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Long-Term Care Center requirements: preparedness

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Karl SchmittFounder & CEO


 

cms long-term care center definition

  • Skilled Nursing Facility:  An institution (or a distinct part of an institution) which: is primarily engaged in providing skilled nursing care and related services for residents who require medical or nursing care, or rehabilitation services for injured, disabled, or sick persons, and is not primarily for the care and treatment of mental diseases; has in effect a transfer agreement (meeting the requirements of §1861(1)) with one or more hospitals having agreements in effect under §1866; and meets the requirements for a SNF described in subsections (b), (c), and (d) of this section.
  • Nursing Facility: An institution (or a distinct part of an institution) which is primarily engaged in providing skilled nursing care and related services for residents who require medical or nursing care, rehabilitation services for injured, disabled, or sick persons, or on a regular basis, health-related care and services to individuals who because of their mental or physical condition require care and services (above the level of room and board) which can be made available to them only through institutional facilities, and is not primarily for the care and treatment of mental diseases; has in effect a transfer agreement (meeting the requirements of §1861(1)) with one or more hospitals having agreements in effect under §1866; and meets the requirements for a NF described in subsections (b), (c), and (d) of this section.

 

accrediting organization(s)

The Joint Commission Logo


part 483 — requirements for states and long-term care facilities, Page: 172 (64030)

20. Add §483.73 to read as follows:

§483.73 Emergency Preparedness

The LTC center must comply with all applicable Federal, State, and local emergency preparedness requirements. The LTC center must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the elements below:

 

(a) The LTC center must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following:

  • (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
  • (2) Include strategies for addressing emergency events identified by the risk assessment.
  • (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC center has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
  • (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the LTC center's efforts to contact such officials and, when applicable, its participation in collaborative and cooperative planning efforts.

 

frequently asked questions about the rule

cms frequently asked questions document, rounds one, two, three, and four

Technical Correction(s) Notice 

Correct, there is a typo. The standard for evacuation drills is located at 483.470(i), not (h).
Correct, there was an omission. §485.625(e)(2) should state, The CAH must implement emergency power system inspection, testing and maintenance requirements found in the Health Care Facilities Code, NFPA 110, and the Life Safety Code.

Policies and Procedures and Documentation

The regulation is clear that facilities must have “policies and procedures” in place as opposed to “operating guidelines.” Policies are considered a more formal, definite method or course of action to be adhered to. Therefore facilities must develop and maintain “policies” and procedures to meet the requirements of the regulation. Facilities may choose to include relevant language from their “operating guidelines” in their policies and procedures as appropriate. Facilities should be aware that surveyors may ask to see a copy of the facilities “policies” and not “operating guidelines.”
We are not specifying the format of documentation to allow for flexibility. However, we would encourage facilities who chose a functional versus community based test to show why this approach was more favorable- i.e. community based testing is not available due to the rural area/geographic location of the facilities.
Facilities are required to provide subsistence needs for staff and patients, whether they evacuate or shelter in place. Those provisions include but are not limited to: food, water, medical supplies and pharmaceutical supplies.

risk assessment/documentation/plans

Providers and suppliers must have a written Risk Assessment based on an “all-hazards” approach, or HVA. We are not requiring a specific format to be used, however, we recommend facilities who have not prepared a Risk Assessment to reach out to ASPR TRACIE who can provide additional resources. Additional guidance will be forthcoming in the Interpretive Guidelines that will include survey procedures for surveyors.
We are not specifying the format of documentation to allow for flexibility. However, we would encourage facilities who chose a functional versus community based test to show why this approach was more favorable- i.e. community based testing is not available due to the rural area/geographic location of the facilities.
We are not requiring a specific format for how a facility should have their Emergency Plans documented and in which order. Upon survey, a facility must be able to provide documentation of these requirements in the plan and show where the plans are located.
We are not requiring a specific format for the manner in which a facility should have their Emergency Plans documented. Upon survey, a facility must be able to provide documentation of the policies and procedures and show surveyors where the policies and procedures are located.
We did not find any references to the term “business resilience” in the final rule. Business continuity and continuity of operations have the same meaning in the context of this rule.

The Assistant Secretary for Preparedness and Response has developed a document that includes information to assist facilities in planning for continuity of operations. The document may be found at: http://www.phe.gov/Preparedness/planning/hpp/reports/Documents/hc-coop2-recovery.pdf
The regulation does not affect providers and suppliers participating in the HPP. There is no relationship between the HPP and the regulation, as HPP works with the Health Care Coalitions (HCC) and State Departments. The Assistant Secretary for Preparedness and Response (ASPR) administers the HPP which provides leadership and funding through grants and cooperative agreements to states, territories, and eligible municipalities to improve surge capacity and enhance community and hospital preparedness for public health emergencies. For additional information, please contact ASPR’s Technical Resources, Assistance Center, and Information Exchange (TRACIE) at askasprtracie@hhs.gov
Providers and suppliers must document efforts made by the facility to cooperate and collaborate with emergency preparedness officials. While we are aware that the responsibility for ensuring a coordinated disaster preparedness response lies upon the state and local emergency planning authorities, the rule states that providers and suppliers must document efforts made by the facility to cooperate and collaborate with emergency preparedness officials. Since some aspects of collaborating with various levels of government entities may be beyond the control of the provider/supplier, we have stated that these facilities must include in their emergency plan a process for cooperation and collaboration with local, tribal, regional, state, and federal emergency preparedness officials. We also encourage providers and suppliers to engage and collaborate with their local HCC, which commonly includes the health department, emergency management, first responders, and other emergency preparedness professionals. Facilities are required to coordinate with local management officials, such as with their communication plans. For instance, facilities are required to have documentation of their efforts to contact such officials and, when applicable, its participation in collaborative and cooperative planning efforts. Facilities are required to have contact information for emergency officials and who they should contact in emergency events; maintain an emergency preparedness communication plan that complies with both federal and state law; and be able to demonstrate collaboration through the full-scale exercises. We are not requiring official “sign-off” from local emergency management officials; however, if the state requires this action, we would expect that facilities comply with their state laws.
We cannot address how the new regulation will affect state licensure laws. Facilities should contact their state licensing agencies for clarification.
We did not define ‘‘community’’, to afford providers the flexibility to develop disaster drills and exercises that are realistic and reflect their risk assessments. However, the term could mean entities within a state or multi-state region. The goal of the provision is to ensure that healthcare providers collaborate with other entities within a given community to promote an integrated response. In the proposed rule, we indicated that we expected hospitals and other providers to participate in healthcare coalitions in their area for additional assistance in effectively meeting this requirement. Conducting exercises at the healthcare coalition level could help to reduce the administrative burden on individual healthcare facilities and demonstrate the value of connecting into the broader medical response community, as well as the local health and emergency management agencies, during emergency preparedness planning and response activities.
The State Survey Agencies (SA), Accreditation Organizations (AOs), and CMS Regional Offices (ROs) will be involved in monitoring for compliance as is the case with all other requirements for participation in Medicare. Facilities may choose to work with local health and emergency management officials to review the facility's plan to meet local requirements. The facility has the option of choosing to seek approval of its plan from state/local emergency preparedness officials. We do not regulate state and local emergency management officials.
Providers/suppliers have one year to implement the emergency preparedness requirements. Surveying for compliance to these requirements will begin in November 15, 2017. There will be no exceptions for the requirements and non-compliance will follow the same process non-compliance with any other Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) for the facility at hand.
The implementation of this new regulation is not linked to an incentive program. Facilities found to be out of compliance with the requirements will follow the same enforcement process as with any other CoP/CfC that is found to be out of compliance. These new regulations are a condition or requirement to participate in Medicare. We anticipate releasing the Interpretive Guidelines and Survey Procedures in spring of 2017. In the interim, we are posting helpful tools and relevant information on the Survey and Certification Group (SCG) Emergency Preparedness Website to assist facilities in meeting the requirements.
As always, surveyors will use the Interpretive Guidelines and Survey Procedures in the State Operations Manual (SOM). Surveyors will also be trained on the requirements before implementation.

Accrediting Organizations (AOs)

Please see: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf
AOs will follow the same process for developing standards that will meet or exceed CMS requirements of the new rule.
AOs will need to submit their emergency preparedness standards/programs to CMS for review. AOs are required to meet or exceed the CMS CoPs/CfCs requirements; therefore the AOs must demonstrate to CMS that their standards meet or exceed all CMS’ new emergency preparedness requirements.

Testing and Training

Facilities are required to participate in a full-scale exercise that is community-based or when a an individual facility-based exercise when a community-based exercise is not accessible AND conduct an additional exercise that may include a second full-scale community or facility-based exercise or a tabletop exercise (as described in the regulations.) So yes, a facility is required to conduct two tests annually. If the facility experienced an emergency and had to activate its emergency plan between November 15, 2017 and December 31, 2017 that would satisfy one of the annual testing requirements and would exempt the facility from engaging in a community or facility based exercise for one year following the date of the actual emergency event. The “annual” testing requirement will not be measured on a calendar year basis which is January 1 through December 31. The annual requirement will be measured from the date of the last actual emergency event or the date the exercise/testing took place.
Per 416.54(d)(2)(i) of the final rule an ASC is required to participate in a full-scale exercise that is community-based. If the ASC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event. (64024 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations)

Please refer to page 63900 of the final rule that stated if a community disaster drill is not available, we would require an ASC to conduct an individual facility-based disaster drill.
A well organized, effective training program must include initial training for new and existing staff in emergency preparedness policies and procedures as well as annual refresher trainings. The facility must offer annual emergency preparedness training in which staff can demonstrate knowledge of emergency procedures. The facility must also conduct drills and exercises to test the emergency plan to identify gaps and areas for improvement. We expect facilities to delineate responsibilities for all of their facility’s workers in their emergency preparedness plans and to determine the appropriate level of training for each professional role. Therefore facilities will have discretion in determining what encompasses appropriate training for the different staff positions/roles.
Employees or the term ‘‘staff’’ refers to all individuals that are employed directly by a facility. The phrase ‘‘individuals providing services under arrangement’’ means services furnished under arrangement that are subject to a written contract conforming with the requirements specified in section 1861(w) of the Act. We refer providers back to the regulation text for further information (81 FR. 63891).
CMS does not expect to develop training specifically for providers and suppliers. Healthcare associations and state, local and other Federal healthcare agencies may provide training for providers and suppliers. However, training provided by these organizations is only a tool to assist facilities in preparing for implementation of the rule and does not mean that a provider or supplier is in compliance by having received the training.

Examples of Table-Top Exercises (TTX) or Full-Scale Exercises 

The training and exercise requirements of the regulation call for individual-facility and/or full-scale community-based exercises, the below are some examples of exercise considerations:
  • Earthquakes
  • Hurricane
  • Flooding
  • Fires
  • Cyber Security Attack
  • Single-Facility Disaster (power-outage)
  • Medical Surge (i.e. community disaster leading to influx of patients)
  • Infectious Disease Outbreak
  • Active Shooter Tornadoes

Alternate Sources of Energy

The following providers have a mandatory requirement based on the new EP regulation to have an emergency and standby power system, i.e. a generator: Hospitals, LTC, and CAHs.

The following providers have a mandatory requirement based on the new EP regulation to have an alternate source of energy to maintain temperatures to protect [patient, resident, participant, client] health and safety and for the safe and sanitary storage of provisions: RNHCI, Hospice (inpatient), PRTF, PACE, Hospitals, LTC, ICF/IIDs, and CAH.

During an emergency situation, the providers listed above with a mandatory requirement for alternate sources of energy, must be able to maintain temperatures. Maintaining temperatures could involve heating or cooling the facility to maintain temperature levels within the facility to protect the individual’s health and safety, as well as the safe and sanitary storage of provisions.

During the risk assessment a provider will need to determine how they will be able to maintain temperatures that will protect the health and safety of (patient, resident, participant, client) and the safe and sanitary storage of provisions if their facility loses power. The provider needs to determine how they will provide heating or cooling to their facility, if required, to maintain temperatures during an emergency situation, if they lose power.

We recommend facilities also review the preamble at Page 63882 Federal Register / Vol. 81, No. 180/ Friday, September 16, 2016. Additional guidance will be forthcoming in the Interpretive Guidelines.
The regulation does not make a distinction between ICF/IIDs and “small” ICF/IIDs. According to §483.475(b)(ii) ICF/IIDs have a mandatory requirement to provide alternate sources of energy to maintain the following items: §483.475(b)(ii) Alternate sources of energy to maintain the following:
  1. (A) Temperatures to protect client health and safety and for the safe and sanitary storage of provisions.
  2. (B) Emergency lighting.
  3. (C) Fire detection, extinguishing, and alarm systems.
  4. (D) Sewage and waste disposal.
As per the previous FAQs posted (11-18-16), the above provision does not specify or require that a facility must have a generator. The Emergency Preparedness regulation requires Hospitals, Critical Access Hospitals and Long-term Care Facilities to have generators.

Additionally, the Home and Community Based Waiver (1915(c)) participate in Medicaid only and are not surveyed for the emergency preparedness requirements.
Provisions include: food, water, pharmaceuticals or medications and medical supplies. At §482.15(b)(1)(ii)(D), we proposed that the hospital develop policies and procedures to address the provisions of sewage and waste disposal including solid waste, recyclables, chemical, biomedical waste, and waste water. This provision also includes policies and procedures which address ‘pharmaceuticals or medications/medical supplies (Reference Page 63880 Federal Register / Vol. 81, No. 180).

Transfer Agreements and Coordination Required

The regulation does not specify provider and supplier MOUs; however, the regulation does speak to the need for transfer agreements depending on the facility type. For example, during an emergency, if a patient requires care that is beyond the capabilities of the ASC, we would expect that ASCs would transfer patients to a hospital with which the ASC has a written transfer agreement, as required by existing § 416.41(b), or to the local hospital, that meets the requirements of §416.41(b)(2), where the ASC physicians have admitting privileges. (Federal Register /Vol. 81, No. 180 / Friday, September 16, 2016 /Rules and Regulations 63899) Therefore, we recommend facilities review current CoPs/CfCs for specific details on transfer agreements. A sample Transfer Agreement is also located under the download section at https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/SurveyCertEmergPrep/Emergency-Prep-Rule.html. ASPR TRACIE may also provide sample transfer agreements currently available.

Life Safety Code (LSC)

The Emergency Preparedness regulation requires Hospitals, Critical Access Hospitals and Long-term Care Facilities to have generators. The regulation also requires health care facilities to have alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. If a facility needs a generator to meet the temperature requirement then it must provide the necessary level of generator with a capacity to run a HVAC system.
The LSC may require a generator at certain PACE locations if the services provide electrical life support or other critical care.. The Emergency Preparedness regulation also requires PACE facilities to have alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. If a facility needs a generator to meet the temperature requirement then it must provide the necessary level of generator with a capacity to run a HVAC system.
NFPA 110, Standard for Emergency and Standby Power Systems has many requirements for the installation, maintenance and testing of generators, depending on the type of generator. Basic requirements are that a generator be inspected weekly and test run for 30 minutes monthly.
The emergency preparedness rule requires long term care (LTC) facilities to have a generator. The regulation also requires LTC facilities to have alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. If a facility needs a generator to meet the temperature requirement then it must provide the necessary level of generator with a capacity to run a HVAC. There may be state and local regulations that have additional requirements regarding the generator and any required fuel capacity.
CMS does not recommend a specific type of generator. Generator selection is dependent on the needs of the facility to meet the requirements of the regulation.
The requirements for LTC facilities are located at 483.73(e) of the final rule (Federal Register /Vol. 81, No. 180 / Friday, September 16, 2016 /Rules and Regulations page 64031.) Regarding “whole building” generators, the new rule does not specify that a facility must have a generator that would support the operations of a “whole building.”
Under 482.15 (b)(1)(ii)(A) temperatures to protect patient health and safety and for the safety and sanitary storage of provisions. Refer also to (i) provisions which refers to pharmaceutical supplies as provisions. So yes they need to maintain temperatures of storage areas.
The “emergency and standby power systems” requirement only applies to hospitals, CAHs and LTC facilities and requires these facilities to have a generator. The “alternate sources of energy” requirement applies to hospitals, CAHs, LTC facilities, RNCHIs, hospices, PRTFs, PACE organizations, and ICF/IIDs. This standard/requirement does not specify that the facility (other than hospitals, CAHs and LTC facilities) must have a generator. However, in order maintain safe temperatures, emergency lighting, etc., facilities may have to install generators if they do not have other adequate alternate sources of energy to be in compliance with the rule.

Miscellaneous

The regulation does not require any specific items and quantities that facilities must have to be in compliance with the rule. It is up to each individual facility to conduct an assessment of its facility’s supply needs during an emergency and make purchases based on its assessment.
No, the regulation does not apply to stand alone, community pharmacies. The rule does apply to pharmacies that are considered a department of a Medicare participating facility (hospital, ASC, CAH, etc.)
The new Emergency Preparedness requirements do not apply to physician offices that are not part of a certified Medicare participating facility. Physicians’ offices or practices that are considered part of a certified Medicare participating facility would be required to meet the regulations.
If a Medicaid provider is required to meet the requirements for participation in Medicare in order to receive Medicaid payment, that provider is required to comply with the Emergency Preparedness requirements, along with all of the other Medicare CoPs or CfCs for that provider. For example, Medicaid only hospitals must meet the Medicare requirements, so they must comply with all of the hospital CoPs, including the Emergency Preparedness requirements. Note that not all provider types have a provision requiring them to meet the Medicare requirements in order to be Medicaid participating.
The regulation is applicable to 17 Medicare and/or Medicaid providers and suppliers. The complete listing can be found under our download section on this website. This regulation does not apply to ADHCPs. If a non-participating entity (such as a ADHCP) is located within a Medicare and/or Medicaid participating facility, we would expect the participating facility to consider the non-participating entity when developing its emergency plans.