The newest memo on surveys — QSO-21-16-Hospitals, "Resuming Hospital Survey Activities Following 30-day Restrictions"— was posted online March 26 but carried an effective date of March 23.
CMS surveyors could be on your doorstep tomorrow if you have faced a complaint in the last two months that did not involve an immediate jeopardy (IJ) to patients, staff or visitors.
Effective now, CMS surveyors are resuming hospital surveys on the limited basis as set out in a Quality, Safety & Oversight Group memo last August. Up first are uninvestigated complaints, with a target survey within 45 days.
Since January 20, CMS state surveyors were only investigating serious patient safety issues that potentially put patients, staff or visitors in immediate jeopardy (IJ), as outlined in QSO-21-13-Hospitals. Most other surveys were on hold as CMS evaluated the continuing impact of the COVID-19 pandemic.
The newest memo on surveys — QSO-21-16-Hospitals, “Resuming Hospital Survey Activities Following 30-day Restrictions”— was posted online March 26 but carried an effective date of March 23. In it, CMS also told state survey agencies that hospital complaints that did not involve an IJ should be investigated within 45 days.
Kurt Patton, MS, RPh, founder of Patton Healthcare Consulting and former director of accreditation services with TJC, said the memo was pretty straight-forward, but that hospitals should particularly take note of two deadlines.
The first is the 45-day window for CMS surveyors to catch up on non-IJ hospital complaints, says Patton. In addition, hospitals should be prepared to submit plans of correction (POC) within 10 days of March 23, which is April 2.
However, if your facility is in the middle of a COVID-19 surge, there is some flexibility.
According to the CMS memo, “All open surveys with cited deficiency tags must have an acceptable POC and supporting evidence in order for the tags to be corrected. Providers have 10 calendar days from the effective date of this guidance to submit their POC for surveys that ended on or after January 20, 2021.”
In a note that follows, CMS said, “Providers who may have difficulty allocating resources to develop and implement a POC because they are currently experiencing an outbreak of COVID-19 in their area should contact their SA and/or CMS location to request an extension on submitting a POC.”
“Onsite revisits are authorized and should resume as appropriate,” according to the memo.
The January memo temporarily suspending all but major CMS surveys was effective for 30 days, with 30-day renewal notices. That last renewal was up March 22.
The commission has been pushing hospitals to focus on maternal health and infant safety for years, and most recently implemented new maternal health standards.
Review how your hospital did in reducing falls, unintentional retention of foreign objects, suicides, delays in treatment, and wrong surgery in the last year. Those five sentinel events are once again in the top five of patient safety problems reviewed by The Joint Commission (TJC) in 2020, according to recently released statistics.
In highlighting the most commonly reviewed sentinel events, TJC officials brought special attention to falls involving infants as “an underrecognized issue” among other patient falls.
TJC reminded organizations that, according to its Quick Safety Report No. 40, issued in 2018, “Preventing newborn falls and drops,” that maternal risk factors for infant falls included problems related to Cesarean birth, use of pain medication within four hours, issues on the second or third postpartum night, specifically midnight to early morning hours, and drowsiness associated with breastfeeding.
The commission has been pushing hospitals to focus on maternal health and infant safety for years, and most recently implemented new maternal health standards.
Overall, patient falls held the top spot for 2020 sentinel events with 170 incidents reviewed by TJC, the highest since 2005.
Almost 90% of the 794 overall sentinel events reviewed by TJC were voluntarily self-reported, and officials reiterated that “it is estimated that less than 2% of all sentinel events that occur in health care are reported to The Joint Commission. Therefore, these data are not an epidemiologic data set, and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
TJC said it “works with organizations reporting sentinel events to identify contributing factors and actions the organization can take to reduce risk.”
The Joint Commission (TJC) is returning to its more traditional survey activities – onsite and unannounced, as of March 15.
In a statement in its Joint Commission Online weekly publication, TJC noted that COVID-19 caseloads have been decreasing. “The Joint Commission will return to its usual procedures prior to the pandemic. Organizations will no longer be receiving a phone call or email from their account executive when it has been determined the area is low risk for The Joint Commission’s accreditation survey team to visit. All available resources will be utilized to conduct onsite, unannounced accreditation surveys.”
TJC says it is also working with CMS to prioritize hospitals and other healthcare organizations that have accreditation dates past due. “An organization’s existing accreditation remains in effect until a new survey takes place and a new accreditation decision has been rendered,” according to the statement.
In addition, “organizations should continue to monitor the Notification of Scheduled Events section of their Joint Commission Connect® extranet page for notification on the first day of the unannounced survey. Additionally, the organization’s primary accreditation contact and chief executive officer will continue to receive email notification of the scheduled event on the first day of the unannounced survey.”
Even as survey activities return to normal, TJC offers the reminder that its surveyors “are considered essential workers and are following the most up-to-date guidelines from the Centers for Disease Control and Prevention.”
“While the survey team will be onsite, they will continue to:
Practicing safe physical distancing by limiting the number of individuals in group sessions, minimizing the number of staff who accompany a surveyor or reviewer during tracer activities, and driving in separate vehicles (or, for surveyors and reviewers, their own vehicles) to offsite locations or home visits.
Wearing personal protective equipment by requiring Joint Commission surveyors and reviewers to wear masks and asking that health care organizations provide masks and/or other personal protective equipment to surveyors and reviewers.
Utilizing enhanced technology to support physical distancing, such as: using screen sharing or projection to review electronic medical records and interview care recipients or staff; and incorporating audio/video conference calls to safely expand the number of meeting attendees.”
After some delay, The Joint Commission’s (TJC) 2021 Survey Activity Guide (SAG) is finally online.
Be sure to check the “What’s New for 2021” section. Many of the updates, such as the elimination of the Environment of Care session, are not unexpected. Other items did not change, such as the documents that will be requested on the first day of survey.
However, be aware that TJC is “clearly trying to get more time for tracers,” notes Jennifer Cowel, RN, MHSA, CEO of Patton Healthcare Consulting and a former TJC executive and nurse surveyor.
“They eliminated the initial surveyor planning session the first morning after the opening conference. This was normally used to review the day one documents and plan the detailed agenda,” says Cowel.
She said they have also combined two of the 30-minute sessions, Issue Resolution and Team Meeting/Surveyor Planning, into a single meeting. That means, she says, there will be “more tracer time and less time for surveyors to plan and digest and consult with each other.”
“I would recommend that day one documents are organized, easy to access (no plastic sleeves you need to pull documents out of) and ready the very start of day one,” advises Cowel.
She suggests you also be prepared for food to be immediately available at the start of the 30-minute lunch period. “Give them lunch and give them quiet time during this very limited lunch break. The surveyors can plan their combined 30-minute issue resolution/team meeting/surveyor planning either during the day, end of day or just after lunch. Get the team leads opinion and plans.”
Other observations from Cowel about the revisions and what it means for surveys:
Environment of Care (EC): The EC session has been eliminated and according to the SAG “The topics that were addressed during this session will now be covered throughout the survey by Life Safety Code® surveyors and clinical surveyors during Individual Tracer, Facility Orientation, and Building Assessment activities.” Cowel notes that “related to this, the Life Safety & Environment of Care Document List and Review Tool has been expanded to add more detail on requirements.”
New Survey Tools introduced: “They have included survey tools for Medical Staff System tracer, a kitchen tracer survey guide and a tracer tool to focus the review of the various imaging modalities and required document review,” notes Cowel. The kitchen tracer guide change was announced at the annual American Society for Health Care Engineering’s 2020 conference.
“These tools have been circulating in 2020 and they are welcome addition to the survey guide,” notes Cowel. “We strongly recommend that hospitals share these tools with the subject matter experts and have the required documents pulled, reviewed, updated and waiting for the surveyor when that portion of the survey occurs.”
“These are open book tests,” she continues. “You should also use these documents to do your own internal self-assessment of readiness.”
One tool eliminated is the Perinatal Survey Guide. Cowel notes that new standards are in effect this year in addition to TJC publishing a related R3 report. “I would suggest using the standards and the guidance in the R3 reports to self-assess compliance with these new important standards.”
The SAG notes the tool has “been removed from the guide for editing and refinement for health care organizations.”
Review your infection control plan for Ebola now that the CDC is recommending that all U.S. healthcare settings should ask about international travel while screening patients and visitors for signs and symptoms of COVID-19.
As of March 4, the CDC is also requiring all airlines and other aircraft operators to collect and transmit contact information to the CDC “for appropriate public health follow-up and intervention for all passengers boarding a flight to the United States who were in the Democratic Republic of the Congo (DRC) or the Republic of Guinea within the 21 days before their arrival in the United States.”
The alerts from the CDC comes as reports increase about the ongoing Ebola Virus Disease outbreaks in DRC and Guinea.
In addition, it recommends that facilities “ask about and document international travel histories to alert healthcare personnel to the possibility of other communicable infections, such as viral hemorrhagic fevers, that need specific infection control precautions and/or treatment,” said the alert.
“Post contact information for infection control personnel and the local public health jurisdiction for reporting of communicable diseases, including EVD, in easily visible locations,” it added.
The Association for Professionals in Infection Control and Epidemiology (APIC) advised members that “personnel are asked to share this information with all personnel who might conduct screening and triage activities or be responsible for initial clinical management of patients (e.g., including Emergency Medical Services, outpatient, and emergency department personnel).”
The CDC clinical alert also included the following additional recommendations and resource information:
Current infection prevention and control recommendations for EVD in U.S. healthcare facilities
Current CDC infection prevention and control guidance for U.S. healthcare facilities is available on the CDC Ebola website for clinicians. Specific guidance and tools that may be of interest to facilities include:
A PPE Calculator Tool is available to assist healthcare facilities in determining the appropriate supply of PPE to have on hand to manage a PUI or patient with confirmed EVD.
A healthcare facility evaluating a PUI or treating a patient with EVD should consult with public health authorities if they are unable to meet these recommendations due to PPE shortages caused by the COVID-19 pandemic.
The Regional Treatment Network for Ebola and other special pathogens
Healthcare facilities and public health officials should be familiar with the tiered U.S. Regional Treatment Network for Ebola and other special pathogens.
Healthcare facilities should understand their role in the tiered network as a Frontline facility, State-designated Assessment Hospital, State-designated Treatment Center, or HHS-designated Regional Treatment Center.
Healthcare facilities and public health officials should have established plans for how PUIs or EVD patients are to be managed and referred.
CDC continues to coordinate with the HHS Office of the Assistant Secretary for Preparedness and Response, Hospital Preparedness Program and the National Emerging Special Pathogens Training and Education Center (NETEC) to increase U.S. capability to safely manage patients with EVD and other special pathogens. NETEC maintains online resources at the link above, and remains available to provide consultation to hospitals for managing patients with EVD.
However, in many cases hospitals still may be subject to their regular onsite, triennial reaccreditation survey. And they will be unannounced, as usual.
Be aware: As COVID-19 cases go down, your odds for on onsite reaccreditation survey might go up.
Until at least March 22, CMS is continuing to limit its onsite hospital surveys, except those involving complaints of immediate jeopardy to patients or in cases where patients are considered to be in eminent danger.
In a memo initially issued January 20 to CMS’ state survey agencies (SA) and revised on February 18, the federal overseer of Medicare said it was directing accreditation organizations (AO) to also limit hospital surveys based on certain criteria.
However, in many cases hospitals still may be subject to their regular onsite, triennial reaccreditation survey. And they will be unannounced, as usual.
DNV GL Healthcare, in an advisory to clients on February 15, said hospitals due for a triennial reaccreditation survey may be eligible for a two-week postponement, based on criteria provided to the AOs by CMS.
That criteria, according to DNV, states that your hospital cannot have:
A history of COVID-19-related complaints
Reported OSHA violations
Media reports about health or safety concerns
In addition, the main hospital facility must be in an area with a high prevalence of COVID-19 cases, and you must be able to show objective evidence of a heavy patient surge.
That evidence must be in the form of data you have reported to CMS, as required, about COVID-related cases, or documentation that you have informed your state health authorities that you have implemented crisis-of-care standards, as defined by the CDC, HHS’ Assistant Secretary of Preparedness and Response, or your state or local health authority, said DNV officials during a webinar explaining the new criteria on February 18.
CMS keeping a list
Be aware that CMS has told AOs that it is generating a monthly list of hospitals that are up for their triennial reaccreditation, but that also have COVID-related complaints, OSHA violations, or other health or safety concerns reported by the media.
Any hospital on that subset list must be surveyed on time and on site, DNV told clients.
Those facilities that qualify for a postponement maybe able to ask for another delay if they still face a heavy surge, but it is not automatic, said DNV.
Heavy prevalence of cases is determined by the positivity rate CMS has been publishing every week on its data website: https://data.cms.gov/stories/s/q5r5-gjyu. While the site says it reflects nursing home data, it is the stated data CMS and the AOs have been using since last year to gauge surge.
The data is separated into county or locality and color coded, with red or yellow as areas with the highest number of current cases.
“Hospitals in low or medium-prevalence counties (10% or lower COVID-19 positivity over 14 days, indicated in green or yellow on the CMS table) that are due for reaccreditation in 2021, may now be scheduled for full onsite survey at any time,” noted DNV in its advisory. “These surveys will continue to be unannounced.”
If you are in a surge and within your reaccreditation window, and can show evidence of the surge as set out in the criteria, DNV sending information to the DNV client dropbox at DNVClientDropBox@dnvgl.com.
Criteria for onsite surveys continues to change
Since the COVID pandemic was declared last spring, DNV and the other AOs — The Joint Commission (TJC), HFAP and the Center for Improvement in Healthcare Quality (CIHQ) —have postponed or conducted virtual or remote surveys as allowed by CMS.
As of the end of January, most AOs were trying to do onsite surveys unless it was dangerous for their surveyors or for the hospital to host as they tried to meet an infectious surge.
The information from CMS continues to change. At one point CMS was allowing partial remote surveys, but said AOs would have to do full reaccreditation surveys onsite at a later date. TJC, HFAP and CIHQ all said they were trying to avoid having hospitals go through what amounted to a double survey.
On February 17, TJC issued a statement that while it had paused surveys through the end of May, it had been contacting organizations about the possibility of remote surveys.
“Currently, not all programs or organizations are eligible for an offsite event. For example, some states have restrictions on allowable offsite processes. As the pandemic has progressed, however, so has the eligibility criteria,” stated TJC. “Offsite events are conducted for eligible organizations located in counties at higher risk of COVID-19 transmission. However, if an organization is in a county determined to be at a lower risk of transmission, an onsite survey or review may still be scheduled if program-specific criteria are met.”
“If an organization meets criteria for an offsite survey or review, it will be contacted by another outreach method (email or phone call) by a member of The Joint Commission’s staff. After this initial outreach, a test of required technology will be scheduled. If an organization has not yet been contacted, it is likely because the organization is not currently eligible for this type of event,” according to TJC’s statement.
Overdue hospitals may go first
In addition, TJC said that “organizations with overdue survey and/or review events due to the pandemic may be prioritized over organizations with upcoming events. Questions may be directed to an organization’s designated account executive.”
DNV’s statement noted that “CMS will continue to monitor national conditions and may modify AO guidance at any time. DNV GL will review any changes and communicate any future adjustments as they emerge.”
Many of DNV’s other survey activities, including its annual surveys, can be conducted remotely, said DNV officials. “DNV GL may continue conducting these surveys remotely, or onsite where it is safe, so if your hospital has been provided a date or advance notice of any of these activities, please be prepared to continue with survey until further notice or clarification from DNV GL.”
CMS told its own state survey agencies in January it was putting a general hold on hospital surveys, except for those dealing with immediate jeopardy situations, for at least 30 days, in recognition of growing COVID-19 patient surges in many areas.
DNV GL Healthcare, the second largest of the hospital accrediting organizations (AO), announced on February 5 that it was altering its on-site and remote survey process based on new guidance from CMS.
The Center for Improvement in Healthcare Quality (CIHQ) CEO Richard Curtis RN, MS, HACP, told Accreditation Insider that they had no plan to change current practices.
CMS’ Quality, Safety & Oversight Group had promised the new guidance in an announcement on January 20 that the agency was temporarily suspending or limiting on-site surveys because of the COVID-19 patient surge.
(Inside Accreditation & Quality is asking other AOs if they will follow suit and has requested the information from CMS as well. This article will be updated as that information becomes available.)
CMS told its own state survey agencies in January it was putting a general hold on hospital surveys, except for those dealing with immediate jeopardy situations, for at least 30 days, in recognition of growing COVID-19 patient surges in many areas.
At the time, CMS said AOs were also being asked to do the same, but that more information would be made available to the AOs later. DNV President Patrick Horine, MHA, told IAQ at the time that the memo seemed to catch some people even inside CMS by surprise.
Horine also reiterated what DNV, The Joint Commission and other AOs have said in the past—if a hospital is within their three-year survey window but is in the middle of a COVID patient surge, hospital accreditation officers should inform their AO liaison.
Similarly, CMS has said that hospitals and states where crises of care protocols were being implemented or considered should also reach out to the federal agency for help.
DNV’s latest announcement noted that the newest CMS’ guidance again is based on the county-level positivity data—ranked as red, yellow, and green—the agency has been collecting to use, in part, as a starting point for if and when a facility can be surveyed. Hospitals in areas with high positivity rates, meaning there is a higher COVID-19 patient surge, have a lower priority for survey.
CIHQ said in note to clients that AOs received a letter from CMS on February 1 requesting “a hold on most routine reaccreditation surveys scheduled to be performed through February 19, 2021. The hold can be extended for additional 30-day increments for the duration of the public health emergency (PHE). This follows a notification to State Agency’s earlier in January to do the same.”
The Texas-based AO said, “during this time, CMS has instructed AO’s to base the decision to proceed with scheduled reaccreditation surveys on State/County COVID-19 prevalence data. CMS utilizes a green (mild) to red (severe) color coded display of the data which is updated in 14-day increments.”
CIHQ told clients that “reaccreditation surveys will continue to occur as scheduled for any hospital that is in a ‘green’ zone. For hospitals in any other zone (yellow through red), the AO may delay the survey for up to two weeks if the situation in the hospital would make a survey burdensome or otherwise not advisable.”
In addition, CMS has also given CIHQ and the other AOs “the option of utilizing a ‘Hospital Focused Modified Reaccreditation Survey Model’ (HFMS). If an AO chooses to do so, CMS will provide the AO with a list of hospitals due for reaccreditation that will receive an HFMS survey, regardless of their county prevalence. Hospitals will be placed on this list based on the following:
Complaints received by the AO (or immediate jeopardy occurrences) during the PHE related to infection control and patient safety;
Media reports regarding health and safety concerns during the PHE; or
OSHA violations during the PHE.”
“The HFMS model consists of limiting the number of surveyors/days on-site and conducting aspects of the survey remotely (virtually). Activities such as patient interviews, observations of care, limited building tours, infection control observations, and assessing restraint use would be conducted on-site. Other activities such as document review, medical record review, and staff / leadership interviews would be done remotely. An AO will be required to submit specific policies and procedures to CMS for approval before being granted permission to perform an HFMS,” wrote CIHQ.
“This allowance is different than that which may have been previously granted to an AO to perform virtual surveys requiring follow-up on-site surveys once the PHE ends. Under the HFMS model, it appears the survey will be accepted by CMS. A hospital would not be required to undergo a second reaccreditation survey once the PHE ends.”
According to DNV:
“Based on the new guidance, DNV GL is adjusting our schedule of NIAHO® accreditation surveys for hospitals, critical access hospitals and psychiatric hospitals to align with the new CMS survey priorities, effective immediately:
Hospitals in low-prevalence counties (less than 5% positivity over 14 days, indicated in Green on the CMS table), that are due for reaccreditation in the first half of 2021, may now be scheduled for full onsite survey at any time. These surveys will continue to be unannounced.
Hospitals in medium- or high-prevalence counties (5% or greater positivity over 14 days, indicated in Yellow or Red on the CMS table), and who are also near or beyond the accreditation effective date shown on their NIAHO® certificate, will be prioritized for county prevalence monitoring and scheduled for unannounced survey as soon as county prevalence drops below 5%.
Other DNV GL accredited hospitals in medium- or high-prevalence counties with reaccreditation due in 2021 may be considered for HFMS survey if the suspension period is extended beyond February 19. If the suspension period ends February 19, DNV GL will begin scheduling reaccreditation surveys as soon as possible with priority based on certificate expiration dates and prior year survey timing. CMS may provide subsequent revisions to prioritization at that time and we will communicate any adjustments as they emerge.
Annual/Periodic accreditation surveys in all counties will continue to be conducted remotely until further notice. Hospitals that are expecting an annual survey (non-reaccreditation) in the first half of 2021 may be scheduled for survey at any time. These surveys remain unannounced but we will continue to follow the advance notice provision in our established procedure for remote surveys.”
The DNV announcement went on to say that the AO “is considering participation in the HFMS program and is working with CMS on practical implementation matters, the likelihood of additional 30-day suspension periods, and potential benefits to our accredited hospitals. CMS is also developing lists of hospitals for each AO, identifying specific hospitals that meet qualifying criteria for the HFMS program and those that must have a 100% onsite survey. We will provide more information on HFMS participation, program details and qualifying criteria once we have more information and approval from CMS.”
DNV GL said its “survey and audit activities that are not governed by CMS QSO oversight, such as service-line certification programs, ISO-only audit activities, CIP, VAD and annual/periodic accreditation surveys are not subject to these restrictions but may still be limited due to local COVID-19 conditions. DNV GL may continue conducting these surveys remotely, or onsite where it is safe, so if your hospital has been provided a date or advance notice of any of these activities, please be prepared to continue with survey until further notice or clarification from DNV GL.”
The CIHQ letter to clients observed that CMS’ “request to hold /postpone reaccreditation surveys reflects the ongoing challenges [of a] ‘business as usual’ method during the pandemic. The allowance for a HFMS model is likely the result of requests by some AOs for increased latitude in conducting reaccreditation surveys to avoid extensive backlog.”
That means providers will have at least 60 days’ notice before the blanket waivers of certain Medicare Conditions of Participation and Conditions of Coverage will no longer be in effect.
With a nod to the likely reality that the pandemic will last through at least 2021, The Department of Health and Human Services (HHS) has said that it will give states — and therefore hospitals and other healthcare organizations — 60 days’ notice before it officially ends the COVID-19 public health emergency (PHE).
That means providers will have at least 60 days’ notice before the blanket waivers of certain Medicare Conditions of Participation and Conditions of Coverage will no longer be in effect. And you will have at least that much time to come into compliance.
But you will still have to be in compliance when those waivers, which have allowed providers certain flexibilities to put resources and energy into meeting the challenges of the COVID-19 patient surges, end along with the PHE.
HHS Acting Secretary Norris Cochran informed the nation’s governors about the change in a letter on January 25.
In a note to its clients, hospital accrediting organization DNV GL Healthcare noted the second paragraph of Cochran’s letter to governors:
“We are writing to you today to share more details regarding the public health emergency (PHE) for COVID-19, as declared by the Secretary of Health and Human Services (HHS) under section 319 of the Public Health Service Act (42 U.S.C. §247d). The current public health emergency was renewed effective January 21, 2021, and will be in effect for 90 days. To assure you of our commitment to the ongoing response, we have determined that the PHE will likely remain in place for the entirety of 2021, and when a decision is made to terminate the declaration or let it expire, HHS will provide states with 60 days’ notice prior to termination.”
While the reprieve from uncertainty every 90-days on when the waivers would end is good news, DNV warned its clients that compliance will still be required whenever the waivers do end.
“DNV GL Healthcare has fielded many questions over the course of the PHE regarding the PHE’s end date and questions regarding hospital’s compliance expectations at the end of the PHE, particularly regarding 1135 blanket Waivers. While CMS has continued to indicate that there will be no grace period to return to compliance when the PHE ends, the 60 days’ notice prior to ending the PHE will allow hospitals some time to move towards being compliant at the end of the PHE.”
Whether you are a hospital or off-campus location, you must take several key precautions both with administering the vaccine and ensuring the safety of its storage and handling.
This article was originally published January 29, 2021 on PSQH.
It might take weeks or months before the U.S. gets the COVID-19 vaccine out to all of those who want it. The CDC and most states are first offering the shots to healthcare workers and other essential personnel.
Whether you are a hospital or off-campus location, you must take several key precautions both with administering the vaccine and ensuring the safety of its storage and handling.
Be extra careful with the vaccine and with the dry ice that will keep it cold—mishandling the dry ice can cause injury and even death, warned Ramya Krishnan, senior project engineer of device evaluations for ECRI, during the patient safety organization’s online Q&A session on December 16, 2020.
Also, think through how you will schedule and move patients through your facility, advised David Watson, vice president of ECRI’s European operations. Watson is based in the United Kingdom, where the first Pfizer-BioNTech vaccines were administered on December 8.
You will need space to take a patient history (including any previous allergic or anaphylactic reactions to food, drugs, or insects), to administer the vaccine, to provide at least 15 minutes of observation for adverse reactions afterward, and an area to care for anyone who does have a reaction—all while maintaining the same social-distancing and infectious-disease precautions you’ve had since the pandemic began, he noted.
Patients with a history of allergies should be observed for 30 minutes. In the first days of vaccination in the U.S., a nurse in Alaska, with no prior history of allergic reactions, did have a serious anaphylactic response to the vaccine on December 15 but recovered quickly.
The U.S. government is shipping the Pfizer-BioNTech vaccine to various states, which will then be in charge of distributing the thermal containers to predesignated locations according to each state’s vaccine rollout plan. Moderna’s vaccine is expected to follow soon.
The CDC has published playbooks and other information to help organizations with the rollout.
Remember to freeze or chill, but do not shake
Accurate and frequent logging of your refrigerator or freezer temperatures will be among the most important tasks as hospitals and other healthcare providers begin administering the first of two doses of the vaccine.
The vaccines are extremely sensitive to temperature. In addition, they will come in multi-dose vials that must be diluted and then slowly mixed by inverting the bottle back and forth, according to manufacturer’s instructions.
The Pfizer-BioNTech COVID-19 vaccine is being shipped frozen, in thermal containers, to keep the serum at ultra-cold temperatures, and then must be kept in those containers or moved to ultra-cold freezers until they are ready for use.
The Moderna vaccine does not need to be kept frozen but is still temperature sensitive.
Both companies are shipping initial storage and administration supplies with each container, as well as detailed instructions on storage and handling, defrosting, and ultimately providing the inoculations to patients, said the ECRI experts.
Follow these manufacturer instructions closely, they advised. You do not want to waste any of the vaccine doses.
That includes following the strict, time-honored guidelines for using multi-dose vials with multiple patients, warned Stephanie Uses, PharmD, MJ, JD, a patient safety analyst with ECRI. Use one needle on one patient, discard the needle in the appropriate sharps container, then use a new needle on the next patient, she said.
Measure carefully
Also, be careful to precisely measure the preservative-free sodium chloride the manufacturer provides to dilute the vaccine before slowly inverting the vial back and forth the required number of times, Uses said.
If you reconstitute the vaccine with too much or too little of the preservative-free mixture, you risk giving too little or too much of the vaccine. Too little may render it ineffective, and too much may invoke a stronger side effect in the patient. Uses repeated that point several times, noting it was emphasized by the manufacturers.
The vials are marked as containing five doses. However, after the initial rollout, the FDA and others reported that some sites were getting an additional dose out of the vials than expected.
“It is not uncommon for manufacturers to include overfill when manufacturing injectable medications. The overfill accounts for possible spillage or loss when drawing up the medication,” noted Uses, in response to a query from Inside Accreditation & Quality.
“The dose of the Pfizer COVID-19 vaccine is 0.3 mL per dose, which would add up to a total volume of 1.5 mL needed for five doses. The reconstitution instructions are to add 1.8 mL of preservative-free sodium chloride. You will have an excess of the 1.5 mL needed for the five doses based on adding 1.8 mL of diluent to the medication; if there is minimal loss of medication when drawing up the dose, there can be enough overfill for an extra dose,” said Uses.
“What is important is to ensure that the vaccine is being reconstituted properly with 1.8 mL of diluent,” she said.
Uses and others noted that while the vaccine is approved by the FDA and has been shown to be both effective and safe, there is still not a lot of information about the serum.
Don’t rush to buy ultra-cold freezers
While many facilities are rushing to buy ultra-cold freezers, that is not necessary and not even recommended by the CDC, noted Jonathan Gaev, MSE, business line manager of biomed and device evaluations for ECRI.
The shipping containers provided by Pfizer will be sufficient to keep the vaccines frozen as long as the 50-pound supply of dry ice is replaced every five days. Pfizer says it will allow facilities to keep the containers for 30 days.
In addition, each container is equipped with a digital thermometer that will alert Pfizer if temperatures are outside the optimal range, which must stay under at least -20°C (-4°F). Pfizer will then alert the facility to deal with the problem.
If you transfer the vaccine to your own freezer, you must keep track of its temperature. In addition, make sure you plan for emergency power outages, warned Gaev.
Moderna vaccines are not shipped frozen, but they must be kept cold according to manufacturer instructions, said Krishnan.
Beware handling the dry ice
If you choose to use the shipping containers and replace the dry ice—frozen carbon dioxide—as required, you will need cryogenic gloves, not regular gloves, to handle the dry ice. You will also need to train staff how to handle the ice as well as the vaccine.
Since the gloves are expensive, if you decide to have multiple people use a single pair of cryogenic gloves, they should also each wear a clean pair of exam gloves to maintain infection control, Krishnan said.
Also remember that as dry ice degrades and warms, it becomes carbon dioxide gas, which can cause respiratory problems or even death if the area is not vented adequately, she warned. So, when replacing the dry ice, ensure that the area is either well ventilated or that you open the container and allow the gas to dissipate before reentering the area.
Even more importantly, when carbon dioxide gas is trapped in a tightly contained area such as a freezer, it can pressurize and explode, she warned, damaging the freezer and anyone near it.
Also, do not throw dry ice away in your normal waste containers. It must be handled and disposed of with special care, she said.
(Several safety data sheets are available about dry ice online. Here is one from the University of Washington.)
Manage your medication: Keep vaccines separate
However you choose to store your vaccines, do not store the Moderna and Pfizer vaccines together. If you only have one freezer or refrigerator, at least put them on separate shelves, said the ECRI team.
Also ensure the patient gets a follow-up shot from the same manufacturer. The two vaccines are different and not designed to be used together.
And when you educate the patient on side effects, be sure to also give them an appointment for the follow-up. Be prepared to not only send a text or phone call reminder, said Watson. The U.K. medical offices are prepared to go physically find patients for their follow-up shot.
Here is a checklist provided by ECRI to review your vaccine implementation program. Your program should include:
Safe and secure handling of vaccines
Cryogenic safety equipment and training
Scheduling and handling, to include:
Screening and consent documents
Verification of recipients’ ID
Post-injection observation period
Scheduling of follow-up
Nurses and pharmacists trained on procedures and answering questions
The page also includes links to several key resources, including an ECRI list of manufacturers of dry ice and dry ice coolers, and an ECRI Exclusive Hazard Report on “Dry Ice for Storing Vaccines—How to Handle It Safely.”
CMS is putting a general hold on hospital surveys, except for those dealing with immediate jeopardy situations, for at least 30 days, in recognition of growing COVID-19 patient surges in many areas.
Hospitals facing recertification will be automatically extended for that 30 days.
Accreditation organizations are being asked to follow suit, although more information will be sent out later, said CMS.
In a memo to CMS state agencies, officials also asked hospitals and states where crises of care protocols were being implemented or even just considered to reach out to the federal agency for help.
Within the last few weeks, several states have said they were reaching crisis in their patient loads. Paramedics in Los Angeles were told at one point not to transport patients with a low likelihood of survival.
Regions in other states said they were considering implementing crisis of care standards allowing hospitals to determine who did or did not receive care. A hospital in Nevada last week declared a disaster.
According to memo QSO-21-13-Hospitals, agency officials said “CMS is aware that many states have Crisis Standards of Care protocols in place for hospitals that are experiencing extreme conditions due to patient surge, staffing shortages, or a lack of supplies and other resources. Hospitals that are contemplating or implementing crisis standards of care should notify their appropriate State Health Agency.”
“States that have hospitals in, or approaching, crisis standards of care are asked to contact their CMS Survey Operations Group location for information about additional flexibilities and assistance,” said the memo.
CMS officials said complaint investigations must and still will be carried out, but that to “ensure quality of care oversight, while providing hospitals the ability to focus on serving their patients and communities,” the federal agency is limiting the scope of hospital surveys for at least the next 30 days, with the potential for 30-day renewals to follow.
Hospital complaint surveys will be restricted to immediate jeopardy complaint allegations, and CMS will prioritize investigations based on:
Imminent danger to patients at the hospital.
Noncompliance with Medicare Hospital Conditions of Participation (CoPs) likely exists.
And if “immediate action must be taken to protect the health and safety of patients.”
“The investigation will be limited only to those CoP(s) necessary to ensure the health and safety of patients in imminent danger. CMS will only authorize and require investigation of the Infection Control CoP if the allegations support findings in this area. CMS will require Focused Infection Control surveys only for those complaints with allegations that support their inclusion.”
“While the circumstances above outline the priority expectations, CMS may authorize onsite investigations anytime, as determined appropriate by the CMS Survey Operations Group Location.”
In addition, hospital recertification surveys will be “suspended, except for a subset of hospital reaccreditation surveys, per additional guidance that will be forthcoming. Hospitals due to receive a recertification or reaccreditation survey will have their certification automatically extended for at least 30 days.”
“Additional guidance on Accrediting Organization reaccreditation surveys will be forthcoming. Accrediting Organizations will be directed (via separate notice) to similarly suspend reaccreditation surveys for 30 days and instead perform a targeted sample of reaccreditation surveys using a modified survey process in hospitals that meet defined parameters.”
“Hospital enforcement actions for deficiencies that do not represent immediate jeopardy will have their termination date extended for at least 30 days. while expected to continue to ensure safety and quality, hospitals will not need to submit a plan of correction nor will a revisit survey by the state survey agency (including desk review) be required,” said the memo.
Note that hospitals with an “uncorrected immediate jeopardy must demonstrate removal of the immediate jeopardy findings through an onsite survey. Once the immediate jeopardy has been removed, the above protocol will apply. Following this thirty (30) day period, or unless otherwise notified, hospitals will have up to 60-days to demonstrate compliance with any outstanding deficiencies. Further guidance will be issued outlining this process prior to the termination of this temporary survey prioritization.”
Look to the Accreditation & Quality Compliance Center for more information as it becomes available.
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