As reflected in the HTM Levels Guide, providing compliance with applicable standards and regulations is the most fundamental requirement of any HTM department. It is essentially the price of admission to work in our industry. Fail to do so and don't expect to be around long before being replaced by someone who can … and with good reason. Human lives are at stake.

There are many regulatory agencies to be aware of that directly impact the HTM profession. They include:

  • TJC—Besides the hospital accreditation program, TJC has eight others: ambulatory health care, behavioral health care, critical access hospitals, home care, laboratory, nursing/long-term care, office-based surgery, and international accreditation. It is beyond the scope of this manual to compare the requirements of all these programs. However, the hospital requirements are the most comprehensive. In most cases, if you comply with the medical equipment management requirements of the hospital accreditation program, you will be in compliance with more than the minimum requirements of the other accreditation programs.

  • Food and Drug Administration (FDA)—The FDA's biggest impact is on manufacturers. However, the FDA also affects healthcare providers via the Safe Medical Devices Act of 1990. The FDA's Medical Device Reporting (MDR) regulation 21 CFR Part 803 requires that device user facilities (e.g., hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility that is not a physician's office) report a suspected medical device-related death to both the FDA and the manufacturer within 10 days of becoming aware of the event. User facilities must also report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown, within the same 10-day time frame.

  • CMS—The Social Security Act requires that healthcare providers meet health and safety standards and that laboratories meet Clinical Laboratory Improvement Amendments (CLIA) standards. CMS provides oversight for compliance. For a healthcare organization to receive Medicare or Medicaid payments, it must meet these standards. Hospitals with TJC accreditation are deemed to meet the federal standards for the CMS programs.

  • Accreditation Association for Ambulatory Health Care (AAAHC)—The AAAHC accredits ambulatory care centers.

  • AABB (formerly the American Association of Blood Banks)—The AABB accredits facilities for collecting, processing, testing, distributing, and administering blood and blood products. Their standards for the testing of blood warmers include a unique requirement for recording the temperature at which the alarm trips.

  • American Society for Histocompatibility and Immunogenetics (ASHI)—The ASHI accreditation program evaluates laboratories for compliance with ASHI standards.

  • Center for Improvement in Healthcare Quality (CIHQ)—CIHQ is a new national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

  • College of American Pathologists (CAP)—The CAP Laboratory Accreditation Program has deeming authority from CMS and is recognized by TJC.

  • COLA—COLA accredits laboratory compliance with CLIA standards. It has deeming authority from CMS and is recognized by TJC.

  • DNV GL—DNV GL provides certification services to a variety of industries. Their National Integrated Accreditation for Healthcare Organizations (NIAHO) standards comply with CMS requirements. In addition, they require compliance with the ISO 9001 Quality Management System standard.

  • Healthcare Facilities Accreditation Program (HFAP)—HFAP is authorized by CMS to provide accreditation to all hospitals, ambulatory care/surgical facilities, mental health facilities, physical rehabilitation facilities, clinical laboratories, and critical access hospitals.

  • National Fire Protection Association (NFPA)—The NFPA creates consensus standards for fire and electrical safety. Of particular interest to HTM personnel are NFPA 70: National Electrical Code, and NFPA 99: Health Care Facilities Code. NFPA 70 applies to the design and installation of electrical distribution systems and equipment in general. It is adopted by state and local governments and thus carries the force of law. NFPA 99 is based largely on NFPA 70, but covers more than electrical systems and equipment in healthcare. It also has requirements for healthcare facility and equipment management.

The two most employed accrediting agencies today are TJC and DNV GL. Both have deeming authority from CMS and as such are very similar in their standards requirements.

TJC is currently the most widely used accrediting agency and has many accreditation programs available. The two that apply most directly to HTM are the Hospital Accreditation Program (HAP) and the Critical Access Hospital Program (CAH).

TJC accreditation standards are comprehensive and constantly evolving. Fortunately, sources that provide the most up-to-date assistance with understanding the changing standards include:

  • Joint Commission Resources (JCR) is a subsidiary of TJC. It has publications, educational programs, and consultants to help organizations comply with TJC standards and to prepare for surveys. Its website is www.jcrinc.com.

  • Association for the Advancement of Medical Instrumentation (AAMI) has publications particularly useful to clinical engineers (CEs) and biomedical equipment technicians (BMETs)—including this manual, ANSI/AAMI EQ56, ANSI/AAMI EQ89, and the recently published AEM Program Guide. The AAMI Exchange (formerly Annual Conference & Expo) always has a variety of educational sessions that provide the latest advice from experienced CEs and BMETs. AAMI also has an e-forum for members that is dedicated to TJC standards discussions. The website is www.aami.org.

  • American Society for Healthcare Engineering (ASHE) is a division of the American Hospital Association (AHA) that provides educational material for hospital facilities engineers and clinical engineers. It also provides seminars and publications on Environment of Care standards. ASHE's website is www.ashe.org.

  • ECRI Institute is a private, nonprofit organization that has publications, programs, and consultants that cover all aspects of medical equipment management. ECRI Institute's website is www.ecri.org.

Many chapters of the TJC Comprehensive Accreditation and Certification Manual3 impact all hospital departments, including:

  • Human Resources (HR)—This chapter focuses on the verification of staff qualifications and competency, as well as ongoing training and performance evaluations.

  • Infection Prevention and Control (IC)—Just as the name indicates, this chapter is focused on infection prevention and control. In recent years, this area is receiving much greater attention, with reimbursements being tied to healthcare-associated infections (HAIs) and the increased efforts to keep patients from harm. This topic was addressed specifically by George Mills during the 2017 AAMI Conference & Expo, as he felt the need for a much higher level of infection control due diligence from the HTM community.

  • Information Management (IM)—This chapter focuses on the appropriate management of protected health information (PHI), including HIPAA (Health Insurance Portability and Accountability Act) compliance and systems integration for better management of that health information toward the improvement of patient care.

  • Leadership (LD)—This chapter focuses on the leadership structure of an organization and holds it accountable for ensuring the organization has the resources it needs to provide the highest level of care to its patients.

The chapter that most directly affects HTM, however, is the Environment of Care (EC) chapter. Specifically, the following two standards and their associated Elements of Performance (EPs) within the Environment of Care chapter are the areas surveyors will focus on in HTM departments for meeting compliance requirements:

  • EC.02.04.01 The hospital manages medical equipment risks

  • EC.02.04.03 The hospital inspects, tests, and maintains medical equipment

You will find these standards and associated EPs in Appendix 4 of this manual.

DNV GL's NIAHO standards comply with CMS requirements. As such, the general requirements are very similar to TJC requirements. In addition, they require compliance with the ISO 9001 Quality Management System standard. Overall, DNV GL standards tend to be more concise. However, each section also contains Interpretive Guidelines, which provide clarification on the standard and its intent, and a Surveyor's Guideline section to give both the surveyor and surveyed entity a better idea on what to look for relative to compliance. DNV GL also has online resources available at www.dnvglhealthcare.com/resources.

Like TJC, there are chapters in the DNV GL NIAHO Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance1 that apply broadly across all departments. These include:

  • Staffing Management (SM)—Like TJC's HR chapter, this chapter focuses on the verification of staff qualifications and competency, as well as ongoing training and performance evaluations.

  • Quality Management System (QM)—This chapter contains all aspects of quality documentation, measurement, and monitoring as they relate to patient care and patient safety.

  • Infection Prevention and Control (IC)—Almost identical in content and intent as the TJC IC chapter. Again, this area is receiving much greater attention with reimbursements being tied to HAIs and the increased efforts to keep patients from harm.

  • Governing Body (GB)—Like the LD chapter in TJC's accreditation manual, this chapter focuses on the leadership structure of an organization and holds it accountable for ensuring the organization has the resources it needs to provide the highest level of care to its patients.

In recent years, [infection prevention and control is receiving much greater attention, with reimbursements being tied to healthcare-associated infections (HAIs) and the increased efforts to keep patients from harm.

The chapter that most directly affects HTM is the Physical Environment (PE) chapter. Specifically, the following standard and associated Standard Requirements (SRs) within the Physical Environment chapter are the ones surveyors will be most looking to HTM departments to for meeting compliance requirements:

  • PE.7 Medical Equipment Management System

While both TJC and DNV GL draw directly from CMS requirements to create their standards, DNV GL is more descriptive as it relates to the requirements and expectations of an AEM program. Current DNV-GL Standards are available online to download free of charge at www.dnvgl.us/assurance/healthcare/standards/niaho-ac-dl.html.

Regardless of the accreditation agency your organization uses, all will have deeming authority from CMS and thus will have nearly identical requirements for compliance. There are many excellent resources identified in this chapter, most available from AAMI, and I have no intention of replicating any of them here. However, in the 40+ years I have worked in this industry as an HTM tech, manager, director, and most recently as a consultant, I have found several things remained consistent throughout that time relative to expectations from any accrediting agency. They are:

  1. Have a complete and accurate inventory. One of the things I find so consistent in organizations I work with, and something I had to work very hard to overcome in my own organizations, is the likelihood that items that should be on your equipment inventory find ways into the organization without your knowing about them. In my consulting work, I have identified as many as 15 different portals of entry for medical equipment in a single organization, most of which sidestepped the HTM incoming inspection process. Unfortunately, this issue is common in most organizations. How can one hope to have a complete and accurate inventory when this is the case? Even if you have a good process and policies and procedures for receipt of capital, consider the number of devices in your inventory today that fall below the capital threshold. Most organizations have moved that threshold to $5,000, and some even higher. It is imperative that you go through the process of identifying all the ways equipment is coming in and work with your accounting, finance, and supply chain/purchasing departments to close those holes. If you don't, your organization is at great risk for noncompliance or worse—patient injury or death—because of a failed device that you never inspected (See EC02.04.01, EPs 2, 3,4,5, and 7 and EC02.04.03, EPs 1, 2, and 3). Don't be afraid to engage your risk management department for additional leverage if necessary. One place to start is to provide a list of all non–capital medical devices to your procurement group and ensure the same processes you have in place for your capital equipment are followed for these devices as well.

  2. Say what you do. Any accrediting agency is first going to look to see whether you have written policies dictating how you manage your operations. This is especially true with the new standards around AEM programs. The surveyor is going to want to see what criteria you used to determine what you included in your AEM program and whether they are defensible. Your medical equipment management plan (MEMP) is also a key document to outline what you do.

  3. Do what you say. Once the surveyor is satisfied you have the written procedures and relevant documents, he or she is going to want to see evidence that you are following them. That is where your documentation practices come into play. Much will be said in this manual about the importance of good documentation and data integrity. They are critical to achieving a higher level of operational and financial performance. If you have individuals who are unwilling to comply with your documentation and data integrity policies, you need to ask yourself if accommodating them is worth putting your entire program at risk.

It is imperative that you go through the process of identifying all the ways equipment is coming in and work with your accounting, finance, and supply chain/purchasing departments to close those holes.

In the 2015 Environment of Care standards, TJC dictated that

  • The hospital identifies the activities and associated frequencies, in writing, for maintaining, inspecting, and testing all medical equipment on the inventory.

  • These activities and associated frequencies are in accordance with manufacturers' recommendations or with strategies of an AEM program.

TJC also expressed that the strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice. Devices that were deemed ineligible for inclusion in an AEM program were:

  • Equipment subject to federal or state law

  • Imaging and radiologic equipment

  • Medical device lasers

  • New medical equipment (new in that adequate history was not yet available to make a comprehensive evaluation of risks and failure rates)

For all equipment not in an AEM program: the organization would need to follow manufacturers' recommendations (or establish more stringent maintenance requirements).

These expectations remain unchanged in the 2018 Standards, although TJC did cite examples of accepted standards of practice, such as EQ56.

What changed in the survey process post-2017 includes:

  • No more Direct and Indirect EP designations

  • Consolidated Evidence of Standards Compliance (ESC) into one time frame (all ESC now 60-day time frame)

  • No more Measures of Success (MOS)

  • No more Opportunities for Improvement (OFIs)

  • See it/Cite it (In the past, surveyors might have looked past a single violation unless over the course of the survey they observed multiple violations of the same type. Now, however, when they see it, they cite it.)

  • No more A or C categories (high-risk vs. non–high-risk)

TJC also adopted the “SAFER Matrix” scoring methodology that replaced the category A and C scoring, shown in Figure 1.

Figure 1.

Survey Analysis for Evaluating Risk (SAFER) Matrix. © The Joint Commission, 2018. Reprinted with permission.

Figure 1.

Survey Analysis for Evaluating Risk (SAFER) Matrix. © The Joint Commission, 2018. Reprinted with permission.

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The change that has caused the most stir is the requirement of 100% completion rate of all high-risk and non–high-risk equipment, whether it is in an AEM program or not. The key here is that the 100% completion rate target applies to “available” equipment. “Unable to Locate (UTL)” and “In Use” devices are not included in the 100% calculation. I would argue those two exclusions are the only legitimate reasons for not being at 100% anyway. However, you must have a policy to address “UTL” and “In Use” devices.

An effective “UTL” policy requires documented attempts to locate missing equipment and may include:

  • Requesting aid in writing from owners/operators.

  • Requiring HTM staff to perform sweeps.

  • Declaring equipment permanently gone (including notification to users and leadership of its status) and archiving from inventory after a reasonable number of missed intervals.

An effective “In Use” policy would require scheduled maintenance be conducted as soon as equipment becomes available and may include:

  • Placing a prominent “Inspection Due Before Next Use” tag on “In Use” equipment.

  • Asking operator to notify HTM after removing from patient.

  • Notifying owners and organization leadership of all equipment not receiving scheduled maintenance on time because it was in use.

  • Educating owners/users on the policy and process for informing HTM when equipment becomes available.

Surveyors will always be asking:

  • Do you have procedures in place?

  • Did you follow the procedures?

  • Did you follow the prescribed frequencies in accordance with your policies?

Take Your HTM Department to the Next Level

The Healthcare Technology Management Manual covers all aspects of running a successful HTM department. It provides:

  • Guidance on department operations.

  • Resources to achieve a higher level of financial and operational performance.

  • Relevant standards from The Joint Commission.

  • Recommended practices for developing highly competent, engaged, and productive staff.

  • Strategies that help minimize the cost of maintaining the equipment inventory you support.

Details on this and other resources can be found by visiting the AAMI Store (https://my.aami.org/store).

With these things in mind, here are some “best practice” strategies I and others have employed to get our arms around consistent compliance, especially when it comes to meeting the 100% completion requirement of all available equipment:

  1. Develop a comprehensive risk scoring methodology. AAMI is leading efforts to develop a standard around this, which should make things easier. In 2015, AAMI announced support for the Maintenance Practices Task Force (MPTF), led by Malcom Ridgway and other industry leaders. Two articles authored by this group and published in BI&T in 2018 include “A Rational Approach to Efficient Equipment Maintenance, Part 1: A Simple, Basic AEM Program” and “A Rational Approach to Efficient Equipment Maintenance, Part 2: A Comprehensive AEM Program,” which provide excellent background and guidance.

  2. Practice good time management and preplanning. All too often, your staff will fall into the trap of avoiding planned or preventive maintenance procedures (PMs) until the last week of the month. That means that for a week, no corrective maintenance (CM) work is being completed, and the quality of the PMs that are being done is in question. Also, the likelihood of meeting your completion rates without compromising quality and integrity is limited, at best. I described an alternative process to my techs at one point and it was as if a light went on. I said, “The way it mostly works now is you do correctives for three weeks, then planned maintenance for the last week. So, our turnaround times on anything that breaks the last week is poor, your PMs are poorly done, and if you happen to get sick during that last week, I must reassign your work to someone else. That doesn't even consider the vendor PMs that most likely won't get done or the devices that need PM kits you didn't order yet that won't get done. So, let us envision that PM and CM work within a rectangle that represents a month. Right now, you are slicing that rectangle vertically with the divider being 75% of the way into the month. Imagine instead that you sliced the rectangle horizontally, where you spent 75% of any given day doing correctives and 25% doing planned. And let's also imagine that you got your assigned PMs for the month the week prior and spent part of a day ordering whatever PM kits you needed, contacting vendors to schedule those PMs they must do, and contacting your customers to find out if there are going to be any times in the coming month that are slower than others that will increase your access. Then let's imagine that you determined you were going to be at work 20 days in the coming month and had 60 PMs due. Now you know you need to complete at least three PMs per day to stay on top of things. Which method do you think has the least amount of stress and the greatest likelihood of success?” Once it sinks in, make it a standard practice with policies, procedures, and performance measures to support it.

  3. Issue PMs in advance (up to 30 days). See #2 for the importance of employing this strategy.

  4. Schedule vendor PMs in advance. See #2 for the importance of employing this strategy.

  5. Connect with user departments in advance. See #2 for the importance of employing this strategy.

  6. Send lists of PMs due to departments in advance. See #2 for the importance of employing this strategy.

  7. Order PM kits in advance. See #2 for the importance of employing this strategy.

  8. Real-time data entry and data integrity. If you have a mobile app that works well with your computerized maintenance management system (CMMS) or an automated system with stored procedures, this is both a time saver and creates consistency and integrity of data and process.

  9. Employ real-time location system (RTLS) solutions, if possible. This will help your team locate the sometimes hard-to-find items, and increase their productivity and completion rates.

  10. Create a culture of accountability. Set up a system and process where each team member has direct ownership. Whether it is assignment by department or device type, or both, this increases the likelihood of compliance. Create dashboards in your system that shows progress week by week and/or day by day. Some have had great success making this dashboard public. It creates both peer pressure and a competitive situation that benefit both the department and the people it serves.

  11. Require ongoing progress throughout the month (25% each week). See #10 for the importance of employing this strategy.

  12. Target 100% of high-risk and original equipment manufacturer (OEM)–scheduled PMs in first two weeks. Your accrediting agency will be thrilled to see you are placing emphasis on those things that are most important.

  13. Document attempts to find/access and conduct random audits on PMs closed with “UTL” and “In Use.” This is a strategy you will need to employ to show you have a process for addressing UTL PMs.

  14. Promote idea of shared responsibility. Most clinical departments look at PM completion being entirely the responsibility of HTM. It is interesting to note that TJC surveyors don't look at it that way. In fact, they want to see evidence that it is a shared responsibility. You should have that concept outlined in your MEMP and support it with policies and procedures. Generating annual inventory reports you require your customers to validate, reports of monthly PMs due and PMs completed that are sent to department leaders, as well as lists of UTLs will help promote this concept. If you follow the previously outlined strategies, you should be able to identify missing and in-use equipment while you still have time in the current month to address them. I even went so far as to copy my finance and loss prevention departments on the UTL reports. Finance's perspective on it was, “If you can't keep track of what you have, I'm not likely to buy you more of them.” Loss prevention's perspective is almost self-explanatory.

Most clinical departments look at PM completion being entirely the responsibility of HTM. It is interesting to note that TJC surveyors don't look at it that way. In fact, they want to see evidence that it is a shared responsibility.

These are important strategies to employ regardless of the year-over-year changes in standards. As standards are constantly updated and may subsequently render the most recent changes outlined in this manual obsolete over time, it is incumbent on you to keep up with the changes to standards and adjust your program as needed to remain in compliance.

1.
DNV GL
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National Integrated Accreditation for Healthcare Organizations (NIAHO®) Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance, Revision 18-1
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Author notes

Alan Gresch is vice president of client success at Accruent in Austin, TX. Email: [email protected]

Editor's note: The following article is an excerpted chapter from the AAMI-published book, Healthcare Technology Management Manual, by Alan Gresch. (Gresch A. Chapter 2: Accreditation Information and Standards. In: Healthcare Technology Management Manual. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2019.)