By K. Richard Douglas
“Evidence” has become a very important concept in health care and HTM departments. What has, or hasn’t, worked in the past provides the best guidelines for what path to take. Physicians and other clinicians make decisions using evidence-based practices. Treatment protocols, as well as PM schedules, can result from evidence-based information. AEM programs make decisions based on historic evidence. It should not be a surprise that evidence is cited as support for ISO 9001 certification.
For instance, according to the International Organization for Standardization (ISO) organization, there are more than a million companies in 170 countries with ISO 9001 certification. It is a quality management system with a focus on the customer, the process and continual improvement.
The International Organization for Standardization is a non-governmental organization that was formed in 1947. It is composed of representatives from a number of national standards organizations. It is headquartered in Geneva, Switzerland, but was founded originally in London. While previously being a standard and model for the manufacturing industry, ISO 9001 today has been broadened and can be applied to any type of organization.
The standard looks at the processes used to achieve results.
DNV-GL Healthcare has had CMS Deeming Authority since 2008. The organization, through its NIAHO program, accredits nearly 500 hospitals across the U.S. The organization says that implementing an “effective quality management system, is the first step for organizations looking to become certified.”
The DNV-GL Healthcare website states: “As DNV GL hospitals often say, ISO provides the structure for the staff to focus on common goals, like patient care and safety.”
The designation of ISO 9001 certification demonstrates to customers or patients the certification-holder’s focus on customer satisfaction. The certification can also demonstrate to professional contacts and the customers or independent service and parts organizations, that they follow a quality management system.
“As medical equipment technology, health care reform and cybersecurity continue to progress, there will be a need to ensure HTM organizations are meeting standard requirements to provide a safe environment for patients. This must be accomplished while continuing to focus on reducing cost for the health care consumer. So, it becomes imperative that ‘all’ organizations work together to focus on moving in the right direction,” says F. Mike Busdicker, CHTM, FACHE, system director of clinical engineering at Intermountain Healthcare in Midvale, Utah.
“This effort must include health care delivery organizations, manufacturers, independent service organizations, regulatory agencies and others involved with healthcare technology management,” Busdicker adds.
Busdicker says that over the years, the topic of patient safety in relation to healthcare technology management continues to be a topic of discussion, so he doesn’t think it is just a trend, but a reoccurring theme.
“It is time we all get on the same page, stop protecting our ‘turf’ and work together for the benefit of our health care consumers,” he says.
HTM Preparation for ISO 9001
While HTM departments strive daily to meet many standards and regulatory requirements, it is the department in an organization accredited through DNV-GL Healthcare that also focuses on the ISO 9001 certification standard.
“Make sure all of your documentation is complete and accurate. Have current calibration certificates on all test equipment used for PMs, etcetera. Have a means of documenting which items of test equipment were used during the PM procedure and record it in every record,” suggests Matt Yates, director of biomedical engineering services, who is with The Intermed Group and assigned to Pardee UNC Healthcare in Hendersonville, North Carolina.
Yates says that in his second-year interview, he was asked “What happens when you have a piece of test equipment fail calibration testing?”
“He suggested that I write a policy so that if for some reason I wasn’t here, there would a guideline to follow. I wrote the policy stating step-by-step instructions in the event that this happened. I did have this happen a few years ago and was able to see what equipment was tested with the failed analyzer,” Yates says.
“In my next interview with the DNV inspector, I was asked the same question. I was able to show the exact actions taken from notification to completion per our policy. During the summation meeting, he stated that the documentation ‘would hold up in a court of law.’ Make sure that you follow exactly what your policy states,” Yates adds.
“I feel that it’s good for HTM departments to be under the guidelines of ISO 9001. First of all, the requirements to achieve certification make you more efficient. DNV is an unannounced, annual inspection with ISO every third year, so you have to stay ready,” he says.
Courtney Haschke, biomed supervisor at BSA Health System in Amarillo, Texas also has experience with DNV-GL accreditation and the ISO 9001 certification. She says that one of the more obvious differences of DNV is the annual inspection versus every three years. Being inspected every year is one of the best parts of being accredited through DNV.
“Get your MEMP in order and documentation. Documentation is the key to your success. DNV wants to know that you – the clinical engineering department – knows what is going on with your equipment. Whether the equipment is in service and PMs are up to date, not located and in the process of trying to find and complete service, or out of service waiting on parts or vendor service,” she says.
Haschke says that another great stride her team made to have a successful survey is getting clinical staff involved.
“We have set up processes and educated staff on what to do if equipment is broken or malfunctioning, how to read our PM stickers, and what to do if the equipment is past due for service. The opening of communication between clinical staff and clinical engineering has been the game changer on our surveys. I remember sitting through a seminar at MD Expo in Nashville about reaching 100 percent completion rates, provided by Steven Kelley. We have adopted the mentality he spoke on, that PM completion is patient safety, and patient safety is everyone’s responsibility,” Haschke says.
She sees the more frequent inspections as a benefit.
“With only nine to 12 months between inspections, there is constant talk of the upcoming, next or most recent inspection. We are always on topic of how to improve our next survey. Which has us striving to be the best possible health organization. DNV stays in the forefront of everyone’s mind and there is less opportunity to stray away from policies and procedures, and to become lax in our day-to-day operations,” Haschke says.
“Annual inspections are very stressful but so rewarding. Under ISO guidelines, I know that my organization is top notch and constantly aiming to improve,” she adds.
One of the broadest implementations of the ISO 9001 standard in health care is related to accreditation by DNV-GL. What suggestions do they offer to HTM departments, that are part of a health care organization seeking ISO 9001 certification?
“I would suggest first of all that the HTM department obtain a copy of the ISO 9001:2015 requirements. They are published by the International Organization of Standardization. Once the HTM department obtains the requirements they should review them and familiarize themselves with the terminology and try to get a good understanding of what is being required. The ISO 9001 standards are a Quality Management System (QMS) that requires those implementing it to perform risk-based thinking, which comes naturally for a health care organization,” says Kelly Proctor CHFM, CHSP, CHOP, physical environment sector lead with DNV-GL Healthcare.
Proctor would know since he holds the ISO 9001 Lead Auditor Certification, has 30 years of health care engineering experience and has a master’s degree in mechanical engineering.
Proctor says that the ISO 9001:2015 requirements were originally written for manufacturing and will require those implementing them in the health care business to think about how they apply to health care.
“For example, ISO 9001 mentions ‘interested parties;’ these are individuals who have an impact on the hospital’s quality management system (QMS) and it leaves it up to the hospital to determine who these ‘interested parties’ are. The requirements also mention ‘customers.’ Typically speaking, just about anyone can be the hospitals customer, but for the most part, the hospital should consider the customer as the patient. The ISO requirements also mention products and services. Products are considered things such as durable medical equipment, blood, medication and even food. ‘Services’ are services such as emergency services, ambulance service, imaging, dialysis, rehabilitation and even housekeeping,” Proctor says.
He says that one of the most important and effective requirements of ISO 9001 is the “internal audit” process. Internal audits are expected to be performed in areas where the organization sees the need for improvement.
“For the HTM departments, this is more than just rounding, it’s identifying a weak or broken process and then identifying where the failure is occurring and establishing a corrective action plan (CAP) to improve on the weak or broken process. Once the CAP is established, the health care organization is required to follow up on the CAP to ensure it is effective. If the CAP is not effective, or is not making an improvement, it is the organization’s responsibility to reconsider the CAP and make adjustments in an effort to make the CAP effective. Internal audits have proven to be very beneficial for the HTM departments as well as other departments throughout the health care organization,” Proctor says.
Proctor says that once the ISO 9001 requirements are understood, they become easier to implement and manage.
“Once properly implemented, the ISO 9001 requirements will prove to reduce risks, errors and will save time. ISO 9001 implemented in the health care setting is one of the best steps a hospital can take to better itself and to ensure constant improvement,” Proctor says. “Those hospitals, who are accredited by DNV-GL, are required to implement ISO 9001 within three years. DNV-GL does not expect the hospitals to have a perfect ISO 9001 QMS at the three-year mark, but expects the hospital to have the basics in place and to improve on its QMS over time.”
While the entire health system or hospital is taking specific steps to implement ISO 9001, it is the HTM department that has an important role in this process.
“The HTM department has numerous roles in the organization’s QMS and meeting the ISO 9001 requirements. Some of the items that stand out for the HTM department are for example, the verification of competencies. ISO 9001 requires that anyone working under the hospital’s control be competent to perform the duties they are doing. Sometimes this can be simple and sometimes it can get a little complex. Basically, it is the organization’s responsibility to ensure that those working on the medical gas are certified or licensed, those working on the fire alarm system are certified to do so and those working on the fire sprinkler system are certified to do so. It also requires that the hospital’s own staff be competent and meet the requirements specified in the job descriptions,” Proctor says.
He says that ISO 9001 also requires that the organization have an effective process in place to ensure that measuring equipment such as testing/calibration tools be calibrated per the manufacturer’s recommendations.
“This is one of the areas where DNV-GL and ISO 9001 stand out amongst the accreditation organizations. ISO 9001 requires that measuring devices be calibrated per the manufacturer’s recommendations with traceability to a national organization such as the National Institute of Standards and Technology (NIST); this ensures the organization is using calibrated and safe test equipment and has a process in place to prevent the unintended use of equipment that is not suitable to be used. This requirement is not limited to the organization’s biomedical department, but also includes measuring tools that may be used in the organizations HTM departments,” Proctor says.
He adds that the ISO 9001 requirements force the organization to have an effective process in place for the control of customer and external providers property, control of documents both internal and external, and ensures continual improvement is supported by top management.
“ISO 9001 requires top management to communicate the QMS to staff as well as interested parties and holds them responsible for providing resources to support an effective QMS. Basically, ISO 9001 is the foundation for all of the organization’s processes and works very well with LEAN programs and other quality management programs,” Proctor says.
While ISO certification may prove of great benefit to patients and customers, it is not yet a requirement of the government for HTM departments. In the last couple of years, the government has been hesitant to add to the thousands of pages of regulations that already help protect patients and guide health care providers.
The FDA considered additional regulation at one time as it pertained to medical device servicing and any risk to the public health based on current practices.
“On May 15, 2018, FDA published on its website a report entitled ‘FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices’ in accordance with section 710 of the FDA Reauthorization Act of 2017 (FDARA). The report discussed the continued quality, safety and effectiveness of servicing of medical devices by original equipment manufacturers and third-party entities,” says Kristen Pluchino, Ph.D. MPH, press officer in the office of media affairs, office of external affairs at the U.S. Food and Drug Administration.
“The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. Based on the available information, the FDA stated the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements at this time,” she says.
Pluchino says that the “report” included several actions that FDA intends on pursuing. One of these actions is publishing a draft guidance to assist in differentiating servicing and remanufacturing to allow more consistent interpretation and categorization. In turn, this will clarify regulatory responsibilities for entities performing these activities and allow FDA to focus its regulatory oversight on those activities that have the greatest impact on the quality, safety and effectiveness of medical devices.
She says that in accordance with FDA’s Good Guidance Practices, FDA intends to publish the guidance in draft form and accept public comments before issuing final guidance.
“We encourage all stakeholders to comment when the draft becomes available,” Pluchino says.
Will there come a time when the FDA does look for some evidence that a quality management system exists? Possibly.
“I do feel, as the FDA continues to evaluate the safety/quality related to the servicing of medical equipment, there is a very high probability that there will be a recommendation, if not a standard, that will drive towards a Quality Management System (QMS)/process-type activities. I don’t believe it will be prescriptive to the point of ISO 9001/13485 or any other specific program, however, the essence/intent behind the value of a QMS will be required,” says Dave Francoeur, senior vice president of marketing and sales, Tech Knowledge Associates (TKA), based in La Palma, California.
Francoeur says that organizations with a responsibility to provide service on medical equipment will, at some point in the future, be required to demonstrate components of servicing that validates safety/quality.
“There is a collaborative community established currently comprised of 25 individuals representing OEMs, ISOs, HDOs, regulatory and auditing bodies. These groups are being asked to participate in additional subcommittee’s that would help demonstrate safe/quality of servicing medical equipment,” Francoeur says.
He says that the topics identified (in no particular order) are QMS best practices, training, crosswalk education and benchmarks/data collection.
“My belief is that something will come out of each of these opportunities, driving consistency, quantifiable, repeatable and impacting safe/quality servicing of medical equipment,” Francoeur adds.
According to Francoeur, the collaborative community he referred to is a formal group established by the FDA in December of 2018. Busdicker is also a member of this group.
“We have been meeting monthly since. The collaborative community was established in an effort to create a solution/response to the MITA claim that individuals performing service on medical devices, other than OEMs or not being trained/approved by OEMs, are performing less than safe/quality medical equipment servicing,” he says.
He says that as of October, the FDA created four sub groups.
“This is in an effort to spend focused attention in these areas looking to generate outcomes moving the group forward,” Francoeur says.
Whether or not the QMS practices of ISO 9001 will ever be a regulatory requirement for HTM departments and their parent organizations as a directive of the government is in doubt. The drive toward QMS best practices or standardization is more likely.
“We already have the FDA, CMS, TJC, DNV, ACR and state health departments, just to name a few. These regulatory agencies, along with many others, perform routine inspections to ensure HTM departments are performing in accordance with standards. In my opinion, a well-run HTM department is already accomplishing the majority, if not all, of the requirements under ISO 9001,” Busdicker says.
“In my opinion, we all need to be on the same page when it comes to certifying that an HTM program has a robust QMS and is providing a safe and cost-effective environment for the patients we serve. The industry must support a collaborative community, or steering committee, that is willing to include all appropriate personnel in the process of achieving objectives outlined by the FDA,” Busdicker adds.
The end goal of HTM departments and the organizations they belong to comes down to patient safety. The goal of a good quality management system in health care is aligned with this goal as well.
In the end, the patient wins and that’s what it is all about.
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