Photo courtesy of ECRI Institute
The Joint Commission was particularly active through the first half of this year issuing, and in one case retracting, a number of rulings of importance to hospitals and other health care facilities.
Not only did the Joint Commission rescind for further research new diagnostic imaging and medical equipment standards that were released earlier in the year, but it added two more rounds of prepublication standards that were effective July 2, and the midcycle update to the Hospital Accreditation Standards contains some significant language changes.
This is not to mention the announced changes in enforcement on relocatable power taps [see sidebar, Page 46], process changes for equivalencies and Plans for Improvement (PFIs) for the Statement of Conditions (SOC), and the survey report itself.
Most of the changes included in the middle of the annual cycle were mandated by the Centers for Medicare and Medicaid Services (CMS).
Changes this summer
Prepublication standards were released June 20 to include two new elements of performance (EPs) and two minor revisions in the Environment of Care (EC) chapter to correspond with deeming requirements. Previously, several new standards related to the maintenance, testing and inspection of medical equipment were issued, based on the CMS decision to permit alternative maintenance strategies to those identified by the equipment manufacturer. These were replaced with revisions in a July 1 update.
Both updates were effective July 2 [see sidebar].
The first round of prepublication standards contains two new EPs, both within standard EC.02.02.01, Hazardous Materials and Waste. EP 18 requires radiation exposure monitoring for all radiation workers and EP 19 requires a procedure for storage and disposal of trash. Most hospitals already have these in place.
There were a few wording changes released at the same time, both of which should be fairly inconsequential. In EC.02.03.01, EP 10, the Fire Response Plan must now describe how to sound “and report” a fire alarm. EC.02.05.03 itemizes the areas that require emergency power. Additions to EP 6 include “intensive care” and “emergency rooms.”
The second release of prepublication standards includes a number of changes to the requirements for medical equipment and utilities management, and some of these will have a more significant impact. The requirements are parallel for both types of equipment.
Looking at EC.02.04.01 for medical equipment and EC.02.05.01 for utilities, EP 2 requires an inventory of equipment or components. A distinction is drawn between non-deemed status organizations, where the inventory either can include all equipment or be risk-based. For deemed status organizations, the only option is to include all equipment in the inventory.
There is also a change in terminology that appears in both the program standards and the inspection, testing and maintenance standards for both medical equipment and utilities.
For medical equipment, they are EC.02.04.01 and EC.02.04.03, respectively; for utilities, EC.02.05.01 and EC.02.05.05. A piece of equipment or component that previously was classified as “life support” is now classified as “high risk,” with a note that “high risk includes life support” equipment or components. “Non-life support” becomes “non-high risk.” Utilities management retains the third category — infection control components — without a name change. High risk is defined to include life support equipment or components, and high-risk equipment or components must be identified in the inventory.
Current EPs 3 and 4 were deleted for both EC.02.04.01 and EC.02.05.01. In their stead is a new EP4, which states that maintenance, testing and inspection activities are based either on manufacturers’ recommendations or alternative equipment maintenance (AEM) strategies that do not reduce safety, and are based on acceptable standards of practice. Examples of these acceptable standards are those by the Association for the Advancement of Medical Instrumentation for medical equipment; and the National Fire Protection Association’s NFPA 99, Health Care Facilities Code, 1999 edition, for utilities.
In deemed-status organizations, medical equipment that requires maintenance, testing and inspection based on manufacturers’ recommendations include those required by the CMS Conditions of Participation (COPs) or law and regulation, diagnostic imaging equipment, lasers and new equipment. For utilities, manufacturers’ recommendations must be followed as required by COPs, law and regulation, or for new equipment. Whether medical equipment or utilities, a qualified individual must determine when alternative maintenance strategies may be used based on written criteria. This is likely in place at most hospitals.
Any medical equipment or utilities components that will be maintained under an AEM strategy must be identified on the inventory. This will probably require another field in the inventory database so that these items can be appropriately flagged.
In both EC.02.04.03 (medical equipment maintenance, testing, and inspection) and EC.02.05.05 (maintenance, testing and inspection for utilities), EP 1 addresses performance and safety testing. In both standards, this was previously required before initial use. For deemed-status organizations, this testing is required both before initial use and any time significant repairs or upgrades are made. This will be another addition to the record-keeping process.
As a result of these changes, there has been the following renumbering of other elements of performance:
• EC.02.04.01 EP 8: Safe Medical Devices Act (formerly EP 5);
• EC.02.04.01 EP 9: Written failure procedures (formerly EP 6);
• EC.02.05.01 EP 14: Waterborne pathogens (formerly EP 5);
• EC.02.05.01 EP 15: Airborne contaminants (formerly EP 6);
• EC.02.05.01 EP 16: Mapping distribution (formerly EP 7).
In the July update to the 2014 Hospital Accreditation Standards, there are a number of changes to the Environment of Care and Life Safety chapters, most of which involve references and are relatively inconsequential. But two are significant:
• EC.02.03.03 addresses fire drills. EP 3 has stated that at least 50 percent of fire drills are unannounced. New language adds “fire drills are held at unexpected times and under varying conditions.” This could be a significant change for some hospitals that typically run fire drills at a designated hour on each shift, or always conduct drills on a designated day of the month or a designated week of the quarter. Staff members quickly figure this out, and the times become expected.
• LS.02.01.20, EP 1 previously stated, “Doors in a means of egress are unlocked in the direction of egress.” This is replaced by new language: “Doors in a means of egress are not equipped with a latch or a lock that requires the use of a tool or key from the egress side.” The new language gives this requirement an entirely different but related meaning.
Speaking of waivers
Speaking of categorical waivers, there are 13 items for which both the Joint Commission and CMS will permit compliance with the 2012 edition of NFPA 101, the Life Safety Code, and NFPA 99 prior to their anticipated adoption. A listing of the permitted waivers can be found at www.ashe.org/resources/ashenews/2013/pdfs/cms_approves_lsc_waiver_chart_v3_130909.pdf.
If an organization chooses to adopt one or more of these waivers, some additional steps must be taken:
• Waivers pertinent to the Life Safety Code must be listed in the “Additional Information” section of the Basic Building Information of the Statement of Conditions. The locations of the conditions addressed under the waiver must be included.
• If the waiver does not relate to the Life Safety Code, documentation of its acceptance must be contained in the minutes of the EC committee.
• All categorical waivers in use must be declared during the Joint Commission or CMS opening conference at the start of the survey or they will not be considered.
Two changes in process will impact the volume of the Joint Commission survey report, with two new categories included in the report.
The first is titled “Opportunities for Improvement.” This section will contain a listing of all category C elements of performance with only one finding. It’s important to note that two findings result in a Recommendation for Improvement. This will just be a list, with no evidence of standards compliance required, and no opportunity for clarification and removal from the report.
A second list will be titled “Open PFIs,” and will include all open PFIs that have been accepted by the surveyor. Likewise, these require no evidence of standards compliance and have no opportunity for clarification but, of course, all PFIs must be appropriately resolved.
For many organizations, these two lists will result in a much thicker survey report than has been received in the past. They will not affect the accreditation decision, but it is wise that the organization’s leadership is forewarned, to avoid the shock of a much bigger stack of paper.
Also, any past-due PFIs will result in coaching calls to the organization, starting with the facility and quality managers and escalating to senior leadership. This is an attempt to resolve any issues with the organization’s process and to keep the corrections on track. These calls will be noted in the Joint Commission’s history audit trail for the organization.
Finally, any requested equivalencies — whether a traditional equivalency or a Fire Safety Evaluation System-based equivalency — will be forwarded to CMS for its process of granting a waiver.
If successful, an organization will receive both a Joint Commission equivalency and a CMS waiver with only one submission. Any requests for a traditional equivalency must now be field-verified by an architect, fire protection engineer or authority having jurisdiction.
Most health care organizations have these processes in place and minimal changes will result in compliance. However, it’s probably time to update management plans.
New requirements on facilities issues
Prepublication requirements were released June 20 to include two new elements of performance and two minor revisions in the Environment of Care chapter to correspond with deeming requirements.
The two rounds of prepublication standards can be found at www.jointcommission.org/assets/1/6/HAP_Deeming_Prepub_June2014.pdf and www.jointcommission.org/assets/1/18/HAP_Equip_Maint_Revisions_July2014.pdf.
Some of the new requirements apply only to organizations that use Joint Commission accreditation for deemed-status purposes. In some cases, distinctions are drawn between deemed-status organizations and those that are not within a single element of performance.
Health facilities professionals should consult the full text for specific requirements of these updates, which were effective July 2.
Organizations to resolve power taps issue
In response to urging from the Centers for Medicare & Medicaid Services (CMS), the Joint Commission announced in June that relocatable power taps (also known as “power strips”) were not permitted to be used with medical equipment in patient care areas, based on the requirements of the 1999 edition of National Fire Protection Association’s NFPA 99, Health Care Facilities Code.
This always has been in the code, but largely has been overlooked by the Joint Commission and other accrediting bodies as medical equipment has proliferated. While prohibiting their use is code-compliant, it also renders many, if not most, operating rooms in the country useless. The ban also would apply to patient rooms, exam rooms, recovery rooms, diagnostic areas and other spaces.
This largely will be corrected in the 2012 edition of NFPA 99, with the limitation that those power taps approved for patient care equipment must be UL1363A rated, and those for non-patient care equipment must be rated UL 1363.
This was discussed at length at the meeting of the Healthcare Interpretations Task Force when it met in June at the 2014 NFPA conference. A decision was made to request that CMS issue an additional categorical waiver to permit compliance with the 2012 edition. This is still in progress at the time of this writing.
Meanwhile, both the American Society for Healthcare Engineering and ECRI Institute, Plymouth Meeting, Pa., have advised hospitals not to completely remove all existing power taps, with the caveat that any recommendations or findings based on their presence during the interim period must be managed appropriately. One strategy would be to conduct an inventory of the present location of the power taps and determine if they are rated appropriately.