Update on Equipment Maintenance Issue...
CMS Reviewing Data Supplied by AAMI, ASHE
MEMORANDUM SUMMARY |
U.S. Centers for Medicare & Medicaid Services (CMS) officials are reviewing a 244-page packet of information submitted by AAMI and the American Society for Healthcare Engineering (ASHE) that addresses the December 2011 CMS “clarification” memo (S&C 12-07) regarding equipment maintenance practices. The packet was submitted to CMS as a follow-up to a June meeting AAMI and ASHE representatives held with CMS officials.
The December memo set off a firestorm in the healthcare technology management (HTM) community because it set limits on how and when hospitals could deviate from manufacturers’ recommendations when it comes to equipment maintenance.
AAMI and ASHE compiled data on typical HTM practices, including what’s often referred to as “evidence-based maintenance,” after the June meeting at the request of CMS.
For instance, CMS wanted to learn more about common algorithms and methodologies used to determine maintenance methodologies or frequencies; existing guidance in use by the field; examples of evidence-based maintenance and equipment history documentation; estimates of the impact of the CMS letter on the field; and other items.
The packet submitted to CMS—available at www.aami.org/cmspacket.pdf—addresses those and other related issues using documentation from hospital systems, published articles, guidance documents, and other resources, to demonstrate that evidence-based maintenance strategies employed in hospitals are safe and effective.
At the June meeting with CMS, Karen Waninger of AAMI’s Technology Management Council (TMC) represented AAMI, along with AAMI President Mary Logan; Patrick Bernat, AAMI’s director of Healthcare Technology Management; and Robert Stiefel, president of RHS Biomedical Engineering Consulting. ASHE was represented by its executive director, Dale Woodin.
Waninger noted that the CMS reps expressed surprise by the HTM field’s negative response to the December letter because CMS “thought they were giving us more opportunity to optimize our programs than we had previously. As the meeting progressed, however, conversations allowed each of us to gain a wider perspective, and to talk about what would be the most beneficial for patient care and safety in the future. We ended with a commitment to collect and provide more information that CMS believes will be meaningful to them.”
That information, requested by CMS, is included in the packet supplied by AAMI and ASHE.
“It is our understanding from the meeting that CMS wants an evidence-based standard—something national in scope—so that their surveyors can use an objective, scientifically sound approach to assess whether a healthcare organization’s maintenance program meets some minimum performance standards, based on sound risk assessments,” Waninger added. “They also want a consistent process for any adjustments to maintenance intervals on all equipment. Their end goal is similar to the profession’s own end goal. We just need to keep working on finding common ground for how we get there.”
AAMI and ASHE intend to follow up with CMS to assess the agency’s reaction to the material provided. The AAMI/ASHE material noted that, “While a welcomed first step toward updating regulations, the CMS clarification statement created confusion, and concern, among those responsible for supporting medical devices and facilities equipment in the healthcare organizations. This [packet] is the first response to questions that were raised by CMS representatives…Through ongoing direct communication between our organizations, we expect to bring further clarity to the remaining points of concern. Collaboration in this manner should serve to eliminate the current differences between actual standards and what is understood (and therefore accepted as common practice) within the field of healthcare technology management.”
The ultimate goal is for CMS to change its position, based on the extensive evidence that has been submitted to demonstrate that the profession's well-honed, evidence-based approach to maintenance is acceptable. AAMI and ASHE also outlined three additional goals that they hope to achieve by continuing to work with CMS:
- Addition of further clarifications and updates to the current State Operations Manual Interpretive guidelines
- Development of a compliance assessment guide for use by surveyors
- Creation of a recommended practice or standard for equipment risk analysis and maintenance management that would be agreeable to the HTM field
Accrediting organizations will continue to work with CMS to determine how the content of the memo will (or will not) change their survey processes. In conversations between representatives of AAMI and the CMS Healthcare Facilities Accreditation Program (HFAP), there is shared interest in aligning compliance expectations. HFAP representatives are reviewing the AAMI/ASHE-submitted material, and may make some internal decisions about how programs will be evaluated through their accreditation surveys. At this time, they have clearly stated they expect to enforce the CMS standards as written. Future updates will be provided as these collaboration efforts between AAMI and HFAP move forward.
The current CMS practice of subjecting a randomly chosen 5% of all accredited organizations to a validation survey performed by designated state survey agencies will continue. It is during these validation surveys—regardless of which accrediting organization performed the regular accreditation survey—that questions may be asked by the state surveyors to determine whether the organization is following the requirements outlined in the CMS memo. Some of the questions that have been asked during such surveys include:
- Explain how the risk score was determined, how often it was updated, how it tied into incoming inspection if it was a new item to the organization, and who makes the decisions to change it.
- Have you ever decreased the quality or frequency of preventive maintenance (PM) from the vendor's recommendations?
- Can you show a maintenance history on a high-risk/ life-safety item?
- Explain your process if an item is not found.
- What is reported to Environment of Care (use errors and similar tracking)?
AAMI, ASHE OFFER GUIDANCE
The phrase “equipment critical to patient health and safety” in the CMS memo has resulted in some confusion among the HTM field. CMS does not accept what The Joint Commission(TJC) has traditionally defined as “life support equipment,” as being strictly equivalent to what CMS has termed “equipment critical to patient health and safety.” CMS also indicates that it is not appropriate for CMS to issue a list of the types of devices that they would consider to be “critical.” Until this and other related issues are resolved, the AAMI/ASHE team offers the following information and guidance:
• TJC has indicated there will be no immediate changes to its survey process, as it has approval from CMS to continue to survey according to its standards. DNV has received similar approval, and is not expected to change from its previous process either.
• In case a facility is selected for a state-implemented validation survey, it would be prudent for the manager of the equipment maintenance program to be prepared to justify—“based on an assessment by qualified personnel”—why any equipment not being maintained according to the interval recommended by the manufacturer is not “critical to patient health and safety.” The manager should also be prepared to have a concisely documented justification for using procedures other than manufacturer-specific procedures.
• Many states have a process of granting waivers for certain aspects of the licensure rules. If that is applicable for your organization, verify that you have a copy of the “order to grant a waiver” readily available, and that such a waiver is clearly applicable to each specific facility or organization being surveyed.
• CMS representatives did confirm that all validation survey findings that are not in conformance with the recent clarification would probably be cited in the validation survey report. But they also indicated that not all cited deficiencies are necessarily required to be corrected immediately. Since CMS appears to be sympathetic to reasonable efforts to keep healthcare costs down, it would be helpful if the suggested analysis offers documentation of the estimated cost impact of changing from generic to manufacturer-specific procedures—particularly for those items that the facility considers to be non-critical equipment. CMS does have a process for granting waivers for situations that could create a financial hardship.
• HTM professionals are encouraged to begin the process of analyzing and documenting those aspects of their programs that are not consistent with the CMS memo. Administrative representatives of the facility should be advised of any discrepancies between the new CMS requirements and the program that is currently in place in their organization.
• Because TJC and DNV will not be changing their current requirements, and given the relatively small likelihood that the facility will be selected for a validation survey, it seems likely that many currently accredited organizations will choose not to make any changes to their current maintenance program until a more definitive strategy for addressing the issue has been developed.
Posted: August 15, 2012