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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report C Crisis Standards of Care Implementation Guidance Scenarios Applying the guidance and principles laid out in the report, the committee developed two brief case studies that may serve to illustrate the implementation crisis standards of care. Recognizing the current attention and concern around the 2009 influenza A (H1N1) pandemic, one scenario focuses on a gradual-onset pandemic flu modeled around potential issues that may arise this upcoming flu season. The second scenario focuses on the issues that would arise due to a no-notice, sudden-onset event, and uses a devastating earthquake event as the model. For each scenario specific activities are indicated in italics and mapped by number to key elements and core components from the committee’s guidance. Major Influenza Pandemic Scenario Key elements/core components Scenario Description: An influenza pandemic was selected to demonstrate a response to the need to implement crisis standards of care as a result of a gradual-onset disaster event. This scenario is based on response to an infectious agent of high transmissibility and low pathogenicity with greater impact on younger age groups. Scenario: Preevent Planning: 1State Public Authority Process: Guideline development group In anticipation of a possible severe influenza pandemic, the state health department convened a multidisciplinary group composed1 of ethics, medical, legal, public health, emergency management, and emergency management services
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 2State Public Authority Process: State Disaster Medical Advisory Committee (EMS) experts and members of the public (represented by key faith, cultural, and at-risk group representatives) to provide advice on pandemic preparedness. This group suggested enabling legislation for declaring a public health emergency, improving liability protection during disasters for volunteer and non-volunteer healthcare providers, and expanding the scope of practice for many healthcare providers. A smaller medical advisory committee2 of critical care, infectious disease, emergency, and pediatric physicians developed draft guidelines dealing with potential alterations in the healthcare system during the time of a pandemic. These guidelines dealt with alteration in standards of care to crisis standards of care, if necessary, during a pandemic, addressing issues such as intensive care unit (ICU) admission criteria using Sequential Organ Failure Assessment (SOFA) scoring and ventilator allocation based on work done in New York and Minneapolis. These guidelines were carefully reviewed by the larger advisory committee with state-wide provider and community engagement and incorporated the ethical principles3 of fairness, duty to care, duty to steward resources, transparency, consistency across institutions and accountability. This group also established indicators4 (ICU bed availability, ventilator availability, emergency department [ED] average wait times) to follow on regional and state levels to assist in the monitoring of disease progression and status, which were already tracked by a state-wide EMS and hospital monitoring system5. The Disaster Medical Advisory Committee was tasked with obtaining quarterly data from this system and determining thresholds that would prompt an alert to the regional hospital coalition that patient care demand for services was increasing. State preparation also included planning for the establishment of alternate care facilities, if necessary, for acute, palliative, and behavioral health care. Purchases of antiviral medications, N95 masks, materials to provide care at an alternate care site, and a small number of ventilators were purchased using federal grant funding as well as a state legislative appropriation. 3Ethical Elements: Core ethical components listed 4Indicators and Triggers: Event-specific resource availability 5Indicators and Triggers: Situational awareness monitoring
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 6State Public Authority Process: Event-based use of State Disaster Medical Advisory Committee The Event: 7Incident Management – State Role; Community and Provider Engagement: Stakeholder roles and involvement In early fall, a novel influenza virus was detected in the United States. Cases rapidly spread across pockets of the United States. The virus exhibited a mortality rate double the usual expected influenza mortality, with a predilection toward school-age children. Emergency departments across the state began to see a marked rise in patient volumes, and concerns were expressed that resources required for the sustained delivery of patient care might be strained. The state disaster medical advisory committee6 was convened, with supplemental representation from pediatric and pediatric critical care in addition to the committee’s usual representatives. The committee made revisions to their prior guidance to manage a surge in patient care demand based on available epidemiologic information. Information was circulated to clinicians and nursing personnel7 reminding them of the planning work and several interviews and television news features were used as an opportunity to reinforce hopeful, yet realistic messaging about preparedness8 for a possible scarce resource situation. The state Department of Health (DOH) opened their Department Operations Center9 to monitor the situation, passing along updates from the Centers for Disease Control and Prevention (CDC) and other partners as needed. The State Disaster Medical Advisory Committee (SDMAC) worked with DOH staff to develop and vet outpatient screening tools. A few of the in-state regional hospital coalitions convened their own regional advisory committees10 to modify and customize this guidance to make it applicable for their local needs. At the hospital level, pandemic planning included members of the predesignated disaster clinical care committees11, who approved and/or modified these tools and guidance for institutional use. As the pandemic increased in intensity, state and regional advisory committee members updated contact information and participated in weekly conference calls. 8Crisis Standards of Care Operations: Use of Regional Disaster Medical Advisory Committee 9Department Operations Center 10Incident management – State Agency Role 11Clinical Process and Operations: Clinical care in crisis situations 12Indicators and Triggers: Situational awareness Monitoring12 of hospital ICU occupancy, hospital divert status, healthcare provider absenteeism, and business closures demonstrated a worsening situation in the state in late October. The state requested activation of the Strategic National Stockpile (SNS) for delivery of additional antiviral medications and personal protective equipment
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 13Legal Authority and Environment: mutual aid agreements; Crisis standard of care operations: Use of the Regional Medical Coordinating Center (RMCC) (PPE). The state’s emergency operations center (EOC) was opened and interfacility Memorandums of Understanding13were activated. The State DOH coordination efforts relocated to the state EOC. Area hospitals moved from conventional care to contingency care as the pandemic worsened, with many reducing elective surgeries, boarding ICU patients in stepdown units, boarding floor patients in procedure and postanesthesia care areas, and setting up rapid screening and treatment areas14 for the mildly ill apart from the emergency department, where volumes had escalated to nearly double usual daily volumes. Homecare agencies noted a significant increase in the acuity and volume of their patient referrals. Ambulatory care clinics had to clear schedules to accommodate the volume of acute illness, despite media messages15 to stay home unless severely ill and it was difficult reaching clinics because there phone lines were tied up much of the time. Hospitals activated their Hospital Incident Command System16, using action planning cycles and providing daily updates to staff. The Regional Medical Coordinating Center (RMCC) for the local hospital coalition of 24 hospitals was stood up and provided situational awareness17 and acted as the liaison among hospitals and public health, EMS, and emergency management. Conference calls became daily, and a web-based information sharing system was also used to post guidelines, talking points, and other information and issues. 14State Public Authorities Process: Public health emergency 15Clinical Process and Operations: Communications strategies 16Clinical Process and operations: Resource-sparing strategies 17Community and Provider engagement: Crisis risk communications 18Clinical Process and Operations: Incident management principles State-wide, a public health emergency18 was declared by the governor. This declaration allowed for the temporary adaptation of certain licensing, medical supervision, and credentialing regulations19. More generous nurse-patient ratios were also allowed. Alternate care facilities were opened, initially to provide early treatment to those with minor illness, but as the situation worsened, the RMCC worked with public health and EMS agencies to broaden the scope of care20 to include intravenous fluid hydration, and EMS was allowed to transport patients directly to these centers. The SDMAC participated in several conference calls with RMCC and regional medical advisors to facilitate and provide ideas on care provision and staffing21, as these functions were not included in the initial planning for “flu centers”. 19Clinical Process and Operations: Intrastate regional consistency 20Legal Authority and Environment: State declaration of public health emergency 21Legal Authority and Environment: Licensing and credentialing
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 22Legal Authority and Environment: Scopes of practice for healthcare professionals Hospital and EMS staffing requirements were waived by the governor. The Secretary of Health and Human Services issued a waiver of sanctions22 for noncompliance with certain EMTALA requirements. The state Department of Health (DOH) engaged in aggressive risk communication to try to reduce patients with mild illness presenting to clinics or EDs, taking care that its messages were consistent with those provided by the CDC. 23Legal Authority and Environment: Special emergency protections The state DOH requested that the RMCCs submit their incident action plans (IAPs)23 on a consistent 8am cycle, and these were reviewed and summarized within the state IAP at 10am. Occasional discrepancies in medical care decision making was noted in review of the regional IAPs. Those that demonstrated a significant lack of consistency24 were discussed with the chair of the SDMAC, and as needed with the full committee, and then were addressed with the region25. 24Clinical Process and Operations: Healthcare facility responsibilities – clinical care committee 25Legal Authorities: Executive order As demand increased, hospital incident commanders convened their clinical care committees26 in order to prioritize available hospital resources toward patient care, as well as anticipating those resources that may soon be in short supply. Many of these committees used prior guidance for scarce resource situations from the state DOH and other “evidence-based” sources in their recommendations at each operational period to the incident commander27. ICU capacity was generally spilling over to monitored units, with stable patients from floor beds being transferred to alternate care sites or sent home with homecare28. Ventilators were now noted to be in extremely short supply. The clinical care committees reviewed triage processes recommended by the state and assured that staff and policies were prepared in case ventilator triage was required29. 26Clinical Process and Operations: Intrastate regional consistencies 27Clinical Process and Operations: Communications strategies 28Clinical Process and Operations: Coordination of resource management 29Clinical Process and Operations: Coordination extends through all elements of health system 30Clinical Process and Operations: Application of decision support tools and triage teams; Legal Authority and Environment: Medical and legal standards of care Based on the worsening situation, and state DOH estimates that ventilator triage would be required at any time, the governor issued an executive order30 recognizing a “crisis standard of care” and providing legal protections to healthcare workers who were responding according to existing plans in a good-faith manner. The state DOH formally issued ventilator triage guidance31 as well as guidance on conservation of oxygen use which had been previously recommended and approved as a resource-sparing strategy32 by the SDMAC and guideline advisory group. The SDMAC met by 31Clinical Process and Operations: Application of decision support tools 32Clinical Process and Operations: Resource-sparing strategies
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report conference call frequently to discuss possible updates to the guidance, but the epidemiology of the disease did not allow for incorporation of further prognostic indicators based on the specific epidemic virus. 33Community and Provider Engagement: Community trust and assurance As conditions continued to deteriorate, some reports of public unrest were noted. Tempers ran high as wait times in private physician offices, ambulatory clinics and hospital emergency departments lengthened. Community leaders issued messages33 via the local print and broadcast media reiterating the extensive health and medical response planning that had already been conducted, as well as a description of those plans presently under consideration, including the possibility that resources may become in exceedingly short supply. 34State Public Authority Process: Triage teams The situation was worsening. Institutional surge capacity was exceeded, especially by pediatric patients, with many hospitals having to move to crisis care with implementation of ICU triage criteria and ventilator allocation. “Triage teams34” were thus activated to assist with these clinical allocation decisions by their institutional clinical care committees. Rural hospitals used a phone-in metropolitan hospital triage team (three were set up in the state via the RMCC in coordination with state DOH) when a patient in respiratory failure presented to their facility – if the patient qualified for a ventilation trial, the metro team arranged for transfer to a tertiary center. Such calls were few, however, as all hospitals had an understanding35 of the types of patients eligible for ventilation trials based on daily conference calls hosted by the RMCC (in which the state DOH participated in) and the Internet communication system used by that hospital coalition. 35Clinical Process and Operations: Communications strategies 36Clinical Process and Operations: Inclusion of palliative care principles Palliative care36 areas were designated in several facilities and were set up in a hotel in one case. The RMCC requested operational guidance for that facility from the SDMAC, which worked with preidentified subject-matter experts to create printed guidance and recommendations for this novel operation, which was then shared with all the hospitals37 in the state. Slowly, intensive care admits began to decline, and the triage team was 37Clinical Process and Operations: Intrastate regional consistencies
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 38Clinical Process and Operations: Mental health needs disbanded, though the clinical care committee was required to supervise phased transition back through contingency and crisis care. After 7 weeks, the pandemic began to abate, and clinical care returned to conventional status, though the work of behavioral health practitioners had just begun. Patients with mental health needs38 continued to stress many elements of the healthcare delivery system and required significant resources. Alternate care sites that were once used as “flu centers” or to help decompress overwhelmed hospitals were now being used to provide mental health screening and therapeutics, when indicated. This aspect of the recovery phase would continue to tax healthcare workers and the public at large for many weeks, as many patients who had deferred their usual or chronic care during the pandemic now presented to clinics and emergency departments. 39Community and Provider Engagement: Community cultural values and boundaries; Continuity of community education and awareness The state DOH and SDMAC prepared after-action reports which were reviewed by the broader guideline advisory group and a larger group of medical stakeholders prior to their release to the RMCCs and public. The guideline advisory group and state DOH also hosted hearings in each of the regions39 to allow public and provider input, as well as making an anonymous online system available for comments in order to improve response for future events.
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report Major Earthquake Scenario Key elements/core components Scenario Description: A major earthquake scenario was selected to demonstrate the need to implement crisis standards of care as a result of a catastrophic, sudden onset disaster event. This scenario is based on response to a devastating disaster event that is regional in scope. However, it highlights many of the basic key elements and core components required to implement crisis standards of care in a disaster. Scenario: It is a relatively quiet afternoon in the emergency department of Hillendale Hospital in Southern California, a 232-bed Level 2 trauma center, when without warning, the shaking begins. Personnel respond quickly to protect patients according to emergency plans. A magnitude 7.8 earthquake has occurred on the southernmost 300 km (200 mi) of the San Andreas Fault, between the Salton Sea and Lake Hughes, California. The sudden rupture of this fault produced very strong shaking near the fault line, with medium to long durations. Along with the initial shaking came liquefaction and devastating landslides. 1Clinical Process and Operations: Incident management principles After the initial shaking stops, the nursing supervisor activates the hospital emergency operations plan1 and assumes the initial incident command role under the Hospital Incident Command System (HICS). The emergency operations center is opened and callbacks to staff2 are attempted. An initial damage survey is conducted by facility engineers and reveals that the hospital has numerous critical mission functions that are disrupted. The hospital campus is reliant on generator power. Water pressure is dangerously low. There is no major structural damage to the facility, however. Based on radio reports and “tweets” through the online service Twitter3, this major quake has shut down main highways and roads across the area to the south, disrupted cellular phone and landline phone service, and left most of the area without power4. Several fires are burning 2Clinical Process and Operations: Coordination of resource management 3Indicators and Triggers: Situational awareness and management 4Indicators and Triggers: Critical infrastructure disruption
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report out of control in the metropolitan area about 12 miles south of the hospital. 5Clinical Process and Operations: Resource-sparing strategies Within 20 minutes after the quake, a steady stream of those with minor injuries and occasional major trauma begin arriving. The walking wounded are triaged to the cafeteria and provided first aid. The emergency room begins to fill with more seriously wounded who are moved upstairs to beds as quickly as possible. As usual, the hospital was fairly full, but a procedure area has been converted to patient care. Surgeons take several cases to the operating room, performing bailout procedures in order to free staff and space for subsequently arriving cases. Due to the power outage, no elective cases are being performed5. 6Clinical Process and Operations: Coordination of resource management, use of clinical care committee A few staff are able to make it in to the hospital, including an administrator who takes over the role of incident commander and requests that the nursing supervisor pull together members of the predetermined clinical care committee in order to take stock of available resources6 and, in conjunction with the planning chief, determine ways to conserve7 blood products, intravenous fluids, narcotics, antibiotics, and surgical supplies. The hospital administrator assumes that resupply of these key resources is unlikely for the next few days. Fortunately, the hospital has prepared well for food, water, and utilities disruption and can safely continue to operate for now. 7Clinical Process and Operations: Resource-sparing strategies; Ethical Elements: Duty to steward resources 8Clinical Care and Operations: use of the Regional Medical Coordination Center The Regional Medical Coordination Center (RMCC) for Hillendale’s hospital coalition has been established now at the back-up jurisdictional emergency operations center (EOC)8. This is because the primary EOC has been heavily damaged due to fire. Hillendale requests assistance to provide patient care and advises that they will need fuel, water and supplies within a few days, but several other regional hospitals have been more heavily damaged9, and their requests take priority. The RMCC notes that a common challenge for hospital response is the lack of blood products and intravenous fluids sufficient to treat crush injuries. Patients requiring regularly scheduled dialysis are also an issue, as are patients with home ventilators that lack power. Finally, with resupply of hospital liquid oxygen in doubt, questions of conservation arise. The RMCC works with public health10 to identify resources for the home ventilator 9Indicators and Triggers: Disruption of social and community functioning 10Legal Authority and Environment: Mutual aid agreements
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 11Clinical Process and Operations: State Disaster Medical Advisory Committee population, and the RMCC contacts the state Department of Health (DOH) about the other issues – the state DOH posts prepared guidance on dialysis patients and blood products which has previously been developed by the State Disaster Medical Advisory Committee11. The chair of that group was contacted about the oxygen issue, and, after discussion with subject matter experts knowledgeable about the delivery of respiratory therapies12, guidance was provided by that evening on the state DOH website13. The state DOH worked with emergency management at the State EOC14 to airlift additional blood and fluid supplies to the most severely impacted hospitals. 12Legal Authority and Environment: Scope of practice 13Clinical Process and Operations: Communications strategies 14Clinical Process and Operations: Incident management—jurisdiction 15Clinical Operations and Process: Incident management—state and federal Meanwhile, the jurisdictional EOC has requested15 rotor-wing and ground ambulances from the State EOC to assist with evacuation, and has asked the state to request Federal Disaster Medical Assistance Teams (DMATs). The state has determined that National Disaster Medical System (NDMS) evacuation support for approximately 800 patients who require evacuation from unsafe facilities will be required. This will take days to occur, however, given the broad geographic distribution of severely impacted healthcare facilities, the extent of critical infrastructure disruption, and the time required to mobilize these resources from across the country. 16Indicators and Triggers: Situational awareness The multiagency public health and medical emergency support function 8 (ESF-8)16 desk at the jurisdictional EOC gets updates on field situations and begins to provide situational awareness17 to the healthcare sector. It is noted during the initial field reports that all 911 services are engaged, affected by the earthquake and unable to respond or unable to transport18 patients. 17Clinical Process and Operations: Coordination extends through all elements of health system 18Indicators and Triggers: Disruption of community functioning 19Community and Provider Engagement: Provider roles and involvement Hillendale is one of the few functioning trauma centers in the area and, as situational awareness improves, trauma patients are arriving in increasing numbers to Hillendale Hospital. The hospital “clinical care committee” has included burn and trauma triage information19 with its daily recommendations to the incident commander because of this anticipated surge in demand for care. Given that staff surgeons will perform triage based on their clinical judgment, there is no need to activate the plan for a hospital “triage team”. This is generally reserved for tertiary triage of critical care resources20, which is not yet an issue. 20Clinical Process and Operations: Resource-sparing strategies
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 21Clinical Process and Operations: Communication strategies; Clinical Process and Operations: Incident management—jurisdiction However, the committee has touched base21 with the critical care physicians to assure that they are prepared to implement critical care triage should that be needed. With only a few surgeons available, a few severely burned elderly patients have been triaged as expectant22 and moved to private rooms and made comfortable with analgesia and constant volunteer presence. The hospital continues to have problems notifying staff, who are having problems reaching the facility. 22Clinical Process and Operations: Inclusion of palliative care principles 23Indicators and Triggers: Critical infrastructure disruption Movement of water, petroleum products, telecommunications, and general transportation repairs will be slow, with many roads and highways impassable in the first few days after the earthquake because of debris on the roads, damage to bridges, and lack of power23 for the traffic signals. 24Indicators and Triggers: Situational awareness The following morning, television reports and tweets24 are making it clear that thousands of persons have been injured or killed. The state Office of Emergency Management has fully activated its EOC25 and the governor has provided the media26 with an initial briefing. As outlined in the National Response Framework they are attempting to coordinate with the downstate EOCs and mobilize resources to send into the affected area. A state disaster declaration27 has been signed, and a request for federal declaration of disaster has been made and will be approved this morning. Select National Guard assets have been activated. The Health and Human Services Regional Emergency Coordinator has requested the Secretary’s Operation Center place the NDMS system on alert, and DMAT activation and patient evacuation planning are in process. 25Clinical Process and Operations: Incident management principles 26Community and Provider Engagement: Crisis risk communications 27Legal Authority and Environment: State and federal declarations 28Indicators and Triggers: Illness and injury incidence and severity Reports continue to come in to the state EOC that hospitals that are functioning in the affected disaster zone are being inundated with patients seeking care. Hillendale Hospital reports that complete reliance on back-up generator power has limited the number of critical care medical devices that can be supported, while the number of patients requiring critical care interventions continues to rise. Due to the number and severity of suspected injuries28, the state DOH has asked the governor to issue an emergency order authorizing crisis standards of care29 in the affected counties. This order provides additional legal protections to healthcare practitioners and professionals involved 29Legal Authority and Environment: Medical and legal standards of care
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report in the establishment of and delivery of healthcare services in alternate care sites and shelter environments, which are being set up around the perimeter of the worst affected area. 30Clinical Process and Operations: Resource-sparing strategies and use of the clinical care committee The “clinical care committee” (which is limited in its ability to contemplate and deliberate on the complete set of issues related to scarcity of resources due to staffing constraints) meets to determine priorities prior to making recommendations to the incident commander at the hospital at 9:00 a.m. Providers are asked to abandon computer charting30 and use simple template charts for minor care. A tent is set up in the parking lot for minor care and is staffed by subspecialty physicians. Intensive care units have overflowed into step-down units. Limited electricity supply continues to affect medical equipment, resulting in some ventilated patients being hand ventilated with use of a bag-valve mask for prolonged periods of time. Because of the continued presentation of trauma patients31, blood products and surgical supplies are running very low. The requests for assistance to the EOC are repeated, but remain one of many put on hold by the EOC due to more pressing demands. 31Indicators and Triggers: Loss of surge capacity Later that day, rotor-wing units bring needed supplies and blood from a tertiary care hospital 70 miles north, and take 1 to 2 critical patients back at a time. A large aftershock rattles through the hospital and breaks several more windows. The Planning Chief requests an evacuation list from Operations, which prioritizes existing in-patients for air or ground evacuation and related requirements. 32Clinical Process and Operations: Resource-sparing strategies The following day, potable water, generator fuel, and food arrive via National Guard helicopter. The staff is exhausted. That afternoon, members of an internal state disaster response team arrive to begin relieving surgeons and emergency department (ED) physicians. Two days from now, a DMAT team will arrive and set up in an adjacent parking lot, and a larger generator will arrive and be hooked into the hospital electrical supply. Communications is improving. Regional blood supply continues to be tenuous. The “clinical care committee” also has been made aware of very limited availability of tetanus vaccine32, and asks ED staff to vaccinate only for high-risk wounds.
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Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report 33Legal Authority and Environment: Scope of practice The State Health Department has also issued interim guidance33 for tetanus vaccine administration in response to this common complaint and is monitoring the daily conference calls and RMCC web-based messaging to identify other issues for the state DOH and the State Disaster Medical Advisory Committee. Fortunately, despite huge demands on the hospital, Hillendale was never forced to appoint a “triage team” or restrict access to critical care resources. Despite seeing 987 patients in the first 3 days, many of the injuries were minor. Although there were a number of severe trauma cases, the general surgery staff helped to augment34 the few trauma surgeons on staff in managing these patients. Twenty-one patients have been airlifted out, the rest remain hospitalized. 34Legal Authority and Environment: Scope of practice 35Clinical Process and Operations: Recognition of mental health needs The staff are exhausted. Many have lost homes, as have many patients and their family members. Extended family and friends remain unaccounted for or are known to be injured or dead. Psychological first aid35 is provided to victims and staff by trained staff, and social workers try to assist with reunification. The road to recovery will be long and difficult, as the mental health and logistical challenges are just beginning, but Hillendale has played a key part in supporting the needs of the community during this major disaster.
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