Comments

New England Donor Services - CTOP and MAOB | 10/02/2019

NEDS supports the Ops and Safety Committee’s project to collect additional data related to transportation and logistics to assess the impact of broader organ distribution on ischemic times, unnecessary loss of organs, delays in transplant, recipient outcomes and organ donation processes. Travel modes and timing of travel for each step from organ recovery to transplantation will be essential elements of this assessment. Organ allocation times and organ donation case durations should also be evaluated. Broader distribution of hearts and lungs has resulted in longer cases times in the NEDS service areas. Because extended times can have an impact on OPO relationships with donor hospitals, donor families and increase the staffing needs of OPOs, this should be monitored. Organ evaluation time should also be assessed and benchmarked.Transplant Programs should minimize any communication barriers that delay organ allocation and often result in unnecessary late declines (such as offers not being reviewed by the medical decision-maker). To better understand CIT when an organ arrives at the transplant center, data collection should be required. Standardized “check-in” procedures by transplant programs could be helpful in obtaining this data. OPOs are required to use Transnet but it is optional for transplant programs. This might be something to consider as well.

OneLegacy | 10/02/2019

• What data elements would be helpful to assess the logistical impact of broader distribution? o We feel the proposal has addressed the key elements. • What challenges would additional data collection present? o More time spent on data collection retrospectively from the donation/transplant event, may prove problematic for centers. • What (if any) data elements should be included? o They have been addressed in the proposal. • Is the Deceased Donor Registration (DDR) form the correct data source to use? o We feel the new data elements should be added to the DDR. • Do OPOs have the necessary information to report this data? o The OPO’s can report the transportation modality and who recovered the organ. The time from donor OR to Transplant center should be exclusively monitored by requiring transplant centers to report in the TransNet system.

Anonymous | 10/02/2019

There was a comment that it will be necessary to collect the proposed data with broader distribution. It was also noted that some areas in upstate New York already fly for approximately 80% of their organs, which shows that travel practices vary by geographic area. Members also noted that Region 9 is unique because many transplant programs in the downstate area coordinate their own travel and do not rely on OPOs. However, regional sharing agreements in Region 9 have allowed OPOs and transplant programs to work together, when necessary, on travel and logistical issues. A member also commented that a recent paper concluded that organs procured by the primary transplant surgeon tend to perform better than organs procured by a local surgeon. The member suggested that this be further monitored.

Carolina Donor Services | 10/02/2019

Carolina Donor Services supports the concept of data collection to evaluate the impact of wider organ distribution. An OPTN priority should be to develop mechanisms to capture the relevant data points that currently are collected in systems such as DonorNet and TransNet and not add such fields to the DDR for OPO manual completion. Alternatively, if data collection for this purpose is not automated through TransNet, the accepting center should be responsible for reporting data concerning when the organ was checked in to the recipient hospital. To place this data-reporting requirement on OPOs by tracking down the information from transplant centers would be burdensome, inefficient, and unnecessary.

American Society of Transplant Surgeons | 10/02/2019

The American Society of Transplant Surgeons (ASTS) recognizes the need to decisively address the increasing challenges in the logistics of organ transportation. The OPTN Operations and Safety Committee has developed guidance documents to provide suggestions for best practices in organ transportation. The development of these documented highlighted the lack of national data on organ transportation. The submitted proposal is designed to prospectively collect data on the mode of transportation (air/ground), the provider of this transportation, and the time from pick up to arrival at the transplant program. These data will be collected through the DDR form by the recovering OPO. The ASTS supports the effort to increase knowledge of transportation issues and the use of the DDR to rigorously collect the data. The preliminary proposal includes basic data that should be readily available at the time of the organ placement. However, there are other elements that will not be captured using this data that are important in assessing the impact of changing allocation on organ placement. 1. The Committee should consider adding a field for organ discard due to transportation issues. This would capture organs that were discarded due to prolong cold ischemic time resulting from the lack of commercial aircraft or issues with charter services. 2. Was an organ discarded due to damage from a transportation related issue? 3. Was the organ reallocated after initial acceptance due to a transportation issue (prolonged delay resulting in primary center refusing the organ)? 4. For renal allografts in particular, it would be useful to know if the organ was placed on the pump: A) never, B) transported to accepting center on pump, C) initially on pump and then changed to cold storage, or D) placed on cold storage and then perfused at accepting OPO? 5. Can OPOs document delays due to pilot in-service time issues (e.g. timing out at the recovery center)? Specifically, was crossclamp delayed? 6. Can OPOs document which organs are recovered at organ recovery centers and which are recovered at the donor hospital? The ASTS appreciates the opportunity to comment. We also caution the committee that issues including cost and safety of organ recovery teams must also be addressed in addition to efficiency and accessibility in considering the logistical issues in organ transportation. While capturing cost data directly may be difficult, it should be possible to work with subject matter experts to develop a mean cost per mile transported for air and ground which can be applied to the collected data to determine an estimated cost.

Anonymous | 10/02/2019

The OPTN Transplant Coordinators Committee heard a presentation on the Operations and Safety Committee’s request for feedback during a meeting on September 9, 2019. Members shared two strategies that have been used successfully: • The use of local recovery teams more frequently • Training OPO staff to perform donor nephrectomies The Committee shared that the increase frequency of traveling procurement teams adds complexity to scheduling and coordinating procurement procedures. Real world experience has seen an increase in operating room delays as a result. The Committee suggested the following: • Transplant programs would benefit from analysis of their OPTN Standard Transplant Analysis and Research (STAR) file data in order to see if the respective transplant programs acceptance practices (including ischemic time limits) are helping achieve desired recipient and graft survival outcomes. • OPTN gather and analyze the impact of organ preservation pumps on organ acceptance practices and outcomes • Careful examination of actual organ departure and check-in times, to include an “out of ice” time for organs. • Carefully consider the impact of expedited procurements in the setting of donor decompensation, and that organ allocation may not start until after procurement. At the conclusion of the discussion, the Committee members shared their support for this initiative, that Deceased Donor Registration (DDR) forms may be the most intuitive, but not the only mechanism, to collect this important data. TransNetSM may be another OPTN-based source for data. For transplant program-related data, the Transplant Recipient Registration (TRR) form may be a useful approach for perioperative data on “out of ice” or “back table” times. The Committee appreciated the opportunity to provide feedback on this initiative.

Anonymous | 10/02/2019

The group liked that the Committee wants to track transport time vs. cold ischemic time. One member stated that this data collection will be important to the community as it will shed light on some missing information that is currently missing. As this moves into a proposal, there could be push back about cost and logistics; the focus needs to be on WHY we need to collect this information. Several members suggested additional data points: • Who is doing the transportation (OPO, courier, subcontractor, etc.) • Whether the organ is accompanied or not • Track who is doing the procurement: attending, training or non-surgeon as well as the name in order to link to outcomes; some of this could already be covered by the donor record • Track ‘near-miss’ situations • Could use the data to develop some kind of predicted or estimated travel time

Anonymous | 10/01/2019

Members discussed suggested data elements and data sources that should be used in this data collection effort. A member stated that there should be data points collected that influence the suggested data elements such as if any other local recovery was offered, and how far the organ would need to be transported to determine who received the offer. The member continued by suggesting that late declines and late allocations should be collected as it is a huge problem anyway and should be collected for broader distribution. Another member asked how decline would be measured? Decline would need to be clearly defined. A members stated that there would be an administrative burden as the data elements being suggested are not typically reported and OPOs would be entering new data elements. Members agreed that the DDR would be the most appropriate data source and that OPOs would be knowledgeable of the data elements being requested. Members agreed that transplant programs would need to collect data in regards to organ check-in. If OPOs were to document this, the transplant program would have to send this information to the OPOs. It was agreed that the TRR form would be the most appropriate data source for transplant programs to collect this information as this information is already being collected.

Anonymous | 10/01/2019

OPTN Operations and Safety Committee-Data Collection to Evaluate the Logistical Impact of Broader Distribution, Members of the region felt that potentially adding fields to the Deceased Donor Registration (DDR) form would be a heavy burden for OPOs to complete, and it may be difficult to garner the correct data. Instead of moving in the direction of a permanent data collection proposal, the committee should look at collecting the proposed data for a short time period, say six months. After the trial period, an assessment can be done to see if the collected data proved useful in evaluating the logistical impacts of broader distribution

American Society of Transplantation | 09/30/2019

The American Society of Transplantation is supportive of this proposal in concept, recognizing that the change to broader organ distribution will have significant impacts on organ procurement and transportation. The Society offers the following comments from our constituents for the Operation and Safety Committee’s consideration: General comments: • The impact of broader distribution of organs may result in cost increases due to increasing time spent for procurement, greater frequency of “dry runs”, and increased use of advanced technology for organ preservation. While we agree that it will be challenging to capture all costs, collection of this data is important, and we encourage the OPTN Operations and Safety Committee’s ongoing efforts to develop a methodology for cost assessment. • Potential impacts provide strong justification for the capture of cost information. These impacts include: o Viability of transplant programs. This impact may be greater for smaller centers and centers in areas of lower population density. o The loss of programs may impose additional travel burdens on patients requiring transplant evaluation and care. o Potential disproportionately higher burdens may be borne by programs with unfavorable payor mixes. Transportation-related items: • If the organ was flown, ease and time to hiring aircrafts (aircraft and pilot availability), type of chartered aircraft, number of pilots, and other measures of air travel safety • On the “drive” dropdown within transportation modes, OPO Staff Vehicle and Hospital Staff Vehicle are confusing. If these are intended to include vehicles owned by the OPO or hospital, staff should be removed. If they are intended to describe staff using their own private vehicles, separate options should be added for OPO- or hospital-owned vehicles. • All modes of transportation that were considered (air, land, both) and rationale for selection and if a second choice was made. • Were multiple organs transported by the same transport service (same flight or vehicle)? Preservation: • Collection of mode of preservation i.e. cold static vs pump vs other Recovery personnel: • Number of transplant surgeons involved in procurement and transplantation of organ, particularly those organs that are procured by the center itself. Did a procuring physician procure multiple organs for one program, or for multiple centers? • Procurement by local surgeon? Time of organ transport: • To fully assess the time impact of broader organ sharing, the “round trip” time needs to be assessed. The total time spent by the procuring team is an important component of the logistical impact of broader sharing. The time for coordination of multiple teams from multiple centers is likely to be affected. The total time should include the time for travel to and from the donor hospital as well as the time spent at the donor hospital prior to and including procurement. • Factors affecting delays such as: weather, traffic, team and OR coordination should be noted. • For time of transportation, using receipt in OR does not account well for organs preserved on pump or normothermic device outside the recipient hospital OR. Additionally, such time should probably be accounted (as it might be intentional delay, not a consequence of travel/allocation/logistics). We would suggest recording departure time from donor hospital, time placed on preserving perfusion device (if any), time of removal from perfusion device (if any), and time of entry into recipient hospital OR. This also doesn’t deal with organs that are delivered to one hospital and then redirected, though that may be infrequent enough to ignore. Data collection: • Placing the responsibility of reporting on the OPO will alleviate the burden from the recipient transplant center but will mandate clear communication regarding the timing of recipient operations, travel times, costs associated with transplantation, etc. • Consideration should be given to having the OPO collect the data elements leading up to arrival in recipient OR – that would better be added to the TRR form to be recorded by the recipient hospital: Time of arrival at the transplant center, and the actual OR time; Both to be reported by the receiving Transplant Center. (This would enable identifying the time the organ is stored at the center, which clinical data indicates is an option utilized for machine perfused organs.) • Better granularity in the decline codes should be offered to help understand why organs are discarded (did logistics and/or travel play a factor?). Pediatric considerations: • Broader sharing is predicted to result in increased transplant rates for pediatric DD candidates but the pediatric community is concerned that broader sharing may also lead to higher CIT and hence higher DGF rates which in turn may lead to higher rejection rates and lower GFR and shorter graft survival. Prior allocation policies under which children have been advantaged, have also resulted in poorer matching with negative downstream effects which are not captured in 1-year graft survival rates. These effects will be an unaccounted for “cost” that is neither measured by this proposal nor measured well by current OPTN policy. • For adult and pediatric recipients (of at least kidney transplants), the cost of dialysis required post-transplant due to DGF should be considered in the calculation of effects and costs of broader sharing. • Successful transplantation of children is accomplished by expedited transplant with well-matched, suitable kidneys which result in low DGF rates, low rejection rates and longer graft survival. The projected need for a functioning kidney in a child is longer than that required in many older adults. The Society’s pediatric constituencies support any policies that adequately address these aggregate concerns that jeopardize the safety and quality life-years of the most vulnerable transplant candidates.

Shanna Nimmons | 09/30/2019

Other potential questions are for the airlines (FAA) and courier companies, are they prepared to handle organs in an even more expedited manner when the ischemic times become even greater. Will there be an approach on how well a courier company that is used is maintaining accuracy for given ETA's. Factors such as the 2 hour lock out windows and off loading times from a commercial airplane could be useful data points as well..

Anonymous | 09/27/2019

• Concern that with additional data collection it will become more likely to blame bad outcomes for recovering surgeon, when there is nothing wrong with the liver. • Need cost data – either direct or surrogate o This is the an important data element related to broader distribution especially with small programs, so need to figure out how to capture it if possible • Reimbursement to procuring surgeons varies wildly – need to encourage people to go out and do procurements. Now, reimbursement only happens if organ is recovered, so it doesn’t incentivize local recovery, especially DCDs. • Many recoveries involve multiple modes of transportation. Pilot duty restrictions should be considered in the proposal.

James Sharrock | 09/26/2019

In some ways, the United States is defined by its variability, which makes it hard to implement national policies that are effective and efficient in all circumstances. This problem is intensified by the broad lack of knowledge and understanding within the transplant community of how such policies impact other programs and other parts of the country As policy changes are made, it is important to study the logistical impact of such changes in a methodical and systematic way. I strongly support studying the impact of broader distribution as an important tool in obtaining the best possible results of such policies .

Donor Alliance | 09/26/2019

The logistical impact of broader distribution is a concern to every OPO and transplant center. While gathering data surrounding transportation logistics could lend some sense of the expense broader distribution places on centers, we must make sure we are looking at the right data. There are many center specific practices around importing organs. We need to make sure the data captured is reflecting true logistical data. The Committee has asked for feedback on the following: Transportation mode and how, specifically, the organ was transported- this could be captured by the host OPO on the DDR if they are arranging these logistics. Often, the importing center arranges their own transportation and then the host OPO who is responsible for the DDR would not know that information. How should the two scenarios mesh? Who recovered the organ? This is currently on the DDR. Time (hours) of organ transport from donor hospital to recipient hospital: Again, this is variable. Is the host OPO arranging transportation and is the arrival at the recipient hospital really giving you the data you want? For instance, our OPO will often pick up a kidney from the airport, bring it to our center and place it on a pump, delivering that organ later to the recipient hospital. If we use arrival at the recipient hospital as the end of transportation, are we capturing the right data? Additionally, any data collected should be incorporated into existing documentation (DDR, OPO Report, etc,) to simplify the reporting process.

Anonymous | 09/26/2019

Suggestion that the committee compare estimated/intended travel time to actual travel time. There was a recommendation to use tracking devices to collect data. Some commented that there is data fatigue in the community and it is a unfunded mandate. OPOs commented that once the organ travels, it is no longer within the OPO and it may be hard for the host OPO to collect the data. There was concern that the more we travel, the more we are going to need to take into account procurement surgeon issues, pilot shortage and mover toward streamlining travel arrangements. Some members recommended identifying reasons for OR delays since OR time will become more important when flying versus driving organs. As kidneys travel further, pumping will be more important for utilization. There has to be something in place to improve efficiency. Many kidneys are discarded simply because they have too much ischemic time. There was a suggestion that OPOs and centers should split the cost of travel.

LifeShare Transplant Donor Services of Oklahoma | 09/26/2019

LifeShare (OKOP) strongly supports efforts to understand the logistical impact of broader distribution. In our opinion, too much broader allocation policy is being made based upon modelling that cannot identify all variables (ground time to airports form hospitals, flight delays, etc.) and efforts need to be made to better understand these issues to avoid organ wastage, to maximize utilization, and to ensure maximum benefit of the precious gifts our donors make.

Anonymous | 09/24/2019

Region 1 had the following comments: Suggestion that the committee compare estimated/intended travel time to actual travel time. There was a recommendation to use tracking devices to collect data.

Anonymous | 09/20/2019

Region 2 had the following comments: The region suggested the following data points to help evaluate the logistics of broader distribution: • Information on delaying donor cases to accommodate recipient OR time. • Pumping data. • Track kidney distribution time (some OPOs in Region 2 are already doing this). • Collect data on steps in allocation. For example, reallocation in the OR.

American Nephrology Nurses Association | 09/20/2019

American Nephrology Nurses Association supports that we need more data collection to measure logistics, the cost and type of travel, and the impact on the transplant center related to length of stay, delayed graft function, the number and timing of crossmatches performed, communication, and the increase in on-call hours for transplant coordinators.

Anonymous | 09/12/2019

The OPO Committee offers the following comments on the Operation and Safety Committee’s request for input to collect additional data to evaluate the logistical impact of broader distribution: One Committee member expressed support for collecting additional data on transportation in order to evaluate the impact of broader distribution. He noted that the data elements being proposed would not be a huge burden on OPOs. He also acknowledged that organ disposition times would present a challenge for OPOs to collect that information from the transplant hospitals. There was a brief discussion about transplant hospital use of TransNetsm to help collect information on organ check-in times. Since transplant hospitals are not currently required to use TransNet, there is inconsistent practices across organ types when it comes to checking in the organs. OPOs and transplant hospitals will have to work together to share information in order for this data to be collected.

Anonymous | 09/11/2019

The Pancreas Committee thanks the Operations and Safety Committee for its work developing this proposal and for the opportunity to provide feedback. Committee members agreed with the usefulness of the ultimate goal of this project, to collect both travel distance and travel time data when recovering organs. A member commented that it may be challenging to collect accurate travel data because of variation in travel mode and difficulties in centers or OPOs capturing the data in real time. Another member noted that travel time doesn’t necessarily account for time of day and whether teams operate in the middle of the night or wait until the next day. The Committee discussed the idea of a GPS tracker to collect the data and know where the organ is, and the presenter acknowledged this type of tracker may be a viable option to collect the data most effectively. Another Committee member noted a GPS tracker could add cost, but it would be particularly useful if such a system linked with a UNOS database. The Committee was also informed of a jointly sponsored ASTS and AOPO summit on safety and transportation – the Operations and Safety Committee should not duplicate efforts but make sure to be informed of the concurrent work which is progressing. A Committee member asked whether accurate data on recovery teams is currently available; the presenter clarified that only limited data is available and more reliable data is needed. The Committee members indicated 75% strongly support and 25% neutral sentiments for the proposal.

Anonymous | 09/04/2019

The OPO would not have all of the information to be able to report his data. Once an outside transplant center leaves the OR with their organ, we have no further communication with them as far as what time they arrive back at the transplant center.

Anonymous | 09/04/2019

OPTN Transplant Administrators Committee The Transplant Administrators Committee supports collecting valuable data on the logistics of broader distribution. The Committee expresses concern about the potential additional burden on the administrative staff at centers and OPOs in collecting this data, so creation of an efficient process is strongly encouraged.

Anonymous | 09/03/2019

Region 7 comments are as follows: Comments: Attendees requested the Committee consider the impact on families of deceased organ donors that may come from wider distribution of donor organs (extended donor management time or OR delays). Also, this initiative will help promote quality data reporting; this was very timely given the increased scrutiny of OPOs and OPO performance. Attendees also supported analyses of: • cost information • Cold ischemic time (CIT) • Who procured the organ [local surgeon or team from another transplant program] • Length of time to perform hepatectomy? • Consideration of what data should be collected now to allow more robust analyses for future allocation changes. • Transportation o Total cold time o Time to get the organ to the center (perhaps captured through TransNet) o Could be multiple modes – this detail doesn’t seem like it would be helpful • Need time of actual acceptance of the organ • Gamesmanship – do the same rules apply everywhere

OPTN TAC Member | 08/30/2019

Support

OPTN Region 4 | 08/30/2019

Feedback: • Factor in time wasted to coordinate flights and set up travel when there is a turn down in the OR • Need to talk about systems to facilitate local recovery teams instead of having recovery teams travel to the organ o Concerns about teams passing in the air o Barrier is trust when dealing with more areas and different people o May be appropriate to treat differently based on the individual case (candidate MELD, etc.) • Crossclamp time v. time scanned in to the hospital; Is it just travel time that matters, or also this time that is more in control of the hospital and more variable? • Need to focus on what the goal is for gathering the data – what is the hypothesis? o Question: will there be new challenges as a result of broader sharing (hypothesis/assumption=yes); What are the important pieces of data for giving national guidance on broader sharing o Use to help develop future allocation systems using better data on how much time it actually takes to move organs (it’s important to get it right) • It’s important to be accurate in discussions. Lung recruitment is important to changing the amount of time a case takes and has more of an impact than flying. Experiencing lots of waiting for thoracic teams to be set up and then have to leave immediately • Look at Share35 – o Are organs being transplanted into the intended recipients? o Is there an increase in coordination time, not just actual travel time o Who covers rates for outside teams who don’t end up keeping the organ because of a crashing patient (especially if the organ isn’t used) o Costs and billing • Members agreed that the DDR is the correct data source to use • Question about whether transplant centers know the mode of transportation used to ship the organ

OPTN TAC member | 08/30/2019

Support - with some concern of the data burden on transplant centers and additional regulatory impact if data not timely or accurate

OPTN TAC Member | 08/29/2019

Support

OPTN TAC Member | 08/29/2019

Support

UNOS TAC Committee | 08/29/2019

I believe that we need to collect additional data but we need to do it in a manner that places the least amount of burden on our transplant centers and our OPOs. Automating as much as possible will be key to the success. This is an area where the transplant administrator committee and the transplant coordinator committee should provide input. In general I support the idea to collect data to evaluate the logistical impact of broader distribution as long as it is done with as little impact to center/OPO staffing as possible.

Data Advisory Committee | 08/29/2019

The OPTN Data Advisory Committee (DAC) appreciates the opportunity to provide feedback on this public comment item. A DAC member noted that who procures each organ can change throughout the procurement process so the response to this particular data collection element may not be a simple answer. The DAC agreed that the suggested data collection elements should be added to the DDR, except for “organ check-in” which should be added to the TRR. A DAC member suggested that the data included in the proposal be collected prior to the removal of DSA and Region from allocation so that there can be a comparison between the different allocation systems. The DAC also suggested that the Operations and Safety Committee carefully consider the granularity of the expected responses. For example, a DAC member noted that most cases involve the use of a car even if an airplane was the primary method of transportation, and suggested that the Operations and Safety Committee consider if the use of a car in these instances should be recorded. Another DAC member noted that it would be a burden for OPOs to enter the date/time that each organ is checked-in to the transplant center and suggested that this data be entered by the transplant center instead. Another DAC member commented that the Operations and Safety Committee should consider collecting different data for each organ. The DAC also noted that the use of perfusion should be taken into account when adding the proposed data fields. The DAC also suggested creating a pilot program to evaluate the magnitude of any increased burden caused additional data entry. The DAC looks forward to future collaboration on this project with the Operations and Safety Committee.

OPTN Liver and Intestinal Organ Committee | 08/29/2019

The Liver Committee requested more information on how transportation time will be calculated. The Liver Committee also discussed whether the data collection would be necessary on an ongoing basis, or only for a short period of time. Collecting the information for a short period of time would be less of a burden on members.

OPTN TAC Member | 08/29/2019

Support this proposal.

OPTN TAC Member | 08/29/2019

Support

UNOS TAC member | 08/29/2019

Strongly support as this data is very valuable in assessing the impact on broader distribution.

Transplant Administrative Committee Member | 08/28/2019

If the opo is able to report this as part of the DDR that would be the most efficient route. Asking transplant programs to report this retrospectively will be difficult as the staff that handle the travel logistics are often different than those that submit TRR forms. If it does need to go to the transplant program, could you consider including it as part of the waitlist removal process for transplant?

Anonymous | 08/28/2019

The proposed data to be collected would be helpful for future benchmarking

Anonymous | 08/28/2019

Do not support

Rebecca Pirozzi | 08/28/2019

Since the new allocation system for heart transplant started we double chart the same information in the risk stratification and tiedi within days of someone being listed. It would be helpful to choose a box that says last data imputed is the most current. Otherwise the system don’t let you move on. Very time consuming!

LifeGift | 08/22/2019

LifeGift supports this work of the Ops & Safety Committee to develop a better understanding of what is actually happening with logistics of organ transportation and preservation. It is important to collect this information to develop evidence for various phases of the movement of organs in a broader distribution system. Please consider adding a data point on preservation mode as this extends preservation time, and current use of mileage as a proxy for cold ischemia time is an antiquated approach. New preservation technologies are rapidly developing that impact assumptions of CIT limits. Examples: cold vs. warm, static vs. pulsatile/continuous, etc. This information is critical to include in development of different ways of implementing distribution systems to see what impact is made upon baseline situation.