Apr 10 2017

Addressing Common Misconceptions Regarding Waivers and Equivalencies

Category: BlogBKeyes @ 12:00 am
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There has been much confusion and differing of opinions regarding the process to submit waiver and equivalency requests, and once they have been approved, how long they are valid. The Centers for Medicare & Medicaid Services (CMS) recently implemented new procedures that resulted in changes on how the accreditation organizations processed waiver and equivalency requests.

Up until a couple of years ago, CMS always said that approved waivers are only valid for 1-year. After the 1-year cycle, the federal agency wanted hospitals to resubmit their waiver request for another 1-year cycle. When Det Norske Vertitas (DNV) came on the scene in 2008 or so, CMS told them straight out-of-the-box that DNV cannot approve waivers or equivalencies. DNV would be required to send them to the appropriate CMS Regional Office for approval. DNV was okay with that because they wanted deeming authority, so they complied. The odd thing though, CMS did not inform Healthcare Facilities Accreditation Program (HFAP) or The Joint Commission of the same policy at that time.

Joint Commission and HFAP always recognized that CMS was the only entity that could approve waivers, but these two accreditors always considered equivalencies as different animals and were not considered to be waivers. It was always understood that the difference between a waiver and an equivalency is a waiver is requesting a specific Life Safety Code requirement to be ‘waived’ and the hospital would not have to comply with it due to significant hardships. An equivalency does not ‘waive’ any Life Safety Code requirements, but instead analyzes surrounding features of fire-safety and assigns numerical values. The numerical values are run through a formula and if the result is a positive number then that confirms there is a equivalent level of safety even with the Life Safety Code deficiency. This concept is supported by section 1.4.3 of the 2012 Life Safety Code. But CMS never saw it the same way and decided an equivalency is similar to a waiver, and needs to be processed the same. Therefore, only they (CMS) could approve equivalencies.

In 2012 CMS notified HFAP that they can no longer approve equivalencies, and CMS wanted HFAP to submit the waiver/equivalency requests to the appropriate CMS Regional Office for approval, just like DNV. But, for reasons known only to them, it wasn’t until July, 2014, that CMS got around to telling Joint Commission the same rules. Joint Commission agreed to discontinue approving equivalencies and would forward them on to the appropriate CMS Regional Office. So, for the first time since 2008, the big three accreditors for hospitals (Joint Commission, DNV and HFAP) were all on the same page and on a level playing ground regarding the approval process for equivalencies. But immediately, there was confusion; not the least of which the CMS Regional Offices were not prepared to handle the influx of the paper requests for waivers and equivalencies. Some of the busier Regional Offices started to misplace the equivalency requests, which meant the hospitals would have to resubmit them. Most of the accreditors required the equivalencies to be submitted on paper rather than electronically because the equivalencies required drawings of the facility, and at that time electronic files of drawings were not easily read without CAD software. That led to large, bulky paper submissions, which were easily misplaced.

By 2015, CMS took action to resolve the serious problem concerning misplaced copies of waiver and equivalency requests, so they contracted with Healthcare Management Solutions (HMS), a vendor, to create an electronic process to accept waiver and equivalency requests and track their progress through the approval process. In May, 2015 HMS unveiled a rather slick and easy process to the accreditors called Sharepoint, whereby the accreditors can submit waiver and equivalency requests electronically from their clients to HMS. Representatives from HMS will review the submissions to ensure that significant information is included, and once they consider it to be an acceptable submission, they will then send it electronically to the appropriate CMS Regional Office for review and approval. At this time (in May, 2015), they submitted a 6-page document to the AOs explaining the process for waivers and equivalencies to be submitted and approved. Highlights of this document says:

  1. Only CMS Regional Offices can approve waivers and equivalencies.
  2. Waiver and equivalency requests will only be considered for existing Life Safety code deficiencies; they will not consider a request if the deficiency has not been cited by the accreditor. (This is contrary to the way that Joint Commission and HFAP operated, as they would approve equivalencies prior to the Life Safety Code deficiency being cited.)
  3. The hospital will submit their waiver or equivalency request directly to their accreditation organization as part of their Plan of Correction to resolve a deficiency cited during a survey.
  4. If the AO agrees with the hospital’s request for a waiver or an equivalency, then they submit the request electronically along with a cover letter recommending approval to the HMS Sharepoint. If the AO does not agree with the request made by the hospital, then they simply do not submit the request to HMS Sharepoint, and the request is effectively denied. This allows the AOs a right of first-denial.
  5. Once the request submission meets the requirements, then HMS sends it on to the appropriate CMS Regional Office. Originally, CMS said they expected the Regional Offices to approve or disapprove requests within 30 days, but that has not always been the case as the influx of waiver and equivalency requests has created a back-log.
  6. The CMS Regional Office decides whether or not to approve the waiver/equivalency request and they make their decision in writing and inform the hospital and the AO of their decision. If they approve the request, it is only valid until the next triennial survey whereby if the deficiency is not resolved at that time, it will be cited again. If they deny the request, the hospital must submit an alternative Plan of Correction to resolve the deficiency.

In addition, when the CMS Regional Office sends a letter of approval to the hospital, they include language that says: “If you are not in compliance with the above requirements at the time of your next survey, you will be required to either submit a plan to correct deficiencies or renew your request for waiver, in order to continue your participation on the Medicare program.” This reinforces the CMS position that waivers and equivalencies are only valid until the next survey.

Since an approved waiver or equivalency is only valid until the next survey, that implies the waiver or equivalency is a short-term, temporary process. This is different than what used to be considered in the past. CMS now allows waiver requests to extend up to 3 years, rather than 1-year; and approved equivalencies are now limited to no more than 3 years, rather than indefinitely or until there is renovation in the area as Joint Commission and HFAP used to allow. Hospitals started to change their strategy and submitted more waiver request rather than equivalencies since equivalencies cost more resources to prepare.

CMS will allow a time-limited waiver request which is essentially the hospital requesting permission to continue to operate the facility with the cited Life Safety Code deficiency for a short-period of time until the hospital can either resolve the deficiency or implement other measures to qualify for an equivalency. CMS has stated that if a hospital cannot resolve a Life Safety deficiency within 60 days of the end of the survey, then they would expect the hospital to submit a time-limited waiver request.

You may wonder why CMS has not issued a public notice explaining the changes with the waiver and equivalency requests. I don’t know for sure, but I suspect it may be that they really don’t see that there have been any significant changes on their part to explain. Other than the HMS Sharepoint process which is really a private conversation between the CMS and the AOs, the statement that the waivers and equivalencies are only valid until the next survey has always been the case with CMS. It really was the Joint Commission and HFAP that had different procedures and allowed equivalencies to be valid indefinitely or until there was renovation in the area. Once CMS got those two AOs to stop approving equivalencies, then everything else fell into place.

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Feb 20 2014

Problems with the CMS Categorical Waivers

Category: BlogBKeyes @ 6:00 am
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I have been receiving some feedback from friends and readers of the Keyes Life Safety Compliance website concerning the CMS categorical waivers. One of the issues seems to focus around whether a building is fully sprinklered or not.

The whole concept of what constitutes a fully sprinklered building seems to be different among various AHJs. Some want every square inch to be protected with water-based fire protection systems, and others will permit the exceptions found in NFPA 13. Here is how I see the issue:

Sections 18/19.3.5.1 in the 2000 LSC says new healthcare construction needs to be protected with automatic sprinkler systems in accordance with section 9.7. The exception to 18/19.3.5.1 allows for areas of buildings where the AHJ will not permit sprinklers, to be protected by ‘alternative protection measures’ (whatever that means) without the building being classified as nonsprinklered. This exception was inserted to account for those areas of the country where the local AHJ would not permit sprinklers in electrical rooms or elevator equipment rooms. The phrase ‘alternative protection measures’ means whatever the AHJ wants it to mean; from installing clean agent suppression systems (Halon, FM-200, CO2, etc.) to perhaps just a smoke or heat detection system. Or, it can mean something else.

Section 9.7.1.1 says where automatic sprinklers are required by the occupancy chapter, they must be in accordance with NFPA 13 (1999 edition). NFPA 13 has some exceptions where a building does not have to have sprinklers installed in certain areas and it still would qualify as ‘being protected with automatic sprinklers in accordance with NFPA 13’. Therefore, with the exceptions allowed by NFPA 13, I see the Life Safety Code as saying these buildings are protected with automatic sprinklers in accordance with NFPA 13.

The CMS categorical waivers on unoccupied openings in exit enclosures references the new 2012 LSC, section 7.1.3.2.1 (9)(c), which says existing openings in an exit enclosure are permitted as long as it meets multiple conditions, one of which being the building is protected with automatic sprinklers in accordance with section 9.7. There we are… back to 9.7, which references NFPA 13, which has some exceptions in certain buildings to not have sprinklers, but the building still has an ‘automatic sprinkler system in accordance with NFPA 13’. If the hospital implements any of these NFPA 13 exceptions then I would say it qualifies for the CMS categorical waiver. But technically, the hospital is not “fully sprinklered”, but would be considered protected with automatic sprinklers in accordance with section 18/19.3.5 and 9.7 of the 2000 LSC. The CMS S&C memo 13-58-LSC does not require a fully sprinklered building in order to qualify for the categorical waiver on the unoccupied openings to an exit enclosure. It only requires automatic sprinklers in accordance with section 9.7, which references NFPA 13.

But it never matters what I say; only what the AHJs say. If you have an AHJ that will not allow the CMS categorical waivers due to an approved NFPA 13 exception, then use the above logic as an argument that it should be allowed.

I also have some reports that certain state department of public health (DOH) do not recognize the CMS categorical waivers and will not permit them in the hospitals under their jurisdiction. That’s okay, as the state AHJs do not have to follow what CMS says, if they are assessing compliance with their own regulations and standards. Even if the state DOH is the official designated state survey agency for CMS, the most restrictive codes and regulations apply, and in this case the state regulations would take precedence of the CMS categorical waivers.

I hope this information is helpful…

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Sep 06 2013

CMS Issues New Categorical Waivers for the LSC

Category: BlogBKeyes @ 5:00 am
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CMS just issued another S&C memo describing the process for hospitals and nursing homes can take advantage of additional categorical waivers for some of the new 2012 Life Safety Code issues right away, instead of waiting another year or so when CMS finally adopts the new LSC. I have copied it word-for-word for you in this blog and it is rather lengthy, but I wanted you to know that it is available for you to use right away, and what it says.

Watch for future posts on the blog for specifics on each issue.

CMS Logo 2

 

 

 

 

 

Center for Clinical Standards and Quality /Survey & Certification Group

Ref: S&C: 13-58-LSC

DATE:           August 30, 2013

TO:                 State Survey Agency Directors

FROM:           Director, Survey and Certification Group

SUBJECT:    2000 Edition National Fire Protection Association (NFPA) 101® Life Safety Code (LSC) Waivers

Various regulations governing certain certified providers and suppliers require compliance with the 2000 edition of the NFPA 101: LSC.  The LSC establishes minimum requirements for the design, operation, and maintenance of buildings and structures to protect individuals from fire and related hazards.

As allowed by the regulations at §482.41(b)(2), §485.623(d)(3), §483.70(a)(2), §416.44(b)(2), and §418.110(d)(2), CMS may waive specific provisions of the 2000 edition of the LSC in hospitals, critical access hospitals, long-term care facilities, ambulatory surgical centers, and inpatient hospice, which, if rigidly applied, would result in unreasonable hardship upon a provider or supplier, but only if the waiver does not adversely affect the health and safety of patients or residents.  CMS has determined that the 2000 edition of the LSC contains several provisions that may result in unreasonable hardship for providers/suppliers, for which an adequate alternative level of protection may be achieved.  Accordingly, CMS is making available several categorical waivers to new and existing providers and suppliers subject to the LSC.

Waiver Process

Providers and suppliers that want to take advantage of one or more of the categorical waivers identified below must formally elect to use one or more of the waivers and must document their election decision.  If a provider/supplier conforms to the requirements identified for each categorical waiver elected, it will not need to apply specifically to CMS for the waiver, nor will it need to wait until being cited for a deficiency in order to use this waiver.  At the entrance conference for any survey assessing LSC compliance, a provider/supplier that has elected to use a categorical waiver must notify the survey team of this fact, and that it meets the applicable waiver provisions.  It is not acceptable for a healthcare facility to first notify surveyors of waiver election after a LSC citation has been issued.

The survey team will review the provider’s/supplier’s documentation electing to use one or more of the categorical waivers and confirm it is meeting all applicable categorical waiver provisions.  This will ensure an adequate level of protection is afforded.  The waiver(s) elected by the provider/supplier must be described under Tag K000.  Categorical waivers do not need to be cited as deficiencies nor do they require Regional Office approval.  Therefore the applicable field on the Form CMS-2786 should be marked as “Facility Meets, Based Upon, 3. Waivers.”  If the survey team determines that the waiver provisions are not being met, the provider/supplier will be cited as a deficiency under §482.41(b)(2), §485.623(d)(3), §483.70(a)(2), §416.44(b)(2), or §418.110(d)(2), as appropriate.

Categorical Waivers Available:

 1.      Medical Gas Master Alarms

The 1999 NFPA 99, Health Care Facilities Code is cross-referenced in the 2000 LSC and, as a result, it contains requirements applicable to providers and suppliers who must meet the 2000 edition of the LSC under our regulations.  The 1999 NFPA 99, sections 4-3.1.2.2(b)(2) requires medical gas master alarms to be located in two separate locations and section 4-3.1.2.2(a)(9) does not allow a centralized computer as a substitute for any medical gas alarm panel.  The use of computers to continuously monitor critical signals has increased in health care facilities and the use of computers to monitor medical gas can improve surveillance and shorten response time.  As a result, the 1999 NFPA 99 provision required under the 2000 LSC is not only outmoded and unduly burdensome to providers and suppliers, but also arguably less efficient in promoting fire safety.    As a result, in the 2005 edition of NFPA 99, the NFPA began to permit a centralized computer system to be substituted for one of the master alarms, and this policy is continued in section 5.1.9.4 of the 2012 NFPA 99.  Accordingly, we are permitting a waiver to allow a centralized computer system to substitute for one of the Category 1 medical gas master alarms, but only if the provider/supplier is in compliance with all other applicable 1999 NFPA medical gas master alarm provisions, as well as with section 5.1.9.4 of the 2012 NFPA 99.

2.      Openings in Exit Enclosures

 

The 2000 LSC limits opening in exit enclosures (e.g., stairwells) to doors from normally occupied spaces and corridor, and doors for egress from the enclosure, with a few exceptions.  Existing health care facilities often have unoccupied mechanical equipment spaces that have an exit access door to an exit enclosure.  Providing an alternative exit access to these areas is typically impractical and unduly burdensome with respect to the cost of the reconstruction that would be required.  With the 2003 LSC, the NFPA began to permit existing unoccupied openings to mechanical equipment spaces with fire-rated doors to open into exit enclosures, and continuation of this policy is reflected  in section 7.1.3.2(9)(c) of the 2012 LSC.  Accordingly, we are permitting a waiver to allow existing openings in exit enclosures to mechanical equipment spaces that are protected by fire-rated door assemblies.  These mechanical equipment spaces must be used only for non-fuel-fired mechanical equipment, must contain no storage of combustible materials, and must be located in sprinklered buildings.  This waiver allowance will be permitted only if the provider/supplier is in compliance with all other applicable 2000 LSC exit provisions, as well as with section 7.1.3.2.1(9)(c) of the 2012 LSC.

3.      Emergency Generators and Standby Power Systems

Section 9.1.3 of the 2000 LSC requires emergency generators and standby power systems to be installed, tested, and maintained in accordance with 1999 NFPA 110, Standard for Emergency and Standby Power Systems.  Section 6-4.2.2 of the 1999 NFPA 110 requires diesel-powered generators that do not meet the monthly testing requirements under section 6-4.2 to be run annually with various loads for a total of two (2) continuous hours.  Shorter generator run times will reduce undue cost burden and negative environmental impacts.  In the 2010 NFPA 110, the NFPA began to allow for total test duration of one hour and 30 minutes (1-1/2 continuous hours).  Accordingly, we are permitting a waiver to allow for a reduction in the annual diesel-powered generator exercising requirement from two (2) continuous hours to one hour and 30 minutes (1-1/2 continuous hours), but only if the provider/supplier is in compliance with all other applicable 1999 NFPA 110 operational inspection and testing provisions, as well as with section 8.4.2.3 of the 2010 NFPA 110.

4.      Doors

Section 18/19.2.2.2.2 through 18/19.2.2.2.5 of the 2000 LSC permits door locking arrangements where the clinical needs (e.g., psychiatric units, Alzheimer units, dementia units) of the patients require specialized security measures for their safety, provided adequate provisions are made for the rapid removal of occupants by means such as remote control locks or keys carried by staff at all times.  The need for door locking arrangements may extend to other circumstances, such as instances when patients pose a security risk (e.g., some patients in emergency departments) or when a patient requires specialized protective measures for safety (e.g., pediatric units, newborn nurseries).  In the 2009 LSC, the NFPA recognized this and began to allow for door locking arrangements when patients pose a security risk or when patients require specialized protective measures for safety, and continuation of this policy is reflected in the 2012 LSC, in sections 18/19.2.2.2.2 through 18/19.2.2.2.6.  Accordingly, we are permitting a waiver to allow door locking arrangements where there are clinical needs justifying them, patients pose a security risk, or where patients require specialized protective measures for their safety, but only if the provider/supplier is in compliance with all other applicable 2000 LSC door provisions, as well as with sections 18/19.2.2.2.2 through 18/19.2.2.2.6 of the 2012 LSC.

Section 19.2.2.2.4 of the 2000 LSC permits delayed-egress locks in the means of egress, provided not more than one such device is located in an egress path.  However, where the clinical needs (e.g., psychiatric units, Alzheimer units, dementia units) of the patients require specialized security measures for their safety, or where patients pose a security risk (e.g., some patients in emergency departments) or when a patient requires specialized protective measures for safety (e.g., pediatric units, newborn nurseries), more than one delayed egress lock may be required along the path of egress in order to accommodate the clinical, security, and other special needs of patients.  In the 2009 LSC, NFPA began to allow for more than one delayed-egress lock in an egress path, and continuation of this policy is reflected in sections 18/19.2.2.2.4 of the 2012 LSC, provided that the facility also employs the compensating safety measures specified in those sections which facilitate rapid removal of occupants.  Accordingly, we are permitting a waiver to allow more than one delayed-egress lock in the egress path, but only if the provider/supplier is in compliance with all other applicable 2000 LSC door provisions, as well as with sections 18/19.2.2.2.4 of the 2012 LSC.

5.      Suites

Sections 18/19.2.5 of the 2000 LSC requires every habitable room to have an exit access door leading directly to an exit access corridor; allows for exit access from a suite to include intervening rooms only under certain circumstances; requires suites of certain size to have two exit access doors remotely located from one another; and limits the size of sleeping room suites to 5,000 ft2.  Suites are used to create groupings of rooms and spaces that can function more efficiently than individual rooms located off of a corridor.  The specific limitations on suite size and design in the 2000 LSC limit their efficiency and the ability for facilities to accommodate suites in their building space, which results in undue burden.  In the 2006 LSC, NFPA began to include additional provisions to further accommodate the use of suites, and continue to be reflected in sections 18/19.2.5.7 of the 2012 LSC.  Accordingly, we are permitting a waiver to further accommodate the use of suites by allowing: (1) one of the required means of egress from sleeping and non-sleeping suites to be through another suite, provided adequate separation exists between suites; (2) one of the two required exit access doors from sleeping and non-sleeping suites to be into an exit stair, exit passageway, or exit door to the exterior; and (3) an increase in sleeping room suite size up to 10,000 ft2.  This waiver allowance will be permitted only if the provider/supplier is in compliance with all other applicable 2000 LSC suite provisions, as well as with sections 18/19.2.5.7 of the 2012 LSC.

6.      Extinguishing Requirements

Section 9.7.5 of the 2000 LSC requires all automatic sprinkler and standpipe systems to be inspected, tested, and maintained in accordance with the 1998 edition of NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-based Fire Protection Systems.  Sections 2-3.3 and 5-3.2 of the 1998 NFPA 25 require the quarterly testing of vane-type and pressure switch type waterflow alarm devices, and weekly testing of electric motor-driven pump assemblies.  Reducing the frequency of testing requirements will reduce cost burden.  In the 2011 NFPA 25, the NFPA began allowing for the testing of vane-type and pressure switch type waterflow alarm semiannually and electric motor-driven pump assemblies monthly.  Accordingly, we are permitting a waiver to allow for the reduction in the testing frequencies for sprinkler system vane-type and pressure switch type waterflow alarm devices to semiannual, and electric motor-driven pump assemblies to monthly.  This waiver allowance will be permitted only if the provider/supplier is in compliance with all other applicable 1998 NFPA 25 (as referenced in section 9.7.5 of the 2000 LSC) testing provisions, as well as with sections 5.3 and 8.3 of the 2011 NFPA 25.

7.      Clean Waste & Patient Record Recycling Containers

Sections 18/19.7.5.7 of the 2000 LSC limit the size of trash collection containers to 32-gallons when located outside of a hazardous storage area and not attended.  Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids.  Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden.  In the 2012 LSC, the NFPA began allowing containers used solely for recycling clean waste or for patient records awaiting destruction outside a hazardous storage area to be a maximum capacity of 96-gallons.  Accordingly, we are permitting a waiver to allow the increase in size of containers used solely for recycling clean waste or for patient records awaiting destruction outside of a hazardous storage area to be a maximum of 96-gallons,but only if the provider/supplier is in compliance with sections 18/19.7.5.7.2 of the 2012 LSC.

8.      Clarification of Process for LSC Waivers permitted under S&C-12-21

CMS memorandum S&C-12-21-LSC, dated March 9, 2012, also provided for categorical waivers of several provisions of the 2000 LSC, but required each provider/supplier waiver to be evaluated separately before a survey was to be conducted, with final approval by the CMS Regional Office.  Providers/suppliers seeking to take advantage of these categorical waivers may now use the categorical waiver process described above, so long as they are in compliance with all other requirements identified in S&C-12-21-LSC.

Questions:  If you have questions regarding this memorandum please contact Lieutenant Commander Martin Casey at Martin.Casey@cms.hhs.gov.

Effective Date:  Immediately.  This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators within 30 days of this memorandum.

/s/

Thomas E. Hamilton

cc:  Survey and Certification Regional Office Management

 

 

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