Aug 05 2017

Changes to Smoke Barrier Door Testing

Category: BlogBKeyes @ 12:00 am
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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.

 

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Jul 22 2017

Follow-Up From an Earlier Post….

Category: BlogBKeyes @ 12:00 am
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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.

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Jul 01 2017

Clarification on Emergency Department Occupancy Classification

Category: BlogBKeyes @ 12:00 am
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If you’ve been reading my blog postings over the past few months ( see http://keyeslifesafety.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.

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Mar 02 2017

CMS Interprets Emergency Departments to be Healthcare Occupancies

Category: BlogBKeyes @ 12:00 am
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The following article was published today online by the HCPro newsletter ‘Healthcare Life Safety Compliance’, and is reprinted here with permission.

In a rather surprising interpretation by the Centers for Medicare and Medicaid Services (CMS), all Emergency Departments (ED) are now required to be classified as healthcare occupancies only. For many hospitals this may not be a problem, but for those hospitals that have already classified their EDs as ambulatory healthcare occupancy, they will have to make a change back to healthcare occupancy. This also affects those free-standing Emergency Departments that were designed and approved as ambulatory healthcare occupancies; according to CMS’ recent interpretation, they also must meet the requirements for a healthcare occupancy. And it appears this decision is retroactive to existing conditions.

This all came-about when the accreditation organizations (AO) submitted their revised and updated standards to CMS last fall for the change to the new 2012 Life Safety Code. One particular AO created an introduction to their Life Safety chapter and explained the differences in occupancies and gave an ED as an example of an ambulatory healthcare occupancy. CMS wrote back and said EDs cannot be ambulatory healthcare occupancies and must be classified as healthcare occupancies because they provide sleeping accommodations for patients who are on 24-hour observation.

Many of the AOs objected to this change and pointed out that the ED does not provide sleeping accommodations but rather examination rooms. Even patient-safety advocate groups like the American Society for Healthcare Engineering (ASHE) objected to this new ruling in the initial proposed rule.

“If a patient is on 24-hour observation in an ED, they are still being examined even if they are sleeping”, says Chad Beebe, Deputy Executive Director of ASHE. “It’s an entirely different staffing model than you would find in a nursing floor. It is very similar to Sleep Labs; even though the patient is sleeping, the patient is still being examined. And Sleep Labs are not required to be located in healthcare occupancies because they are providing outpatient services.”

Just like Sleep Labs, patients in an Emergency Department are considered to be out-patients and not inpatients. According to section 3.3.188.7 of the 2012 LSC, a healthcare occupancy is used to provide medical or other treatment of care simultaneously to four or more patients on an inpatient basis, where such patients are mostly incapable of self-preservation.

“How can CMS consider an Emergency Department is required to meet healthcare occupancy if the patients in the department are not even inpatients?” says Brad Keyes, owner and Senior Consultant for Keyes Life Safety Compliance, LLC. “The NFPA definition for ambulatory healthcare occupancy specifically describes emergency departments as ambulatory healthcare occupancies because they are outpatients, not inpatients. Why does CMS feel the need to depart from the NFPA definitions, that have been used in healthcare for decades?”

The financial implications by this excessive interpretation is far-reaching. Many free-standing Emergency Departments have been designed, approved and constructed in compliance with ambulatory healthcare occupancy requirements. Basic egress issues would suddenly be non-compliant, such as corridor width. Healthcare occupancies require 8-foot corridor widths for new construction, where ambulatory healthcare occupancies only require 44 inches. In healthcare occupancies, doors are required to separate the corridor from the exam rooms. In ambulatory healthcare occupancies, doors are not required. The cost to meet these new egressing requirements would be excessive.

Another difference between healthcare occupancies and ambulatory healthcare occupancies is the construction type, which identifies the combustibility and fire-resistance rating of the structural members of the building.

“A free-standing single-story Emergency Department that was constructed to ambulatory healthcare occupancy requirements, is not restricted in the construction type used to build the facility”, says Keyes. “However, that’s not true for Emergency Departments that are required to meet healthcare occupancy requirements. Unprotected wood-frame facilities and certain buildings with exterior non-combustible structural elements are not permitted to be used for healthcare occupancies.”

Converting an existing Emergency Department that has non-compliant construction type for healthcare occupancies would be very costly, if not prohibitively so.

“An additional cost may be in sprinklers”, says Keyes. “New ambulatory healthcare occupancies are not required to be protected with sprinklers, but new healthcare occupancies are. So, if the ED that was constructed to ambulatory healthcare occupancy requirements was not protected with sprinklers, it would have to when it is converted to healthcare occupancy. That will be a substantial cost to install sprinklers in an occupied facility.”

Even if the Emergency Department was constructed as a healthcare occupancy and designed to meet egress requirements for suites, that would have to change. If designed as a non-sleeping suite, the maximum size of the suite is 10,000 square feet. Now, according to CMS the Emergency Department is no longer a non-sleeping suite, but must meet the requirements of a sleeping suite which can be required to be half the area of a non-sleeping suite. That would require the installation of new barriers and doors.

“For many Emergency Departments, the cost to comply with the new CMS interpretation will be an unreasonable hardship”, says Beebe. “Facilities will have to be cited for non-compliance and then submit a waiver request. And there is no guarantee that the waiver will be approved by the CMS regional office.”

This latest interpretation by CMS seems to be in contrast to President Trump’s initiative to lower the cost of regulation. In fact, the new Administration is working to identify and repeal federal regulations that are unreasonable and costly. This interpretation by CMS seems to fit that bill.

Keyes offers an explanation why this interpretation by CMS is not made public. “CMS did communicate with those AOs with hospital deeming authority last fall regarding this interpretation, but so far, they have not notified the public”, says Keyes. “It could very well be that CMS has always believed Emergency Departments to be healthcare occupancies and they now feel there is no reason to make a formal notice, such as a Survey & Certification letter.”

“ASHE has already received reports from members that they have been cited for having Emergency Departments and hospital outpatient departments located in ambulatory healthcare occupancies or even business occupancies”, says Beebe. “The enforcement of this interpretation has already started, and will only grow when the AOs begin their enforcement as well.”

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Dec 09 2016

Incorrect Interpretations on Smoke Door and Fire Door Testing

Category: BlogBKeyes @ 12:00 am
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I just found out yesterday that CMS is teaching their state agency LS surveyors that smoke barrier doors need to be tested in healthcare occupancies. This interpretation of the 2012 Life Safety Code from CMS is incorrect, but your state agency on behalf of CMS may be expecting you to do this.

Yes… section 7.2.1.15.2 of the 2012 LSC says (in part) smoke door assemblies need to be tested. But that conflicts with the occupancy chapter for healthcare and section 4.4.2.3 says when specific requirements in the occupancy chapters differ from the general requirements contained in the core chapters, the occupancy chapter shall govern. Section 19.3.7.8 says doors in smoke barriers shall comply with section 8.5.4. Section 8.5.4.2 says where required by chapters 11 -43 doors in smoke barriers that are required to be smoke leakaged-rated, must comply with section 8.2.2.4 (which requires testing). Chapters 18 & 19 (healthcare occupancies) do not require smoke doors to be smoke leakaged-rated: Therefore, smoke barrier doors do not have to be tested in healthcare occupancies.

Now… you may have a state agency that believes differently. You may show them this code trail and perhaps they will allow you to not test your smoke doors, but ultimately they are an authority and if they say you have to test smoke doors, then you have to test smoke doors.

But it is not required in healthcare occupancies according to the 2012 LSC.

Also, CMS has instructed their state agency LS surveyors that healthcare occupancy doors in 7.2.1.15.1 must be tested, even if they are not fire-rated doors. This also is incorrect. The doors identified in 7.2.1.15.1 do not apply to healthcare occupancies so they are exempt from having to be tested. Only doors in assembly occupancies and residential board & care occupancies need to comply with 7.2.1.15.1.

But be aware: If you have areas of your healthcare facility that qualify as assembly occupancy, even if you do not declare that area as assembly occupancy, then you must comply with 7.2.1.15.1 and test those doors. This would include doors in assembly occupancies that:

  • Have panic hardware or fire-rated hardware;
  • Are located in an exit enclosure;
  • Are electrically controlled egress doors;
  • Delayed egress, access-control, and elevator lobby locked (per 7.2.1.6).

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Sep 22 2016

Oops! Brad Made a Mistake…

Category: BlogBKeyes @ 12:00 am
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I need to apologize to you, as I made an error in an earlier post where I stated the expected dates for the new testing/inspection requirements of the new 2012 Life Safety Code.

Previously, I said healthcare organizations needed to get their first quarterly, annual, 3-year, and 5-year test/inspection completed by November 1, 2016, which is the date CMS said the requirements of the new 2012 LSC will be enforced.

That wasn’t quite true… I received an email from a friend who also is a reader of my blog and said that is not what Joint Commission said at the annual ASHE conference. So, I contacted CMS directly in Baltimore, and communicated with the people who make these interpretations, and they told me this:

Although CMS will begin surveying to the new 2012 LSC on November 1, 2016, the regulation still requires the facility to be in compliance with the 2012 LSC and the 2012 NFPA 99 as of July 5, 2016.

Therefore, when CMS begins to survey on November 1, 2016, the healthcare facility should be able to verify compliance with any new daily, weekly, or quarterly requirements as it has been over 3 months since July 5th. But a facility would not yet be required to meet the new annual, 3-year, or 5-year requirements.

The email from CMS went on to explain that the first annual test/inspection activity that is a new requirement of the 2012 LSC is due July 5, 2017. Similarly, the first 3-year activity is due July 5, 2019, and the first 5-year is due July 5, 2021.

Just as a refresher, here is a list of the new testing/inspecting requirements of the 2012 LSC and the 2012 NFPA 99:

  • Quarterly main drain test on one system riser downstream of the backflow preventer where the sole water supply to the sprinkler system is through a backflow preventer;
  • Quarterly inspection of fire hose valves;
  • Annual test/inspection of all fire-rated door assemblies;
  • Annual test of the 2.5 inch fire hose valves;
  • 18-month test of non-stationary medical gas booms and articulating assemblies using flexible connectors for medical gas outlets;
  • 3-year test of the 1.5 inch fire hose valves;
  • 5-year internal inspection of sprinkler pipe.

So… according to the information provided by CMS, when they begin surveying to the 2012 LSC on November 1, 2016, you need to have your first quarterly main drain test conducted and your first quarterly inspection of fire hose valves. However, the annual, 18-month, 3-year, and 5-year new requirements are not due until their respective anniversary from the July 5, 2016 effective date.

I apologize for this miscommunication…. And I’m glad my friend took the time to point that out to me.

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Sep 15 2016

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

Category: BlogBKeyes @ 12:00 am
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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.

 

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Sep 09 2016

CMS Announces New Rule on Emergency Management

Category: BlogBKeyes @ 12:00 am
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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

FOR IMMEDIATE RELEASE September 8, 2016

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.

 

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Aug 04 2016

How the Changes to the SOC Process Will Affect Life Safety Compliance

Category: BlogBKeyes @ 12:00 am
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On July 13, 2016, The Joint Commission issued the following statement:

 “Effective Aug. 1, 2016, changes will become effective to the Statement of Conditions™ (SOC) process that will affect the survey of Life Safety (LS) chapter requirements. Following Aug. 1, 2016, the following changes to survey will occur:

  1. The open Plan for Improvement (PFI) items will no longer be reviewed by the survey team.
  2. The open PFI will no longer be imported into the Final Report.
  3. All Life Safety (LS) chapter deficiencies identified during survey will become Requirements for Improvement (RFI) with a 60-day Evidence of Standards Compliance (ESC). For those deficiencies that require more than 60 days, a Time-Limited Waiver process is available.
  4. Only equivalency requests related to survey events will be reviewed.

The Joint Commission has had the SOC as part of its accreditation program since 1995. The SOC was originally created to allow organizations a process to develop a plan for improvement to correct deficiencies they self-identified within a justifiable time frame based on budgeting and scheduling needs, with Interim Life Safety Measures (ILSM) to ensure patient safety. Initially, these self-identified actions were not documented during survey because the SOC already documented the deficiency. The Joint Commission also created the ILSM process to mitigate risk while resolving the deficiencies. This allowed the SOC process to be the method for organizations to create and submit their Plan for Improvement (PFI), with an amount of time to make the correction that the organization could manage, while still providing a safe environment. Occasionally, an organization would need additional time to complete the corrective action, and The Joint Commission granted extension requests. Many of these extension requests occurred during the six-month automatic extension period.      

CMS has identified required changes to the SOC process, including:  

  • No longer allowing the SOC to document self-identified deficiencies, instead, taking the self-identified deficiencies and converting those to RFIs by the surveyor 
  • No longer allowing more than 60 days for corrective actions unless approved by the CMS regional office
  • The surveyor citing all deficiencies replacing the extension request component with a Time Limited Waiver process, using the Survey-related Plan For Improvement (SPFI) process that will be managed and tracked by the CMS regional office
  • Managing the survey-related equivalency process, as defined by CMS, using Salesforce and the SOC to manage and track the CMS regional office action  
  • Removing the six-month automatic extension
  • No longer granting requested extensions
  • Joint Commission leadership, after reviewing the restrictions being placed on the SOC, has determined that the Basic Building Information and PFI components of the SOC no longer fit the quality assessment program it was originally designed as, and will become an optional management program and will not be a part of the survey process. Post survey, the CMS Time Limited Waiver and equivalency components of the SOC will be used to manage survey-related deficiencies. All questions should go to The Joint Commission Department of Engineering at 630-792-5900.”

 

This is another sad event for patient safety caused by a federal agency that cannot see the positive that the SOC / PFI process had for healthcare organizations. This action by CMS is not a knee-jerk reaction that was not carefully considered; rather this decision by CMS to not allow the hospitals and ambulatory surgical centers to have a process of self-identification of Life Safety Code deficiencies and an incentive to be proactive has been long-coming for years.

Back in 2008 when Det Norske Veritas (DNV) Healthcare received deeming authority from CMS, the new accreditor wanted a system similar to the Statement of Conditions PFI list, but was told by CMS that they could not. Similarly, in 2012 HFAP applied for a system similar to the PFI list but was also denied by the federal agency.

In 2014 when CMS issued their proposed rule to adopt the 2012 Life Safety Code, the public responded with many comments. Quite a few commenters mentioned that CMS should keep the SOC/PFI system and allow all of the accreditation organizations a chance to utilize it.

When CMS issued their final rule on May 4, 2016, they made it very clear that there will not be any Plan For Improvement list in the way that Joint Commission was operating. That was the writing on the wall and it became clear that the major hospital accreditor would have to discontinue its use.

This is a very sad event, because now it is feared that many hospitals will no longer be proactive and self-identify their own Life Safety Code deficiencies because any incentive to do so (i.e. not citing the deficiency on the survey report) has been removed. CMS has struck harder and put a stop to hospital self-identifying the projected completion date, and now makes all LSC deficiencies cited during a survey to be resolved within 60 days of the end of the survey.

Since major LSC deficiencies cannot be resolved that quickly, CMS is now requiring the healthcare organizations to request a time-limited waiver through the accreditor. This is another example of CMS tightening their grip on the accreditation process. In this case, it reduces the level of safety for the patients. Where is the logic in that?

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Mar 02 2016

CMS Enforces Different Time-Description

Category: BlogBKeyes @ 12:00 am
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I received the following comment from a reader:

During a recent CMS life safety survey a surveyor stated that my kitchen hood suppression testing intervals were out of compliant even though they’re we’re clearly within The Joint Commision’s plus or minus 20 day window for semi-annual testing. He said CMS goes by the NFPA code (not JC) and that, that window is not in the code so therefore the testing must be completed before the 6 month anniversary. However, he stated that the quarterly inspections and testing can be done in a calendar basis and not by the revised quarterly interval parameters that JC has implemented (every 3 months, plus or minus 10 days).

This is an example where the accreditation organization has developed a thoughtful and practical interpretation of the NFPA standards regarding frequency of inspections and tests. Then CMS comes along and denies the practicality of the interpretation because it is not permitted in the NFPA codes or standards. That’s one of the problems with the NFPA standards is they don’t define time, such as what “semi-annual” or “every 6 months” means.

I’ve heard some state agencies surveying on behalf of CMS actually require the annual inspection or testing activity to occur exactly on the same date as the previous activity, one year later. So if it was last tested on April 15, it had to be next tested on April 15 of the next year, regardless what day of the week that landed on. That was extreme and I hope responsible people came to their senses.

But part of the problem is the people who are interpreting these rules have never worked in a hospital. They seem to not understand that hospitals need a reasonable window of opportunity to schedule these inspections and tests. Facility departments have decreasing resources available to them and it would sure be helpful if the government would just give them a little help now and then by interpreting issues with a little kinder attitude.

Wouldn’t it be nice if all of the authorities having jurisdiction (i.e. CMS, accreditation organizations, state fire marshals, etc.) were on the same page for critical issues like this?

 

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