|
Items in cart [0] |
Questions? Call 888-624-8373 |
PAPERBACK PDF BOOK Free Resources |
||||||||||||||||
|
||||||||||||||||
|
|
|||||||||||||||
| ||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Copyright © 2009. National Academy of Sciences. All rights reserved. Terms of Use and Privacy Statement |
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 67
III
New Ideas for Safely and
Monitoring
OCR for page 68
OCR for page 69
Information Technology and Blood Safely
]. Michael Fi~zmaurice
Assume there is a newly discovered virus in donor blood that is detectable
by a test, and it is associated with a small number of people initially. You
want to trace those who received the infected blood, and you may also want
to trace those donors who were potentially exposed via their reported behavior.
Maybe you can find that out through answers to their blood and interview
questions. Do you have the information system to do it? What would it take
to develop that capability?
I want to talk about what a computer-based patient record is, what a
clinical decision support system is, what evidence there is that they work, what
barriers stand in the way of the development of a computer-based patient
record system, and then what is the applicability to a blood information
system.
A computer-based patient record is just a collection of health data in
electronic form and is part of the health information system of a physician or
of a hospital. It could also be part of a health information system in a
managed care organization or an insurance company. In electronic form that
information is legible and available. When you ask for it, with the proper
authority, you can get it, and if somebody else asks for it, they can get it at the
same time. It is communicable, and you can search it.
It is also a powerful tool for organizing patient care data, improving
patient care, and strengthening communication among health care providers.
That may be one of its strongest points: retrieving medical knowledge that is
applicable to that particular patient at the time you make a decision. The
operating hypothesis is that computer-based patient record systems can
improve both physician performance and patient outcomes of care.
The primary role for this collection of electronic data is to support the
delivery of care to a particular patient. It brings the information to the
physician, promotes communication, documents care, and records the reasoning
behind the choices that are made. The secondary role of the computer-based
patient record is to build a clinical data repository. All the data do not have
69
OCR for page 70
70
BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
to be linked together and located in one place, as long as you can find what
you want and pull it in.
My agency, the Agency for Health Care Policy and Research (AHCPR),
was created by Congress to determine what works in the community's practice
of medicine. We know what works in the ideal setting of a clinical trial. In
the community, patients behave differently and skill levels are not all the same.
What are the differences? Why do we find so much variation across the
country in procedures and in patient outcomes? These are important questions.
The computer-based patient record is valuable for improving population-based
care because you can query a large number of records and learn a great deal
about the community factors that lead to those patient conditions and outcomes
of care.
A clinical decision support system, utilizing computer-based patient
records, is simply computer software that aids decision making by providing
diagnostic suggestions, treatment suggestions, testing prompts, drug alerts for
potential drug-drug or drug-food interactions, therapeutic protocols, and
practice guidelines. AHCPR promotes the development of practice guidelines.
We would love to be able to drop them into computerized patient record
systems to find out what difference they make in the process of care and
patient outcomes, and even to research and test patient care pathways.
A clinical decision support system requires a knowledge server, and that
is simply a link between the patient and the information necessary for that
patient's care. Normally, a physician is that link, but a physician using a
mechanical instrument like a computer and a computerized record can do so
much more and doesn't have to worry about forgetting.
What does a good clinical decision support system require? It requires
a body of data about the patient that a physician considers important. It
requires knowledge sources; if this, then that, and then that. How do I test for
this; how do I test for that? Suppose I suspect a given diagnosis? In what
order should I do the tests; do I do an X-ray, then an MRI (magnetic
resonance image), then a CAT (computer-assisted tomography) scan, and then
a PET (positron emission tomography) scan?
It requires a knowledge server that is the link between the computer-based
patient record and the information source. You can describe the components
of that knowledge server as medical logic modules, sentences that say, "If this
is a female patient over 50 years old, and you don't find a Pap smear result in
her record, then suggest that she get one. If you don't find a mammography
result in her record, suggest that she get one. If the patient is 65 years of age,
has asthma, and there is no evidence of an immunization for the most recent
flu virus, suggest that the patient get one." It also needs a common
nomenclature so that physicians talk the same language and can query the
OCR for page 71
NEW IDEAS FOR SAFETY AND MONITORING
71
computerized knowledge base and can query the scientific literature using the
same language, or else you need a good translator for that language.
These decision support systems improve patient care processes. In some
cases they have measurably improved patient outcomes, but most of the studies
that have looked at such systems are about improving patient care processes.
For example, providing preventive care infonnation to physicians and their
patients improves compliance with immunizations. However, if you take the
computer assist away, then immunization goes back down to previous levels.
These systems also support diagnosis of high-risk patients, and of course, you
often treat high-risk patients differently than you treat low-risk patients. The
systems also help determine the sometimes toxic drug dose for obtaining the
desired therapeutic levels. With these systems we can avoid having to look up
in tables the many different patient factors and doing all of the extensive
research necessary for a particular patient. If you haven't seen a patient like
that for awhile, the computer can help you remember drug and test ordering.
In a clinical trial supported by AHCPR, the researcher had one set of
physicians with regular computer screens for drug and test ordering and
another set of physicians with special computer screens for drug and test
ordering that were geared to question drug selection.54 Both groups of
physicians had screens and both groups did test ordering. Those with the
special screens designed to question the choice of drug or test on the basis of
the suspected diagnosis and medical knowledge found in the literature and to
put cost savings suggestions up front wound up saving money and reducing
lengths of stay. However, those physicians spent about 5.5 more minutes per
patient per 10-hour shift. Thus, you have technology that improves the process
of care, but costs the physician time. The physician does not get paid any
more for the extra time. There must be some way to get the benefits down to
the decision maker for taking the time to enter the information and query the
system, thereby improving the care of the patient and the process of care.
Other studies, also funded by AHCPR and its predecessor, the National
Center for Health Services Research, showed improved blood use through
computer-based screening of orders, and that a computer-based patient
interview elicited more HIV-related risk factors in the health histories of blood
donors than one conducted by a staff member. These donors considered being
queried by a computer to be more private, and they were more honest with
their answers. We need to look at improving the sensitivity not only of the lab
screening but of donor screening as well.
54Tierney, WM, ME Miller, JM Overhage, CJ McDonald (1993). Physician inpatient order
writing on microcomputer workstations: Effects on resource utilization. Journal of the Almerican
Medical 'association, 26963): 379-383.
OCR for page 72
72
BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
Clinical decision support systems also reduce malpractice threats.
Massachusetts physicians have lower emergency room malpractice premiums
if they use a particular system. The reason is not because the system results in
better decisions, but because it produces better documentation. More court
cases are lost because of a lack of documentation than because it is proven that
someone made a bad decision.
If we are going to use these clinical decision support systems, what are
some of the questions we need to answer? Most of the studies that I described
were single-site studies in academic medical centers. We need more multiple-
site tests of the same system. We need to know how much user perfonnance
is enhanced. We need to know how much patient outcomes are improved. In
10 randomized trials that were studied, only three of them measured patient
outcomes. The others dealt with the process of care. You might assume that
improving the process leads to improved patient outcomes, but that can be a
big assumption not necessarily a wrong assumption, but a big one. We need
to know the costs of achieving these gains. Specifically, knowledge is needed
about the costs of equipment, training, time, and energy spent convincing other
peers to use a computer-based patient record system, as well as the costs of
maintaining both a paper-based system and a computer-based system for a time
so that people feel comfortable with the new system. We also need to
investigate whether system-wide health care costs are contained, or we are just
swapping one set of costs for another with no net gain.
We need to support an accessible medical knowledge base, and medicine
is doing a good job of building that base. We also need to determine how
strong a match of medical terms is needed, because we don't all talk the same
language. How much do our words have to mean the same thing before we
can communicate medical information upon which others are willing to act?
How do we integrate clinical decision support systems into the environment
and provide these systems with features that physicians will want, whether that
involves communicating by typing, writing, speaking, or pushing a button.
The mechanism itself may be on your desktop, or maybe its a clipboard,
or perhaps its hand held, or even at the bedside of the patient. Whatever it is,
it must be flexible enough to improve the provider-patient relationship.
There is very little written in the scientific literature about how you best
go about the implementation of these systems. What has led to success and
what has led to failure? We know that physicians are reluctant to enter data;
there is an uncertain effect on physician productivity and income. The
confidentiality and privacy of physician's text notes are important to them, and
there is also a variation in use of clinical decision support systems within a
given hospital department by department. Those who are used to working
with high-tech equipment are more willing to work with a computer-based
patient record. Furthermore, there is insufficient information in the scientific
OCR for page 73
NEW IDEAS FOR SAFETY AND MONITORING
73
literature about the factors that lead to the successful implementation of a
clinical decision support system in hospitals and physicians' offices. One
thing is certain: you will know they have arrived when managed care
organizations begin using them extensively.
There are many extended uses of computer-based patient record data
beyond the care of the specific patient. Among these are their use for
research, quality assurance, patient care treatment paths, treatment strategies
assessment and medical technologies assessment. Computer-based patient
record data can provide infonnation to a wide range of users for making many
different choices, depending upon how they are aggregated and analyzed.
This patient care data should be
· uniformly defined,
· linked accurately
· collected together into databases, and
· held confidentially.
This is an ambitious vision. We don't as yet have widespread
computer-based patient records. Some patient care data are normally
computerized, such as lab records and radiology test reporting. Unfortunately,
what happens is that the data are printed out of the auto analyzer onto paper
and the paper is sent to the patient's floor, where two or three holes are
punched in it and it is slapped into a paper medical record. We lose the
advantage of computerization.
Today many decisions are based on data of inferior quality. Many
decisions are made on the basis of claims data, not just Medicare claims data,
which are the best in the world, but also private insurance company claims
data. Decisions are being made on the basis of those large claims databases
without sufficient clinical information. Clinical, medical record patient care
data are becoming more valuable for decision making. For example, Kaiser
Permanente has planned over the next 5 years to spend millions of dollars
developing and implementing a computer-based patient record system. The
Mayo Foundation is also developing a computer-based patient record system.
To support the growing private sector use of computer-based patient records,
AHCPR and the National Library of Medicine are funding eight test beds to
test the commonality of nomenclature and how easy it is to exchange clinical
information across different computer-based patient record systems.
What do you need to know if you are going to get involved in
computer-based patient records? First, you need standards. You need
definitions for signs, symptoms, and conditions of patients. That is, you need
codes for the diagnoses of patients and procedures performed on patients, and
they have to be used for more than just billing. You also need to define file
contents. What data do you want to see to make a particular decision about
OCR for page 74
74
BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
whether to admit a patient to the hospital or to order another series of drug
tests or order an X-ray? You need to define those data and be able to pull
them up electronically for that decision.
Second, you need confidentiality and privacy protection for the patient
care data. You need to define what is individually identifiable data, balance
the benefits against the potential harm, and then specify what is a fair
treatment of those data. In addition, someone has to be responsible for data
quality assurance. When the data aren't accurate, somebody's head not the
patient's has to roll.
Electronically stored records are essential, but the current environment is
not especially receptive to their use. There are variations across states in
health care privacy laws, regulations, and practices. Some states have "quill
pen" laws, which means you have to sign in pen and ink for the medical
record to be admissible as evidence in court. This rules out electronic
signatures.
Third, standard unique identifiers for patients, health care providers, and
payers must be developed. These are essential to obtain economies of scale
in information technology.
Fourth, malpractice concerns must be addressed. Are you giving medical
advice across borders when you are dealing with drug information? Do you
need to be licensed in each state in which you are exchanging information?
Who has legal jurisdiction in case there is an exchange of erroneous
information and the patient is hanned?
Fifth, the security and integrity of your system must be ensured. You will
have to deal with purposeful violations of privacy as well as accidental
violations. You also have to deal with the accuracy of medical knowledge in
clinical decision support systems and the accuracy of data transmissions. Who
is to blame if important data get lost in the phone wire or an electronic switch
or a faulty file server? Who is legally responsible for bad patient outcomes
due to a flaw in a transmitted image or misreported medical knowledge?
We need better benefit/cost methodologies, but whose benefits and whose
costs should be the focus of study? We have to assess the business risks, as
well as the business benefits, because, after all, this is a business investment
. .
( .eclslon.
Once you have computerized patient records, can you pull the patient care
data together into a regional health repository? How is it governed? Who
owns the data? Who gets to use the data? Who sets the rules? Do the
owners set it? Does the regulatory agency set it? Do you want all these data
packed together in a centralized database or distributed? If distributed, every
time you send a question out to be answered, do the data suppliers get to
decide whether they want to answer your question or withhold the data?
OCR for page 75
NEW IDEAS FOR SAFETY AND MONIT0~2ING
75
What about the use of computerized patient records to register blood
information? Let us assume that the purpose is to reduce the incidence of
blood-borne disease by identifying and excluding bad blood using a
computerized database. A second purpose could be to trace back to the source
of the contaminated blood. Let us assume that you already have a
computerized system in place. Then you identify the hurdles and how to
overcome them.
We can assume that blood donors and recipients voluntarily report
necessary personal information. What happens if they don't? Do you deny
a transfusion to a patient who refuses to provide you with information? We
can assume the patient consents to blood donation, collection of personal
characteristics, linkage with other information, and disclosure, but to get that
informed consent you may have to define exactly what disclosures you plan.
The use of the database has to be governed. Who does it? Government?
The private sector? At a national level? At a local level? Again, you have to
identify the hurdles and who is responsible for addressing them.
You have to have a disclosure policy. There is no federal privacy law
that generally governs health data, except those related to AIDS and some
other communicable diseases. By and large there is no federal law that protects
the privacy of your own health data. You have to rely on your state and your
health care provider.
Who determines the user authorization and that an inquiry is really from
that authorized user? You need a system of inquiry, and you have to decide
how you are going to respond to the inquiries: by computer, by telephone, in
writing, or in person?
We have covered the database structure before when we talked about
computer-based patient records, but do you have a database in each blood
bank? Do you have a database nationally? You have to decide that. You
need standards for this database, and you need to define the database content.
What are you going to use to identify the person: Social Security number?
Suppose the patient refuses? You say, "Well, then I will get the name, date
of birth, sex, and mother's maiden name. That will give me 95 to 98 percent
accuracy." But is that good enough?
You have to have some individual or some institution monitoring the data
quality: confidentiality and privacy, what laws apply, who bears the legal
responsibility for this, how secure the storage system is, and what protections
is built into your system?
Then we get into system liability. Who is responsible? The caregiver is
responsible for his or her own decisions, but when decisions are shared among
several providers in separate states, how is responsibility determined? Who
is responsible for the system liability? If you have information in the decision
support system about contraindications, who is responsible for the integrity and
accuracy of that information?
OCR for page 76
76
BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
Finally? how do we overcome these barriers? Many people believe there
should be a national privacy law that would set out appropriate uses of
personally identifiable health data and specify the conditions under which they
can be used. What are the penalties if somebody misuses these data? How
much do they have to pay? How long do they have to spend in jail?
Should there be federal relief from liability due to system failure?
Somebody ought to be liable for it. You might say, "Well, we can take care
of that with federal no-fault compensation." Yes, but it comes out of the
pockets of the taxpayers and creates undesirable incentives. Some things that
could be useful to get a system off the ground may not be wise in the long
term. There should be informed consent forms for both the donor and the
patient. There should be a review of existing secured systems to know what
kind of model to adopt for a secure blood bank registry system. And there
should be a development of Finding sources. Who benefits from this? If the
public benefits, should there be a public payment for this? If it is solely a
private benefit, then do you add the cost to the charge per unit of blood? Do
major health insurers like the Health Care Financing Administration agree that
a computerized system of blood records is needed, and will these insurers pay
the additional charge? All of this should be pilot and market tested. You
cannot just rush into it. You need to pilot test it in a couple of places, work
out the kinks, look at the benefits, look at the costs, and then move ahead.
What is at stake is the potential to increase the value and security of our
national blood and blood product system by using applications of health
information technology. A greater knowledge of the barriers and hurdles will
lead to better public and private solutions.
OCR for page 77
Strategies for Dealing with
Potentially Infected Recipients
Ernest R. Simon
The basic premise underlying strategies for dealing with potentially
infected recipients is that recipients may have a need, and certainly have the
right, to know if they may have been infected. Clearly, with the right to know
goes the right not to know. There is substantial evidence that, when asked,
many recipients elect not to know if they may have been infected.
The second basic premise is that look-back is ineffective, inefficient, and
certainly costly, more so for hospitals and physicians than for blood centers.
Only a tiny portion of the time, effort, and cost of current look-back programs
for human immunodef~ciency virus (HIV) and human T-lymphotropic virus
(HTLV) I/II yield productive results. With hepatitis C virus (HCV), the
problems are magnified.
The issue is not look-back versus no look-back, but look-back versus
something better than look-back. Look-back provides a cosmetic approach; I
propose a substantive solution.
There are two situations, those dealing with future recipients (which I will
discuss) and those dealing with prior recipients. For future recipients, a
transfusion episode should be considered to consist of three distinct
components: pretransfusion, the transfusion itself, and posttransfusion actions.
Several weeks before the anticipated need, the prospective transfusion recipient
should be provided with information regarding the benefits of transfusion, as
well as risks and alternatives. In addition, the rationale for testing the potential
recipient for infectious disease markers both prior to the transfusion and after
the transfusion should be clearly explained. The patient should be told of
possible personal benefits that testing might provide. Conditions may be
revealed that modify the type of care that the patient should receive and may
even help with diagnosis. It is important that the testing in no way interferes
with the appropriate care that the patient may get on the basis of the results of
the test. In addition, testing may possibly help identifiable partners of the
patient avoid infection if the patient practices appropriate preventive behavior.
77
OCR for page 78
78
BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK
A second rationale deals with the possible benefit to hospital staff if they
know of the presence of certain potential infectious agents in the patient.
Despite the practice of universal precautions, such knowledge may provide
additional safety to the hospital staff. And finally, pretransfusion testing may
provide a baseline to assuage liability concerns.
It is clear that such viral marker testing is not necessarily limited to
potential transfusion recipients. One can and should consider testing all
surgical patients, or for that matter all patients, because the likelihood of the
presence of infectious agents in patient populations is at least two orders of
magnitude higher than it is in the volunteer donor population. Therefore, the
yield of positive results from testing hospitalized patients is very much higher
than is the yield from testing donors. Such viral marker testing is feasible for
elective surgery. In the case of emergency surgery, a pretransfusioh sample
could be collected and held for subsequent testing as necessary.
The third phase of the transfusion episode takes place 6 to 12 months
after the transfusion and completes the transfusion episode. At this time, the
physician is reminded to contact the patient and/or the patient is reminded to
contact the physician. The testing is repeated. If reactive results are obtained,
confirmatory testing is done and the patient is counseled appropriately. This
approach is analogous to other follow-ups, for example, in surgery, cancer cell
therapy, and so forth.
For hepatitis B virus (HBV), HIV, HCV, and HTLV I/II, current testing
may benefit the patient, a third party, or both. It is clear that both are
benefited with HIV and HBV testing, but with HCV it is unclear whether a
third party is benefited in addition to the patient. For HTLV I/II the benefits
to the patient or third party are questionable. With current screening of the
blood supply and pretransfusion testing of the patient, the incremental
additional yield of positive results at 6 to 12 months posttransfusion would be
expected to be very low.
The advantages over look-back are significant. Because posttransfusion
follow-up is independent of the donor, it casts a wider net. It does not depend
on a repeat donor who is now positive for the marker. It includes recipients
of blood from one-time donors and repeat donors who have not returned or
who have since been eliminated from the donor pool by surrogate tests
performed prior to anti-HCV testing and donors who were subsequently
disqualified without donating.
Furthermore, it reduces or eliminates unproductive administrative
complexities including a tortuous and sometimes flawed records trail and
interventions and follow-ups by blood centers, transfusion services, hospital
records departments, and multiple physicians. It targets surviving recipients
and avoids tracing deceased patients. It embraces future transmissible agents
with ease and shortens the interval between putative transmission and
OCR for page 79
NEW IDEAS FOR SAFETY AND MONITORING
79
detection. Finally, by acknowledging that zero risk for transfusion is not
achievable now, it should be a powerful incentive to decrease the inappropriate
use of blood components.
Implementation is simple.
Informed choice, by which the patient is
informed of possible unexpected outcomes, should precede the transfusion
episode. On discharge the message can be reinforced and specific information
regarding mechanisms for follow-up can be provided. The responsibility for
follow-up could rest with the patient as it should, or it could be expanded by
including the physician. If the patient is transfused and discharged alive, the
hospital information system could trigger automatic reminders to the attending
physician and/or the patient after ~ to 12 months.
An acceptable approach is essential. The specifics are not. By linking
it to appropriate community and physician education with the active
involvement of the U.S. Public Health Service, state and local health
departments, medical and blood service organizations, blood centers, hospitals,
manufacturers, and in particular the national media, routine posttransfi~sion
follow-up becomes an extension of the HIV program recommended by the
Presidential AIDS Commission and the American Hospital Association to its
member hospitals. The message must emphasize that transfusion accounts for
a small fraction of these diseases and that the focus on transfusion recipients
is merely a part of our overall health strategy.
In summary, this approach to future recipients does not mean look-back
versus no look-back, but look-back versus something better than look-back.
The testing approach advocated is substantive. Look-back is cosmetic. A
substantial yield of pretransfusion testing may be expected. The additional
incremental yield of posttransfusion testing is expected to be very low given
the sensitivity of currently used tests.
OCR for page 80
Representative terms from entire chapter:
decision support
