SUPPLEMENTAL DIGITAL CONTENT 1.doc TABLE OF CONTENTS TOPIC PAGE ACRONYM LISTING DEFINITIONS RADIALOGICAL SCENARIOS DIAGNOSTIC CRITERIA TABLES S2 S5 S7 S14 S1 ACRONYM LISTING AFRRI .................................................................... Armed Forces Radiobiology Research Institute AFRAT ................................................................................Air Force Radiation Assessment Team Am................................................................................................................................... Americium AML.......................................................................................................... Area Medical Laboratory ANSI .................................................................................... American National Standards Institute ARS ........................................................................................................ Acute Radiation Syndrome ASPR................................................................ Assistant Secretary for Preparedness and Response B ......................................................................................................................................Blast Injury BARDA............................................ Biomedical Advanced Research and Development Authority C ........................................................................................................................................Cutaneous CBRN....................................................................Chemical, Biological, Radiological and Nuclear CDC ...................................................... United States Centers for Disease Control and Prevention CDG ...................................................................................................... Clinical Decision Guidance CHP .......................................................................................................... Certified Health Physicist Ci ...............................................................................................................................................Curie CM ......................................................................................................... Consequence Management CONOPS ....................................................................................................... Concept of Operations COTS ........................................................................................................ Commercial off-the-shelf CRN ........................................................................................ Chemical, Radiological and Nuclear Cs .......................................................................................................................................... Cesium D........................................................................................................................................... Delayed DEARE .................................................................... Delayed Effects of Acute Radiation Exposure DMRTI..................................................................... Defense Medical Readiness Training Institute DOD ............................................................................................................. Department of Defense DOE ............................................................................................................... Department of Energy DSCA ..................................................................................... Defense Support of Civil Authorities DTRA......................................................................................... Defense Threat Reduction Agency DU ........................................................................................................................ Depleted Uranium S2 E ............................................................................................................................................... Event E .........................................................................................................................................Expectant EM............................................................................................................. Emergency Management EMEDS .......................................................................................... Expeditionary Medical Systems Eq ..................................................................................................................................... Equivalent FDA.................................................................................................. Food and Drug Administration FM ................................................................................................................................ Field Manual G............................................................................................................................... Gastrointestinal GI ............................................................................................................................. Gastrointestinal Gy...................................................................................................................................... Gray Unit H................................................................................................................................. Hematopoietic HHS....................................................................................................... Health and Human Services HIV ............................................................................................... Human Immunodeficiency Virus HLS .....................................................................................................................Homeland Security I ........................................................................................................................................ Immediate IACUC ..................................................................... Institutional Animal Care and Use Committee IAEA ...................................................................................... International Atomic Energy Agency IRT ......................................................................................................... Independent Review Team JCB.............................................................................................................. Joint Capabilities Board JP .............................................................................................................................Joint Publication JTF-CS ............................................................................................. Joint Task Force-Civil Support KI ........................................................................................................................... Potassium Iodide M .......................................................................................................................................... Minimal mCi.....................................................................................................................................Millicurie MCMs ......................................................................................................Medical Countermeasures METREPOL ....................................Medical Treatment Protocols for Radiation Accident Victims MFM ...................................................................................................... Mass Fatality Management MORTT........................................................................ Model of Resource and Time-Based Triage mSv ................................................................................................................................. Millisievert N................................................................................................................................. Neurovascular S3 NATO ....................................................................................... North Atlantic Treaty Organization NCI............................................................................................................ National Cancer Institute NCRP ............................................... National Council on Radiation Protection and Measurements NGDS ..................................................................................... Next Generation Diagnostics System NIAID ........................................................... National Institute of Allergy and Infectious Diseases NIH ...................................................................................................... National Institutes of Health NRC .............................................................................................. Nuclear Regulatory Commission NRRPT.................................................... National Registry of Radiation Protection Technologists OCONUS .............................................................................. Outside the Continental United States Po ....................................................................................................................................... Polonium R ................................................................................................................................ Radiation Dose RBCs ....................................................................................................................... Red Blood Cells RBE .............................................................................................. Relative Biological Effectiveness RC .......................................................................................................................Response Category RC1 ...................................................................................................... Response Category 1 – Mild RC2 .............................................................................................. Response Category 2 – Moderate RC3 ...................................................................................................Response Category 3 – Severe RC4 .......................................................................................... Response Category 4 – Very Severe RDD ..................................................................................................Radiological Dispersal Device REMM ........................................................................ Radiation Emergency Medical Management RTD............................................................................................................................Return to Duty SME ............................................................................................................... Subject Matter Expert T ................................................................................................................................ Thermal Injury TBq ............................................................................................................................. Terabecquerel TRA........................................................................................... Technology Readiness Assessment TRL ..................................................................................................... Technology Readiness Level U.S. .............................................................................................................................. United States USANCA ................... U.S. Army Nuclear and Combating Weapons of Mass Destruction Agency S4 DEFINITIONS CONDUCT INITIAL SCREENING TRIAGE - The purpose of screening triage is simply to separate personnel with clinically significant exposures that need immediate treatment from those who do not. Screening triage needs to be rapid, possess a low minimum exposure detection capability, have a high sensitivity, and be a go/no-go process. CONDUCT TREATMENT-TRIAGE - The purpose of treatment-triage is to prioritize patient treatment so that resources (including evacuation assets) can be effectively utilized for treating personnel who have entered the medical treatment system. DETERMINE TREATMENT - Treatment is based on: the total injury (radiation and nonradiation) sustained by the patient; the tactical situation; and the availability of resources. Radiological diagnostics inform treatment decision-making. GUIDE ONGOING TREATMENT - Radiological diagnostics provide information concerning treatment effectiveness and the need to alter or cease treatment. GRAY EQUIVALENT - The sum of all equivalent dose components from neutrons, secondary gamma rays, weapon gamma rays, and delayed gamma rays. ROLE 1 MEDICAL TREATMENT – The first medical care military personnel receive is provided at Role 1 (also referred to as unit-level medical care). It includes immediate lifesaving measures. Major emphasis is placed on those measures necessary for the patient to return to duty (RTD) or to stabilize the patient and allow for evacuation to the next role of care. This role includes treatment provided by combat medics, self-aid and buddy aid, combat lifesavers, medical personnel (JP 4-02, 26 July 2012, III-1, 2, and 3). ROLE 2 MEDICAL TREATMENT – Role 2 provides advanced trauma management and emergency medical treatment including continuation of resuscitation started in Role 1. Role 2 provides a greater capability to resuscitate trauma patients than is available at Role 1. If necessary, additional emergency measures are instituted, but they do not go beyond the measures dictated by immediate necessities. Role 2 care has the capability to provide packed red blood cells (liquid), limited x-ray, laboratory, dental support, combat and operational stress control, preventive medicine, and Role 2 veterinary medical and resuscitative surgical support. Role 2 has a limited hold capability (i.e., no bed capacity). Role 2 aid stations are highly mobile and designed to support land maneuver formations. (JP 4-02, 26 July 2012, III-1, 2, and 3). ROLE 3 MEDICAL TREATMENT – In Role 3, the patient is treated in a medical treatment facility (field hospital) that is staffed and equipped to provide care to all categories of patients, to include resuscitation, initial wound surgery, and post-operative treatment. This S5 role includes provisions for providing care for all categories of patients (JP 4-02, 26 July 2012, III-1, 2, and 3). ROLE 4 MEDICAL TREATMENT – Role 4 medical care is found in U.S. base hospitals and robust overseas facilities with the ability to provide advanced definitive care (JP 4-02, 26 July 2012, III-1, 2, and 3). STOCHASTIC HEALTH EFFECTS – An effect whose probability of occurrence is dose dependent, but the severity of the effect is independent of dose. A stochastic effect is not considered to have a threshold dose, i.e. a dose below which the effect does not occur. S6 RADIOLOGICAL SCENARIO INFORMATION Scenario 1 – 100kT Detonation in a Rear Area Supporting Combat Operations Scenario 1 is a 100 kT nuclear air detonation, with 278 meters height of burst that has occurred over a major U.S. logistics node located in a major Outside the Continental United States (OCONUS) medium-sized urban port city where U.S. and Coalition Forces are conducting combat operations. The incident affects 45,000 Coalition Forces, 33,402 of whom are U.S. personnel. The host nation may request support, but at this point has not asked for assistance. Table S1 is a summary of the casualty types resulting from a scenario. The scenario assumes that one battalion aid station, one area support medical company, and the fleet hospital are functioning in the aftermath of the detonation. The insult category lists the type of injury where (T) is thermal injury; (B) is blast injury; and, (R) is radiation dose. The insult category numbers represent the degree of injury for thermal and blast; and the radiation dose in Gy for radiation. It should be noted that in combat medical planning, the casualty focus is on "operational casualties" (e.g. a soldier in the middle of combat whose performance capability drops below 25%) (AMedP 8(A), 2002). The performance degradation caused by burns is due primarily to pain. While a service member with a serious burn injury will require treatment, they are not considered an “operational casualty” unless the pain reduces their operational effectiveness below 25%. The resulting performance algorithm involving burns may lead to the non-intuitive appearance of non-casualties in Table S1. The table makes it clear that combined injuries (radiation plus conventional) will represent the majority of the patient population. Figure S1 shows the results of the NBC CREST modeling for the disposition of casualties over a 48 hour period. The first observation is the importance of Role 1 screening and having the ability to make accurate RDT decisions. Over half of the soldiers arriving at Role 1 can be RTD if Role 1 medical personnel have rapid and accurate methods to estimate dose. The RTD decision is also important at Role 2 as it reduces the patient load and increases the forces that are able to continue mission requirements. The final observation is that almost all of the patients that are not RTD at Role 1 eventually will be evacuated to a Role 4 facility. S7 Table S1. Summary of Casualties from the NBC CREST Modeling for a 100 kT Air Burst. Figure S2. Patient flow estimated for Scenario 1 – 100 kT Air Burst Targeting a Rear Area. Figure accounts for the first two days following the nuclear detonation incident. The 100 kT air burst in the rear area of an active combat theater provides a plausible worst-case scenario that was used to identify the types of patients, and a worst-case estimate of numbers of S8 patients that each military Role of Care1 would see. The drawback to this scenario is that each Role of Care will be overwhelmed. If only this maximum scenario were used, the diagnostic would be required to meet patient loads that no other part of the medical care system can meet. The second drawback to using the single scenario is the lack of trade-space that could be used to develop an optimal solution. The third drawback is the relative unimportance of internal contamination in this scenario. There are no reasonable scenarios where a Role 1 – Role 3 facility would be concerned with the internal contamination from fallout. Scenario 2 was developed to overcome these shortcomings. Scenario 2 – Dispersive Radiological Dispersal Device This scenario depicts a radiological dispersal in the form of radiological isotopes (Cs-137 and Am-241) mixed into the soda dispenser at the dining facility. The key events and timelines of this scenario are loosely modeled on the outcomes of the 1987 Cs-137 dispersal that occurred in Goiânia, Brazil (International Atomic Energy Agency [IAEA], 1988). The Goiânia incident is important because: 1. It showed that it is possible for a person to survive long enough to disperse a large quantity of Cs-137. At the time of the incident, there was 50 TBq (1,300 Ci) of Cs-137 in the capsule that was the source of the event. 2. There was a significant time lapse (approximately 16–19 days) between the event and the discovery of the event. During this time several people began exhibiting signs of radiation sickness and were misdiagnosed. 3. The event generated a significant number of personnel who were not exposed but reported to medical facilities to be screened. Scenario 2 Sequence of Events The setting for Scenario 2 is the same as for Scenario 1, the rear area in an established combat theater. Intelligence indicates that there is a high probability of the enemy use of an RDD. In response to the threat, a portion of the Air Force Radiation Assessment Team (AFRAT) was deployed to the theater with the equipment needed to respond to an RDD event. At the time of the event the AFRAT was operational. The scenario is initiated when a local national working in a dining facility was recruited to spike one of eight bags of soda with a mixture of 10 Ci of Cs-137 and 10 mCi of Am-241. The spiked soda was delivered to an active dining facility and placed into service. Approximately 68 hours after placing the contaminated bag into service, the local national was told to report to the 1 Refer to the supporting information for definitions of military roles of care adapted from JP 4-02, 26 July 2012, III-1, 2, and 3. S9 medical facility when he became ill and began vomiting. Facility management feared food poisoning and wanted a medical determination to allow appropriate actions to be taken. As a precaution, the dining facility was closed and patrons were re-routed to another facility. Event (E)+68 hrs. Medical personnel became suspicious when they noticed what appeared to be second degree burns on the hands of the local national. Fearing radiation exposure, medical personnel requested the assistance of the AFRAT. The AFRAT personnel rapidly determined the patient was contaminated with Cs-137 and an as-of-yet unidentified alpha emitter. E+78 hrs. The AFRAT re-deployed to the dining facility and found significant contamination in the dining area. A survey of the area led the team to the empty soda bag. Very high levels of contamination were found on the bag. The AFRAT took a sample of the remaining liquid for isotopic identification and initiated actions to identify personnel who used the facility and initiated procedures to survey facility patrons. Medical personnel began screening patients in the hospital and found five patients with very high radiation readings. The patients were admitted with flu-like symptoms. E+ 90 hrs. Multiple screening stations were established and priority was given to personnel who frequented the dining facility. Scenario 2 Dose Modeling The personnel exposure used in the modeling effort is shown in Figure S3. The figure shows the total number of people that drank soda from the eight bags purchased from the local national. A total of 192 persons drank soda from the contaminated bag and a total of 1,344 persons drank from the seven remaining uncontaminated bags. The NBC CREST scenario assumes the Cs-137 was in a soluble form and was distributed uniformly in the soda. The Am-241 was assumed to be in a relatively insoluble form and would tend to settle with time. Soda from this style of bag is dispensed from the bottom of the bag which means the intake of Am-241 would be non-uniform. As shown in Figure 4, the settling of Am-241 resulted in a non-uniform distribution of Am-241 in which only the first 17 cups of soda contained Am-241. The intakes and the estimated doses from Cs-137 are shown in Table S2. The first variable considered is the amount of ice in the cup. The second was the number of cups consumed. The table provides two doses; the first is the RBE-weighted dose to the bone marrow for a 30-day period after the intake of Cs-137. NCRP 161, 2011, uses the 30-day dose to provide an estimate of the deterministic effects. The second dose (gray-equivalent dose with the hematopoietic syndrome as the endpoint) gray-equivalent was estimated by DTRA, and takes into account the impact of dose rate on the total dose needed to cause a health endpoint. The same dose delivered at a lower dose rate will have less of an impact. S10 The intakes of Am-241 and the resulting gastrointestinal (GI) doses, as a function of cups dispensed, are shown in Figure 5. The Am-241 was assumed to decrease as an exponential function of cups taken. The GI doses were estimated by DTRA and are in units of Gy-Eq for GI syndrome. The combined GI dose from the Cs-137 and the Am-241 is shown in Table S3. The Am-241 dose is the dose resulting from the ingestion of each cup dispensed. The maximum and minimum possible Cs-137 doses are provided to yield a maximum and a minimum GI dose for each of the Am-241 intakes listed in the table. The model indicated 13 fatalities and 124 symptomatic patients are likely in the RDD event along with 1399 individuals with negligible effects. Two conclusions can be drawn from the preceding analysis: 1. The potential is high that a few of the 192 personnel ingesting the mixture will have sufficient bone marrow damage and GI damage to have both hematopoietic and GI syndromes. 2. All of the 192 will need to be tested to determine the levels of Cs-137 and Am241 that are in each person, so that effective prioritized treatment can be initiated. This treatment will be based upon the uptake of Am-241 and Cs-137. The 100 kT scenario highlighted the importance of the return to joint service duty decisions at each of the roles of care but especially at Roles 1 and 2. Well over half of the casualties (17,593 out of 27,344) were returned to duty at Roles 1 and 2. This is significant because the dose thresholds for return to duty are low (75 cGy and 125 cGy) for exposure only and very low for personnel with injuries. Personnel with injuries and any radiation exposure are evacuated out of theater. A dispersive RDD overcomes the shortcomings of the 100 kT air burst. An explosive RDD is routinely used for homeland security planning purposes. Use of the explosive RDD will significantly reduce the number of patients seen at each of the Roles of care; however, the level of internal contamination is relatively unimportant for an explosive RDD. Primary medical concerns—especially at Role 3—are injuries and external exposure. The use of a dispersive RDD, where radioactive material is purposefully introduced into food or water, heightens the importance of internal contamination to the point where it is the primary concern while maintaining the importance of diagnostics for acute radiation injury if a high-energy gamma emitter such as Cs-137 is the source. The RDD scenario used showed that, unlike explosive RDDs, dispersive RDD scenarios can result in sufficient internalization to generate ARS. The primary unknown at this point is whether the Am-241 intake would result in GI syndrome. The modeling used by DTRA resulted in GI tract doses sufficient to cause GI syndrome. The IAEA assumes the RBE for alpha S11 emitters in the GI tract is “0” because it is unlikely that the alpha particles emitted by the Am241 in the lumen of the GI tract primary will irradiate the sensitive portions of the GI tract. The purpose of developing CONOPS for the radiological diagnostics is to ultimately establish operational scope, context, and conditions for the candidate technologies and explore “if and how” the candidate diagnostic tools can be integrated into the current DOD radiological medical CONOPS in support of military operations. Table S2. Estimated range of bone marrow doses – 30d and Gray-Equivalent #Cups Ice Intake (mCi) Bone Marrow Dose From Cs-137 30d Dose (Gy) 1 1/2 Ice 26 2.86 Gray Equivalent (Gy-Eq) 1.7 2 1/2 Ice 52 5.72 3.3 1 Very Little Ice 52 5.72 3.3 2 Very Little Ice 104 11.4 6.6 Figure S3 Distribution of radioactive material in the soda bags 1 bag contaminated with Cs-137 and Am-241 192 people injest radioactive soda 8 soda bags purchased 7 bags unaffected 1,344 people think they could have ingested radioactive soda S12 1,536 people present to medical treatment facility Table S3. Estimated GI Dose from Am-241 and Cs-137 Based on NBC CREST Scenario 2 Model Am-241 Cs-137 Total GI Dose Intake (mCi) GI Dose (Gy-Eq) Min Dose to a Person Max Dose to a Person Max GI Dose (Gy-Eq) 6.6 Min GI Dose (Gy-Eq) 30 5 28 1.7 2.5 14 1.7 6.6 16 21 1.25 0.63 7 1.7 6.6 8.7 14 3.5 1.7 6.6 5.2 10 0.31 1.7 1.7 6.6 3.4 8.3 0.16 0.9 1.7 6.6 2.6 7.5 0.078 0.43 1.7 6.6 2.1 7.0 0.039 0.22 1.7 6.6 1.9 6.8 0.020 0.11 1.7 6.6 1.8 6.7 0.010 0.06 1.7 6.6 1.8 6.7 0.005 0.03 1.7 6.6 1.7 6.6 0.002 0.01 1.7 6.6 1.7 6.6 0.001 <0.01 1.7 6.6 1.7 6.6 35 The two scenarios were used to estimate the throughput requirements for the radiation injury treatment diagnostic and the diagnostic to determine treatment to reduce the level of an internalized radionuclide. Estimated throughput requirements for radiation injury diagnostics were determined using both Scenario 1 and Scenario 2, as shown in Table S4. Scenario 1 provided the high-volume throughput and Scenario 2 will provideprovided an estimate of the threshold throughput requirements. Scenario 2 was also used to estimate the throughput requirements for diagnostics that will determine the amount of a radionuclide in a patient. Table S4. Patient throughput requirements for Scenario 1 and Scenario 2 Role Scenario 1: 100 kT Detonation Intake (# of Patients) Patients/h Role 1 27344 Role 2 Role 3 2 2 Scenario 2: Dispersive RDD Intake (# of Patients) Patients/h 570 1536 32 10577 220 192 4 9745 203 192 4 Based on 48 hour timeframe. S13 DIAGNOSTIC CRITERIA TABLES Table S5. Screening triage parameters for external exposure Parameter Value Rationale Dose 0.5 Gy; 0.75 Gy, 1.5 Gy, 2 Gy, and ~10 Gy Uninjured Dose ~1 Gy - Combined Injury (Swartz et al., 2010) The first dose (0.5 Gy) is used as the demarcation between exposed and unexposed personnel. 3 The second (0.75 Gy) is used for an RTD decision at Role 1. The next two doses (1.5 Gy, 2 Gy) are used by the DOD and BARDA respectively, to determine those requiring treatment based on radiation exposure only. The last dose (10 Gy) is for triage into the expectant category. This is the dose quoted by Swartz et al., 2010 as the dose that will change outcomes for some combined injuries. Results Obtained Seconds to minutes per patient Results need to be obtained onsite under austere environmental conditions without need to go to a laboratory or conduct long analysis False Positive Moderate Degree (Swartz et al., 2010) The second screening will be able to find the false positives. False Negatives Avoid (Swartz et al., 2010) A false negative results in a patient who needs treatment not being reevaluated. Accuracy and Precision From ±0.25 Gy to ±0.5 Gy This is based on the dose interval between key screening-triage doses. Throughput Screening Triage Optimal: 500 patients/h Threshold: 30 patients/h Time period signal is present Signal is present and usable for at least 12–24 hours after the exposure Time before signal is present Immediately to minutes after exposure Training Required Supplies 3 Minimal The Role 1 values are used for the optimal value. A technology that is adequate for screening at Role 1 will be adequate for the remaining roles. Role 1 is a rapid screening phase where RTD decisions are made quickly. Some patients will be rapidly transported to Role 1 facilities and will need to be rapidly screened. Training at Role 1 is basic life-saving. None to very limited These doses were selected based on deterministic effects being the end-points of interest. S14 Table S6. Screening-Triage parameters for internal exposure Parameter Value Rationale Dose 1 CDG Dose 1/5th CDG This is the value used for pregnant women and children weighing less than 70 pounds. Results Obtained Within 1 hour per patient Needs to be done onsite without the need to go to a laboratory or conduct long analysis. False Positive Moderate Degree The second screening will be able to find the false positives – sensitivity >90%. Avoid A false negative results in a patient who needs treatment not being reevaluated. False Negatives Throughput Time period signal is present Time before signal is present Training Required Supplies This is the value currently being used by the NCRP for adults. Currently, the DOD does not have a value specified in doctrine. Threshold – 4 samples per hour Optimal 32 samples per hour Signal is present and usable for at-least 1224 hours after the exposure These values are taken from the results of Scenario 2. Immediately to minutes after exposure Role 1 is a rapid screening phase where RTD decisions are made quickly. Minimal None to very limited Role 1 is a rapid screening phase where RTD decisions are made quickly. Training at Role 1 is basic life-saving. Minimize support burden S15 Table S7. Summary of technical criteria for dose-based radiological diagnostics used for treatment-triage and treatment medical decisions Parameter Dose Range Dose Accuracy Value Rationale 0.5 Gy to 10 Gy Exposures less than 0.5 Gy require no immediate medical treatment. Doses in excess of 10 Gy are considered expectant (FM 4-02.283, 2001; AFRRI, 2010; Coleman et al., 2011) If the device is less accurate than the threshold, it will not be useful for estimating lowest doses in the dose range. The optimal dose accuracy is based on the analysis in Swartz et al., 2010. The 24 hour mark is key for cytokine treatment and determining when surgery should be performed (AFRRI, 2010; Coleman et al., 2011) Once the correct treatment category is assigned and the initial treatment (treatment required in 24–48 hrs) is completed, the time constraints are days to weeks. Doses or follow-on diagnostics obtained during treatment will be able to find the false positives. Threshold: ±0.25 Gy Optimal: ±0.05 Gy Results Obtained Treatment-Triage 1 to <24h Results Obtained Treatment Hours to Days False positive/negative treatment-triage False Positive/Negative Treatment Minimum Detection Dose Moderate degree Throughput Treatment-Triage, Treatment Time Period Signal is Present Treatment-Triage Threshold – 4 patients/hour Optimal 200 Patients/hour Signal is present and usable within hours and persists for days Time Period Signal is Present Treatment Signal is present and usable within hours and persists for weeks Training Treatment-Triage and Treatment Required Supplies Advanced training is possible Avoid This should not be an issue at this point in the process because of the data accumulated to date. 0.5 Gy Treatment-triage detection thresholds need to be able to distinguish non-exposed from those exposed to at least 0.5 Gy. The threshold value was based on Roles 2 and 3 for Scenario 2. The optimal value was based on Roles 2 and 3 for Scenario 1. Similar to current hospitals Initial treatment needs to occur within 24 hours, surgery needs to be performed within 24–48 hours after the exposures. Treatment is a long-term process that will continue for weeks to months depending on the dose. Treatment-triage and treatment will take place at hospitals and experts can be used for the analysis. Ideally, the diagnostic will use equipment and reagents that are already in use in most hospitals. S16 Table S8. Summary of Technical Criteria for Organ-Injury-Based Diagnostics Used for Treatment-Triage and Treatment Medical Decisions Parameter ARS RC, degree ARS RC accuracy treatment triage and treatment Value Rationale 1 – 4 RC Technology must be able to place the patient in all four of the RCs for the targeted organ system. These values inform the need for immediate and delayed treatment. ±1/3rd RC degree ARS RC degree range was selected using the rationale that the variation in response to the same dose would render more precise estimates clinically irrelevant. Results obtained treatment triage <1 to <24 h Results obtained treatment Hours to days False positive/negative treatment-triage Moderate degree The 24 hour mark is important for cytokine treatment and determining when surgery should be performed. Once the correct treatment category is assigned and the initial treatment (treatment required within 24–48 hrs) is completed, the time constraints are days to weeks. ARS risk diagnostics obtained during treatment will be able to find the false positives. False positive/negative treatment Minimum detection level Avoid This should not be an issue at this point in the process because of the data accumulated to date. RC 0 The system must be able to identify personnel who do not need any form of medical attention and can be returned to duty. Throughput treatment-triage and treatment Time period signal is present treatment-triage Threshold – 4 patients/h Optimal 200 Patients/h Signal is present and usable within hours and persists for days The threshold value was based on Roles 2 and 3 for Scenario 2. The optimal value was based on Roles 2 and 3 for Scenario 1. Time period signal is present treatment Signal is present and usable within hours and persists for weeks Treatment is a long-term process that will continue for weeks to months depending on the ARS risk. Training treatmenttriage and treatment Required Supplies Advanced training is possible Similar to current hospitals Treatment-triage and treatment will take place at hospitals and experts can be used for the analysis. Ideally, the diagnostic will use equipment and reagents that are already in use in most hospitals, many of which contribute to the assessment of radiation exposure. Initial treatment-triage needs to occur within 24 to 48 hours after the exposure. S17
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