CMS Waiver Approval

Q: If a building changes ownership, do waivers stay active with their 1-year window or do the new owners have to resubmit if the building is cited the same deficiency?

A: Interesting question… I’ve never had this issue come up before.

My guess would be the waivers would be valid only to the organization for which they were approved. The way that CMS writes their approval letters is the approval of the waiver is addressed to the healthcare organization, and not to the building owner. In other words, CMS grants approval to the healthcare organization to not have to comply with a particular section of the Life Safety Code. This approval would not appear to be transferrable, since it is addressed to the healthcare organization.

But if the ownership of the healthcare organization changes hands, then I could see where the waiver approval would follow the healthcare organization. CMS tracks the waiver requests and the subsequent approvals via their own CMS Certification Number (CCN), which is assigned to healthcare organizations, not their owners.

To answer your question, if a deficiency is cited and the healthcare organization chooses to submit a waiver request rather than resolve the deficiency, then yes, a new waiver request would have to be submitted.

 

AEM Program for Fire Alarm and Sprinklers

Q: Are sprinklers, smoke detectors, etc. considered to be operating components of the utility systems? If so, our inspections are based on the pertinent NFPA references. I think that the fire system inspections could be considered preventive maintenance or at least the means to determine what maintenance needs to be completed. Can we use the CMS AEM program to alter our PM activities on the fire alarm and sprinkler systems?

A: You cannot use the CMS AEM program for Fire Alarm inspection and testing requirements. The CMS S&C letter 14-07 that describes the AEM program says the following regarding when the AEM program is not appropriate: “Other CoPs require adherence to manufacturer’s recommendations and/or set specific standards. For example: The National Fire Protection Association Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance, and compliance with these requirements are assessed on Federal surveys.”

So… you must follow the NFPA requirements specified for sprinkler and fire alarm testing and inspection, and the AEM program is not applicable.

Power Strips

Q: There is so much discussion on the proper use of power strips that it can cause confusion amongst even the seasoned facility managers. There is absolutely no guarantee that the different power strips will remain in their ‘designated areas’. The OR is much easier to control, but as technology quickly progresses, the space between patient care vicinities and non-patient care vicinities quickly losing the defined lines. What’s your thoughts on the power strip issue?

A: I do see your point that power strips may be difficult to control as they may move around the hospital, in and out of patient care vicinities. And I respect your comment that there is confusion on the proper use of power strips. But I find CMS’ explanation regarding power strips under their K-Tag 920 to be refreshingly simple:

  • Power strips in a patient care vicinity are only used on movable patient-care related electrical equipment and are permanently attached to the equipment, and are UL 1363A or UL 60601-1.
  • Power strips in a patient care vicinity may not be used for non-patient-care related electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient-care related electrical equipment.
  • Power strips for patient-care related electrical equipment must meet UL 1363A or UL 60601-1.
  • Power strips for non-patient-care related electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
  • In non-patient care rooms, power strips meet other UL standards.

Section 3.3.139 defines “patient care vicinity” as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor.

It appears K-Tag 920 is permitting qualified personnel to permanently attach UL 1363A or UL 60601-1 power strips to movable patient-care related electrical equipment, provided it meets section 10.2.3.6 of NFPA 99-2012, which is:

  • The power strip is permanently attached to the equipment assembly;
  • The sum of the ampacity of all appliances connected to the outlets does not exceed 75% of the ampacity of the flexible cord supplying the outlets;
  • The ampacity of the flexible cord is in accordance with NFPA 70-2011, National Electrical Code.
  • The electrical and mechanical integrity of the assembly is regularly verified and documented.

This section does not explain what makes one “qualified”, so that determination should be left to the AHJ and the healthcare facility. While NFPA 99-2012 does not specify how frequent “regularly verified” means, the general consensus is annually, based on annual receptacle inspection requirements in Chapter 6.

You will note that section 10.2.3.6. (5) was deleted per Tentative Interim Amendment (TIA) 12-5.

K-Tag 920 is also clear that outside of a non-patient care room (i.e. OR, PACU, procedure room, patient sleeping room, etc.) CMS no longer regulates which UL power strip to use on non-patient-care related electrical equipment, other than it must be UL listed. That means a power strip used at a nurse station on office equipment, or in an office environment does not have to be UL 1363, UL 1363A, or UL 60601-1; it just has to be UL listed.

Contractors During a Survey

In preparation for a survey hospitals frequently train their staff to only answer the questions of the surveyors without providing any more information. This has proven to be good advice over the years because many deficiencies are discovered by surveyors based on information provided by the staff after they have answered the surveyor’s questions.

An example of this may be when a surveyor asks a hospital worker what they would do in the event of a fire, and the worker correctly replies by describing the actions suggested by the acronym RACE – Rescue, Alarm, Confine, and Extinguish (or Evacuate). But when the surveyor simply does not respond and the awkward silence builds, the hospital worker gets a bit nervous and continues to speak, eventually revealing some errant activity that is not part of the fire safety plan. That often opens the door for disaster.

Nowhere is this more dangerous than when surveyors are permitted to talk with contractors in the hospital. It has always been my belief that as the survey team walks in the front door of the hospital on the first day of the survey all of the contractors should be walking out the back door. For the most part (and I do understand that there are exceptions), contractors should be sent away once you know there are surveyors in the house. Why? Because they will get you in trouble one way or another.

I recently received an email from a reader who shared this story:

During our triennial survey the life safety surveyor asked me how we knew that the fire alarm system signal was received by our monitoring company. I could not immediately answer the question, but we were lucky to have the service contractor in the building doing his quarterly testing and I suggested we ask him.

 The service technician explained that the software in the fire alarm control system will indicate if the alarm is received by the monitoring company within the designated amount of time. I was quite happy with the service technician’s explanation until the surveyor said “Prove that it happened at least quarterly for the past 12 months”. [This was back when the signal was required to be tested quarterly… today it is only required to be tested annually.]

 The service technician said nobody could prove it; we just have to take his word for it. [Wrong answer.] The surveyor asked “Don’t you call them by telephone to confirm they received the signal?” The service technician replied, saying “Well, would you trust me if I said I did call?”

The surveyor was correct to ask the questions that he/she did. The service technician was probably answering them to the best of his ability, but the real problem is the facility manager allowed the surveyor to enter into a conversation with a contractor. During a survey, the hospital staff should try and control the process as much as possible. By allowing a surveyor to ask questions of a contractor, the facility manager lost control of the situation and will suffer any consequences of what a contractor may say.

Contractors are not trained and educated in the regulatory requirements the same way the hospital staff are (or should be). The contractors may not even know or understand the significance of an accreditation survey, or even a CMS certification survey. Service technicians have a tendency to take an attitude that they know more about the system they are working on than the hospital does, and for the most part they do; otherwise, the hospital would not hire them. But the service technician may not know what specific regulations that the hospital must comply with and therefore may say something to a surveyor that may get you in trouble.

I’m not saying you should not be transparent in your processes, but during a survey, you need to control as much as you can of the survey process. This is not unethical or wrong; it is just smart business. Let the surveyor go where he/she wants; let the surveyor ask questions all they want; but eliminate the potential “loose cannons” that are not very well educated on the survey process by sending them home during the survey.

Another reader sent me an email earlier this year explaining that on a day during the accreditation survey a roofing contractor set a pallet of roofing material right in the middle of the exit discharge of a staff entrance/exit to the hospital. Nobody from the hospital was aware that the roofing contractor was about to do that, but the surveyor noticed it as soon as it happened and it went into the survey deficiency report.

When I was a surveyor for The Joint Commission, I would purposely seek out contractors and ask them what training the hospital provided them on fire safety procedures. Ultimately, contractors are expected to know the same fire response procedures as the staff. Invariably they could not answer the question satisfactory and it would be cited in the survey deficiency report.

I know that in some situations you cannot send the contractors home for the duration of the survey, but it seems that a large percentage of them could. At the hospital where I worked as the Safety Officer, I asked the project management team to send the contractors away during the week of the survey (this was when the surveys were announced). The project managers thought that was a good idea, but we were over-ruled by the COO of the hospital, because he did not want the opening of the new renovated unit to be delayed. That ended up being a costly mistake.

The hospital had a policy that every contractor had to receive basic safety orientation before they begin their work on the campus of the organization. Unbeknownst to the hospital, the general contractor brought in a sub-contractor to install flooring in one area, and they did not go through the safety training because the general thought it would be “okay” since the sub was only going to be there for one day. Sure enough, the surveyor found that one sub who had not received the safety training which led to a finding on the survey deficiency report.

You need to control what you can, and sending the contractors away is the smart thing to do during a survey.

Waiver and Equivalency Validation

Q: During a recent webinar, the presenter said waivers and equivalencies are only valid until the next triennial survey.   Does that really mean if CMS approved a waiver or an equivalency we need to go through that same process again even if things have not changed in 3yrs and get this reapproved?

A: Yes it does. Once a waiver or equivalency request is approved by CMS, it is only valid until the next survey, regardless if the next survey is the triennial survey by your accreditation organization, or a validation survey by your state agency. At that time, the waiver or equivalency is no longer valid, and the surveyor will inspect the area to determine if the deficiency still exists, and if it does, the deficiency will be cited again. Then the hospital has the choice to either resolve the deficiency or submit a waiver (or equivalency) request again.

According to a statement from CMS, this process of having waivers and equivalencies valid until the next survey is a checks-and-balance system to ensure that the conditions in the hospital that allowed the waiver to be approved in the first place have not changed in the time since the waiver (or equivalency) was granted. It makes sense, in that CMS is ensuring that the conditions are still acceptable for a waiver or an equivalency.

However, the expense of submitting waivers or equivalencies every 3 years may be a real burden to some organizations, and there is no guarantee that CMS will approve a waiver (or equivalency) request for the same deficiency a second time. It is a very subjective process. That is why hospitals need to seriously consider resolving the deficiency instead.

Immediate Jeopardy Decision?

Q: Our hospital has a room that is used for seclusion in a Behavioral Health unit. The door to this room is locked and it does not allow the patient to leave the room; only staff may release the door lock. Is this in any way an Immediate Jeopardy situation?

A: Not necessarily… Section 19.2.2.2.5.1 of the 2012 Life Safety Code allows doors to be locked in the path of egress where the clinical needs of the patients require specialized security measures or where the patients pose a security threat, provided staff can unlock the doors at all times. Clinical needs locks are permitted for use for psychiatric patients, dementia patients, Alzheimer’s patients and substance abuse patients. A seclusion room in a Behavioral Health unit would likely meet the definition for clinical needs locks, provided staff was watching the patient 24 hours/day.

Changes to Smoke Barrier Door Testing

The following article was published in HCPro’s Hospital Safety Insider, on August 3, 2017:

More than three weeks after a well-publicized compliance deadline passed, CMS announced Friday that the deadline would be pushed back nearly six months, giving facilities until New Year’s Day 2018 to comply with an annual testing requirement for certain doors.

David Wright, director of the CMS Survey and Certification Group, made the announcement in a memo to state survey agency directors. He acknowledged that there had been a fair amount of confusion concerning the change, and he offered some pretty consequential clarifications that could affect whether the new requirement applies to your facility at all.

“[C]onsidering the level of reported misunderstanding of this requirement, CMS has extended the compliance date for this requirement by six months,” Wright wrote.

Within the National Fire Protection Association’s (NFPA) 2012 Life Safety Code® (LSC), which CMS adopted last year, there is a requirement that fire doors and smoke barrier doors be tested annually. Officials with CMS had taken the position that the new requirement applies to healthcare occupancies; that position, however, was met with pushback.

A petition objecting to the CMS position was discussed at length in June by members of the NFPA Healthcare Interpretations Task Force (HITF), says Brad Keyes, CHSP, owner of Keyes Life Safety Compliance. That petition objected to the notion that the LSC specifically requires annual inspections of smoke barrier doors in healthcare occupancies.

“The HITF members did discuss the issue and agreed that healthcare occupancies were exempt from complying with section 7.2.1.15.2 … because the healthcare occupancies did not specifically require compliance with that section,” Keyes says in an email.

The committee decided to table its decision on the matter to give CMS an opportunity to review its position, as it did, Keyes says.

“I am pleased that the system worked in favor for the many hospitals that are certified by the Federal agency,” he adds.

Although the LSC does include provisions requiring annual inspections of smoke barrier doors and fire doors alike, section 7.2.1.15.1 states that these standards apply only where required by Chapters 11–43. Since the chapters governing healthcare occupancies make no direct reference to Section 7.2.1.15.1, the door inspection provisions do not apply to healthcare occupancies, Wright acknowledged in his memo.

Based on that conclusion, Wright spells out a few key takeaways:

  1. Fire doors. In healthcare occupancies, all fire door assemblies must be inspected and tested annually in healthcare occupancies, based on section 8.3.3.1 of the 2012 LSC, which applies to all occupancies.
  2. Smoke barrier doors. Non-rated doors (including smoke barrier doors and corridor doors to patient care rooms) aren’t subject to the annual inspection and testing requirements, but they “should be routinely inspected as part of the facility maintenance program.”
  3. Deadline. The compliance deadline has been pushed back from July 6, 2017, to January 1, 2018.
  4. Citations. Any LSC deficiencies related to annual fire door inspections should be cited under K211—Means of Egress—General.

But what if a healthcare organization was already cited at some point during the three-week gap between the original compliance date and the clarifying memo (July 6–28) for a failure to conduct an annual test of its smoke doors? Multiple CMS representatives did not respond to requests for an answer. Keyes says CMS has been a stickler in the past, holding that a finding cannot be removed once it is written on a survey report.

“There was an accreditation organization [AO] that used to allow findings to be removed from their survey report if the hospital could demonstrate compliance at the time of the survey,” Keyes says. “CMS has said that the AOs may no longer remove findings, even if the hospital was compliant at the time of the survey.”

The Joint Commission stated in the July edition of Perspectives that it requires annual testing for fire door and smoke door assemblies alike, despite acknowledging that the healthcare occupancy chapters don’t cite section 7.2.1.15 specifically. (To support the requirement, The Joint Commission noted that Section 18/19.2.2.2.1 references section 7.2.1, and cited a belief that the annual tests are beneficial.)

Keyes adds a word of caution: “The AOs are not locked into complying with everything CMS says or does. The AOs may have standards that exceed what CMS requires.”

That means the guidance in Wright’s memo might not trickle down to the AOs and state agencies that conduct surveys at your facilities, especially considering how widely advertised the original compliance date has been.

“So, I suspect many of the AOs will keep the start date at July 5, 2017, since they are already enforcing that,” Keyes says.

With that in mind, he recommends that all healthcare facilities have their fire doors tested as soon as possible, rather than waiting until the new deadline—because another authority having jurisdiction might keep to the stricter timeline.

 

AHJ on Fire Door Inspections

Q:  Does the authority having jurisdiction have the final say whether or not an individual has the ‘knowledge and understanding’ required to perform fire door inspections?

A: Yes they do. Take a look at 4.6.1.1 of the 2012 LSC “The authority having jurisdiction shall determine whether the provisions of this Code are met.” That means the AHJ decides if the organization is compliant with the applicable NFPA codes and standards. But, keep in mind the typical hospital has 5 or 6 different AHJs that inspect their facility for compliance with the LSC:

  • CMS
  • Accreditation organization
  • State health department
  • State agency with over-sight on hospital construction
  • State fire marshal
  • Local fire inspector
  • Liability insurance company

Not one AHJ can over-ride another AHJ’s decision. All AHJs are equal… but different. If 5 AHJs say the qualifications of the person performing the fire door inspections are fine, but 1 AHJ says no, then the hospital must comply with the most restrictive requirements and comply with the latter AHJ’s desires. An AHJ may have rules and requirements that exceed NFPA standards, as well they should. NFPA standards are minimal standards, and most hospitals exceed the NFPA standards in some capacity, often due to local ordinances or state regulations (and sometimes at the whim of the design professional). But, if the AHJ decides to have standards that exceed the minimal NFPA requirements, they need to be able to justify that decision.

It is not at all uncommon for a healthcare organization to seek permission from a state or local AHJ (i.e. state fire marshal) to install a particular device or have a particular feature, only to find out later that their accreditation organization does not agree, and cites the issue. Both the state or local AHJ and the accreditation organization are correct; they are interpreting the Life Safety Code as they see fit. Whatever was approved by the state or local AHJ is just an approval for the state or local regulations. What was cited by the accreditation organization was cited based on the accreditation organization’s regulations and understanding of the Life Safety Code.

This is why healthcare organizations need to obtain permission and interpretations from all of their AHJs… not just one or two.

Follow-Up From an Earlier Post….

I recently posted on documentation retention, and how long you should keep test/inspection records. A reader contacted me and said they attended a recent ASHE regional event where the speaker said the CMS K-Tags require some records to be kept for the life of the building, and the reader wanted to know if I was familiar with this requirement.

I said no, I was not, but I decided to get an answer direct from CMS themselves. I did receive a reply from CMS which is considered an informal non-public response, and here is a summary of what they said:

  • CMS has not issued any formal policy on retention of records for LS test/inspections.
  • Surveyors typically look back one (1) year to establish compliance.
  • However, the extent of the record review would consider the frequency of a particular test/inspection requirement.
  • If the test/inspection requirement was a monthly requirement, the surveyor may review 12-months’ worth of documentation to confirm compliance.
  • If the test/inspection requirement was an annual requirement, then the surveyor may review 3-years’ worth of documentation to confirm compliance.
  • In addition, retention of records would consider any NFPA, State, or manufacturer requirements.

It’s important to point out that there is a special requirement in NFPA 99-2012, section 5.1.14.4.1 that does require ‘permanent’ records of certain medical gas tests. Permanent would mean retention for the life of the building (or system), but section 5.1.14.4.1 only refers to initial system verification test records… not routine annual inspections. And it only applies to medical gas and vacuum systems, not other mechanical or electrical systems identified in NFPA 99.

CMS K-Tags 907 and 908 refer to a routine maintenance program and a test/inspection program for medical gas systems. These K-Tags says records are to be maintained as required. Since the K-Tags are a CMS product, they are obviously saying maintenance records and routine test/inspection records are to be kept long enough to establish a pattern of compliance. For annual test/inspection records, that would mean you must retain the records for 3-years, not necessarily for the life of the building.

Similarly, K-Tag 921 discusses a testing and maintenance program for electrical equipment, and it says records are maintained for a period of time to demonstrate compliance. This is consistent with the CMS informal comment that a ‘period of time’ would be 1-year for monthly requirements and 3-years for annual requirements.

Since accreditation organizations operate with the authority granted to them by CMS, it would be expected that the accreditation organizations would comply with the same requirements and informal policies as CMS.

But, I will fallback on what I believe: You should never throw away any records that demonstrate compliance with a regulatory requirement. That’s Brads opinion.

Clarification on Emergency Department Occupancy Classification

If you’ve been reading my blog postings over the past few months ( see http://keyeslife.wpengine.com/?s=emergency+department), you’ve read were I have reported that CMS has issued informal, non-public letters to the accreditation organizations (AOs) regarding the occupancy classification of emergency departments. To review how this issue started, CMS issued a letter to one of the AOs last fall (in 2016) regarding the occupancy classification of Emergency Departments. In this letter, CMS said Emergency Departments needed to be classified as healthcare occupancies. This information was then shared to the other AOs.

This set-off quite a stir in the healthcare community, as many people and organizations objected to this strict interpretation, since the 2012 Life Safety Code actually permits Emergency Departments to be classified as ambulatory healthcare occupancies.  Many free-standing Emergency Departments have already been constructed to meet ambulatory healthcare occupancy requirements, and to make physical changes after the facility has been occupied would be an unreasonable hardship.

Apparently, the objections to this rather strict interpretation have been heard, and CMS has again issued an informal, non-public communication that says they have not issued any policy regarding Emergency Department classification. Therefore, according to CMS, occupancy classification of Emergency Departments would be determined in accordance with 2012 Life Safety Code.

This means according to 3.3.188.1, an Emergency Department may be classified as an ambulatory healthcare occupancy provided it does not have sleeping accommodations for 4 or more patients on a 24-hour basis. CMS considers a bed used for 24-hour observation to be ‘sleeping accommodations’ and if the Emergency Department has 4 or more observation beds, then the Emergency Department must be classified as a healthcare occupancy.

Also, another item to consider… If you have an Emergency Department that is considered a suite and is required to be classified as a healthcare occupancy due to ‘sleeping accommodation’ rooms, then the Emergency Department would have to meet the requirements of section 19.2.5.7.2 “Sleeping Suites”. This means, where you previously may have enjoyed a suite that is up to 10,000 square feet in size, you may now be limited to just 5,000 square feet. However, take a look at section 19.2.5.7.2.3 as you may qualify to meet the requirements to bump the suite size up to 7,500 square feet or perhaps even to 10,000 square feet.

This clarification from CMS is helpful, and should go a long way to explain the occupancy classification of Emergency Departments.