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4250 HOSPITAL DR

MARIANNA, FL 32446

GOVERNING BODY

Tag No.: A0043

Based on observation, staff interviews, review of hospital policies related to infection control, review of Quality Assessment and Process Improvement (QAPI) activities, and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital governing body failed to ensure the hospital was in compliance with all Conditions of Participation and had adequate resources allocated to measure, assess, improve and sustain the hospital's response to the COVID-19 pandemic to reduce risk of exposure to patients and staff. The governing body failed to ensure the hospital implemented state and national guidelines for infection prevention (refer to A0747, A0749, A0771, and A0772) and failed to ensure that a comprehensive QAPI program was in place (refer to A0263 and A0283).

These governing body failures resulted in a determination of Immediate Jeopardy. The hospital Risk Manager was notified of the Immediate Jeopardy on April 27, 2020 at approximately 2:38pm. The Immediate Jeopardy was determined to start on 04/13/2020 and was ongoing.

Individuals who are 65 years and older, and those with chronic underlying medical conditions are at high risk for developing serious complications from COVID-19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID-19 infection can lead to death. COVID-19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID-19 infection, which is a highly transmissible disease.

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on March 13, 2020 and approved a major disaster declaration for Florida on March 27, 2020.

The findings include:

On 4/24/2020 at 2:13 PM, a telephone interview with the governing body chairperson (GB chair) took place. The GB chair reported having served on the governing body for 3-4 years and stated the board meets monthly and no specific meetings of the board have been held regarding the hospital's response to the COVID-19 pandemic. The GB chair said the past meeting in March 2020 was limited to only the executive board for the purpose of social distancing and confirmed the meeting did not include topics related to COVID-19. The GB chair said the hospital's materials manager had reached out to her over the past two months regarding the acquisition of facemasks and supplies related to her personal business dealings, but she was not able to support the hospital with providing supplies. She said the CEO requested funding for local tests for the virus because there is not enough access to testing materials to perform the tests. The GB chair said the board has not been involved in quality monitoring and would expect that to be covered in the next meeting. She said the board had not been provided with quality guidelines to consider, but annually the board has special educational sessions to walk them through understanding quality metrics and used HCAHPS (hospital consumer assessment of healthcare providers and systems) as an example of metrics that have been explained and reviewed with the board.

Refer to the Condition of Participation of Quality Assurance Performance Improvement, A0263: Based on observation, staff interview, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital failed to develop and implement hospital-wide, data-driven quality measures focused on indicators related to the COVID-19 pandemic, a state and nationally declared public health emergency. This hospital-wide failure resulted in the hospital's lack of data to determine whether national and state recommendations for infection prevention and control were implemented effectively to prevent the transmission of COVID-19 to patients, health care personnel and the community the hospital serves. The hospital Quality Assurance and Performance Improvement (QAPI) committee failed to adopt recommendations and directives regarding staff screening, personal protective equipment (PPE) usage to include facial masks, and COVID-19 patient testing criteria. The hospital QAPI failed to conduct quality review of patient records for testing and surveillance per the guidance and directives.

Refer to the Condition of Participation of Infection Control, A0747: Based on observations, interviews, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital failed to implement a hospital-wide infection control program for the surveillance, prevention, and control of COVID-19, a highly transmissible disease that can lead to death for which there is no vaccine or no approved treatment. The hospital failed to employ methods to prevent the transmission of COVID-19 infections within the hospital and between the hospital and other institutions and settings for staff and patients; failed to ensure that the infection control and prevention program, in conjunction with the quality assessment and performance improvement (QAPI) activities, ensured Florida department of health (DOH), Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) recommended infection control practices related to the COVID-19 pandemic were consistently and fully implemented; failed to develop and implement hospital-wide surveillance, prevention and control policies and procedures that adhere to national and state guidelines in response to the COVID-19 pandemic to reduce risk of exposure to patients and staff, including the vulnerable elderly (about 33 inpatients, 600 staff, plus emergency room and other outpatients).

QAPI

Tag No.: A0263

Based on observation, staff interview, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital failed to develop and implement hospital-wide, data-driven quality measures focused on indicators related to the COVID-19 pandemic, a state and nationally declared public health emergency. This hospital-wide failure resulted in the hospital's lack of data to determine whether national and state recommendations for infection prevention and control were implemented effectively to prevent the transmission of COVID-19 to patients, health care personnel and the community the hospital serves. The hospital Quality Assurance and Performance Improvement (QAPI) committee failed to adopt recommendations and directives regarding staff screening, personal protective equipment (PPE) usage to include facial masks, and COVID-19 patient testing criteria. The hospital QAPI failed to conduct quality review of patient records for testing and surveillance per the guidance and directives (refer to A0283).

The cumulative effect of these systemic QAPI failures resulted in the hospital's inability to evaluate and prevent the possible transmission of COVID-19, a serious illness, to staff, patients, and to the community the hospital serves, and resulted in a finding of Immediate Jeopardy. The hospital Risk Manager was notified of the Immediate Jeopardy on April 27, 2020 at approximately 2:38pm. The Immediate Jeopardy was determined to start on 04/13/2020 and was ongoing.

Individuals who are 65 years and older, and those with chronic underlying medical conditions, are at high risk for developing serious complications from COVID-19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID-19 infection can lead to death. COVID-19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID-19 infection, which is a highly transmissible disease.

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on March 13, 2020 and approved a major disaster declaration for Florida on March 27, 2020.

The findings include:

Refer to A0283: Based on observation, staff interview, record review, policy review and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital quality assurance and performance review committee (QAPI) failed to utilize its resources effectively and efficiently to identify opportunities for improvement regarding patient safety and quality of care. The hospital QAPI failed to revise hospital policies to establish criteria and address quality metrics in response to the nationally declared public health emergency. The hospital QAPI committee failed to adopt recommendations and directives regarding staff screening, personal protective equipment (PPE) usage to include facial masks, and COVID-19 patient testing criteria. The hospital QAPI failed to conduct quality reviews of patient records for testing and surveillance per the guidance and directives. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on observation, staff interview, record review, policy review and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital quality assurance and performance review committee (QAPI) failed to utilize its resources effectively and efficiently to identify opportunities for improvement regarding patient safety and quality of care. The hospital QAPI failed to revise hospital policies to establish criteria and address quality metrics in response to the nationally declared public health emergency. The hospital QAPI committee failed to adopt recommendations and directives regarding staff screening, personal protective equipment (PPE) usage to include facial masks, and COVID-19 patient testing criteria. The hospital QAPI failed to conduct quality reviews of patient records for testing and surveillance per the guidance and directives. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients.

This hospital-wide QAPI failure to implement and evaluate CDC guidelines, directives, recommendations and surveillance of COVID-19 led to a finding of Immediate Jeopardy due to the serious risk to patients and staff of exposure to COVID-19, a highly transmissible disease that can lead to death. The hospital Risk Manager was notified of the Immediate Jeopardy on 4/27/2020 at approximately 2:38 PM. The Immediate Jeopardy was determined to start on 04/13/2020 and was ongoing. Cross Reference: A0747, A0749, A0771 and A0772.

Individuals who are 65 years and older, and those with chronic underlying medical conditions, are at high risk for developing serious complications from COVID-19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID-19 infection can lead to death. COVID-19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID-19 infection, which is a highly transmissible disease.

The findings included:

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on 03/13/2020 and approved a major disaster declaration for Florida on 03/27/2020.

On March 4, 2020, the Centers for Medicare & Medicaid Services (CMS) Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (QSO) issued memo QSO-20-13-Hospitals, "Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge." CMS wrote: This memorandum responds to questions we have received and provides important guidance for hospitals and critical access hospitals (CAH's) in addressing the COVID-19 outbreak and minimizing transmission to other individuals. The same screening performed for visitors should be performed for hospital staff. Screening should include: 1. Fever or symptoms of a respiratory infection, such as a cough and sore throat; 2. International travel within the last 14 days to restricted countries; and 3. Contact with someone with known or suspected COVID-19. Health care providers (HCP) who have signs and symptoms of a respiratory infection should not report to work. On March 30, 2020, CMS updated the staff screening questions in to include:
1. Signs or symptoms of a respiratory infection, such as a fever, cough, or difficulty breathing.
2. Contact with a person who is positive for COVID-19 or with someone who is considered a PUI or someone who is ill with respiratory illness.
3. Travel within the last 14 days to areas with widespread or ongoing COVID-19 community spread.
4. Residence or working in a community where community-based spread of COVID-19 is occurring.

On March 9, 2020, the Agency for Health Care Administration (AHCA), the state survey agency, issued an Alert to all Florida Hospitals entitled, "CDC Infection Prevention and Control Guidelines". The directive stated: On behalf of Florida's Surgeon General and the Florida Department of Health, the Agency for Health Care Administration wants to ensure patients and staff are protected by following CDC infection prevention and control guidelines, including use of recommended personal protective equipment (PPE). Please review the information below and evaluate your facilities' practices when admitting and triaging/screening patients with respiratory symptoms as they enter your emergency department. Guidance of note includes:
-Immediately place a facemask on any individual entering the emergency department or triage/ screening area of the hospital who presents with a cough, fever, runny nose, etc. This patient should be held in a separate triage area if not already. If worn properly, a facemask helps block respiratory secretions produced by the wearer from contaminating other persons and surfaces.
-All staff working triage desk must wear appropriate PPE (facemask, etc.) Staff must be properly trained on the usage of PPE and the prevention of transmission of infectious agents. The directive included CDC links for PPE conservation guidelines, information on how to properly don, use, and doff PPE in a manner to prevent self-contamination is available here, recommendations for preventing spread of COVID-19 and OSHA training videos.

On 3/18/20 the Agency for Health Care Administration (AHCA), issued an Alert to all Florida Hospitals entitled, "Hospital and Physician COVID-19 Testing Criteria for Elderly and Medically Frail." The purpose of the directive was: "To provide hospitals and physicians with clear guidance and testing criteria for the elderly or individuals with serious underlying medical conditions, the Department of Health and the Agency for Health Care Administration have developed a tool." The alert directed hospitals and clinicians to test for COVID-19 when the following criteria were met: 1: Individuals 65 or older OR Individuals with serious underlying medical conditions, AND 2. Presents with these symptoms: New onset fever of 100.4 degrees Fahrenheit (F) or greater AND cough OR other respiratory signs including shortness of breath.

On 4/22/2020 from approximately 7:15 AM - 8:00 AM, observations were made at the hospital beginning in the front entrance, moving through the main lobby to elevators, onto the 3rd floor inpatient area, to the emergency room entrance, and then to the 4th floor to the hospital's administrative offices. The observations revealed that healthcare personnel were not screened prior to entering the hospital and visitors from the Sheriff's department were allowed entry to the hospital for the purpose of eating in the cafeteria and were not screened or offered facemasks to wear inside the hospital. Staff were observed inside the hospital and inside a patient room not wearing any facemasks or facial coverings. In an interview at approximately 7:45 AM, staff G, a nurse supervisor, reported staff are not screened prior to entering the hospital, but are expected to self-monitor at home.

On 4/22/20 at approximately 8:00 AM during an interview with senior hospital leadership, the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Infection Preventionist (IP), Risk Manager (RM), and Director of Quality explained the hospital had not implemented recommendations for universally wearing facemasks, not actively screened staff members and had not developed policies or quality metrics in response to the COVID-19 pandemic. The IP stated the hospital follows Centers for Disease Control and Prevention (CDC) guidelines, but the hospital had not developed formal written policies because of the frequency of new information. The Director of Quality said they talked about screening staff but planned to wait until there was an in-house positive case. The Infection Preventionist (IP) reported there were no patients currently in the hospital on droplet precautions; there were 2 patients in the hospital on contact precautions for MRSA (methicillin resistant staphylococcus aureus) and 1 patient on contact precautions for Clostridium Difficile.

Medical record reviews revealed the hospital had not implemented or adhered to AHCA or CDC recommendations for testing elderly and frail individuals for COVID-19 and had not implemented droplet isolation precautions for patients meeting COVID-19 testing criteria for elderly and frail individuals. Three current patients with a respiratory -associated diagnosis were selected to review. Patient #1 was a 73 year-old admitted on 4/21/20 from long term care facility fever of 103.2 degrees F, pneumonia, and oxygen saturation of 88%. No COVID-19 test was performed and patient was not placed on droplet or airborne precautions. Patient #1 met the COVID-10 testing criteria due to age (73) and fever (103.2 degrees F) with respiratory issues and hypoxia (low oxygen saturation). Patient #2 was a 64 year old serious underlying medical conditions admitted on 4/22/20 from a long term care facility with a chief complaint of respiratory arrest/failure and a temperature fever 99.7 degrees F. Patient #2 was admitted, ordered a continuous positive airway pressure (CPAP) and her fever rose to 101.5 degrees F. No COVID-19 test was ordered or performed and patient #2 was not placed on droplet or airborne precautions. Patient #2 met the criteria for COVID-19 testing criteria due to being medically frail, high fever and respiratory failure. Patient #3 was a 69 year old male admitted 4/14/20 with a diagnosis acute respiratory failure. A COVID-19 test was not performed until 7 days later, on 4/21/20, and only then as a screening was required for placement in a long term acute care facility. Patient #3 was not identified as a PUI and not placed on droplet or airborne precautions. Patient #3 met the state agency testing criteria for elderly and frail individuals at the time of admission due to age (69) and condition (respiratory failure).

On 4/22/20 at 11:00 AM, staff K, the Quality Coordinator, stated she does record reviews for the hospital within the quality department, but record reviews are not directed specific to COVID-19.

In a telephone interview on 4/24/20 at 11:36 AM with the Risk Manager (RM) and Director of Quality, the RM explained both are on the quality committee which meets every 2 months and covers many things, including infection control. The RM said a COVID-19 task force was put in place in March and met this morning (4/24/20) to get a plan to get facemasks for all employees and to start screening employees. She explained the hospital got a notification from Joint Commission on 4/23/20 with new guidelines. The Joint Commission, an accrediting agency, issued a statement on 4/23/20 in support of recommendations made by the CDC on 4/13/20.

The RM confirmed no record reviews were done specific to COVID-19, but Staff K, the Quality Coordinator, performs daily reviews of charts and quality but not specific to COVID-19. The RM stated they are looking at that, but not in an organized way, adding the infection preventionist (IP) is tracking and is notified any time someone is tested and is a potential (COVID-19 patient). The RM said the hospital was not specifically tracking or collecting data other than what the infection preventionist collects and tracks for tests and results. During the interview, the RM confirmed staff K is the one who reviews charts for quality and was not instructed or trained to review charts to compare if a patient met testing criteria and wasn't tested. The RM confirmed there were no metrics (system or standard of measurement) for record reviews.

The RM said the hospital does not have an organized plan for tracking metrics related to COVID-19 and were using the sepsis core measures which she described as similar. Sepsis is defined by the National Institutes for Health at nigms.nih.gov as a serious medical condition caused by an overwhelming immune response to infection caused by many types of microbes including bacteria, fungi, and viruses. Symptoms are described as fever, chills, rapid breathing and heart rate, rash, confusion and disorientation.

When the surveyor asked if metrics were collected regarding cleaning and disinfecting in response to the COVID-19 pandemic, the RM explained the housekeeping director is on the daily safety huddle calls and is sending staff through to do doors and extra cleaning and infection control that was added for COVID-19. The RM was unaware if the housekeeping director was keeping a log, but said they were keeping a log of other staff members that are being pulled to do extra cleaning for the purpose of logging hours of the employees. The RM was unaware if there were any measures to monitor how often high touch surfaces were cleaned.

When asked if the hospital was measuring compliance with hand hygiene and use of personal protective equipment (PPE), the RM replied that other than the IP rounding and observing for surveillance of hand hygiene and PPE nothing additional has been put in place to develop quality metrics for hand hygiene or PPE. The RM added the hospital implemented the use of new software for event reporting which was not a response to the COVID-19 pandemic, but the software company developed a rounding tool specifically made for COVID-19 and the hospital had not implemented this tool but had plans to use it.

The RM stated the quality committee meets at the same scheduled frequency as before the pandemic but now meetings are combined with other meetings and mostly conducted over phone to limit exposure and comply with social distancing. No additional meetings of the quality committee were convened related to the hospital's efforts to respond to the pandemic.

The surveyor asked the RM and Director of Quality if the quality committee had reviewed and incorporated into the hospital infection control response expert resources from the CDC or CMS including The Comprehensive Hospital Preparedness Checklist for Coronavirus Disease 2019 or CMS memo QSO-20-13-Hospitals-CAHs: Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs): FAQs, Considerations for Patient Triage, Placement, Limits to Visitation and Availability of 1135 waivers. The RM answered that she'd seen some tools on there, but had not personally used them in the role of risk management. The Director of Quality said she didn't remember discussing anything related to COVID-19 during the quality meeting and doesn't remember specific guidance that the quality committee is using. The Director of Quality then reiterated that the quality committee is planning to use the rounding tool in the software.

The RM and Director of Quality agreed there had not been full meetings of quality because of COVID-19. They added the governing body has a monthly board meeting but has not had a specific board meeting that addresses COVID-19. The last meeting was last Wednesday (4/15/20), they were not sure if COVID-19 was on the agenda.

The RM said weekly physician meetings were implemented to disseminate information to the physicians. The RM explained every Wednesday there is a call with physicians at 7:00 AM to go over new regulations or guidelines and said the hospital uses the latest guidelines for testing and described them as nothing to do with travel, explaining fever and shortness of breath are the criteria. The RM said the hospital has a limited supply of tests. The surveyor requested copies of the hospital's criteria for testing. In response to the request for testing criteria, the RM provided an April 7, 2020 agenda of the Emergency Department Provider's Meeting. This documentation provided links to guidance from CDC and described the course of the disease from presentation, including various symptoms, clinical disease progression, and treatment options. The agenda did not identify a hospital-based testing criteria.

During an interview on 4/22/20 at approximately 8:00 AM, the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Infection Preventionist (IP), Risk Manager (RM), and Director of Quality confirmed the hospital did not establish metrics for determining required amounts of PPE to respond to the COVID-19 pandemic. The CEO stated if all staff wore facemasks the supply would be depleted. The IP added if the hospital had all staff wear facemasks, they would be out by Friday (4/24/2020). The surveyor asked if this was based on a PPE burn rate projection, and the CEO responded the hospital has not calculated a PPE burn rate. The CEO stated the next step for the hospital was to figure out the burn rate (usage) for PPE supplies, but they did not currently have any estimation of the PPE burn rate. The CNO added that the hospital had 3 rule out cases of COVID-19 in the past ("rule out" refers to a patient under suspicion of a condition that has not yet been determined) and during the care of the 3 patients the hospital went from an inventory of 1000 N95 facemasks to 20. The staff stated they currently do not have any patients identified as a PUI or who have known COVID-19 infection in the hospital.

The CEO said the materials manager could provide the inventory for PPE and this was subesquently provided. The document revealed that the inventory count for 4/21/2020 was:
Facemasks:
N95 REG - 5318
N95 Small - 1872
Procedure - EL (ear loop) - 1299
Surgery - Tie - 3450
Fluidshield - Tie - 230
Total facemasks = 12169
Goggles:
Frame - 1980
Lens - 3974
FaceShield = 1742
Isolation Gowns = 2265
Bouffants (head covering) = 5200
Caps = 2000
Shoe Covers = 4025
Stethoscopes = 246

The CEO added the N95 facemasks are secured and they do not allow staff to bring in their own facemasks unless it goes through our sterilization process. The CEO speculated that the complaint originated from 1 employee who brought in her own facemask and was told she couldn't use it unless it went through our sterilization. The CEO said, "you know what, if you make us all wear facemasks all the time, I'll make sure she gets her facemask last." The surveyor informed the CEO at this time that complaints are anonymous and come from many sources and that identities of complainants cannot be confirmed or discussed; however, it would be improper to retaliate or withhold equipment from an employee.

The surveyor asked the CEO again about estimates of burn rates for PPE supplies and replied, "we're working on a burn rate; it has not been consistent. We have a total of 600 staff with roughly 250 staff working daily and we have not furloughed even one employee."

During an interview on 2/24/20 at 10:16 AM, the materials manager stated the hospital currently had approximately 10 times the inventory of facemasks than levels prior to the COVID-19 pandemic. The materials manager verbally provided the typical inventory amounts of PPE prior to the COVID-19 pandemic:
Ear loop facemasks is usually about 350
Filter facemasks, about 100
Surgery and tie facemasks is usually 200
N95 regular size facemasks are usually 6 boxes of 30 per box, so about 180 total, and about the same amount of size small, about 180-200 total.
Gowns are usually 17 cases which is 85 total.
Face shields are usually 1000.
The materials manager stated that they usually get 3 shipments a week, and they haven't had any additional shipments in. We have to vet the suppliers who say they have supplies to make sure they are qualified vendors. The materials manager said he was not screened when coming into work today (4/24/20) but had a meeting about putting a procedure in place to do that, adding "we aren't screening employees now but working on that."

The surveyor requested copies of relevant infection control and prevention policies and procedures to determine hospital compliance. The documents revealed:
1. An undated, unsigned copy of an Exposure Control Plan which referenced Occupational Safety and Health Administration (OSHA) bloodborne pathogens and "other potentially infectious materials" including Hepatitis B and C viruses and HIV (Human Immunodeficiency Virus). No mention of COVID-19 or specific protocol for organisms requiring droplet precautions were mentioned in the plan. The plan contained blank spaces for committee approval of the plan and for annual review and approval.
2. A Respiratory Policy-Infection Control Plan with an effective date of 08/1994 did not contain reference to COVID-19. The policy was identified as an adjunct to the hospital-wide infection control manual.
3. An Isolation Policy with no effective date or review date identified and no committee approval identified which did not contain references to COVID-19. The policy defined standard precautions and transmission-based precautions.
4. A copy of the Pandemic Policy dated 04/20 contained a plan for cohorting patients. The plan for staffing documented using emergency credentialing protocols set by local and/or state agencies to bring staff to hospital from the community to work. The plan did not mention COVID-19 but identified the purpose of the plan as "to ensure the hospital is prepared to efficiently provide health services during a pandemic." The policy then describes the pandemic response as a response to influenza. Procedures identified included: Establish and maintain inventory of PPE, Obtain from DOH (Department of Health) and public health authorities case definitions, protocols, and algorithms to assist with case finding, management, infection control, and surveillance reporting. Review, revise as needed, and activate guidelines for prevention and control measures. Conduct surveillance and testing for influenza. Implement a plan for early detection, reporting and treatment of health care personnel (staff). Reinforce infection control procedures to prevent the spread of influenza and utilize appropriate PPE. Maintain high index of suspicion that patients presenting with influenza-like illness could be infected with the pandemic strain. Increase environmental cleaning efforts. Summarize and analyze the pandemic response and lessons learned for the next wave. Review and revise the Pandemic Influenza Plan based on outcome measurements and performance results of current plan. The plan identified the CEO, CFO (Chief Financial Officer) and CNO (Chief Nursing Officer) as responsible for obtaining and disseminating information from outside agencies and resources as the nature and extent of the emergency and ensuring the safety of the staff and patients during the emergency.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on observations, interviews, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital failed to implement a hospital-wide infection control program for the surveillance, prevention, and control of COVID-19, a highly transmissible disease that can lead to death for which there is no vaccine or no approved treatment. The hospital failed to employ methods to prevent the transmission of COVID-19 infections within the hospital and between the hospital and other institutions and settings for staff and patients (refer to A0749); failed to ensure that the infection control and prevention program, in conjunction with the quality assessment and performance improvement (QAPI) activities, ensured Florida department of health (DOH), CDC and CMS recommended infection control practices related to the COVID-19 pandemic were consistently and fully implemented (refer to A771); failed to develop and implement hospital-wide surveillance, prevention and control policies and procedures that adhere to national and state guidelines in response to the COVID-19 pandemic to reduce risk of exposure to patients and staff, including the vulnerable elderly (about 33 inpatients, 600 staff, plus emergency room and other outpatients) (refer to A772).

The cumulative effect of these systemic infection control failures resulted in a finding of Immediate Jeopardy. The hospital Risk Manager was notified of the Immediate Jeopardy on April 27, 2020 at approximately 2:38pm. The Immediate Jeopardy was determined to start on 04/13/2020 and was ongoing.

Individuals who are 65 years and older, and those with chronic underlying medical conditions, are at high risk for developing serious complications from COVID-19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID-19 infection can lead to death. COVID-19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID-19 infection, which is a highly transmissible disease.

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on March 13, 2020 and approved a major disaster declaration for Florida on March 27, 2020.

The findings include:

Refer to A0749: Based on observations, interviews, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital failed to employ methods to prevent the transmission of COVID-19 infections within the hospital and between the hospital and other institutions and settings for staff and patients. The hospital failed to develop a policy on COVID-19 to address CDC, CMS and AHCA guidelines for prevention and control including staff screening, facemask usage, testing criteria and isolation precautions. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients, the staff who worked with these patients, and the community at large.

Refer to A0771: Based on observations, interviews, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital's governing body failed to ensure that the infection control and prevention program, in conjunction with the quality assessment and performance improvement (QAPI) activities, ensured CDC, CMS and AHCA recommended infection control practices related to the COVID-19 pandemic were consistently and fully implemented. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3.

Refer to A0772: Based on observation, staff interview, record review, policy review and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), the infection preventionist failed to develop and implement hospital-wide surveillance, prevention and control policies and procedures that adhere to national and state guidelines in response to the Coronavirus Disease 2019 (COVID-19) pandemic to reduce risk of exposure to patients and staff. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, interviews, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital failed to employ methods to prevent the transmission of COVID-19 infections within the hospital and between the hospital and other institutions and settings for staff and patients. The hospital failed to develop a policy on COVID-19 to address CDC, CMS and AHCA guidelines for prevention and control including staff screening, facemask usage, testing criteria and isolation precautions. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients, the staff who worked with these patients, and the community at large.

Individuals who are 65 years and older and those with chronic underlying medical conditions, are at high risk for developing serious complications from COVID 19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID 19 infection can lead to death. COVID 19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID 19 infection, which is a highly transmissible disease.

The hospital failure employ methods for preventing COVID-19 transmission led to a finding of Immediate Jeopardy. The hospital Risk Manager was notified of the Immediate Jeopardy on 4/27/2020 at approximately 2:38 PM.The Immediate Jeopardy was determined to start on 04/13/2020 and was ongoing. Cross Reference: A0771 and A0772.

The findings included:

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on 03/13/2020 and approved a major disaster declaration for Florida on 03/27/2020.

On March 4, 2020, the CMS Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (QSO) issued memo QSO-20-13-Hospitals, "Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge." CMS wrote: This memorandum responds to questions we have received and provides important guidance for hospitals and critical access hospitals (CAH's) in addressing the COVID-19 outbreak and minimizing transmission to other individuals. The same screening performed for visitors should be performed for hospital staff. Screening should include: 1. Fever or symptoms of a respiratory infection, such as a cough and sore throat; 2. International travel within the last 14 days to restricted countries; and 3. Contact with someone with known or suspected COVID-19. Health care providers (HCP) who have signs and symptoms of a respiratory infection should not report to work. On March 30, 2020, CMS updated the staff screening questions in to include:
1. Signs or symptoms of a respiratory infection, such as a fever, cough, or difficulty breathing.
2. Contact with a person who is positive for COVID-19 or with someone who is considered a PUI or someone who is ill with respiratory illness.
3. Travel within the last 14 days to areas with widespread or ongoing COVID-19 community spread.
4. Residence or working in a community where community-based spread of COVID-19 is occurring.

On March 9, 2020, the AHCA, the state survey agency, issued an Alert to all Florida Hospitals entitled, "CDC Infection Prevention and Control Guidelines". The directive stated: On behalf of Florida's Surgeon General and the Florida Department of Health, the Agency for Health Care Administration wants to ensure patients and staff are protected by following CDC infection prevention and control guidelines, including use of recommended personal protective equipment (PPE). Please review the information below and evaluate your facilities' practices when admitting and triaging/screening patients with respiratory symptoms as they enter your emergency department. Guidance of note includes:
-Immediately place a facemask on any individual entering the emergency department or triage/ screening area of the hospital who presents with a cough, fever, runny nose, etc. This patient should be held in a separate triage area if not already. If worn properly, a facemask helps block respiratory secretions produced by the wearer from contaminating other persons and surfaces.
-All staff working triage desk must wear appropriate PPE (facemask, etc.) Staff must be properly trained on the usage of PPE and the prevention of transmission of infectious agents. The directive included CDC links for PPE conservation guidelines, information on how to properly don, use, and doff PPE in a manner to prevent self-contamination is available here, recommendations for preventing spread of COVID-19 and OSHA training videos.

On 3/18/20 the AHCA, issued an Alert to all Florida Hospitals entitled, "Hospital and Physician COVID-19 Testing Criteria for Elderly and Medically Frail." The purpose of the directive was: "To provide hospitals and physicians with clear guidance and testing criteria for the elderly or individuals with serious underlying medical conditions, the Department of Health and the Agency for Health Care Administration have developed a tool." The alert directed hospitals and clinicians to test for COVID-19 when the following criteria were met: 1: Individuals 65 or older OR Individuals with serious underlying medical conditions, AND 2. Presents with these symptoms: New onset fever of 100.4 degrees Fahrenheit or greater AND cough OR other respiratory signs including shortness of breath.

On 4/22/2020 at approximately 7:10 AM, a Jackson County Sheriff's deputy in uniform was observed to pass the visitor screening line at the main entrance to the hospital and spoke with the screening nurse, staff B, then proceeded in through the main entrance doors not wearing a facemask. It was not evident if the officer's temperature was taken. During an interview, staff B stated the officer comes in every day to eat in the cafeteria and no facemask is required.

At approximately 7:15 AM, a patient room on the 3rd floor was observed with the door open and a contact isolation sign on the door as well as a stop sign alerting visitors to check at the nurses' station prior to entering room. Two staff members were visible through the open doorway, one standing at the foot of the bed and the other standing beside the bed, roughly at the midway point between the head and the foot of the bed. Neither employee was wearing a facemask, face shield, or gown at the time of the observation. Patient #2 was observed to be in the bed wearing an oxygen mask at the time of the observation.

Immediately following this observation, 6 staff members were observed at the 3rd floor nurses' station. None of the staff members were wearing a facemask. Registered nurse D (RN D) approached the nurses' station and identified herself as the director of the PCU/SCU (progressive care unit/special care unit). RN D was not wearing a facemask and explained that facemasks are worn with patients on isolation and stated there were no COVID-19 patients on the floor at this time. Respiratory Therapist (RT) staff E walked to the elevator near the nurses' station and was not wearing a facemask. In an interview, RT E stated facemasks are only worn in patient rooms and only when the patient is on isolation.

On 4/22/20 at approximately 7:17 AM, housekeeper, staff F, was observed cleaning an unoccupied patient room on the third floor wearing gloves but no facemask. Staff F stated that since the onset of the COVID-19 pandemic, the only change in cleaning procedures after a patient is discharged was a change in the cleaning chemical product that is utilized.

While still on the third floor inpatient unit, on 4/22/20 at approximately 7:20 AM, RN G, a house supervisor, introduced herself and was not wearing a facemask. In an interview, RN G stated facemasks are for droplet precautions only and staff may wear a facemask if they choose. After requesting to see where staff are being screened, RN G escorted the surveyor to the emergency department entrance. At approximately 7:25 AM, two staff were observed, neither wearing facemasks, sitting at a table outside the emergency department entrance to the hospital. The employees, RN H and RN I, stated in an interview they were trained by supervisors to conduct patient screening.

During the observation near the entrance to the emergency department between 7:30 AM - 7:45 AM, approximately 7 staff members were observed walking up a ramp near the entrance to the emergency department and entering through a side door, and none were screened. At several times during the observations, staff members were seen huddling together or embracing with an arm around each other in greeting. None of the staff members were wearing facemasks. Nurse G explained staff are not screened; they are expected to self-monitor for symptoms. During this observation, 3 Jackson County Sheriff's deputies in uniform approached the table where RN H and RN I were sitting and RN G was standing near the table. The deputies did not adhere to the distancing stickers on the ground and were not directed to do so by staff. One of the deputies approached RN G and hugged her and the 3 deputies and RN G stood within 1-2 feet of each other in conversation before the deputies entered the building through the main, glass emergency department doors. None of the deputies wore a facemask and were not screened prior to entry.

During an interview with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Infection Preventionist (IP), Risk Manager (RM), and Director of Quality on 4/22/20 at approximately 8:00 AM, the IP stated the hospital follows CDC guidelines, but the hospital has not developed formal written policies because of the frequency of new information. The CEO stated if all staff wore facemasks universally the supply would be depleted and that the hospital has reported this to the Emergency Operations Center (EOC) and daily in reports to the Emergency Status System (ESS). The CEO stated he was informed supplies would not be provided to the hospital if the hospital reported what they had. He gave the example that 900 facemasks were donated to the hospital by a local church and this was posted to the hospital Facebook website. The CEO said as a result of that, the state did not provide a shipment of facemasks the hospital expected to receive. The IP added if the hospital had all staff wear facemasks they would be out by Friday, (4/24/20, in two days). The surveyor asked if this was based on a PPE burn rate projection, the CEO stated the hospital has not calculated a PPE burn rate. The CEO stated the next step for the hospital was to figure out the burn rate for PPE supplies, but they did not currently have any estimation of the burn rate. The CNO added that the hospital previously had 3 rule out cases of COVID ("rule out" refers to a patient under suspicion of a condition that has not yet been determined) and during the care of the 3 patients the hospital went from (an inventory of) 1000 N95 facemasks to 20. There were currently no PUI (persons under investigation) patients in the hospital, nor were there any patients diagnosed with COVID-19.

The CEO said the materials manager could provide the inventory for PPE, and this was subsequently provided. The document revealed that the inventory count for 4/21/2020 was:
Facemasks:
N95 Regular - 5,318
N95 Small - 1,872
Procedure - EL (ear loop) - 1,299
Surgery - Tie - 3,450
Fluidshield - Tie - 230
Total facemasks = 12,169
Goggles:
Frame - 1,980
Lens - 3,974
Face Shield = 1,742
Isolation Gowns = 2,265
Bouffants (head covering) = 5,200
Caps = 2,000
Shoe Covers = 4,025
Stethoscopes = 246

The CEO added the N95 facemasks are secured and they do not allow staff to bring in their own facemasks unless it goes through our sterilization process. The CEO speculated that the survey complaint originated from 1 employee who brought in her own facemask and was told she couldn't use it unless it went through our sterilization. The CEO said, "you know what, if you make us all wear facemasks all the time, I'll make sure she gets her facemask last." The surveyor informed the CEO at this time that complaints are anonymous and come from many sources and that identities of complainants cannot be confirmed or discussed; however, it would be improper to retaliate or withhold equipment from an employee.

The hospital provided an email dated 4/14/2020 from the IP to all staff regarding employees bringing in their personal N-95 facemasks and/or respirators. Staff were instructed not to bring in personal facemasks/respirators and not to take issued N-95 facemasks home to disinfect. The email stated all necessary PPE will be provided by Jackson Hospital until further notice.

In continued interview on 4/22/2020 which began at 8:00am, the surveyor again asked the CEO about estimates of burn rates for PPE supplies, and he replied, we're working on a (PPE) burn rate; it has not been consistent. We have a total of 600 staff with roughly 250 staff working daily and we have not furloughed even one employee. The CEO was informed that the CDC published a burn rate calculator on it's website on 4/7/2020 found at https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/burn-calculator.html.

During an interview on 2/24/20 at 10:16 AM, the materials manager stated the hospital currently had approximately 10 times the inventory of facemasks than levels prior to the COVID-19 pandemic. The materials manager verbally provided the typical inventory amounts of PPE prior to the COVID-19 pandemic:
Ear loop facemasks is usually about 350
Filter facemasks, about 100
Surgery and tie facemasks is usually 200
N95 regular size facemasks are usually 6 boxes of 30 per box, so about 180 total, and about the same amount of size small, about 180-200 total.
Gowns are usually 17 cases which is 85 total.
Face shields usually keep 1000.
The materials manager stated that they usually get 3 shipments a week, and they haven't had any additional shipments in. "We have to vet the suppliers who say they have supplies to make sure they are qualified vendors." The materials manager said he was not screened when coming into work today (4/24/20) but had a meeting about putting a procedure in place to do that, adding "we aren't screening employees now but working on that."

On 4/24/20 at 2:29 PM, the surveyor conducted an interview with physician L, who was the admitting physician for all 3 of the sampled patients (1,2, and 3). The surveyor asked if the hospital had established criteria to test patients for COVID-19, and physician L responded the infection preventionist (IP) sent emails since "it all started, daily with all the updates and guidelines, suggestions, testing and updates. Everybody is reading those and following those to the best of our abilities. What we did 2-3 weeks ago is different from today, some are based on how readily available the test supplies are. Fever, cough, shortness of breath - 2 of the 3 you would consider testing. I still look at those primarily, but with testing supplies a little more available, if someone had a known exposure, you think a little differently. Still fever cough, shortness of breath. If they traveled from New Orleans, New York, or somewhere else. I have had patients I have wanted to test but didn't based on supply of testing materials. I have not had a patient that I had a high suspicion for that I couldn't test. I had a couple that had a low rate of suspicion and we tested and they came back negative. The most common reason I have tested in the last few weeks is because they were at a residential facility. I understand the ramifications from that, but then I have to wait 5 days or so to discharge them. I have canceled some tests because the test couldn't be picked up due to logistical reasons." Physician L said he was aware of the guidelines from the state agency for elderly and frail patients and added, "I do think about the diagnosis and screening of patients in the hospital every day."

During the interview on 4/22/20 at approximately 8:00 AM, senior hospital leadership were unable to clearly define established, hospital-wide criteria to test patients for COVID-19. In a follow up interview on 4/24/20 at 11:36 AM, the RM said the hospital used the "latest guidelines" for testing and that used to include travel, but now has nothing to do with travel; instead fever and shortness of breath are the criteria. In response to a request for testing criteria, the RM provided an April 7, 2020 agenda of the Emergency Department Provider's Meeting. This documentation provided links to guidance from CDC and described the course of the disease from presentation, including various symptoms, clinical disease progression, and treatment options. The documentation did not identify a hospital-based testing criteria.

The surveyor conducted medical record reviews to determine if CDC and AHCA recommendations for testing, identifying PUIs (persons under investigation), and isolation were implemented. This medical record review revealed the hospital had not implemented or adhered to AHCA recommendations for testing elderly and frail individuals for COVID-19 and had not implemented droplet isolation precautions for patients meeting COVID-19 testing criteria for elderly and frail individuals.

A record review for current patient #1 revealed patient #1 was a 73 year old female admitted on 4/21/20 from a long term care facility (nursing home) with report from the nursing home of decreased oxygen saturation of 88% and altered mental status. The chief complaint for patient #1 was bilateral leg pain and fever of 103.2 degrees F and the admitting diagnoses were pneumonia, osteomyelitis, and sepsis. Patient #1 was subsequently diagnosed with pneumonia with hypoxia. The record revealed no documentation regarding the status of the resident related to COVID-19 exposure at the nursing home where she resided. The record did not contain a screening questionnaire for COVID-19, but it did contain one for Communicable Diseases and Sepsis. Under the Communicable Disease screening on 04/21/2020 at 2:47 PM the nurse documented, "The patient has not traveled outside the United States within the last 30 days. The patient has not had exposure to any communicable diseases. Based on the answers provided during the communicable diseases screening, there was no medical indication for isolation." Patient #1 was described as having hypoxia (low oxygen saturation) and the documented diagnostic considerations included Coronavirus. No COVID-19 test was performed and patient #1 was not placed on droplet or airborne precautions. Patient #1 was placed on contact isolation. This patient met the state agency, DOH and CDC testing criteria for elderly and frail individuals due to age (73) and fever (103.2 degrees F) with hypoxia.

A record review of patient #2, who was the patient observed earlier with 2 staff in the room not wearing facemasks, revealed the patient was a 64 year old with serious underlying medical conditions who resided at an intermediate care facility and presented to the hospital with a chief complaint of respiratory arrest/failure and a temperature of 99.7 degrees F rectally on 4/22/20 at 1:50 AM. Patient #2 was administered oxygen for a low oxygen saturation level of 92%. Patient #2 had orders for CPAP/BIPAP initiated on 4/22/20 at 2:25 AM and for daily CPAP/BIPAP on 4/22/20 at 7:00 AM. CPAP/BIPAP is continuous positive airway pressure/bilateral positive airway pressure used in the treatment of sleep apnea, lung disease, and to treat respiratory weakness. Patient #2 did not have a diagnosis of sleep apnea and pneumonia and respiratory failure were included as diagnostic considerations. On 4/22/20 at 11:44 PM, patient #2 was noted to have a temperature of 101.5 degrees F, the doctor was notified and ordered acetaminophen (Tylenol) for fever. The fever continued and on 4/23/20 at 8:30 AM, doctor L was notified of temperature of 101.3 degrees F and ordered a urinalysis. At the time of record review on 4/23/2020 at 11:18 AM, patient #2 had not been considered for placement on droplet precautions and no test for COVID-19 was ordered. The record did not contain a screening questionnaire for COVID-19, but it did contain one for Communicable Diseases dated 4/22/20 at 1:13 AM. The nurse documented, "The patient has not traveled outside the United States within the last 30 days. The patient has not had exposure to any communicable diseases. Based on the answers provided during the communicable diseases screening, there was no medical indication for isolation." Patient #2 met the criteria for COVID-19 testing established by the state agency titled "Hospital and Physician COVID-19 Testing Criteria for the Elderly and Medically Frail" published on 3/18/20.

A record review indicated patient #3 was a 69 year old male admitted 4/14/20 with a chief complaint of nausea, vomiting, diarrhea, weakness for a few days at home and diagnosed with acute respiratory failure. Patient #3 was on a ventilator from 4/14/20 to time of review on 4/22/20 and the diagnosis was Acute Hypercarbic Respiratory Failure/Altered Mental Status (improving). The record did not contain a screening questionnaire for COVID-19, but it did contain one for Communicable Diseases and Sepsis. Under the Communicable Disease screening on 04/14/2020 at 9:42 PM the nurse documented, "The patient has not traveled outside the United States within the last 30 days. The patient has not had exposure to any communicable diseases. Based on the answers provided during the communicable diseases screening, there was no medical indication for isolation." There were no further screenings for COVID-19 documented in the record until 7 days later on 4/21/2020 at 9:43 AM, when a physician entered, that the screening criteria was met, per the Department of Health, and that the test was ordered for placement in an LTACH (long term acute care hospital) for continued ventilator support. The COVID-19 test resulted as negative on 4/24/20. Patient #3 met the state agency testing criteria for elderly and frail individuals at the time of admission due to age (69) and condition (respiratory failure).

The surveyor requested copies of relevant infection control and prevention policies and procedures to determine hospital compliance. A review of documents provided revealed:
Copies of relevant infection control and prevention policies and procedures were requested to demonstrate hospital compliance. A review of documents provided revealed:
1. An undated, unsigned copy of an Exposure Control Plan which referenced Occupational Safety and Health Administration (OSHA) bloodborne pathogens and "other potentially infectious materials" including Hepatitis B and C viruses and HIV (Human Immunodeficiency Virus). No mention of COVID-19 or specific protocol for organisms requiring droplet precautions were mentioned in the plan. The plan contained blank spaces for committee approval of the plan and for annual review and approval.
2. A Respiratory Policy-Infection Control Plan with an effective date of 08/1994 did not contain reference to COVID-19. The policy was identified as an adjunct to the hospital-wide infection control manual.
3. An Isolation Policy with no effective date or review date identified, and no committee approval identified which did not contain references to COVID-19. The policy defined standard precautions and transmission-based precautions.
4. A copy of the Pandemic Policy dated 04/20 contained a plan for cohorting patients. The plan for staffing documented using emergency credentialing protocols set by local and/or state agencies to bring staff to hospital from the community to work. The plan did not mention COVID-19, but identified the purpose of the plan as "to ensure the hospital is prepared to efficiently provide health services during a pandemic." The policy then described the pandemic response to influenza. Procedures identified included: Establish and maintain inventory of PPE, Obtain from DOH (Department of Health) and public health authorities case definitions, protocols, and algorithms to assist with case finding, management, infection control, and surveillance reporting. Review, revise as needed, and activate guidelines for prevention and control measures. Conduct surveillance and testing for influenza. Implement a plan for early detection, reporting and treatment of health care personnel (staff). Reinforce infection control procedures to prevent the spread of influenza and utilize appropriate PPE. Maintain high index of suspicion that patients presenting with influenza-like illness could be infected with the pandemic strain. Increase environmental cleaning efforts. Summarize and analyze the pandemic response and lessons learned for the next wave. Review and revise the Pandemic Influenza Plan based on outcome measurements and performance results of current plan. The plan identified the CEO, CFO (Chief Financial Officer) and CNO (Chief Nursing Officer)as responsible for obtaining and disseminating information from outside agencies and resources as the nature and extent of the emergency and ensuring the safety of the staff and patients during the emergency.

On April 21, 2020, the CDC website contained information entitled "Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings", updated April 13, 2020, at https://www.cdc.gov/coronavirus/2019-ncov/hcp/dialysis.html. The guidance documented: Current data suggest person-to-person transmission most commonly happens during close exposure to a person infected with the virus that causes COVID-19, primarily via respiratory droplets produced when the infected person speaks, coughs, or sneezes. Droplets can land in the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those within close proximity. Transmission also might occur through contact with contaminated surfaces followed by self-delivery to the eyes, nose, or mouth. The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely. Recent experience with outbreaks in nursing homes has reinforced that residents with COVID-19 frequently do not report typical symptoms such as fever or respiratory symptoms; some may not report any symptoms. Unrecognized asymptomatic and pre-symptomatic infections likely contribute to transmission in these and other healthcare settings. Source control, which involves having the infected person wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions, might help reduce the risk of transmission of SARS CoV-2 from both symptomatic and asymptomatic people.
-This guidance is applicable to all U.S. healthcare settings.
-Universal Source Control: Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCP. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms. This approach is consistent with a recommendation to the general public advising them to wear a cloth face covering whenever they must leave their home.
-Healthcare Personnel: As part of source control efforts, HCP should wear a facemask at all times while they are in the healthcare facility. When available, facemasks are generally preferred over cloth face coverings for HCP as facemasks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others. If there are anticipated shortages of facemasks, facemasks should be prioritized for HCP and then for patients with symptoms of COVID-19 (as supply allows). Cloth face coverings should NOT be worn instead of a respirator or facemask if more than source control is required. Some HCP whose job duties do not require PPE (e.g., clerical personnel) might continue to wear their cloth face covering for source control while in the healthcare facility. Other HCP (e.g., nurses, physicians) might wear their cloth face covering for part of the day when not engaged in direct patient care activities, only switching to a respirator or facemask when PPE is required. To avoid risking self-contamination, HCP should consider continuing to wear their respirator or facemask (extended use) instead of intermittently switching back to their cloth face covering. They should also be instructed that if they must touch or adjust their facemask or cloth face covering they should perform hand hygiene immediately before and after. Ensure triage personnel who will be taking vitals and assessing patients wear a respirator (or facemask if respirators are not available), eye protection, and gloves for the primary evaluation of all patients presenting for care until COVID-19 is deemed unlikely. Triage personnel should have a supply of facemasks or cloth face coverings; these should be provided to all patients who are not wearing their own cloth face covering at check-in, assuming a sufficient supply exists.
-Ensure that, at the time of patient check-in, all patients are asked about the presence of fever, symptoms of COVID-19, or contact with patients with possible COVID-19. Incorporate questions about new onset of COVID-19 symptoms into daily assessments of all admitted patients. Monitor for and evaluate all new fevers and symptoms consistent with COVID-19 among patients. Place any patient with unexplained fever or symptoms of COVID-19 on appropriate Transmission-Based Precautions and evaluate. Prioritize patients with suspected COVID-19 who require admission to a hospital or congregate care setting (e.g., nursing home) for testing.
-Adhere to Standard and Transmission-Based Precautions: Standard Precautions assume that every person is potentially infected or colonized with a pathogen that could be transmitted in the healthcare setting. Elements of Standard Precautions that apply to patients with respiratory infections, including COVID-19, are summarized below. Attention should be paid to training and proper donning (putting on), doffing (taking off), and disposal of any PPE.
-Eye Protection: Put on eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face) upon entry to the patient room or care area, if not already wearing as part of extended use or reuse strategies to optimize PPE supply. Personal eyeglasses and contact lenses are NOT considered adequate eye protection.
-Gowns: Put on a clean isolation gown upon entry into the patient room or area. Change the gown if it becomes soiled. Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area. Disposable gowns should be discarded after use. Cloth

HOSP ACQUIRED INFECTIONS AND QAPI

Tag No.: A0771

Based on observations, interviews, reviews of medical and administrative records, review of policies and procedures and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), issued pursuant to the Coronavirus Disease 2019 (COVID-19) pandemic, the hospital's governing body failed to ensure that the infection control and prevention program, in conjunction with the quality assessment and performance improvement (QAPI) activities, ensured CDC, CMS and AHCA recommended infection control practices related to the COVID-19 pandemic were consistently and fully implemented. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients, the staff who worked with these patients, and the community at large.

Individuals who are 65 years and older and those with chronic underlying medical conditions, are at high risk for developing serious complications from COVID 19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID 19 infection can lead to death. COVID 19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID 19 infection, which is a highly transmissible disease.

This failure resulted in a lack of COVID-19 policy development, a lack of following CDC and state prevention and control recommendations, and a serious risk to patients and staff of exposure to COVID-19 (about 600 staff, 33 inpatients plus emergency room and other outpatients) which led to a determination of immediate jeopardy. The hospital Risk Manager was notified of the Immediate Jeopardy on 4/27/2020 at approximately 2:38 PM. The Immediate Jeopardy was determined to start on 04/13/2020 and was ongoing. Cross Reference: A0747 and A0772.

The findings included:

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on 03/13/2020 and approved a major disaster declaration for Florida on 03/27/2020.

On March 4, 2020, the CMS Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (QSO) issued memo QSO-20-13-Hospitals, "Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge." CMS wrote: This memorandum responds to questions we have received and provides important guidance for hospitals and critical access hospitals (CAH's) in addressing the COVID-19 outbreak and minimizing transmission to other individuals. The same screening performed for visitors should be performed for hospital staff. Screening should include: 1. Fever or symptoms of a respiratory infection, such as a cough and sore throat; 2. International travel within the last 14 days to restricted countries; and 3. Contact with someone with known or suspected COVID-19. Health care providers (HCP) who have signs and symptoms of a respiratory infection should not report to work. On March 30, 2020, CMS updated the staff screening questions in to include:
1. Signs or symptoms of a respiratory infection, such as a fever, cough, or difficulty breathing.
2. Contact with a person who is positive for COVID-19 or with someone who is considered a PUI or someone who is ill with respiratory illness.
3. Travel within the last 14 days to areas with widespread or ongoing COVID-19 community spread.
4. Residence or working in a community where community-based spread of COVID-19 is occurring.

On March 9, 2020, the Agency for Health Care Administration, the state survey agency, issued an Alert to all Florida Hospitals entitled, "CDC Infection Prevention and Control Guidelines". The directive stated: On behalf of Florida's Surgeon General and the Florida Department of Health, the Agency for Health Care Administration wants to ensure patients and staff are protected by following CDC infection prevention and control guidelines, including use of recommended personal protective equipment (PPE). Please review the information below and evaluate your facilities' practices when admitting and triaging/screening patients with respiratory symptoms as they enter your emergency department. Guidance of note includes:
-Immediately place a facemask on any individual entering the emergency department or triage/ screening area of the hospital who presents with a cough, fever, runny nose, etc. This patient should be held in a separate triage area if not already. If worn properly, a facemask helps block respiratory secretions produced by the wearer from contaminating other persons and surfaces.
-All staff working triage desk must wear appropriate PPE (facemask, etc.) Staff must be properly trained on the usage of PPE and the prevention of transmission of infectious agents. The directive included CDC links for PPE conservation guidelines, information on how to properly don, use, and doff PPE in a manner to prevent self-contamination is available here, recommendations for preventing spread of COVID-19 and OSHA training videos.

On March 18, 2020, the Agency for Health Care Administration, issued an Alert to all Florida Hospitals entitled, "Hospital and Physician COVID-19 Testing Criteria for Elderly and Medically Frail." The purpose of the directive was: "To provide hospitals and physicians with clear guidance and testing criteria for the elderly or individuals with serious underlying medical conditions, the Department of Health and the Agency for Health Care Administration have developed a tool." The alert directed hospitals and clinicians to test for COVID-19 when the following criteria were met: 1: Individuals 65 or older OR Individuals with serious underlying medical conditions, AND 2. Presents with these symptoms: New onset fever of 100.4 degrees Fahrenheit or greater AND cough OR other respiratory signs including shortness of breath.

Medical record reviews revealed the hospital had not implemented or adhered to AHCA or CDC recommendations for testing elderly and frail individuals for COVID-19 and had not implemented droplet isolation precautions for patients meeting COVID-19 testing criteria for elderly and frail individuals. Three current patients with a respiratory -associated diagnosis were selected to review. Patient #1 was a 73 year-old admitted on 4/21/20 from long term care facility fever of 103.2 degrees Fahrenheit (F), pneumonia, and decreased oxygen saturation of 88%. No COVID-19 test was performed and patient was not placed on droplet or airborne precautions. Patient #1 met the COVID-19 testing criteria due to age (73 years old) and fever (103.2 degrees F) with respiratory issues and hypoxia (low oxygen saturation). Patient #2 was a 64 year old with serious underlying medical conditions. The patient was admitted on 4/22/20 from a long term care facility with a chief complaint of respiratory arrest/failure and a temperature fever 99.7 degrees F. Patient #2 was admitted, ordered a continuous positive airway pressure (CPAP) and her fever rose to 101.5 degrees F. No COVID-19 test was ordered or performed and patient #2 was not placed on droplet or airborne precautions. Patient #2 met the criteria for COVID-19 testing criteria due to being medically frail, high fever and respiratory failure. Patient #3 was a 69 year old male admitted 4/14/20 with a diagnosis acute respiratory failure. A COVID-19 test was not performed until 7 days later, on 4/21/20, and only then as a screening was required for placement in a long term acute care facility. Patient #3 was not identified as a PUI and not placed on droplet or airborne precautions. Patient #3 met the state agency testing criteria for elderly and frail individuals at the time of admission due to age (69 years old) and condition (respiratory failure). Cross Reference A0749.

On 4/22/2020 from approximately 7:15 AM - 8:00 AM, observations were made at the hospital beginning in the front entrance, moving through the main lobby to elevators, onto the 3rd floor inpatient area, to the emergency room entrance, and then to the 4th floor to the hospital's administrative offices. The observations revealed that healthcare personnel were not screened prior to entering the hospital and visitors from the Sheriff's department were allowed entry to the hospital for the purpose of eating in the cafeteria and were not screened or offered facemasks to wear inside the hospital. Staff were observed inside the hospital and inside a patient room not wearing any facemasks or facial coverings. In an interview at approximately 7:45 AM, staff G, a nurse supervisor reported staff are not screened prior to entering the hospital, but are expected to self-monitor at home.

On 4/22/20 at approximately 8:00 AM during an interview with senior hospital leadership, the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Infection Preventionist (IP), Risk Manager (RM), and Director of Quality explained the hospital had not implemented recommendations for staff wearing facemasks universally, not actively screened staff members and had not developed policies or quality metrics in response to the COVID-19 pandemic. The IP stated the hospital followed CDC guidelines, but the hospital had not developed formal written policies because of the frequency of new information. The Director of Quality said they talked about screening staff but planned to wait until there was an in-house positive case. The CEO stated they were not following the recommendation for all staff members to wear facemasks inside the hospital because of anticipated shortages and only symptomatic patients are being asked to wear a facemask. The Infection Preventionist (IP) reported there were no patients currently in the hospital on droplet precautions; there were 2 patients in the hospital on contact precautions for MRSA (methicillin resistant staphylococcus aureus) and 1 patient on contact precautions for Clostridium Difficile.

The IP said there was not a policy for patients to wear facemasks outside of their rooms, patients only wore facemasks if they had a suspected case of COVID-19. The IP said in-patients were screened on admission, but were not screened daily during the inpatient stay. The CNO stated that vital signs were taken to include temperature a minimum of every 8 hours for all admitted patients based on protocol, but it was not considered as an additional screening for COVID-19. The CNO and IP agreed there was not any communication to healthcare providers to screen patients daily or consider COVID-19 after the initial admission assessment. The senior hospital leadership were unable to clearly define established, hospital-wide criteria to test patients for COVID-19.

The CEO said the materials manager could provide the inventory for PPE. The inventory documentation revealed the hospital had over 12,000 total facemasks. The CEO stated the hospital employs approximately 600 staff, with approximately 250 working on any given day and the inpatient census on 4/22/20 was reported as 33.

On 4/23/20 at approximately 10:16 AM, the hospital's material manager reviewed inventory levels with the surveyor and stated the hospital currently had approximately 10 times more than the usual PAR (periodic automatic replenishment) levels for PPE including facemasks.

In a follow up interview on 4/24/20 at 11:36 AM, in response to a request for testing criteria, the RM said the hospital used the "latest guidelines" for testing and that used to include travel, but now the screening criteria has nothing to do with travel; fever and shortness of breath are the current criteria. The RM provided an agenda of the Emergency Department Provider's Meeting, dated April 7, 2020. This documentation provided links to guidance from CDC and described the course of the disease from presentation, including various symptoms, clinical disease progression, and treatment options. It did not identify a hospital-based testing criteria.

On 4/24/20 at 2:29 PM an interview was conducted with physician L, who was the admitting physician for all 3 of the sampled patients (1,2, and 3). In an interview on 4/24/20 at 2:29 PM, when asked to identify the hospital-based criteria for testing patients, physician L responded that the IP has sent emails since "it all started, daily with all the updates and guidelines, suggestions, testing and updates. Everybody is reading those and following those to the best of our abilities. What we did 2-3 weeks ago is different from today, some is based on how readily available the test supplies are. Fever, cough, shortness of breath - 2 of the 3 you would consider testing. I still look at those primarily, but with testing supplies a little more available, if someone had a known exposure, you think a little differently. Still fever cough, shortness of breath. If they traveled from New Orleans, New York, or somewhere else." The physician did not verbalize any specific hospital developed testing criteria.

In a telephone interview on 4/24/20 at 11:36 AM with the RM and Director of Quality, the RM explained both are on the quality committee which meets every 2 months and covers many things, including infection control. The RM said a COVID-19 task force was put in place in March of 2020 and met this morning (4/24/20) to get a plan to get facemasks for all employees and to start screening employees. She explained the hospital got a notification from Joint Commission on 4/23/20 with new guidelines. The Joint Commission, an accrediting agency, issued a statement on 4/23/20 in support of recommendations made by the CDC on 4/13/20.

The RM confirmed no record reviews were done specific to COVID-19, but Staff K, the quality coordinator, performs daily reviews of charts and quality but not specific to COVID-19. The RM stated they are looking at that, but not in an organized way, adding the infection preventionist (IP) is tracking and is notified any time someone is tested and is a potential (COVID-19 patient). The RM said the hospital was not specifically tracking or collecting data other than what the infection preventionist collects and tracks for tests and results. During the interview, the RM confirmed staff K is the one who reviews charts for quality and was not instructed or trained to review charts to compare if a patient met testing criteria and wasn't tested. The RM confirmed there were no metrics (system or standard of measurement) for record reviews.

The RM stated the hospital does not have an organized plan for tracking metrics related to COVID-19 and were using the sepsis core measures which she described as similar. Sepsis is defined by the National Institutes for Health at nigms.nih.gov as a serious medical condition caused by an overwhelming immune response to infection caused by many types of microbes including bacteria, fungi, and viruses. Symptoms are described as fever, chills, rapid breathing and heart rate, rash, confusion and disorientation.

When the surveyor asked if metrics were collected regarding cleaning and disinfecting in response to the COVID-19 pandemic, the RM explained the housekeeping director is on the daily safety huddle calls and is sending staff through to do doors and extra cleaning and infection control that was added for COVID-19. The RM was unaware if the housekeeping director was keeping a log, but said they were keeping a log of other staff members that are being pulled to do extra cleaning for the purpose of logging hours of the employees. The RM was unaware if there were any measures to monitor how often high touch surfaces were cleaned.

The RM said that other than the IP rounding and observing for surveillance of hand hygiene and PPE nothing additional had been put in place to develop quality metrics for hand hygiene or PPE. The RM added the hospital implemented the use of new software for event reporting which was not a response to the COVID-19 pandemic, but the software company developed a rounding tool specifically made for COVID-19 and the hospital had not implemented this tool but had plans to use it.

The RM confirmed no quality committee meetings were held specifically to address COVID-19 response, adding they have the same meetings, but now meetings are combined with other meetings and mostly conducted over phone to limit exposure and comply with social distancing.

The surveyor asked the RM and Director of Quality if the quality committee had reviewed and incorporated into the hospital infection control response expert resources from the CDC or CMS including The Comprehensive Hospital Preparedness Checklist for Coronavirus Disease 2019 or CMS memo QSO-20-13-Hospitals-CAHs: Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs): FAQs, Considerations for Patient Triage, Placement, Limits to Visitation and Availability of 1135 waivers. The RM answered that she'd seen some tools on there but had not personally used them in the role of risk management. The Director of Quality said she didn't remember discussing anything related to COVID-19 during the quality meeting and doesn't remember specific guidance that the quality committee is using. The Director of Quality then stated that the quality committee is planning to use the rounding tool in the software.
The RM and Director of Quality agreed there had not been full meetings of quality because of COVID-19, adding the committees were meeting in place of specific quality meetings. They added the governing body has a monthly board meeting but has not had a specific board meeting that addresses COVID-19. The last meeting was last Wednesday (4/15/20), they were not sure if COVID-19 was on the agenda.

On 4/24/2020 at 2:13 PM, a telephone interview with the governing body chairperson (GB chair) took place. The GB chair reported having served on the governing body for 3-4 years and stated the board meets monthly and no specific meetings of the board have been held regarding the hospital's response to the COVID-19 pandemic. The GB chair said the past meeting in March 2020 was limited to only the executive board for the purpose of social distancing and confirmed the meeting did not include topics related to COVID-19. The GB chair said the hospital's materials manager had reached out to her over the past two months regarding the acquisition of facemasks and supplies related to her personal business dealings, but she was not able to support the hospital with providing supplies. She said the CEO requested funding for local tests for the virus because there is not enough access to testing materials to perform the tests. The GB chair said the board has not been involved in quality monitoring and would expect that to be covered in the next meeting. She said the board had not been provided with quality guidelines to consider, but annually the board has special educational sessions to walk them through understanding quality metrics and used HCAHPS (hospital consumer assessment of healthcare providers and systems) as an example of metrics that have been explained and reviewed with the board.

The surveyor requested copies of relevant infection control and prevention policies and procedures to determine hospital compliance. A review of documents provided revealed:
Copies of relevant infection control and prevention policies and procedures were requested to demonstrate hospital compliance. A review of documents provided revealed:
1. An undated, unsigned copy of an Exposure Control Plan which referenced Occupational Safety and Health Administration (OSHA) bloodborne pathogens and "other potentially infectious materials" including Hepatitis B and C viruses and HIV (Human Immunodeficiency Virus). No mention of COVID-19 or specific protocol for organisms requiring droplet precautions were mentioned in the plan. The plan contained blank spaces for committee approval of the plan and for annual review and approval.
2. A Respiratory Policy-Infection Control Plan with an effective date of 08/1994 did not contain reference to COVID-19. The policy was identified as an adjunct to the hospital-wide infection control manual.
3. An Isolation Policy with no effective date or review date identified, and no committee approval identified which did not contain references to COVID-19. The policy defined standard precautions and transmission-based precautions.
4. A copy of the Pandemic Policy dated 04/20 contained a plan for cohorting patients. The plan for staffing documented using emergency credentialing protocols set by local and/or state agencies to bring staff to hospital from the community to work. The plan did not mention COVID-19, but identified the purpose of the plan as "to ensure the hospital is prepared to efficiently provide health services during a pandemic." The policy then described the pandemic response to influenza. Procedures identified included: Establish and maintain inventory of PPE, Obtain from DOH (Department of Health) and public health authorities case definitions, protocols, and algorithms to assist with case finding, management, infection control, and surveillance reporting. Review, revise as needed, and activate guidelines for prevention and control measures. Conduct surveillance and testing for influenza. Implement a plan for early detection, reporting and treatment of health care personnel (staff). Reinforce infection control procedures to prevent the spread of influenza and utilize appropriate PPE. Maintain high index of suspicion that patients presenting with influenza-like illness could be infected with the pandemic strain. Increase environmental cleaning efforts. Summarize and analyze the pandemic response and lessons learned for the next wave. Review and revise the Pandemic Influenza Plan based on outcome measurements and performance results of current plan. The plan identified the CEO, CFO (Chief Financial Officer) and CNO (Chief Nursing Officer)as responsible for obtaining and disseminating information from outside agencies and resources as the nature and extent of the emergency and ensuring the safety of the staff and patients during the emergency.

On April 21, 2020, the CDC website contained information entitled "Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings", updated April 13, 2020, at https://www.cdc.gov/coronavirus/2019-ncov/hcp/dialysis.html. The guidance documented: Current data suggest person-to-person transmission most commonly happens during close exposure to a person infected with the virus that causes COVID-19, primarily via respiratory droplets produced when the infected person speaks, coughs, or sneezes. Droplets can land in the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those within close proximity. Transmission also might occur through contact with contaminated surfaces followed by self-delivery to the eyes, nose, or mouth. The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely. Recent experience with outbreaks in nursing homes has reinforced that residents with COVID-19 frequently do not report typical symptoms such as fever or respiratory symptoms; some may not report any symptoms. Unrecognized asymptomatic and pre-symptomatic infections likely contribute to transmission in these and other healthcare settings. Source control, which involves having the infected person wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions, might help reduce the risk of transmission of SARS CoV-2 from both symptomatic and asymptomatic people.
-This guidance is applicable to all U.S. healthcare settings.
-Universal Source Control: Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCP. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms. This approach is consistent with a recommendation to the general public advising them to wear a cloth face covering whenever they must leave their home.
-Healthcare Personnel: As part of source control efforts, HCP should wear a facemask at all times while they are in the healthcare facility. When available, facemasks are generally preferred over cloth face coverings for HCP as facemasks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others. If there are anticipated shortages of facemasks, facemasks should be prioritized for HCP and then for patients with symptoms of COVID-19 (as supply allows). Cloth face coverings should NOT be worn instead of a respirator or facemask if more than source control is required. Some HCP whose job duties do not require PPE (e.g., clerical personnel) might continue to wear their cloth face covering for source control while in the healthcare facility. Other HCP (e.g., nurses, physicians) might wear their cloth face covering for part of the day when not engaged in direct patient care activities, only switching to a respirator or facemask when PPE is required. To avoid risking self-contamination, HCP should consider continuing to wear their respirator or facemask (extended use) instead of intermittently switching back to their cloth face covering. They should also be instructed that if they must touch or adjust their facemask or cloth face covering they should perform hand hygiene immediately before and after. Ensure triage personnel who will be taking vitals and assessing patients wear a respirator (or facemask if respirators are not available), eye protection, and gloves for the primary evaluation of all patients presenting for care until COVID-19 is deemed unlikely. Triage personnel should have a supply of facemasks or cloth face coverings; these should be provided to all patients who are not wearing their own cloth face covering at check-in, assuming a sufficient supply exists.
-Ensure that, at the time of patient check-in, all patients are asked about the presence of fever, symptoms of COVID-19, or contact with patients with possible COVID-19. Incorporate questions about new onset of COVID-19 symptoms into daily assessments of all admitted patients. Monitor for and evaluate all new fevers and symptoms consistent with COVID-19 among patients. Place any patient with unexplained fever or symptoms of COVID-19 on appropriate Transmission-Based Precautions and evaluate. Prioritize patients with suspected COVID-19 who require admission to a hospital or congregate care setting (e.g., nursing home) for testing.
-Adhere to Standard and Transmission-Based Precautions: Standard Precautions assume that every person is potentially infected or colonized with a pathogen that could be transmitted in the healthcare setting. Elements of Standard Precautions that apply to patients with respiratory infections, including COVID-19, are summarized below. Attention should be paid to training and proper donning (putting on), doffing (taking off), and disposal of any PPE.
-Eye Protection: Put on eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face) upon entry to the patient room or care area, if not already wearing as part of extended use or reuse strategies to optimize PPE supply. Personal eyeglasses and contact lenses are NOT considered adequate eye protection.
-Gowns: Put on a clean isolation gown upon entry into the patient room or area. Change the gown if it becomes soiled. Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area. Disposable gowns should be discarded after use. Cloth gowns should be laundered after each use.
-Screen all HCP at the beginning of their shift for fever and symptoms consistent with COVID-19. Actively take their temperature and document absence of symptoms consistent with COVID-19. If they are ill, have them keep their cloth face covering or facemask on and leave the workplace. Fever is either measured temperature of 100.0 degrees or greater Fahrenheit or subjective fever. Note that fever may be intermittent or may not be present in some individuals, such as those who are elderly, immunosuppressed, or taking certain medications. Clinical judgement should be used to guide testing of individuals in such situations. Respiratory symptoms consistent with COVID-19 are cough, shortness of breath, and sore throat. Medical evaluation may be warranted for lower temperatures (less than 100.0 degrees Fahrenheit) or other symptoms (e.g., muscle aches, nausea, vomiting, diarrhea, abdominal pain headache, runny nose, fatigue) based on assessment by occupational health. Additional information about clinical presentation of patients with COVID-19 is available.
-Information about Facemasks: If worn properly, a facemask helps block respiratory secretions produced by the wearer from contaminating other persons and surfaces (often called source control).

IC PROFESSIONAL RESPONSIBILITIES POLICIES

Tag No.: A0772

Based on observation, staff interview, record review, policy review and review of infection control directives, recommendations and guidelines from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the State Survey Agency (Agency for Health Care Administration/ (AHCA)), the infection preventionist failed to develop and implement hospital-wide surveillance, prevention and control policies and procedures that adhere to national and state guidelines in response to the Coronavirus Disease 2019 (COVID-19) pandemic to reduce risk of exposure to patients and staff. This failure affected 3 of 3 patients sampled for review of COVID-19 screening and testing, #1, 2, and 3 and had the potential to affect all current 33 inpatients, the staff who worked with these patients, and the community at large.

Individuals who are 65 years and older, those with chronic underlying medical conditions and are at high risk for developing serious complications from COVID 19 illness. Individuals who are infected could develop serious disease with difficulty breathing, and might require intensive care for the treatment of multi organ failure, respiratory failure, and septic shock. COVID 19 infection can lead to death. COVID 19 is a new disease, caused be a new coronavirus that has not previously been seen in humans. Currently, there is no vaccine and no approved treatment for COVID 19 infection, which is a highly transmissible disease.

This failure of policy development and implementation could result in COVID-19 transmission between staff and patients including the vulnerable elderly (about 33 inpatients, 600 staff, plus emergency room and other outpatients) and led to a determination of immediate jeopardy. The hospital Risk Manager was notified of the Immediate Jeopardy on 4/27/2020 at approximately 2:38 PM. The Immediate Jeopardy was determined to start on 04/13/2020, when the CDC updated its guidance on asymptomatic and pre-symptomatic transmission of COVID-19. The Immediate Jeopardy was ongoing at the conclusion of the survey. Cross Reference: A0749 and A0771.

The findings included:

On March 1, 2020, The Office of the Governor issued Executive Order Number 20-51 directing the Florida Department of Health to issue a Public Health Emergency. The Executive Order documented, "Coronavirus Disease 2019 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza."

On March 9, 2020, The Office of the Governor issued Executive Order Number 20-52 declaring a state of emergency for the entire State of Florida as a result of COVID-19.

The President declared a Nationwide emergency for COVID-19 on 03/13/2020 and approved a major disaster declaration for Florida on 03/27/2020.

On March 4, 2020, the Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (QSO) issued memo QSO-20-13-Hospitals, "Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge." CMS wrote: This memorandum responds to questions we have received and provides important guidance for hospitals and critical access hospitals (CAH's) in addressing the COVID-19 outbreak and minimizing transmission to other individuals. The same screening performed for visitors should be performed for hospital staff. Screening should include: 1. Fever or symptoms of a respiratory infection, such as a cough and sore throat; 2. International travel within the last 14 days to restricted countries; and 3. Contact with someone with known or suspected COVID-19. Health care providers (HCP) who have signs and symptoms of a respiratory infection should not report to work. On March 30, 2020, CMS updated the staff screening questions in to include:
1. Signs or symptoms of a respiratory infection, such as a fever, cough, or difficulty breathing.
2. Contact with a person who is positive for COVID-19 or with someone who is considered a PUI or someone who is ill with respiratory illness.
3. Travel within the last 14 days to areas with widespread or ongoing COVID-19 community spread.
4. Residence or working in a community where community-based spread of COVID-19 is occurring.

On March 9, 2020, the Agency for Health Care Administration, the state survey agency, issued an Alert to all Florida Hospitals entitled, "CDC Infection Prevention and Control Guidelines". The directive stated: On behalf of Florida's Surgeon General and the Florida Department of Health, the Agency for Health Care Administration wants to ensure patients and staff are protected by following CDC infection prevention and control guidelines, including use of recommended personal protective equipment (PPE). Please review the information below and evaluate your facilities' practices when admitting and triaging/screening patients with respiratory symptoms as they enter your emergency department. Guidance of note includes:
-Immediately place a facemask on any individual entering the emergency department or triage/ screening area of the hospital who presents with a cough, fever, runny nose, etc. This patient should be held in a separate triage area if not already. If worn properly, a facemask helps block respiratory secretions produced by the wearer from contaminating other persons and surfaces.
-All staff working triage desk must wear appropriate PPE (facemask, etc.) Staff must be properly trained on the usage of PPE and the prevention of transmission of infectious agents. The directive included CDC links for PPE conservation guidelines, information on how to properly don, use, and doff PPE in a manner to prevent self-contamination is available here, recommendations for preventing spread of COVID-19 and OSHA training videos.

On March 18, 2020, the Agency for Health Care Administration, issued an Alert to all Florida Hospitals entitled, "Hospital and Physician COVID-19 Testing Criteria for Elderly and Medically Frail." The purpose of the directive was: "To provide hospitals and physicians with clear guidance and testing criteria for the elderly or individuals with serious underlying medical conditions, the Department of Health and the Agency for Health Care Administration have developed a tool." The alert directed hospitals and clinicians to test for COVID-19 when the following criteria were met: 1: Individuals 65 or older OR Individuals with serious underlying medical conditions, AND 2. Presents with these symptoms: New onset fever of 100.4 degrees Fahrenheit or greater AND cough OR other respiratory signs including shortness of breath.

On 4/22/2020 from approximately 7:15 AM - 8:00 AM, observations were made at the hospital beginning in the front entrance, moving through the main lobby to elevators, onto the 3rd floor inpatient area, to the emergency room entrance, and then to the 4th floor to the hospital's administrative offices. The observations revealed that healthcare personnel were not screened prior to entering the hospital and visitors from the Sheriff's department were allowed entry to the hospital for the purpose of eating in the cafeteria and were not screened or offered facemasks to wear inside the hospital. Staff were observed inside the hospital and inside a patient room not wearing any facemasks or facial coverings. In an interview at approximately 7:45 AM, staff G, a nurse supervisor, reported staff are not screened prior to entering the hospital, but are expected to self-monitor at home.

During an interview with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Infection Preventionist (IP), Risk Manager (RM), and Director of Quality on 4/22/20 at approximately 8:00am, the IP stated the hospital follows CDC guidelines, but the hospital has not developed formal written policies because of the frequency of new information. When asked about screening staff, the Director of Quality said we talked about screening staff but planned to wait until there was an in-house positive case. The CEO stated they are not following the recommendation for all staff members to wear facemasks universally inside the hospital because of anticipated shortages and only symptomatic patients are being asked to wear a facemask. The CEO stated they are not screening staff based on community recommendations because there are only 11 positive cases in Jackson County. Only screening if they have an elevated temperature or if they are exposed to potential COVID-19. The IP said that there is not a policy for patients to wear facemasks outside of their rooms. Patients only wear facemasks if they have a suspected case of COVID-19. The IP said in-patients are screened on admission. When asked if admitted patients are screened daily, the IP said no, they are monitored. The CNO said that vital signs are taken to include temperature a minimum of every 8 hours for all admitted patients based on protocol, but it was not considered as an additional screening for COVID-19. When asked if there was any communication to healthcare providers to screen patients daily or consider COVID-19 after the initial admission assessment, they agreed there was not.
When the surveyor asked them to define the criteria for testing patients, they were unable to clearly define established, hospital-wide criteria to test patients for COVID-19.

In a follow up interview on 4/24/20 at 11:36 AM, in response to a request for testing criteria, the RM said the hospital used the "latest guidelines" for testing and that used to include travel, but now the screening criteria has nothing to do with travel; fever and shortness of breath are the current criteria. The RM provided an agenda of the Emergency Department Provider's Meeting, dated April 7, 2020. This documentation provided links to guidance from CDC and described the course of the disease from presentation, including various symptoms, clinical disease progression, and treatment options. It did not identify a hospital-based testing criteria.

On 4/24/20 at 2:29 PM an interview was conducted with physician L, who was the admitting physician for all 3 of the sampled patients (1,2, and 3). In an interview on 4/24/20 at 2:29 PM, when asked to identify the hospital-based criteria for testing patients, physician L responded that the IP has sent emails since "it all started, daily with all the updates and guidelines, suggestions, testing and updates. Everybody is reading those and following those to the best of our abilities. What we did 2-3 weeks ago is different from today, some is based on how readily available the test supplies are. Fever, cough, shortness of breath - 2 of the 3 you would consider testing. I still look at those primarily, but with testing supplies a little more available, if someone had a known exposure, you think a little differently. Still fever cough, shortness of breath. If they traveled from New Orleans, New York, or somewhere else." The physician did not verbalize any specific hospital developed testing criteria.

Medical record reviews revealed the hospital had not implemented or adhered to AHCA or CDC recommendations for testing elderly and frail individuals for COVID-19 and had not implemented droplet isolation precautions for patients meeting COVID-19 testing criteria for elderly and frail individuals. Three current patients with a respiratory -associated diagnosis were selected to review. Patient #1 was a 73 year-old admitted on 4/21/20 from long term care facility fever of 103.2 degrees Fahrenheit (F), pneumonia, and decreased oxygen saturation of 88%. No COVID-19 test was performed and patient was not placed on droplet or airborne precautions. Patient #1 met the COVID-19 testing criteria due to age (73 years old) and fever (103.2 degrees F) with respiratory issues and hypoxia (low oxygen saturation). Patient #2 was a 64 year old with serious underlying medical conditions. The patient was admitted on 4/22/20 from a long term care facility with a chief complaint of respiratory arrest/failure and a temperature fever 99.7 degrees F. Patient #2 was admitted, ordered a continuous positive airway pressure (CPAP) and her fever rose to 101.5 degrees F. No COVID-19 test was ordered or performed and patient #2 was not placed on droplet or airborne precautions. Patient #2 met the criteria for COVID-19 testing criteria due to being medically frail, high fever and respiratory failure. Patient #3 was a 69 year old male admitted 4/14/20 with a diagnosis acute respiratory failure. A COVID-19 test was not performed until 7 days later, on 4/21/20, and only then as a screening was required for placement in a long term acute care facility. Patient #3 was not identified as a PUI and not placed on droplet or airborne precautions. Patient #3 met the state agency testing criteria for elderly and frail individuals at the time of admission due to age (69 years old) and condition (respiratory failure). Cross Reference A0747, A0749, and A0771.

The surveyor requested copies of relevant infection control and prevention policies and procedures to determine hospital compliance. A review of documents provided revealed:
Copies of relevant infection control and prevention policies and procedures were requested to demonstrate hospital compliance. A review of documents provided revealed:
1. An undated, unsigned copy of an Exposure Control Plan which referenced Occupational Safety and Health Administration (OSHA) bloodborne pathogens and "other potentially infectious materials" including Hepatitis B and C viruses and HIV (Human Immunodeficiency Virus). No mention of COVID-19 or specific protocol for organisms requiring droplet precautions were mentioned in the plan. The plan contained blank spaces for committee approval of the plan and for annual review and approval.
2. A Respiratory Policy-Infection Control Plan with an effective date of 08/1994 did not contain reference to COVID-19. The policy was identified as an adjunct to the hospital-wide infection control manual.
3. An Isolation Policy with no effective date or review date identified, and no committee approval identified which did not contain references to COVID-19. The policy defined standard precautions and transmission-based precautions.
4. A copy of the Pandemic Policy dated 04/20 contained a plan for cohorting patients. The plan for staffing documented using emergency credentialing protocols set by local and/or state agencies to bring staff to hospital from the community to work. The plan did not mention COVID-19, but identified the purpose of the plan as "to ensure the hospital is prepared to efficiently provide health services during a pandemic." The policy then described the pandemic response to influenza. Procedures identified included: Establish and maintain inventory of PPE, Obtain from DOH (Department of Health) and public health authorities case definitions, protocols, and algorithms to assist with case finding, management, infection control, and surveillance reporting. Review, revise as needed, and activate guidelines for prevention and control measures. Conduct surveillance and testing for influenza. Implement a plan for early detection, reporting and treatment of health care personnel (staff). Reinforce infection control procedures to prevent the spread of influenza and utilize appropriate PPE. Maintain high index of suspicion that patients presenting with influenza-like illness could be infected with the pandemic strain. Increase environmental cleaning efforts. Summarize and analyze the pandemic response and lessons learned for the next wave. Review and revise the Pandemic Influenza Plan based on outcome measurements and performance results of current plan. The plan identified the CEO, CFO (Chief Financial Officer) and CNO (Chief Nursing Officer)as responsible for obtaining and disseminating information from outside agencies and resources as the nature and extent of the emergency and ensuring the safety of the staff and patients during the emergency.

On April 21, 2020, the CDC website contained information entitled "Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings", updated April 13, 2020, at https://www.cdc.gov/coronavirus/2019-ncov/hcp/dialysis.html. The guidance documented: Current data suggest person-to-person transmission most commonly happens during close exposure to a person infected with the virus that causes COVID-19, primarily via respiratory droplets produced when the infected person speaks, coughs, or sneezes. Droplets can land in the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those within close proximity. Transmission also might occur through contact with contaminated surfaces followed by self-delivery to the eyes, nose, or mouth. The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely. Recent experience with outbreaks in nursing homes has reinforced that residents with COVID-19 frequently do not report typical symptoms such as fever or respiratory symptoms; some may not report any symptoms. Unrecognized asymptomatic and pre-symptomatic infections likely contribute to transmission in these and other healthcare settings. Source control, which involves having the infected person wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions, might help reduce the risk of transmission of SARS CoV-2 from both symptomatic and asymptomatic people.
-This guidance is applicable to all U.S. healthcare settings.
-Universal Source Control: Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCP. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms. This approach is consistent with a recommendation to the general public advising them to wear a cloth face covering whenever they must leave their home.
-Healthcare Personnel: As part of source control efforts, HCP should wear a facemask at all times while they are in the healthcare facility. When available, facemasks are generally preferred over cloth face coverings for HCP as facemasks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others. If there are anticipated shortages of facemasks, facemasks should be prioritized for HCP and then for patients with symptoms of COVID-19 (as supply allows). Cloth face coverings should NOT be worn instead of a respirator or facemask if more than source control is required. Some HCP whose job duties do not require PPE (e.g., clerical personnel) might continue to wear their cloth face covering for source control while in the healthcare facility. Other HCP (e.g., nurses, physicians) might wear their cloth face covering for part of the day when not engaged in direct patient care activities, only switching to a respirator or facemask when PPE is required. To avoid risking self-contamination, HCP should consider continuing to wear their respirator or facemask (extended use) instead of intermittently switching back to their cloth face covering. They should also be instructed that if they must touch or adjust their facemask or cloth face covering they should perform hand hygiene immediately before and after. Ensure triage personnel who will be taking vitals and assessing patients wear a respirator (or facemask if respirators are not available), eye protection, and gloves for the primary evaluation of all patients presenting for care until COVID-19 is deemed unlikely. Triage personnel should have a supply of facemasks or cloth face coverings; these should be provided to all patients who are not wearing their own cloth face covering at check-in, assuming a sufficient supply exists.
-Ensure that, at the time of patient check-in, all patients are asked about the presence of fever, symptoms of COVID-19, or contact with patients with possible COVID-19. Incorporate questions about new onset of COVID-19 symptoms into daily assessments of all admitted patients. Monitor for and evaluate all new fevers and symptoms consistent with COVID-19 among patients. Place any patient with unexplained fever or symptoms of COVID-19 on appropriate Transmission-Based Precautions and evaluate. Prioritize patients with suspected COVID-19 who require admission to a hospital or congregate care setting (e.g., nursing home) for testing.
-Adhere to Standard and Transmission-Based Precautions: Standard Precautions assume that every person is potentially infected or colonized with a pathogen that could be transmitted in the healthcare setting. Elements of Standard Precautions that apply to patients with respiratory infections, including COVID-19, are summarized below. Attention should be paid to training and proper donning (putting on), doffing (taking off), and disposal of any PPE.
-Eye Protection: Put on eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face) upon entry to the patient room or care area, if not already wearing as part of extended use or reuse strategies to optimize PPE supply. Personal eyeglasses and contact lenses are NOT considered adequate eye protection.
-Gowns: Put on a clean isolation gown upon entry into the patient room or area. Change the gown if it becomes soiled. Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area. Disposable gowns should be discarded after use. Cloth gowns should be laundered after each use.
-Screen all HCP at the beginning of their shift for fever and symptoms consistent with COVID-19. Actively take their temperature and document absence of symptoms consistent with COVID-19. If they are ill, have them keep their cloth face covering or facemask on and leave the workplace. Fever is either measured temperature of 100.0 degrees or greater Fahrenheit or subjective fever. Note that fever may be intermittent or may not be present in some individuals, such as those who are elderly, immunosuppressed, or taking certain medications. Clinical judgement should be used to guide testing of individuals in such situations. Respiratory symptoms consistent with COVID-19 are cough, shortness of breath, and sore throat. Medical evaluation may be warranted for lower temperatures (less than 100.0 degrees Fahrenheit) or other symptoms (e.g., muscle aches, nausea, vomiting, diarrhea, abdominal pain headache, runny nose, fatigue) based on assessment by occupational health. Additional information about clinical presentation of patients with COVID-19 is available.
-Information about Facemasks: If worn properly, a facemask helps block respiratory secretions produced by the wearer from contaminating other persons and surfaces (often called source control).