move in the right direction that will show outside agencies that the industry has voluntarily committed to meet high standards.
Will BOC Offer Central Fabrication Accreditation?
When asked if it has plans to introduce a similar central fabrication accreditation program, Board of Certification/Accreditation, International (BOC) representatives said they do not, but that the organization "values the importance of credentialing in the profession.
"We recognize the excellence of BOC-certified professionals and BOC-accredited facilities to assure the industry of their competence, professionalism, and safe practice environments," BOC said in a written statement. "Our commitment to patient safety and setting standards has always been at the forefront of BOC's mission. Whether it was the introduction of the certified orthotic fitter and certified mastectomy fitter certifications or the progression of our eligibility prerequisites for orthotists and prosthetists, we have always made these decisions with that same commitment to patient safety and standard setting."
Mike Verhoff, owner of PSL Fabrication, Fulton, Missouri, says that what is voluntary today will likely be mandatory in the future. "I don't see any way around that," he says. PSL, he adds, is already preparing for that eventuality. "We are a paperless company," he says. "We have been working on our standards and procedures documentation. We've been a CAD/CAM facility for years, so we digitize everything we do, which gives us a digital file and 'virtual' paper trail on all of our work."
While Wickman says that he doesn't believe central fabrication accreditation will become mandatory, in part because of the difficulty it would take to get there, he doesn't discount the possibility entirely and urges central fabricators to seriously consider becoming accredited.
The timing is never good for added regulation, he explains, but in this instance it may deflect federal regulators from foisting their own rules upon the profession. "If we don't do it, somebody else probably will and that may be the FDA [U.S. Food and Drug Administration]," he says. "It may not be enough to quench the regulation, but if they come looking we can go: 'Hey, we got it covered.'
"The good thing is that if you go through ABC's facility accreditation and you make it and get used to that environment, if the FDA comes in you are going to be pretty darn close to what the FDA is going to want you to do," Wickman continues. "It will also make a future transition easier if it happens."
C-Fabs Express Interest
Carter says that there has been great interest in the program so far and that several facilities have indicated that they are ready to seek central fabrication accreditation when it becomes available.
Verhoff says that accreditation coming to the central fabrication side of the business "is long overdue. This will finally give some legitimacy and standardization to the technical side of the business," he says.
"I really haven't talked to any other labs about their feeling on this," he adds. "But any lab that is a professional lab should be excited about it. Hopefully, it will...keep unqualified people out of the business."
If Wickman's initial polling of central fabricators is an indicator, acceptance won't come easy, he says. But for those fabricators who take advantage of ABC's central fabrication accreditation program, there will be other benefits, he adds. Fabricators who earn the accreditation will be able to use it for marketing and to boost sales. That's the kind of bottom-line impact that can push even the most controversial initiatives over the top.
Garrison Wells is an award-winning freelance writer and author based in Colorado Springs, Colorado. He has written for newspapers and magazines nationwide and authored five books on martial arts. He can be reached at