Blood Safety Summary - April 2000
DATE: May 1, 2000
TO: Interested Parties
FROM: Stephen D. Nightingale, M. D. Executive Secretary, Advisory Committee on Blood Safety and Availability
SUBJECT: Summary of April 25 and 26, 2000 Meeting
The Advisory Committee on Blood Safety and Availability met for the eleventh
time on April 25 and 26, 2000 at the Hyatt Regency Capitol Hill Hotel, 400
New Jersey Ave., N.W., Washington, D.C. Voting members present were Dr. Caplan,
the Chairman; Mr. Allen; Drs. AuBuchon, Busch, Davey, Gilcher, Gomperts, Guerra,
Haas, Hoots, and Kuhn; Mss. Lipton and Pahuja; Drs. Penner, Piliavin, and
Secundy; Mr. Walsh; and Dr. Winkelstein. Non-voting members present were Drs.
Chamberland and Epstein; COL Fitzpatrick; and Drs. Goosby, McCurdy, and Snyder.
Also present were Dr. Nightingale, the Executive Secretary; CAPT McMurtry,
the Deputy Executive Secretary; and approximately 50 members of the public.
Dr. David Satcher, the Assistant Secretary for Health and Surgeon General,
opened the meeting by commending the members for their exceptional efforts
to overcome the inclement weather and attend the last meeting. Dr. Satcher
reviewed the April 24, 2000 letter of Donna Shalala, the Secretary of Health
and Human Services, to Dr. Caplan regarding the recommendations made at that
last meeting, and he charged the Advisory Committee to respond to this letter.
The Honorable Horace Krever, recently retired from the Court of Appeal for
Ontario, Canada, then discussed the Duty to Inform under Canadian law. He
discussed Stamos v Davies [21 D.L.R. (4th), pp 507-530], in which
then Mr. Justice Krever found that the defendant was obligated to inform the
plaintiff that the plaintiff's spleen had been punctured during a lung biopsy.
This judgement was based on the fiduciary duty, rather than on any contractual
duty, of a physician to a patient. Furthermore, the Justice held that this
fiduciary duty to inform exists even when a failure to inform does not constitute
negligence.
Mr. Krever observed that denying the patient such information would be equivalent
to denying the patient access to her or his own medical record. He noted that
the information in the medical record was obtained because of the fiduciary
relationship between the physician and the patient. He also noted that the
sanction to compel compliance with the duty to inform might be found within
the power of the licensing or regulatory bodies of the profession.
Mr. Krever then observed that this fiduciary duty would ordinarily conflict
with the contractual obligation of a physician to her or his insurer not to
admit fault. He said this was one of several reasons why the Commission of
Inquiry on the Blood System in Canada had recommended no-fault compensation
for blood-related injuries. He added that another reason for this recom-mendation
was the limited capacity of tort law to provide appropriate relief for those
affected by inevitable events. He described the compensation provided in Canada
to victims of certain transfusion-transmitted illnesses as a partial, but
not full, response to the limitations of tort law.
Dr. Ronald Westrum of Eastern Michigan University then spoke on the scientific
foundations of error management. He described the model of error proposed
by Dr. James Reason in which actions of operators at the "sharp end" of a
complex technology, such as airplane pilots, expose "latent pathogens" within
those systems. Latent pathogens are acts or omissions within a complex system,
such as placing a file cabinet in front of a fire escape, that are not detected
until the concurrence of other events reveal their existence. Latent pathogens
are considered inevitable components of complex systems, and systematic efforts
to identify and correct these latent pathogens are considered essential components
of error management systems.
Dr. Westrum noted that such efforts are now well established in aviation
and in several other comparably complex industries. Under Dr. Reason's leadership,
these efforts have evolved from retrospective analysis of high-profile accidents
to prospective efforts to prevent such accidents. Dr. Westrum quoted Dr. Reason
as saying
Are companies doomed to fighting the last fire or trying to preventing
the last crash? The answer must be yes if complex, hazardous organizations
continue to rely principally on outcome measures in order to navigate the
safety space. But there is a workable alternative: the regular assessment
of organizational procedures that are common to both quality and safety.
Latent accident-producing conditions are present now. It is not necessary
to wait for bad events to find out what they are. But we cannot expect to
remedy them all at once. Systems need principled ways of identifying their
most urgent process problems in order to deploy their limited remedial resources
in the most efficient and timely manner. Making and acting upon proactive
assessments of the system's vital signs together with the intelligent application
of near miss reporting will not guarantee freedom from accidents. What it
will do is take an organization closer to the only reasonably achievable
safety goal, acquiring the maximum amount of intrinsic resistance to hazards
and sustaining it.
Dr. Westrum noted that management hires the system operators, sets goals
(and exerts pressure on operators to meet these goals), determines how much
money and other resources will be devoted to achieving these goals, and establishes
the dynamics and the culture of the system. For these reasons, management
shares responsibility for accidents and for their prevention.
CAPT Scott Griffith of American Airlines then discussed the aviation industry's
and his airline's approaches to error management. He began by describing the
NASA/AMES Aviation Safety Reporting System (ASRS). This program, which was
established in 1976, receives voluntary, confidential reports of flight safety
information that do not result in accidents.
CAPT Griffith noted that ASRS provides reports to industry on aggregate data,
but does not have the capacity to correct the root causes of each individual
error reported to it. American Airlines' Aviation Safety Action Partnership
(ASAP) was established in 1994 to meet this need. ASAP has subsequently received,
evaluated, and determined the appropriate corrective action for over 22,000
voluntary reports.
CAPT Griffith said that an ASAP report must be filed within 24 hours of the
time of an event, or within 24 hours of the time a reporter becomes aware
of the event, so that corrective action can be initiated as soon as possible.
The report has to be of an inadvertent, unintentional, non-criminal act, and
there must be consensus among management, labor, and the regulator about the
appropriate response to the report (for example, change in a procedure, or
additional training for an individual). Once consensus has been achieved,
a summary of the report is circulated among the airline's approximately 12,000
pilots.
CAPT Griffith emphasized the following differences between ASRS and ASAP
reports in regard to confidentiality. ASRS reports are stripped of all unique
identifiers, so that the FAA never knows the identity of the reporter, and
only sees aggregate data. In contrast, individual ASAP reports are provided
to FAA along with the airline's plan for corrective action. In ASAP reports,
the identity of the individuals are encoded, but the key to this code is retained
by the airline. If FAA agrees with the corrective action proposed in the ASAP
report, FAA takes no further action against the airline or the individual,
and maintains no further record of the event that would identify an individual.
Public access to FAA records is restricted by law during an investigation
to preserve the integrity of the investigation, and public access to FAA records
after the investigation under the Freedom of Information act would not identify
the individual. The confidentiality of the airline's own documentation of
these investigations has been upheld in court. CAPT Griffith suggested that
participation by the FAA in the airline's quality assurance program might
be a very important part of the public's acceptance of the program, and of
the protection from disclosure that is an integral part of it.
In the discussion that followed, CAPT Griffith graciously responded to numerous
inquiries from the Advisory Committee about details of the ASAP program. In
one of those responses, he noted that American Airlines shares every one of
its ASAP reports with the ASRS.
Dr. Robert Helmreich of the University of Texas then discussed the application
of the aviation error management experience to medicine. He discussed how
his own research had evolved from the study of aviation to the study of medicine,
and his methodology of observing individuals and teams in their natural work
settings, such as the cockpit or the operating room. This experience has led
him to classify errors into five categories:
1. Violating regulations (e.g., landing before the aircraft is fully stabilized);
2. Procedural errors (e.g., entering a wrong altitude into the airplane's
computer);
3. Communication (e.g., information is not provided, or misunderstood);
4. Proficiency (e.g., not knowing or being able to perform a necessary act);
5. Decision (e.g., choosing an option that unnecessarily increases risk).
Dr. Helmreich presented the overall distribution of aviation errors into
these categories, and then presented a very different distribution of the
subset of these errors that were judged to be "consequential," by the fact
that they led to the commission of additional errors. Violations of regulations
were the most common error overall, but only 2% of these violations were consequential;
most consequential errors were proficiency or decision errors. However, crews
that committed a violation error were 1.5 times more likely to commit another
error, and these other errors were 1.8 times more likely to be consequential.
Dr. Helmreich noted that aviation was very extensively proceduralized, whereas
medicine was at the other extreme. He also noted that the atmosphere of trust
essential for the aviation error reporting programs was not always found in
medical environments. Dr. Helmreich has noted some form of conflict in about
10% of surgical operations he has observed, but in less than 1% of flight
operations he has observed. Other examples of the cultural differences between
medicine and aviation were the lower percentages of physicians than pilots
who acknowledged they either:
1. Perform less efficiently in critical situations when fatigued;
2. Were unable to leave personal problems behind in professional situations;
3. Were not as good at making decisions in emergencies as in routine situations.
Dr. Helmreich then compared the distribution of the 5 types of errors he
had observed in the cockpit to the distribution of these errors he had observed
in the operating room. He found a much higher frequency of procedural and
communication errors in the operating room. He suggested that the excess of
procedural errors in medicine were caused by uncoordinated introduction of
new technology, and that the less efficient communication he observed might
be due to greater status differences within the medical than within the aviation
professions.
Dr. Helmreich then presented an analysis of a therapeutic misadventure to
demonstrate how error management techniques developed in aviation could be
applied to medicine. His analysis identified latent pathogens in this event,
such as an air heater in an anesthesia machine that would continue to function
even if the temperature probe became disconnected from the patient.
Dr. Stephen Small of Massachusetts General Hospital then discussed the potential
application of error management to other areas of medicine. He began by discussing
progress in anesthesiology, which he acknowledged was driven in part by escalation
in that discipline's malpractice premiums. He described the movement of anesthesiology
towards greater standardization of equipment and procedures, the introduction
of safer anesthetics, the establishment of a closed malpractice claims data
bank, and better qualifications of recent applicants.
Dr. Small then compared the normalization of anesthesia practice to the much
less controlled practice of emergency medicine. He described the use of various
simulators to train individual practitioners and health care teams in various
specialties, and the increasing fidelity of these simulators, and the situations
in which they are used, to actual medical events. He discussed the variable
acceptance of this educational technology in different medical areas, the
impact that debriefing health care professionals on their performance during
a simulation can have, and the factors that contribute to institutional ambivalence
towards this field of inquiry.
Dr. Small commented on differences that had previously been described by
CAPT Griffith between the ASRS and ASAP. These are that
1. ASRS is anonymous, while ASAP is confidential;
2. ASRS is a research tool, while ASAP is a legal alternative to government
enforcement of regulations.
Dr. Small suggested that introduction of an error management system comparable
to ASAP in one area of medicine, such as blood transfusion, might facilitate
its acceptance in other medical areas. He noted that high reliability systems
have a leadership committed to safety as a core value, redundancy in critical
areas, workers that share management's commitment to safety, and an organization
that is continually in a learning mode; he implied that an ASAP-like program
might promote comparable developments in medicine.
In the public comment that followed, Dr. Rosalyn Yomtovian, representing
the American College of Clinical Pathologists, supported efforts to include
events outside as well as within the blood bank in efforts to improve transfusion
safety. Mr. James McPherson of America's Blood Centers reiterated his organization's
support for the MERS-TM system, for the previous speaker's comment, and for
no-fault compensation for unavoidabe transfusion-associated injury. Mr. Rich
Vogel of the Hemophilia Federation of America supported inquiry into more
effective error management techniques, but expressed concern that the distinction
between error and negligence be retained.
The Advisory Committee engaged in vigorous discussion for the remainder of
the day, and agreed to continue it on the following day. After this further
discussion on the following morning, Dr. Penner moved, and Dr. Hoots seconded,
the following two resolutions:
1. The Advisory Committee on Blood Safety and Availability
recommends the establishment and implementation of a national reporting
and analysis system for transfusion medicine as a basis for action
to reduce and prevent morbidity and mortality due to human and system
error.
The Advisory Committee is favorably impressed with the accomplishments
of the error reporting and correction systems that have been developed
to improve the safety of air travel by the aviation industry, and
by the interaction of federal regulatory agencies with this system.
The Advisory Committee acknowledges the efforts of the FDA
working with the blood and plasma collection industries in reducing
errors and accidents, and is favorably impressed with the results
to date of the MERS-TM error management system. While a great deal
has been accomplished in blood collection and processing, the Committee
now believes that the opportunity exists to apply these principles
to transfusion practice.
Error management systems should acknowledge the right of
patients to know of any risk or harm suffered as a consequence of
any error or accident related to blood products received. At the same
time, there should be statutory protection from disclosure for voluntarily
reported information and of quality assurance activities that are
not associated with potential or actual harm, provided that the information
is also not associated with reckless or intentionally harmful acts.
These error management systems should complement, and not replace,
current regulatory activities, notably but not exclusively in the
area of product safety. All analyses of collected data should be made
available in a timely manner to regulatory agencies, national transfusion
medicine surveillance programs, and other participants in a reporting
system.
Congress should appropriate sufficient funds to develop
these systems and for an infrastructure sufficient to support and
maintain them in the FY 2001 budget. Congress should stipulate that
these funds should not be reallocated for other purposes and that
no other funding should be reduced because of the availability of
these funds. Funds necessary to maintain these systems should be appropriated
annually.
2. There is a small but non-zero risk associated with the
use of blood products or plasma derivatives that cannot be eliminated
with current technologies. The Advisory Committee therefore supports
the prior recommendation of the Institute of Medicine, and of others,
that a national system to compensate prospective national system for
recipients for injuries or death caused by blood products or plasma
derivatives and not associated with a reckless or intentionally harmful
act should be enacted and funded by Congress.
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Both motions were approved unanimously, with no abstentions.
After a break, the Advisory Committee addressed the second item on its agenda,
reimbursement for blood products and plasma derivatives. Dr. Nightingale summarized
the recommendations made by the Advisory Committee on this subject in August
1999, the Secretary's response to those recommendations, and the Final Rule
published by the Health Care Financing Administration on April 7, 2000 on
Prospective Payment for Hospital Outpatient Services under Medicare. Dr. Nightingale
then noted that a component of the recommendations of the Interagency Task
Force on blood availability that were incorporated into the FDA Blood Action
Plan in November 1999 was to address the economic concerns of the blood and
plasma industries, and the purpose of this portion of the Advisory Committee
meeting was to solicit any residual concerns from these industries, and to
solicit Advisory Committee consideration of any such concerns.
Dr. Jong-Hoon Lee of FDA opened the session with a discussion of FDA's position
on universal leukodepletion. He reviewed the September 1997 recommendation
of the FDA's Blood Products Advisory Committee on this issue, and the discussion
on how to implement this recommendation at the FDA December 1999 workshop.
He indicated that FDA was aware of concerns about the availability of filters,
and about the impact of the cost of this procedure on various parties. He
concluded by noting that FDA remains fully supportive of universal leukodepletion,
and that it intends to issue either a Guidance Proposed Rule on this subject.
Dr. AuBuchon opened the discussion by vigorously dissenting from the FDA
position. He stated that there remained scientific debate on this issue, and
that implementation of universal leukodepletion would cost half a billion
dollars a year. Dr. Epstein responded by pointing out the need to separate
the scientific from the economic debate over this position, and the adverse
consequences of failure to do so. He explained why FDA has approached leukodepletion
as an issue of Good Manufacturing Practice. Dr. Nightingale stated that the
Department of Health and Human Services strongly supported Dr. Epstein's position,
and invited comment on how best to deal with its economic consequences.
Dr. Gilcher stated that the cost of leukoreduction at his facility was approximately
$20.00 per unit, and that as demand for leukoreduced blood increased, it was
more expensive to maintain a leukoreduced and a non-leukoreduced inventory.
Ms. Lipton noted the impact of leukoreduction on the budgets of hospital transfusion
services, and stated that relief was urgently needed. Dr. Davey urged FDA
to move forward with a regulation on this issue. Dr. Busch expressed concern
that the Advisory Committee had been bypassed in decision making on leukoreduction
and on British donor deferral policies. Dr. Gilcher noted that cost and reimbursement
for leukoreduction were really separate issues; Dr. AuBuchon emphasized his
concern over cost. Dr. Caplan suggested that it would be appropriate for the
Advisory Committee to consider this issue.
Dr. Alan Marengo-Rowe of Baylor Medical Center in Dallas, representing the
American Hospital Association, pointed out that the cost of blood and drugs
to his institution had risen over 15% in the past year, while other costs
had increased only marginally. He requested HCFA develop an inflation index
that captures increasing costs of blood, which at his institution have increased
by $35 per unit for leukodepletion.
Mr. Rick Axelrod of Pall Corporation stated that his company would be able
to meet current and projected demands for filters used for leukodeplention.
He stated that approximately 11 units of blood had been leukoreduced with
his company's filters, and only six adverse reactions related to their use
had been reported. He also stated that almost complete recovery of red cells
could be achieved with the use of his company's filters.
Mr. Bob Barrett of Chiron Corporation stated that nucleic acid testing of
blood samples with his company's test methodology had identified 4 HIV- and
28 HCV-infected units not identified by other tests.
Mr. Alan Darlington of HemaCare Corporation stated that the proposed reimbursement
for APC 011, therapeutic plasma exchange, was insufficient for the mobile
services his company provides.
Ms. Theresa Lauerhaus-Wegman of the American Association of Blood Banks urged
the Advisory Committee to recommend that HCFA inpatient reimbursements fairly
account for the costs of providing state-of-the-art safety measures for blood.
Ms. Jan Lane of the American Red Cross urged that HCFA reimbursement policies
explicitly respond to FDA-mandated safety measures.
Dr. Gerald Sandler of Georgetown University stated that the increased cost
of leukodepletion had created a budget shortfall in his department, and that
in turn had decreased the safety of the blood supply at his institution. He
said he was receiving 200 units of leukodepleted blood each month from his
supplier, the American Red Cross, that he did not order, and that he was being
billed $40.00 per unit, or $8,000.00 per month, for this unwanted service.
Ms. Kristin Smith of America's Blood Centers requested that Congress increase
Medicare funding by amounts equal to the cost of new blood safety measures
that have been recommended by FDA or adopted and the standard of care in transfusion
medicine.
Ms. Susan Reardon of Johnson and Johnson spoke in support of the recommendations
of AABB, ABC, and ARC for legislative relief for the increased cost of leukodepleted
blood.
Mr. Dennis Jackman of the Plasma Protein Therapeutics Association urged HCFA
to issue a guidance to entities covered by the new outpatient prospective
payment system so that proper coding for the use of plasma derivatives could
be performed, so that correct utilization data would be available when the
system was reevaluated.
Dr. Robert Weinstein of St. Elizabeth's Medical Center in Boston requested
that HCFA review its reimbursement for CPT 36521, which includes extracorporeal
reabsorption therapies for individuals with refractory hyperlipidemias, rheumatoid
arthritis, and inhibitors of clotting factors.
After a break, there was further discussion by the Advisory Committee of
issues related to reimbursement. Dr. AuBuchon proposed, and Dr. Penner seconded,
the following motion:
3. Whereas the Advisory Committee on Blood Safety and Availability
is dedicated to insuring patient access to safe blood products and services,
and whereas the Committee recognizes that fair, accurate, and timely reimbursement,
including Medicare, for blood-related therapies is critical to insuring
patient access to the safest possible blood, the Advisory Committee, consistent
with its prior recommendations, recommends that the Secretary and Congress
support legislation to insure fair and accurate reimbursement for inpatient
blood-related products and services. Such legislation should provide sufficient
funding to account for increased blood-related costs, including those associated
with new blood safety measures, and require that these costs be reflected
in annual updates of inpatient diagnosis related groups.
The motion was approved unanimously, without abstentions.
Mr. Walsh then moved, and Dr. Kuhn seconded, the following motion:
4. The Advisory Committee recommends that HCFA
promptly distribute guidelines for coding and billing of blood and plasma
products to all entities covered by the outpatient prospective payment rule.
Furthermore, the Advisory Committee urges HCFA to work with stakeholders,
including consumers, outpatient departments and manufacturers to capture
actual utilization and billing data to be used to establish a permanent
payment system for blood derivatives administered in outpatient settings.
The motion was approved unanimously, without abstentions.
In the discussion that followed, Dr. Epstein endorsed the suggestion of Dr.
AuBuchon that the Advisory Committee examine the role of cost-benefit and
related assessment techniques in decision making related to blood safety and
availability. Dr. Epstein also suggested that the Advisory Committee examine
alternative decision-making strategies, such as a zero-risk mandate, the precautionary
principle, and the FDA mandate for approval based on safety and efficacy without
regard for cost. Dr. Piliavin then moved and Dr. Hoots seconded the following
motion:
5. Recognizing the significant economic issues
currently affecting the blood system, the Advisory Committee seeks to review
the role of various considerations in decision making related to new and
existing blood safety measures.
The motion was approved unanimously, without abstentions.
The next item on the agenda was a presentation on the World Health Organization's
Global Collaboration for Blood Safety by Dr. Jean Emmanuel, the Director of
the Department of Blood Safety and Clinical Technology Department at WHO.
Dr. Emmanuel began by stating that the Director General of WHO has made blood
safety one of the organization's highest priorities. He said that here are
approximately 75 million units of blood collected around the world each year.
However, there are dramatic differences in blood collection rates around the
world: 80% of the world's population has access to only 20% of the supply.
Furthermore, of the 30 million units of blood collected annually in the lesser
developed countries, 43% is not tested for transfusion-transmissible disease.
The goal of the Global Collaboration for Blood Safety is to promote tangible
support for efforts to improve blood safety throughout the world, particularly
efforts to promote volunteer donation, appropriate tests for transfusion-transmissible
diseases, and appropriate clinical use. These efforts should increase public
awareness that a safe blood supply is essential for the care of pregnant women,
trauma victims, chronic diseases such as thalassemias and bleeding disorders,
and surgical patients. To achieve this goal, WHO will promote exchanges of
ideas and proposals among the developed countries as well as interactions
between the developed and the developing countries.
The last items on the agenda were updates on the availability of blood products
and plasma derivatives. Dr. McCurdy presented preliminary data on collection
rates and inventories of blood by blood group that is being obtained by the
National Heart, Lung, and Blood Institute through its contract with the National
Blood Data Resource Center. Dr. McCurdy noted plans to expand data collection
to hospital transfusion services, and to identify any instances when transfusion
services are unable to respond to a request for a blood product in a timely
manner, or when a surgical procedure has to be canceled because blood is not
available.
Mr. Larry Guiheen of Baxter discussed the availability of his company's recombinant
Factor VIII. He acknowledged that demand had exceeded supply since last December.
He announced that Baxter has expanded its manufacturing facilities, and that
it submitted an application last month to FDA to permit use of one of these
facilities. He also announced that Baxter is developing another facility,
and he expressed hope that additional supply could be available from this
facility within two years.
Mr. Jason Bablak of the Plasma Protein Therapeutics Association presented
a summary of the production and inventory data that his association has been
collecting for the past two years. He noted that current inventories are at
a 3 to 4 week level, compared with a 2 to 3 week level a year ago. Mr. Bablak
mentioned his association's support of emergency supply programs and the collaboration
of these programs with consumer groups, expansion of industry capacity, and
interaction with FDA as components of the industry's effort to meet demand
for plasma products.
Mr. Christopher Healy of the American Blood Resources Association informed
the Advisory Committee that there had been a 7% decline in new plasma donors
between 1997 and 1999. He said that there was still sufficient plasma to meet
the needs of manufacturers, but that the trend in plasma donation was of concern.
In the general discussion that followed, Mr. Walsh noted that there remained
a shortage of fraction 4.1 paste used in the manufacture of alpha-1 antitrypsin.
He also drew the Advisory Committee's attention to the Five Points of Light
bicycle ride in the early fall that would call national attention to the need
for blood and tissue donations.
There being no further business, the meeting was adjourned at 4:19 P.M.
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