DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C2-21-16 Baltimore, Maryland 21244-1850 Center for Clinical Standards and Quality/Quality, Safety & Oversight Group Ref: QSO-20-20-All DATE: March 20, 2020 TO: State Survey Agency Directors FROM: Director Quality, Safety & Oversight Group SUBJECT: Prioritization of Survey Activities Memorandum Summary • The Centers for Medicare & Medicaid Services (CMS) is committed to taking critical steps to ensure America’s health care facilities are prepared to respond to the threat of disease caused by the 2019 Novel Coronavirus (COVID-19). • On Friday, March 13, 2020, the President declared a national emergency, which triggers the Secretary’s ability to authorize waivers or modifications of certain requirements pursuant to section 1135 of the Social Security Act (the Act). Under section 1135(b)(5) of the Act, CMS is prioritizing surveys by authorizing modification of timetables and deadlines for the performance of certain required activities, delaying revisit surveys, and generally exercising enforcement discretion for three weeks. • During this three-week timeframe, only the following types of surveys will be prioritized and conducted: • Complaint/facility-reported incident surveys: State survey agencies (SSAs) will conduct surveys related to complaints and facility-reported incidents (FRIs) that are triaged at the Immediate Jeopardy (IJ) level. A streamlined Infection Control review tool will also be utilized during these surveys, regardless of the Immediate Jeopardy allegation. • Targeted Infection Control Surveys: Federal CMS and State surveyors will conduct targeted Infection Control surveys of providers identified through collaboration with the Centers for Disease Control and Prevention (CDC) and the HHS Assistant Secretary for Preparedness and Response (ASPR). They will use a streamlined review checklist to minimize the impact on provider activities, while ensuring providers are implementing actions to protect the health and safety of individuals to respond to the COVID-19 pandemic. • Self-assessments: The Infection Control checklist referenced above will also be shared with all providers and suppliers to allow for voluntary self-assessment of their Infection Control plan and protections. Page 1 of 9 Memorandum Summary Continued • • • During the prioritization period, the following surveys will not be authorized: Standard surveys for long term care facilities (nursing homes), hospitals, home health agencies (HHAs), intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and hospices. This includes the life safety code and Emergency Preparedness elements of those standard surveys; and revisits that are not associated with IJ. Furthermore, for Clinical Laboratory Improvement Amendments (CLIA), we intend to prioritize immediate jeopardy situations over recertification surveys, and generally intend to use enforcement discretion, unless immediate jeopardy situations arise. Finally, initial certification surveys will continue to be authorized in accordance within current guidance and prioritization. Background CMS is committed to taking critical steps to ensure America’s health care facilities, providers, and clinical laboratories are prepared to respond to the threat of COVID-19 and other respiratory illness. Specifically, under section 1135(b)(5) of the Act, CMS is prioritizing and suspending certain federal and SSA surveys, and delaying revisit surveys, pursuant to federal requirements for the next three weeks, beginning March 20, 2020, for all certified provider and supplier types. Also, for Clinical Laboratory Improvement Amendments (CLIA), we intend to prioritize immediate jeopardy situations over recertification surveys, and generally intend to use enforcement discretion, unless immediate jeopardy situations arise. During this three-week timeframe, SSAs and CMS surveyors will prioritize and conduct surveys (including revisit surveys) related to complaints and facilityreported incidents (FRIs) that are triaged at the Immediate Jeopardy (IJ) level, for all allegations, in addition to a review with a Focused Infection Control survey. Federal surveyors will perform targeted Infection Control surveys of facilities in those areas most in need of additional oversight, as identified through collaboration with the CDC and ASPR. If state or federal surveyors are unable to meet the Personal Protective Equipment (PPE) expectations outlined by the latest CDC guidance to safely perform an onsite survey due to lack of appropriate PPE supplies, they are instructed to refrain from entering the /provider, and obtain information necessary remotely, to the extent possible. Surveyors should continue the survey once they have the necessary PPE to do so safely. The Focused Infection Control Survey is available to every provider in the country to make them aware of Infection Control priorities during this time of crisis, and providers and suppliers may perform a voluntary self-assessment of their ability to meet these priorities. This shift in approach will allow health care providers time to implement the most recent infection control guidance from both CMS and the Centers for Disease Control and Prevention (CDC). At the same time, we are doing our duty to protect patients from harm, and ensuring providers are implementing actions to prevent the spread of COVID-19. Page 2 of 9 Therefore, during the prioritization period, the following surveys will not be authorized: • Standard surveys for long term care facilities (nursing homes), hospitals, home health agencies (HHAs), intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and hospices. This includes the life safety code and Emergency Preparedness elements of those standard surveys; • Revisits that are not associated with IJ. As a result, the following enforcement actions will be suspended, until revisits are again authorized: • For nursing homes – Imposition of Denial of Payment for New Admissions (DPNA), including situations where facilities that are not in substantial compliance at 3 months, will be lifted to allow for new admissions during this time; • For HHAs – Imposition of suspension of payments for new admissions (SPNA) following the last day of the survey when termination is imposed will be lifted to allow for new admissions during this time; • For nursing homes and HHAs – Suspend per day civil money penalty (CMP) accumulation, and imposition of termination for facilities that are not in substantial compliance at 6 months. • For CLIA, we intend to prioritize immediate jeopardy situations over recertification surveys. This announcement follows previous action to focus survey activity on infection control. On March 4, 2020, CMS announced a suspension of inspections for federal and state inspectors (https://www.cms.gov/medicareprovider-enrollment-andcertificationsurveycertificationgeninfopolicy-and/suspension-survey-activities). This earlier announcement focused on immediate jeopardy complaints, complaints alleging infection control concerns – especially COVID-19 – statutorily required surveys, revisit surveys to resolve enforcement actions, initial certifications, inspections for facilities with histories of infection control deficiencies in the last three years, and inspections of facilities with histories of infection control deficiencies at low levels of severity. This action supersedes the March 4th announcement, and prioritizes surveys related to complaints and FRIs triaged at the IJ level, while suspending the other types of surveys. Prioritization of Surveys When conducting surveys related to complaints and facility-reported incidents (FRIs) that are triaged at the Immediate Jeopardy (IJ) level, and revisit surveys necessary to verify removal of IJ which has been previously cited, surveyors and CMS Regional Offices should adhere to the following guidelines: 1. SSAs follow their normal process for triaging complaints and FRIs: a. If a complaint or FRI is triaged at the IJ level, the state should follow the normal policies and procedures for surveying the provider. For example, a survey of a long term care facility (LTC) would be conducted within two business days of receipt of the allegation (State Operations Manual (SOM), Chapter 5, Section 5075.9). Page 3 of 9 b. If a complaint or FRI is triaged at the non- IJ level, the state would enter the allegation into the ASPEN Complaints/Incidents Tracking System (ACTS) per the instructions in the SOM Chapter 5. An onsite survey will not be conducted during the prioritization period. CMS will issue guidance related to these nonIJ complaints or FRIs in the next few weeks. c. This normal complaint triaging process also applies to CLIA complaints. 2. For facilities that have been cited for IJ-level deficiencies and that surveyors have not verified that the IJ has been removed, surveyors would proceed as normal, and conduct a revisit survey to verify the IJ is removed. a. If the revisit survey determines there is continuing noncompliance, but not at the IJ level, surveyors would not conduct another onsite revisit survey. The provider may submit a plan of correction (POC), but an onsite revisit survey will not be conducted during the prioritization period, and these cases will be held. The provider may delay submission of a plan of correction until this prioritization period is over. b. If a survey is conducted because a complaint or FRI was triaged at the IJ level, and the provider is cited for noncompliance, but not at the IJ level (e.g., Level 3 – actual harm), surveyors would not conduct a revisit survey. The provider may submit a plan of correction (POC), but an onsite revisit survey will not be conducted during the prioritization period, and these cases will be held. The provider may delay submission of a plan of correction until this prioritization period is over. c. For level-3 (LTC) or condition level (Non-LTC) citations (for which an onsite revisit survey would normally be conducted), the provider may submit a plan of correction (POC), but an onsite revisit survey will not be conducted during the prioritization period, and these cases will be held. The provider may delay submission of a plan of correction until this prioritization period is over. CMS will issue guidance on how to verify compliance with these citations in the next few weeks. d. For level-2 (LTC) or standard level (non-LTC) citations, the provider may submits a POC, and providers and survey agencies could verify compliance through normal procedures through a desk review. The provider may delay submission of a plan of correction until this prioritization period is over. e. For clinical laboratories, surveyors will conduct a revisit survey to verify removal of IJ once a credible allegation of compliance has been received. 3. Federal CMS and State Surveyors will conduct focused Infection Control surveys in areas deemed necessary through collaboration with CDC and ASPR. Please note this workload for SSAs is contingent on their ability to perform surveys based on PPE availability and fulfillment of other State Emergency Response responsibilities (such as staffing medical shelters or testing stations). a. Revisit surveys: Surveyors will follow the same guidance for revisit surveys explained in section 2 above. b. Enforcement actions will also follow the guidance for all other surveys during the prioritization period explained in section 4 below. 4. Enforcement Actions: a. For pending enforcement cycles during the prioritization period where the provider is currently not in substantial compliance or has not had a revisit Page 4 of 9 survey to verify substantial compliance, and a per day civil money penalty (CMP), or DPNA (for nursing homes) or SPNA (for HHAs) was imposed for noncompliance that occurred prior to the prioritization date of surveys: These remedies will be suspended (stopped) as of the start of the survey prioritization date. In other words, the CMP will stop accruing and the DPNA/SPNA will end as of the suspension date. Additionally, CMS will not impose any new remedies to address noncompliance that occurred prior to the start of the survey prioritization period. NOTE: This does not apply to unremoved IJs. Enforcement actions will proceed as usual per the SOM for unremoved IJ deficiencies. CMS will issue guidance on how to reconcile these actions in the next few weeks. b. For pending enforcement cycles during the prioritization period where the provider is currently not in substantial compliance or has not had a revisit survey to verify substantial compliance, and for pending enforcement cycles with new noncompliance cited after the issuance of this memo, and a per day CMP, or DPNA (for nursing homes) or SPNA (for HHAs) was imposed for IJ level noncompliance (where the IJ has not been removed): Surveyors will follow normal policies and procedures for removing the IJ. CMS will also follow normal policies and procedures for imposing enforcement remedies for remediating the noncompliance. For example, for noncompliance cited at the IJ level, that has not been removed at the time of the survey exit, the CMS Office will impose an enforcement remedy (e.g., CMP, 23 day termination), and the state surveyors will conduct a revisit survey. On the revisit survey, surveyors will either verify substantial compliance, or cite noncompliance at a lower level if warranted. i. If the IJ noncompliance is reduced and cited at level 3 (LTC) or condition level (non-LTC), an onsite revisit survey will not be conducted during the prioritization period, and these cases will be held. CMS will issue guidance on how to impose enforcement and verify compliance with these in the next few weeks (see 2.c.). ii. If the IJ noncompliance is reduced and cited at level 2 (LTC) or standard level (non-LTC), facilities and survey agencies would verify compliance through normal procedures through a desk review (see 2.d.). However, CMS should not impose remedies during the prioritization period for any noncompliance that was identified before or after the start of the survey prioritization period, unless the noncompliance is an unremoved IJ. c. The three-month mandatory DPNA and six-month mandatory termination (nursing homes) for not being in substantial compliance (for nursing homes and HHAs) will not take place, and be deferred for an evaluation at a later date. However, enforcement actions related to IJ remain and continue under normal procedures. d. If CMS has previously imposed an alternative sanction (e.g., SPNA, CMP) on a HHA for noncompliance identified prior to the suspension, the six-month mandatory termination will not take place, and be deferred for an evaluation at a later date. Page 5 of 9 e. For existing CLIA enforcement cases where a civil money penalty (CMP) per day of non-compliance was imposed, accrual of CMP will stop as of the survey COVID-19 suspension date. CMS will issue guidance on how to reconcile these actions in the next few weeks. Other CLIA enforcement actions that have been initiated will be handled on a case-by-case basis with consultation DCLIQ managers and staff. 5. If during an IJ complaint or FRI survey, the surveyor identifies that there is an active COVID-19 case in the facility: If the COVID-19 case is, or is not, related to the IJ, surveyors should report the case and facility to their agency, the state health department (to coordinate with the Centers for Disease Control and Prevention (CDC)), and the CMS Regional Office. These agencies should coordinate and decide on any further actions that should be taken. The Infection Control focused survey process can be used to investigate noncompliance and ensure the provider takes steps to minimize transmission. For onsite surveys that were started prior to the prioritization period and don’t fall under this guidance, survey teams should end the survey and exit the facility. Lastly, any initial certification surveys remain authorized to increase the health care capacity of the country. Note: While CMS’ directive applies to the CMS’ federal surveyors and state agency surveyors, CMS also urges other surveyors, including accrediting organizations (AOs), to follow suit. Additionally, CMS’ survey prioritization applies to surveys for compliance with federal regulations, not state surveys pursuant to state licensure. Additional Instructions for Nursing Homes We are disseminating the Infection Control survey developed by CMS and CDC so facilities can educate themselves on the latest practices and expectations. We expect facilities to use this new process, in conjunction with the latest guidance from CDC, to perform a voluntary self-assessment of their ability to prevent the transmission of COVID-19. This document may be requested by surveyors, if an onsite investigation takes place. We also encourage nursing homes to voluntarily share the results of this assessment with their state or local health department Healthcare-Associated Infections (HAI) Program. Contact information for each state’s health departments is identified on the Centers for Disease Control & Prevention’s (CDC’s) website at: https://www.cdc.gov/HAI/state-based/index.html. Furthermore, we remind facilities that they are required to have a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility, and when and to whom possible incidents of communicable disease or infections should be reported (42 CFR 483.80(a)(2)(i) and (ii)). CDC recommends that nursing homes notify their health department about residents with severe respiratory infection, or a cluster of respiratory illness (e.g., > or = 3 residents or HCP with new-onset respiratory symptoms within 72 hours). Local and state reporting guidelines or requirements may vary. Monitor the CDC website for information and resources to help prevent the introduction and spread of COVID-19 in nursing homes (CDC Preparing for COVID-19: Long-term Care Facilities, Nursing Homes: https://www.cdc.gov/coronavirus/2019Page 6 of 9 ncov/healthcare-facilities/prevent-spread-in-long-term-care-facilities.html). We urge providers to review the tools and implement actions to protect the health and safety of individuals to respond to the COVID-19 pandemic. Additional Instructions for Other (Non-Long Term Care) Provider Types Education and Signage Where the patient/resident is sleeping at the health care facility, signage on the patient’s room is important to ensuring that all staff are aware of the necessary infection control steps. https://www.cdc.gov/infectioncontrol/pdf/droplet-precautions-sign-P.pdf In the home setting, health care staff may have little control over the home environment, but must 1) educate staff, patients and family members regarding infection control procedures and how to avoid transmission of COVID-19, and 2) maintain clean equipment and supplies and follow appropriate infection control procedures during home visits and transport of reusable patient care items. For further information refer to CDC’s interim guidance for home care of people not requiring hospitalization for COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-homecare.html). Limitations on Visitors To mitigate the spread of the COVID-19 virus, CMS is providing guidance to restrict visitation in health care facilities such as hospitals, critical access hospitals, psychiatric hospitals, inpatient hospice units, and intermediate care facilities for individuals with developmental disabilities. For CMS restrictions on visitation in nursing homes, see QSO-20-14 https://www.cms.gov/files/document/qso-20-14-nh-revised.pdf. CMS is providing the following expanded guidance to prevent the spread of COVID-19: a) Visitors should receive the same screening as patients, including whether they have had: • Fever or symptoms of a respiratory infection, such as a cough and sore throat. • International travel within the last 14 days to CDC Level 3 risk countries. For updated information on restricted countries visit: https://www.cdc.gov/coronavirus/2019ncov/travelers/index.html • Contact with someone with known or suspected COVID-19. b) Health care facilities should set limitations on visitation. For example, limitations may include restricting the number of visitors per patient, or limiting visitors to only those that provide assistance to the patient, or limiting visitors under a certain age. c) Health care facilities should provide signage at entrances for screening individuals, provide temperature checks/ ask about fever, and encourage frequent hand washing and use of hand sanitizer before entering the facility and before and after entering patient rooms d) If visiting and not seeking medical treatment themselves, individuals with fevers, cough, sore throat, body aches or runny nose or not following infection control guidance should be restricted from entry. e) Facilities should screen and limit visitors for any recent trips (within the last 30 days) on cruise ships as well as close contact with a suspect or laboratory-confirmed COVID-19 patient within the last 14 days, or overseas travel from certain countries. Page 7 of 9 https://www.cdc.gov/coronavirus/2019-ncov/travelers/after-travel-precautions.html, https://wwwnc.cdc.gov/travel/page/covid-19-cruise-ship f) Facilities should instruct visitors to limit their movement within the facility (e.g., reduce walking the halls, trips to cafeteria, etc.) g) Facilities should establish limited entry points for all visitors and/or establish alternative sites for screening prior to entry. h) Facilities can implement measures to: • Increase communication with families (phone, face-time, skype, etc.). • Potentially offer a hotline for with a recording that is updated at set times so families can get an update on the facility’s general status. • If appropriate, consider offering telephonic screening of recent travel and wellness prior to coming in for scheduled appointments. This may help limit the amount of visitor movement throughout the organization and congestion at entry points. i) Consider closing common visiting areas and encouraging patients to visit with loved ones in their patient rooms. In home and community-based settings, health care providers should advise patients with COVID19 of the CDC guidance to mitigate transmission of the virus. This includes isolating at home during illness, restricting activities except for medical care, using a separate bathroom and bedroom if possible, and prohibiting visitors who do not have an essential need to be in the home. The certified Medicare/Medicaid provider is expected to share this information with patients with the COVID-19 virus and his/her caregiver. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidanceprevent-spread.html Some states have chosen to establish more restrictive criteria than described above. Health care providers to follow the more restrictive criteria when present. Access for Healthcare Staff CMS is aware that some providers (nursing homes, assisted living facilities, etc.) have significantly restricted entry for staff from other Medicare/Medicaid certified providers who are providing direct care to patients. In general, if the staff is appropriately wearing PPE, and do not meet criteria for restricted access, they should be allowed to enter and provide services to the patient (interdisciplinary hospice care, dialysis, organ procurement, home health, etc.). For hospitals, this would also apply to organ procurement coordinators. Ensuring that individuals have continued access to life-saving organs is critical. We understand that hospitals are preparing for a potential surge in COVID-19 patients however, we would ask that donor hospitals continue with operations in regards to allowing organ procurement coordinators into hospitals to discuss organ donation with families. Hospital and OPO leadership should communicate on risk assessments in their communities and any potential impacts for organ recovery operations. CMS will continue to evaluate the survey prioritization in light of the situation on the ground in areas with large numbers of COVID-19 cases, to determine if CMS needs to continue this past the initial three weeks. Section 3087 of the 21st Century Cures Act, signed into law in December 2016, added subsection (f) to section 319 of the Public Health Service Act. This new subsection gives the HHS Secretary the authority to Page 8 of 9 waive Paperwork Reduction Act (PRA) (44 USC 3501 et seq.) requirements with respect to voluntary collection of information during a public health emergency (PHE), as declared by the Secretary, or when a disease or disorder is significantly likely to become a public health emergency (SLPHE). Under this new authority, the HHS Secretary may waive PRA requirements for the voluntary collection of information if the Secretary determines that: (1) a PHE exists according to section 319(a) of the PHS Act or determines that a disease or disorder, including a novel and emerging public health threat, is a SLPHE under section 319(f) of the PHS Act; and (2) the PHE/SLPHE, including the specific preparation for and response to it, necessitates a waiver of the PRA requirements. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been designated as the office that will coordinate the process for the Secretary to approve or reject each request. The information collection requirements contained in this information collection request have been submitted and approved under a PRA Waiver granted by the Secretary of Health and Human Services. The waiver can be viewed at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers . Contact: Questions about this document should be addressed to QSOG_EmergencyPrep@cms.hhs.gov. Effective Date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators immediately. /s/ David R. Wright cc: Survey and Operations Group Management Page 9 of 9 COVID-19 Focused Survey for Nursing Homes Infection Control This survey tool must be used to investigate compliance at F880 and determine whether the facility is implementing proper infection prevention and control practices to prevent the development and transmission of COVID-19 and other communicable diseases and infections. Entry and screening procedures as well as resident care guidance has varied over the progression of COVID-19 transmission in facilities. Facilities are expected to be in compliance with CMS requirements and surveyors will use guidance that is in effect at the time of the survey. Refer to QSO memos released at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-toStates-and-Regions. This survey tool provides a focused review of the critical elements associated with the transmission of COVID-19, will help surveyors to prioritize survey activities while onsite, and identify those survey activities which can be accomplished offsite. These efficiencies will decrease the potential for transmission of COVID-19, as well as lessen disruptions to the facility and minimize exposure of the surveyor. Surveyors should be mindful to ensure their activities do not interfere with the active treatment or prevention of transmission of COVID-19. If citing for noncompliance related to COVID-19, the surveyor(s) must include the following language at the beginning of the Deficient Practice Statement or other place determined appropriate on the Form CMS-2567: “Based on [observations/interviews/record review], the facility failed to [properly prevent and/or contain – or other appropriate statement] COVID-19.” If surveyors see concerns related to compliance with other requirements, they should investigate them in accordance with the existing guidance in Appendix PP of the State Operations Manual and related survey instructions. Surveyors may also need to consider investigating concerns related to Emergency Preparedness in accordance with the guidance in Appendix Z of the State Operations Manual (e.g., for emergency staffing). For the purpose of this survey tool, “staff” includes employees, consultants, contractors, volunteers, and others who provide care and services to residents on behalf of the facility. The Infection Prevention and Control Program (IPCP) must be facility-wide and include all departments and contracted services. Surveyor(s) reviews for: • The overall effectiveness of the Infection Prevention and Control Program (IPCP) including IPCP policies and procedures; • Standard and Transmission-Based Precautions; • Quality of resident care practices, including those with COVID-19 (laboratory-positive case), if applicable; • The surveillance plan; • Visitor entry and facility screening practices; • Education, monitoring, and screening practices of staff; and • Facility policies and procedures to address staffing issues during emergencies, such as transmission of COVID-19 _____________________________________________________________________________________________________________________ 1. Standard and Transmission-Based Precautions (TBPs) CMS is aware that there is a scarcity of some supplies in certain areas of the country. State and Federal surveyors should not cite facilities for (3/20/2020) Page 1 COVID-19 Focused Survey for Nursing Homes not having certain supplies (e.g., PPE such as gowns, N95 respirators, surgical masks) if they are having difficulty obtaining these supplies for reasons outside of their control. However, we do expect facilities to take actions to mitigate any resource shortages and show they are taking all appropriate steps to obtain the necessary supplies as soon as possible. For example, if there is a shortage of PPE (e.g., due to supplier(s) shortage which may be a regional or national issue), the facility should contact their healthcare coalition for assistance (https://www.phe.gov/Preparedness/planning/hpp/Pages/find-hc-coalition.aspx), follow national and/or local guidelines for optimizing their current supply or identify the next best option to care for residents. Among other practices, optimizing their current supply may mean prioritizing use of gowns based on risk of exposure to infectious organisms, blood or body fluids, splashes or sprays, high contact procedures, or aerosol generating procedures (AGPs), as well as possibly extending use of PPE (follow national and/or local guidelines). Current CDC guidance for healthcare professionals is located at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html and healthcare facilities is located at: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html. Guidance on strategies for optimizing PPE supply is located at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html. If a surveyor believes a facility should be cited for not having or providing the necessary supplies, the State Agency should contact the CMS Regional Location. General Standard Precautions Are staff performing the following appropriately: • Respiratory hygiene/cough etiquette, • Environmental cleaning and disinfection, and • Reprocessing of reusable resident medical equipment (e.g., cleaning and disinfection of glucometers per device and disinfectant manufacturer’s instructions for use)? Hand Hygiene Are staff performing hand hygiene when indicated? If alcohol-based hand rub (ABHR) is available, is it readily accessible and preferentially used by staff for hand hygiene? If there are shortages of ABHR, are staff performing hand hygiene using soap and water instead? Are staff washing hands with soap and water when their hands are visibly soiled (e.g., blood, body fluids)? Do staff perform hand hygiene (even if gloves are used) in the following situations: • Before and after contact with the resident; • After contact with blood, body fluids, or visibly contaminated surfaces; • After contact with objects and surfaces in the resident’s environment; • After removing personal protective equipment (e.g., gloves, gown, facemask); and • Before performing a procedure such as an aseptic task (e.g., insertion of an invasive device such as a urinary catheter, manipulation of a central venous catheter, and/or dressing care)? When being assisted by staff, is resident hand hygiene performed after toileting and before meals? (3/20/2020) Page 2 COVID-19 Focused Survey for Nursing Homes Interview appropriate staff to determine if hand hygiene supplies (e.g., ABHR, soap, paper towels) are readily available and who they contact for replacement supplies. Personal Protective Equipment (PPE) Determine if staff appropriately use PPE including, but not limited to, the following: • Gloves are worn if potential contact with blood or body fluid, mucous membranes, or non-intact skin; • Gloves are removed after contact with blood or body fluids, mucous membranes, or non-intact skin; • Gloves are changed and hand hygiene is performed before moving from a contaminated body site to a clean body site during resident care; and • An isolation gown is worn for direct resident contact if the resident has uncontained secretions or excretions. Is PPE appropriately removed and discarded after resident care, prior to leaving room (except in the case of extended use of PPE per national/local recommendations), followed by hand hygiene? If PPE use is extended/reused, is it done according to national and/or local guidelines? If it is reused, is it cleaned/decontaminated/maintained after and/or between uses? Interview appropriate staff to determine if PPE is available, accessible and used by staff. • Are there sufficient PPE supplies available to follow infection prevention and control guidelines? In the event of PPE shortages, what procedures is the facility taking to address this issue? • Do staff know how to obtain PPE supplies before providing care? • Do they know who to contact for replacement supplies? Transmission-Based Precautions (Note: PPE use is based on availability and latest CDC guidance. See note on Pages 1-2) Determine if appropriate Transmission-Based Precautions are implemented: • For a resident on Contact Precautions: staff don gloves and isolation gown before contact with the resident and/or his/her environment; • For a resident on Droplet Precautions: staff don a facemask within six feet of a resident; • For a resident on Airborne Precautions: staff don an N95 or higher level respirator prior to room entry of a resident; • For a resident with an undiagnosed respiratory infection: staff follow Standard, Contact, and Droplet Precautions (i.e., facemask, gloves, isolation gown) with eye protection when caring for a resident unless the suspected diagnosis requires Airborne Precautions (e.g., tuberculosis); • For a resident with known or suspected COVID-19: staff wear gloves, isolation gown, eye protection and an N95 or higher-level respirator if available. A facemask is an acceptable alternative if a respirator is not available. Additionally, if there are COVID-19 cases in the facility or sustained community transmission, staff implement universal use of facemasks while in the facility (based on availability). When COVID-19 is identified in the facility, staff wear all recommended PPE (i.e., gloves, gown, eye protection and respirator or facemask) for the care of all residents on the unit (or facility-wide based on the location of affected residents), regardless of symptoms (based on availability). (3/20/2020) Page 3 COVID-19 Focused Survey for Nursing Homes o Some procedures performed on residents with known or suspected COVID-19 could generate infectious aerosols (i.e., aerosolgenerating procedures (AGPs)). In particular, procedures that are likely to induce coughing (e.g., sputum induction, open suctioning of airways) should be performed cautiously. If performed, the following should occur:  Staff in the room should wear an N95 or higher-level respirator, eye protection, gloves, and an isolation gown.  The number of staff present during the procedure should be limited to only those essential for resident care and procedure support.  AGPs should ideally take place in an airborne infection isolation room (AIIR). If an AIIR is not available and the procedure is medically necessary, then it should take place in a private room with the door closed.  Clean and disinfect the room surfaces promptly and with appropriate disinfectant. Use disinfectants on List N of the EPA website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-COV-2 or other national recommendations; • Dedicated or disposable noncritical resident-care equipment (e.g., blood pressure cuffs, blood glucose monitor equipment) is used, or if not available, then equipment is cleaned and disinfected according to manufacturers’ instructions using an EPA-registered disinfectant for healthcare setting prior to use on another resident; • Objects and environmental surfaces that are touched frequently and in close proximity to the resident (e.g., bed rails, over-bed table, bedside commode, lavatory surfaces in resident bathrooms) are cleaned and disinfected with an EPA-registered disinfectant for healthcare setting (effective against the organism identified if known) at least daily and when visibly soiled; and • Is signage on the use of specific PPE (for staff) posted in appropriate locations in the facility (e.g., outside of a resident’s room, wing, or facility-wide)? Interview appropriate staff to determine if they are aware of processes/protocols for Transmission-Based Precautions and how staff is monitored for compliance. If concerns are identified, expand the sample to include more residents on Transmission-Based Precautions. 1. Did staff implement appropriate Standard (e.g., hand hygiene, appropriate use of PPE, environmental cleaning and disinfection, and reprocessing of reusable resident medical equipment) and Transmission-Based Precautions (if applicable)? Yes No F880 2. Resident Care If there is sustained community transmission or case(s) of COVID-19 in the facility, is the facility restricting residents (to the extent possible) to their rooms except for medically necessary purposes? If there is a case in the facility, and residents have to leave their room, are they wearing a facemask, performing hand hygiene, limiting their movement in the facility, and performing social distancing (efforts are made to keep them at least 6 feet away from others). If PPE shortage is an issue, facemasks should be limited to residents diagnosed with or having signs/symptoms of respiratory illness or COVID-19. Has the facility cancelled group outings, group activities, and communal dining? (3/20/2020) Page 4 COVID-19 Focused Survey for Nursing Homes Has the facility isolated residents with known or suspected COVID-19 in a private room (if available), or taken other actions based on national (e.g., CDC), state, or local public health authority recommendations? For the resident who develops severe symptoms of illness and requires transfer to a hospital for a higher level of care, did the facility alert emergency medical services and the receiving facility of the resident’s diagnosis (suspected or confirmed COVID-19) and precautions to be taken by transferring and receiving staff as well as place a facemask on the resident during transfer (as supply allows)? For residents who need to leave the facility for care (e.g. dialysis, etc.), did the facility notify the transportation and receiving health care team of the resident’s suspected or confirmed COVID-19 status? Does the facility have residents who must leave the facility regularly for medically necessary purposes (e.g., residents receiving hemodialysis and chemotherapy) wear a facemask (if available) whenever they leave their room, including for procedures outside of the facility? 2. Did staff provide appropriate resident care? Yes No F880 3. IPCP Standards, Policies and Procedures Did the facility establish a facility-wide IPCP including standards, policies, and procedures that are current and based on national standards for undiagnosed respiratory illness and COVID-19? Does the facility’s policies or procedures include when to notify local/state public health officials if there are clusters of respiratory illness or cases of COVID-19 that are identified or suspected? Concerns must be corroborated as applicable including the review of pertinent policies/procedures as necessary. 3. Does the facility have a facility-wide IPCP including standards, policies, and procedures that are current and based on national standards for undiagnosed respiratory illness and COVID-19? Yes No F880 4. Infection Surveillance How many residents and staff in the facility have fever, respiratory signs/symptoms, or other signs/symptoms related to COVID-19? How many residents and staff have been diagnosed with COVID-19 and when was the first case confirmed? How many residents and staff have been tested for COVID-19? What is the protocol for determining when residents and staff should be tested? Has the facility established/implemented a surveillance plan, based on a facility assessment, for identifying (i.e., screening), tracking, monitoring and/or reporting of fever (at a minimum, vital signs are taken per shift), respiratory illness, and/or other signs/symptoms of COVID-19 and immediately isolate anyone who is symptomatic? Does the plan include early detection, management of a potentially infectious, symptomatic resident that may require laboratory testing and/or Transmission-Based Precautions/PPE (the plan may include tracking this information in an infectious disease log)? (3/20/2020) Page 5 COVID-19 Focused Survey for Nursing Homes Does the facility have a process for communicating the diagnosis, treatment, and laboratory test results when transferring a resident to an acute care hospital or other healthcare provider; and obtaining pertinent notes such as discharge summary, lab results, current diagnoses, and infection or multidrug-resistant organism colonization status when residents are transferred back from acute care hospitals? Can appropriate staff (e.g., nursing and unit managers) identify/describe the communication protocol with local/state public health officials? Interview appropriate staff to determine if infection control concerns are identified, reported, and acted upon. 4. Did the facility provide appropriate infection surveillance? Yes No F880 5. Visitor Entry Review for compliance of: • Screening processes and criteria (i.e., screening questions and assessment of illness); • Restriction criteria; and • Signage posted at facility entrances for screening and restrictions as well as a communication plan to alert visitors of new procedures/restrictions. For those permitted entry, are they instructed to frequently perform hand hygiene; limit their interactions with others in the facility and surfaces touched; restrict their visit to the resident’s room or other location designated by the facility; and offered PPE (e.g., facemask) as supply allows? What is the facility’s process for communicating this information? For those permitted entry, are they advised to monitor for signs and symptoms of COVID-19 and appropriate actions to take if signs and/or symptoms occur? 5. Did the facility perform appropriate screening, restriction, and education of visitors? Yes No F880 6. Education, Monitoring, and Screening of Staff Is there evidence the facility has provided education to staff on COVID-19 (e.g., symptoms, how it is transmitted, screening criteria, work exclusions)? How does the facility convey updates on COVID-19 to all staff? Is the facility screening all staff at the beginning of their shift for fever and signs/symptoms of illness? Is the facility actively taking their temperature and documenting absence of illness (or signs/symptoms of COVID-19 as more information becomes available)? If staff develop symptoms at work (as stated above), does the facility: • Place them in a facemask and have them return home; • Inform the facility’s infection preventionist and include information on individuals, equipment, and locations the person came in contact with; and (3/20/2020) Page 6 COVID-19 Focused Survey for Nursing Homes • Follow current guidance about returning to work (e.g., local health department, CDC: https://www.cdc.gov/coronavirus/2019ncov/healthcare-facilities/hcp-return-work.html). 6. Did the facility provide appropriate education, monitoring, and screening of staff? Yes No F880 7. Emergency Preparedness - Staffing in Emergencies Policy development: Does the facility have a policy and procedure for ensuring staffing to meet the needs of the residents when needed during an emergency, such as a COVID-19 outbreak? Policy implementation: In an emergency, did the facility implement its planned strategy for ensuring staffing to meet the needs of the residents? (N/A if a emergency staff was not needed) 7. Did the facility develop and implement policies and procedures for staffing strategies during an emergency? Yes No E0024 Section 3087 of the 21st Century Cures Act, signed into law in December 2016, added subsection (f) to section 319 of the Public Health Service Act. This new subsection gives the HHS Secretary the authority to waive Paperwork Reduction Act (PRA) (44 USC 3501 et seq.) requirements with respect to voluntary collection of information during a public health emergency (PHE), as declared by the Secretary, or when a disease or disorder is significantly likely to become a public health emergency (SLPHE). Under this new authority, the HHS Secretary may waive PRA requirements for the voluntary collection of information if the Secretary determines that: (1) a PHE exists according to section 319(a) of the PHS Act or determines that a disease or disorder, including a novel and emerging public health threat, is a SLPHE under section 319(f) of the PHS Act; and (2) the PHE/SLPHE, including the specific preparation for and response to it, necessitates a waiver of the PRA requirements. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been designated as the office that will coordinate the process for the Secretary to approve or reject each request. The information collection requirements contained in this information collection request have been submitted and approved under a PRA Waiver granted by the Secretary of Health and Human Services. The waiver can be viewed at https://aspe.hhs.gov/public-health-emergency-declarationpra-waivers. (3/20/2020) Page 7 Summary of the COVID-19 Focused Survey for Nursing Homes This is a summary of the COVID-19 Focused Survey for Nursing Homes and the Survey Protocol. Surveyors should review the Survey Protocol for more detailed information as well as the Focused Survey. Facilities can review the Focused Survey to determine CMS’s expectations for an infection prevention and control program during the COVID-19 pandemic. Offsite Survey Activity • • • • • For facilities with an active COVID-19 case, the survey team should contact their State Survey Agency (SSA), the state health department, and CMS Regional Location to coordinate activities for these facilities. Ensure surveyors are medically cleared, and have personal protective equipment (PPE) that could be required onsite. Conduct offsite planning to limit interruptions to care while onsite. Obtain information on: o Facility-reported information; o CDC, state/local public health reports; o Available hospital information regarding patients transferred to the hospital; and/or o Complaint allegations. Identify survey activities that will be conducted offsite, such as: o Medical record review o Telephonic interviews, such as:  Surveillance policies  First onset of symptoms  Communication to facility leaders and health officials o Policy/Procedure Review  Infect. Control/Prev. Plan  Emerg. Prep. Plan, including contingency strategies (e.g., staffing) Conduct survey exit discussion telephonically and draft the CMS-2567 offsite. Onsite Survey Activity • • • • • • Limit the onsite team to one to two surveyors. Identify onsite assignments for activities, such as: Resident Care Observations: o Hand hygiene practices o Proper use/discarding of PPE o Cleansing medical equipment o Effective Transmission-Based Precautions Environmental observations: o Signage at entrances and resident rooms o Screening (staff at shift change, entrances, limiting nonessential staff) o Hand hygiene stations Interviews: o Policy/Procedure knowledge o Surveillance for sign/symptoms o Notifying local health officials Adhere to all CDC guidance for infection prevention and control related to COVID-19. Provide the facility with the COVID-19 Entrance Conference worksheet and utilize this to request necessary information. Identify and arrange for interviews that can be done telephonically. Be alert of other immediate jeopardy (IJ) situations that may be present, and investigate appropriately. Facility Self-Assessment Facilities should utilize the COVID-19 Focused Survey for Nursing Homes as a selfassessment tool. Priority areas for self- assessment include all of the following: 1. Standard Precautions; a. Hand hygiene b. Use of PPE c. Transmission-Based Precautions 2. Resident care (including resident placement); 3. Infection prevention and control standards, policies and procedures; 4. Infection surveillance; 5. Visitor entry (i.e., screening, restriction, and education); 6. Education, monitoring, and screening of staff; and 7. Emergency preparedness – staffing in emergencies Summary of the COVID-19 Focused Survey for Nursing Homes Section 3087 of the 21st Century Cures Act, signed into law in December 2016, added subsection (f) to section 319 of the Public Health Service Act. This new subsection gives the HHS Secretary the authority to waive Paperwork Reduction Act (PRA) (44 USC 3501 et seq.) requirements with respect to voluntary collection of information during a public health emergency (PHE), as declared by the Secretary, or when a disease or disorder is significantly likely to become a public health emergency (SLPHE). Under this new authority, the HHS Secretary may waive PRA requirements for the voluntary collection of information if the Secretary determines that: (1) a PHE exists according to section 319(a) of the PHS Act or determines that a disease or disorder, including a novel and emerging public health threat, is a SLPHE under section 319(f) of the PHS Act; and (2) the PHE/SLPHE, including the specific preparation for and response to it, necessitates a waiver of the PRA requirements. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been designated as the office that will coordinate the process for the Secretary to approve or reject each request. The information collection requirements contained in this information collection request have been submitted and approved under a PRA Waiver granted by the Secretary of Health and Human Services. The waiver can be viewed at https://aspe.hhs.gov/public-healthemergency-declaration-pra-waivers. COVID-19 Focused Infection Control Survey: Acute and Continuing Care General guidance: This survey tool provides a focused review of the critical elements associated with the transmission of COVID-19, will help surveyors to prioritize survey activities while onsite, and identify those survey activities which can be accomplished offsite. These efficiencies will decrease the potential for transmission of COVID-19, as well as lessen disruptions to the facility and minimize exposure of the surveyor. Surveyors should be mindful to ensure their activities do not interfere with the active treatment or prevention of transmission of COVID-19. Entry and screening procedures as well as patient care guidance has varied over the progression of COVID-19 transmission in facilities. Facilities are expected to be in compliance with CMS guidance that is in effect at the time of the survey. Refer to QSO memos released at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions. Content within this tool may be generally applied to any setting. However, CMS recognizes that not all acute and continuing care providers have the same acuity or capacity and therfore, depending upon the setting, not all information will be applicable on every survey (e.g.; aerosol generating procedures section). If citing for noncompliance related to COVID-19, the surveyor(s) must include the following language at the beginning of the Deficient Practice Statement or other place determined appropriate on the Form CMS-2567: “Based on [observations/interviews/record review], the facility failed to [properly prevent and/or contain – or other appropriate statement] COVID-19.” If surveyors see concerns related to compliance with other requirements, they should investigate them in accordance with guidance in the appropriate provider/supplier appendix of the State Operations Manual and related survey instructions. Surveyors may also need to consider investigating concerns related to Emergency Preparedness in accordance with the guidance in Appendix Z of the State Operations Manual (e.g., for emergency staffing). For purposes of this document, “staff” includes employees, consultants, contractors, volunteers, and others who provide care and services to patients on behalf of the facility. Additionally, the general term “facility” means inpatient, congregate settings, hospitals, intermediate care facilities for individuals with intellectual disabilities, dialysis facilities, and clinics, and “home” refers to settings such as hospice and home health where care is provided in the home. Entering the Facility/Triage/Registration/Visitor Handling Prior to entering the facility: • Is signage posted at facility entrances with visitation restrictions and screening procedures? • Are signs posted at entrances with instructions to individuals seeking medical care with symptoms of respiratory infection to immediately put on a mask and keep it on during their assessment, cover their mouth/nose when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after contact with respiratory secretions? Upon entering the facility: • Are staff trained on appropriate processes (e.g., questions to ask and actions to take) to rapidly identify and isolate suspect COVID-19 cases? • Is there a process that occurs after a suspected case is identified to include immediate notification of facility leadership/infection control? Page 1 COVID-19 Focused Infection Control Survey: Acute and Continuing Care Visitation • Facilities should limit visitation. • Are facilities actively screening visitors (CDC currently recomends staff are checking for fever and signs and/or symptoms of respiratory infection, and other criteria such as travel or exposure to COVID-19)? • What is your current screening criteria? • For permitted visitors are they instructed to frequently perform hand hygiene; limit their interactions with others in the facility; restrict their visit to the patient’s room or other location designated by the facility; and offered personal protective equipment (PPE) as supply allows? Did the facility perform appropriate screening of visitors? Yes No (see appropriate IPC tags for the provider/supplier type) Standard and Transmission-Based Precautions (TBPs) CMS is aware that there is a scarcity of some supplies in certain areas of the country. State and Federal surveyors should not cite facilities for not having certain supplies (e.g., PPE such as gowns, N95 respirators, surgical masks) if they are having difficulty obtaining these supplies for reasons outside of their control. However, CMS does expect facilities to take actions to mitigate any resource shortages and show they are taking all appropriate steps to obtain the necessary supplies as soon as possible. For example, if there is a shortage of PPE (e.g., due to supplier(s) shortage which may be a regional or national issue), the facility should contact their healthcare coalition for assistance (https://www.phe.gov/Preparedness/planning/hpp/Pages/find-hc-coalition.aspx), follow national and/or local guidelines for optimizing their current supply or identify the next best option to care for patients. Among other practices, optimizing their current supply may mean prioritizing use of gowns based on risk of exposure to infectious organisms, blood or body fluids, splashes or sprays, high contact procedures, or aerosol generating procedures (AGPs), as well as possibly extending use of PPE (follow national and/or local guidelines). Current CDC guidance for healthcare professionals is located at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html and healthcare facilities is located at: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html. Guidance on strategies for optimizing PPE supply is located at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html. If a surveyor believes a facility should be cited for not having or providing the necessary supplies, the State Agency should contact the CMS Regional Location. General Standard Precautions Are staff performing the following appropriately: • Respiratory hygiene/cough etiquette, • Environmental cleaning and disinfection, and • Reprocessing of reusable patient medical equipment (i.e., cleaning and disinfection per device and disinfectant manufacturer’s instructions for use)? Page 2 COVID-19 Focused Infection Control Survey: Acute and Continuing Care Hand Hygiene Are staff performing hand hygiene when indicated? If alcohol-based hand rub (ABHR) is available, is it readily accessible and preferentially used by staff for hand hygiene? Staff wash hands with soap and water when their hands are visibly soiled (e.g., blood, body fluids), If there are shortages of ABHR, hand hygiene using soap and water is used instead? Do staff perform hand hygiene (even if gloves are used) in the following situations: • Before and after contact with patients; • After contact with blood, body fluids, or visibly contaminated surfaces or other objects and surfaces in the care environment; • After removing personal protective equipment (e.g., gloves, gown, facemask); and • Before performing a procedure such as an aseptic task (e.g., insertion of an invasive device such as a urinary catheter, manipulation of a central venous catheter, medication preparation, and/or dressing care). Interview appropriate staff to determine if hand hygiene supplies are readily available and who they contact for replacement supplies. Did staff implement appropriate hand hygiene? Yes No (see appropriate IPC tags for the provider/supplier type) Personal Protective Equipment (PPE) Determine if staff appropriately use PPE including, but not limited to, the following: • Gloves are worn if potential contact with blood or body fluid, mucous membranes, or non-intact skin; • Gloves are removed after contact with blood or body fluids, mucous membranes, or non-intact skin; • Gloves are changed and hand hygiene is performed before moving from a contaminated site to a clean site during care (body, equipment, etc); • An isolation gown is worn for direct patient contact if the patient has uncontained secretions or excretions; • A facemask, gloves, isolation gown, and eye protection are worn when caring for a patient with new acute cough or symptoms of an undiagnosed respiratory infection unless the suspected diagnosis requires airborne precautions (e.g., tuberculosis) If PPE use is extended/reused, is it done according to national and/or local guidelines? If it is reused, is it cleaned/decontaminated/maintained after and/or between uses? Interview appropriate staff to determine if PPE is available, accessible and used by staff. • Are there sufficient PPE supplies available to follow infection prevention and control guidelines? In the event of PPE shortages, what procedures is the facility taking to address this issue? • Do staff know how to obtain PPE supplies before providing care? • Do they know who to contact for replacement supplies? Page 3 COVID-19 Focused Infection Control Survey: Acute and Continuing Care Aerosol – Generating Procedures • Appropriate mouth, nose, clothing, gloves, and eye protection (e.g., N95 or higher-level respirator, if available; face shield, gowns) is worn for performing aerosol-generating and/or procedures that are likely to generate splashes or sprays of blood or body fluids and COVID-19 is suspected; • Some procedures performed on patient with known or suspected COVID-19 could generate infectious aerosols. In particular, procedures that are likely to induce coughing (e.g., sputum induction, open suctioning of airways) should be performed cautiously. If performed, the following should occur: o Staff in the room should wear an N95 or higher-level respirator, eye protection, gloves, and a gown. o The number of staff present during the procedure should be limited to only those essential for care and procedure support. o AGPs should ideally take place in an airborne infection isolation room (AIIR). If an AIIR is not available and the procedure is medically necessary, then it should take place in a private room with the door closed. o Clean and disinfect procedure room surfaces promptly as and with appropriate disinfectant. Use disinfectants on List N of the EPA website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARSCOV-2 or other national recommendations; Did staff implement appropriate use of PPE? Yes No (see appropriate IPC tags for the provider/supplier type) Transmission-Based Precautions Determine if appropriate transmission-based precautions are implemented, including but not limited to: • Signage on the patient’s room regarding need for transmission-based precautions. • PPE use by staff (i.e., don gloves and gowns before contact with the patient and their care environment while on contact precautions; don facemask within three feet of a patient on droplet precautions; for facilities that use/have N-95 masks - don an fit-tested N95 or higher level respirator prior to room entry of a patient on airborne precautions); • Dedicated or disposable noncritical patient-care equipment (e.g., blood pressure cuffs, blood glucose monitor equipment) are used, or if not available, then equipment is cleaned and disinfected according to manufacturers’ instructions using an EPA-registered disinfectant prior to use on another patient or before being returned to a common clean storage area; • When transport or movement is medically-necessary outside of the patient room, does the patient wear a facemask? • Contaminated surfaces, objects and environmental surfaces that are touched frequently and in close proximity to the patient (e.g., bed rails, over-bed table, bathrooms) are cleaned and disinfected with an EPA-registered disinfectant for healthcare use (effective against the organism identified if known) at least daily and when visibly soiled. Interview appropriate staff to determine if they are aware of processes/protocols for transmission-based precautions and how staff is monitored for compliance. For providers of care in the home, has the provider, educated patients and family members regarding transmission of infectious diseases and specifically mitigating transmission of COVID-19. Page 4 COVID-19 Focused Infection Control Survey: Acute and Continuing Care Interview appropriate staff to determine if they are aware of processes/protocols for transmission-based precautions and how staff is monitored for compliance. If concerns are identified, expand the sample to include more patients with transmission-based precautions. Did the staff implement appropriate transmission-based precautions? provider/supplier type) Yes No (see appropriate IPC tags for the Standards, Policies and Procedures Did the facility establish a facility-wide IPCP including written standards, policies, and procedures that are current and based on national standards for undiagnosed respiratory illness and COVID-19? Does the facility’s policies or procedures include when to notify local/state public health officials if there are clusters of respiratory illness or cases of COVID-19 that are identified or suspected? Concerns must be corroborated as applicable including the review of pertinent policies/procedures as necessary. Did the facility develop and implement an overall IPCP including policies and procedures for for undiagnosed respiratory illness and COVID-19? Yes No (see appropriate IPC tags for the provider/supplier type) Infection Surveillance Does the facility know how many patients in the facility have been diagnosed with COVID-19 (suspected and confirmed)? The facility has established/implemented a surveillance plan, based on a facility assessment, for identifying, tracking, monitoring and/or reporting of fever, respiratory illness, or other signs/symptoms of COVID-19. The plan includes early detection, management of a potentially infectious, symptomatic patient and the implementation of appropriate transmission-based precautions/PPE. The facility has a process for communicating the diagnosis, treatment, and laboratory test results when transferring patients to an acute care hospital or other healthcare provider. Can appropriate staff (e.g., nursing and leadership) identify/describe the communication protocol with local/state public health officials? Interview appropriate staff to determine if infection control concerns are identified, reported, and acted upon. Did the facility provide appropriate infection surveillance? Yes No (see appropriate IPC tags for the provider/supplier type) Education, Monitoring, and Screening of Staff • Is there evidence the provider has educated staff on COVID-19 (e.g., symptoms, how it is transmited, screening criteria, work exclusions)? Page 5 COVID-19 Focused Infection Control Survey: Acute and Continuing Care • How does the provider convey updates on COVID-19 to all staff? • Is the facility screening all staff at the beginning of their shift for fever and signs/symptoms of illness? Is the facility actively taking their temperature and documenting absence of illness (or signs/symptoms of COVID-19 as more information becomes available)? • If staff develop symptoms at work (as stated above), does the facility: o have a process for staff to report their illness or developing symptoms; o place them in a facemask and have them return home for appropriate medical evaluation; o inform the facility’s infection preventionist and include information on individuals, equipment, and locations the person came in contact with; and o Follow current guidance about returning to work (e.g., local health department, CDC: https://www.cdc.gov/coronavirus/2019ncov/healthcare-facilities/hcp-return-work.html). Did the facility provide appropriate education, monitoring, and screening of staff? provider/supplier type) Yes No (see appropriate IPC tags for the Emergency Preparedness - Staffing in Emergencies Policy development: Does the facility have a policy and procedure for ensuring staffing to meet the needs of the patients when needed during an emergency, such as a COVID-19 outbreak? Policy implementation: In an emergency, did the facility implement its planned strategy for ensuring staffing to meet the needs of the patient? (N/A if a emergency staff was not needed) Did the facility develop and implement policies and procedures for staffing strategies during an emergency? Yes No (see appropriate Emergency Preparedness tag for the provider/supplier type) The following sections are specific nuances to consider and assess when on survey. Considerations Specifically for Surveys of Hospitals and Critical Access Hospitals Patient Care • Is the facility restricting patients (to the extent possible) to their rooms except for medically necessary purposes? If patients have to leave their room, are they wearing a facemask, performing hand hygiene, limiting their movement in the facility, and performing social distancing (stay at least 6 feet away from others). If PPE shortage is an issue, facemasks should be limited to patients diagnosed with COVID-19 or has signs/symptoms of respiratory illness or COVID-19. Page 6 COVID-19 Focused Infection Control Survey: Acute and Continuing Care • Has the facility isolated residents with known or suspected COVID-19 in a private room (if available), or taken other actions based on national (e.g., CDC), state, or local public health authority recommendations? Did staff provide appropriate care for patients with known or suspected COVID-19? C-0278) Yes No (Hospital Tag A-0747, CAH Tag Environmental Cleaning • • • • During environmental cleaning procedures, personnel wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection)? Environmental surfaces in patient care areas are cleaned and disinfected, using an EPA-registered disinfectant on a regular basis (e.g., daily), when spills occur and when surfaces are visibly contaminated? Use disinfectants on List N of the EPA website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-COV-2 or other national recommendations; Cleaners and disinfectants, including disposable wipes, are used in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time). The hospital decontaminates spills of blood or other body fluids according to its policies and procedures, using appropriate EPA-registered hospital disinfectants? Did staff provide appropriate environmental cleaning for facilities with known or suspected COVID-19? A-0747, CAH Tag C-0278) Yes No (Hospital Tag Additional Considerations Specifically for Dialysis Facility Surveys Hand Hygiene Considerations • Perform handwashing with soap and water at dedicated handwashing sinks if hands are visibily soiled (see § 494.30(a)(1)(i)) • Remove gloves and perform hand hygiene between each patient or dialysis station Cleaning and Disinfection Considerations • Items taken to the dialysis station must be either disposed of, dedicated for use on a single patient or cleaned and disinfected before being taken to a common clean area or used on another patient • Use proper aseptic technique during vascular access care, medication preparation and administration • Proper cleaning and disinfection of the dialysis station including the dialysis machine, chair, prime waste receptacle, reuseable acid and bicarbonate containers after the previous patient fully vacates the station. Page 7 COVID-19 Focused Infection Control Survey: Acute and Continuing Care • • • Clean areas should be clearly designated for the preparation, handling and storage of medications and unusued supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Proper disposal of bio-hazard waste Isolation Considerations • Ensure dedicated machines, equipment, instruments, supplies, and medications that will not be used to care for non-isolation patients. Did staff implement appropriate hand hygiene, cleaning/disinfection and isolation considerations? CFR 494.30 and Tags V110-V148) Yes No (see Condition 42 Section 3087 of the 21st Century Cures Act, signed into law in December 2016, added subsection (f) to section 319 of the Public Health Service Act. This new subsection gives the HHS Secretary the authority to waive Paperwork Reduction Act (PRA) (44 USC 3501 et seq.) requirements with respect to voluntary collection of information during a public health emergency (PHE), as declared by the Secretary, or when a disease or disorder is significantly likely to become a public health emergency (SLPHE). Under this new authority, the HHS Secretary may waive PRA requirements for the voluntary collection of information if the Secretary determines that: (1) a PHE exists according to section 319(a) of the PHS Act or determines that a disease or disorder, including a novel and emerging public health threat, is a SLPHE under section 319(f) of the PHS Act; and (2) the PHE/SLPHE, including the specific preparation for and response to it, necessitates a waiver of the PRA requirements. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been designated as the office that will coordinate the process for the Secretary to approve or reject each request. The information collection requirements contained in this information collection request have been submitted and approved under a PRA Waiver granted by the Secretary of Health and Human Services. The waiver can be viewed at https://aspe.hhs.gov/public-health-emergency-declarationpra-waivers. Page 8 Summary of the COVID-19 Focused Survey for Acute and Continuing Care Providers This is a summary of the COVID-19 Focused Survey for acute and continuing care providers (Non-Long term care facilities). Surveyors should review the Focused Infection Control Survey tool in light of the established State Operations Manual Survey Protocol for more detailed information. Facilities can review the Focused Survey to determine CMS’s expectations for an infection prevention and control program during the COVID-19 pandemic. Offsite Survey Activity • • • • • If the survey team plans to enter a facility with an active COVID-19 case, the survey team should contact their State Survey Agency (SA), the state health department, and CMS Regional Location to coordinate activities for these facilities. SAs should ensure surveyors are medically cleared, trained in the appropriate use of and have needed personal protective equipment (PPE) that could be required onsite. Conduct offsite planning to limit interruptions to care while onsite. Obtain information on: o Facility-reported information; o CDC, state/local public health reports; o Complaint allegations. Identify survey activities that will be conducted offsite, such as: o Medical record review o Telephonic interviews o Facility Policy/Procedure review Conduct any survey exit discussion with the facility by telephone and draft the CMS-2567 offsite. Onsite Survey Activity • • • • • • If the survey team identifies an active COVID-19 case after entering a facility, the survey team should contact their SA, the state health department, and CMS Regional Location to coordinate activities for the facility. Limit the onsite team to one to two surveyors. Identify onsite assignments for activities, such as: Observations: o Hand hygiene practices o Proper use/discarding of PPE o Cleansing medical equipment o Effective Transmission-Based Precautions Interviews: o Policy/Procedure knowledge o Surveillance for sign/symptoms o Notifying local health officials Adhere to all CDC guidance for infection prevention and control related to COVID-19. Identify and arrange for interviews that can be done telephonically. Be alert of other immediate jeopardy (IJ) situations that may be present, and investigate appropriately. Facility Self-Assessment Facilities should utilize the COVID-19 Focused Survey as a self-assessment tool. Priority areas for self- assessment include all of the following: 1. Standard Precautions; a. Hand hygiene b. Use of PPE c. Transmission-Based Precautions 2. Patient care (including patient placement); 3. Infection prevention and control standards, policies and procedures (hand hygiene, PPE, cleaning and disinfection, surveillance); 4. Visitor entry (i.e., screening, restriction, and education); 5. Education, monitoring, and screening of staff; and 6. Emergency preparedness – staffing in emergencies Summary of the COVID-19 Focused Survey for Acute and Continuing Care Providers Section 3087 of the 21st Century Cures Act, signed into law in December 2016, added subsection (f) to section 319 of the Public Health Service Act. This new subsection gives the HHS Secretary the authority to waive Paperwork Reduction Act (PRA) (44 USC 3501 et seq.) requirements with respect to voluntary collection of information during a public health emergency (PHE), as declared by the Secretary, or when a disease or disorder is significantly likely to become a public health emergency (SLPHE). Under this new authority, the HHS Secretary may waive PRA requirements for the voluntary collection of information if the Secretary determines that: (1) a PHE exists according to section 319(a) of the PHS Act or determines that a disease or disorder, including a novel and emerging public health threat, is a SLPHE under section 319(f) of the PHS Act; and (2) the PHE/SLPHE, including the specific preparation for and response to it, necessitates a waiver of the PRA requirements. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been designated as the office that will coordinate the process for the Secretary to approve or reject each request. The information collection requirements contained in this information collection request have been submitted and approved under a PRA Waiver granted by the Secretary of Health and Human Services. The waiver can be viewed at https://aspe.hhs.gov/public-health-emergency- declaration-pra-waivers.