March 31, 2014
Marilyn B. Tavenner
Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, D.C. 20201
Re: CMS 3178-P, Medicare and Medicaid Programs;
Emergency Preparedness Requirements for Medicare and Medicaid Participating
Providers and Suppliers; Proposed Rule, Dec. 27, 2013
Dear
Ms. Tavenner:
On
behalf of our 142 member hospitals and related health systems, the Minnesota
Hospital Association (MHA) appreciates the opportunity to comment on the
Centers for Medicare & Medicaid Services’ (CMS) proposed rule to establish
national emergency preparedness requirements for Medicare- and Medicaid-participating
providers and suppliers.
Hospitals are dedicated to meeting the
challenges posed by all types of disasters. The public recognizes that in
times of crisis hospitals are places of safe refuge and comfort, and hospital
leaders and caregivers know that their communities depend on them. Hospitals
often serve larger community needs during emergencies, from providing places
where individuals who depend on medical equipment requiring electricity can
“plug in” to housing, feeding and protecting members of the community whose
homes have lost power or otherwise been damaged. Every hospital works to be
prepared. However, unanticipated challenges can and do occur during
emergencies. Thus, hospitals must plan for, and be ready to handle, the
unexpected.
MHA supports CMS’s goal for Medicare
providers and suppliers to have comprehensive emergency preparedness plans and
generally think that CMS has chosen the correct framework for the proposed
Conditions of Participation (CoPs) and Conditions for Coverage (CfCs). We
encourage CMS to consider five principles put forth by the American Hospital
Association (AHA) and to examine more closely its estimates of both the
associated burden and cost as it finalizes its recommendations.
Guiding
Principles. The number one
priority of hospitals during a disaster is to ensure that patients in the
hospital’s care are safe and can receive the services they need. This is why the majority of hospitals already
meet existing emergency operations standards promulgated by The Joint
Commission (TJC), National Fire Protection Association (NFPA) and/or the
Hospital Preparedness Program (HPP), as well as state and local governments.
Hospitals plan and drill for disasters regularly.
MHA urges CMS to ensure that its proposed
requirements enhance readiness without adding confusion or creating additional
administrative burden. We suggest that CMS consider five guiding
principles:
- Align policies
with existing and current standards – CMS standards should be aligned as
much as possible with existing standards, laws and regulations to avoid
conflict and confusion, and the standards should be evaluated and updated
periodically to reflect new knowledge and advances in technology.
- Define
leadership roles for community planning – CMS should recognize that local
emergency management and public health authorities are the best-placed entities
to coordinate their communities’ disaster preparedness and response,
collaborating with hospitals as instrumental partners in this effort.
- Accept an
integrated approach to emergency planning – Integrated health systems
should have the option to maintain one coordinated emergency plan in cases when
a single plan improves preparedness.
- Collaborate to
develop interpretive guidance – CMS should use a transparent process
working with stakeholders to develop interpretive guidance.
- Balance
implementation and compliance with education – State surveyors should
assess compliance as appropriate and also realize that they can play an
important educational role in helping providers meet and exceed the standards.
Need for Accurate Estimates. MHA agrees with AHA that CMS’s projections of
burden and cost for compliance with this proposed rule are greatly
underestimated.
Many of our members, especially smaller hospitals and critical access hospitals,
have expressed concern about the financial implications for compliance with
certain provisions. In addition, CMS severely underestimates the amount of time
and work it will take many providers and suppliers to come into compliance with
the proposed requirements. For example, tasks such as updating policies and
procedures involve more than merely assembling key hospital staff to attend a
limited number of meetings, draft revisions and obtain approval. Updating
policies and procedures also involves researching alternatives, assessing any
costs involved (such as technology that may be needed), reviewing potential
changes with employees who may be affected, implementing the changes, training
staff and testing outcomes.
While the
appropriate timeframe for each provider or supplier to implement the proposed
requirements will depend upon the final requirements, as well as the
circumstances and resources of each individual facility, we believe the proposed one-year timeframe will likely be
too short for many hospitals and other providers and suppliers. For
TJC-accredited hospitals, we believe that two years should be sufficient. Some
hospitals may need more time. In cases where hospitals must make significant
structural changes, the affected hospitals should be able to articulate to CMS
a reasonable period of time to comply. Other providers and suppliers, including
critical access hospitals (CAHs), home health agencies and hospices, also may
need additional time.
SPECIFIC RECOMMENDATIONS FOR HOSPITALS
AND CAHS
RISK ASSESSMENT
All-Hazards Approach. CMS discusses the need to take an “all
hazards” approach to emergency planning throughout the proposed rule, and confusion
exists about what this term means. CMS’s preamble language emphasizes that
“all-hazards planning does not specifically address every possible threat” but
instead “ensures that hospitals and all other providers will have the capacity
to address a broad range of related emergencies.” Further, CMS explains that it
would expect a hospital to identify “all risks or emergencies that the hospital
may reasonably expect to confront.”[1] MHA supports the AHA recommendation that
CMS clarify this concept in the final rule by adding proposed language at § 482.15(a)(1)
to require that the emergency plan “[b]e based on and include a documented,
facility-based and community-based risk assessment (or HVA), utilizing an
all-hazards approach that identifies the
emergencies that the hospital may reasonably expect to confront.”
We
agree with CMS that a hospital should evaluate both community-based and
facility-based risks in emergency planning. However, CMS does not provide sufficient
clarity about which entity is expected to conduct the community-based risk
assessment. CMS explains in the preamble that it expects a community-based risk
assessment to be conducted outside of
the hospital. Yet it is unclear whether CMS would expect a hospital to conduct
its own community assessment outside of the hospital or rely on an assessment
developed by other entities, such as regional health care coalitions or local
emergency management and public health agencies.
With regard to the community-based plan,
we agree with AHA’s suggestion that CMS allow hospitals to either: (1) use a
comprehensive community-based risk assessment (or HVA) developed by a different
organization(s), where available, if the hospital deems it to be adequate; or
(2) conduct their own community-based assessments, with input from key organizations
in the community, as is consistent with TJC and NFPA standards.
THE EMERGENCY PLAN
Organization of the Emergency Plan. While we generally agree with CMS’s
proposed framework for emergency preparedness, the organization of the proposed
rule and the accompanying preamble discussion indicate that CMS may view an
emergency plan as separate from emergency preparedness policies and procedures.
Hospitals typically have an emergency preparedness plan that consists of
emergency policies and procedures in a single document that is updated
periodically. MHA supports AHA’s
position that hospitals be allowed to have a single, integrated document that
contains the plan, policies and procedures. Further, CMS should recognize that
the plan itself may represent the policies and procedures.
Clarifying
the Role of the Hospital in Community Planning. In proposed § 482.15(a)(4), CMS would
require the emergency plan to “[i]nclude a process for ensuring cooperation and
collaboration with local, tribal, regional, State, and Federal emergency
preparedness officials’ efforts to ensure
[emphasis added] an integrated response during a disaster or emergency
situation, including documentation of the hospital’s efforts to contact such
officials and, when applicable, its participation in collaborative and
cooperative planning efforts.” As CMS acknowledges, providers cannot ensure
that officials will work with all health care entities in disaster planning.
Therefore, MHA supports AHA’s
suggestion that this language be modified to state that the emergency plan must
“[i]nclude a process for ensuring the
hospital’s/CAH’s cooperation and collaboration with local, tribal,
regional, State, and Federal emergency preparedness officials’ efforts with the goal of implementing an
integrated response during a disaster or emergency situation, including
documentation of the hospital’s efforts to contact such officials and, when
applicable, its participation in collaborative and cooperative planning
efforts.”
In addition, we note that one of
the entities with which a hospital would be asked to collaborate would likely
be the agency that surveys that hospital for compliance with the emergency
preparedness requirements. State agencies play multiple roles with respect to
hospitals, such as licensing them, disbursing HPP funding and conducting CoP
surveys. We ask CMS to address how it believes state agencies should respond
when these multiple roles present a potential conflict of interest for the
state agency.
Addressing
Patient Population. CMS proposes, at
§ 482.15(a)(3), that a hospital’s emergency plan must “address patient
population, including, but not limited to, persons at risk; the type of
services the hospital has the ability to provide in an emergency; and
continuity of operations, including delegations of authority and succession
plans.”
CMS
defines “at-risk” to include populations that may have additional needs in
functional areas, such as maintaining independence, communication,
transportation, supervision and medical care, as well as children, seniors,
pregnant women, those who have disabilities, live in institutionalized
settings, are from diverse cultures, have limited English proficiency, have
chronic medical disorders or pharmacological dependency.
We
agree that hospitals should, and already do, plan to care for patients who need
additional response assistance during an emergency. At the same time, we acknowledge
that the wording of this regulation may create the expectation that hospitals
should care for all individuals in the community who have additional needs. For
example, individuals who are dependent on medical equipment that requires
electricity may come to the hospital’s emergency department to access power in
an emergency. Ideally, community-wide planning will ensure that alternate locations
are established for this purpose. In addition, some hospitals are able to
provide this service for their communities. For others, however, this
expectation could cause overcrowding and may hinder a hospital’s efforts to
provide urgent medical treatment to patients who are acutely ill or injured.
MHA supports AHA’s suggestion that the
regulatory language at § 482.15(a)(3) should emphasize the hospital’s unique role
of providing acute medical treatment and should require the plan to “address patient population, including
at-risk patients needing acute care services and/or treatment in an emergency; the
type of services the hospital has the ability to provide in an emergency; and
continuity of operations, including delegations of authority and succession
plans.” This
change would not prohibit hospitals
from providing additional services but would help keep the focus on a
hospital’s unique responsibility during an emergency – a mission that other
entities cannot fulfill for the community.
POLICIES AND PROCEDURES
MHA
agrees with CMS’s proposal that a hospital’s emergency plan should address how
it will safely evacuate or shelter in place, what system it will use to preserve,
protect and access medical records, whether and how it will use volunteers, and
how it will develop arrangements with other facilities to receive patients.
Below we outline recommendations and observations about three areas for
policies and procedures that CMS outlines in its proposed rule.
Patient
Tracking. CMS would
require policies and procedures to address “[a] system to track the location of
staff and patients in the hospital’s care both during and after the emergency.”
Although a hospital could use either a paper-based or electronic system, CMS states
in the preamble that it would expect “the information [to] be readily
available, accurate, and shareable among officials within and across the
emergency response system as needed in the interest of the patient.”
Patient tracking in an emergency
is a most difficult challenge. Patient tracking within the hospital should be
distinguished from patient tracking outside of the hospital. We note that the
proposed regulation focuses on tracking patients “in the hospital’s care,” and
that is appropriate. It is reasonable to expect that a hospital would track the
location of the patients in its care during and after a disaster, whether they
are located within the hospital or at an alternate care site operated by the
hospital. In addition, if a hospital is managing the transfer or evacuation process
for its own patients, it should know the next care setting to which its patients
are sent.
However, moving and tracking
patients may also be the responsibility of an entity other than the hospital. In
those cases, the hospitals will not necessarily know the destination of each of
those individuals.
With regard to “tracking the
location of staff,” hospitals have systems to locate personnel in an emergency.
However, we believe this is different from “tracking” staff, which sounds more
expansive than would be necessary in the event of most emergencies. Thus, MHA supports AHA’s recommendation
that CMS change the language of the proposed regulation so that a hospital
would be required to have “[a] process to
locate staff and track the location of patients in the hospital’s/CAH’s care
both during and throughout the emergency.”
Subsistence
Needs. CMS proposes
that the hospital’s policies and procedures address the provision of
subsistence needs for staff and patients, whether they evacuate or shelter in
place, including food, water and medical supplies. Hospitals generally have
adequate plans for providing subsistence needs for staff and patients in the
event that the facility shelters in place in an emergency. However, AHA and MHA recommend that CMS delete the language requiring
that the hospital provide for staff and patient subsistence needs in the event
that the facility evacuates its population to another facility. Instead, hospitals
should address these subsistence needs as part of their plans under proposed § 482.15(b)(7),
requiring the development of arrangements with other providers to receive
patients in an evacuation.
CMS requests comment on whether
hospitals should be required to maintain a store of extra provisions for volunteers,
visitors and individuals from the community who may arrive at the hospital to
offer assistance or seek shelter. We believe that provisions for volunteers would
be addressed by the proposed requirement at § 482.15(b)(6), which would require
hospitals to address the role and use of volunteers in an emergency. Further, as
noted above, we think that identifying shelters for individuals from the
community is best coordinated through community planning. Hospitals may, if
they have the capacity and have considered factors that could affect patients
and non-patients, serve as one location for this purpose. In the end, these
decisions must be made on a case-by-case basis by individuals who are most
knowledgeable about the resources of the hospital and the community. Therefore, MHA agrees with AHA’s position
to not recommend that CMS add such a requirement in the final rule.
At § 482.15(b)(1)(ii), CMS
proposes that hospitals have policies and procedures to address the provision
of alternate sources of energy to maintain: (1) temperatures to protect patient
health and safety and for the safe and sanitary storage of provisions; (2)
emergency lighting; (3) fire detection, extinguishing and alarm systems; and (4)
sewage and waste disposal. MHA agrees
that these needs should be addressed by the emergency plan.
In addition, these requirements should
be interpreted in a way that aligns with current NFPA standards. Current CoPs require hospitals to
follow NFPA 99 standards as referenced in chapters 18 and 19 of the 2000
version of the Life Safety Code. We expect federal regulations to be updated to
reflect standards outlined in the 2012 version of the Life Safety Code in the
near future. The NFPA standards detail the utilities a facility must plan to
continue providing during an emergency, including the equipment that must be on
the essential electrical system, consisting of the life safety, critical, and
equipment branches. For example, current standards require the life safety
branch to include power for illumination for means of egress, fire alarms, and
communication systems and the critical branch to include power for, among other
things, critical care and patient care areas.
Experts at AHA’s affiliate, the
American Society for Healthcare Engineering (ASHE), advise that facilities may
not have the capability to provide total climate control and refrigerated
storage of perishables with emergency power. During an emergency, hospital engineers
will manage the needed utilities depending on the situation. For example, a
hospital that does not need to be evacuated may limit the number of
elevators in service in order to create electrical capacity for heating or
cooling. If a hospital evacuates, it may prioritize elevators over other
utilities, such as refrigeration.
Hospitals should be able to
describe in their emergency plans how they will mitigate specific scenarios,
such as if they are unable to maintain temperatures or refrigeration. At the
same time, hospitals ought to review their current emergency power capacity and
assess whether upgrades should be made using a capital expenditures planning
approach. CMS’s proposal could be interpreted to increase the requirements for
what must be included on essential electrical systems and require existing
facilities to upgrade their systems to meet the increased requirements. We do
not believe that the proposed rule should be interpreted to require substantial
retrofits of buildings, unless the hospital assesses that there is no other way
to ensure patient safety in an emergency.
The
expectations for sewage and waste disposal are also unclear. The language of
the proposed regulatory text would require hospitals to address alternate sources of energy to maintain
sewage and waste disposal. However, energy is not always required for these processes.
Further, while some hospitals have incinerators or compactors for waste
disposal, these items are not generally included on the essential electrical
system. In addition, many hospitals have eliminated their incinerators in
recent years due to changes in environmental and permitting requirements and currently
have waste removed. CMS should instead require
hospitals to have back-up plans should their primary waste-handling operations
become disabled or disrupted. This could include storing waste in a secure
area until removal can be arranged.
With
regard to sewage disposal, ASHE observes that a hospital may experience sewage
backup if the municipal plant is disabled by a disaster or if a discharge line
is broken or clogged. We believe that a hospital
should identify and assess the risks related to its facility’s wastewater system
and describe in its emergency plan how it will address specific scenarios in
which sewage could become a problem. For example, the hospital may relocate
patients off-site in some cases or move them to other areas of the hospital
that are unaffected by a disrupted discharge line.
Alternate Care Sites (ACSs). CMS would require a hospital’s policies
and procedures to address “[t]he role of the hospital under a waiver declared
by the Secretary, in accordance with section 1135 of the Act, in the provision
of care and treatment at an alternate care site identified by emergency
management officials.” MHA supports
AHA’s suggestion that CMS instead use more general language similar to TJC requirements
that the emergency plan identify “alternative
sites for the care, treatment and services that meet the needs of the
hospital’s/CAH’s patients during emergencies.”
COMMUNICATION PLAN
MHA agrees with CMS’s proposal
for hospitals to develop and maintain communication plans that comply with
federal and state law and to review these plans annually. We, along with AHA,
support the proposed framework for these plans and offer several
recommendations to strengthen these provisions and bolster information
infrastructure.
First, CMS would require
providers to implement certain provisions of the proposed communications plan
in compliance with the Health Insurance Portability and Accountability Act of
1996 (HIPAA). Hospitals should already have HIPAA compliance plans that, among
other things, address emergency situations. In addition, Minnesota has stricter
privacy laws than HIPAA and these state laws are not preempted by HIPAA. Therefore, the regulatory language should make clear that the communication plan
should comply with applicable state privacy laws in addition to HIPAA.
Second,
CMS proposes that the hospital’s communication plan include “[a] method for
sharing information and medical documentation for patients under the hospital’s
care, as necessary, with other health care providers to ensure continuity of
care.” We agree with CMS that this
proposed requirement should remain flexible and should not require the use of
any specific technology, as technologies often become obsolete. In fact,
compliance with this provision may not involve technology at all. In many
instances, implementation of this aspect of the emergency plan likely would
include sharing paper-based documentation that travels with a patient.
We
share the vision of a health care system in which interoperable systems
exchange secure information to support quality of care during emergencies and
non-emergencies. Our members and partners enthusiastically support the promise
of the Health Information Exchange (HIE) networks. The goal of these networks
is to allow providers to share patient information among one another in a
manner that is secure and can be backed up. In Minnesota, this work is far from
complete for all providers.
MHA
joins AHA in urging CMS and the Office of the National Coordinator (ONC) to
support policies that accelerate the development of a robust infrastructure for
health information exchange networks.
Finally,
we are concerned about the discussion in the rule’s preamble that the hospital
would share “comprehensive” information, because that term is not defined. We
encourage CMS to focus on relevant information that enables a subsequent
care provider to determine promptly what medical services and treatments are
appropriate for each patient and to deliver that care safely.
TRAINING AND TESTING
Training Programs. The proposed
rule would require a hospital to provide “[i]nitial training in emergency
preparedness policies and procedures to all new and existing staff, individuals
providing services under arrangement, and volunteers, consistent with their
expected role.” The proposed rule would require a CAH to provide “[i]nitial
training in emergency preparedness policies and procedures, including prompt
reporting and extinguishing of fires, protection, and where necessary,
evacuation of patients, personnel, and guests, fire prevention, and cooperation
with firefighting and disaster authorities, to all new and existing staff,
individuals providing services under arrangement, and volunteers, consistent
with their expected role.” Hospitals and CAHs would need to provide and
document training annually. In addition, hospitals and CAHs would be required
to ensure that staff can demonstrate knowledge of emergency procedures.
We agree that
training of staff and volunteers is a significant aspect of emergency planning.
In a disaster, many members of the hospital staff will continue to perform the
same job they do every day. Thus, we read the proposed rule to require the
hospital to ensure employees are aware of its emergency plan, policies and
procedures, and that each employee understands what he/she is required to do in
an emergency. Most hospitals already provide basic awareness level training to
staff as well as more comprehensive training for employees who are assigned a leadership
or management role in the hospital’s incident command system (e.g., the
Hospital Incident Command System (HICS)) during an emergency, especially if the
hospital has received HPP funding. In particular, the HPP requires hospitals
that receive preparedness funding to implement the activities identified in
Federal Emergency Management Agency’s (FEMA’s) National Incident Management
System (NIMS)[2],
including the identified training and exercise requirements.
The
proposed regulation imposes a duty to provide training about policies and
procedures related to emergency preparedness for staff (new and existing),
individuals providing services under arrangement, and volunteers in
relationship to the duties they perform. We believe it would be helpful for CMS
to provide detailed examples of what is meant by “individual providing services
under arrangement” to eliminate any confusion about the use of the phrase.
Another concern about this
provision relates to the cost of training. Training is valuable and necessary,
but it also can be expensive. This is especially true with some workforces
within the hospital that experience high turnover. For this reason, MHA questions
CMS’s cost and burden estimates related to developing a training program. CMS
estimated that it would cost about $2,000 for non-TJC accredited hospitals and
$834 for CAHs to develop a training program. These estimates appear to be low. In
addition, the proposed rule does not take into account the cost of implementing the training program. MHA
and AHA urge CMS to update its cost estimates in the final rule to recognize
the significant investment that hospitals and other providers make in order to
prepare for emergencies. CMS and its surveyors must understand the full context
of what it is asking providers and suppliers to do so that the final
expectations and timetables will be realistic.
Testing. The proposed rule would require a hospital
to conduct drills and exercises to test the emergency plan. Each year, the hospital
would be required to participate in at least one community-based drill (or a
facility-based drill if a community-based drill was not available) and conduct
one paper-based tabletop exercise. However, if the hospital experienced an
emergency and activated its emergency plan, the hospital would not need to
participate in the community-based or facility-based drill. The hospital also would
be required to analyze the results of the drills and exercises.
Testing the emergency plan is an
extremely important aspect of disaster planning. Currently, TJC requires hospitals
to conduct two drills per year instead of one, as CMS proposes. We believe that hospitals and CAHs that
conduct at least two drills annually (either community-based drills and/or
facility-based drills) should be exempt from the table-top exercise.
While
we agree with the value of testing, CMS has greatly miscalculated the time and
expense required to plan and carry out a community-based drill. CMS estimates
that it will take non-TJC accredited hospitals 57 burden hours and cost $3,883
to comply with the proposed drill and exercise requirements. For non-accredited
CAHs, CMS estimates that it would take 28 hours and cost $1,620. While most
unaccredited hospitals probably would not be starting from scratch with regard
to drills and exercises, CMS’s description of the tasks and burdens associated
with organizing a drill is completely insufficient. CMS outlines only a few
steps of the emergency drill process, such as creating scenarios and methods of
documentation and participating in the drills. Below we provide a more thorough
picture of the steps hospitals might take to develop and/or participate in
community-based emergency drills.
Some
hospitals that choose to take a leadership role in planning will:
- contact
other providers, suppliers and community emergency response agencies;
- bring
these stakeholders together to determine what will happen during the drill;
- convene
this group on a regular basis, such as once a month for an hour and a half or
two hours to develop the scenario, and then meet weekly for longer periods of
time as the date of the exercise gets closer;
- write
the hospital’s part of the exercise and ensure that each provider or supplier
writes its part of the exercise;
Hospitals
that participate in community drills will:
- engage
personnel in each participating hospital department, educating them and
obtaining feedback;
- recruit
observers and evaluators, which includes educating them about the drill and
expectations;
- recruit
volunteers to play the disaster victims/patients;
- prepare
the volunteers, who are typically given scripts with symptoms and injuries;
- develop
a way to inform actual patients about the drill;
- possibly
obtain union approval for some participants, such as the local fire department;
work
through the hospital’s financial
approval process for conducting the drills;
- carry
out the drills;
- gather
feedback;
- analyze
the results; and
- revise
the hospital’s emergency plan to reflect the lessons learned from the drill.
In
fact, it could take six months to a year to plan and carry out a comprehensive
emergency drill.
CMS should revise its estimates to consider
the complexity and coordination that community drills require and accordingly
adjust the final rule provisions to reflect the time and resources involved.
EMERGENCY POWER REQUIREMENTS
Generator Location. The
proposed rule would require a hospital’s generator to be located in accordance
with the requirements found in NFPA 99, NFPA 101, and NFPA 110. MHA, like
AHA, supports this proposal and believes that hospitals already conform to
these standards because the CoPs currently require compliance with the Life
Safety Code (NFPA 101), which cross references NFPA 99 and NFPA 110. Further,
we believe CMS should be aligned with NFPA in how it implements these
standards.
The location of generators and associated equipment can be a
crucial factor in ensuring that hospitals will be able to function and provide
critical services to patients in a disaster. The optimal location for a
hospital generator and its associated equipment depends upon the individual
circumstances of each hospital. Ideally, the placement should be based upon the
hospital’s HVA, an assessment of the types of disasters that may impact the
facility, as well as how the generator location could affect patient care due
to noise and vibrations. Hospitals and local building officials will typically
consider, for example, the NFPA standards in conjunction with reference
documents such as flood maps, weather pattern charts, and zoning plans. Local building
requirements may also impact the decision of where to place a generator and
associated equipment, such as city codes that limit where fuel may be stored
within the building.
We believe that hospitals should routinely review their emergency
power supply systems to ensure that generators and associated equipment are
located in the safest places possible. If, based upon its HVA, a hospital
determines that the likelihood exists for a disaster to incapacitate its
generators based upon their location (or the location of associated equipment),
the hospital should develop strategies to move its generators or take
mitigating actions that will address risks of harm to patients. The hospital
should preserve, to the best of its ability, the capacity to care for those in
need of medical attention during the disaster and its immediate aftermath.
We recognize that some of these projects will require major capital
expenditures and that the
lack of funding for these projects may be an impediment, especially for smaller
hospitals and safety net hospitals.
For example, ASHE
estimates it can cost an average of $1.5 million for a hospital to move two
generators. Therefore, we urge CMS and the Office of the Assistant Secretary
for Preparedness and Response to create funding opportunities to expedite
equipment location changes where they are needed.
Generator
Testing. CMS proposes to
require hospitals to test their generators annually for a minimum of four
continuous hours at a test load of 100 percent. CMS does not offer a rationale
for this level or frequency of testing, and the proposed 100 percent load
requirement does not align with any existing NFPA requirement. The power needs
for a facility can differ significantly depending on the time of year and time
of day, and therefore a straightforward requirement to test at a 100 percent load does
not consider the variation in power needs.
MHA joins AHA in urging CMS to consult ASHE and NFPA about appropriate
standards for generator testing.
Hospitals currently employ
multiple processes for testing generators. For example, hospitals typically
perform weekly inspections as well as monthly generator tests for 30 minutes. In
addition, TJC and NFPA standards require hospitals to test generators for a
minimum of four hours every three years at a 30 percent load (for diesel
powered generators).
Emergency Generator Fuel. The proposed
rule states, “hospitals that maintain an onsite fuel source to power emergency
generators must maintain a quantity of fuel capable of sustaining emergency
power for the duration of the emergency or until likely resupply.” This
language is incomplete, because it does not consider the situation in which a
hospital would evacuate or close during a prolonged emergency. MHA supports changing it to: “The hospital must have a plan for how it
will keep emergency power systems functioning during the emergency, unless it
evacuates.”
TRANSPLANT CENTERS
Under the proposed rule, CMS
would require transplant centers to have agreements with at least one other
Medicare-approved transplant center to provide transplantation services and
related care for its patients during an emergency. In addition, the transplant
center must ensure that the written agreement required under § 482.100
addresses the duties and responsibilities of the hospital and the organ
procurement organization (OPO) during an emergency.
MHA agrees with CMS’s goal in
proposing this requirement, which is to increase the likelihood that patients
will receive transplants if organs become available during an emergency, and
that the transplant center’s current patients will continue to receive vital
post-transplant care. As hospitals
develop their emergency plans, they already evaluate their services and
consider the needs of all of their patients, including transplant patients. Therefore,
we do not think that a separate regulation is needed for transplant centers,
especially as CMS proposes to require that hospitals consider “at-risk”
individuals in the patient population in its emergency plan. If CMS does
finalize its proposal, it should not duplicate or contradict the requirements
of the United Network for Organ Sharing (UNOS).
Thank
you for the opportunity to comment on these proposed rules. Please contact me
with any questions.
Sincerely,
Matthew L. Anderson, J.D.
Vice President, Regulatory/Strategic Affairs
[1]
Similarly, according to TJC, an “all hazards”
approach supports a general response capability that is sufficiently nimble to
address a range of emergencies of different duration, scale and cause.
[2] NIMS provides a systematic,
proactive approach guiding departments and agencies at all levels of
government, the private sector, and nongovernmental organizations to work
seamlessly to prepare for, prevent, respond to, recover from, and mitigate the
effects of incidents, regardless of cause, size, location, or complexity, in
order to reduce the loss of life, property, and harm to the environment.