Remember that instruments used on patients with infectious prion diseases like Creutzfeldt-Jakob Disease (CJD) require special cleaning and handling, so dispose of those single-use bronchoscopes carefully.
Be aware that the FDA has issued new recommendations on reprocessing flexible bronchoscopes that recommends using disposable versions of the device if there is increased risk of spreading infection or when reusable versions cannot be reprocessed.
Most of the recommendations, issued in 2015, remain the same.
However, in the June 25 update, the FDA notes it is providing the following new recommendations:
Consider “using a single-use bronchoscope in situations where there is increased risk of spreading infection (for example, multidrug resistant microorganisms, immunocompromised patients, or patients with prion disease) or when there is no support for immediate reprocessing of the bronchoscope.”
And “when treating patients with the 2019 coronavirus (COVID-19), refer to recent recommendations from the American Association for Bronchology & Interventional Pulmonology (AABIP).”
Remember that instruments used on patients with infectious prion diseases like Creutzfeldt-Jakob Disease (CJD) require special cleaning and handling, so dispose of those single-use bronchoscopes carefully.
Under recommendations from the CDC on infection control related to CJD, the agency recommends that “all disposable instruments, materials, and wastes that come in contact with high infectivity tissues (brain, spinal cord, and eyes) and low infectivity tissues (cerebrospinal fluid, kidneys, liver, lungs, lymph nodes, spleen, and placenta) of suspected or confirmed TSE patients should be disposed of by incineration.”
Meanwhile, the CDC notes that “surfaces and heat-sensitive re-usable instruments that come in contact with high infectivity and low infectivity tissues should be decontaminated by flooding with or soaking in 2N NaOH or undiluted sodium hypochlorite for 1 hour and rinsed with water.” CDC also adds the caution that “sodium hypochlorite may be corrosive to some instruments.”
OSHA is working on workplace violence prevention standards for healthcare and social service workers, in part because of Bureau of Labor statistics that show 73% of reported workplace injuries and illnesses due to violence were among healthcare workers.
This article was originally published June 25, 2021 on AQCC.
Implementing The Joint Commission’s (TJC) workplace violence prevention requirements is going to take a multidisciplinary committee that is not afraid to ask hard questions about your organization’s culture of safety.
And it will take strong leadership at a high level to emphasize how important the problem is and how serious your organization is about solving it, says AlGene Caraulia, MBA, vice president of Integration and Sustainability with the Crisis Prevention Institute (CPI), which provides training for healthcare professionals on verbal and nonviolent crisis intervention.
Not protecting workers impacts both morale and a hospital’s bottom line, says representatives of healthcare workers and federal regulators.
OSHA is working on workplace violence prevention standards for healthcare and social service workers, in part because of Bureau of Labor statistics that show 73% of reported workplace injuries and illnesses due to violence were among healthcare workers--and those were just the reports that were not fatal.
The cost of each incidence of workplace violence can reach into the thousands of dollars, especially if a worker is sidelined to recover from injury or, worse, must be replaced, says Caraulia.
The committee formed to oversee your workplace violence prevention program needs “to be prepared to ask the uncomfortable questions” to provide a real analysis of your hospital, says Caraulia.
For more tips on implementing the new and revised standards, see the September issue of Inside Accreditation & Quality.
Editor’s note: This story was updated on July 7, 2021.
The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities related to requirements under the Conditions of Participation (CoP) and other regulations.
This article was originally published June 22, 2021 on PSQH
If your healthcare organization has taken advantage of federal 1135 blanket waivers during the national public health emergency (PHE), be sure to review the use of those waivers as you prepare for survey to check if any were inconsistent with requirements under your state emergency or pandemic plan.
The blanket waivers will remain in effect as long as the PHE declaration remains in force, and CMS surveyors and accreditation organizations (AO), in general, will be held to allowing those blanket waivers, says Darra James Coleman, special counsel with the law firm Nexsen Pruet in South Carolina.
However, some of the waivers could be superseded by requirements set by state or local authorities having jurisdiction, if that is stated in that particular waiver and is included in your state’s emergency or pandemic plan, she notes.
Following the PHE’s initial declaration in March 2020 and several extensions, Health and Human Services (HHS) Secretary Xavier Becerra reauthorized the PHE declaration on April 21. By law, that means the declaration is good for another 90 days—in this case through July 20—unless otherwise stated by the secretary.
In January, HHS Acting Secretary Norris Cochran notified the nation’s governors earlier this year that HHS would give them at least a 60-day notice before declaring an end to the PHE.
Waivers provide flexibility with some CoPs
The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities related to requirements under the Conditions of Participation (CoP) and other regulations.
CMS has said that although the waivers are in effect through the term of the PHE, once that ends, so do the waivers. CMS also has stated that hospitals could be held accountable for any backlog of maintenance, testing, or fire safety requirements that were specifically waived by the 1135 declarations.
It’s worth noting, says Coleman, that the federal PHE is different from any emergency declarations by individual states, which set their own emergency requirements. Even at a federal level, the president’s declaration of an emergency is different from the HHS secretary’s authority to declare a PHE.
Meanwhile, states can set their own emergency requirements in an emergency preparedness or pandemic plan.
It can all be confusing, Coleman says, especially as some states are declaring the pandemic emergency to be over and lifting social distancing, masking, or other public safety precautions.
Those are different from specific pandemic-related regulations or other requirements for healthcare providers, which may remain in place unless otherwise stated by local or state officials, she notes.
In reviewing the 1135 waivers, hospitals should remain aware that a few of the federal blanket waivers say the specific flexibility is allowed “so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan,” says Coleman.
That means as the end of the PHE approaches, hospitals “need to be very familiar with their own state’s emergency preparedness or pandemic plan” to ensure they are in compliance.
Waivers can vary
Not every waiver has the phrase about not being inconsistent with a state’s emergency preparedness plan, adding to the confusion.
As an example, under anesthesia services, the 1135 waiver states: “CMS is waiving requirements under 42 CFR §482.52(a)(5), §485.639(c) (2), and §416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician in paragraphs §482.52(a)(5) and §485.639(c)(2). CRNA supervision will be at the discretion of the hospital and state law. This waiver applies to hospitals, CAHs, and Ambulatory Surgical Centers (ASCs). These waivers will allow CRNAs to function to the fullest extent of their licensure, and may be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.”
If a surveyor were to find an inconsistency, they are required to defer to the state’s requirements as long as those requirements are part of the state’s preparedness plan, Coleman says. If your hospital is unsure, check your state’s emergency preparedness or pandemic plan and go with that, she says.
Remember, you did not have to make a specific request to CMS to qualify for the blanket waivers, says Gayle Nash, RN, MPH, president of Nash Healthcare, a compliance consulting firm headquartered in El Paso, Texas.
The Joint Commission and other accreditation organizations have said that surveys are resuming as normal, meaning they will be unannounced and on-site. This applies unless the hospital is in the middle of a COVID-19 patient surge, its incident command center is still active to deal with the PHE, and it is considered unsafe to go on-site.
Surveys resuming
However, by late April such incident command activation was unnecessary in many parts of the country, observes Nash.
“Many hospitals are not utilizing their incident command as they now have well-defined processes in place for screening, isolating, and treating patients,” says Nash. “It is common to see hospitals continue to include COVID-19 patient numbers and also patient location in the daily safety huddles, leadership reports, [and] of course infection prevention surveillance rounds, but the incident command is not needed in many cases for daily management of COVID patients.”
Nash is among several consultants from across the country who have been busy helping hospitals and other organizations prepare for upcoming accreditation visits, many of which are overdue after surveys were suspended at the start of the pandemic.
“As we travel from hospital to hospital, week after week, the level of hospital staff resiliency is remarkable,” says Nash. “The nurses say, ‘We are following our policies, using proper PPE, cleaning and disinfecting properly, and working closer as a team to manage COVID-19 patients.’ We also see the volume of infectious patients are becoming less, although occasionally there are small surges.
“In these surge cases, staff are now used to using alternative sites to manage COVID-19 patients, and some hospitals based upon need are keeping these alternative sites open and available,” says Nash.
Note that accreditation organizations will be following CMS’ lead as surveys return to normal.
DNV Healthcare told the Accreditation & Compliance Center that “The Public Health Emergency is a distinctly federal concept and the current PHE is national, affecting providers participating in federal health benefit programs, so we follow the same procedures everywhere.”
Include COVID-19 vaccination status as part of your emergency room triage and medical history and educate clinicians on how to address vaccine hesitancy.
The CDC is encouraging hospitals and urgent care centers to step up outreach to vulnerable patient populations by offering COVID-19 vaccinations to patients at discharge from emergency departments (EDs).
The agency is also asking jurisdictions to allocate portions of their vaccine supplies to hospitals and urgent care centers to carry out the effort. However, jurisdictions will not be provided extra vaccine doses, according to a CDC fact sheet.
In its weekly summary, the CDC noted that “EDs serve as the primary health care access point for up to a fifth of the U.S. population and UCs account for up to 29% of all primary care visits. These settings are therefore important access points for people who have not yet been vaccinated.”
The CDC told providers “we are asking you to promote this effort as an important way to protect the communities you serve and to encourage them to participate in vaccinating patients upon discharge if they are not already doing so. Please also help to spread the word that facilities interested in becoming a COVID-19 vaccine provider should reach out to the health department or visit How to Enroll as a COVID-19 Vaccination Provider | CDC for more information.”
After establishing efforts to increase vaccinations upon discharge from EDs, the CDC is encouraging hospitals to “expand COVID-19 vaccination efforts at discharge to all hospital departments,” according to the fact sheet, which the American Hospital Association (AHA) says it helped to develop.
The AHA noted in a news update that the CDC’s latest effort is “is meant to reach unvaccinated individuals at their primary point of health care. CDC stressed that there is no special allocation channel for this program; jurisdictions would use already-received inventory.”
“Providers are encouraged to enroll to become COVID-19 vaccinators, which will enable them to legally store, handle and administer the vaccines to patients,” noted the AHA.
The fact sheet includes a list of best practices for facilities, including assessing vaccination status at triage and as part of the medical history, and addressing vaccine hesitancy.
The fact sheet notes that EDs and urgent care centers can bill a patient’s insurance for administration of the COVID-19 vaccine but as a separate service from the reason for the patient’s visit. “ Patients cannot be charged directly for the vaccine administration fee if they do not have health insurance and cannot be denied vaccination because of a lack of insurance,” according to the fact sheet.
Many of those elements, such as patient screening and management and precautions against transmission, should already be in place in your hospital or health organization.
Be prepared to implement the elements of a new OSHA emergency temporary standard on COVID-19 safety for workers in your hospital or other parts of your healthcare system where potential exposure to the deadly coronavirus is possible.
Some elements of the emergency standard will be effective as quickly as 14 days from when it is published in the Federal Register and 30 days for the rest of it, according to fact sheets posted by OSHA. A publication date is said to be soon, but it is unclear how soon.
Many of those elements, such as patient screening and management and precautions against transmission, should already be in place in your hospital or health organization. However, any healthcare workplace with more than 10 employees will be required to have a written plan developed and implemented according to OSHA requirements.
That includes a requirement that employees be given reasonable time off and paid leave to receive a COVID-19 vaccination and deal with any side effects.
The plan also requires training with the relevant policies and procedures outlined, recordkeeping and reporting on training and in-house occupational exposures to COVID-19 including fatalities, as well as an anti-retaliation policy.
The temporary emergency standard has been both hailed nursing organizations as necessary to continue to protect healthcare works during the continuing pandemic and criticized by the American Federation of Teachers because it covers only the healthcare industry.
Review your current COVID-19 policies and procedures and work now on translating those into OSHA documents. The standard, which is being offered also as a proposed rule to be made permanent in OSHA requirements under Subpart U.
Here are the basic elements, according to the OSHA Fact Sheet:
COVID-19 plan: Develop and implement a COVID-19 plan (in writing if more than 10 employees) that includes a designated safety coordinator with authority to ensure compliance, a workplace-specific hazard assessment, involvement of non-managerial employees in hazard assessment and plan development/implementation, and policies and procedures to minimize the risk of transmission of COVID-19 to employees.
Patient screening and management: Limit and monitor points of entry to settings where direct patient care is provided; screen and triage patients, clients, and other visitors and non-employees; implement patient management strategies.
Standard and Transmission-Based Precautions: Develop and implement policies and procedures to adhere to Standard and Transmission-Based precautions based on CDC guidelines.
Personal protective equipment (PPE): Provide and ensure each employee wears a facemask when indoors and when occupying a vehicle with other people for work purposes; provide and ensure employees use respirators and other PPE for exposure to people with suspected or confirmed COVID-19, and for aerosol-generating procedures on a person with suspected or confirmed COVID-19.
Aerosol-generating procedures on a person with suspected or confirmed COVID-19: Limit employees present to only those essential; perform procedures in an airborne infection isolation room, if available; and clean and disinfect surfaces and equipment after the procedure is completed. Physical distancing: Keep people at least 6 feet apart when indoors.
Physical barriers: Install cleanable or disposable solid barriers at each fixed work location in non-patient care areas where employees are not separated from other people by at least 6 feet.
Cleaning and disinfection: Follow standard practices for cleaning and disinfection of surfaces and equipment in accordance with CDC guidelines in patient care areas, resident rooms, and for medical devices and equipment; in all other areas, clean high-touch surfaces and equipment at least once a day and provide alcohol-based hand rub that is at least 60% alcohol or provide readily accessible handwashing facilities.
Ventilation: Ensure that employer-owned or controlled existing HVAC systems are used in accordance with manufacturer’s instructions and design specifications for the systems and that air filters are rated Minimum Efficiency Reporting Value (MERV) 13 or higher if the system allows it.
Health screening and medical management: (1) Screen employees before each workday and shift; (2) Require each employee to promptly notify the employer when the employee is COVID-19 positive, suspected of having COVID-19, or experiencing certain symptoms; (3) Notify certain employees within 24 hours when a person who has been in the workplace is COVID-19 positive; (4) Follow requirements for removing employees from the workplace; (5) Employers with more than 10 employees, provide medical removal protection benefits in accordance with the standard to workers who must isolate or quarantine.
Vaccination: Provide reasonable time and paid leave for vaccinations and vaccine side effects.
Training: Ensure all employees receive training so they comprehend COVID-19 transmission, tasks and situations in the workplace that could result in infection, and relevant policies and procedures.
Anti-Retaliation: Inform employees of their rights to the protections required by the standard and do not discharge or in any manner discriminate against employees for exercising their rights under the ETS or for engaging in actions required by the standard. Requirements must be implemented at no cost to employees.
Recordkeeping: Establish a COVID-19 log (if more than 10 employees) of all employee instances of COVID-19 without regard to occupational exposure and follow requirements for making records available to employees/representatives. Report work-related COVID-19 fatalities and in-patient hospitalizations to OSHA.
Reporting COVID-19 fatalities and hospitalizations to OSHA: Report to OSHA each work-related COVID-19 fatality within 8 hours of learning about the fatality, and each work-related COVID-19 in-patient hospitalization within 24 hours of learning about the in-patient hospitalization.
Mini respiratory protection program (29 CFR 1910.504): Under certain circumstances in the ETS, and only for employees who are not exposed to suspected/confirmed sources of COVID-19 or other hazards that may require respirator use covered under the normal Respiratory Protection Standard (29 CFR 1910.134), the employer must provide training on inspecting, putting on, removing, and using respirators like N-95s; the limitations and capabilities of the respirator; procedures and schedules for storing, maintaining, and inspecting respirators; how to perform a user seal check; and how to recognize medical signs and symptoms that may limit or prevent the effective use of respirators
The CDC’s recent new guidance to the general public that fully vaccinated people do not have to wear masks indoors does not apply to healthcare settings.
Don’t change your policies on masking inside your hospital or other healthcare facilities anytime soon.
The CDC’s recent new guidance to the general public that fully vaccinated people do not have to wear masks indoors does not apply to healthcare settings, warns the American Hospital Association (AHA).
The AHA says it reached out to the CDC in an email asking the federal agency to clarify its May 13 guidance on masking recommendations to protect against COVID-19.
“CDC said health care facilities should continue to refer to CDC’s infection prevention and control guidance for recommendations regarding source control and physical distancing in health care settings,” according to the announcement by the AHA. The CDC said it would alert the AHA and others if and when there were changes to guidance for healthcare settings.
“This means that staff, patients, residents and visitors should continue to wear masks as recommended in all healthcare facilities,” the agency told the AHA.
It should be noted that the new guidance from the CDC made clear that the new requirements on physical distancing did not apply “where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.”
The federal agency is seeking comment, which is due 90 days after it is formally published in the Federal Register. It is set to be published May 13, meaning the deadline for comment is August 11.
CMS pre-published an interim final rule today that sets COVID-19 vaccine requirements for long-term care (LTC) facilities and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID).
The changes to the Conditions of Participation (CoP) for those facilities primarily require vaccines to be offered to residents, clients, and staff when available. They also set education and CDC reporting requirements.
While the rule covers only those two types of facilities so far, CMS notes in the rule it may want to expand those requirements to other healthcare organizations, including psychiatric hospitals and inpatient hospice facilities.
The federal agency is seeking comment, which is due 90 days after it is formally published in the Federal Register. It is set to be published May 13, meaning the deadline for comment is August 11.
In announcing the interim rule, CMS noted that to “ensure LTC facilities receive support for COVID-19 vaccination efforts, they are now required to report weekly vaccination data of residents and staff to the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN), the nation’s most widely used healthcare-associated infection tracking system.”
“LTC facilities are already required to report COVID-19 testing, case, and mortality data to the NHSN for residents and staff, but have not been required to report vaccination data. As data becomes available, CMS will post facility-specific vaccination status information reported to the NHSN for viewing by facilities, stakeholders, and the public on CMS’ COVID-19 Nursing Home Data website.”
CMS’ Quality Safety and Oversight (QSO) Group has also published a new memo, QSO-21-19-NH, for state survey agencies saying surveyor tools to assess compliance with the new rule have already been updated with the new expectations.
Those expectations include “new requirements for educating residents or resident representatives and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine, and offering the vaccine,” said the memo.
“Transparency: CMS will post the new information reported to the NHSN for viewing by facilities, stakeholders, or the general public on CMS’s COVID-19 Nursing Home Data website,” told surveyors.
“Noncompliance related to the new requirements for educating and offering COVID-19 vaccination to residents and staff will be cited at F-tag 887, and noncompliance related to COVID-19 vaccination reporting will be cited at F-tag 884.”
The QSO memo also offers information to surveyors on vaccine administration, vaccine refusal and documentation, as well as a list of online resources for additional information.
The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities from requirements under the Conditions of Participation and other regulations.
If your healthcare organization has taken advantage of federal 1135 blanket waivers during the national public health emergency (PHE), be sure to review those waivers as you prepare for survey to check if any were inconsistent with requirements under your state emergency or pandemic plan.
The blanket waivers will remain in effect as long as the PHE is in effect, and CMS surveyors and accreditation organizations (AO), in general, will be held to allowing those blanket waivers, says Darra James Coleman, special counsel with Nexsen Pruet law firm in South Carolina.
The 1135 blanket waivers apply to requirements for federal programs. However, some of the waivers could be superseded by requirements set by state or local authorities having jurisdiction, if that is stated in a particular waiver and is included in your state’s emergency or pandemic plan, she notes.
PHE reauthorized
Secretary of Health and Human Services Xavier Becerra reauthorized the PHE on April 21. By law, that means the PHE is good for another 90 days—in this case through July 20—unless otherwise stated by the secretary.
In January, HHS Acting Secretary Norris Cochran notified the nation’s governors that he would give them at least a 60-day notice before declaring an end to the PHE.
The blanket waivers were designed to give hospitals and other healthcare providers a spectrum of flexibilities from requirements under the Conditions of Participation and other regulations.
CMS has said that while the waivers are in effect through the term of the PHE, once that ends, so do the waivers and hospitals could be held accountable for any backlog of maintenance, testing or fire safety requirements that were specifically waived by the 1135 declarations.
It’s worth noting, says Coleman, that the federal PHE is different from any emergency declarations by individual states, which set their own emergency requirements. Even at the federal level, the president’s declaration of an emergency is different from the HHS’ Secretary’s authority to declare a public health emergency and issue 1135 blanket waivers.
Remember states can set own requirements
Meanwhile, the states can set their own emergency requirements in an emergency preparedness or pandemic plan.
It can be confusing, Coleman says, especially as some governors are declaring the pandemic emergency to be over and lifting social distancing, masking or other public safety guidelines.
Those guidelines are different from specific pandemic-related regulations or other requirements for healthcare providers, which may remain in place unless otherwise stated by local or state public health officials, she notes.
In reviewing the 1135 waivers, hospitals should remain aware that some of the federal blanket waivers say the specific flexibility is allowed “so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan,” says Coleman.
That means as the end of the PHE approaches, hospitals “need to be very familiar with their own state’s emergency preparedness or pandemic plan” to ensure they are in compliance.
Not every waiver has the phrase, adding to the confusion.
As an example, under anesthesia services, the 1135 waiver states: “CMS is waiving requirements under 42 CFR §482.52(a)(5), §485.639(c) (2), and §416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician in paragraphs §482.52(a)(5) and §485.639(c)(2). CRNA supervision will be at the discretion of the hospital and state law. This waiver applies to hospitals, CAHs, and Ambulatory Surgical Centers (ASCs). These waivers will allow CRNAs to function to the fullest extent of their licensure, and may be implemented so long as they are not inconsistent with a state’ s emergency preparedness or pandemic plan.”
If a survey were to find an inconsistency between the 1135 waiver used in this example and state restrictions, they are required to defer to the state regulatory requirements, Coleman says. If your hospital is unsure whether an 1135 waiver is consistent with your state law, check your state’s emergency preparedness or pandemic plan and go with that, she says.
Incident command centers slowly closing
Remember, you did not have to make a specific request to CMS to qualify for the blanket waivers, says Gayle Nash, RN, MPH, president of Nash Healthcare, a compliance consulting firm headquartered in El Paso, Texas.
The Joint Commission and other accreditation organizations have said that triennial surveys are resuming as normal, meaning they will be unannounced and on site, unless the hospital is in the middle of a COVID-19 patient surge, has its incident command center still active to deal with the PHE and it considered unsafe to go on-site.
However, by late April such incident command activation was unnecessary in many parts of the country, observes Nash.
“Many hospitals are not utilizing their incident command as they now have well-defined processes in place for screening, isolating, and treating patients,” says Nash. “It is common to see hospitals continue to include COVID-19 patient numbers and also patient location in the daily safety huddles, leadership reports, of course infection prevention surveillance rounds but the incident command is not needed in many cases for daily management of COVID patients.”
Nash is among several consultants from across the country who have been busy helping hospitals and other organizations prepare for upcoming accreditation visits, many of which are overdue after surveys were suspended at the start of the pandemic.
“As we travel from hospital to hospital, week after week, the level of hospital staff resiliency is remarkable,” says Nash. “The nurses say, we are following our policies, using proper PPE, cleaning and disinfecting properly and working closer as a team to manage COVID-19 patients. We also see the volume of infectious patients are becoming less, although occasionally there are small surges.”
“In these surge cases, staff are now used to using alternative sites to manage COVID-19 patients and some hospitals based upon need are keeping these alternative sites open and available,” says Nash.
Note that AOs will be following CMS’ lead as surveys return to normal.
DNV Healthcare told the Accreditation & Quality Compliance Center that “the Public Health Emergency is a distinctly federal concept and the current PHE is national, affecting providers participating in federal health benefit programs, so we follow the same procedures everywhere.”
Similarly, CMS on April 8 told its state survey agencies that it was ending some blanket waivers for long-term care facilities regarding notification of room changes and discharges.
Be aware that as COVID-19 cases are declining and vaccination rates are climbing, the emergency waivers and measures approved by the federal government to get through the public health emergency (PHE) will be changing.
The FDA sent a notice to hospitals and others today (April 9) encouraging healthcare organizations to start moving away from the emergency measures taken to preserve and reuse medical devices and other supplies early in the PHE.
“The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse,” according to the online alert.
“Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems.”
Similarly, CMS on April 8 told its state survey agencies that it was ending some blanket waivers for long-term care facilities regarding notification of room changes and discharges because “nursing homes have developed policies or other practices that we believe mitigates the need for certain waivers.”
Blanket waivers for hospitals and other facilities are only in effect until Health and Human Services (HHS) declares the PHE has ended. The current PHE is good through April 21, but HHS has promised it will give at least 60 days’ notice before the legal end of the emergency.
While the PHE continues for now, things will be changing.
By now you should know that unannounced, onsite surveys are resuming after several months and weeks of only virtual or delayed visits by CMS and accreditation organizations. And you should know that surveyors don’t have to show they’re vaccinated when they do show up (although, as always, follow your hospital policy on screening.)
FDA recommendations
Regarding devices and supplies, the FDA announced included these recommendations for healthcare personnel and facilities:
Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFR) or if you are unable to obtain any new respirators.
Transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other FFRs.
Increase inventory of available NIOSH-approved respirators—including N95s and other FFRs, elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room, and powered air-purifying respirators (PAPR). Even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator.
CMS issues nursing home memo
In CMS Quality, Safety and Oversight group memo QSO-21-17-NH, “Updates to Long-Term Care (LTC) Emergency Regulatory Waivers issued in response to COVID-19,” CMS said it is announcing it is ending:
The emergency blanket waivers related to notification of Resident Room or Roommate changes, and Transfer and Discharge notification requirements
The emergency blanket waiver for certain care planning requirements for residents transferred or discharged for cohorting purposes.
The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).
CMS is providing clarification and recommendations for Nurse Aide Training and Competency Evaluation Programs (NATCEP)
The statement apparently was in answer to a query from The Joint Commission (TJC), which was acting on the behalf of someone else, according to the Health Facilities Management Insider.
Ready or not, yes, you must let surveyors on site at your hospital or other facilities even if they haven’t been vaccinated against COVID-19 yet.
That applies to CMS and all other surveyors acting in their capacity as deeming authorities to ensure patient safety and allow your facility to bill Medicare.
The statement apparently was in answer to a query from The Joint Commission (TJC), which was acting on the behalf of someone else, according to the Health Facilities Management Insider.
The statement from CMS said, “To clarify, Federal and state surveyors are not required to be vaccinated and must be permitted entry into facilities unless they exhibit signs or symptoms of COVID-19. Surveyors should also adhere to the core principles of COVID-19 infection prevention and adhere to any COVID-19 infection prevention requirements set by state law (refer to QSO-20-39-NH). While we recognize this is a NH specific memo, this would also apply to all providers and suppliers.”
And if anyone in your hospital asks, CMS’ response to the TJC inquiry also notes the regulations that say it has legal authority to ask for any records at any time:
“Medicare or Medicaid providers must grant access to provider records requested by surveyors, pursuant to Section 1864(a) of The Social Security Act (The Act) and Federal regulations at 42 CFR §488.10 and §488.11 to access providers and suppliers with the Requirements of Participation, Conditions of Participation, or Conditions for Coverage. Pursuant to Section 1866 of The Act and 42 CFR §489.53(a)(18), CMS may terminate the Medicare provider agreement of any provider that fails to grant immediate access to records upon a reasonable request to a state survey agency or other authorized entity for the purpose of determining, in accordance with §488.3, whether the provider or supplier meets the applicable requirements, conditions of participation, conditions for coverage, or conditions for certification.”
But also remember that you should make sure the survey team adheres to whatever infection control screening and prevention measures you have in place in response to the COVID-19 pandemic. Because, as always, you can be surveyed against your own policies.
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