To ensure timely compliance with new requirements, hospitals must review and revise their medical equipment management policies and practices

In December 2013, the Centers for Medicare & Medicaid Services (CMS) issued a survey and certification memo that made substantial changes in hospital equipment maintenance guidelines used by surveyors to determine a hospital’s eligibility for Medicare and Medicaid reimbursement.1 Those CMS changes referenced the ANSI/AAMI standard EQ56:2013, “Recommended practice for a medical equipment management program.”2 Six months later, The Joint Commission (TJC) released substantial changes to its Environment of Care (EC) accreditation standards to align with the new CMS guidelines for those hospitals that use TJC accreditation for “deeming” status.3 (CMS has granted “deeming” authority to TJC and DNV Healthcare, so that hospitals accredited by these organizations under CMS guidelines are considered “deemed” as having met CMS requirements.)

The effects of these changes will be substantial. They will require the vast majority of US hospitals to make significant modifications to their procedures, and will have a long-term impact on the medical equipment maintenance management landscape.

The New Requirements

Under the new requirements, hospitals must maintain an inventory of all medical equipment in the organization (regardless of ownership or service source). Previously, many hospitals could elect to maintain an inventory of medical equipment that they determined to be of sufficient risk (that is, a risk-based approach to including medical equipment on the inventory). The latitude to leave medical equipment of sufficiently low risk off the inventory is no longer an option.

Hospitals must also identify “critical/high-risk” medical equipment in the inventory. Any medical equipment that, if it were to fail, could result in serious injury or death of a patient or staff member is defined as “critical” by CMS and “high-risk” by TJC. Note that “life support” equipment (a former focus of TJC) is a subset of critical/high-risk equipment.

Maintenance activities and frequencies for maintaining, inspecting, and testing all medical equipment in the inventory must be documented in writing. Before medical equipment is first used—as well as after major repairs or upgrades—safety, operational, and functional checks must be performed.

These new requirements must be met in accordance with manufacturers’ recommendations for the following categories of equipment:

  • Equipment subject to federal or state laws or Medicare Conditions of Participation (CoP) by which maintenance be in accordance with manufacturers’ recommendations, or which otherwise establishes more stringent requirements.
  • Medical laser devices.
  • Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes).
  • New equipment with insufficient maintenance history to consider an alternate equipment maintenance (AEM) program.

For equipment not in the categories above, hospitals may deviate from manufacturers’ recommendations and institute an AEM program under the following conditions:

  • Available medical equipment histories suggest that deviating from manufacturer recommendations would have no adverse affect on patient or staff safety.
  • Qualified staff (for example, a clinical engineer or biomedical engineering technician) use written criteria to support any determination to apply an AEM approach. These written criteria should encompass how the equipment is used (including the seriousness or prevalence of harm during normal use), the likely consequences of equipment failure, the availability of backup equipment, incident history of the same or comparable equipment, and maintenance requirements.

Recommended Steps

Compliance with these new requirements can best be achieved if there is an effective plan for implementation, such as outlined in the following 10 steps.

1) Meet with hospital leadership and compliance office to inform them of the new standards. Keep them up to date on plans to achieve compliance and the progress made in executing those plans. They should also be apprised of the resources (including manpower and financial support) necessary to achieve compliance.

2) Verify that the medical equipment inventory is complete. It should include equipment regardless of ownership (such as loaners, leased, rentals, etc) and regardless of how it is serviced (in-house, contractor, vendor time, and materials).

3) Obtain manufacturer recommendations for maintenance frequencies and activities. Use inventory to create a list of unique manufacturer-model combinations and request that manufacturers provide recommendations for their models. Keep records of all communications attempts. You should also require vendors to provide manufacturer recommended maintenance frequencies and activities for all new acquisitions. In making requests for this documentation, consider citing excerpts from two standards that address the manufacturers’ obligation to provide documentation.

One is NFPA 99 (2012) Health Facilities Code. It states that the “manufacturer of the appliance shall furnish documents containing at least a technical description, instructions for use, and a means of contacting the manufacturer,” and that these documents “shall include … preventive and corrective maintenance and repair procedures.”

The second standard to cite is AAMI/ANSI ES60601-1:2005 (R) 2012, “Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance.” It states that “equipment shall be accompanied by … instructions for use and a technical description,” and that “instructions for use shall instruct the OPERATOR or RESPONSIBLE ORGANIZATION in sufficient detail concerning preventive maintenance, maintenance and calibration to be performed by them, including the frequency of such maintenance.”

4) In the complete medical equipment inventory, have the ability to flag the following characteristics:

  • Equipment that is considered critical or high-risk because knowledgeable hospital staff agree “there is a risk of serious injury or death if the equipment should fail” (CMS and TJC requirement).
  • Equipment that is identified as “AEM ineligible” (that is, medical lasers and imaging and therapeutic radiology equipment).
  • Equipment for which analysis by knowledgeable hospital staff has resulted in decision to apply an “alternative equipment maintenance” approach (CMS and TJC requirement)
  • Whether manufacturers recommendations for maintenance activities and frequencies are on file (attach to the CMMS as a PDF file where possible).
  • Source of service (in-house staff or vendor) and location of file with service staff credentials (or attach PDF with credentials where possible).

5) In corrective maintenance records, have the ability to categorize the degree and type of equipment failure. The degree of failure may be categorized as either major, where equipment is “hard down,” or minor, where equipment remains operational and does not compromise safety. The goal is to be able to focus on “operational failures” or “safety-related” failures in service history.

The types of failure are maintenance preventable, spontaneous, and use- or process-related. Maintenance preventable or “wear and tear” failure is the result of gradual degradation of one or more components over a period of time that may be detected by regular testing or prevented by recalibration or prophylactic replacement of parts. Spontaneous failure is where no reasonable frequency of inspections, testing, or preventive maintenance could have predicted or prevented failure. Use- or process-related failure is the result of factors external to the equipment. In assigning the types of failure, the goal is to be able to focus on “maintenance preventable” failures in service history.

6) Establish policies and procedures that describe under what circumstances deviation from manufacturer-recommended maintenance is considered acceptable and how the risk assessment to determine any such deviation is conducted. Identify the multidisciplinary team that will participate in judging the severity and frequency of equipment failures (that is, the basis of risk assessment). Typically, the team would include clinicians, clinical engineering, risk management specialists, safety officers, and others as appropriate.

7) Document sources of service histories used to conduct risk assessment. These sources could include in-house records, associations such as ECRI or AAMI, vendors, or other authorities.

8) Document the credentials of those participating in the risk assessment process leading to inclusion of equipment in an AEM program, such as degrees, certifications, and training certificates.

9) Include language in service contracts that requires vendors to follow manufacturer-recommended frequencies and activities for medical equipment, or, if applicable, to follow the AEM program; to document all service performed (according to the organization’s own service documentation requirements); and to demonstrate the qualifications of vendor staff providing service.

10) Finally, assign responsibility for monitoring compliance with CMS requirements and TJC standards regardless of service source, and document the credentials of the responsible party.

The Experience of One Healthcare System

To understand some of the challenges posed by compliance with these new requirements, it is useful to look at how one healthcare system is preparing itself to address the requirements and the issues arising from its efforts.

Care New England (CNE) is a group of four hospitals and other affiliates located in and around Providence, Rhode Island. Healthcare technology management services at CNE are provided through the organization’s resident clinical engineering department, which is operated under contract by ABM Healthcare Support Services. Clinical engineering supports a combined inventory of 13,500 medical devices using a resident staff of 11 clinical engineers and biomedical engineering technicians, as well as a number of managed service contracts.

The Compliance Process. The CNE clinical engineering department began its compliance process by preparing and making presentations to the Environment of Care and Safety Committees at each hospital. These presentations were designed to inform key stakeholders on those committees of the new requirements and the implications for their hospital, and to outline a plan to meet those requirements. Stakeholders were afforded the opportunity to make suggestions that would make the plan and its implementation most effective. Clinical engineering also informed senior leadership at each hospital of the requirements, the plan for addressing the requirements, and the resources that would be needed to achieve the plan. Clinical engineering staff members and key vendors were also informed of the new requirements and plan and of their expected role in its implementation.

Inventory Management. Early in the plan’s execution, clinical engineering recognized that the medical equipment inventory was going to increase significantly. Before the new rules, hospitals were able to establish and follow a process that permitted the removal of low-risk equipment from their inventories. Because the new requirements mandate tracking of all medical equipment, clinical engineering had to enlist the help of various stakeholders and committees to identify the equipment not previously tracked.

One of the challenges of inventorying and tracking groups of equipment (particularly, small items like regulators/flowmeters) involved tracking them by device type and location rather than by specific asset or serial numbers. This “group” approach helped avoid the burden of having to track equipment in excessive detail while still satisfying the new requirements.

Another challenge involved departments like central processing (CPD), which clinical engineering identified as having maintained an inventory of the medical equipment those departments processed. The new rules don’t require the use of one common inventory, but only that all inventories be available in one location, on demand. As a result, clinical engineering was able to work with CPD and other departments to ensure that they continued to maintain an adequate inventory and could provide that inventory to clinical engineering as needed. Rounding by clinical engineering staff helps to ensure proper inventories are being maintained in these departments and also to detect medical equipment that may have been previously undetected.

As a complete picture of the entire inventory emerged, clinical engineering identified and flagged all equipment categories it considered high-risk/critical with a user-defined field. After clinical engineering made the initial identification, the appropriate safety or environment of care committee was asked to verify the classification and their decision was documented.

Manufacturers’ Maintenance Recommendations. Another challenge clinical engineering has encountered is obtaining manufacturers’ maintenance recommendations for all medical equipment. Under the new requirements, having documentation of these recommendations is necessary to ensure that staff and vendors are either following those recommendations or deviating from them appropriately (that is, following established AEM program guidelines). Fortunately, clinical engineering already had manufacturers’ maintenance recommendations for most of the most critical equipment.

Where the department did not have the recommendations—or had conflicting versions of them—obtaining them from manufacturers has proven to be a labor-intensive and slow process. In some cases, manufacturers consider the documentation proprietary, withholding it unless the organization is willing to pay for the documentation and the “required” training.

The department contacts manufacturers with a form letter requesting their recommendations for each model in their list. Priority is being given first to manufacturers and models serviced in-house by clinical engineering staff, and will eventually extend to those under service contract by the manufacturers themselves.

Also, all purchase orders for new equipment now include the request for manufacturers’ maintenance recommendations. All new service contracts require the vendor to provide work orders verifying that their maintenance complies with manufacturers recommendations or with clinical engineering’s AEM approach, if that is an option. The department documents all its communications with manufacturers to demonstrate its efforts.

Alternate Equipment Maintenance. Without the option of adopting an AEM approach, clinical engineering would be forced by the new requirements to follow manufacturers’ maintenance recommendations on all of the hospitals’ medical equipment. The overall support cost and number of clinical engineering staff necessary would likely have to double as a result.

To apply an AEM approach to some number of medical equipment categories on the inventory, clinical engineering was able to analyze a multiyear service history for all of its medical equipment categories from a database provided by the its clinical engineering contractor. Analysis of the service history revealed that about 60% of the medical equipment on the inventory would experience no compromise in safety if clinical engineering followed an AEM approach. For the remaining 40% of the inventory, manufacturers’ recommendations would be followed either because the service history could not justify the AEM approach or because the particular equipment category was ineligible for the AEM.

Once it was determined that an equipment category qualified for the AEM approach, clinical engineering had to update appropriate maintenance activities and schedules for those categories, making sure to reference manufacturers’ recommendations as a baseline, and then to apply industry best practices and clinical engineering’s own experience.

To ensure that medical equipment maintenance is sufficiently effective in minimizing maintenance-related (wear and tear) failures, clinical engineering updated the failure cause codes in its work order system to call out these types of failures and to distinguish them from spontaneous failures (those where no scheduled maintenance could have realistically prevented the failure) or use- or process-related failures. The ability to call out maintenance-related failures is extremely helpful in evaluating the real effect of the medical equipment maintenance program.

There are many other elements involved in implementing a compliance plan to meet the new requirements. This partial list of steps taken by CNE and its clinical engineering services illustrates some of the issues associated with the more significant steps. Other issues are important too, including the significant rewriting required for the medical equipment management plan and related medical equipment policies and procedures.

Conclusion

These new requirements and standards will require a substantial expenditure of resources on the part of healthcare organizations and their healthcare technology management and clinical engineering programs in order to achieve any significant level of compliance. However challenging, these requirements are the new reality and are in effect now. While compliance will take time, healthcare organizations need to ensure that they fully understand the requirements, have a plan for achieving compliance, and can demonstrate that they are making a good-faith effort in executing that plan.

Stephen L Grimes, FACCE, FAIMBE, FHIMSS, is chief technology officer for ABM Healthcare Support Services, Boston, Mass. Jillyan Morano, BSE, MHA, is director of clinical engineering services for Care New England, Providence, RI. For more information, contact editorial director John Bethune at jbethune@allied360.com.

 References

  1. Centers for Medicare & Medicaid Services. Hospital equipment maintenance requirements. S&C: 14-07-Hospital. December 20, 2013. Available at: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf. Accessed February 18, 2015.
  2. ANSI/AAMI EQ56:2013. Recommended practice for a medical equipment management program.
  3. The Joint Commission. Revised Requirements for the Environment of Care (EC) Chapter. Available at: http://www.jointcommission.org/assets/1/18/EC_PrepubReport_HAPandCAH_July2014release_20140304.pdf. Accessed February 18, 2015.