CMS 1135 Waiver – Suspending Tests, Inspections, and Drills

During this period of COVID-19 crisis, many readers have written asking if they can discontinue conducting routine Life Safety tests and inspections in order to limit service technicians from entering the building and to suspend fire drills to allow staff to focus on patient care and the pandemic emergency. The response from this website has been consistent and focused on the CMS Condition of Participation (Condition for Coverage for Ambulatory Surgical Centers) that regulates nearly all of the non-government healthcare facilities: Until such time CMS (or your accreditation organization) makes an announcement regarding changes in required tests, inspections, and drills, the answer is no, you may not. You still have to conduct all of the required tests, inspections, and drills that are required in the Life Safety Code.

But there is a glimmer of hope on this subject. When CMS issued its Final Rule on Emergency Preparedness on September 16, 2016, they explained that there is available for healthcare providers an 1135 waiver process that allows the healthcare organization to not have to meet certain CMS standards during a declared emergency. What is unclear, if the 1135 waiver process applies to the testing, inspecting and fire drill requirements.

Accreditation organizations, member organizations, and this website have written CMS asking them if the 1135 waiver process would apply to the required testing, inspection and fire drills found in the Life Safety Code. So far, CMS has not replied to any of those who have inquired.

But the American Society for Health Care Engineering (ASHE) issued a communication to its members on Friday, April 3, 2020, providing instructions on using a template for a letter that you can send to the appropriate CMS Regional Office asking for specific 1135 Waiver exemptions on testing, inspections, and fire drill requirements. While this 1135 Waiver letter can only help the situation, it is important to understand that as of today, CMS has not indicated that suspension of testing, inspection, and fire drills is permitted under the 1135 Waiver request.

With the approval from ASHE, we are providing a couple of link connections to their webpage that explains the 1135 Waiver process and the template letter:

We repeat ASHE’s introductory paragraph for this 1135 Waiver in case you missed this important information:

Health care facilities can access a templated letter and table to request a waiver under Section 1135 of the Social Security Act. The waiver will allow facilities to delay inspection, testing, maintenance and certain drills required by the Centers for Medicare & Medicaid Services. The letter must be modified to include the health care organization’s information. The table, which should be submitted with the letter, gives guidance on how requirements should be modified during the COVID-19 emergency. Waivers help to limit non-essential persons from entering health facilities and risking exposure, while also allowing health care staff to focus on patients.

Decontamination Activation

Q: Is there a specific time-limit required by the accreditation organizations for decontamination purposes, from activation of a drill to being able to put victims through a decontamination tent?

A: While there is no specific standard which spells out the amount of time required to set-up a decontamination tent, the time-frame must be evaluated to determine its effectiveness.

The emergency management standards require an effective disaster plan which must be written and educated to the staff of the organization. These same standards require disaster drills that are evaluated by observers for effectiveness. The results of the drill observations must be relayed to the Safety Team which uses the information to improve the hospital’s capacity to respond to disasters. The whole disaster response process includes an on-going evaluation to determine the effectiveness of the organization’s emergency response efforts.

So, while the amount of time to set-up a decontamination tent and run your first patient through is not specified, the catch-all is it must be effective. You may ask who judges whether or not the amount of time is effective? First, the hospital makes that determination but ultimately, the surveyor may make a judgment on that as well. If a surveyor decides that the amount of time to set-up a decontamination tent is too long, then that can lead to a finding.

The bottom line: Run a disaster drill which includes setting up the decontamination tent, and make an evaluation of the time it took from the start of the drill to when a patient can first use the tent. Report that process to your safety committee, and have them decide if it is an adequate amount of time. If the safety committee decides it is adequate, then there is a good chance the surveyor will view it the same.

Comments and Observations in the CMS EM Final Rule – Part 1

I have started to review the new CMS Final Rule on Emergency Preparedness. Here are some of the highlights, along with my comments…

Comments and Observations in the CMS EM Final Rule

1) CMS says there are three key essential requirements for maintaining access to healthcare services during emergencies:

  • Safeguarding human resources
  • Maintaining business continuity
  • Protecting physical resources

2) CMS has identified four core elements that are central to emergency preparedness program:

  • Risk assessment and emergency planning: CMS requires all facilities to perform a risk assessment that uses an “all hazards” approach prior to establishing an emergency plan. (NOTE: This is the HVA currently required)
  • Policies and procedures: CMS requires the facility to develop and implement policies and procedures that support the execution of the emergency plan.
  • Communication plan: CMS is requiring the facility to develop and maintain an emergency preparedness communication plan.
  • Training and testing: CMS is requiring the facility to develop and maintain an emergency preparedness training and testing program. (NOTE: This applies to all staff and must include annual refresher training).

3) CMS states in their Final Rule that “Currently, in the event of a disaster, healthcare facilities across the nation will not have the necessary planning and preparation in place to adequately protect the health and safety of the patients. In addition, we believe that the current regulatory patchwork of federal, state, and local laws and guidelines, combined with various accrediting organizations’ emergency preparedness standards, falls short of what is needed for healthcare facilities to be adequately prepared for a disaster.” (OUCH! CMS is saying The Joint Commission’s EM standards and HFAP’s EM standards are inadequate and ‘falls short’ for healthcare facilities to be adequately prepared for a disaster. I don’t agree with that comment.)

4) CMS defines an “emergency” or a “disaster” as an event that can affect the facility internally as well as the overall target population or the community at large. Emergencies can be internal, man-made, or natural events, and can be small or large events.

5) CMS states that their new emergency preparedness requirements focus on continuity of operations, not recovery of operations. Facilities may choose to include recovery of operations planning in their emergency preparedness plan, but they have not made recovery of operations planning a requirement.

6) CMS states facilities are required to track the location of patients and staff in the facility’s care during the emergency.

7) CMS says individual physicians are not required, but are encouraged, to develop and maintain emergency preparedness plans. In addition, physicians that are employed by the facility and all new and existing staff must participate in emergency preparedness training and testing. CMS has not mandated a specific role for physicians during an emergency or disaster event, but they expect facilities to delineate responsibilities for all of their facility’s workers in the emergency preparedness plans and to determine the appropriate level of training for each professional role.

8) Based on a response they received during the public comment period, CMS has changed their proposed rule to allow integrated health systems to have a coordinated emergency preparedness program. CMS revised their proposed requirements by adding a separate standard to the CoPs and CfCs. This separate standard will allow any separately certified healthcare facility that operates within a healthcare system to elect to be a part of the healthcare system’s unified emergency preparedness program.


CMS Announces New Rule on Emergency Management

Well… here it is. CMS has announced that they will publish their Final Rule on the new standards for Emergency Management. It appears the new rule will not be published in the Federal Register until September 16, 2016, which is a week away, but take time now to read their press release below… and start learning all the changes you will need to know.

According to the press release, the new rule becomes effective 60 days after it is published in the Federal Register, which would be November 15, 2016. But it also says the new requirements will not be enforced until November, 2017, so the healthcare organizations and the AOs have a year to get ready for these changes.

CMS News


Contact: CMS Media Relations (202) 690-6145 | CMS Media Inquiries

CMS finalizes rule to bolster emergency preparedness of certain facilities participating in Medicare and Medicaid

Today, the Centers for Medicare & Medicaid Services (CMS) finalized a rule to establish consistent emergency preparedness requirements for health care providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters.

Over the past several years, and most recently in Louisiana, a number of natural and man-made disasters have put the health and safety of Medicare and Medicaid beneficiaries – and the public at large – at risk. These new requirements will require certain participating providers and suppliers to plan for disasters and coordinate with federal, state tribal, regional, and local emergency preparedness systems to ensure that facilities are adequately prepared to meet the needs of their patients during disasters and emergency situations.

“Situations like the recent flooding in Baton Rouge, Louisiana, remind us that in the event of an emergency, the first priority of health care providers and suppliers is to protect the health and safety of their patients,” said CMS Deputy Administrator and Chief Medical Officer Patrick Conway, M.D., MSc. “Preparation, planning, and one comprehensive approach for emergency preparedness is key. One life lost is one too many.”

“As people with medical needs are cared for in increasingly diverse settings, disaster preparedness is not only a responsibility of hospitals, but of many other providers and suppliers of healthcare services. Whether it’s trauma care or long-term nursing care or a home health service, patients’ needs for health care don’t stop when disasters strike; in fact their needs often increase  in the immediate aftermath of a disaster,” said Dr. Nicole Lurie, HHS assistant secretary for preparedness and response. “All parts of the healthcare system must be able to keep providing care through a disaster, both to save lives and to ensure that people can continue to function in their usual setting. Disasters tend to stress the entire health care system, and that’s not good for anyone.”

After reviewing the current Medicare emergency preparedness regulations for both providers and suppliers, CMS found that regulatory requirements were not comprehensive enough to address the complexities of emergency preparedness. For example, the requirements did not address the need for: (1) communication to coordinate with other systems of care within cities or states; (2) contingency planning; and (3) training of personnel. CMS proposed policies to address these gaps in the proposed rule, which was open to stakeholder comments.

After careful consideration of stakeholder comments on the proposed rule, this final rule requires Medicare and Medicaid participating providers and suppliers to meet the following four common and well known industry best practice standards.

1. Emergency plan: Based on a risk assessment, develop an emergency plan using an all-hazards approach focusing on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters specific to the location of a provider or supplier.

2. Policies and procedures: Develop and implement policies and procedures based on the plan and risk assessment.

3. Communication plan: Develop and maintain a communication plan that complies with both Federal and State law. Patient care must be well-coordinated within the facility, across health care providers, and with State and local public health departments and emergency systems.

4. Training and testing program: Develop and maintain training and testing programs, including initial and annual trainings, and conduct drills and exercises or participate in an actual incident that tests the plan.

These standards are adjusted to reflect the characteristics of each type of provider and supplier. For example:

  • Outpatient providers and suppliers such as Ambulatory Surgical Centers and End-Stage Renal Disease Facilities will not be required to have policies and procedures for provision of subsistence needs.
  • Hospitals, Critical Access Hospitals, and Long Term Care facilities will be required to install and maintain emergency and standby power systems based on their emergency plan.

In response to comments, CMS made changes in several areas of the final rule, including removing the requirement for additional hours of generator testing, flexibility to choose the type of exercise a facility conducts for its second annual testing requirement, and allowing a separately certified facility within a healthcare system to take part in the system’s unified emergency preparedness program.

The final rule also includes a number of local and national resources related to emergency preparedness, including helpful reports, toolkits, and samples. Additionally, health care providers and suppliers can choose to participate in their local healthcare coalitions, which provide an opportunity to share resources and expertise in developing an emergency plan and also can provide support during an emergency.

These regulations are effective 60 days after publication in the Federal Register. Health care providers and suppliers affected by this rule must comply and implement all regulations one year after the effective date.

For more information please see a blog by Dr. Lurie, HHS assistant secretary for preparedness and response, and the CMS Survey & Certification – Emergency Preparedness webpage.


Emergency Showers

imagesRFIMRIFGEmergency showers are often found in hospital laboratories and at times, in plant operation areas. There seems to be some confusion about emergency showers and eyewash stations, and what is acceptable to the accreditation organizations. To be sure, there are no standards that are being enforced by a national authority over hospitals that are specific to emergency showers and eyewash stations. Even OSHA does not rigidly enforce a specific set of rules concerning these emergency first-aid devices, although they do refer to ANSI Z358.1-2009 as a guide.

George Mills, director of engineering for The Joint Commission recently commented during a meeting of hospital engineers that they (Joint Commission) do not rigidly enforce the guidelines in ANSI Z358.1-2009. Joint Commission only requires a monthly water-flow test for an unspecified amount of time, and then it appeared to only apply to eyewash stations.

A lot has been written about eyewash stations (search: eyewash), but not so much for emergency showers. What should a hospital do in regards to testing and inspecting an emergency shower? In order to be prepared for any inspection by an authority who may enforce the full requirements of ANSI Z358.1-2009, here are the basics concerning emergency showers:

There are two types of Emergency Showers:

  • Plumbed Shower:      An emergency shower permanently connected to a source of potable water
  • Self-Contained Shower:      A shower that contains its own flushing fluid, and must be refilled or      replaced after use

 The specifications below are for plumbed showers only.

  • Heads
    • Positioned 82″-96″ from floor
    • Spray pattern will have a minimum diameter of 20″ at 60″ above the floor
    • Flow Rate equals 20 gallons per minute (GPM) at 30 pounds per square inch (PSI)
    • The center of the spray pattern shall be located at least 16 inches from any obstruction
  • Valves
    • Activate in one second or less
    • Stay-open valve (no use of hands)
    • Valve remains on until the user shuts it off
  • Installation
    • Emergency Shower shall be located in an area that requires no more than ten seconds to reach.
    • Shower location shall be in a well-lit area and identified with a sign
    • Shower shall be located on the same level as the hazard
  • Maintenance and Training
    • Plumbed emergency showers will be activated weekly to verify correct operation
    • All employees who might be exposed to a chemical splash shall be trained in the use of the equipment
    • All showers shall be inspected annually to make sure they meet with ANSI Z358.1 requirements

Emergency Response Plan

Q: We are going to prepare an action card for fire safety as part of our major emergency response plan. What information regarding fire safety would you suggest we include on the Emergency Response job action card?

A: Emergency response preparedness (i.e. Emergency Preparedness) involves many different aspects, including fire safety. In order to write a job action sheet (or job action card) for fire safety, I would suggest that you utilize your basic fire response plan for the internal portion of emergency preparedness. Many hospitals utilize the familiar acronym RACE to help remind their staff as to the organization’s fire response plan:

  • R = Rescue anyone in harm’s way of the fire
  • A = Activate the alarm by pulling the manual fire alarm station and dialing______
  • C = Contain the fire by closing all the doors
  • E = Extinguish the fire with portable extinguishers, OR Evacuate patients from the scene of the fire

For external fires, a job action sheet may include some (or all) of the following:

  • Shutting down all of the fresh-air intakes for the hospital’s ventilation system.
  • Placing boards on windows
  • Taking pro-active action and wetting-down combustible portions of the facilities or grounds
  • Possible relocating patients from one wing or area to another
  • Emptying parking lots and garages which are close to the hospital
  • Possible evacuation of hospital
  • Re-directing traffic away from the hospital
  • Controlling access to the Emergency Department
  • Suspending shift change and proceeding to a 12 hour on/12 hour off rotation

CMS Issues New Proposed Rule on Disaster Preparedness

CMS Logo 2The Centers for Medicare & Medicaid Services (CMS) has issued a new proposed rule in the Federal Register on Friday, December 27, 2013. This is a Notice of Proposed Rulemaking and is not a Final Rule. CMS is soliciting comments on this proposed rule concerning healthcare facility disaster preparedness, and the general public has 60 days to respond.

Being a Federal Agency, CMS must follow the Administrative Procedure Act of 1946 whenever they want to add, remove or change a rule or regulation, and they must issue a public notice in the Federal Register that they are proposing a new rule. Then there is a 60-day window for the public to respond with comments to the proposed rule. After the 60-day window is over, CMS will take the time to review the comments made and will respond to them when they issue a final rule, in about 6 months or so (my guess of time- not theirs). The changes that CMS is proposing are to the respective Conditions of Participation or Conditions for Coverage to 17 different sets of rules (or laws) for healthcare organizations.

I have started an initial review of the proposed rule and I like what I see. CMS  identified four core elements that they believe are central to an effective emergency preparedness system and must be addressed by healthcare organizations to offer a more comprehensive framework of emergency preparedness requirements for the various Medicare- and Medicaid-participating providers and suppliers. The four elements are—(1) risk assessment and planning; (2) policies and procedures; (3) communication; and (4) training and testing.

CMS admits that they took into consideration the existing standards and regulation of national agencies, such as The Joint Commission and AOA/HFAP. The current CMS Conditions of Participation (CoP) for acute care hospitals are light on specific requirements for emergency management, and most experts agree that The Joint Commission Emergency Management chapter provided better guidance for healthcare facilities than any other standard.

Below is the link to the proposed disaster preparedness rule that was published today.

I encourage you to review the proposed new rule and if you have a comment, please follow the directions and submit it to the CMS. They will appreciate your insight and considerations.

After you have reviewed the proposed new rule, please let me know what you think of it.