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www.newsday.com SUNDAY, APRIL 7, 2002 ● LONG ISLAND EDITION

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Bad
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A Taste For
Their Work

Blood
Newsday Investigation Finds Transfusion Errors
In Hospitals Kill Scores of Patients Each Year
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 A5

Getting Bad Blood

Hospitals’ transfusion errors cost patients their lives
First in a series
By Kathleen Kerr
STAFF WRITER
The woman with the painful gallstone in Room
242 was scheduled for surgery.
During morning rounds, a phlebotomist went to
the room at Long Beach Medical Center to draw a
blood sample from the woman, 91, to determine a
good match in case she needed a transfusion.
But the phlebotomist made a mistake.
Instead of drawing the sample from the woman,
he drew it from her roommate. He then labeled the
sample with the gall bladder patient’s name.
Soon the sample was on its way to the hospital’s
blood lab for testing and crossmatching. Based on
that lab work, units of blood were prepared for the
gall bladder patient.
Within hours of receiving that blood, the patient
in Room 242 was dead.
* * *
Blood transfusions meant to help save lives have
instead ended in the deaths of hundreds of hospital
patients across the country.
Overall, at least 441 patients died between 1995
and 2001 fol-
lowing trans-
fusions, a
Newsday in-
vestigation
found.
Moreover,
experts sus-
pect the actu-
al number of
transfusion-related deaths is much higher and that Photo by Michael Geissinger
some hospitals fail to report them to the government At least 441 Americans have died as a result of blood transfusion errors between 1995 and 2001, a Newsday investigation finds.
as required. Flaws in state and federal reporting sys-
tems, insufficient government monitoring of hospi- much safer by greatly reducing the risk of HIV in- a variety of reasons, we haven’t found a method
tals and ambiguous federal regulations all help to fection from blood. that’s fail-safe. The number of deaths is remaining
minimize the problem and keep it from the public But little progress has been made in reducing stable because we’re doing nothing about it.”
eye. transfusion error; in fact they have increased from While using the wrong type of blood is the most
A review of government records shows nearly 53 in 1995 — with a spike of 85 in 1998 to 68 in dramatic of all transfusion errors, it also is the most
one in every five of the transfusion-related deaths 2001. preventable. Computer systems, patient wristbands,
was easily preventable: At least 78 of the deaths blood bags which identify patient blood types and
“There are going to be relatively more people who special locks all are available to prevent errors.
reported to the Food and Drug Administration oc- die getting blood and from ABO errors [the wrong
curred after hospital workers gave patients the But the failure of health-care workers to consis-
wrong type of blood. blood],” said Dr. S. Gerald Sandler, director of the tently use these safeguards — sometimes because
Errors like transfusing patients with the wrong blood bank and blood donor service at Georgetown staff cutbacks have increased their workload and
blood, which can be toxic, and incorrect handling of University Hospital in Washington, D.C. “We’ve
blood, which can cause it to develop dangerous clots, reached a transition point with regard to safety. For See BLOOD on A36
have taken a deadly toll. While in some deaths, gov-
ernment officials detected no obvious culprits, in

Transfusion Mistake
most cases involving the wrong type blood, human
error played a role.
Nurses failed to check blood bags to make sure pa-
tients received the right blood. Phlebotomists, who
draw blood, took it from the wrong patients and mis-
labeled samples. And technicians released the wrong
blood for transfusions.
Newsday’s examination of government records ob-
tained through Freedom of Information Act requests
Mars a Nurse’s Career
found eight New York State cases in which patients
By Kathleen Kerr to the job. “I was orienting two new nurses who
died after receiving the wrong type blood between
STAFF WRITER were totally overwhelmed,” Flamm says. “I was
1995 and 2001. frazzled because I was dealing with two girls who
Among the hospitals reporting transfusion-relat- Pamela Flamm is the first to admit she was
frazzled that spring day when she made the were frazzled.”
ed deaths was Harlem Hospital Center, a city-run Both of the young nurses had patients. One
hospital in Manhattan. A unidentified man with worst mistake of her career.
nurse had two patients and both needed blood
burns on his face and arms was taken to the emer- Flamm, a registered nurse, had reported for
transfusions. One patient was a young black
gency room after being found in a vacant build- work at Winthrop-University Hospital in Mineo- woman in her 30s; the other a white man who
ing. He had multiple medical problems, including la. The intensive care unit, where Flamm was close to 70, Flamm says.
NEWSDAY, SUNDAY, APRIL 7, 2002

kidney disease, and died after receiving a transfu-
sion of the wrong type blood.
At Lutheran Medical Center in Brooklyn, a nurs-
ing home patient with a hip fracture received a unit
of incompatible blood during surgery and died.
And at New York University Downtown Hospital
in Manhattan, an 85-year-old woman admitted with
gastrointestinal bleeding died after receiving mis-
matched blood.
To be sure, the vast majority of transfusions re-
ceived by 5 million patients every year in the
United States are uneventful. Recently, new
screening procedures have made the blood supply
worked, was buzzing with patients needing care.
For seven years, Flamm, now 59, had nursed
patients in the intensive care and surgical inten-
sive care units at Winthrop. She travelled daily
from her home in Centerport and enjoyed her job.
It was, she says, the only work she ever wanted
to do.
Accustomed to a high volume of work in inten-
sive care, Flamm hadn’t been assigned to any pa-
tients that day, April 4, 1994.
Instead, Flamm says, the head nurse asked her
to help oversee two young nurses who were new
The young nurse, apparently nervous, needed
help taking blood samples. Flamm stepped in to
do the procedures herself to make sure all went
well.
“I jumped in to help her,” said Flamm. “I was
trying to take the burden off her.”
Flamm drew blood to be typed and cross-
matched from both patients. But moments later,
Flamm did something that would change her ca-
reer forever — she mistakenly labeled one of the
See NURSE on A36
A36
Mistake Disrupts Nurse’s Career
NURSE from A5
blood specimens with the wrong patient’s name.
Then she sent the specimens off to the hospital’s lab.
Flamm and the other nurses obtained doctors’ or-
ders for the transfusions based on those samples.
Once they had the orders, Flamm received a unit of
blood for the female patient from the hospital’s blood
lab. She hung the unit and began transfusing the
NEWSDAY, SUNDAY, APRIL 7, 2002
woman.
Then the phone rang. It was the lab. A technician
had a question about the blood samples Flamm had
drawn and suddenly she realized she had made a ter-
rible mistake.
“I was totally at fault,” says Flamm. “I quick ran
in and stopped the woman’s transfusion.”
Flamm said the patient hadn’t received much
blood and appeared to be fine. Flamm believes the
woman never knew she’d gotten the wrong blood.
“She was fine; it was amazing,” says Flamm. “I
just prayed to God and I was so grateful that every-
one was OK.”
Newsday / Linda McKenney
That was not the end of it.
The hospital reported Flamm’s mistake to the
New York State Education Department’s Office of
the Professions. She was charged with gross negli-
gence.
Flamm’s case dragged on as professional disci-
pline cases often do. Finally, the State Board of Re-
gents suspended Flamm on March 13, 1996, for one
year with the understanding that the suspension
would be stayed.
“I didn’t fight it,” Flamm says. “I had made a mis-
take.”
Winthrop-University Hospital fired Flamm, and
she never again worked in a hospital. While Flamm
accepts full responsibility for her error — a mistake
that could have killed the patient — she doesn’t
think she should have lost her job. She blames that
on hospital politics.
“I believe I was fired as an example that you can’t
make a mistake, you have to be very careful,” says
Flamm. “I don’t think I deserved to be terminated.
That was the most devastating thing that ever hap-
Errors
BLOOD from A5
prompted them to seek shortcuts —
have experts worried.
“Staffing at blood facilities is al-
ready critically low,” warned Susan
Wilkinson, then president of the Amer-
ican Association of Blood Banks, in
1999. “With additional cuts, we can ex-
pect to see a different kind of safety
failure. While we are relatively safe
from known transmissible diseases,
more errors and accidents are likely to
occur as overworked people make mis-
takes.”
Government statistics probably
don’t reflect the full scope of the trans-
fusion problem. While the FDA re-
quires hospitals to report such deaths
within seven days, transfusion experts
said they suspect many hospitals fail
to report, skewing government figures.
Dr. Kathleen Sazama, a vice presi-
dent at the University of Texas M.D.
Anderson Cancer Center, says the
FDA’s reporting system is flawed.
After comparing FDA figures to medi-
cal literature on transfusion-related
deaths, Sazama estimates as little as 5
percent of all transfusion-related
deaths are reported.
“The problem has been that until re-
cently, many hospitals didn’t realize
they were required to report the
deaths,” Sazama said.
Agency officials discount claims of
problems. “We do not perceive underre-
porting as a problem,” said Jason Brod-
sky, an FDA spokesman. “However,
we have seen during our inspections in-
stances when reports were not sent in,
and we realize as with any regulatory
requirement, there’s always room for
improvement.”
* * *
After the Long Beach Medical Cen-
ter blood lab crossmatched the blood
sample labeled with the name of the
gall bladder patient in Room 242, she
was prepared for surgery. Later, on
Dec. 3, 1996, her operation began.
The surgeon performed a minimally
invasive procedure that required just a
small abdominal incision. He inserted
a surgical tool equipped with a small
basket. The idea was to grab the gall-
stone, crush it and remove it.
But the gallstone was large and the
surgeon couldn’t crush it.
He decided to try again the next day
with another instrument and trans-
pened to me.”
Winthrop officials declined to comment for this
story.
Suddenly, the veteran nurse — who says she was
Phi Beta Kappa with a degree in languages from
Hunter College and president of her class at Belle-
vue School of Nursing — was suspended by the state
nursing board for one year. In the same action, the
state stayed the suspension of Flamm’s license and
put her on probation for one year.
“I never wanted to be a nurse again,” Flamm says.
“I didn’t look for a job.”
Eventually, Flamm took a sales job in the home de-
partment at Macy’s in Huntington, selling linens
and other household goods. Later, she went into
homecare, nursing patients in their homes.
For four years, Flamm confined her work to home
care, but now she also works at a nursing home part
time. Along the way, she has taken refresher courses
in nursing and she still has a state nursing license.
“I love nurturing people and taking care of peo-
ple,” says Flamm. “My private patients are terrific.”

Costing Hospital Patients’ Lives
ferred the woman to intensive care for
observation while she awaited the sec-
ond procedure.
Before her second surgery, the
woman needed a transfusion to in-
crease her red blood cell count.
Shortly after the transfusion began,
the woman’s condition went into a
free-fall. Her blood pressure plum-
meted and she had chills, signs of a
blood mismatch.
Nurses stopped the transfusion, dis-
covering that the Type O negative pa-
tient had received Type A positive.
With the wrong type blood circulat-
ing throughout her body, the woman
suffered “an acute transfusion reac-
tion to this unit of blood” according
to FDA records. “It was found that
the blood given did not match the pa-
tient’s blood.”
At about 4 a.m. on Dec. 4, 1996, she
died.
* * *
Like the case of the woman in Room
242, most transfusion-related deaths
are shrouded in secrecy with govern-
ment officials refusing to name pa-
tients and workers involved in their
care. Officials say they need to protect
patient privacy, but they also worry
about the reputations of those who
make errors.
Arthur Caplan, director of the bioet-
hics center at the University of Penn-
sylvania, until recently headed a U.S.
Department of Health and Human Ser-
vices blood safety committee. Caplan
says the government needs to address
the fear of lawsuits that he believes
keeps hospitals from reporting all the
transfusion-related deaths.
“Liability fears completely corrupt
and compromise adverse event report-
ing,” Caplan said. “It stinks.”
Caplan wants a no-fault system
with fixed penalties for errors and
limits on lawsuits so that hospitals
wouldn’t fear multimillion dollar pay-
ments.
During the Clinton administration,
Caplan’s committee asked the govern-
ment to require all blood establish-
ments — including hospital transfu-
sion services — to report all errors.
Last year, the government began re-
quiring such reporting. But hospitals
must only report laboratory errors, not
mistakes on patient floors, where the
majority of errors happen.
Acting like a crimson poison, the
wrong type blood can kill by triggering
the body’s natural defense system.
There are four blood types: A, B, AB
and O. Technicians test patients’ blood
samples prior to transfusion so they re-
ceive good matches.
Reactions to the wrong blood can be
compared to reactions to bee stings:
Most people suffer only mild reactions,
but some die.
As with bee venom, when the body
receives the wrong blood it marshals
its defenses. If only a small volume of
the wrong blood is transfused, a pa-
tient’s protective antibodies may suc-
cessfully attack and kill the foreign
proteins in the blood, leaving the pa-
tient unharmed.
But in a serious reaction, shock, clos-
ing of the airways and severe loss of
blood pressure may occur. That’s be-
cause as the body’s antibodies attack
the large numbers of foreign proteins
attached to red blood cells, they de-
stroy the cells as well.
Blood safety experts caution pa-
tients to know their own blood type
when they enter a hospital and to dis-
cuss it with friends, relatives, doctors
‘There are going to be
relatively more people
who die getting blood
. . . We’ve reached a
transition point with
regard to safety. For a
variety of reasons, we
haven’t found a method
that’s fail-safe.’
— Dr. S. Gerald Sandler
and nurses.
Statewide, the number of reported
deaths which followed transfusions of
the wrong blood is about 10 percent of
the national total. But New York has
more stringent reporting require-
ments than some states, which may ac-
count for its higher numbers.
The transfusion problem extends
from coast to coast, government
records show. At the University of Cin-
cinnati Medical Center, for example, a
man died after receiving two units of
Type B blood instead of Type O. A tech-
nician entered the wrong digit into a
Photo by Michael Geissinger
Newsday File Photo
computer when entering the patient’s
ID number for a crossmatch.
And at the St. Francis Medical Cen-
ter in Lynwood, Calif., a man died
after receiving Type A positive blood in-
stead of Type O positive after a nurse
mixed up units of blood stored in a hos-
pital refrigerator.
Dr. James AuBuchon, pathology
chairman at Dartmouth-Hitchcock
Medical Center in Lebanon, N.H., esti-
mates at least 25 people nationwide
die each year — or 150 since 1995 —
after receiving the wrong blood, far
more than the government’s count.
A37
“I think we’re concerned about them
[wrong blood errors] because they are
preventable and they are so devastat-
ing [to] the patients . . . They die
quickly and in spite of our best ef-
forts,” AuBuchon said.
FDA regulations require a written
report on the deaths within seven
days. But the regulations are fuzzy, al-
lowing hospitals to make subjective
judgments about a transfusion’s role
in a death.
Dr. Jeanne Linden, director of
blood and tissue resources for the
New York State Health Department,
says she does not count all deaths
which follow transfusion errors as
transfusion-related.
Linden says she counted only five
transfusion-related deaths in the state
over a 10-year period, while FDA
records showed 20 reports between
1995 and 2000 — eight involving
wrong blood transfusions.
Linden considers the underlying
cause for hospitalization. If, for exam-
ple, a patient is treated for severe kid-
ney disease, receives the wrong blood
and dies, the death might be blamed
on the kidney problem.
Those hospitals that don’t report
deaths at all are a major problem.
AuBuchon says the FDA needs a bet-
ter tracking system.
“Frankly, the FDA doesn’t help
you very much with the investiga-
tion [of the deaths] or coming up
with an alternative. Their ability to
analyze the data and feed back to
the blood bankers of the country is
very limited by their staffing num-
bers and their other responsibilities,
so that they cannot provide assis-
tance to solve the problem.”
Some say cases like that of the Long
Beach Medical Center woman, whom
officials refuse to identify, illustrate
the problems with the federal report-
ing system.
“The system doesn’t bring patients
justice, it doesn’t compensate those
who are injured and it drives the re-
porting underground,” says Caplan, of
the University of Pennsylvania.
After all, Caplan says, “Blood is to
health care as oil is to transportation.”
* * *
Long Beach Medical Center officials
acknowledge the transfusion error
that occurred before the woman in
Room 242 died.
“Our conclusion from the investiga-
tion was that he [the phlebotomist who
drew the woman’s blood for testing]
failed to properly identify the pa-
tients,” said Cheryl Chapman, a hospi-
tal spokeswoman.
The phlebotomist should have
checked the wristband of the patient
whose blood he drew, making sure
he drew the sample from the right
patient. He should have confirmed
her name.
The hospital suspended the phleboto-
mist, who resigned two days later, and
entered into a undisclosed legal settle-
ment with the woman’s family.
NEWSDAY, SUNDAY, APRIL 7, 2002
After the death of the woman in
Room 242, transfusion workers at
Long Beach Medical Center received
additional training on procedures to
follow.
Chapman, the hospital spokeswom-
an, said there were no immediate
plans to install a computer system
aimed at preventing similar transfu-
sion errors. She said: “We have not at
this time investigated that type of sys-
tem because we do not feel at this
point in time that that’s necessary.”
A6 By Kathleen Kerr
STAFF WRITER
T
wice within three hours, amid a
series of serious mistakes, work-
ers at Coney Island Hospital
transfused Ira Medjuck, a car
crash victim, with the wrong type of
blood.
Almost three weeks later, Medjuck
died. Coney Island Hospital main-
tained Medjuck’s injuries from the
crash caused his death on Aug. 10,
1995. Medjuck’s family blamed the
botched transfusions.
A state investigation found six em-
ployees made transfusion-related er-
rors in the case, and the state health
commissioner at the time, Barbara De-
Buono, ordered the hospital to file
monthly reports to show “that all or-
ders for administration of blood and
blood components are issued through
the computer.” Medjuck received the
wrong blood after a technician failed to
make computerized checks.
Now, more than six years later,
Newsday has found that while state of-
ficials assumed from the hospital’s
monthly reports that it was using a
computer to avoid more transfusion
mistakes, that was not the case.
In fact, the hospital’s blood bank
computer broke on Dec. 29, 1995, a few
months after Medjuck died, and work-
ers checked blood destined for transfu-
sion by hand for 10 months. The hospi-
tal did not have a fully operational
computer to make transfusion match-
es until the summer of 1997.
State Health Department officials
said last week they thought Coney Is-
land was using a blood bank computer,
although one of the hospital’s reports
seemed vague. The state would have
considered hand checks “an acceptable
alternative” had they known about
them, Health Department spokeswom-
an Kristine Smith said.
“We will be looking into this issue
further to determine the basis for the
miscommunication about use of the
computer,” Smith said.
Coney Island Hospital spokesman
Brian Palmer confirmed the 10-month
period when the blood bank didn’t use
a computer to match blood. Palmer
said the manual checks of transfusion
blood, later coupled with the use of a
nonvalidated computer, were safe.
“ ‘Validated’ means it had not yet
been properly put through all its paces
so it could be used accurately,” Palmer
said.
Health Department officials were
also unaware, until informed by News-
day, that in 1997 federal inspectors
criticized the Coney Island blood bank
for not using a fully operational com-
puter, Smith said. At that time, Coney
Island had combined its hand checks
of blood with checks on a computer
that hadn’t undergone necessary test-
Lack of ID Adds to Harlem Error
NEWSDAY, MONDAY, APRIL 8, 2002
By Kathleen Kerr
STAFF WRITER
When the man identified later as UBM2 was
found in an abandoned building in Manhattan, he
had been struck in the head, and burns covered his
face and arms. An ambulance raced him to the hospi-
tal.
On Jan. 15, 1997, UBM2 arrived at the Harlem
Hospital Center emergency room. He was in a coma
and his brain was hemorrhaging.
Workers in the emergency room couldn’t find any
When Checks
Of Blood Type
Fail a Patient
Man’s death exposes gaps
in state monitoring of errors
Photo by Richard Harbus
Workers at Coney Island Hospital gave Ira Medjuck, below, the wrong type of blood, twice.
‘He was the world,
the whole world.’
— Yetta Medjuck about
her son Ira, left
ing for accuracy. Whether or not Coney Island Hospi-
The federal inspectors’ report stat- tal used a computer to process blood
ed, in part: “During the inspection, cer- after Medjuck’s death was important
tain glitches were found in the system because it was a technician’s failure to
. . . . Mr. Buglione [in the blood bank] do computerized blood checks that led
was informed that any information ob- to the transfusion errors in his case.
tained using a nonvalidated computer Years before, the hospital had realized
system is highly unreliable.” the importance of a blood-matching
identification for UBM2. He was a middle-aged
black man with a mustache and salt-and-pepper
hair. Emergency room workers wrote “UBM2” on his
wristband, for “unidentified black male.” The “2” dis-
tinguished him from another unidentified patient,
UBM3, with similar physical characteristics.
UBM2 had chronic kidney failure unrelated to his
injuries. A urine screen showed cocaine and opiates
in his system. After two weeks in the hospital and
several transfusions, UBM2 needed still more blood.
A physician’s assistant went to the hospital’s blood
computer when it installed one after
another blood mismatch in 1992.
Medjuck’s case starkly illustrates
the continuing failure of government
officials to monitor transfusion errors
adequately, said Arthur Caplan, a med-
ical ethicist at the University of Penn-
sylvania’s School of Medicine.
“The state’s performance is incredi-
bly unacceptable. It’s a breach of the
public trust for the state not to be vigi-
lant when the citizens of New York de-
pend on safe blood,” Caplan said. “In a
case like this, if you’ve got errors, the
state has to go in and enforce its over-
sight.”
On July 20, 1995, Ira Medjuck had
just finished his overnight shift with
New York City’s Emergency Medical
Service in Brooklyn and was driving
home.
Medjuck, a paramedic, headed to-
ward Mill Basin, where he and his
wife, Leah, rented an apartment just
steps from the brick house where he
grew up. They often ate meals with
Medjuck’s parents. Medjuck planned
to move to Israel with Leah and pro-
vide medical services in the occupied
territories.
Suddenly, on the Belt Parkway near
Knapp Street, another car jumped the
median and hit Medjuck’s car from the
front.
Within minutes, an ambulance was
speeding Medjuck to Coney Island Hos-
pital’s emergency room.
Leah and Medjuck’s parents rushed
to the hospital. Yetta Medjuck remem-
bers the phone call telling her that Ira,
her first child, born after 19 years of
marriage, had been in a terrible acci-
dent.
Medjuck had two fractured legs and
serious internal injuries. Later that
day, doctors at Coney Island operated
to stop internal bleeding.
“The doctor worked on him all day
Thursday; we made sure they should
call us if there were problems,” Med-
juck’s mother recalled as she sat at her
kitchen table sorting through wedding
pictures of her dark-haired son and his
wife.
“He was the world, the whole world,”
she said.
By 3:23 a.m. Friday, the day after
the accident, Medjuck needed blood.
Doctors ordered a transfusion compati-
ble with Medjuck’s own blood type, O
positive.
Standard procedure at Coney Is-
land, operated by the New York City
Health and Hospitals Corp., called
for technicians to use a computer to
make sure patients received the
right blood. But the blood bank tech-
nician on duty didn’t use the comput-
er. She mistakenly took a unit of A
positive blood and released it for
transfusion.
Then a second mistake occurred.
A nurse in surgical intensive care
failed to check the identification on
Medjuck’s wristband, which didn’t
match the identification on the blood
bag.
The nurse transfused Medjuck with
the blood. The transfusion was the
worst possible mismatch: A positive
See HOSPITAL on A27
bank with pickup slips for O positive blood for
UBM2. Meanwhile, another physician’s assistant
had already gone there for A positive blood for
UBM3 but didn’t take the necessary pickup slip. The
worker promised to return in 10 minutes with the
pickup slip for blood for UBM3.
There was clearly room for confusion.
Soon, a unit of A positive blood was dripping slow-
ly through a plastic tube into UBM2, who required O
positive. The worker who picked up the blood for his
See BLOOD on A27

Case Shows Gaps in Monitoring
HOSPITAL from A6
blood going into an O positive pa-
tient. Those blood types have the
most violent reactions to each other.
With the wrong blood coursing
through Medjuck’s veins, his blood
pressure dropped and his tempera-
ture rose from 100.6 degrees to 103.9
degrees. Still, nurses failed to recog-
nize his abnormal reactions. The
transfusion continued.
Later, a surgical resident and a su-
pervising fifth-year resident also
failed to recognize that Medjuck was
having textbook reactions to mis-
matched blood.
Around 6:00 a.m., a second unit of
blood was requested for Medjuck.
The blood bank again issued the
wrong type blood, and a nurse again
neglected to check Medjuck’s identifi-
cation.
At 7 a.m., the blood bank received
a third request for blood for Medjuck.
This time the blood bank discov-
ered the earlier mistakes. It was too
late, however; his body had already
begun to react to the incompatible
blood. His kidneys were shutting
down. Hospital workers began dialy-
sis.
Later that morning, Medjuck’s
younger brother, Bruce, called the
hospital and learned about the trans-
fusion errors. Medjuck’s family raced
to the hospital.
“They said they ran into a prob-
lem,” Yetta Medjuck remembers.
“The doctors said they gave him the
wrong blood, but they were working
on it.”
She said she “got the feeling things
were going wrong. They had to take
him down to surgery a couple of
times. For three weeks, he strug-
gled.”
Then, while Medjuck’s parents ob-
served a Jewish fast day in the syna-
gogue near their home, he took a
turn for the worse.
“Someone came in and said, ‘You
have to go to the hospital right
away,’ ” Yetta Medjuck said.
Hours later, on Aug. 10, 1995, Med-
juck died. He was buried in Wellwood
Cemetery in Suffolk County, but Med-
Harlem Patient’s Lack of ID Contributes to Death
BLOOD from A6
transfusion had picked up two units
meant for the other unknown patient
by mistake, and the person on duty in
the blood bank hadn’t caught the
error.
Another unit of A positive blood was
placed in a storage refrigerator on the
floor for possible transfusion into the
patient later on.
Then, his doctors requested still
more blood for him. A blood bank em-
ployee reviewed the requisition slip, re-
alized an error had occurred and
warned hospital workers to retrieve
the remaining unit of blood stored in
the refrigerator.
According to a report on the case
Newsday found in Food and Drug Ad-
ministration files: “Recognizing that a
mismatched transfusion had occurred,
the supervisor notified the blood bank
director and the physicians taking
care of the patients immediately after
the mismatch.”
Neither the blood bank supervisor
nor the employee who picked up blood
for the patient had done the required
juck’s death didn’t end his case.
The care that Medjuck received at
Coney Island, as well as details on
the transfusion-related errors, are
documented in a report state investi-
gators wrote within months of the
paramedic’s death.
Coney Island officials didn’t report
Medjuck’s death to the Food and
Drug Administration. While FDA reg-
ulations require reporting of all trans-
fusion-related fatalities, the rules are
open to interpretation, with some hos-
pitals reporting any death in which a
troublesome transfusion might have
played a part and others reporting
only those deaths clearly caused by
transfusions.
The reporting requirement is in-
tended as a means to track deaths
and respond to the transfusion
error problem in hospitals across
the country.
When FDA inspectors learned
about Medjuck’s death during a rou-
tine inspection, they wrote a report
critical of Coney Island’s failure to re-
port it to the agency.
After visiting Coney Island in early
1996, FDA inspectors David DeLucia
and Evelyn Taha wrote a report stat-
ing that the hospital “failed to notify
the Director, Office of Compliance,
Center for Biologics Evaluation and
Research within 7 days after a fatal
recipient transfusion reaction.”
The report continued: “I informed
Dr. Fernandez [the hospital’s blood
bank director] and other blood bank
staff that soon after they discovered
that two units of incompatible red
blood cells were transfused, and that
the patient had a hemolytic transfu-
sion reaction and subsequently ex-
pired, it is their obligation to report
such an incident to the Office of Com-
pliance.”
A letter from the hospital’s Gloria
Fernandez to the FDA states Med-
juck died as a result of complications
of his injuries, not from the transfu-
sions.
“In view of the above conclusions,
it was decided that this fatality was
not a reportable incident to the
FDA,” Fernandez wrote.
An FDA official overruled the find-
checks. They failed to check pickup
slips, a blood compatibility slip and
the label affixed to the blood bags,
FDA records show. And both a physi-
cian transfusionist and a nurse failed
to make the required checks before
transfusing him.
It was too late.
Already seriously ill from his inju-
ries and chronic kidney disease, the
man had a severe reaction to the mis-
matched blood. He began wheezing
and went into kidney failure, a com-
mon reaction to mismatched blood.
Hospital workers began dialysis in an
attempt to save him.
Eight hours later, at 7:40 p.m. on
Jan. 30, 1997, he died.
Dr. Diane Karluk of the New York
City medical examiner’s office per-
formed an autopsy. Karluk’s autopsy
report described the cause of death
this way: “Transfusion reaction from
mismatched blood transfusion for
treatment of complications of second-
and third-degree scald burns of face
and extremities (10% total body sur-
face) and blunt impact to head with
subdural hemorrhage.”
ings of the agency’s inspectors and
said a hospital report on Medjuck’s
death was not necessary.
Jerome Woyshner, director of the in-
vestigations branch of the New York
district office, wouldn’t discuss Med-
juck’s case with Newsday but sent a
letter to the newspaper stating:
“The medical examiner’s determi-
nation lists the immediate cause of
death as blunt impact injuries sus-
tained during a head-on motor vehi-
cle collision.”
Along with his letter, Woyshner in-
cluded a photocopy of what appears
to be a page from the medical examin-
er’s report which confirms his state-
ment. Another entry on that page
states that a “reaction to transfu-
sions of unmatched blood” was a sig-
nificant condition that contributed to
Medjuck’s death.
Neither regional nor national FDA
officials were willing to discuss Med-
juck’s case in an interview.
Caplan, the University of Pennsyl-
vania medical ethicist, says the hospi-
tal should have reported Medjuck’s
death to the FDA. Until recently, Ca-
plan headed a blood safety advisory
committee for the U.S. Department
of Health and Human Services,
which oversees the FDA.
“I find it appalling, unacceptable,”
Caplan said. “They should have such
a report. Transfusion mistakes are
major, but unpublicized, problems in
the world of blood. I think it would be
fair to say it is vital to have all
deaths reported so that problems can
be detected, patterns observed and ac-
tion taken.”
The New York State Department
of Health investigated Coney Is-
land after the transfusion mistake
and criticized the hospital’s blood
bank procedures as well as nurses
and doctors on duty when Medjuck
received the wrong blood. The
Health Department fined Coney Is-
land $20,000 for the errors in Au-
gust 1995 but immediately reduced
the amount to $13,000.
A head nurse, a nursing supervi-
sor, a staff nurse and a laboratory
technician all resigned. The state
nursing board ordered a one-year sus-
Karluk listed hypertensive cardio-
vascular disease and chronic renal fail-
ure as contributory to the death and
wrote that the patient’s overall progno-
sis had been poor because of his inju-
ries.
A synopsis of a meeting of Harlem
Hospital Center’s transfusion commit-
tee differs somewhat from Karluk’s
conclusion, blaming his death on his
pre-existing illnesses: “The mistransfu-
sion occurred because of human error
associated with failure to follow trans-
fusion policy and procedure . . . The
cause of death was, however, not the
mistransfusion but the pre-existing ill-
nesses — in particular acute renal fail-
ure.”
Yet another report filed with the
FDA states: “Patient expired about 12
hours later of disease-related causes,
per his physician. Administration of
wrong type blood unit may have con-
tributed to patient’s compromised con-
dition.”
New York City Medical Examiner
Charles Hirsch said in an interview
that different conclusions about a
death can be a question of judgment.
A27
pension for one of the nurses but
stayed the suspension, placed her on
probation and fined her $500.
On Jan. 17, 1996, the state ordered
the hospital to make monthly reports
for a period of six months, showing
that all orders for transfusion blood
were issued through a computer and
that everything was in order.
While the hospital filed monthly
reports, it didn’t use a computer to
monitor blood and instead did man-
ual checks for 10 months. The hos-
pital’s computer had crashed on
Dec. 29, 1995, and wasn’t replaced
until October 1996. Health depart-
ment officials say they weren’t
aware of the manual checks.
Dr. Jeanne Linden, the state
Health Department’s director of
blood and tissue resources, said:
“They told us they were using the
computer.”
FDA inspectors who visited
Coney Island in June and July
1997 discovered continuing prob-
lems, including the blood bank’s
failure to validate or test a new
computer, which was installed in
October 1996 but wasn’t fully func-
tional because it needed validation.
Agency inspectors cited the hospi-
tal for its failure to use a validated
computer system, calling the practice
a deficiency.
In 1999, the New York City Health
and Hospitals Corp., which runs
Coney Island Hospital, agreed to pay
Medjuck’s wife, Leah, a $2.23 million
settlement. Avir Kagan, medical di-
rector at Coney Island Hospital, later
told Newsday: “The settlement of a
malpractice case does not necessarily
mean anyone has accepted what the
cause of death was.”
“He [Medjuck] had very, very se-
vere injuries,” Kagan said. “He was
really not destined to make it, in
our opinion. In our opinion, we
don’t know what the major cause of
death was.”
Leah Medjuck has moved to Israel
and remarried. Yetta Medjuck still
disagrees with the hospital about
what caused her son’s death.
“What finished him,” Yetta Med-
juck says, “was the blood.”
“It is indeed possible that we looked
at it, evaluated it and expressed our
opinion,” Hirsch said. “Maybe they
had a panel [of medical experts] and
came to a different conclusion.”
Dr. Glendon Henry, medical director
at Harlem Hospital, said he believes
hospital systems in place at the time,
rather than the employees, were to
blame for the bungled transfusion.
“It had to be the process,” Henry
said. “It’s not unusual for inner-city
hospitals to have a number of un-
known individuals at one time.”
Henry said unidentified patients at
NEWSDAY, MONDAY, APRIL 8, 2002
Harlem Hospital are now given what
he describes as more precise identifica-
tion. The wristband of such a patient
might read, for example, Jan. 15,
2002, Patient Number 1. Blood sam-
ples must be accompanied by a slip
identifying the worker who drew the
blood. Two people in the blood bank
must verify that signed blood samples
and units sent out for transfusion
match.
“We require our staff to label it
[blood] right away and make sure it’s
for the right person,” Henry said.
 Newsday TUESDAY, APRIL 9, 2002

HEALTH&DISCOVERY
ECOLOGY
The Plight
Of Yellowstone’s
Quaking
Aspens
D3

PLUGGED IN
Web Site Fees

Computers
In the Car

Lou Dolinar
On Online
Accounts
D8-9

THE HEALTHY MAN

Photo by Michael Geissinger

A nurse at Georgetown University Hospital scans a code on a unit of blood at a patient’s bed to confirm its suitability.

Tracking
Transfusions
N

Going Out
To the Ballgame?
Easy on the Hot Dogs Last in a Series / Pages D6-7
D4
D6
ERROR-FREE TRANSFUSIONS
Health & Discovery
Last in a series
By Kathleen Kerr
STAFF WRITER
ECHNOLOGICAL advances,
T
including sophisticated new com-
puter systems and special locks
designed to prevent hospital
workers from making tragic mis-
takes, could hold the key to safer
blood transfusions.
More patients die from receiving the
wrong blood than from any other transfu-
sion error. Sheer carelessness and over-
worked hospital staffs are often the cul-
prits. Transfusion experts estimate that
as many as one in 12,000 units of blood
may be given to the wrong patient.
While most people suffer no lasting inju-
ries following transfusion mistakes, the
consequences for those who are affected
can be severe, even deadly. And the prob-
lem, experts say, is growing.
“The real issue is that most of the errors
that occur don’t have to do with the testing;
they have to do with misidentification of the
unit or patient,” says
Kay Gregory, director
of regulatory affairs
for the American Asso-
ciation of Blood
Banks. “This is some-
thing that every hospi-
tal worries about all
the time.”
Mismatched blood
is dangerous because the body’s immune
system rallies its defenses to fight against
blood of the wrong type. That can lead to
kidney or lung damage and even death.
Before blood can be transfused, laborato-
ry technicians test samples of patients’
blood to determine whether their type is
A, B, AB or O. Then they make sure that
the hospital has enough of the right blood
on hand for the patient.
But getting the right blood to the right
patient is another matter. Although most
hospitals train transfusion workers how to
check blood both in the blood bank and at
the patient’s bedside to make sure it goes
the right person, training alone can’t pre-
vent errors and deaths.
Now, some transfusion experts say en-
hanced computer systems may hold the
key to error-free transfusions.
At Georgetown University Hospital in
Washington, D.C., the staff is using a so-
phisticated computer system aimed at wip-
NEWSDAY, TUESDAY, APRIL 9, 2002
ing out transfusion errors in its outpatient
transfusion unit. While other hospitals do
have computerized transfusion systems,
Georgetown believes its system is the most
comprehensive one in use in U.S. hospitals.
Georgetown uses handheld computers
To read the entire
blood transfusion
safety series, log on
to www.newsday.com.
I n
A look at one approach — considered the most foolproof error prevention system in use
and bar codes to track blood samples from
the time they’re drawn from patients to
the blood lab. The same method is used to
match blood in the lab and to make sure it
gets transfused into the right patients.
The Georgetown system, called I-TRAC
and developed by the Immucor company of
Norcross, Ga., uses a handheld computer
similar to a Palm Pilot that goes through a
series of checks.
If a nurse or technician skips an identifi-
cation check at any point during the trans-
fusion process, the computer will not per-
mit them to continue. The system tracks a
blood sample from the patient’s bedside
through the blood bank. Then the system
tracks a blood unit that matches the sam-
ple from the blood bank to the point of
transfusion.
Dr. Gerald Sandler, director of George-
town’s blood bank and blood donor service,
thinks the I-TRAC may be the most fool-
proof transfusion error prevention system.
“In my opinion, 100 percent of these [er-
rors] are preventable,” Sandler said. “I can
save and prevent every transfusion error
in this hospital.”
Sandler said that
as far as he knows,
Georgetown hasn’t
had a single fatality
due to a blood mis-
match since it began
using the system more
than three years ago.
Sandler cautioned,
however, that the
I-TRAC system isn’t suited for all sections
of a hospital. Emergency rooms, where
quick treatment is often necessary, might
be better served with a wristband system
using color coding instead of the more
time-consuming bar code / computer sys-
tem, Sandler said.
Noel Brown, a vice president for Im-
mucor, estimates that licensing and soft-
ware fees for the system would cost a
hospital a one-time payment of $75,000.
The hardware — one set for every 11
beds — would cost about $3,000 per set.
And there would be a $6,000 annual soft-
ware maintenance fee.
Brown calculated that such a system
would add about $1.39 to the cost of each
unit of transfused blood.
While high-tech computer systems ap-
pear to offer one of the best ways to pre-
vent transfusion-related deaths, some hos-
pitals use a more modest but effective lock-
ing device to prevent mistakes.
Dr. James AuBuchon, a transfusion ex-
pert and pathology chairman at Dart-
mouth-Hitchcock Medical Center in Leba-
non, N.H., finds blood locks effective.
“It prevents a human error that may
have happened in the chain from causing
a disaster,” AuBuchon said.
Patients have three-letter codes on their
wristbands. When a blood sample is
drawn to be tested, the patient code is writ-
ten on the tube of blood. When the hospi-
tal blood bank sends out a unit of blood for
transfusion into a specific patient, it em-
beds the patient’s code into a small plastic
lock at the top of a plastic bag resembling
S e
The I-TRAC system in action
5 6
The blood sample is
delivered to the lab,
where bar coding
prevents technician
from ordering an
incorrect unit of blood.
Compiled by staff
Step-by-Step
1 2
Using a computer, a
doctor orders a unit
Photo by Michael Geissinger
of blood for a patient.
The process begins
by taking a blood
sample to determine
the patient’s blood
type.
7 8
The technician puts a
second bar code on
the blood unit to be
transfused, and the
blood is delivered to
patient’s bedside.
a r c h O f
a Ziploc bag. The actual blood bag is in-
The I-TRAC transfusion safety system is in use at
Georgetown University Hospital. Here’s a look at how it works.
serted into the bag with the lock.
The transfusionist reads the patient’s
wristband code and uses it as a combina-
tion to unlock the blood lock on the plastic
bag. If the code doesn’t unlock the lock,
3 4
blood can’t be transfused.
Still, not all hospitals like the locks.
“Some hospitals think it is too cumber-
some, and indeed it took us about six
months’ worth of meetings to set up all
the systems to use the blood lock,” AuBu-
chon said. He said some hospitals think
The phlebotomist uses a The handheld the expense of installing blood locks isn’t
hand held computer to computer is
worth the effort. The locks cost about $3
scan first his or her ID connected to a each. But “this $3 cost would prevent
badge – which contains portable printer, about two dozen deaths per year nation-
a bar code with crucial which generates a bar wide,” AuBuchon said.
tracking information – code label for the By comparison, the most recent test for
then the patient’s blood sample taken The sample is HIV costs about $8 per test and prevents
wristband code. from the patient. immediately labeled. about one HIV transmission per year,
AuBuchon said.
In New York State, over a nine-year pe-
riod, patients received the wrong blood
427 times. But transfusions of the wrong
type blood aren’t the only errors that
REPOR occur in hospitals.
9 REPORT
T Between October 1999 and September
2000, a nationwide total of 23,528 trans-
fusion-related errors and accidents were
BEEP reported to the Food and Drug Adminis-
tration, mostly by manufacturers of
blood and plasma products. Most of the
errors had to do with problems like
blood processing and contamination,
The nurse examines Beep or visual signal After transfusion, the poor storage that made blood products
the patient’s wristband, confirms positive IDs. nurse scans his or her less potent and the collection of blood
confirms it by scanning ID badge, patient’s from unsuitable donors exposed to vari-
bar code, and scans wristband and the ous diseases and the like.
the blood bag barcode blood label to generate Testifying in 2000 before a U.S. Health
to confirm a medical record and and Human Services Department blood
compatibility. a record for the blood safety committee, Dr. Jeanne Linden, di-
bank.
rector of blood and tissue resources for the
New York State Health Department, de-
Newsday / Linda McKenney
scribed the problem in New York.
“I think the systems are complex and
human beings are prone to error,” Lin-
den later told Newsday in an interview.
“The systems can be improved to make
things easier for people, to make those
mix-ups less frequent.
“The No. 1 problem is the right blood
Georgetown gets all the way to the hospital floor and
University a nurse administers it to the wrong per-
Hospital uses son,” Linden said. “Our experience is
handheld that the wristband often is not checked.
computers They should match the blood bag to the
and bar codes wristband. Sometimes the nurse just
to track blood compares paperwork on the requisition
samples from the order.”
hospital’s blood But the wristband doesn’t guarantee
bank, where Al safety.
Langeberg works, “Sometimes in the operating room, the
left, to the wristband is removed,” Linden said.
patient’s bedside Hospital staffing shortages also pose a
for the transfusion, huge problem: Harried technicians and
prepared by nurses may cut corners under pressure
registered nurse and make fatal mistakes.
Jennifer Jay, Preventing errors isn’t the only problem
right. associated with transfusion deaths. Incom-
plete reporting of transfusion errors
masks the full extent of the problem.
The problem is so urgent that the
Health and Human Services blood safety
Photos by Michael Geissinger committee suggested more than a year
D7
Health & Discovery
Prevention
For Patients
Sarah Foer, a spokeswoman
for the American Association
of Blood Banks, says
hospital patients can take
these steps to avoid receiving
transfusions of the wrong blood:
1. Ask hospital personnel as
many questions about an upcom-
ing transfusion as possible.
2. Know your own blood type
and Rh factor before entering the
hospital. Make sure when you
enter the hospital that the blood
information on your wristband is
correct.
3. Before a transfusion, ask
questions to make sure the blood
unit about to be transfused is the
right type.
4. Ask to see the label on the
bag and check it for blood type.
5. Tell relatives and friends
your blood type so they can
check if you’re unconscious or
asleep while being transfused.
Have someone act as an advocate
for you.
ago, under the Clinton administration,
that the government start a system requir-
ing hospitals and independent blood
banks to report all blood-related errors.
The proposal is still pending.
Until May 2001, the Food and Drug Ad-
ministration required only federally li-
censed blood banks to report nonfatal
transfusion errors, such as bacterial con-
tamination that occurred in their labs.
Most hospital blood banks didn’t fall into
that category.
Since May 2001, the government has re-
quired hospitals to report transfusion-re-
lated errors that occur in their own blood
NEWSDAY, TUESDAY, APRIL 9, 2002
banks such as giving the wrong blood to a
nurse for a patient.
But most hospital transfusion errors
tend to occur on the floor and not in the
blood bank, experts say. The government
doesn’t require reports of errors that occur
in hospitals but outside their blood labs.
Hospitals must report all transfusion-re-
lated fatalities, no matter where they
occur, to the FDA.
Richard Lewis, deputy director of the
FDA’s Office of Blood Research and Re-
view, says that although more errors have
See BLOOD on D10
D10 SKYWATCH CONTINUING ED
By Dennis Mammana
COPLEY NEWS SERVICE

Finance
E
ACH YEAR around this time our planet is
oriented in space to allow us a great view
of our home star city — the Milky Way
Galaxy. This colossal, disk-shaped structure
contains hundreds of billions of stars, planets
At a Glance
DOLINAR from D9
Health & Discovery

and clouds of gas and dust.

Every star in our nighttime sky is part of this
structure, but it’s the combined light of count- able to aggregate my 401(k), IRA and
less stars that gives the Milky Way its most non-retirement accounts. It didn’t
prominent feature: a hazy band of light span- even burp when I threw in the three
ning the nighttime sky. Stargazers far from city checking accounts I keep at Fleet
lights now have an excellent view of this specta- Bank. Mortgages? Goodness gracious,
cle, both after dark and before dawn. it ate four out of five and gave me my
In the evening, the outer rim is visible. It’s rel- mortgage balances. This was particu-
atively thin and faint and passes from the north- larly impressive, in that I had not pre-
western to the southern horizon. In early morn- viously signed up to view these mort-
N

ing, observers can look toward the galaxy’s cen- gages online — the program took me di-
ter, where more stars create a considerably thick- rectly to the lenders’ Web sites, where
er and brighter band stretching from the south- I set up accounts and passwords. Re-
ern to the northeastern horizons. member, all different banks, all differ-
The hazy band, of course, is an illusion. It’s ent Web sites.
caused by so many stars at such great distances There was even a spot in the data-
that the eye is unable to see them as individual base for hotel rewards and airline mile-
points of light. To see individual stars, aim bin- age programs, which I’ve been using a
oculars or a telescope toward one of the brighter lot when I take my daughter to swim
regions. meets. Of course, like any good net
Many American Indian tribes believed the worth program, there’s room for static
Milky Way to be a road that led the souls of dead assets like houses that don’t show up
to their resting places. The seafaring Polyne- in the online world. All told, it took per-
sians saw it as a great blue shark. But it was the haps two hours to come up with a com-
ancient Greeks who described its appearance as prehensive net worth statement in
that of milk spilled across the dark sky, and which 90 percent of the components up-
that led to the name we use today. Copley News Service / Paul Nasri dated automatically.
Other services are available, too:
Had I been so inclined, I also could
have aggregated a page of online calen-
HEALTH CALENDAR dars (you know, the kind they have on
EVENTS Shore University Hospital at Glen FOOT HEALTH AWARENESS MONTH Yahoo and MSN) as well as Web and
Cove, 101 St. Andrew’s Lane. Call for Bethpage pop e-mail. Throw in Fidelity’s Yahoo-
“COPING AND CARING” IN SPANISH
appointment, 516-674-7852. New Island Hospital presents a free like ability to create a custom home
Hempstead page, with news, links, calendars and
lecture about foot health by podiatrist
Long Island Alzheimer’s Foundation so forth, and you have a pretty impres-
“THE NATURAL NURSE” John Hoina, 7 p.m. Monday at New Is-
presents its conference in Spanish for sive permanent home on the Web.
Oceanside land Hospital, 4295 Hempstead Tpke.
families and health care professionals Now the service wasn’t perfect.
Ellen Kamhi talks about the benefits Reserve, 516-520-2487.
caring for those with Alzheimer’s or re- Oddly, it couldn’t download my Quicken
lated dementia, 6:30-9 p.m. today in and dangers of herbs, vitamins, miner-
als, nutritional supplements, 7:30 p.m. BREAST CANCER VOLUNTEERS NEEDED Visa card account, possibly because
the auditorium, Kennedy Park, 335 Quicken is trying to sell its own aggrega-
Greenwich St. Register, 866-789-5423. Thursday at Barry & Florence Fried- Garden City
berg South Shore Y JCC, 15 Neil Ct. tion service. A quirk in the way I’m regis-
Adelphi NY Statewide Breast Cancer tered at the HBSC mortgage site need-
Fee: $8; 516-766-4341, ext. 114. Hotline and Support Program needs
ALTERNATIVES FOR BREAST CANCER ed to be fixed manually, which is going
breast cancer survivors, women and to take a couple of weeks. Southwest
Manhattan men, for community outreach, fund-rais-
HEIGHTENING COLON CANCER AWARENESS Airlines, meanwhile, wouldn’t let me
Drs. Raymond Chang and Deborah Ax- ing, hotline or office work. A five-week
Old Brookville register online, but I should get a pass-
elrod talk about alternative treat- training session, 10 a.m.-1 p.m., begins
ments to traditional western medicine, Cancer Care of Long Island and Colon word for them in a couple of weeks, as
and Rectal Surgical Associates of Long Monday. Call 516-877-4335 or 516-877- well. But it was close enough to perfect
6-8 p.m. today at St. Vincent’s Compre- 4315.
hensive Cancer Center, 25 W. 15th St. Island present a colon cancer aware- that I could put up with the minor short-
Reserve, 888-44-CANCER. ness workshop 7-9 p.m. Thursday at comings. In fact, I like it so much I’ll
DeMatteis Center for Cardiac Re- ORGAN OR TISSUE DONATION AND RELIGION probably switch my credit card just to
search and Education, Northern Boule- Valley Stream be able to throw it into the pot, too. One
STROKE AND CARDIAC RISKS vard, Northern Boulevard. Register, Msgr. Thomas J. Hartman is the guest caution: Depending on how you set this
Glen Cove 516-364-8130. speaker at a free conference, “Gift of up, you may be allowing one-password
North Shore University Hospital at Life — Exploring a Pastoral Response access to all your account information.
Glen Cove holds a free community OPEN FORUM FOR STUTTERERS to Organ and Tissue Donation,” 9 a.m. The moral for this week, then, is to
health program about cardiovascular Hempstead April 17 at Franklin Hospital Medical check out the financial services you al-
disease 7:45-9:15 p.m. tomorrow in its Long Island Speech-Language-Hear- Center, 900 Franklin Ave.; 516-256- ready have, and you may be surprised
restorative dining room, 1 South, 101 ing Association presents “Children 6050. at what you find.
St. Andrews Lane; 516-674-7833. and Adults Who Stutter: Families, Pro- COMPILED BY ELAYNE FELD

FREE ALCOHOL SCREENINGS

Glen Cove
Screenings include a 30-minute confi-
dential meeting with a counselor, 9
a.m.-8:30 p.m. Thursday at North
In Search of Error-Free Transfusions
BLOOD from D6
NEWSDAY, TUESDAY, APRIL 9, 2002
fessionals and Friends Working To-
gether,” 10 a.m.-4 p.m. Saturday at
Hofstra University, Hempstead Turn-
pike. Fee: $25, $40 two family mem-
bers. Register, 631-858-0949 or 516-
463-5433.
ern Medical Center, James Battles, a
Send notices of health events, three
weeks in advance, to: Health Page,
Events Desk, Newsday, 235 Pinelawn
Rd., Melville, N.Y. 11747-4250; fax 631-
843-2065 or e-mail elayne.feld@news
day.com.
ment of Health and Human Services
Web Service for Fee
FEES from D9
ners game while in Las Vegas, people
are willing to pay for the services we
offer.”
Other consumers seem willing to
pay for access to specialized informa-
tion. While general search engine use
(such as Google) is not expected to be-
come a pay service, paid access to spe-

biomedical communications professor, committee that urged the government to

been reported in recent years, he
thinks it’s due to increased reporting
by blood banks and not because work-
ers are making more mistakes.
Lewis says that in addition to blood
mismatches, bacterial contamination
of blood accounts for many error re-
ports. Blood can become contaminated
through unsafe laboratory practices.
And when blood is stored at the wrong
temperatures, its potency decreases,
rendering it useless.
At the University of Texas Southwest-
has studied ways to track transfusion er-
rors and near misses — transfusions in
which mistakes were made but were dis-
covered in time to prevent harm.
It is essential that we get people
within health care organizations to re-
port near misses [and] no harm events
so we can study them so we can identi-
fy things that set people up for fail-
ure,” Battles said.
Arthur Caplan, head of the bioethics
center at the University of Pennsylva-
nia, until recently headed a U.S. Depart-
initiate a better error reporting system.
Caplan said the government needs
to address the fear of lawsuits that
he believes keeps hospitals from re-
porting transfusion-related deaths
and errors.
“Liability fears completely corrupt
and compromise adverse event report-
ing,” Caplan said. “It stinks. If we do
not change the climate concerning mal-
practice, there will never be adequate
reporting. The road to blood safety
runs through liability reform.”
cific information and databases (via
services like LexisNexis) has become a
popular research tool in fields of aca-
demia and business.
But while people seem to be willing
to pay for services that add value to
their lives, most say the typical Inter-
net user cannot afford to pay for all of
the services they rely on.
“To generate revenues effectively,
companies must be selective,” said
CIBC’s Corcoran. “In the end, no one
will be able to charge for every service
they offer.”
A6

FDA Plasma Warning

New variety processed on LI connected to liver deaths
By Kathleen Kerr
STAFF WRITER
A controversial blood plasma —
sold by the American Red Cross to
thousands of hospitals and processed
by a former Long Island company —
has been linked to the deaths of six
liver transplant recipients in Los An-
geles in 2000, Newsday has learned.
Even more deaths than the Los An-
geles cluster have been reported to
the Food and Drug Administration,
but it is unclear where they occurred
or how many people died.
In late March, the FDA quietly sent
doctors a letter advising them that a
“black box warning” — the agency’s
most serious labeling alert — had
been issued for the cutting-edge plas-
ma because of concern over the Los
Angeles deaths. Those patients
ranged from a
pregnant 17-year-
old to a 64-year-
old woman and all
died at Cedars-
Sinai Medical Cen-
ter in Los Angeles.
The FDA action
means a warning
Ying Lung Chiu Wong received wrong blood type twice. label rimmed in black will be added
to plasma containers and read:
“Should not be used in patients un-
dergoing liver transplant or in pa-
cessed it until 2001 under a contrac-
tual arrangement with the American
Red Cross. V.I. Technologies used a
technique to cleanse the plasma of
dangerous viruses that was patented
by the New York Blood Center in
Manhattan and licensed to the
Melville company. A 2002 financial
statement indicates that the blood
center has an 8.8 percent stake in
V.I. Technologies.
Christopher Lamb, vice president
of plasma operations at the Ameri-
can Red Cross in Washington, D.C.,
told Newsday in mid-April that
there was only “a temporal associa-
tion with the product in these inci-
dents.” On Friday, Lamb acknowl-
edged the warning, saying that it
was decided sometime in March that
the plasma required further safety
measures.
Dr. William
Jarvis, of the Cen-
ters for Disease
Control and Pre-
vention in Atlan-
ta, said the agen-
cy’s investigators
found that SD
plasma, when given in large volumes,
triggered unusual reactions including
bleeding in the Los Angeles patients.
The FDA’s black box warning now

Blood Mix-Up tients with severe liver disease and

known [clotting problems.]”
But it is unclear how the warning
will affect use of the plasma. Produc-
tion was suspended last year and
calls for careful monitoring of pa-
tients who receive large amounts of
SD plasma.
“The finding was the use of SD
plasma, especially in high volume,

Caused Death transfusion-related deaths, support

By Kathleen Kerr
STAFF WRITER
The estate of an 85-year-old
woman who died after receiving two
transfusions of the wrong blood is
suing NYU Downtown Hospital.
Twice within six days during
April 2000, the lawsuit says, Ying
Lung Chiu Wong of Chinatown
was transfused with the wrong
type of red blood cells and plasma.
Shortly after the second incorrect
transfusion, Wong died.
Hospital records obtained by
Newsday from the Food and Drug
Administration, which monitors
the lawsuit’s allegations.
Wong, who emigrated from
China with her husband, Quong
Lai, is one of hundreds of hospi-
tal patients who have died fol-
lowing blood transfusions.
A Newsday investigation, pub-
lished last month, found that be-
tween 1995 and 2001, 441 hospi-
tal patients died following trans-
fusions, including 78 who re-
ceived the wrong blood.
In reaction to the series findings,
See VICTIM on A28
the existing plasma already in stock
doesn’t contain the warning. The
FDA took almost two years to issue
the warning, after the agency initial-
ly issued a milder notice about the
deaths in 2000.
The more stringent warning came
about a month after Newsday began
investigating the link between the
plasma and the deaths of liver trans-
plant patients. The warning does not
state where the deaths occurred, but
Newsday found in government docu-
ments that they occurred at Ce-
dars-Sinai. Newsday learned about
the warning on Friday.
The FDA regulates the plasma,
called Plas+SD or SD plasma, like a
drug. SD refers to the solvent deter-
gent process used to clean the plasma.
V. I. Technologies in Melville pro-
was the source of adverse events,”
Jarvis told Newsday.
FDA documents obtained by News-
day under the Freedom of Informa-
tion Act only detail the six deaths at
Cedars-Sinai and not the others men-
tioned in the agency’s warning letter
to doctors. The FDA could not imme-
diately identify where the other
deaths occurred or the number of vic-
tims, in interviews late last week.
The records indicate only one other
hospital in the country was using
the plasma for liver transplants
when the Los Angeles deaths oc-
curred. A Cedars-Sinai spokeswom-
an said Friday hospital officials were
not available for comment.
The FDA warning strengthens an
See PLASMA on A28

Andersen Trial to ‘Drive Stake Deeper’

THE ASSOCIATED PRESS
Arthur Andersen’s federal trial on obstruction of
justice charges could be the knockout punch in the
company’s fight to survive client losses, fleeing part-
NEWSDAY, MONDAY, MAY 6, 2002
ron’s complex web of accounting. faces a fine of up to $500,000 and probation for up to
The indictment alleges that the firm destroyed 5 years.
“tons of paper” related to Enron at its offices in Hous- The firm publicly acknowledged the shredding in
ton, London and Portland, Ore., as well as in its Chi- January, shortly after reporting it to the Depart-

ners and severe damage to its reputation.
Unless attorneys reach a last-minute settlement,
jury selection will begin today in the first criminal
trial to emerge from Enron Corp.’s collapse last year.
“All the trial will do is allow the Justice Depart-
ment to bring a lot more dirt out on Andersen and
drive the stake deeper into its heart,” said Arthur
Bowman, editor of Atlanta-based Bowman’s Account-
ing Report, an industry publication.
Members of the accounting firm are accused of
shredding documents and deleting computer
records related to Enron audits as the Securities
and Exchange Commission began examining En-
cago headquarters. Rusty Hardin, Andersen’s lead
lawyer in the criminal case, argued March 20 for a
speedy trial to expose what he called flimsy evidence
from prosecutors. Top Andersen officials had turned
over documents to prosecutors and had testified be-
fore Congress that they knew nothing of intentional
shredding to thwart Enron investigations.
U.S. District Judge Melinda Harmon agreed and
set today’s trial date. She also has ruled that jury se-
lection would last no longer than a day and attorneys
would give opening statements tomorrow.
Negotiations to settle the criminal case broke
down in mid-April. If convicted, Arthur Andersen
ment of Justice. Since then, nearly $1 billion in reve-
nue has vanished as more than 300 publicly traded
clients, such as United Airlines and Merck & Co.,
dumped the smallest of the Big Five auditing firms
— most after the indictment was unsealed March 14.
Meanwhile, Andersen’s international network
has been dissipating as partners in more than
two dozen countries moved to join competitors.
The firm has laid off thousands of workers.
“Even an acquittal doesn’t reverse all the damage of
the past three to four months,” Bowman said. “But this
is a firm that truly believes in its innocence as a firm,
and apparently is willing to go to its death to prove it.”
A28
A Blood Transfusion Mistake
VICTIM from A6
State Sen. Kemp Hannon (R-Garden City), has intro-
duced a bill to provide for development of computer-
ized hospital systems designed to avoid transfusion
errors. The bill would empower the state health com-
missioner to require such computerized systems in
hospitals and would provide for appropriating funds.
It was added as a provision to a bill aimed at prevent-
ing other medical errors.
Medical experts have expressed increasing concern
over deaths associated with transfusion errors, fearing
that the real number of such deaths is vastly under-
counted because some hospitals fail to report them.
Wong entered NYU Downtown in lower Manhattan
on April 4, 2000, suffering from gastrointestinal bleed-
ing. She also had diabetes and coronary heart disease.
An FDA inspection report concerning Wong’s
death states: “The inspection confirmed that the
transfusion reaction and subsequent fatality were
Blood Plasma Linked to Deaths
PLASMA from A6
earlier Oct. 20, 2000, notice to doctors, advising
them of a cluster of deaths in liver transplant pa-
tients who received SD plasma and suggesting
that the use of the plasma be carefully monitored.
That notice also suggested that improper storage
and handling of SD plasma could result in prob-
lems.
V.I. Technologies, which is now located in Wa-
tertown, Mass., divested itself of its Melville plas-
ma operation in 2001, less than a year after the
deaths. A V.I. Technologies spokeswoman de-
clined several requests for comment.
SD plasma has been controversial for some
time. The plasma costs more than twice the
amount of ordinary plasma — $125 a unit.
Traditionally, doctors have preferred to trans-
fuse plasma taken from just one donor. Using the
SD method, donated plasma from about 2,000 peo-
ple is pooled — ordinarily risky because the pool
may contain many different viruses from the vari-
ous donors. The solvent detergent process then
dissolves the fatty protective coating of viruses
like HIV and hepatitis C and cleanses the viruses
from the plasma.
When the FDA approved SD plasma in 1998,
NEWSDAY, MONDAY, MAY 6, 2002
due to clerical errors that occurred in the blood
bank. Had [standard operating procedures] cover-
ing identification of specimens been followed, the
error would have been avoided.”
Carol Bohdan, a hospital spokeswoman, said of-
ficials had no comment regarding the incident
since the case is in litigation.
Mitchell Drach, the attorney handling the case for
the law firm of Popick, Rutman & Jaw, said that de-
spite Wong’s health problems, he believes it was the
transfusions that caused her death.
“She was able to live at home with her husband,”
Drach said. “She didn’t have a life-threatening condi-
tion. If she didn’t have the bad transfusions — based on
my discussion with experts and a review of the records
— I don’t think she would have died.”
According to FDA records, a technologist apparently
confused Wong’s blood sample with that of another pa-
tient. A second technologist failed to perform checks
that would have revealed the initial error.
there was some concern that the technique, which
eliminates dangerous viruses, might miss some
pathogens that can cause disease.
In 1999, V.I. Technologies recalled 37 lots,
which amounted to 90,000 units of SD plasma, be-
cause tests revealed the presence of the parvovi-
rus B19 that can seriously affect pregnant women
and people with compromised immune systems.
The FDA apparently did not receive any reports
of serious adverse events associated with the re-
called plasma.
At one point, the Justice Department investigat-
ed the arrangement the Red Cross had with V.I.
Technologies, also known as Vitex, and Novation,
a company which distributes medical supplies to
hospitals, to manufacture and sell SD plasma.
The antitrust investigation raised concerns that
the plasma arrangement created a monopoly but
the probe was eventually dropped.
V.I. Technologies sold its plasma business to
Precision Pharma, also in Melville, in 2001. Preci-
sion has not manufactured SD plasma, but Marge
Gandolfi, a marketing executive for the New York
Blood Center, said the center is in discussions
with Precision about manufacturing a “second gen-
eration” plasma that would combine the solvent
detergent method and another technique.
E-mail correspon-
dence between two
FDA officials — ob-
tained by Newsday as
part of a Freedom of In-
formation Act request
— states: “The labeling
error occurred in the
lab when the bar codes
were generated and
the wrong label was
placed on this [pa-
tient’s] tube.”
As a result of the er-
rors, on April 5, 2000, Newsday Photo / Mayita Mendez
Wong received a trans-
Mary Wong, granddaughter of
fusion of two units of
Type B positive red Ying Lung Chiu Wong.
blood cells instead of
the Type A positive she required. In the days that fol-
lowed, Wong became lethargic and developed breath-
ing difficulties. After testing, she was diagnosed with
sepsis, a serious blood infection. The records do not
clearly state whether she had a reaction to the mis-
matched blood she received on April 5.
But on April 10, 2000, a doctor ordered another
transfusion, this time two units of fresh frozen
plasma. After receiving just one unit, Wong devel-
oped breathing problems and cardiac arrest.
Hospital employees resuscitated Wong but didn’t
stop the transfusion at first. Family members say the
transfusion took place roughly between 10 and 11 p.m.
During the transfusion, a technologist discovered
that Wong’s blood type was really Type A positive and
called a doctor, who then halted the transfusion.
Shortly after that, Wong again required resusci-
tation. At 12:22 a.m. on April 11, she was pro-
nounced dead.
Various documents cite different causes for
Wong’s death. A hospital death note says the cause
of death was cardiac arrest. An autopsy report by
the medical examiner’s office stated the cause of
death was bacteria in the blood due to a urinary
tract infection complicating diabetes.
An FDA document states: “Cause of death de-
layed hemolytic reaction, ABO incompatibility.” A
hemolytic reaction refers to a patient’s response
to receiving the wrong blood; ABO incompatibility
means a mismatch in blood type.
Mary Wong, Wong’s granddaughter, said in an
interview that hospital officials met with family
members about three weeks after she died, admit-
ted that mistakes had occurred and apologized. “I
feel that we’re all very angry and shocked at what
happened,” Wong said. “She should have been
here as we speak. We want to see justice done.”
Recalling
A Battle —
With Pride
Residents of a Mexico City
neighborhood celebrate Cinco de
Mayo, “The Fifth of May,” with a
re-enactment of the Battle of Puebla
yesterday. They were recalling the
victory of the meagerly armed Mexican
troops over a large, elite French militia
in a battle on May 5, 1862.
AP Photo
A36

MDs Warned on Ebola Potential

THE ASSOCIATED PRESS
Chicago — A bioterrorist attack
using Ebola or other so-called bleeding
viruses could be especially insidious be-
cause the early symptoms seem so ordi-
nary and there is no vaccine or ap-
proved drug treatment, experts say in
new guidelines for doctors.
The guidelines, in this week’s Jour-
nal of the American Medical Associa-
tion, aim to help doctors recognize bio-
logical warfare agents that most have
only read about in medical books but
that seem more menacing after last
fall’s anthrax-by-mail attacks.
The recommendations deal with
hemorrhagic fever viruses, whose
most severe symptom is bleeding,
under the skin or from body orifices.
The guidelines note that these virus-
es already have been turned into weap-
ons by the former Soviet Union and the
United States and could cause wide-
spread illness and death.
Dr. Neal Shipley, head of the emer-
gency department at North General
Hospital in Manhattan, said the guide-
lines are useful for doctors like him
who would be on the front line in such
an attack, but the advice needs to be ac-
companied by federal money for train-
ing and equipment.
“It’s one thing to have the masks and
suits sitting in someone’s office. It’s an-
other thing to have personnel on every
shift, 24-7, who know how to use them,”
Shipley said. As for the possibility of a bio-
terrorist attack, “we’re really crossing
our fingers that it doesn’t happen.” The

FBI Chief Assesses Urgent Mission
By Tom Brune
WASHINGTON BUREAU
Washington — Despite the most mas-
sive probe in history, the FBI has found
no paper containing information about
the plot for the Sept. 11 attacks, a fact
that spurs the bureau on to a greater
sense of urgency, FBI Director Robert
Mueller said yesterday.
“Our mission is clear: to stop acts of
terror from ever getting off the ground,”
Mueller told the Anti-Defamation
League yesterday in remarks that fore-
shadow his testimony today at a hear-
ing before the Senate Judiciary Commit-
tee on the reorganization of the FBI.
As he has in other speeches in recent
weeks, Mueller touted his efforts to reor-
ganize the widely criticized FBI while ac-
knowledging the bureau’s inability to
come up with a smoking gun on the
Sept. 11 hijackings or anthrax attacks.
Driving the reorganization, Muel-
ler said, is the FBI’s realization that
Sept. 11 plotters had taken the abili-
ty to blend into America, below the
radar of law enforcement, to a new
level of sophistication.
“Eight months after the attacks —
even after all the information we’ve
turned up, as one reporter put it, from
‘caves to credit cards’ — we have yet to
find a single piece of paper outlining any
element of the attack,” Mueller said.
Mueller said terrorists are “willing
to go to great lengths to destroy
America. We must be willing to go to
even greater lengths to stop them.”
To stop them, the FBI must broad-
en its reach internationally with
more legal attaches, now in 44 coun-
tries, and secure better cooperation
with local law enforcement at home.
The FBI must devote more of its
resources to prevention, shedding
some criminal enforcement responsi-
bilities and increasing the number of
analysts, he said.
It must improve its technologies, he
said. Already, he noted, the FBI will be
spending $600 million to upgrade and
boost its technological capabilities.
Over the past decade, the FBI has
steadily improved in its fight against ter-
rorism, preventing more than 40 at-
tacks in recent years, Mueller said. But
the FBI has more to do.
As he admitted in an April 19 speech
to the Cosmopolitan Club of California
in San Francisco, the FBI had shortcom-
ings that it had “made problems worse
by ignoring or denying them” instead of
embracing constructive criticism.
“We have to acknowledge prob-
lems and be ahead of the curve in fix-
ing them,” he said. “That has been
our approach in recent months, and
it will remain our approach.”
guidelines were created by the Working
Group on Civilian Biodefense, which is
comprised of doctors and public health ex-
perts from the military, civilian govern-
ment agencies and universities.
This is the sixth set of bioterrorism
guidelines from the group, which has
published recommendations in JAMA
for anthrax, smallpox and plague.
“We know that mortality can be di-
minished with good, meticulous medi-
cal care,” said Dr. Luciana Borio of the
Johns Hopkins Center for Civilian Bio-
defense Strategies and lead author of
the guidelines. That would include
steps to reduce fever and blood pres-
sure, and the use of ventilators and
anti-seizure drugs if needed.
Victims of Ebola and other hemorrhag-
ic viruses, such as Marburg, yellow fever
and Rift Valley fever, can show early,
flu-like symptoms within two to 21 days
that can include fevers, facial redness,
lethargy and headaches. The more seri-
ous, telltale symptoms such as bleeding
may take longer to develop.

Flaws at Old Reactors Raise Concerns

THE ASSOCIATED PRESS
Washington — Severe cracks found at one nucle-
ar power reactor and the stunning discovery of a
hole that nearly breached the six-inch steel dome
of another facility are raising new questions
about aging nuclear plants and whether they are
being inspected closely enough.
The hole that went through most of the heavy
reactor cover of the Davis-Besse power plant in
Ohio and the severity of cracks found about a
year earlier at a reactor in South Carolina sur-
prised federal safety regulators and the industry.
Both incidents have had plant operators scurry-
ing to look for cracks in reactor control rod noz-
zles and, more recently, for corrosive boric acid on
reactor domes. It was a government-ordered in-
spection prompted by cracks found in South Caro-
lina early last year that led to the discovery of
the David-Besse hole this past March.
A primary reason for the corrosion was the long-
time escape through nozzle cracks of borated
water from inside the Davis-Besse reactor vessel,
investigators have concluded.
So far, no one else is reporting the kind of corro-
sion found at the Ohio plant. While 14 reactors on
a close-watch list have reported at least 62 nozzle
cracks, most of them have been fixed and the rest
are scheduled for repair, industry and govern-
ment officials said.
A spokesman for Duke Power says the 23
cracks found at its three reactors in Greenville,
S.C., have been fixed.
Still, the discoveries have prompted new ques-
tions about aging nuclear power plants.
“It was material degradation that wasn’t expect-
ed,” acknowledges Alex Marion of the Nuclear En-
ergy Institute, the industry’s trade group. Still,
he added, the problems should not affect relicens-
ing since the problems are identified and being
dealt with.
Some industry critics disagree.
“The concern here is that with this inherently dan-
gerous technology, when it ages it becomes more and
more unpredictable in terms of how rapidly things
can break, leak and crack,” said Paul Gunter, an
anti-nuclear activist and industry watchdog.
Most reactors have a 40-year license, and a grow-
ing number of utilities are planning extensions.
FirstEnergy Corp.’s 25-year-old Davis-Besse re-
actor on the shore of Lake Erie has been shut
down since February, waiting for the hole in the
reactor dome to be patched.
Nuclear experts said the hole was discovered be-
fore anything serious could go wrong. Still, feder-
al safety regulators view the findings so troubling
that some senior officials at the Nuclear Regulato-
ry Commission privately have characterized the
cracking and corrosion as the most significant
safety issue facing the nuclear industry since the
Three Mile Island accident 23 years ago.

Families Never Told of Link in Plasma Deaths

By Kathleen Kerr
STAFF WRITER
The families of six patients who died at Ce-
dars-Sinai Medical Center in Los Angeles after re-
ceiving transfusions of high-tech blood plasma
made in New York were never told that the con-
NEWSDAY, WEDNESDAY, MAY 8, 2002
Los Angeles deaths involving liver transplant pa-
tients occurred in 1999 and not 2000, as originally re-
ported by the FDA, officials confirmed yesterday.
Cedars-Sinai spokeswoman Grace Cheng said the
hospital stopped using the so-called SD, or solvent de-
tergent, plasma in December 1999 after contacting
the technique may allow certain pathogens to linger
and sicken people with poor immune systems.
In March, the FDA issued its most serious warn-
ing to doctors, indicating that the plasma should not
be used in liver transplant patients and that patients
who receive it in large volumes should be carefully

troversial product had been linked to their deaths
nor were they informed of the government investi-
gation that followed.
Now, the deaths of four more hospital patients,
which federal officials say took place around the
same time as the Los Angeles deaths, have been
linked to the plasma, which the American Red
Cross sold to thousands of hospitals, Newsday has
learned. But the Food and Drug Administration
refused yesterday to say where the four addition-
al patients — three with liver transplants and a
fourth with liver disease — died.
Newsday reported Monday the links between the
Los Angeles deaths and the plasma, formerly manu-
factured by V.I. Technologies on Long Island. The
the FDA and the Centers for Disease Control and
Prevention to report the deaths, but never shared its
concerns with relatives.“We do not want to alarm our
patients’ families,” she said. “We don’t know that
there’s a direct cause and effect. It appears there
may be some correlation.”
When Newsday asked whether the government is
currently investigating any other deaths that may be
linked to the use of SD plasma, FDA spokesman
Jason Brodsky said: “I am not in a position to discuss
any talks we may be having. I can’t confirm or deny.”
The controversial SD plasma is created by pooling
plasma from about 2,000 donors and then cleansing
it of dangerous viruses like HIV and hepatitis. Some
medical experts, however, have raised concerns that
monitored for bleeding problems. The FDA has taken
no action to remove SD plasma from the market, al-
though it currently is not in production.
The warning came more than two years after
the Los Angeles deaths and more than a month
after Newsday began investigating them.
The plasma’s manufacturer, V.I. Technologies,
is located in Watertown, Mass., but had a
Melville plasma operation until 2001, when it di-
vested itself of the operation. The company has re-
peatedly refused to comment.
As part of a contractual arrangement with the
Red Cross, V.I. Technologies manufactured the
plasma using a cleansing method that was patent-
ed by the New York Blood Center in Manhattan.
A6

In Search of Security
West Bank Israelis
seeking safeguards
after recent killings
By Matthew McAllester
MIDDLE EAST CORRESPONDENT
Ofra, West Bank — When Hila Hershkovitz heard
on Tuesday that another man had been shot dead
near the spot on the road where her husband was
killed 13 months ago, she could not bear to watch
television.
“It shocked me because I felt, ‘Oh my God, we’re
starting all over again,’ ” said Hershkovitz, 29. “I
turned the TV over [to] . . . something stupid. . . .
My mother-in-law still hopes that every time it will
go away. But no way. It just gets worse and worse.”
Hershkovitz’s shock at the killing of Albert Mal-
oul, 50, was all the greater because there had been
no shooting deaths among Israeli civilians on the
roads of the West Bank since March 24, four days be-
fore the Israeli army invaded Palestinian-controlled
towns on the West Bank. Although Palestinians
have continued shooting at cars with yellow Israeli li-
cense plates, the attacks have been fewer and none
has proved deadly.
That new feeling of comparative security evaporat-
ed on Tuesday. Hours after Maloul’s death, a Pales-
tinian gunman broke into Itamar, a settlement north
of here, and killed three teenage boys before a securi-
ty guard shot him dead. Agence France-Presse Photo
The killings have tightened the atmosphere A barbed wire fence, near the Jewish neighborhood of Gilo, is part of a plan to seal off Jerusalem.
around the Israeli settlements. Among Ofra’s 4,500
people, mainly religious Jews, the killings brought
back memories of a dual tragedy more than a year
ago. Then, Hershkovitz’s husband, Asaf, was killed
only three months after his father was shot dead on
the same road.
“God’s taken as much as he can from me. How
much more can he take?” Hershkovitz said Thursday
night, sitting in her home with strong metal bars on
A Faith in Fences
the windows to prevent Palestinian would-be attack-
ers from breaking in. Her late husband, a metal work-
er, had built the bars to protect his wife and two
Barrier meant to protect Jerusalem
young children. By Jessica Steinberg has sent dozens of suicide bombers into Israel, the
With the latest killings of settlers, local authori- SPECIAL CORRESPONDENT government is at least partly resigned to an idea
ties are re-examining their security arrangements, Jerusalem — At the southern edge of this city, that many of its officials still see as politically
and settler leaders are discussing how best to protect where the Jewish neighborhood of Gilo ends and risky: a physical barrier to shut off at least parts
their communities without turning them into suffo- the Palestinian village of Beit Jala rises just of the West Bank from Israel proper.
cating fortresses. Settlers still strive to keep their ahead, a 9-foot-high web of razor wire stretches Many Israeli officials — notably those most
hometowns calm oases where children can ride their across the dry land. The snaking, gray coils are aligned with Prime Minister Ariel Sharon — worry
bikes in the streets at all times of day. part of a growing physical barrier — 24 miles of that a security fence could eventually evolve into a
Two months ago, the Ofra town council barred Pal- fences, patrol roads, ditches and checkpoints are border that would weaken Israel’s hold over the
estinian laborers from the settlement after settlers planned — to seal Jerusalem off from the Palestin- West Bank, including its Jewish settlements.
in other West Bank communities were killed by their ian towns and villages that flank it.
longtime Palestinian employees. After 20 months of a Palestinian uprising that See FENCE on A17

See WEST BANK on A17

On the Blood Plasma Paper Trail

Deaths of 10 patients linked to product made on LI
By Kathleen Kerr
STAFF WRITER
The death of a pregnant 17-year-old on an operat-
ing table in Los Angeles three years ago sounded the
NEWSDAY, SUNDAY, JUNE 2, 2002
structing doctors not to use the plasma in liver trans-
plant patients and those with liver disease. The
warning came after the 10 deaths and about a month
after Newsday began asking federal officials ques-

first alarm about a high-tech blood plasma processed
on Long Island.
Ultimately, the deaths of five other liver trans-
plant patients at the Cedars-Sinai Medical Center in
Los Angeles would be linked to the plasma, along
with the deaths of four other people around the coun-
try. Internal Food and Drug Administration e-mail
messages and memos obtained by Newsday reveal
that after Cedars-Sinai notified the agency about the
1999 deaths at the hospital, investigators quickly
began focusing on the role the blood plasma played.
In March 2002, the FDA issued a “black box” warn-
ing — the agency’s most serious labeling alert — in-
tions about the deaths.
SD, or solvent detergent plasma, approved by the
FDA in 1998 and received by the Cedars-Sinai pa-
tients, had promised to make transfusions safer. A
scrubbing technique was used to rid pooled batches
of plasma from up to 2,500 donors of dangerous virus-
es such as HIV and hepatitis B and C. Some scien-
tists liken the process to pasteurization of milk: The
technology used to cleanse the plasma could be used
only on large batches. The New York Blood Center in
Manhattan patented the method and licensed it to Newsday Photo / Daniel Goodrich
SD plasma was expected to make transfusions safer, but
See PLASMA on A34 has been linked to 10 deaths around the country.
A34
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Dozens of internal FDA memos and
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reveal details about the deaths and the
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FDA spokesman Jason Brodsky
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about three years from the time of
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black box warning about SD plasma
does not mean the agency dawdled.
Brodsky pointed to an interim warn-
ing issued in 2000 and said a March
2001 death of a patient with liver
disease who received SD plasma but
did not have a transplant prompted
the agency to issue the black box
warning on March 29.
“Each of these situations are decid-
ed on a case-by-case basis,” Brodsky
said. “The agency acts and when it
receives additional information, it
considers what action might be nec-
essary. In this specific case, when it
became clearer that not just patients
undergoing liver transplants were at
risk but [also] those with liver dis-
ease, the FDA decided a stronger
warning was necessary.”
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NEWSDAY, SUNDAY, JUNE 2, 2002
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1-800-543-5436 Cedars-Sinai officials said their liver
transplant program started using the
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As the investigation unfolded, Dr.
Toby Silverman, medical officer at the
FDA’s Center for Biologicals Evalua-
tion and Research, e-mailed co-work-
ers, saying: “I believe it is too early to
decide whether the product is to be im-
www.jcpenney.com/customdecorating ® plicated in this fatal event although I
am concerned that the product may
have exacerbated the patient’s underly-
ing pathology.”
With each new death, Silverman
grew more impatient, expressing mis-
givings in e-mail messages about SD
plasma..
“The additional 3 cases concern me
greatly and must be resolved soon,” Sil-
verman wrote at one point to col-
leagues. “If we do not come to resolu-
tion tomorrow . . . or if, based on the
information we hear tomorrow, we be-
lieve the product to be implicated, we
should act to stop distribution.”
Meanwhile, Cedars-Sinai officials
who reported the deaths to the FDA be-
came skittish — but ultimately cooper-
ated — when federal investigators
asked to examine their records, the
e-mail messages indicate. The hospital
had stopped using SD plasma once it
became aware of the problem.
“Dr. Dennis Goldfinger, director of
Transfusion Medicine Service is very
nervous about FDA coming,” FDA em-
ployee Jonetta Collins notes in one
e-mail message.
And another e-mail message from
FDA employee Tania Hall states: “Dr.
Goldfinger stated that he has already
invited an investigation. However, he
is not sure if the legal department will
approve an investigation.”
A hospital spokeswoman said Gold-
finger was not available for comment.
Silverman expressed her concern in
another e-mail message. “This is very
troubling and I would not wait very
long for an answer from the company,”
Silverman messaged colleagues, al-
though it is unclear whether she was
referring to Cedars-Sinai or the plas-
ma manufacturer. “The product does
no harm when it is not being used.”
Silverman, in one e-mail message, re-
ferred to previous scientific research
that had found low levels of certain pro-
teins in SD plasma could adversely af-
fect the blood’s clotting ability.
The deaths continued to confound
FDA investigators who wondered
whether the SD technique had missed
a dangerous virus. Or was there some-
thing wrong with the equipment Ce-
dars-Sinai used to transfuse the plas-
ma? Could the hospital be thawing the
frozen blood product the wrong way so
as to cause unusual clotting and bleed-
ing?
While first suspecting transfusion
equipment at the hospital, investiga-
tors later discounted that as a cause of
the deaths.
During the initial phase of its investi-
gation, the FDA knew of only one other
hospital that was using SD plasma in
liver transplants and notified it about
the deaths. The FDA has refused to dis-
close the location of that hospital.
In one e-mail message, Thomas
Lynch, who was on the review commit-
tee that approved SD plasma, referred
FDA colleagues to a summary of the
deaths prepared by Silverman and a ra-
tionale for not issuing a widespread
alert: “Broad notification of the medi-
cal community that there is a potential
risk associated with the use of SD plas-
ma would inevitably curtail the use of
this product, including its use under
circumstances where the product ap-
pears to be beneficial.”
On Oct. 20, 2000, about 18 months
after the first reported death, the FDA