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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 committeeâs 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: In anticipation of a possible severe influenza pandemic, the state health department convened a 1StatePublic Authority Process: multidisciplinary group composed1 of ethics, Guideline development group medical, legal, public health, emergency management, and emergency management services 119
120 CRISIS STANDARDS OF CARE GUIDANCE (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 2StatePublic Authority Process: providers, and expanding the scope of practice for State Disaster Medical Advisory many healthcare providers. A smaller medical Committee 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 3Ethical Elements: Core ethical community engagement and incorporated the components listed ethical principles3 of fairness, duty to care, duty to steward resources, transparency, consistency across 4Indicators and Triggers: Event- institutions and accountability. This group also specific resource availability 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 5Indicators and Triggers: by a state-wide EMS and hospital monitoring Situational awareness 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.
APPENDIX C 121 The Event: 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 6StatePublic Authority Process: patient care might be strained. The state disaster Event-based use of State Disaster medical advisory committee6 was convened, with Medical Advisory Committee supplemental representation from pediatric and pediatric critical care in addition to the committeeâs usual representatives. The committee made revisions to their prior guidance to manage a surge 7Incident Management â State in patient care demand based on available Role; Community and Provider epidemiologic information. Information was Engagement: Stakeholder roles circulated to clinicians and nursing personnel7 and involvement reminding them of the planning work and several 8Crisis Standards of Care interviews and television news features were used Operations: Use of Regional as an opportunity to reinforce hopeful, yet realistic Disaster Medical Advisory messaging about preparedness8 for a possible Committee scarce resource situation. The state Department of Health (DOH) opened their Department Operations 9Department Operations Center 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 10Incident management â State Agency Role 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 11Clinical Process and Operations: Clinical care in crisis predesignated disaster clinical care committees11, situations 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 12Indicators and Triggers: and participated in weekly conference calls. 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
122 CRISIS STANDARDS OF CARE GUIDANCE (PPE). The stateâs emergency operations center 13Legal Authority and (EOC) was opened and interfacility Memorandums Environment: mutual aid of Understanding13 were activated. The State DOH agreements; Crisis standard of coordination efforts relocated to the state EOC. care operations: Use of the Area hospitals moved from conventional care to Regional Medical Coordinating contingency care as the pandemic worsened, with Center (RMCC) many reducing elective surgeries, boarding ICU patients in stepdown units, boarding floor patients 14State Public Authorities in procedure and postanesthesia care areas, and Process: Public health setting up rapid screening and treatment areas14 emergency 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 15Clinical Process and clinics had to clear schedules to accommodate the Operations: Communications volume of acute illness, despite media messages15 strategies 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 16Clinical Process and Hospital Incident Command System16, using action operations: Resource-sparing planning cycles and providing daily updates to strategies staff. The Regional Medical Coordinating Center (RMCC) for the local hospital coalition of 24 hospitals was stood up and provided situational 17Community and Provider awareness17 and acted as the liaison among engagement: Crisis risk hospitals and public health, EMS, and emergency communications 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. 18Clinical Process and State-wide, a public health emergency18 was Operations: Incident declared by the governor. This declaration allowed management principles for the temporary adaptation of certain licensing, 19Clinical Process and medical supervision, and credentialing Operations: Intrastate regional regulations19. More generous nurse-patient ratios consistency were also allowed. Alternate care facilities were opened, initially to provide early treatment to those with minor illness, but as the situation worsened, 20Legal Authority and the RMCC worked with public health and EMS Environment: State declaration agencies to broaden the scope of care20 to include of public health emergency 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 21Legal Authority and facilitate and provide ideas on care provision and Environment: Licensing and staffing21, as these functions were not included in credentialing the initial planning for âflu centersâ.
APPENDIX C 123 Hospital and EMS staffing requirements were waived by the governor. The Secretary of Health 22Legal Authority and and Human Services issued a waiver of sanctions22 Environment: Scopes of practice for noncompliance with certain EMTALA for healthcare professionals 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. The state DOH requested that the RMCCs submit their incident action plans (IAPs)23 on a 23Legal Authority and consistent 8am cycle, and these were reviewed and Environment: Special emergency summarized within the state IAP at 10am. protections Occasional discrepancies in medical care decision making was noted in review of the regional IAPs. Those that demonstrated a significant lack of 24Clinical Process and consistency24 were discussed with the chair of the Operations: Healthcare facility SDMAC, and as needed with the full committee, responsibilities â clinical care and then were addressed with the region25. committee As demand increased, hospital incident 25Legal Authorities: Executive commanders convened their clinical care order committees26 in order to prioritize available hospital resources toward patient care, as well as 26Clinical Process and anticipating those resources that may soon be in Operations: Intrastate regional short supply. Many of these committees used prior consistencies guidance for scarce resource situations from the state DOH and other âevidence-basedâ sources in 27Clinical Process and their recommendations at each operational period Operations: Communications to the incident commander27. ICU capacity was strategies generally spilling over to monitored units, with 28Clinical Process and stable patients from floor beds being transferred to Operations: Coordination of alternate care sites or sent home with homecare28. resource management Ventilators were now noted to be in extremely 29Clinical Process and short supply. The clinical care committees Operations: Coordination reviewed triage processes recommended by the extends through all elements of state and assured that staff and policies were health system prepared in case ventilator triage was required29. 30Clinical Process and Based on the worsening situation, and state Operations: Application of DOH estimates that ventilator triage would be decision support tools and triage required at any time, the governor issued an teams; Legal Authority and executive order30 recognizing a âcrisis standard of Environment: Medical and legal careâ and providing legal protections to healthcare standards of care workers who were responding according to existing 31Clinical Process and plans in a good-faith manner. The state DOH Operations: Application of formally issued ventilator triage guidance31 as well decision support tools as guidance on conservation of oxygen use which had been previously recommended and approved as 32Clinical Process and a resource-sparing strategy32 by the SDMAC and Operations: Resource-sparing guideline advisory group. The SDMAC met by strategies
124 CRISIS STANDARDS OF CARE GUIDANCE 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. 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 33Community and Provider departments lengthened. Community leaders issued Engagement: Community trust messages33 via the local print and broadcast media and assurance 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. The situation was worsening. Institutional surge capacity was exceeded, especially by pediatric patients, with many hospitals having to move to 34State Public Authority Process: crisis care with implementation of ICU triage Triage teams criteria and ventilator allocation. âTriage teams34â 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 â if the patient qualified for a ventilation trial, the metro team arranged for 35Clinical Process and transfer to a tertiary center. Such calls were few, Operations: Communications however, as all hospitals had an understanding35 of strategies 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 36Clinical Process and that hospital coalition. Operations: Inclusion of Palliative care36 areas were designated in palliative care principles 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 37Clinical Process and novel operation, which was then shared with all the Operations: Intrastate regional hospitals37 in the state. Slowly, intensive care consistencies admits began to decline, and the triage team was
APPENDIX C 125 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. 38Clinical Process and Patients with mental health needs38 continued to Operations: Mental health needs stress many elements of the healthcare delivery system and required significant resources. Alternate care sites that were once used as âflu centersâ 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. 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 39Community and Provider RMCCs and public. The guideline advisory group Engagement: Community and state DOH also hosted hearings in each of the cultural values and boundaries; regions39 to allow public and provider input, as Continuity of community well as making an anonymous online system education and awareness available for comments in order to improve response for future events.
126 CRISIS STANDARDS OF CARE GUIDANCE 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 After the initial shaking stops, the nursing Operations: Incident supervisor activates the hospital emergency management principles operations plan1 and assumes the initial incident command role under the Hospital Incident 2Clinical Process and Command System (HICS). The emergency Operations: Coordination of operations center is opened and callbacks to staff2 resource management 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 3Indicators and Triggers: facility, however. Based on radio reports and Situational awareness and âtweetsâ through the online service Twitter3, this management major quake has shut down main highways and roads across the area to the south, disrupted cellular 4Indicators and Triggers: Critical phone and landline phone service, and left most of infrastructure disruption the area without power4. Several fires are burning
APPENDIX C 127 out of control in the metropolitan area about 12 miles south of the hospital. 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 5Clinical Process and arriving cases. Due to the power outage, no elective Operations: Resource-sparing cases are being performed5. strategies A few staff are able to make it in to the hospital, including an administrator who takes over the role 6Clinical Process and of incident commander and requests that the Operations: Coordination of nursing supervisor pull together members of the resource management, use of predetermined clinical care committee in order to clinical care committee take stock of available resources6 and, in conjunction with the planning chief, determine 7Clinical Process and Operations: Resource-sparing ways to conserve7 blood products, intravenous strategies; Ethical Elements: fluids, narcotics, antibiotics, and surgical supplies. Duty to steward resources 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. The Regional Medical Coordination Center (RMCC) for Hillendaleâs hospital coalition has 8Clinical Care and Operations: use of the Regional Medical been established now at the back-up jurisdictional Coordination Center 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 9Indicatorsand Triggers: several other regional hospitals have been more Disruption of social and heavily damaged9, and their requests take priority. community functioning 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 10Legal Authority and liquid oxygen in doubt, questions of conservation Environment: Mutual aid arise. The RMCC works with public health10 to agreements identify resources for the home ventilator
128 CRISIS STANDARDS OF CARE GUIDANCE population, and the RMCC contacts the state Department of Health (DOH) about the other issues 11Clinical Process and â the state DOH posts prepared guidance on Operations: State Disaster dialysis patients and blood products which has Medical Advisory Committee previously been developed by the State Disaster 12Legal Authority and Medical Advisory Committee11. The chair of that Environment: Scope of practice group was contacted about the oxygen issue, and, after discussion with subject matter experts 13Clinical Process and Operations: Communications knowledgeable about the delivery of respiratory strategies therapies12, guidance was provided by that evening on the state DOH website13. The state DOH worked 14Clinical Process and with emergency management at the State EOC14 to Operations: Incident airlift additional blood and fluid supplies to the managementâjurisdiction most severely impacted hospitals. 15Clinical Operations and Meanwhile, the jurisdictional EOC has Process: Incident managementâ requested15 rotor-wing and ground ambulances state and federal 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: The multiagency public health and medical Situational awareness emergency support function 8 (ESF-8)16 desk at the 17Clinical Process and jurisdictional EOC gets updates on field situations Operations: Coordination and begins to provide situational awareness17 to extends through all elements of the healthcare sector. It is noted during the initial health system field reports that all 911 services are engaged, 18Indicators and Triggers: affected by the earthquake and unable to respond Disruption of community or unable to transport18 patients. functioning Hillendale is one of the few functioning trauma centers in the area and, as situational awareness improves, trauma patients are arriving in increasing 19Community and Provider numbers to Hillendale Hospital. The hospital Engagement: Provider roles and âclinical care committeeâ has included burn and involvement 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 20Clinical Process and based on their clinical judgment, there is no need to Operations: Resource-sparing activate the plan for a hospital âtriage teamâ. This strategies is generally reserved for tertiary triage of critical care resources20, which is not yet an issue.
APPENDIX C 129 21Clinical Process and However, the committee has touched base21 with Operations: Communication the critical care physicians to assure that they are strategies; Clinical Process and prepared to implement critical care triage should Operations: Incident that be needed. With only a few surgeons available, managementâ jurisdiction a few severely burned elderly patients have been triaged as expectant22 and moved to private rooms 22Clinical Process and and made comfortable with analgesia and constant Operations: Inclusion of volunteer presence. The hospital continues to have palliative care principles problems notifying staff, who are having problems reaching the facility. 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 23Indicators and Triggers: to bridges, and lack of power23 for the traffic Critical infrastructure disruption signals. The following morning, television reports and 24Indicators and Triggers: tweets24 are making it clear that thousands of Situational awareness persons have been injured or killed. The state 25Clinical Process and Office of Emergency Management has fully Operations: Incident activated its EOC25 and the governor has provided management principles the media26 with an initial briefing. As outlined in 26Community and Provider the National Response Framework they are Engagement: Crisis risk attempting to coordinate with the downstate EOCs communications and mobilize resources to send into the affected area. A state disaster declaration27 27Legal Authority and has been signed, and a request for federal Environment: State and federal declaration of disaster has been made and will be declarations approved this morning. Select National Guard assets have been activated. The Health and Human Services Regional Emergency Coordinator has requested the Secretaryâs Operation Center place the NDMS system on alert, and DMAT activation and patient evacuation planning are in process. 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 28Indicators and Triggers: Illness rise. Due to the number and severity of suspected and injury incidence and severity injuries28, the state DOH has asked the governor to 29Legal Authority and issue an emergency order authorizing crisis Environment: Medical and legal standards of care29 in the affected counties. This standards of care order provides additional legal protections to healthcare practitioners and professionals involved
130 CRISIS STANDARDS OF CARE GUIDANCE 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. The âclinical care committeeâ (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 30Clinical Process and hospital at 9:00 a.m. Providers are asked to Operations: Resource-sparing abandon computer charting30 and use simple strategies and use of the clinical template charts for minor care. A tent is set up in care committee 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 31Indicators and Triggers: Loss products and surgical supplies are running very of surge capacity 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. 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. 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 âclinical care 32Clinical Process and committeeâ also has been made aware of very Operations: Resource-sparing limited availability of tetanus vaccine32, and asks strategies ED staff to vaccinate only for high-risk wounds.
APPENDIX C 131 The State Health Department has also issued interim guidance33 for tetanus vaccine 33Legal Authority and administration in response to this common Environment: Scope of practice 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 âtriage teamâ 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 34Legal Authority and surgery staff helped to augment34 the few trauma Environment: Scope of practice surgeons on staff in managing these patients. Twenty-one patients have been airlifted out, the rest remain hospitalized. 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. 35Clinical Process and Psychological first aid35 is provided to victims and Operations: Recognition of staff by trained staff, and social workers try to mental health needs 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.