The Key to Compliance – CMS/TJC Guidelines Combine to Promote Patient Safety
In the health care world, the final word on accreditation always belongs to The Joint Commission. On its say-so, facilities are evaluated on the strength of their compliance with standards designed to uphold and improve patient safety. In turn, these standards and National Patient Safety Goals evolve “if they relate to patient safety or quality of care, have a positive impact on health outcomes, meet or surpass law and regulation, and can be accurately and readily measured,” the agency states on its website.
Two of the biggest standards changes of the past calendar year, in regards to the maintenance of medical devices, involved the definition of a categorical waiver for the use of power strips (or “relocatable power taps”) in health care facilities as well as the outline of an Alternative Equipment Maintenance (AEM) routine designed to cut back on health care spending in the biomedical field.
George Mills, Director of the Department of Engineering, The Joint Commission, said the Centers for Medicare and Medicaid Services (CMS) categorical waiver for power taps addresses power management concerns in patient care areas.
“The problem is that in an older operating room that is 24 x 24 or a new one that is 30 x 30, [tables] electrical receptacles may be 15 feet away from the wall,” Mills said. “If I decided to go with extension cords, on a temporary basis, either I gang them all together into one big cable and I have a huge trip hazard, or I have a bunch lying on the floor. It’s been a problem for years.”
Part of the issue came about in aligning standards for power taps that had been certified by Underwriters Laboratories (UL) with those acknowledged by agencies like CMS and The Joint Commission.
“Although not directly cited in our standards,” Mills said. “UL does impact compliance.”
The Joint Commission does recognize the National Fire Protection Association (NFPA) as the agency that develops codes and standards for facility safety, however, and its documents include reference to the NFPA 99-1999 Health Care Facilities Code, which set limits on the use of relocatable power taps anywhere medical equipment is used. An acceptable alternative, prior to the waiver, was to wire a ceiling drop from a junction box into which devices may be plugged.
In 2014, the Healthcare Interpretations Task Force (HITF) convened to re-evaluate whether a more workable solution could be managed that would benefit health care facilities without compromising patient safety. HITF revisited the standard based on a variety of factors (including the UL 1363A designation) and an updated edition (2012) of the NFPA 99 code that Mills described as “a lot more flexible” in allowing permanently affixed power taps.
After that review, it was recommended to CMS that they revisit the 2012 edition of NFPA 99, and offer a categorical waiver for facilities seeking to use relocatable power taps “with some provisions,” Mills said. This includes ensuring that the facility fully meets the requirements of the 2012 NFPA 99 standards edition, an internal, documented assessment that a facility is using a categorical waiver, and disclosure to any surveyors at the beginning of a survey that a categorical waiver has been employed. The implication is that facilities might consider the use of the categorical waiver, he said, and when they are used they meet the 2012 NFPA 99 standards, that facilities “can document where they are, they have an inventory of them, and they announce before the survey that they’re using the categorical waiver.”
“It’s either you have eight extension cords going to the wall or you have eight medical devices plugged into a power strip,” Mills said. “It just makes sense to bring the power to where you need it. It’s a major safety issue [and] it’s a practical issue as far as consolidating your need to plug in these devices.”
The categorical waiver also restricts the use of relocatable power taps for powering non-medical equipment “in the patient care vicinity,” Mills said, which prevents the patient from plugging in a personal laptop or cellphone, for instance, into a power strip in areas where patient care is administered.
“If a patient brings in their personal laptop, it’s got a current leakage issue, and you plug it into the power strip, you could cause safety problems,” he said.
“I think the good news is that we brought the issue to the HITF, CMS reviewed it, and made a good solid decision to allow the categorical waiver. We all benefited from that one,” Mills said.
David Stymiest, PE, CHFM, CHSP, FASHE, a senior consultant at the Nashville, Tennessee, engineering firm of Smith Seckman Reid Inc., called the categorical waiver “a huge deal,” albeit a complicated one.
“I think a lot of organizations have said, ‘We’re going to invoke this in our facility,’ ” Stymiest said. “I think there are a lot of issues that are going to be confounding issues.
“As with any categorical waiver,” he said, “you have to be in compliance with other requirements; typically a newer standard. I don’t know whether all of the organizations that are adopting the waiver have done their homework with respect to the newer requirements.”
“To me, a categorical waiver is like many other things: the first page giveth in the fine print, and then the second page taketh away,” he said.
Alternative Equipment Management Processes
Similar to the categorical waiver on power strips, another critical change in The Joint Commission’s standards in 2014 was the body’s continued allowance of Alternate Equipment Management (AEM) processes for facilities that elect to not follow the manufacturer’s recommended guidance for preventive maintenance (PM).
To crystallize the need for this approach, Mills offers an example: imagine an engineer tasked with the maintenance of a pair of defibrillators, one designated for ride-alongs with EMTs and another stored in a quiet wing of a hospital facility. The unit that has been through active use in an ambulance reasonably would be maintained to the strictest PM standards, which are typically what is written by the manufacturer — checking the latch, the lids, the plugs, the paddles, etc. That same strategy may not make sense for the unit that sits quietly in the hospital wing because it sees far less use, if any; in turn, a less rigorous PM routine would be sensible in consideration of staff time and resources.
That extensive adherence to manufacturer guidance could have cost the health care industry an estimated $4 to $8 billion, based on man-hours and biomedical test equipment, Mills said; moreover, a 2012 Joint Commission survey asking organizations whether revising manufacturer guidance in favor of AEM processes had resulted in any injuries or harm to patients returned a clear answer: “Out of approximately 2,500 respondents, nobody,” had such an event, he said.
Some equipment that is AEM-eligible is what hospitals may have a more difficult time defining: those mission-critical devices that require a 100 percent, on-time PM completion rate. The Joint Commission now uses the term “high-risk” to describe such technologies, which replaces the term “life-support devices,” a phrase that dated to 1995.
“We had the chance to retire ‘life support’ and use the term ‘high-risk,’” Mills said. “I personally really like it; ‘high-risk’ also includes by default ‘life-support’ devices. A defibrillator is not a ‘life-support device’; when we use it, you’ve already died and we’re using it to bring you back to life. But if you said, ‘How important is it?’ I’d say it’s pretty darn important.”
The new, broader definition, Mills said, turns on whether a device were to fail, resulting in “patient risk, harm, or loss of life.”
“In my mind, you start with life support and then you go into the other areas like surgical robots,” he said. “People say, ‘Is a ventilator high-risk?’ If it’s breathing for you, then yeah. If you’re putting it under your arm when you go to buy groceries, then maybe not. You really need to use some sort of risk criteria [and] your measuring stick is injury, harm, or loss of life.”
“A lot of those recommendations appear to be liability control rather than quality control,” Mills said. “People want flexibility and there’s a reasonableness to [the AEM].”
The statute also restricts from AEM eligibility imaging equipment, lasers, and brand-new equipment with which a facility “has no experience with,” Mills said.
“Once you have that new device for a period of time and learn its reliability you may be able to deviate [from manufacturer’s requirements],” Mills said. “New equipment that you have no experience with is something you couldn’t change the PMs frequency or activities on. ”
Stymiest said that when his clients ask him for advice on determining whether a piece of technology is high-risk, he invites them to contemplate the kinds of questions a surveyor is likely to ask in order to remain in compliance.
“Firstly, the hospitals need to understand that the CMS term ‘critical equipment’ is identical to the Joint Commission term ‘high-risk equipment,’ ” he said. “It means the same thing. Hospitals are struggling with thinking beyond something that’s just life support that has that level of importance.”
“The new rules are very clear,” Stymiest said. “There’s no longer an inventory that’s selected based on risk. The inventory is now everything. Hospitals need to wrap their heads around the fact that they have to think about all other equipment that’s used as medical equipment that they may not have put in their inventories in the past.”
For hospitals that decide to employ an AEM schedule for a device or group of devices, the statute outlines “multiple elements of performance that tell them exactly what elements of risk need to be considered,” Stymiest said. That obligation implies a different risk assessment than what may have previously been followed, which could require rewriting or authoring new policies and procedures. It’s not for everybody, he said.
“I’ve heard some say that they’re going to go with manufacturer’s recommendations because they don’t want to deal with the paperwork,” Stymiest said. “I’ve heard some hospitals say that they don’t want to do what the manufacturers say because it makes no sense.”
“When I first read the letter, it came out in December 2013, my reaction was, ‘Good, CMS is finally giving the industry what the industry has been looking for, which is some flexibility,’ ” he added.
For individuals and organizations who are considering varying from a manufacturer’s recommended maintenance schedules, the AAMI standards committee has developed a pair of guidance documents — EQ56 (Recommended Practice for a Medical Equipment Management Program) and EQ89 (Guidance for the use of Medical Equipment Maintenance Strategies and Procedures) — to help hospital leadership evaluate the requirements, resources, and expertise involved in formulating AEM procedures.
“There are a variety of things that you need to consider before attempting to deviate from the manufacturer’s maintenance recommendations,” said Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, the CTO of ABM Healthcare Support Services of Holliston, Massachusetts, and a member of the AAMI standards committee that developed the documents.
Grimes said the guidance AAMI offers is intended to assist organizations in identifying and evaluating several factors related to appropriate maintenance, including issues that can be analyzed from device service histories. Effective evaluation of service histories requires that organizations keep meaningful data on equipment failures; i.e., which failures are attributable to maintenance issues versus those failures occurring during handling or use error. After analyzing and making changes to maintenance procedures, he said, both the process and result should be fully documented, with periodic follow-up to ensure the intended results are achieved without compromising safety.
“In order to do a good analysis, you’ve got to have good data,” Grimes said. “We’re trying to get organizations to collect good data and code in a way that is meaningful.”
“We’re attempting to give guidelines that will allow organizations to consider the appropriate factors, collect the right data, consider the environment in which the equipment will be used, and deviate from the manufacturer’s recommendations only where they can demonstrate that they can do it safely,” he said.
Grimes said that guidance documents can help institutions make better use of their time, labor, and dollars, redeploying them away from processes “that arguably aren’t making the equipment or the environment safer” and “into some of the areas where we do have real safety issues.”
It’s all part of effective use of resources in an age of risk-based maintenance management, he said.
“The problems we have today generally aren’t maintenance-related,” Grimes said. “Equipment is considerably more reliable and fails less often due to lack of maintenance. It’s often got built-in diagnostics and the kind of failures that do occur are usually picked up by users before any maintenance procedure could detect them.”
“Adopting an AEM approach can be very safe and an effective use of resources, but you should consider it only if you are prepared to demonstrate that you’re doing it properly,” Grimes said.
An attitude of compliance
In addition to giving hospitals some relief in the execution of their responsibilities, Mills said, the thrust of the changes are meant to usher in greater compliance with established standards that help ensure patient safety, which is the ultimate goal.
“When I first got into health care back in 1984 … I realized why we were doing this, and it’s all about patient care,” he said. “Joint Commission standards were the road map to help me provide and create an environment that provides patient safety. For the rest of my career everything has been built around working with and creating standards that make things safe for patients, staff and visitors.”
Stymiest said his advice to clients is that compliance must be an ongoing attitude and not something they attempt to “ramp up” at certain times.
“I really believe that, and I advise my clients of this opinion,” he said. “I really don’t think that’s a practical approach anymore. I think continuous compliance is the only valid approach. And you should be doing the right things for the right reasons, too; there’s an altruistic aspect to it as well as the avoidance of risk.”
Mills shares the same perspective.
“When I see oscillating compliance, it shows me an attitude that is not consistent with all the things that we try to achieve,” he said. “The highly reliable organizations that I have worked with, when you talk to them, the standards are the guidance to what they want to achieve.”
Compliance also has a revenue component, said Robert Grajewski, president of health care incubator Edison Nation Medical.
“Right now, from a purchasing perspective, groups that are buying products are looking for things that can deliver care efficiently and economically due to the need for cost reduction,” he said.
“The reason why there’s compliance is so that people receive the greatest quality of care and the safest care. Any products that are able to make it easy to be more compliant are things that are seen as a positive because it saves time and energy on the back end,” Grajewski adds.
Changes that mandate additional safety requirements can even help to accelerate the development of new technologies, Grajewski said, especially those with a greater focus on safety and process improvement. In conforming with designations of high-risk equipment requirements, for example, he suggested that new products might be modified with high- or low-tech adjustments, such as better alerting systems or different colored components.
“By making these changes we can help save time and money, and most importantly help save lives,”Grajewski said.