Friday, February 15, 2008

Review of - Mass Medical Care with Scarce Resources: A Community Planning Guide

Today I will review another US government planning document. This is from the US Department of health and Human Services (HSS) and the Agency for Healthcare Research and Quality (AHRQ). This one is titled Mass Medical Care with Scarce Resources: A Community Planning Guide, and is available for free at http://www.ahrq.gov/research/mce/ in html and PDF formats. Again, I will be exerpting the ventilator specific sections and making a few comments. The original document is a 181 page pdf file.

This is document has very broad coverage of not only the avian flu threat and pandemics in general but also other mass casualty events. It is a government document and so tends to avoid much discussion of extreme events and generally assumes a pandemic of similar intensity to the 1918 Spanish Influenza as a worst case position. It discusses the ethical decisions that need to be made in the face of difficult choices and provides good background info and principles but generally steers away from making definitive suggestions on what ethical choices to make.

It presents a case study of a Pandemic Flu outbreak and addresses the expected ventilator shortage. They recommend that a triage system be established to decide which patients will get to use the limited supply of ventilators. They also suggest that hospitals may be using manual resuscitation bags to provide ventilation in response to a pandemic influenza. There are also comments about the need to prevent infection of staff by patients on ventilators by using intubation and by having ventilators with an adequate alarm system so that staff do not have to constantly attend patients.

This document, like the one I reviewed last week has a lot devoted to the process of deciding which patients will receive the ventilator therapy and which ones will not and how to be sure this process is very ethical. All of the planning documents I have read so far are similar in this regard. They write about how we will have to have altered standards of care. These altered standards include: waivers of certain legal liabilities for decisions that care providers must make, licensing requirements for caregivers, using drugs such as antivirals and vaccines in different dosage levels than recommended by the FDA in order to stretch supplies, and using physical facilities that would not normally meet the standards required for hospitals.

No one sees the fact that we could alter the standards required for ventilators so that we could double or triple the supply of ventilators available in a short period of time. The plans set forth by the Pandemic Ventilator Project will allow this to happen. I have written letters to many of the authors of government planning documents and told them of our plan and invited their feedback or support. I even sent a letter to one of the authors of this document; John L. Hick, M.D in March of 2007. I have never received any reply from them.
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Here are the excerpts related to ventilators:



EMS in an MCE: Expected Shortages and Needs
In the case of an MCE, many health care resources at the local and regional levels will be overwhelmed or eliminated. Those EMS response agencies that are able to remain operational likely will encounter a demand for services that will outstrip the supply and available resources. EMS systems will confront:
  • Personnel shortages.
  • Breakdowns in supply chains.
  • Lack of coordination and information sharing among diverse EMS providers, public safety, hospitals, trauma center, and public health.
  • Breakdown of logistic support for operational sustainability, including such things as fuel shortages; inadequate availability of transport vehicles; and shortages in supplies, equipment, and pharmaceuticals.
  • Overloading of hospital emergency departments and associated services such as intensive care capabilities; specialty services such as burn care or decontamination units; and specialized equipment such as ventilators, PPE, or negative pressure rooms.
  • Breakdowns in local “burden sharing” strategies (mutual aid agreements) due to overwhelming demand and lack of surge capacity.
  • The need to implement modified treatment protocols to meet the extraordinary conditions of the MCE that may be limited to reasonable life-sustaining activities where appropriate.
Hospital and Acute Care in the Context of a Catastrophic MCE
The overall goal of hospital and acute care response in an MCE is to meet the reasonable care needs of as many patients as possible while also meeting at least minimal obligations for comfort to each patient.63 In the case of a catastrophic MCE, however, hospitals will not have access to many needed resources (e.g., manual resuscitation bags to provide ventilation in response to a pandemic influenza, supply of antitoxin in the case of mass botulism poisoning). Thus, difficult decisions will have to be made regarding the allocation of available resources.

Inadequate Supplies.
Lack of sufficient supplies, particularly of specialized equipment such as personal protective equipment, ventilators, and negative pressure rooms, will be a challenge for most hospitals.

Ideally, hospitals should be able to follow guidance and decision support tools to make resource allocation decisions (e.g., who should receive mechanical ventilation) that are sanctioned and approved at the Federal level and are distributed by the State. Even with the support of these tools or policies, however, it is the hospital that will have to take on the role of implementing them.

Interstate regional coordination is another means of managing allocation of scarce resources. Interstate agreements and cooperation help promote sharing of assets across State lines. These types of agreements also help ensure consistency of response (e.g., National Capital Region) where inconsistencies between State plans could prove problematic. This level of interstate cooperation is difficult to achieve but is one of the most important ways to maximize resource allocation. The development of national-level clinical decision tools to address commonly limited resources (e.g., dialysis, mechanical ventilation) would be very valuable in helping to facilitate greater interstate cooperation.

Using expert panels or planning groups
At this time, no current predictive model is sufficient to serve as a decision framework for determining the allocation of critical care resources (e.g., ventilators, intensive care therapies). One valuable strategy for examining the allocation of scarce resources, however, is to convene a balanced expert panel that can bring in multiple viewpoints and establish decision making guidelines. The panel must be inclusive of relevant stakeholders who reflect the jurisdictional area and its demographics, in addition to recognizing border issues with adjoining States. The composition, functions, and operational role of these groups must be carefully considered.

Convening An Expert Panel To Address The Allocation Of Scarce Resources: The Example Of New York State
In March 2006, the New York State Task Force on Life and the Law (TFLL), in partnership with the State’s Department of Health, convened a workgroup to consider clinical and ethical challenges in the allocation of mechanical ventilators in a public health crisis. The group includes experts in the areas of law, medicine, policymaking, and ethics. Its goal is to develop clinical and ethical guidance for local health care systems that will promote the just allocation of ventilators in an influenza pandemic. The panel considered a range of policy options necessary to support such an allocation system, including the development of recommendations for laws or regulations in areas including liability and appropriate standards of care. Further information on the TFLL is available at www.health.state.ny.us/nysdoh/taskfce/index.

Expansion of critical care capacity by placing select ventilated patients on monitored or step-down beds; using pulse oximetry (with high/low rate alarms) in lieu of cardiac monitors; or relying on ventilator alarms (which should alert for disconnect, high pressure, and apnea) for ventilated patients, with spot oximetry checks

Clinical Adaptations represent the allocation of scarce resources or services based on the ethical principles outlined in Chapter 2.
Examples of clinical adaptations include the following:
  • Triage of patients to home care, acute care sites, or other offsite locals who would otherwise be treated as inpatients
  • Assignment of limited resources (e.g., ventilators, radiographs, laboratory testing) to those most expected to benefit

The hospital should be able to follow State guidance regarding clinical triage decisions. If no guidance exists, it will be incumbent on the hospital to have a plan or strategy for bringing together the appropriate personnel who can make the best decisions possible and reevaluate the situation during each planning cycle (e.g., each shift a day). When there is little advance evidence to guide allocation decisions (for example, not knowing how different age groups with pandemic influenza respond to mechanical ventilation), good clinical judgment by experienced clinicians will be the final common denominator to justify resource allocation decisions. The decision making process, based on ethical judgments that include maximizing good consequences across the many while meeting at least minimal duties and obligations to all, should be shared openly with staff members, patients, and the public and should be as consistent as possible across facilities.

One of the key decision points in the delivery of out-of-hospital care at an ACS is the ability to provide oxygen and respiratory therapy, particularly the ability to provide mechanical ventilation. The logistics and expense of sustaining oxygen delivery systems in an ACS setting, however, is extremely complex and prohibitively expensive. The exception to this may be the use of nursing homes and long-term care facilities in the role of alternative care facilities, given their existing medical gas supply.


The Challenge of Supplemental Oxygen
The use of an ACS for patients who require supplemental oxygen is highly problematic from a logistical point of view. Options to supply supplemental oxygen run from a home fill unit (10L/min maximum, less than $1,000) to deployable oxygen generation or liquid oxygen storage and distribution system (multiple patients, high technology, upwards of $480,000). Given the variables of cost, general availability, ease of use and sustainability, the most promising options for supplying supplemental oxygen would be either a bank of 10L/min home fill units or a rack of eight interconnected “H” oxygen cylinders, each supplying 7,000 liters of oxygen for a cost of approximately $13,000. Even this rack setup is severely limited, however, as the eight “H” cylinders could supply only 50 patients at 2 liters of oxygen per minute for 8 hours. This would necessitate three refills per 24-hour period and would require the rapid installation of a rudimentary gas distribution system. Support for ventilated patients would increase the rate of oxygen consumption significantly, further complicating this issue, and most likely would not be possible.

Locations ordinarily used to care for persons with eventually fatal chronic illnesses (e.g., nursing facilities, home health agencies) need to be ready to handle more severe complications. Plans should address the prospect of not transferring patients needing ventilator support if they are too sick to survive but prepared to provide appropriate palliative care services.

Potential shortages of ventilators could be particularly problematic. In the case of such a pandemic, hospitals may not have an adequate supply of reserve ventilators required to treat patients suffering from acute respiratory failure.

Key AARC Ventilator Capacity Recommendations
  • Increase human resources to assist respiratory therapists and physicians and have easy-to-use ventilators available in the event the respiratory therapists on the hospital staffs cannot handle the volume and noncritical care professionals must be enlisted.
  • Extend ventilator capacity for any mass casualty response, expanding the Strategic National Stockpiling Program by 5,000 to 10,000 ventilators. Additional ancillary supplies for ventilator use also should be stockpiled.
  • Develop a distribution plan for ventilators at both the local and national levels.
  • Intubation (placing a breathing tube down the windpipe) is recommended for patients suffering acute respiratory failure during a pandemic flu, because ventilation by mask may increase the risk for infection to staff and other patients.
  • Prepare for a power outage: each medical center should identify emergency power sources for electricity and compressed gas.

Assess surge capacity (beds, ventilators, etc.) to meet expected increased needs during a pandemic

Conduct Just-in-time-training for staff members, including influenza transmission, general information, infection control information, ventilator management, and hospital plans. Training is to be conducted via e-mail, informational posters, and shift briefings.

Open a joint information center (JIC) with the hospital association acting as liaison with all hospitals in the region. The regional coordinating hospital provides updates and solicits baseline availability of ventilators and patient beds.

Respiratory therapy manages ventilators only; other respiratory care services are to be provided by nurses. Floor nurses are to receive training in basic ventilator monitoring, with floor units supervised by a roving ICU nurse to monitor ventilated patients.

Select operating room and procedure room space to be used for additional ventilated patient care.

Set up a triage team (may consist of one critical care and one infectious disease physician, among others) to review conflicting resource needs (e.g., two patients needing a single ventilator) on a case-by-case basis.

Identify a Bed Czar to monitor the bed and “hard” resource statuses (e.g., ventilators), make assignments based on availability, and implement triage team recommendations.
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There is a mention of where to obtain the Sphere Handbook for Humanitarian Response in the original document. The listed website is incorrect. Here is the correct one:
http://www.sphereproject.org/component/option,com_docman/task,cat_view/gid,17/Itemid,26/lang,English

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