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:

http://www.ashe.org/covid19resourcescovid19resources

https://www.ashe.org/COVID19resources?utm_source=General%20Announcements&utm_medium=email&utm_campaign=COVID%2D19%20Resource%20Roundup

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.

Fire/Smoke Damper Drawings

Q: A California Life Safety Code surveyor enforcing the 2012 edition of the LSC asked for a map of all of the smoke and fire dampers in the building (skilled nursing home) and threatened a deficiency if one could not be produced. I have been searching for the 2012 LSC and cannot find any such reference to this specific requirement. I have not heard of this before. Can you shed any light on this matter?

A: Yes, I can understand the surveyor’s request, although threatening you with a citation seems a bit much.

The surveyor’s position is: How can you effectively maintain all of your fire/smoke dampers if you do not know where they are located? Having them documented on a drawing is logical in that you can then properly maintain the dampers. Without having them documented on a drawing, the chance is great that you would miss one or more dampers and they would not be tested.

But, to be sure, there is no standard that requires you to have drawings showing the locations of all fire/smoke dampers. But if you provide a test report that says you tested 25 dampers, how do you know where these 25 dampers are located, and you don’t have more than 25, and you got them all tested? I can see the surveyor could cite you with a finding that would read something like this: “The organization failed to provide evidence that all fire and smoke dampers were properly tested.”

But I don’t approve of surveyors making threats… that is just unprofessional.

Why ambulatory surgery centers need a compliance plan

According to the National Health Care Anti-Fraud Association (NHCAA), healthcare fraud financial losses are in the tens of billions of dollars each year. A conservative estimate is 3% of total health care expenditures, while some government and law enforcement agencies place the loss as high as 10% of our annual health outlay, which could mean more than $300 billion1.

Beginning in the mid-1990s, many healthcare providers were encouraged to develop and implement compliance plans. While many hospitals and large healthcare systems followed this guidance, many ambulatory surgery centers did not. As a result, those centers may unknowingly be at risk.

But the good news is that it’s never too late to implement a compliance plan. It doesn’t have to be expensive or time-consuming; in fact, there are simple and inexpensive steps that facilities can take to promote compliance and develop strategies2 that will keep your organization safe in the long run.

Choose who will develop the plan.

There are to options for establishing your plan: you can hire a consultant, like Compliance One Group, to develop it for you or you can prepare one yourself. The latter may be appropriate for smaller ASCs that have tighter operating budgets. If you choose to develop the plan yourself, you then have a couple of options: buying a ready-made, off-the-shelf product or starting from scratch. While a pre-developed plan may seem like a good idea at the time, keep in mind that your plan needs to be customized for your facility. Filling in the blanks of an off-the-shelf product will not be effective. 

Perform a facility audit. 

When it comes to audits, there are two that should be conducted: a standards and procedures audit to assess how well you are complying with regulatory requirements and a claims submission audit to examine the claims development and submission process from patient intake through to submission and payment of claims. 

However, these audits are not one-and-done; ASCs should re-audit annually to measure the success of the plan.

Write the plan.

Once you have performed your audits and have a thorough understanding of what your problem areas are, you can begin establishing your compliance plan. 

A standard compliance plan includes:

  • Overview of applicable federal and state laws
  • Duties and responsibilities of the Chief Compliance Officer
  • Acknowledgment form, signed by each owner and employee
  • Code of Conduct, applicable to owners, board members, and employees
  • Corporate compliance checklist
  • HIPAA compliance plan

If you would like to discuss how our team can assist you with effective compliance planning, leave me a message by clicking here.


Resources:

1 https://www.nhcaa.org/resources/health-care-anti-fraud-resources/the-challenge-of-health-care-fraud/

2 http://www.outpatientsurgery.net/issues/2002/05/why-ascs-need-a-compliance-plan

Aerosol Can Storage

Q: Housekeeping products like germicidal, glass cleaner, air freshener are stored in a locked metal box on housekeeping cart. All of our stock of these and other products are stored in two large locked metal lockers. They are not fire rated cabinets. The surveyor said aerosols all have to be stored in fire rated cabinets. While they are in use while on housekeeping carts, they will have to be checked in and out daily from a fire cabinet.

The surveyor did not cite a tag or code for this he just told us we had to do it. I have searched and so much is left to interpretation I am confused on what to do. With all the changes occurring and more to come with state regulations and inspections I would like to be prepared.

A: It is safe to say that there is no NFPA standard, no CMS standard, and no accreditation standard that specifically says aerosol cans must be stored in a fire rated cabinet. However, if access to these aerosol products by unauthorized individuals is a safety risk (i.e. can children get into them) then it may be perceived as an unsafe environment and the surveyor would have a legitimate concern about them.

I suggest you go back to the surveyor and ask them why they believe the aerosol products have to be stored in a fire-rated cabinet. Ask for a specific code, standard, or regulation that they are using to make this recommendation.

Otherwise… it’s not a code violation, but a surveyor’s preference.

Direct Visual Observation Required in Emergency Department

Q: If an Emergency Department is greater than 7500 square feet but less than 10,000 square feet and is deemed to have “sleeping accommodations”, do the requirements of direct visual observation per 19.2.5.7.2.1(D)(1)(a) apply since only “sleeping accommodations” are provided and not a full “patient sleeping room”?

A: According to CMS, the answer is yes. They consider an Emergency Department that provides observation beds to be sleeping accommodations and must comply with healthcare occupancy sleeping suite requirements, and all that is required. They also consider the patient as ‘inpatients’, which seems to be contrary to the what the rest of the world believes.

See if you can do one of the following:

  • Eliminate the ‘observation beds’
  • Relocate those ‘observation beds’ to a regular inpatient unit
  • Divide your ED up into multiple suites to get around the direct observation requirement for sleeping suites over 7500 square feet.

Corridor Doors

Q: A deficiency was found by CMS on a recent survey that stated ‘staff failed to provide a safe and hazard free environment by not having all doors protecting corridor openings ready to close without impediments’. The finding was repeated three separate times as doors to a patient room could not be closed due to obstructions/impediments. In all three instances, the rooms were vacant, being used for storage, and had either a chair or waste basket blocking the door. Although we have regularly explained away this finding with Joint Commission surveyors as being an item we train our staff on (to move obstructions in patient room doorways in case of fire while closing all doors as directed by our fire plan) the CMS surveyor listed it as a deficiency and was not satisfied with our answer. Does this seem like a reasonable action to you? The rooms were vacant, and there were no patients in the rooms! Why would the CMS surveyor care if the doors closed or not? Do I have to attempt a zero-tolerance approach to this deficiency for all patient room doors (which would seem to be futile) or just enforce the regulation for vacant rooms only?

A: Corridor doors must close and latch at all times in the event of an emergency. Even corridor doors to vacant patient rooms used for storage. I believe by what you have described, that the CMS surveyor was correct and justified in citing any corridor door that could not close. If there was an impediment blocking the door, such as a chair or a waste receptacle preventing the door from closing, then that is a deficiency.

Here is the reason why… In an emergency, staff must quickly go through the unit and check rooms and close doors. If there is an impediment to quickly closing the doors, and the staff had to move a chair or a waste receptacle, then that slows down the process. The concept of the corridor door is to separate the room from smoke and fire in either the corridor, or the room. If an impediment prevents the door from closing, then smoke and fire can enter the patient room and then the patient is in serious trouble.

You must enforce maintaining the corridor doors free from impediments to close them throughout your entire hospital, on units that are occupied and units that are not. I do not agree with your comment that seeking a zero-tolerance on this issue would seem futile. On the contrary, nurses have a very keen respect for patient safety, and if you explain keeping corridor doors free of impediments is patient safety, then I’m sure they will buy into that and keep the doors clear.

I’m a bit concerned that you are using vacant patient rooms for storage. Be VERY careful with that. If there are any combustibles stored in those patient rooms, you have a big problem. The room would have to comply with section 43.7.1.2 (2) of the 2012 LSC on hazardous rooms. I would suggest you do not store any combustibles in vacant patient rooms.

ILSM in Business Occupancies

Q: Is there a code requirement for implementing an Interim Life Safety Measure (ILSM) for occupancies other than healthcare (i.e. business occupancies) if a life safety code deficiency has been identified?

A: Yes… ILSM (also known as Alternative Life Safety Measures) is found in chapter 4 of the 2012 Life Safety Code, specifically section 4.6.10.1 of the 2012 LSC. This describes the need to implement ALSMs when features of Life Safety are impaired. This chapter is part of the ‘core’ chapters and applies to all occupancy chapters, so that means it applies to business occupancies as well.

Most accreditation organizations should be enforcing this in offsite locations, such as business occupancies. Some surveyors fail to ask for this, but it is an enforceable requirement.

Access To Electrical Rooms

Q: Please clarify if electrical closets and /or electrical rooms can be accessible to anyone. The NFPA70 National Electrical Code seems to require warning signs limiting access to authorized personnel only.

A: For many years there has not been any specific standard that says access to electrical control panels has to be restricted to authorized individuals only. But with the new NFPA 99-2012, section 6.3.2.2.1.3 now says access to over-current protective devices (i.e. circuit breakers) serving Category 1 or Category 2 rooms is restricted to authorized individuals only. This standard actually only applies to new construction.

But be aware that for many years accreditation organization have cited healthcare facilities for not securing their circuit breaker panels from unauthorized access, and they base this on their “Safe Environment” standard, or as some people call it the ‘General Duty’ clause.

So, it has been enforced for years by accreditation organizations, and by some state agencies, while there has not been an actual standard that required securing the panels. So, I would suggest you do secure all electrical rooms from unauthorized access.

ASC Waiting Area

Q: I am looking at a hospital facility with an Ambulatory Surgery Center in an existing building that is a Business Occupancy and construction type – II (222). We are working to separate the Ambulatory Surgery Center from the other business in the building with a two-hour fire rated partition. The waiting area, which is adjacent to the lobby/elevator area is enclosed by glass. Can we leave the waiting area out of the Ambulatory Surgery Center and make the separation behind the waiting area? This would be just separating the Ambulatory Surgery rooms and recovery area from the rest of the building (i.e. enclosed by a two-hour fire-rated wall).

A: No… I believe you are not permitted to do that. Actually, the LSC does not address this, but the CMS Conditions for Coverage (CfC) does address this. According to CMS Conditions for Coverage §416.44(a)(2), the ASC must have a separate recovery room and waiting area.

The Interpretive Guidelines for §416.44(a)(2) says this about waiting rooms:

The ASC is required to have both a waiting area and a recovery room, which must be separate from each other as well as other parts of the ASC. They may not be shared with another healthcare facility or physician office. (See the interpretive guidelines for §416.2 concerning sharing of physical space by an ASC and another entity.)

While the CfC does not specially say the waiting area must be inside the fire-barriers surrounding the ASC, if the waiting area was outside of these boundaries the surveyors could conclude that the waiting area is shared with other another healthcare facility or physician office.

I suggest you make sure the waiting area is inside the fire-rated barrier separating the ASC from the other entities.

Triennial Surveys by Accreditation Organizations

Q: I heard a rumor that the accreditation organizations (AO) are going to 18 month visits vs. the 3 years it has been. Is there truth to this?

A: No… None of the AOs are going to an 18-month cycle for survey. They all will be staying at the 36-month cycle, which is allocated by CMS. They would have to double the number of surveyors which would be an added cost to the healthcare facilities that are accredited by them.

There is one accreditation organization (DNV-GL) that does visit their client hospital every year, but they still only survey on behalf of CMS every 3 years. The other two annual visits that DNV performs is a requirement of their ISO process, and they use those visits as educational visits. DNV’s process is very well received and annual visits are appreciated by their client hospitals.