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Compliance News: CMS Emergency Preparedness Final Rule Could Require More Equipment on Generators

| David Stymiest

The CMS Emergency Preparedness Final Rule (CMS EPFR) took effect on November 16, 2016, and compliance is expected by CMS starting November 16, 2017.

Per the handout for CMS’ April 27, 2017 webinar, the new CMS-required all hazards approach “is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters, including internal emergencies and a man-made emergency (or both) or natural disaster. This approach is specific to the location of the provider or supplier and considers the particular type of hazards most likely to occur in their areas. These may include, but are not limited to, care-related emergencies, equipment and power failures, interruptions in communications, including cyber-attacks, loss of a portion or all of a facility, and interruptions in the normal supply of essentials such as water and food.”

Based upon the above, it would appear that “all hazards approach” planning should involve preparing utility failure procedures for internal as well as external utility failures.

The CMS EPFR states that the Emergency and Standby Power Systems portion of the requirements applies to  Hospitals (42 CFR Part 482), Long Term Care Facilities (42 CFR Part 483), and Critical Access Hospitals (42 CFR Part 485.625).  Also available is a NFPA CMS 3178F SEPT 2016 Reference Tool, which does a great job of clearly summarizing the applicability of specific requirements to specific provider types.  The NFPA Reference Tool succinctly summarizes the Emergency and Standby Power Systems portion as mandating “specific compliance with NFPA 99, NFPA 101 and NFPA 110 for generator design, location, installation and ongoing ITM.” [Note: ITM means Inspection, Testing, and Maintenance.]

There are three basic sets of criteria within the Emergency and Standby Power Systems portions of the CMS EPFR.  They include:

  • Emergency generator location. This requires compliance with NFPA 99-2012, NFPA 101-2012 and NFPA 110-2010 “when a new structure is built or when an existing structure or building is renovated.”
  • Emergency generator inspection and testing. “The hospital must implement the emergency power system inspection, testing, and maintenance requirements found in the Health Care Facilities Code, NFPA 110, and Life Safety Code.”
  • Emergency generator fuel. “Hospitals that maintain an onsite fuel source to power emergency generators must have a plan for how it will keep emergency power systems operational during the emergency, unless it evacuates.”

Within the CMS Survey & Certification Letter 17-29 Interpretive Guidelines, CMS states that the CMS EPFR requires Hospitals, Critical Access Hospitals and Long Term Care Facilities that maintain onsite fuel sources (e.g., gas, diesel, propane) to have a plan to keep the Essential Electrical System operational for the duration of emergencies as defined by the facilities emergency plan, policy and procedures, unless it evacuates. The CMS surveyors are likely to ask about onsite fuel capacity or arrangements for fuel delivery, fuel delivery planning considering limitations and delays during the event, arranged fuel supply sources that are not limited by other community demands, all resulting in a sufficient amount of onsite fuel until the building or facility is evacuated.

“Subsistence requirement” and “… alternate sources of energy …”

Another broader requirement can be found starting on Federal Register page 64010, bottom of column 1.  Under the (b) Policies & procedures requirements pertaining to all inpatient providers, can be found the following:

“1. Subsistence Requirement.  This final rule will require all inpatient providers to meet the subsistence needs of staff and patients, whether they evacuate or shelter in place, including, but not limited to, food, water, and supplies, alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of such provisions. ….”

The above Subsistence Requirement is also discussed within the 7/2/2017 CMS Survey & Certification Letter S&C 17-29-ALL entitled “Advanced Copy- Appendix Z, Emergency Preparedness Final Rule Interpretive Guidelines and Survey Procedures”.

From PDF page 22 of that CMS S&C 17-29-ALL letter is the following guidance concerning the “alternate sources of energy” portion of the EPFR:

“This specific standard does not require facilities to have or install generators or any other specific type of energy source. (However, for hospitals at §482.15(e), CAHs at §485.625(e) and LTC facilities at §483.73(e) please also refer to Tag E-0041 for Emergency and Stand-by Power Systems.) It is up to each individual facility, based on its risk assessment, to determine the most appropriate alternate energy sources to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions, emergency lighting, fire detection, extinguishing, and alarm systems and sewage and waste disposal. Whatever alternate sources of energy a facility chooses to utilize must be in accordance with local and state laws as well as relevant LSC requirements.”

“Facilities must establish policies and procedures that determine how required heating and cooling of their facility will be maintained during an emergency situation, as necessary, if there were a loss of the primary power source.”

And on pages 22-23 of that same document:

“If a facility determines the best way to maintain temperatures, emergency lighting, fire detection and extinguishing systems and sewage and waste disposal would be through the use of a portable generator, then the Life Safety Code (LSC) provisions, such as generator testing and fuel storage, etc. outlined under the NFPA guidelines would not be applicable. Portable generators should be operated, tested, and maintained in accordance with manufacturer, local and/or State requirements. If a facility, however, chooses to utilize a permanent generator to maintain emergency power, LSC provisions such as generator testing and maintenance will apply and the facility may be subject to LSC surveys to ensure compliance is met.”

However, a caution is in order here.  Although CMS is the ultimate AHJ for Medicare/Medicaid reimbursement purposes, other AHJs may disagree with the above assertion that portable generators “should be” but do not need to be tested in accordance with established codes and standards.  Regardless of an AHJ’s position, in this writer’s opinion a portable generator that is not regularly tested to the NFPA 110 requirements is less likely to operate reliably when and for the duration it is needed to operate.

CMS suggests that the feasibility of alternative energy sources be considered on PDF page 23:

“Facilities are encouraged to confer with local health department and emergency management officials, as well as and [sic] healthcare coalitions, where available, to determine the types and duration of energy sources that could be available to assist them in providing care to their patient population during an emergency. As part of the risk assessment planning, facilities should determine the feasibility of relying on these sources and plan accordingly.”

The CMS S&C 17-29-ALL Interpretive Guidelines suggest that surveyors verify that there are adequate:

  • Policies and procedures for the provision of subsistence needs including, but not limited to, food, water and pharmaceutical supplies for patients and staff by reviewing the plan.
  • Policies and procedures to ensure adequate alternate energy sources necessary to maintain:
    • Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions;
    • Emergency lighting; and,
    • Fire detection, extinguishing, and alarm systems.
  • Policies and procedures to provide for sewage and waste disposal.

The CMS S&C 17-29-ALL Interpretive Guidelines also appear to go beyond the requirements of NFPA 101-2012 and NFPA 99-2012 in the below-listed three types of facilities with overnight sleeping accommodations by stating the following excerpts from PDF pages 67 and 68:

“Therefore, EES in Hospitals, CAHs and LTC facilities should include consideration for design to accommodate any additional electrical loads the facility determines to be necessary to meet all subsistence needs required by emergency preparedness plans, policies and procedures, unless the facility’s emergency plans, policies and procedures required under paragraph (a) and paragraph (b)(1)(i) and (ii) of this section determine that the hospital, CAH or LTC facility will relocate patients internally or evacuate in the event of an emergency.”

“Facilities may plan to evacuate all patients, or choose to relocate internally only patients located in certain locations of the facility based on the ability to meet emergency power requirements in certain locations. For example, a hospital that has the ability to maintain temperature requirements in 50 percent of the inpatient locations during a power outage, may develop an emergency plan that includes bringing in alternate power, heating and/or cooling capabilities, and the partial relocation or evacuation of patients during a power outage instead of installing additional power sources to maintain temperatures in all inpatient locations.”

“NFPA 110 requires emergency power supply systems to be permanently attached, therefore portable and mobile generators would not be permitted as an option to provide or supplement emergency power to Hospitals, CAHs or LTC facilities”

The above requirements have raised numerous questions by the affected facilities.  In response to those and other questions, CMS has issued five sets of Frequently Asked Questions (FAQs) and answers to date.

Within the third round of FAQs [CMS S&C 17-21-ALL (FAQ-3) dated 6/1/17, which can be found at the CMS EPFR webpage, is the following question and clarification:

Q: The regulation states: (ii) Alternate sources of energy to maintain the following:  (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extinguishing, and alarm systems.  (D) Sewage and waste disposal. What is meant by “provisions” in (ii)(a)?

A: 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).

Within the second round of FAQs [CMS S&C 17-21-ALL (FAQ-2) dated 3/2/17], which can also be found at the CMS EPFR webpage, is the following question and clarification:

Q: Can you explain the difference between the [Emergency and Standby Power Systems] requirement and the requirement to have policies and procedures for alternate sources of energy  … ?

A: The “emergency and standby power systems” requirement only applies to hospitals, CAHs and LTC …. 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 …) 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.

Also within that second round of FAQs [CMS S&C 17-21-ALL (FAQ-2) dated 3/2/17], are the following general inquiry questions and clarification:

Q: General inquiry on generator: Does the generator have to be able to power up AC/Heat.

Can you please clarify for me, is that a requirement with the final rule?

A: 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.

Also within that second round of FAQs [CMS S&C 17-21-ALL (FAQ-2) dated 3/2/17], are the following general inquiry questions and clarification:

Q: Does the requirement to maintain temperatures via alternate power (Generators) apply to areas where pharmaceuticals and other temperature limited storage criteria is specified by the manufacturer?

A: 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.

In summary, CMS appears to be requiring a higher degree of analysis regarding the point at which evacuation must be planned than many organizations have previously performed. It appears that the organizations must decide what and where they will meet the stipulated “subsistence requirements” or alternatively what evacuation points will be built into their all hazards emergency planning.

An excellent resource is the HHS Assistant Secretary of Preparedness and Response (ASPR) webpage entitled Technical Resources, Assistance Center and Information Exchange (TRACIE).  Commonly known as ASPR TRACIE it houses more than 1,000 resources.

NFPA Disclaimer: Although the writer is a voting member of (and was the 10-year Chairman of) the NFPA Technical Committee on Emergency Power Supplies, which is responsible for NFPA 110 and 111, the views and opinions expressed in this article are purely those of the writer and shall not be considered the official position of NFPA or any of its Technical Committees and shall not be considered to be, nor be relied upon as, a Formal Interpretation. Readers are encouraged to refer to the entire text of all referenced documents.  NFPA members can obtain NFPA staff interpretations at www.nfpa.org.

The above content was excerpted from a portion of the writer’s presentation at the 54th ASHE annual conference, August 2017, Indianapolis, IN.  You may contact the writer at DStymiest@ssr-inc.com if you have questions on this content.

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