During the COVID-19 pandemic, rules and regulations have been in flux at all levels. Keeping track of what is allowable on a local, state and federal level has been an added challenge for health system leaders.
As they balance normal operations along with pockets of COVID-19 surges, it will be important for providers to take a moment to debrief and audit their response efforts. This energy will be time well spent if it helps hospitals get back to regulatory readiness and prepares them for the next event – whether that be a resurgence of COVID-19 or a disaster related to the active hurricane season.
Where has The Joint Commission been?
The Joint Commission (TJC) suspended all surveying activities in response to the March 4 announcement by the Centers for Medicare & Medicaid Services (CMS) on, which noted the agency would only survey on serious patient safety allegations related to COVID-19 care. At the end of May, TJC lifted its suspension and announced it would resume surveys in June, albeit with an altered surveying process to accommodate the organization operating at 30 percent capacity through the end of the year.
TJC stated its surveys will not retroactively review compliance during the pandemic timeframe. Instead, TJC will work to understand how providers have adapted to the pandemic and review their current practices to assure safe care and a safe environment.
How will TJC decide who to survey? TJC’s decision to survey a hospital will depend on the information that a provider’s account executive receives from the organization. In addition to using The New York Times’ COVID-19 database as their official resource for states/counties as related to their COVID-19 rates, account executives will gather the following information from providers:
- Whether your incident command is still operating, and if the emergency operations plan is still being utilized
- Which waivers have been claimed. Keep in mind that providers should have declared the waivers internally, including when they started (typically March 1) and ended.
- Whether you have any surge units or areas that are caring for COVID-19-positive patients
- Whether you are conducting elective surgeries or procedures
- The number of staff that has tested positive in the last 14 days
- Details about visitor restrictions in place, if applicable
Check out our blog post, Getting Back to Regulatory Readiness, for steps for providers to unwind activities taken under the guides of the 1135 waivers.
Get your documentation in order.
As part of its thorough assessment, TJC will review the documentation associated with a provider’s return to post-pandemic operations. These records should include dates decisions were made, leaders involved in making those decisions, and the timeframe in which the organization discontinued emergency operations and began to return to normal operations.
- Have you documented the dates that the 1135 waivers were claimed, when they were released from practice and steps taken to return to routine operations?
- Have you furloughed any employees or changed their roles? If so, providers should ensure their orientation and competencies have been completed and appropriately documented.
- Do you have documentation of the evaluation of your Emergency Operations Plan?
- Have the appropriate personnel reviewed all patient care policies? These reviews should note whether a provider plans to revert back to pre-pandemic care policies or if the plans will need to be revised when the pandemic subsides.
- A good starting point will be the incident command center, which should be able to help review records to validate the waivers sanctioned and the timeframes.
- Some CMS waivers have catch-up work that providers must complete within a certain timeframe. A good idea is to create a document to track the applicable standard and timeframes that the interim rule was published, implemented and expired, as well as any policies related to the temporary rules.
- Designate a person(s) within each department to act as a liaison with Corporate Compliance to stay up to date with internal interpretations of waivers, as well as to follow state and federal publications regarding rule changes.
Take a closer look at areas of risk.
Temporary changes and the decreased availability of products may have led to an increased risk for diversion or poor documentation that could put the organization at risk. The rigor with which providers audited themselves to ensure compliance with interim standards will be key.
- Did you conduct any additional monitoring in response to changes in process? For example, consider whether you increased the frequency of clean-room sanitation due to the reuse of personal protective equipment (PPE) or whether you altered your beyond-use date of products due to lack of PPE.
- Were any routine audits or preventive maintenance deferred during the business of the pandemic response? Be sure to review and catch up on these practices as routine operations resume.
- Have capital requests, such as for IV room remodels, been put on hold? If a capital request was put on hold, from a pharmacy perspective, this could change your date of full compliance with USP 800.
- Review purchase data and documentation for new or temporary care locations that were established to support COVID-19.
- Almost every U.S. hospital is building safety stock of critical pandemic medications. Ensure medications and supplies that are being stockpiled for temporary service areas are routinely monitored for expiration dates and redistributed to areas of need.
- For any areas of non-compliance, document corrective action plans.
- Within the pharmacy, re-evaluate USP compliance in existing spaces where construction is now deferred. Using a shorter beyond-use date on compounded products may need to continue until full compliance can be achieved.
Reinforce interim policies and procedures within the pharmacy.
Health system pharmacies may have had emergency preparedness policies, but many of those policies are designed for an acute or short-term event. During the pandemic response, some policies and procedures (P&P) were changing on a daily basis due to availability of drugs or PPE. The duration of the crisis has necessitated multiple updates to P&Ps across many practice areas.
- How did you document interim compliance strategies?
- Do your P&Ps reflect what you actually did during emergent and interim guidance periods?
- If you didn’t have a P&P for emergency response, use this time (sooner rather than later) to capture lessons learned and to be better prepared for the next event.
- What: Make it obvious what the changes are (e.g., capital letters, red type) so personnel are clear on what they can and cannot do.
- Who: Educate staff on the changes. However, remember that not all staff need to be aware of all the changes. Target your education. Make sure education is documented as surveyors will likely ask for evidence on how changes were communicated.
- Why: State clearly why you made the changes and what medical or evidence-based guidance was used to make the revision.
- When: Share when the new P&P are to be in effect. Note when the changes were made, as you will have to revert to the old policies and procedures at some point in the future.
Providers should keep the temporary policies and procedures on file. Before returning to historical procedures, ensure all required elements are available to meet compliance (i.e., unwinding changes that may have been made to beyond-use dates due to PPE availability).
Reduce your risk of non-compliance.
Healthcare providers have a new definition for routine operations these days. As you wade through the realities – from increased telehealth utilization to technology that predicts COVID-19 surge – regulatory readiness must also be a part of your operational plans.
Premier’s experts can help with every step, from evaluation and documentation to pharmacy readiness. Our experts understand the nuances and can create an airtight game plan that quickly gets your organization back to regulatory and accreditation readiness.
Contact us today.