Patton Post – February 2021

February 2021

Inside This Issue

Although various vaccination phases of 1A and 1B are well underway across the country, we note that test positivity rates still remain quite high in many states, thus we will again this month try to filter through a very lengthy edition of Perspectives and highlight the top two action items for priority attention.

#1 Performance Measurement Data:

First, there is an article on pages 9 and 10 of Perspectives on functional modifications that have been made to the Certification Measure Information Process, or CMIP, the software application used to submit certification performance measurement data to TJC. There does not appear to be new requirements established, but rather changes to the way in which data is entered which might be new to the individual who enters information. This looks straightforward and our suggestion is to simply refer the two pages to your data entry staff for their review and testing.

The article also summarizes the 2021 data submission deadlines, which you will want to add to calendars or ticklers for attention when due. The first deadline for first quarter data is not until June 30th. While action is not time sensitive, finding the description of these changes in a few months might be difficult, therefore our advice is to share the article now.

#2 Flammable Antiseptics:

Second, this month’s Consistent Interpretation column is a must read for quality, operating room, and procedural setting staff who use flammable antiseptics prior to procedures. The standard at issue is EC.02.03.01, EP 12. While the 2019 noncompliance rate was only 2.34%, the proper use of these agents is somewhat difficult to observe, and much more importantly the result of improper use could result in a surgical fire. The EP requires the use of nonflammable packaging materials for the antiseptic, for the product to be unit dose applicators, and a perioperative “time out” be conducted prior to initiation of the surgical procedure.

The use of the term “time out” is unfortunate as this is not the same as the presurgical time out and requires three verifications. The first is verification that the application site for the antiseptic is dry prior to draping and the use of any surgical equipment. The second verification is that the antiseptic solution has not pooled around the patient or that if there was pooling, it has been wiped up. The third verification is the most confusing in that it mandates the solution-soaked materials have been “removed from the operating room” prior to draping and the use of surgical devices.

We placed quotation marks around the term “removed” because it comes straight from current NFPA language and it is duplicated in the TJC EP. However, the phrase “removed from the operating room” has been interpreted in this case to simply mean removed from the proximity to the patient. Unfortunately, there is no FAQ or note with the EP, explaining this more flexible interpretation, so sharing this column with operating room staff is essential.

Medical Staff Updates:

Perspectives has an announcement about three EP modifications in the medical staff chapter, two of which add more flexibility and one of which has no impact because it is redundant. The first change, without impact is to MS.01.01.01, EP 3 which stated that elements of performance 12-37 of MS.01.01.01, had to be described in the bylaws. However, this was redundant because each of those EPs already stated the requirement needed to be in bylaws.

The second change is to MS.06.01.05, EP 11 which stated that the time period for acting upon completed (privilege) applications needed to be addressed in the medical staff bylaws. The new change now states this time period could be in bylaws, rules and regulations, or policies and procedures.

The third change is interesting, although not likely to be taken advantage of by many Joint Commission accredited hospitals. MS.13.01.01, EP 1 currently allows a hospital to credential and privilege telemedicine providers either through the hospitals own credentialing and privileging process or using the credentialing and privileging information or decision from the distant site organization, if Joint Commission accredited. This has been changed to either Joint Commission accredited, or Medicare participating hospital. This means you could base your privileging decision off of information shared by a nonaccredited hospital. We find few hospitals taking advantage of the information sharing opportunity with accredited hospitals, thus it is not likely this will increase utilization of this expanded flexibility.

Reduced Volume Requirements:

The November Perspectives and Patton Post discussed the temporary volume reductions that were put into place for advanced stroke certification. These reduced volume requirements were put into effect due to national figures being down as a result of Covid-19. The February Perspectives announced that these temporary volume reductions which were due to expire on February 1, 2021 have now been continued until June 1, 2021.

Remote Surveys:

Perspectives also has an update on remote surveys that is of interest. TJC mentions in the article that they had conducted 1,200 such off-site surveys in 2020, although not in all programs or all types of surveys such as full and follow up surveys. Many of our readers have probably started conducting some internal and external business meetings using similar remote technology. We at PHC have also been using remote technology to conduct consultation visits and our consultants and clients have been surprised at how thorough such visits can be.

With deemed status agreements with CMS there is of course hesitancy to use remote technology, however the inability to conduct in person surveys in areas with high Covid-19 infection rates is equally problematic. It is difficult to predict the future but this may be a way for TJC to catch up with a backlog of 2020 surveys and ultimately get to the 2021 schedule. In this month’s CMS section, we discuss the most recent Report to Congress on the Status of Validation Surveys with accreditors.  Both Joint Commission and DNV have indicated that they are expecting written guidance from CMS in the near future, this memo from CMS may or may not offer the accrediting organizations additional flexibility to conduct more offsite or remote surveys.

EM Standards for 2022:

The lead article in this month’s EC News is somewhat of a broad-brush review of what is being planned for change relative to EM standards. TJC reports that they reached out to over 700 healthcare organizations this past summer to gain their feedback about issues that have been important to them during the pandemic.

TJC is now critically evaluating its EM standards and planning revisions to be published in 2021, for implementation in 2022. With the many lessons learned and problems presented, there will likely be many other entities also changing their requirements, and this EC News article discusses anticipated changes from FGI, NFPA, and CDC.

While there is nothing definitive that we can do now to prepare, you will want to keep your eyes open for these changes when TJC does their field review later this year. That feedback opportunity can help shape the direction and content of any new requirements. Remember, your organizations evaluation of EM preparedness may have had some unique solutions that should be factored into standards changes.

After-Action Reports:

Keeping with the theme of emergency management, the second EC News article is about preparing an after-action report either after a drill or an actual emergency. This article also has a boxed section with definitions for the types of exercises that are now permitted under the standards as revised in 2020. These include a full-scale exercise, a functional exercise, and a tabletop exercise.

We would also like to remind readers that an evaluation of the pandemic response (an actual emergency) can substitute for a full-scale exercise and we believe most readers would want to seize that opportunity given the duration and intensity of what has transpired this past year. The article provides links to a 2009 CMS evaluation template which can be accessed through the ASPR TRACIE website.

There is also a link to a Homeland Security after-action evaluation template.

In addition, we would like to remind readers of the template we developed and distributed with our May 2020 Patton Post. Our template was designed using the six critical areas and followed the structure of the TJC standards, formatting specific EP requirements as questions for evaluation.

Hopefully, at some point in near future this pandemic is going to subside and healthcare organizations will be able to resume normal business and conclude an evaluation of this pandemic. Regardless of which template you choose, you will want to circulate this article to your EM team for their use at the appropriate time.

Fire Doors:

EC News has an article on risks associated with fire doors and they focus on two standards/EPs:

1. 02.01.10, EP 11 (functioning)
2. 02.03.05, EP 25 (annual inspections)

LS.02.01.10, EP 11 requires a fire door to properly close and latch, be appropriately rated, labeled, and not be damaged. This has been a requirement since 2017 and since inception, this EP has been one of the most frequently scored issues in hospitals, behavioral, and ambulatory care facilities. In fact, they state it has been scored more than 2,700 times since 2017. The number one reason for scoring is a failure for the fire door to latch properly.

EC.02.03.05, EP 25 requires the organization to perform inspection, testing, and maintenance (ITM) on fire doors and their associated components. This EP has been in effect since mid-2018, and since that time there has been 512 observations of noncompliance. You can think of this EC element of performance as potential causation, and the LS finding as the result of this cause.

If you don’t perform the required inspection and maintenance as required, you are more likely to have an operational failure identified during survey. An operational failure could still occur, even with annual inspection, maintenance, and testing, but it would be a newer and less frequently occurring issue if ITM had been performed.

You may want to take a look at you last survey report to see if you were cited for this issue. If not cited, you are fortunate, but if cited you would like to not see this repeat finding showing up on your next survey report. Sharing this article with the facilities team and analyzing current data on fire door failures being identified from the annual inspection process is suggested.

Hyperbaric Checklist:

EC News finishes with another of their checklists for self-evaluation of services, this month examining hyperbaric oxygen chamber services. These services are always a focus of attention on Joint Commission surveys due to their unique characteristics and risks.

Another resource we have found helpful is the Clinical Hyperbaric Facility Accreditation Manual from the Undersea and Hyperbaric Medical Society.

Wrong-Site Surgeries:

We would also like to draw your attention to an article published in the Patient Safety Journal, “Wrong-Site Surgery in Pennsylvania During 2015-2019.” Pennsylvania state has a mandatory, never-event, reporting program and this article summarizes 368 events reported by 178 facilities. There are always valuable lessons to be learned from someone else’s sentinel events.

Idea Train:

• There will always be valuable lessons to be learned from documented sentinel events
• Valuable lessons will always be learned from either reading of someone else’s sentinel events or being reminded of your own

This report covers wrong side, wrong site, wrong procedure, and wrong patient events. They identified the most problematic procedures with the top three being injections, “other,” and spinal and identified the top three most problematic body parts as spine, head and neck, and lower extremities.

As consultants, we did notice the frequency of spine and head/neck procedures during this period of time.  Performing consultations and discussing the Joint Commission’s universal protocol requirement UP.01.02.01, EP 1 (which calls for general site marking, which may be followed by more precise radiologic verification), we often face resistance relative to the concept of general site marking for spinal procedures.

Not doing general site marking would appear to lose some of the patient and team interaction as everyone verifies and re-verifies the planned location. The publication can be downloaded here.

QSO 21-12, Annual Report to Congress:

On January 19, 2021 CMS published QSO 21-12, the annual report to Congress on the status of the validation surveys CMS performs in comparison with accrediting body surveys. This presents the 2019 report to Congress, which examines surveys performed in 2018. Many different accrediting organizations are included, as are all types of providers where an accreditor has deemed status from CMS. This report does not yet reflect the new concurrent validation survey technique that CMS has been utilizing recently.

Unfortunately, CMS continues to find more noncompliant Medicare COPs than the accrediting bodies do. For the hospital provider type, CMS conducted 107 validation surveys for all accrediting bodies. The state surveyors cited a COP level finding 57 times and CMS reports that 50 of these COP issues were not scored at a COP level by the accreditors.  While the report is very lengthy, you might want to take a look at table #16 on page 44 which summarizes findings for each accreditor.

CMS conducted 78 validation surveys at Joint Commission accredited hospitals and the state surveyors cited a COP level finding 42 times, and they report that TJC missed scoring these issues 36 times. Breaking this down further, 24 COP findings from the state surveyors were in IC and 6 were the physical environment. CMS reports that TJC missed scoring the IC issues at a COP level 12 times and missed scoring the physical environment issues at a COP level 3 times. Since the decision on how to rate a finding as a standard level or a COP level is somewhat subjective, uniformity or concurrence between the accreditor and the state surveyor is difficult to achieve.

As healthcare professionals we have learned the difficulties in evaluating clinical literature and drawing conclusions when sample sizes are small, as are these. In addition, we all perform a “face validity” check on the conclusions presented in that literature. It is difficult for us to understand how CMS could score 42 COP level findings and TJC would miss 36 of them. We know that TJC has reported it is scoring issues at a COP level in a little over 50% of its hospitals.

As we review Joint Commission’s survey reports, it seems that a significant majority have IC and/or EC/LS issues scored at a COP level. The report to Congress states that the state surveyors conduct their surveys without any knowledge of the accreditors reports. We would be curious to hear from our readers if that has been your experience with CMS validation surveys.

The end result is that the published disparity rate has been higher than desired for many years and while it appears that accreditors are scoring more COPs out of compliance, it does not yet appear to be enough. There are already changes planned for concurrent validation surveys, and it is also possible that accreditors will need to score findings more liberally at a COP level, as there is no “credit” for a plain, non-COP level RFI.

QSO 21-12 also published a link to the results of CMS surveys that you might find interesting to study, https://qcor.cms.gov/main.jsp. This provides entry into the database of CMS findings in a searchable format. You can search by provider type, date range, or even just your state. We did a nationwide search for hospitals to identify the most frequently scored tags on CMS hospital surveys. The top ten findings and the percentage of CMS surveys where this tag was scored:

1. A-0144 Care in a safe setting 6%
2. A-0395 Supervision of nursing care 8%
3. A-0115 Patient rights 5%
4. A-0749 Infection control 9%
5. A-0405 Admin of drugs 7%
6. A-0396 Nursing care plan 6%
7. A-0145 Free from abuse/harassment 1%
8. A-2400 Compliance with EMTALA regs 1%
9. A-0043 Governing body 1%
10. A-0385 Nursing services 0%

We encourage our readers to search this site for their own state’s most frequently cited issues. We ran a few and they are different, as different agencies have a different focus. Knowing what the top deficiencies are in your state might help prepare for a CMS survey, conducted by your state’s surveyors.

QSO 21-13, Suspending Surveys:

CMS also published QSO 21-13 for hospitals on January 20, 2021. In this memo CMS announced that they were suspending lower-level complaint-based surveys and routine recertification surveys for 30 days due to the pandemic. They are also extending any pending enforcement actions for 30 days. It appears to us that CMS is facing a similar problem to TJC in that infection rates, patient acuity, and census are still too high for surveyors to be present, in person, conducting a survey. This continuing problem may eventually lead to greater comfort with remote methods of evaluating compliance.