DATE: August 29, 2001
TO: Interested Parties
FROM: Stephen D. Nightingale, MD
Executive Secretary, Advisory Committee on Blood Safety and Availability
SUBJECT: Summary of August 23, 2001 Contractor's Conference Meeting
Contractors participating in the effort of the Department of Health and Human Services to
monitor the demand for blood products in the United States met at the Hyatt Regency Capitol
Hill Hotel, 400 New Jersey Ave., NW, Washington, DC 20202 on August 23, 2001.
Dr. Nightingale opened the meeting with introductions and by summarizing progress to date. He
noted that the supply of blood products had been monitored since October 1999 and that the
supply of plasma derivatives had been monitored since October 1998. Both efforts have provided
useful information, but there have been concerns about the timeliness of the reports, the
relationship of reported supply to actual demand, and the transparency of the reporting processes.
Dr. Nightingale noted problems with the use of price as a measure of demand for either blood
products or plasma derivatives, and explained the proposal to use the ratio of daily inventory
divided by daily release of blood products for this purpose. Daily release includes units
transfused plus units exported to another blood bank plus units outdated during a 24-hour period.
He indicated that this measure would be analyzed to detect overall trends, weekly and seasonal
cycles, transient events (such as holidays), recovery from these transient events, and non-linear
events (such as the imposition of new donor deferral policies). He also indicated that this
measure would be correlated with actions taken at individual sites in response to the discovery
that supply was insufficient to meet demand.
Dr. Nightingale described the 29 transfusion services that had agreed to serve as sentinel sites for
the first phase of this project, and he presented preliminary data obtained from these sites. The
median ratio of inventory to demand of all blood products was 7.4 days, of random donor
platelets was 1.4 days, and of apheresis platelets was 1.1 days. Dr. Nightingale stressed the
limitations of these preliminary data, and discussed his expectations of when more data would be
available for review.
Dr. Nightingale indicated that, after the first phase of this project was completed on December
31, 2001, there would be contracts to continue it so that at least one year of usable data would be
collected, and that he expected the project would continue after that time.
Dr. Gerald Sandler asked about parallel efforts to monitor supply of blood products at the
regional level. Dr. Celso Bianco responded by describing a plan under development by
America's Blood Centers (ABC) to provide such information on its web site. He indicated that,
initially, ABC would indicate that either a 3 or greater, 2, or 1 day supply of blood, for the
country as a whole and for each of the regions monitored by DHHS, would be indicated by
green, yellow, or red at this site.
Dr. Jeffrey McCullough suggested a need to monitor how much work had to be done - for
example, how many phone calls had to be made - to obtain the inventory that each center was
reporting each day. Dr. Darrell Triulzi suggested monitoring of specific events that might
indicate a shortage, such as the number of times O+ cells are substituted for O-, and days on
which elective surgical procedures are canceled (and the actual numbers of such cancellations).
Dr. Harvey Klein suggested monitoring reductions in the number of platelets administered, and
monitoring unfilled or partially filled orders. Dr. Leo McCarthy suggested monitoring "red-tagged" products that were shipped to a transfusion service before testing has been completed.
Dr. Barbara Silverman asked how closely these reports could be linked to individual patient
events. Dr. Carolyn Whitsett indicated that legal issues of patient privacy severely limited such
linkages. Dr. Nightingale commented that inaccuracies in billing information, as had been
recently described by Dr. Paul Ness in the April issue of Transfusion and found in her own work
by Dr. Silverman, also limited linkage of observations in the blood bank to specific clinical
events. Dr. Nightingale noted the benefits of improving the accuracy of this information, and
indicated that this was a continuing interest of his office.
After a break, Dr. Mary Chamberland discussed the perspective of the Centers for Disease
Control and Prevention (CDC) on the establishment of "sentinel sites" for disease monitoring.
She suggested compiling the characteristics of each hospital participating in this study, including
the source(s) of its blood products, and she suggested that the goals of the monitoring project
should determine the final composition of the group.
Dr. Jeanne Linden indicated that the New York State Department of Health would be using the
same data collection instrument to monitor the availability of blood at additional hospitals in her
state.
Dr. McCarthy asked how the data collected would be used. Dr. Nightingale responded that he
hoped the information would make the market for blood products more efficient, and that it
would inform government efforts to deal with shortages of these products. Dr. Klein stressed the
ongoing need for this information, for example to project the impact of a proposed deferral of
blood donors on availability of blood products.
Dr. Nightingale raised the issue of how much detail of the data collected should be released to
the public. There was agreement that data should be released by region (Northeast, South,
Midwest, and West) but not by city or individual hospital. Representatives of the three regional
blood transfusion services (Seattle, Pittsburgh, and Tampa-St. Petersburg) agreed that the
aggregate data from their three centers could also be released.
Dr. Whitsett suggested that there should be conference telephone calls with the entire group to
discuss future issues such as analysis of the data collected. The first such call was scheduled for
September 25, 12:00 noon Eastern Daylight Time. Dr. Glenn Ramsey suggested that the
practices at different centers regarding the acquisition and use of platelets would be an
appropriate topic to discuss on this call.
Dr. Nightingale discussed funding projections for the continuation of this project. CAPT
Lawrence McMurtry described the government's bidding process for contracts. He noted the
government provisions for urgent and compelling purchase of services, and purchase of services
from a sole reliable source. Overhead was discussed. Dr. Sandler noted that it would become
easier for transfusion services to collect this data over time, but that it would become more
difficult to collect the data during times of shortage, when more technician time would have to be
devoted to acquiring blood.
Mr. Bill Harvey of LifeTree Technology, along with Mr. Philip Quarles and Ms. Laurel
McDonnell, described the web site for acquisition and dissemination of data that would be
established in the near future. He indicated that a major purpose of the system was to minimize
the effort needed to enter and analyze data. He discussed security provisions, and electronic
signatures. He presented templates for reporting the data and its analysis.
After lunch, Ms. Virginia Wanamaker led a discussion on standardization of the data that is
being reported by individual centers. She noted that individual centers do not report their
inventory at the same time of day. She emphasized the importance of each center reporting its
own inventory at the same time each day, and she indicated that the effect of reporting inventory
at different times during the day would be evaluated in the future.
Ms. Wanamaker raised the issue of separating cross-matched from "free" inventory, and noted
that it would require additional effort to report these separately. Ms.Cathy Pollei noted that
different systems might count cross-matched and free inventory differently. The conclusion of
the group was that the current practice of not separating cross-matched from free inventory
should be maintained.
Ms. Wanamaker then raised the issue of how to account for partial units of blood transfused to
neonates and small children; one unit of blood in inventory can contribute to several units
transfused, and possibly to units exported or outdated. Counting the entire unit as a unit in
inventory and each aliquot as a unit transfused (or exported or outdated) would lower the ratio of
inventory to transfused, and this effect would vary with the proportion of beds at each hospital
devoted to neonatal and pediatric care. Dr. Ravindra Sarode and others noted the difficulty of
capturing this information both in the transfusion service and on the current data form. Ms.
Siobhan McGurk suggested that a standard formula might be used at each institution to account
for the number of units transfused from a single unit in inventory, based on the historical practice
at that institution. Dr. Ramsey suggested that, because the capacity to obtain this data varies with
the computer system used to manage inventory, contractors should share information about what
computer system each uses. His own system, for example, accommodates a suffix for each of
multiple pediatric units derived from a single adult unit.
Ms. Wanamaker requested that as soon as a whole unit is aliquoted, it be removed from
inventory, and that each unit transfused, regardless of its volume, be considered a unit transfused.
This item will be further reviewed at the September 25, 2001 teleconference.
There was discussion about whether to report a unit of blood as transfused on the day it was
actually transfused or on the day the blood bank learned it was actually transfused. The former
practice would require revising data that had been entered on a previous day. No consensus was
reached on this issue.
This was followed by discussion of whether to report autologous or directed donations as
inventory, or as transfused or outdated. Dr. Edahn Isaak noted that some directed donations, for
example antigen-matched donations for patients with sickle-cell disease, constitute up to one
third of his inventory. He said that these directed donations are moved into general inventory
shortly before their expiration date to assure they will not be wasted, but he also noted that his
computer system does not capture the fact that some of his inventory is available, on a routing
basis at least, to only some recipients. Dr. Hannis Thompson noted that in his transfusion service,
such donations would be less than 1% of inventory.
There was additional discussion about inventory that was acquired after a daily inventory was
taken and transfused in less than 24 hours, so it appears as transfused but not as inventory and
therefore contributes to an underestimation of the latter.
There was then further discussion about specific events associated with product shortages that
should be reported. Dr. Triulzi suggested limiting the size of a platelet dose, and delay or
cancellation of elective or scheduled surgeries, and the number of units of Rh-positive blood
transfused into Rh-negative recipients. Dr. Dennis Goldfinger suggested counting the number of
such patients rather than the number of such units. Dr. Thompson reiterated the suggestion to
record orders not completely filled, and Ms. Sharon Licciardi suggested recording delays of more
than 4 hours in the administration of platelets. Ms. McGurk suggested recording physician
consultations for urgent transfusions, since these are often triggered by concerns about supply.
The meeting concluded with a discussion about manuscripts based on the monitoring study, and
about the considerable work that remained to be done before such manuscripts could be written.
|