Has anyone ever felt anxiety knowing that an accrediting organization would soon make a visit? Is the prospect that The Joint Commission (TJC) surveyor is visiting causing some trepidation or anxiety? Are you part of a new hospital seeking accreditation?
Achieving accreditation means compliance with standards set by a number of organizations; some only in the U.S. and others that have a global presence. For this reason, biomed departments must have a working familiarity with the many factors found within these standards.
Those in the healthcare technology management (HTM) department tasked with achieving accreditation should also have an understanding of hospital operations and regulatory requirements.
There are approximately 17 organizations that can accredit hospitals, many with “deeming” power for Medicare and Medicaid. The Joint Commission accredits more than 4,000 hospitals.
According to the Joint Commission; “all medical equipment is required to be on the medical equipment inventory,” if the facility is accredited through The Joint Commission.
“I would suggest HTM leaders address this topic with a multi-step process,” says Mike Busdicker, MBA, CHTM, FACHE, system director of Clinical Engineering/Intermountain Environment of Care at Intermountain Healthcare in Midvale, Utah.
He says to identify the regulatory agencies governing medical equipment requirements for your facilities; DNV, TJC, CMS, FDA, CDRH, State Health Department.
Understand what those requirements are and how they impact the HTM department and all other departments within the health care facility. What, if anything, is currently in place within the organization to address those requirements?
“Work with compliance, risk, or other appropriate departments to review, refine and develop proper procedures, policies, guidelines,” Busdicker says
He says that there is no need to reinvent the wheel. HTM departments should utilize resources available through organizations like AAMI.
One published resource that can provide guidance is AAMI’s Planned Maintenance Compliance and Definitions Guide, created by AAMI’s Technology Management Council Standardization Subcommittee.
There are a number of baseline best practices that an HTM department can follow to satisfy CMS, TJC, DNV and other accrediting agencies.
In a 2021 AAMI eXchange Rewired presentation, “The Basics: How to Ace the Accreditation Survey,” Danielle Bruno, site health team lead at GE Healthcare, and Josh Virnoche, HTM quality leader at GE Healthcare, laid out the considerations to logically and calmly face this inevitability.
Their session provided an overview for participants to learn the “key components of a successful HTM program” and how to meet the requirements of the major accrediting agencies.
Both presenters have a wealth of experience in HTM, including leadership.
“It sounds remedial, but having a robust and easy-to-follow medical equipment management program (MEMP) and an established annual review process through the EOC committee [are important]. A bonus is having specific measurable goals established for your facility,” says Virnoche.
He asks, if you’re seeing a large influx of physical damage, how can your HTM team help mitigate some of that? Or, if you’re seeing an influx of new equipment bypassing the HTM department, before making its way to the floor, how can you improve the process?
“The MEMP should be the core of all your HTM activities, it should answer the question, how does my department and hospital meet the regulatory standard?” Virnoche says.
He suggests double checking to make sure your processes, policies, procedures and day-to-day activities align with the regulatory standards.
“It’s one thing to have a robust MEMP, but when surveyed, significant gaps are observed between what you say you do and what you practice, there will be further in-depth discussion with the surveyors,” Virnoche says.
He also suggests having an internal mock auditing/survey process that mimics a CMS/TJC/DNV survey. Walk the floors, look at equipment ID tags, PM stickers, broken devices that haven’t been reported. Do a work order/service request audit, to ensure the team is following good documentation practices. Ensure test equipment is listed in the work order.
“Quiz team members on process/policy and where to find them. Make sure annual training is up to date. Knowledge sharing is important, and knowledge of the service program throughout the organization is generally a good sign that there is a well-functioning HTM department,” Virnoche says.
Bruno adds that some additional baseline best practices would include ensuring PM compliance of 100 percent with documented status. She also suggests having proper documentation on hand in case of random audits and maintaining an accurate inventory through the use of passive tags along with scanner.
“Tracking the percentage of devices not touched in two years and determining the status of the device. Less than three percent of inventory should be not touched in 24 months,” she says.
Kirwan adds some best practice suggestions:
He also says to have an executive assigned as an expediter who has the authority to make decisions hospital wide, including overtime, contractor work approval, purchases, etc., adjusts staffing as needed for clearing findings, is responsible for helping to clear any findings, works with department heads to get them what they need and defers only when a decision would violate hospital policy or procedure such as capital purchasing.
“If possible, have a resident expert on medical equipment regulatory requirements for continuous review,” Busdicker says.
He also says to educate all HTM caregivers on regulatory compliance and accreditation for medical equipment. Utilize training and resources provided through the AAMI Exchange, MD Expo conferences, TJC Boot Camp, local/regional HTM societies and other sources.
Part of the goal of attaining the right mindset ahead of a survey is to view the surveyor’s mission in the right light. You are not expected to walk on water. “Half of the battle, so to speak, is knowing the intent of surveyors and what to expect from them. First and foremost, many facilities approach surveys with a sense of trepidation. Sure, hospital accreditation is at stake, however the mission of the surveyors is not to deny accreditation. Their role, generally speaking, is about safety, quality, performance improvement and the exchange of best practices,” says Perry Kirwan, vice president of Technology Management/ENTECH at Banner Health in Phoenix, Arizona.
He says that from the surveyors, you can expect a thorough review of documentation (including personnel files, policies and procedures, medical equipment inventories, billing and maintenance). You can expect them to perform walk-through inspections of the facility and to observe multiple procedures in the hospital. The important thing to remember is that they are there to help.
“From the hospital perspective, it is important to know that perfection is elusive. The main thing you want to avoid is immediate jeopardy, understand that from 8 a.m. to 5 p.m. (typically) is the survey and from 5 p.m. to 8 a.m. is an opportunity to correct findings. As such, it’s good to plan for a bit of overtime and/or extra shifts,” Kirwan says.
He says that from an HTM team’s perspective – have as many people rounding and reporting issues as you can.
“And, in doing so, keep in mind not only your area of responsibility but help look out for other areas as well. It’s advisable to have a head on a swivel mentality – looking at all possible problems and engaging the necessary personnel/teams to help address them. Be prepared for document review,” Kirwan says.
Motivational speaker Zig Ziglar once said that “Success occurs when opportunity meets preparation.”
The opportunity to meet or continue accreditation is best answered with preparation.
“The best survey preparation is having a solid HTM/CE program. Documentation is key. You must have an accurate medical equipment inventory and record full service history on all devices in the program. The service history should include calibrated tools listed on service reports and accurate detailed description of service. Randomly auditing these records is a good way to ensure and instill confidence of this,” Kirwan says.
He says that PM completion percentage, like them or hate them, is a big part of documentation review, so know the requirements and make sure your policies and procedures are very clearly about things like alternative equipment maintenance (AEM) and could-not locates.
“There are a lot more requirements around personnel qualifications. Consider having documentation of background checks, up-to-date shot records and, of course, all training records that reinforce competencies for your service personnel,” Kirwan says.
Know Your Role During a Survey
Kirwan says that a survey is the time to take ownership. Make sure to verify PM completion and documentation and round more frequently.
“Everyone is going to be really busy leading up to the survey, and during the survey, all the while taking care of patients. As such, people may be less available due to extra duties. There may be more needs than normal on the floors so preparing for that makes a big difference,” he says.
He says to create a supportive environment. Even with the greatest amount of preparation, there will still be stress and anxiety during a survey.
“Be sensitive to that and help support each other not only within your areas of responsibility but also outside of it as well. Grace under pressure is a hallmark of HTM professionals and it is really appreciated by executive leadership especially when other departments may not be operating at the same level,” Kirwan says.
He suggests that the HTM department should be the eyes and ears.
“Look at everything from ceiling tiles to floor conditions and ensure that any issues are reported to the command center (if applicable) or those charged with leading the survey effort on behalf of the facility,” Kirwan adds.
“Aside from the major AO’s, the most common stakeholders outside of your organization are going to be specialty accreditations like CAP and AABB. Additionally, sometimes local and state departments of health have specific requirements as well,” Virnoche says.
He says that his best recommendation for CAP and AABB is to make sure you’re aligning with their maintenance requirements. Partner with the director of lab and/or blood bank, as they’ll be the subject matter experts for those specialty accreditations and review the current service procedures and intervals with them to ensure compliance.
“For state and local departments of health, there can be different requirements based on the treatment areas (i.e., oxygen enriched environments, wet areas or other high-risk critical areas). This can pose an entirely different problem than a CAP or AABB accreditation, because generally lab and blood bank equipment is used in the same location or type of location across the health care delivery organization,” Virnoche says.
He says that for the department of health, you could have very generic, low-risk equipment that is highly mobile and used in high-risk areas that required more frequent PMs. But one day, that device could be in a low-risk area that doesn’t meet the requirements for more frequent maintenance, and the next day it does.
“I have two different points of view on this topic. One from my time being an in-house service provider, and one from my current role as a third-party service provider with hospitals in all 50 states,” Virnoche says.
He says that as a third-party service provider, with a broad group of hospitals, the goal is to create a program that meets the ISO13485 regulatory requirements for servicing medical devices, establishing a QMS that meets the ISO9001 requirements, and then we ensure that the MEMP and program meets the CMS requirements surveyed by TJC, DNV, HFAP, CIHQ, etc.
“In this case, because we have such a broad scope, we try to get to the most common denominator for all sites. That would be CMS-based regulations. We rely on specific sites, with additional specific accrediting requirements to tweak the program to meet the customer’s more stringent requirements. We can always be more stringent, but never less,” Virnoche adds.
The predominant message is that preparation, empathy with the surveyor’s job and goals and maintaining a solid MEMP are key. These things will all reduce the stress and anxiety that are often an inherent part of these inspections.
Kirwan says that there are also some considerations for the participants which may be overlooked.
“Take care of the team. Make sure that everyone has the support they need. Check in on your team members and make sure they get enough rest and that they eat. Be kind to those from other departments; they are stressed,” he says.
Kirwan says to remember there is life outside of the hospital. This is temporary.
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