Accreditation – Compliance – Patient Safety
Inside This Issue
November 2020 PHC Newsletter
Flu Vaccine for Staff and LIPs:
This month’s edition of Perspectives does not have any major standards changes or pronouncements. Rather there is a handful of smaller changes in the survey process and several standards that we will briefly mention.
The first minor change is the deletion of IC.02.04.01, EP 5 requiring healthcare organizations to achieve a 90% influenza vaccination rate among its employees. This requirement had been established based on the national Healthy People 2020 goal setting process, but this specific goal was deleted in the 2030 edition. Thus, TJC is also deleting its requirement.
However, don’t forget that PERSPECTIVES
while EP 5 is deleted, there are multiple other EPs that require a focus on employee and LIP vaccination rate including EPs that require your organization to have a program, educate staff and LIPs, provide vaccine, plan out incrementally improved vaccination rates, describe how you calculated your vaccination rate, evaluate reasons for declination, improve rates, and provide feedback to key stakeholders about vaccination rates among staff and LIPs.
Advanced Stroke Requirement Changes:
The second minor and temporary change is in the volume requirements for recertification as a thrombectomy capable stroke center (TSC) and a comprehensive stroke center (CSC). Due to declining nationwide volumes, believed to be due to Covid-19, TJC is decreasing two required volume requirements.
Both the TSC and CSC recertification volume requirement for mechanical thrombectomy is being decreased to 50% of the prior expectation— 8 in 12 months or 16 in 24 months. The CSC requirement for subarachnoid hemorrhage care and aneurysm clipping/coiling is being reduced to 75% of the prior requirement– 11 clipping, coilings in 12 months or 24 in 24 months and 15 aneurysmal SAH care patients in 12 months or 30 in 24 months.
The initial certification requirement is also being reduced, but not as significantly as these organizations have not previously gone through a certification survey. Here, the requirement for the initial survey is being reduce to 80% of the current requirements. The TSC and CSC volume requirement for mechanical thrombectomies is reduced to 12 in 12 months or 24 in 24 months. The CSC volume requirement for aneurysmal care is 16 in 12 months or 32 within 24 months.
At this point in time, these initial and resurvey volume expectations are reduced only until February 1, 2021, however TJC might decide to extend them again if volumes don’t pick up.
EC Survey Change:
Effective 1/1/21 TJC is going to eliminate the one-hour EC sit down discussion that is held with the EC or Safety Committee. They will increase the amount of time dedicated to document review and building tour as a result of this change. In addition, the Survey Activity Guide will be updated and the EOC document list/review tool will be included in the SAG.
Covid and Surveys:
TJC also advised they had modified the Covid-19 threshold for conducting surveys, meaning they should be able to survey in more locations than previous. They are still conducting a planning call to verify that conditions in the organization make conducting a survey appropriate at this point in time before scheduling the survey. If you still have a Covid-19 unit open, surveyors are not visiting these units at this time.
Access to Perspectives:
TJC has simplified the process for your colleagues at each accredited organization to obtain access to Perspectives since January 2020. They have reprinted these instructions again this month. Staff who have an email address in the domain name of the accredited organization can register for access using the link published in Perspectives and reproduced here: https://www.jointcommission.org/about-us/joint-commission-connect-request-guest-access/
They will need your HCO ID #, which you can provide to staff or they can obtain it from Quality Check. Once they submit the request, they will be granted access to Perspectives. This should make things we suggest you share with different department heads easier as you can just send them an email, advising them to review the article on page X, self-assess their readiness and be prepared to discuss at the next organization accreditation meeting. If staff do not have an email address in the domain name of your organization, they can still request access, but the main TJC contact at each organization will have to approve each request.
New MS Tracer Tools:
We have previously discussed activities at a TJC Consultant Forum in this newsletter, and that same group has been combined with several other advisory groups and TJC conducted a teleconference meeting during the past month. One of the issues they discussed this month were some new tracer tools they developed for conducting the medical staff system tracer.
The new tools provide structure for the discussion of credentialing and privileging, OPPE, FPPE, medical staff bylaws review and graduate medical education, as well as a checklist for the file review itself.
gotten away from such checklists in more recent years, however they do create a standardized approach that many organizations like because they now know exactly what to anticipate. We do not currently see these tools posted on the extranet; however, we anticipate they will be published in the 2021 Survey Activity Guide (SAG).
Surveyors have been trained on these new tools and have been encouraged to cover all the material in the tools. The Joint Commission believes this will streamline the Medical Staff System Tracer.
TJC also responded to a question about changes to the hospital NPSG for 2021 and the response was that there are no changes to NPSG for 2021.
There are a couple of new subjects that are undergoing standards development right now, including workplace violence and water management. Drafts are not yet available but these are anticipated in draft form in early 2021, so be on the lookout for these important subjects and provide your feedback before either gets approved.
USP Chapter 825:
It is well known that USP Chapter 797 is still under review and at this time there is no identified approval date. However, a less well-known chapter 825 on radiopharmaceuticals is going to become official on December 1, 2020. Most hospitals that we consult with do not compound or dispense radiopharmaceuticals, they administer radiopharmaceuticals. Our readers will want to verify that their nuclear medicine department has obtained and reviewed this new Chapter.
At present, this can still be downloaded for free from the USP website, but after the chapter becomes official it is anticipated this will become a “for sale” publication. If you don’t already have a copy, you will want to obtain it this month. Section 1 of this new document is particularly important as it identifies who is subject to USP Chapter 825 and who is not.
As previously stated, administration of radiopharmaceuticals is not covered by this new chapter. In addition, preparation or compounding of PET drugs that are not manufactured as approved drugs is also not covered. You will also want your nuclear medicine department to carefully review section 3 of this chapter which discusses immediate use preparation of sterile radiopharmaceuticals. This section exempts the requirement for the SEC and PEC you have become familiar with in your pharmacy, providing the work being done meets the immediate use definitions in this section 3. In this section, they discuss the preparation of radiolabeled red blood cells for immediate use as well as the simple manipulation of a unit dose by the addition of lidocaine.
Again, most hospitals don’t compound or dispense, but rather obtain their radiopharmaceuticals from an offsite compounding radiopharmacy, whom is fully subject to this new chapter. As such, the purchase of these patient specific doses by the hospital is subject to the Joint Commission’s clinical contracting standards under LD.04.03.09. At a minimum you will want to verify that your vendor is compliant with the new USP Chapter 825. We would suggest that your nuclear medicine department and pharmacy staff collaborate to help evaluate the vendors compliance with this chapter.
The American Society of Health System Pharmacists has developed an evaluation tool for offsite pharmacy compounders; however, it is not nuclear medicine specific and The American Pharmaceutical Associations Academy of Pharmacy Practice and Management has prepared a nuclear pharmacy evaluation tool; however, it is still expressed in terms of USP Chapter 797 rather than the newer USP Chapter 825.
Using these templates and your own staff’s expertise, it is likely you can develop a useful tool to help evaluate the offsite radioactive isotope vendor. Whenever possible, we encourage the evaluation of any offsite compounder to include a site visit as many hospitals learned the value of verifying offsite quality data after their experience with the New England Compounding Center.
Cardinal, a large national supplier of medications to hospitals and a dispenser of radiopharmaceuticals, has a web posted document explaining some of the implications of Chapter 825. This can be accessed using the following link: https://www.cardinalhealth.com/content/dam/corp/web/documents/fact-sheet/cardinal-health-usp-825-as-one-chapter-ends-another-begins.pdf
EM Planning and Prep:
This month’s EC News continues the 2020 theme of emergency management planning with its first two articles. The first article describes the work done by a large ambulatory care clinic system, WellMed to prepare for and manage during this year’s Covid-19 national emergency as well as their preparation for their region’s hurricane season. They share some interesting ideas including their approach to telemedicine services and providing home-based patients with some essential medical monitoring equipment prior to their telemedicine appointments. It is well worth sharing with your EM leadership and team.
FEMA & Flooding:
The second article is an in-depth discussion and analysis on flood mitigation and response. The authors note that FEMA has identified flooding as the most common natural disaster hazard in the US, accounting for 70% of presidential disaster declarations. They also provide a link to a FEMA document entitled “Making Hospitals Safe from Flooding.” This is a very extensive document that every organization with risk of flooding should analyze. You can find this resource using the following link:
Several times in the EC News article they suggest the FEMA recommendation to plan and design for the “500-year flood” with a 0.2% probability in any given year. After careful review and analysis of this article, you might want to reconsider your HVA risk rating for floods in your area. In addition to sharing it with your EM leadership and team, this article warrants careful analysis and discussion of potential risks that might not have been recognized previously.
The November EC News also has a refresher article on the requirements for fire drills in various types of care settings. The authors remind organizations that quarterly drills must be spaced more than one hour apart so that they are indeed random and not expected. The authors also mention that drills should not always be conducted on the same day of the week, although we have not seen that scored previously. This may be difficult to identify as the Fire Drill Matrix tool surveyors use identifies dates, but not dates of the week. A link to the TJC Fire Drill Matrix tool is provided in the article and that resource can be downloaded from:
ABHR Fire Safety:
Lastly, there is an advertisement article for a new JCR reference on fire safety and the use of flammable alcohol-based hand rub (ABHR). But they also provide a link to an ABHR Safety Checklist that looks useful. That tool can be downloaded from:
At the time of this writing, there are no new CMS QSO memos posted for the healthcare industry. However, the CDC has certainly been busy this year and as a nation we are looking forward to a Covid-19 vaccine sometime in the near future. There are many recent resources relative to vaccines and specifically plans for the pandemic vaccine program that we have provided links to that you likely will find useful in your planning efforts. We would also encourage our readers to check their state health department websites because some states have already developed more specific guidance for your state.
2020 Vaccine Storage Toolkit:
This is the periodically refreshed, comprehensive CDC summary of guidance on vaccine storage and distribution. This was last updated in January of 2020, just prior to the pandemic, but the guidance is now very detailed and applicable to all vaccine programs.
Pandemic Vaccine Program Distribution, Tracking and Monitoring:
This is a 2-page high level summary and flow chart for national distribution of the Covid-19 vaccine when it becomes available. https://www.cdc.gov/flu/pdf/pandemic-resources/pandemic-influenza-vaccine-distribution-9p-508.pdf
Ten Things Healthcare Professionals Need to Know about Covid-19 Vaccine Distribution Plans:
A narrative discussion of facts about the plan for healthcare professionals with multiple embedded links to more detailed information. https://www.cdc.gov/coronavirus/2019-ncov/hcp/vaccination.html
Covid-19 Vaccination Program Interim Playbook for Jurisdictional Operations:
This is probably the most detailed reference, 56 pages, you can access today describing the national plans for vaccine distribution and tracking. https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf
Explaining Operation Warp Speed:
A description of the national program to accelerate the production of a vaccine by initiating production of vaccine candidates, while phase 3 clinical trials are ongoing and plans for national distribution. https://www.hhs.gov/sites/default/files/fact-sheet-operation-warp-speed.pdf
Developing Safe and Effective Covid Vaccines:
Operation Warp Speeds Strategy and Approach.
Emergency Use Authorization:
A discussion of the emergency use authorization process, that may need to be explained to patients and staff if one or more vaccines are initially available using an EUA. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization