The Greeley Company was delighted to share its insights about how to best prepare for and cope with changes in the survey process as State Agencies and Accreditation Organizations resume CMS survey activities. The following is our response to questions posed during the September 30 webinar.
Q: Will there be attachments/copies of slides from the September 30 Webinar available?
Q: Our hospital had our DNV accreditation survey in June. Are we still vulnerable for a CMS validation survey past 60 days?
A: Sample validation surveys (full-book surveys conducted within 60 days of an accreditation survey) are not on the list of CMS survey priorities. Also, sample validation surveys conducted more than 60 days after an accreditation survey cannot be used to “validate” the accuracy of the accreditation survey process. Therefore, the likelihood of a CMS sample validation survey following a June 2020 DNV survey is extremely low.
However, a “for cause” or “significant allegation” validation survey can happen at any time and is second on the list of CMS priorities. Should CMS become aware of a situation that seems to jeopardize patient safety, they have the option of authorizing a focused (or, less likely, a full-book) “significant allegation” validation survey.
The bottom line: We believe your staff can safely go from DEFCON 2 to DEFCON 3 (“they’re likely to come any day” to “we should always be prepared.”)
Q: We understand CMS is now imposing fines for non-compliance. Do you have any idea what these may look like?
A: CMS has developed and is implementing a process for Civil Monetary Penalties (CMPs) for violations of the Conditions of Participation that apply to Skilled Nursing Facilities. Since this is a new process, we suspect that is what you’ve heard about. The best source for detailed information about CMPs for nursing home violations is on the CMS website.
We are not aware of federal fines that may be levied on non-long-term-care facilities (hospitals, etc.) other than those imposed by the CMS Office of the Inspector General (OIG) related to EMTALA (the federal Emergency Medical Treatment and Labor Act). This fining authority has been in place since EMTALA’s inception in the 1980’s.
There also continues to be the possibility of fines for billing or accounting irregularities for all provider types.
Q: Is there a resource to check for Aerosol-generating procedures? What about resources related to TRAN?
A: [NOTE: Although Greeley and others have discussed this topic in detail with The Joint Commission, the following information should not be taken as a substitute for official TJC guidance.]
For obvious reasons, the definition of an aerosol-generating procedure (“AGP”) has been the source of much debate and discussion in national forums.
We, at Greeley, had discussions with The Joint Commission on this topic in August. As of then (and through the date of this response), we are not aware of a nationally recognized list of procedures that would be classified as AGPs. However, the CDC has a robust discussion of the topic on its website.
That site (which should be checked regularly for updates) indicates that the CDC has not identified a definitive or comprehensive list of AGPs for healthcare settings due to the lack of expert consensus and sufficient supporting data.
Instead the CDC has identified commonly performed medical procedures that are often considered AGPs, or that create uncontrolled respiratory secretions, including:
- open suctioning of airways;
- sputum induction;
- cardiopulmonary resuscitation;
- endotracheal intubation and extubation;
- non-invasive ventilation (e.g., BiPAP, CPAP);
- bronchoscopy; and
- manual ventilation.
The CDC is uncertain whether aerosols generated from other procedures may be infectious, including nebulizer administration* and high flow O2 delivery.
The review article referred to in our Webinar is also referenced by the CDC and was written in 2012 when SARS was prevalent. Here is the complete reference:
Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J (2012) Aerosol Generating Procedures and Risk of Transmission of Acute Respiratory Infections to Healthcare Workers: A Systematic Review. PLoS ONE 7(4); https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3338532/#!po=72.2222
- Tran, et. al. states, in part (emphasis added): “Procedures reported to present an increased risk of transmission included [n; pooled OR(95%CI)] tracheal intubation [n = 4 cohort; 6.6 (2.3, 18.9), and n = 4 case-control; 6.6 (4.1, 10.6)], non-invasive ventilation [n = 2 cohort; OR 3.1(1.4, 6.8)], tracheotomy [n = 1 case-control; 4.2 (1.5, 11.5)] and manual ventilation before intubation [n = 1 cohort; OR 2.8 (1.3, 6.4)]. Other intubation associated procedures, endotracheal aspiration, suction of body fluids, bronchoscopy, nebulizer treatment, administration of O2, high flow O2, manipulation of O2 mask or BiPAP mask, defibrillation, chest compressions, insertion of nasogastric tube, and collection of sputum were not significant. Our findings suggest that some procedures potentially capable of generating aerosols have been associated with increased risk of SARS transmission to HCWs or were a risk factor for transmission, with the most consistent association across multiple studies identified with tracheal intubation.”
The practical result of this uncertainty is that the organization must develop its own list of AGPs based on a review of literature and an assessment of risks. Procedures listed by the hospital as AGPs that are performed on suspected or confirmed COVID-19 patients must be conducted in an appropriate environment and using appropriate process precautions.
Although Greeley does not have a recommended list of AGPs, we suggest that the following information (a risk assessment) be available for review when requested:
- A formal, written list of procedures considered by the organization to be AGPs.
- A description of the precautions that must be taken for suspected or confirmed COVID patients undergoing these AGPs.
- A summary of the literature consulted in developing the list (including at least the two sources listed in this guidance: TRAN and CDC).
- The reason any procedure on the CDC’s more extensive list of possible AGPs is not considered an AGP at your institution.
Q: You mentioned that this was not approved by CMS to date. Would they move forward with this without having CMS approve the process?
A: This response assumes the questioner was referring to elements of the virtual survey process.
It is very unlikely that The Joint Commission will move forward with a virtual survey process for a given provider/supplier category without the prior approval of CMS.
There are some aspects of the virtual survey process, however, that will likely not be an issue. For example, we don’t expect the remote retrospective review of electronic health records to be an issue since this has been a standard practice for state agencies for many years (surveyors take records with them and review them in the office). There may also be no controversy about the pre-survey review of documents assuming the implied “announcement” of an impending survey can be resolved. (See our subsequent Q and A).
Bottom line: We don’t expect The Joint Commission to move forward with remote deemed-status hospital surveys in advance of feedback from CMS. As we covered in the Webinar, the Clinical Laboratory Improvement Amendments (CLIA) part of CMS has approved virtual lab surveys, as has the Substance Abuse and Mental Health Services Administration (SAMHSA) for opioid treatment programs. We would not be surprised if the main (Baltimore) CMS policy branch waited to see how those surveys go before acting on The Joint Commission’s broader proposal. On the other hand, The Joint Commission makes the point that, without the ability to perform at least parts of its surveys remotely, it is likely to be very, very behind on routine re-accreditation surveys for many months to come.
We’ll do our best to keep you posted. Also look for announcements in The Joint Commission’s monthly Perspectives.
Q: We’re due for a survey in fall of 2021. Should we expect that all surveys will be delayed or is The Joint Commission planning on catching up over the next year?
A: It depends entirely on when your state/county opens up.
For now, if your state and county is open according to The Joint Commission criteria and your survey window is open, then you can expect a call from your account representative to see if your organization is able to accommodate an on-site review team. Remember that the survey window can be as early as 18 months after your last survey.
As time goes on, survey resources may become a limiting factor and may cause non-COVID reasons for a delayed survey. However, at present, the folks who are experiencing delayed surveys are mostly hospitals that were due or overdue for a routine survey beginning March 2020 through the end of this year.
Bottom line: Be ready. There is no current reason to believe a fall 2021 survey would be delayed.
Q: Can you elaborate more on the CMS COVID survey?
A: [NOTE: Greeley’s Infection Prevention Readiness Program will be hosting a series of Webinars covering this and related infection prevention challenges. Please watch our website for dates and times.]
The survey you asked about was mandated by CMS in March 2020 in QSO-20-20-All “Prioritization of Survey Activities.”
The memo itself is nine pages. Attached within that memo are two infection prevention surveyor workbooks. The first (starting on page 10) is a “COVID-19 Focused Survey for Nursing Homes.” The second attachment (starting on page 19) is a “COVID-19 Focused Infection Control Survey: Acute and Continuing Care.”
The document speaks for itself, and we encourage you to refer to this source. In general, however, the questionnaire, which is supposed to be completed by reviewers during State Agency and Accrediting Organization surveys, is based on CDC recommendations in effect since March 2020. The survey module touches on the following topics:
- entering the facility (triage, registration, visitors);
- standard and transmission-based precautions;
- hand hygiene;
- personal protective equipment (PPE);
- aerosol-generating procedures (AGPs);
- transmission-based precautions;
- policies and procedures;
- emergency preparedness;
- considerations for specialty and critical access hospitals;
- observations of clinical care;
- observations of environmental cleaning in spaces used for the care of suspected or confirmed COVID cases; and
- special considerations for dialysis facilities.
Q: Is that change a response to the 2-year deeming?
A: CMS was engaged in the review of The Joint Commission’s deeming authority for many months prior to the final 2-year decision in July 2020.
It became apparent to The Joint Commission during the pre-July review process that additional survey resources would be necessary for the ambulatory environment of care. Other issues raised by CMS during its review of The Joint Commission, such as the timing of the leadership conference and the conduct of daily briefings, were addressed in a plan of correction submitted by The Joint Commission following receipt of the final CMS report — similar to what hospitals and other providers go through after State Agency surveys.
We believe the impact of The Joint Commission’s 2-year award of deeming authority to be minimal. Although some may see the shorter term as an embarrassment, its only true impact is that The Joint Commission will have to submit a reapplication for deeming authority sooner than some of its peer accreditation organizations.
Q: Can we extrapolate The Joint Commission to other accrediting agencies?
A: We have not inquired about the impact of the pandemic on other accrediting agencies. However, since all survey agencies have a budget that is based on surveyor-days and since surveyor-days are likely to have been greatly impacted by COVID-related travel restrictions, we suspect that all accreditors are likely feeling the pain and thinking of innovative ways to interact with their client organizations.
Q: How much in advance of your audit can they request the organization’s policies, etc.?
A: The Joint Commission, like all accrediting organizations, can request various documents at almost any time. For example, the electronic application is a living repository of hospital information and is updated throughout the accreditation cycle.
As for the documents specifically requested in the Survey Activities Guide (the documents request on page 22 of the 2020 SAG, which includes minutes, policies, state-agency reports, and other survey documents), The Joint Commission’s current practice is to request the documents a few weeks before the beginning of a virtual survey. However, this is a new process and is subject to change.
If The Joint Commission requests the documents too soon (say at the start of your survey window), many will be out of date by the time the survey takes place.
If The Joint Commission requests the materials just before the start of the survey, the survey date essentially has been announced (“we’re coming sometime in the next few weeks”).
As of today, The Joint Commission is requesting the SAG documents very close to the start of virtual surveys for laboratories, non-deemed hospitals and the other organizations where virtual surveys are approved. We’ll stay tuned to see what tomorrow brings for deemed-status organizations.
Q: Has The Joint Commission said how much time and notice the hospital will be provided to upload the required documents?
A: According to The Joint Commission, an account representative works with each organization to determine a realistic time frame for the document upload process. Some organizations may be able to upload the document in a week while others may take longer due to the format or availability of the documents. For example, some organization may already have most or all documents in electronic form while others may have to scan many of the documents, requiring more time to upload.
This is a new process for everyone, so there’s a learning curve on both sides of the equation.
The Joint Commission recently posted a short video explaining the intra-pandemic survey scheduling process on each organization’s extranet site.