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

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Bad
LI Life
A Taste For
Their Work

Blood
Newsday Investigation Finds Transfusion Errors
In Hospitals Kill Scores of Patients Each Year
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60 Years Of
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COPYRIGHT 2002, NEWSDAY INC., LONG ISLAND, NEW YORK VOL. 62, NO. 216
 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- worked, was buzzing with patients needing care. The young nurse, apparently nervous, needed
sion of the wrong type blood. For seven years, Flamm, now 59, had nursed help taking blood samples. Flamm stepped in to
At Lutheran Medical Center in Brooklyn, a nurs- patients in the intensive care and surgical inten- do the procedures herself to make sure all went
ing home patient with a hip fracture received a unit sive care units at Winthrop. She travelled daily well.
of incompatible blood during surgery and died. from her home in Centerport and enjoyed her job. “I jumped in to help her,” said Flamm. “I was
And at New York University Downtown Hospital It was, she says, the only work she ever wanted trying to take the burden off her.”
in Manhattan, an 85-year-old woman admitted with to do. Flamm drew blood to be typed and cross-
gastrointestinal bleeding died after receiving mis- Accustomed to a high volume of work in inten- matched from both patients. But moments later,
matched blood. sive care, Flamm hadn’t been assigned to any pa- Flamm did something that would change her ca-
To be sure, the vast majority of transfusions re- tients that day, April 4, 1994. reer forever — she mistakenly labeled one of the
ceived by 5 million patients every year in the Instead, Flamm says, the head nurse asked her
United States are uneventful. Recently, new to help oversee two young nurses who were new See NURSE on A36
screening procedures have made the blood supply
A36

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
Newsday / Linda McKenney
with another instrument and trans-

Mistake Disrupts Nurse’s Career

NURSE from A5 That was not the end of it. pened to me.”
The hospital reported Flamm’s mistake to the Winthrop officials declined to comment for this
blood specimens with the wrong patient’s name. New York State Education Department’s Office of story.
Then she sent the specimens off to the hospital’s lab. the Professions. She was charged with gross negli- Suddenly, the veteran nurse — who says she was
Flamm and the other nurses obtained doctors’ or- gence. Phi Beta Kappa with a degree in languages from
ders for the transfusions based on those samples. Flamm’s case dragged on as professional disci- Hunter College and president of her class at Belle-
Once they had the orders, Flamm received a unit of pline cases often do. Finally, the State Board of Re- vue School of Nursing — was suspended by the state
blood for the female patient from the hospital’s blood gents suspended Flamm on March 13, 1996, for one nursing board for one year. In the same action, the
lab. She hung the unit and began transfusing the year with the understanding that the suspension state stayed the suspension of Flamm’s license and
NEWSDAY, SUNDAY, APRIL 7, 2002

woman. would be stayed. put her on probation for one year.

Then the phone rang. It was the lab. A technician “I didn’t fight it,” Flamm says. “I had made a mis- “I never wanted to be a nurse again,” Flamm says.
had a question about the blood samples Flamm had take.” “I didn’t look for a job.”
drawn and suddenly she realized she had made a ter- Winthrop-University Hospital fired Flamm, and Eventually, Flamm took a sales job in the home de-
rible mistake. she never again worked in a hospital. While Flamm partment at Macy’s in Huntington, selling linens
“I was totally at fault,” says Flamm. “I quick ran accepts full responsibility for her error — a mistake and other household goods. Later, she went into
in and stopped the woman’s transfusion.” that could have killed the patient — she doesn’t homecare, nursing patients in their homes.
Flamm said the patient hadn’t received much think she should have lost her job. She blames that For four years, Flamm confined her work to home
blood and appeared to be fine. Flamm believes the on hospital politics. care, but now she also works at a nursing home part
woman never knew she’d gotten the wrong blood. “I believe I was fired as an example that you can’t time. Along the way, she has taken refresher courses
“She was fine; it was amazing,” says Flamm. “I make a mistake, you have to be very careful,” says in nursing and she still has a state nursing license.
just prayed to God and I was so grateful that every- Flamm. “I don’t think I deserved to be terminated. “I love nurturing people and taking care of peo-
one was OK.” That was the most devastating thing that ever hap- ple,” says Flamm. “My private patients are terrific.”
 A37

Costing Hospital Patients’ Lives

ferred the woman to intensive care for “I think we’re concerned about them
observation while she awaited the sec- [wrong blood errors] because they are
ond procedure. preventable and they are so devastat-
Before her second surgery, the ing [to] the patients . . . They die
woman needed a transfusion to in- quickly and in spite of our best ef-
crease her red blood cell count. forts,” AuBuchon said.
Shortly after the transfusion began, FDA regulations require a written
the woman’s condition went into a report on the deaths within seven
free-fall. Her blood pressure plum- days. But the regulations are fuzzy, al-
meted and she had chills, signs of a lowing hospitals to make subjective
blood mismatch. judgments about a transfusion’s role
Nurses stopped the transfusion, dis- in a death.
covering that the Type O negative pa- Dr. Jeanne Linden, director of
tient had received Type A positive. blood and tissue resources for the
With the wrong type blood circulat- New York State Health Department,
ing throughout her body, the woman says she does not count all deaths
suffered “an acute transfusion reac- which follow transfusion errors as
tion to this unit of blood” according transfusion-related.
to FDA records. “It was found that Linden says she counted only five
the blood given did not match the pa- transfusion-related deaths in the state
tient’s blood.” over a 10-year period, while FDA
At about 4 a.m. on Dec. 4, 1996, she records showed 20 reports between
died. 1995 and 2000 — eight involving
* * * wrong blood transfusions.
Like the case of the woman in Room Linden considers the underlying
242, most transfusion-related deaths cause for hospitalization. If, for exam-
are shrouded in secrecy with govern- ple, a patient is treated for severe kid-
ment officials refusing to name pa- ney disease, receives the wrong blood
tients and workers involved in their and dies, the death might be blamed
care. Officials say they need to protect on the kidney problem.
patient privacy, but they also worry Those hospitals that don’t report
about the reputations of those who deaths at all are a major problem.
make errors. AuBuchon says the FDA needs a bet-
Arthur Caplan, director of the bioet- ter tracking system.
hics center at the University of Penn- “Frankly, the FDA doesn’t help
sylvania, until recently headed a U.S. you very much with the investiga-
Department of Health and Human Ser- tion [of the deaths] or coming up
vices blood safety committee. Caplan with an alternative. Their ability to
says the government needs to address analyze the data and feed back to
the fear of lawsuits that he believes the blood bankers of the country is
keeps hospitals from reporting all the very limited by their staffing num-
transfusion-related deaths. bers and their other responsibilities,
“Liability fears completely corrupt so that they cannot provide assis-
and compromise adverse event report- tance to solve the problem.”
ing,” Caplan said. “It stinks.” Some say cases like that of the Long
Caplan wants a no-fault system Beach Medical Center woman, whom
with fixed penalties for errors and officials refuse to identify, illustrate
limits on lawsuits so that hospitals the problems with the federal report-
wouldn’t fear multimillion dollar pay- Photo by Michael Geissinger ing system.
ments. “The system doesn’t bring patients
During the Clinton administration, justice, it doesn’t compensate those
Caplan’s committee asked the govern- who are injured and it drives the re-
ment to require all blood establish- porting underground,” says Caplan, of
ments — including hospital transfu- ‘There are going to be the University of Pennsylvania.
After all, Caplan says, “Blood is to
sion services — to report all errors.
Last year, the government began re-
relatively more people health care as oil is to transportation.”
quiring such reporting. But hospitals
must only report laboratory errors, not
who die getting blood * * *
Long Beach Medical Center officials
mistakes on patient floors, where the . . . We’ve reached a acknowledge the transfusion error
majority of errors happen.
Acting like a crimson poison, the
transition point with that occurred before the woman in
Room 242 died.
wrong type blood can kill by triggering regard to safety. For a “Our conclusion from the investiga-
the body’s natural defense system. tion was that he [the phlebotomist who
There are four blood types: A, B, AB variety of reasons, we drew the woman’s blood for testing]
and O. Technicians test patients’ blood
samples prior to transfusion so they re-
haven’t found a method failed to properly identify the pa-
tients,” said Cheryl Chapman, a hospi-
ceive good matches. that’s fail-safe.’ tal spokeswoman.
Reactions to the wrong blood can be The phlebotomist should have
compared to reactions to bee stings: — Dr. S. Gerald Sandler checked the wristband of the patient
Most people suffer only mild reactions, whose blood he drew, making sure
but some die. he drew the sample from the right
As with bee venom, when the body patient. He should have confirmed
receives the wrong blood it marshals Newsday File Photo
her name.
its defenses. If only a small volume of The hospital suspended the phleboto-
the wrong blood is transfused, a pa- and nurses. computer when entering the patient’s mist, who resigned two days later, and
tient’s protective antibodies may suc- Statewide, the number of reported ID number for a crossmatch. entered into a undisclosed legal settle-
cessfully attack and kill the foreign ment with the woman’s family.
NEWSDAY, SUNDAY, APRIL 7, 2002

deaths which followed transfusions of And at the St. Francis Medical Cen-
proteins in the blood, leaving the pa- After the death of the woman in
the wrong blood is about 10 percent of ter in Lynwood, Calif., a man died
tient unharmed. Room 242, transfusion workers at
the national total. But New York has after receiving Type A positive blood in-
But in a serious reaction, shock, clos- Long Beach Medical Center received
more stringent reporting require- stead of Type O positive after a nurse
ing of the airways and severe loss of additional training on procedures to
blood pressure may occur. That’s be- ments than some states, which may ac- mixed up units of blood stored in a hos- follow.
cause as the body’s antibodies attack count for its higher numbers. pital refrigerator. Chapman, the hospital spokeswom-
the large numbers of foreign proteins The transfusion problem extends Dr. James AuBuchon, pathology an, said there were no immediate
attached to red blood cells, they de- from coast to coast, government chairman at Dartmouth-Hitchcock plans to install a computer system
stroy the cells as well. records show. At the University of Cin- Medical Center in Lebanon, N.H., esti- aimed at preventing similar transfu-
Blood safety experts caution pa- cinnati Medical Center, for example, a mates at least 25 people nationwide sion errors. She said: “We have not at
tients to know their own blood type man died after receiving two units of die each year — or 150 since 1995 — this time investigated that type of sys-
when they enter a hospital and to dis- Type B blood instead of Type O. A tech- after receiving the wrong blood, far tem because we do not feel at this
cuss it with friends, relatives, doctors nician entered the wrong digit into a more than the government’s count. point in time that that’s necessary.”
A6 By Kathleen Kerr computer when it installed one after
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
When Checks 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-

Of Blood Type
blood. sylvania’s School of Medicine.
Almost three weeks later, Medjuck “The state’s performance is incredi-
died. Coney Island Hospital main- bly unacceptable. It’s a breach of the
tained Medjuck’s injuries from the public trust for the state not to be vigi-
crash caused his death on Aug. 10, lant when the citizens of New York de-
1995. Medjuck’s family blamed the pend on safe blood,” Caplan said. “In a

Fail a Patient
botched transfusions. case like this, if you’ve got errors, the
A state investigation found six em- state has to go in and enforce its over-
ployees made transfusion-related er- sight.”
rors in the case, and the state health On July 20, 1995, Ira Medjuck had
commissioner at the time, Barbara De- just finished his overnight shift with
Buono, ordered the hospital to file New York City’s Emergency Medical
monthly reports to show “that all or- Service in Brooklyn and was driving
home.
ders for administration of blood and
blood components are issued through
the computer.” Medjuck received the
Man’s death exposes gaps Medjuck, a paramedic, headed to-
ward Mill Basin, where he and his
wife, Leah, rented an apartment just
wrong blood after a technician failed to
make computerized checks.
Now, more than six years later,
in state monitoring of errors steps from the brick house where he
grew up. They often ate meals with
Medjuck’s parents. Medjuck planned
Newsday has found that while state of-
ficials assumed from the hospital’s to move to Israel with Leah and pro-
monthly reports that it was using a vide medical services in the occupied
computer to avoid more transfusion 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-
mistakes, that was not the case. bers the phone call telling her that Ira,
In fact, the hospital’s blood bank her first child, born after 19 years of
computer broke on Dec. 29, 1995, a few marriage, had been in a terrible acci-
months after Medjuck died, and work- dent.
ers checked blood destined for transfu- Medjuck had two fractured legs and
sion by hand for 10 months. The hospi- serious internal injuries. Later that
day, doctors at Coney Island operated
tal did not have a fully operational
to stop internal bleeding.
computer to make transfusion match- “The doctor worked on him all day
es until the summer of 1997. Thursday; we made sure they should
State Health Department officials call us if there were problems,” Med-
said last week they thought Coney Is- juck’s mother recalled as she sat at her
land was using a blood bank computer, kitchen table sorting through wedding
although one of the hospital’s reports pictures of her dark-haired son and his
seemed vague. The state would have wife.
considered hand checks “an acceptable “He was the world, the whole world,”
alternative” had they known about she said.
Photo by Richard Harbus
them, Health Department spokeswom- By 3:23 a.m. Friday, the day after
an Kristine Smith said. Workers at Coney Island Hospital gave Ira Medjuck, below, the wrong type of blood, twice.
the accident, Medjuck needed blood.
“We will be looking into this issue Doctors ordered a transfusion compati-
further to determine the basis for the ble with Medjuck’s own blood type, O
miscommunication about use of the positive.
computer,” Smith said. Standard procedure at Coney Is-
Coney Island Hospital spokesman
Brian Palmer confirmed the 10-month
‘He was the world, land, operated by the New York City
Health and Hospitals Corp., called
period when the blood bank didn’t use
a computer to match blood. Palmer the whole world.’ for technicians to use a computer to
make sure patients received the
said the manual checks of transfusion right blood. But the blood bank tech-
blood, later coupled with the use of a — Yetta Medjuck about nician on duty didn’t use the comput-
nonvalidated computer, were safe.
“ ‘Validated’ means it had not yet
her son Ira, left er. She mistakenly took a unit of A
positive blood and released it for
been properly put through all its paces transfusion.
so it could be used accurately,” Palmer Then a second mistake occurred.
said. A nurse in surgical intensive care
Health Department officials were failed to check the identification on
also unaware, until informed by News- ing for accuracy. Whether or not Coney Island Hospi- Medjuck’s wristband, which didn’t
day, that in 1997 federal inspectors The federal inspectors’ report stat- tal used a computer to process blood match the identification on the blood
criticized the Coney Island blood bank ed, in part: “During the inspection, cer- after Medjuck’s death was important bag.
for not using a fully operational com- tain glitches were found in the system because it was a technician’s failure to The nurse transfused Medjuck with
puter, Smith said. At that time, Coney . . . . Mr. Buglione [in the blood bank] do computerized blood checks that led the blood. The transfusion was the
Island had combined its hand checks was informed that any information ob- to the transfusion errors in his case. worst possible mismatch: A positive
of blood with checks on a computer tained using a nonvalidated computer Years before, the hospital had realized
that hadn’t undergone necessary test- system is highly unreliable.” the importance of a blood-matching See HOSPITAL on A27

Lack of ID Adds to Harlem Error

NEWSDAY, MONDAY, APRIL 8, 2002

By Kathleen Kerr identification for UBM2. He was a middle-aged bank with pickup slips for O positive blood for
STAFF WRITER black man with a mustache and salt-and-pepper UBM2. Meanwhile, another physician’s assistant
hair. Emergency room workers wrote “UBM2” on his had already gone there for A positive blood for
When the man identified later as UBM2 was UBM3 but didn’t take the necessary pickup slip. The
found in an abandoned building in Manhattan, he wristband, for “unidentified black male.” The “2” dis-
tinguished him from another unidentified patient, worker promised to return in 10 minutes with the
had been struck in the head, and burns covered his pickup slip for blood for UBM3.
face and arms. An ambulance raced him to the hospi- UBM3, with similar physical characteristics.
There was clearly room for confusion.
tal. UBM2 had chronic kidney failure unrelated to his
Soon, a unit of A positive blood was dripping slow-
On Jan. 15, 1997, UBM2 arrived at the Harlem injuries. A urine screen showed cocaine and opiates ly through a plastic tube into UBM2, who required O
Hospital Center emergency room. He was in a coma in his system. After two weeks in the hospital and positive. The worker who picked up the blood for his
and his brain was hemorrhaging. several transfusions, UBM2 needed still more blood.
Workers in the emergency room couldn’t find any A physician’s assistant went to the hospital’s blood See BLOOD on A27
 A27

Case Shows Gaps in Monitoring

HOSPITAL from A6 juck’s death didn’t end his case. ings of the agency’s inspectors and pension for one of the nurses but
The care that Medjuck received at said a hospital report on Medjuck’s stayed the suspension, placed her on
blood going into an O positive pa- Coney Island, as well as details on death was not necessary. probation and fined her $500.
tient. Those blood types have the the transfusion-related errors, are Jerome Woyshner, director of the in- On Jan. 17, 1996, the state ordered
most violent reactions to each other. documented in a report state investi- vestigations branch of the New York the hospital to make monthly reports
With the wrong blood coursing gators wrote within months of the district office, wouldn’t discuss Med- for a period of six months, showing
through Medjuck’s veins, his blood paramedic’s death. juck’s case with Newsday but sent a that all orders for transfusion blood
pressure dropped and his tempera- Coney Island officials didn’t report letter to the newspaper stating: were issued through a computer and
ture rose from 100.6 degrees to 103.9 Medjuck’s death to the Food and “The medical examiner’s determi- that everything was in order.
degrees. Still, nurses failed to recog- Drug Administration. While FDA reg- nation lists the immediate cause of While the hospital filed monthly
nize his abnormal reactions. The ulations require reporting of all trans- death as blunt impact injuries sus- reports, it didn’t use a computer to
transfusion continued. fusion-related fatalities, the rules are tained during a head-on motor vehi- monitor blood and instead did man-
Later, a surgical resident and a su- open to interpretation, with some hos- cle collision.” ual checks for 10 months. The hos-
pervising fifth-year resident also pitals reporting any death in which a Along with his letter, Woyshner in- pital’s computer had crashed on
failed to recognize that Medjuck was troublesome transfusion might have cluded a photocopy of what appears Dec. 29, 1995, and wasn’t replaced
having textbook reactions to mis- played a part and others reporting to be a page from the medical examin- until October 1996. Health depart-
matched blood. only those deaths clearly caused by er’s report which confirms his state- ment officials say they weren’t
Around 6:00 a.m., a second unit of transfusions. ment. Another entry on that page aware of the manual checks.
blood was requested for Medjuck. The reporting requirement is in- states that a “reaction to transfu- Dr. Jeanne Linden, the state
The blood bank again issued the tended as a means to track deaths sions of unmatched blood” was a sig- Health Department’s director of
wrong type blood, and a nurse again and respond to the transfusion nificant condition that contributed to blood and tissue resources, said:
neglected to check Medjuck’s identifi- error problem in hospitals across Medjuck’s death. “They told us they were using the
cation. the country. Neither regional nor national FDA computer.”
At 7 a.m., the blood bank received When FDA inspectors learned officials were willing to discuss Med- FDA inspectors who visited
a third request for blood for Medjuck. about Medjuck’s death during a rou- juck’s case in an interview. Coney Island in June and July
This time the blood bank discov- tine inspection, they wrote a report Caplan, the University of Pennsyl- 1997 discovered continuing prob-
ered the earlier mistakes. It was too critical of Coney Island’s failure to re- vania medical ethicist, says the hospi- lems, including the blood bank’s
late, however; his body had already port it to the agency. tal should have reported Medjuck’s failure to validate or test a new
begun to react to the incompatible After visiting Coney Island in early death to the FDA. Until recently, Ca- computer, which was installed in
blood. His kidneys were shutting 1996, FDA inspectors David DeLucia plan headed a blood safety advisory October 1996 but wasn’t fully func-
down. Hospital workers began dialy- and Evelyn Taha wrote a report stat- committee for the U.S. Department tional because it needed validation.
sis. ing that the hospital “failed to notify of Health and Human Services, Agency inspectors cited the hospi-
Later that morning, Medjuck’s the Director, Office of Compliance, which oversees the FDA. tal for its failure to use a validated
younger brother, Bruce, called the Center for Biologics Evaluation and “I find it appalling, unacceptable,” computer system, calling the practice
hospital and learned about the trans- Research within 7 days after a fatal Caplan said. “They should have such a deficiency.
fusion errors. Medjuck’s family raced recipient transfusion reaction.” a report. Transfusion mistakes are In 1999, the New York City Health
to the hospital. The report continued: “I informed major, but unpublicized, problems in and Hospitals Corp., which runs
“They said they ran into a prob- Dr. Fernandez [the hospital’s blood the world of blood. I think it would be Coney Island Hospital, agreed to pay
lem,” Yetta Medjuck remembers. bank director] and other blood bank fair to say it is vital to have all Medjuck’s wife, Leah, a $2.23 million
“The doctors said they gave him the staff that soon after they discovered deaths reported so that problems can settlement. Avir Kagan, medical di-
wrong blood, but they were working that two units of incompatible red be detected, patterns observed and ac- rector at Coney Island Hospital, later
on it.” blood cells were transfused, and that tion taken.” told Newsday: “The settlement of a
She said she “got the feeling things the patient had a hemolytic transfu- The New York State Department malpractice case does not necessarily
were going wrong. They had to take sion reaction and subsequently ex- of Health investigated Coney Is- mean anyone has accepted what the
him down to surgery a couple of pired, it is their obligation to report land after the transfusion mistake cause of death was.”
times. For three weeks, he strug- such an incident to the Office of Com- and criticized the hospital’s blood “He [Medjuck] had very, very se-
gled.” pliance.” bank procedures as well as nurses vere injuries,” Kagan said. “He was
Then, while Medjuck’s parents ob- A letter from the hospital’s Gloria and doctors on duty when Medjuck really not destined to make it, in
served a Jewish fast day in the syna- Fernandez to the FDA states Med- received the wrong blood. The our opinion. In our opinion, we
gogue near their home, he took a juck died as a result of complications Health Department fined Coney Is- don’t know what the major cause of
turn for the worse. of his injuries, not from the transfu- land $20,000 for the errors in Au- death was.”
“Someone came in and said, ‘You sions. gust 1995 but immediately reduced Leah Medjuck has moved to Israel
have to go to the hospital right “In view of the above conclusions, the amount to $13,000. and remarried. Yetta Medjuck still
away,’ ” Yetta Medjuck said. it was decided that this fatality was A head nurse, a nursing supervi- disagrees with the hospital about
Hours later, on Aug. 10, 1995, Med- not a reportable incident to the sor, a staff nurse and a laboratory what caused her son’s death.
juck died. He was buried in Wellwood FDA,” Fernandez wrote. technician all resigned. The state “What finished him,” Yetta Med-
Cemetery in Suffolk County, but Med- An FDA official overruled the find- nursing board ordered a one-year sus- juck says, “was the blood.”

Harlem Patient’s Lack of ID Contributes to Death

BLOOD from A6 checks. They failed to check pickup Karluk listed hypertensive cardio- “It is indeed possible that we looked
slips, a blood compatibility slip and vascular disease and chronic renal fail- at it, evaluated it and expressed our
transfusion had picked up two units the label affixed to the blood bags, ure as contributory to the death and opinion,” Hirsch said. “Maybe they
meant for the other unknown patient FDA records show. And both a physi- wrote that the patient’s overall progno- had a panel [of medical experts] and
by mistake, and the person on duty in cian transfusionist and a nurse failed sis had been poor because of his inju- came to a different conclusion.”
the blood bank hadn’t caught the to make the required checks before ries. Dr. Glendon Henry, medical director
error. transfusing him. A synopsis of a meeting of Harlem at Harlem Hospital, said he believes
Another unit of A positive blood was It was too late. Hospital Center’s transfusion commit- hospital systems in place at the time,
placed in a storage refrigerator on the Already seriously ill from his inju- tee differs somewhat from Karluk’s rather than the employees, were to
floor for possible transfusion into the ries and chronic kidney disease, the conclusion, blaming his death on his blame for the bungled transfusion.
patient later on. man had a severe reaction to the mis- pre-existing illnesses: “The mistransfu- “It had to be the process,” Henry
Then, his doctors requested still matched blood. He began wheezing sion occurred because of human error said. “It’s not unusual for inner-city
more blood for him. A blood bank em- and went into kidney failure, a com- associated with failure to follow trans- hospitals to have a number of un-
ployee reviewed the requisition slip, re- mon reaction to mismatched blood. fusion policy and procedure . . . The known individuals at one time.”
alized an error had occurred and Hospital workers began dialysis in an cause of death was, however, not the Henry said unidentified patients at
warned hospital workers to retrieve
NEWSDAY, MONDAY, APRIL 8, 2002

attempt to save him. mistransfusion but the pre-existing ill- Harlem Hospital are now given what
the remaining unit of blood stored in Eight hours later, at 7:40 p.m. on nesses — in particular acute renal fail- he describes as more precise identifica-
the refrigerator. Jan. 30, 1997, he died. ure.” tion. The wristband of such a patient
According to a report on the case Dr. Diane Karluk of the New York Yet another report filed with the might read, for example, Jan. 15,
Newsday found in Food and Drug Ad- City medical examiner’s office per- FDA states: “Patient expired about 12 2002, Patient Number 1. Blood sam-
ministration files: “Recognizing that a formed an autopsy. Karluk’s autopsy hours later of disease-related causes, ples must be accompanied by a slip
mismatched transfusion had occurred, report described the cause of death per his physician. Administration of identifying the worker who drew the
the supervisor notified the blood bank this way: “Transfusion reaction from wrong type blood unit may have con- blood. Two people in the blood bank
director and the physicians taking mismatched blood transfusion for tributed to patient’s compromised con- must verify that signed blood samples
care of the patients immediately after treatment of complications of second- dition.” and units sent out for transfusion
the mismatch.” and third-degree scald burns of face New York City Medical Examiner match.
Neither the blood bank supervisor and extremities (10% total body sur- Charles Hirsch said in an interview “We require our staff to label it
nor the employee who picked up blood face) and blunt impact to head with that different conclusions about a [blood] right away and make sure it’s
for the patient had done the required subdural hemorrhage.” death can be a question of judgment. 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 D7

I n S e a r c h O f

ERROR-FREE TRANSFUSIONS
Health & Discovery

Health & Discovery

A look at one approach — considered the most foolproof error prevention system in use
Last in a series and bar codes to track blood samples from a Ziploc bag. The actual blood bag is in-

By Kathleen Kerr
STAFF WRITER
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
Step-by-Step 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-
Prevention
ECHNOLOGICAL advances,
gets transfused into the right patients.
The Georgetown system, called I-TRAC
tion to unlock the blood lock on the plastic
bag. If the code doesn’t unlock the lock,
For Patients

T
1 2 3 4
including sophisticated new com- and developed by the Immucor company of blood can’t be transfused.
puter systems and special locks Norcross, Ga., uses a handheld computer Still, not all hospitals like the locks. Sarah Foer, a spokeswoman
designed to prevent hospital similar to a Palm Pilot that goes through a “Some hospitals think it is too cumber- for the American Association
workers from making tragic mis- series of checks. some, and indeed it took us about six of Blood Banks, says
takes, could hold the key to safer If a nurse or technician skips an identifi- months’ worth of meetings to set up all hospital patients can take
blood transfusions. cation check at any point during the trans- the systems to use the blood lock,” AuBu- these steps to avoid receiving
More patients die from receiving the fusion process, the computer will not per- chon said. He said some hospitals think transfusions of the wrong blood:
wrong blood than from any other transfu- mit them to continue. The system tracks a Using a computer, a The phlebotomist uses a The handheld the expense of installing blood locks isn’t
doctor orders a unit hand held computer to computer is
sion error. Sheer carelessness and over- blood sample from the patient’s bedside worth the effort. The locks cost about $3 1. Ask hospital personnel as

Photo by Michael Geissinger

worked hospital staffs are often the cul- through the blood bank. Then the system of blood for a patient. scan first his or her ID connected to a each. But “this $3 cost would prevent
prits. Transfusion experts estimate that tracks a blood unit that matches the sam- The process begins badge – which contains portable printer, about two dozen deaths per year nation- many questions about an upcom-
as many as one in 12,000 units of blood ple from the blood bank to the point of by taking a blood a bar code with crucial which generates a bar wide,” AuBuchon said. ing transfusion as possible.
may be given to the wrong patient. transfusion. sample to determine tracking information – code label for the By comparison, the most recent test for
While most people suffer no lasting inju- Dr. Gerald Sandler, director of George- the patient’s blood then the patient’s blood sample taken The sample is HIV costs about $8 per test and prevents 2. Know your own blood type
ries following transfusion mistakes, the town’s blood bank and blood donor service, type. wristband code. from the patient. immediately labeled. about one HIV transmission per year, and Rh factor before entering the
consequences for those who are affected thinks the I-TRAC may be the most fool- AuBuchon said. hospital. Make sure when you
can be severe, even deadly. And the prob- proof transfusion error prevention system. The I-TRAC system in action In New York State, over a nine-year pe- enter the hospital that the blood
lem, experts say, is growing. “In my opinion, 100 percent of these [er- riod, patients received the wrong blood
“The real issue is that most of the errors rors] are preventable,” Sandler said. “I can 427 times. But transfusions of the wrong information on your wristband is
that occur don’t have to do with the testing; save and prevent every transfusion error type blood aren’t the only errors that correct.
they have to do with misidentification of the in this hospital.” REPOR occur in hospitals.
unit or patient,” says Sandler said that 5 6 7 8 9 REPORT
T Between October 1999 and September 3. Before a transfusion, ask
Kay Gregory, director as far as he knows, 2000, a nationwide total of 23,528 trans- questions to make sure the blood
of regulatory affairs Georgetown hasn’t fusion-related errors and accidents were unit about to be transfused is the
for the American Asso- had a single fatality BEEP reported to the Food and Drug Adminis- right type.
ciation of Blood due to a blood mis- tration, mostly by manufacturers of
Banks. “This is some- match since it began blood and plasma products. Most of the 4. Ask to see the label on the
thing that every hospi- using the system more errors had to do with problems like bag and check it for blood type.
tal worries about all than three years ago. blood processing and contamination,
the time.” Sandler cautioned, The blood sample is The technician puts a The nurse examines Beep or visual signal After transfusion, the poor storage that made blood products
Mismatched blood however, that the delivered to the lab, second bar code on the patient’s wristband, confirms positive IDs. nurse scans his or her less potent and the collection of blood
5. Tell relatives and friends
is dangerous because the body’s immune I-TRAC system isn’t suited for all sections where bar coding the blood unit to be confirms it by scanning ID badge, patient’s from unsuitable donors exposed to vari- your blood type so they can
system rallies its defenses to fight against of a hospital. Emergency rooms, where prevents technician transfused, and the bar code, and scans wristband and the ous diseases and the like. check if you’re unconscious or
blood of the wrong type. That can lead to quick treatment is often necessary, might from ordering an blood is delivered to the blood bag barcode blood label to generate Testifying in 2000 before a U.S. Health asleep while being transfused.
kidney or lung damage and even death. be better served with a wristband system incorrect unit of blood. patient’s bedside. to confirm a medical record and and Human Services Department blood Have someone act as an advocate
Before blood can be transfused, laborato- using color coding instead of the more compatibility. a record for the blood safety committee, Dr. Jeanne Linden, di-
bank. for you.
ry technicians test samples of patients’ time-consuming bar code / computer sys- rector of blood and tissue resources for the
blood to determine whether their type is tem, Sandler said. Compiled by staff New York State Health Department, de-
A, B, AB or O. Then they make sure that Noel Brown, a vice president for Im- Newsday / Linda McKenney
scribed the problem in New York.
the hospital has enough of the right blood mucor, estimates that licensing and soft- “I think the systems are complex and ago, under the Clinton administration,
on hand for the patient. ware fees for the system would cost a human beings are prone to error,” Lin- that the government start a system requir-
But getting the right blood to the right hospital a one-time payment of $75,000. den later told Newsday in an interview. ing hospitals and independent blood
patient is another matter. Although most The hardware — one set for every 11 “The systems can be improved to make banks to report all blood-related errors.
hospitals train transfusion workers how to beds — would cost about $3,000 per set. things easier for people, to make those The proposal is still pending.
check blood both in the blood bank and at And there would be a $6,000 annual soft- mix-ups less frequent. Until May 2001, the Food and Drug Ad-
the patient’s bedside to make sure it goes ware maintenance fee. “The No. 1 problem is the right blood ministration required only federally li-
the right person, training alone can’t pre- Brown calculated that such a system Georgetown gets all the way to the hospital floor and censed blood banks to report nonfatal
vent errors and deaths. would add about $1.39 to the cost of each University a nurse administers it to the wrong per- transfusion errors, such as bacterial con-
Now, some transfusion experts say en- unit of transfused blood. Hospital uses son,” Linden said. “Our experience is tamination that occurred in their labs.
hanced computer systems may hold the While high-tech computer systems ap- handheld that the wristband often is not checked. Most hospital blood banks didn’t fall into
key to error-free transfusions. pear to offer one of the best ways to pre- computers They should match the blood bag to the that category.
At Georgetown University Hospital in vent transfusion-related deaths, some hos- and bar codes wristband. Sometimes the nurse just Since May 2001, the government has re-
Washington, D.C., the staff is using a so- pitals use a more modest but effective lock- to track blood compares paperwork on the requisition quired hospitals to report transfusion-re-
phisticated computer system aimed at wip- ing device to prevent mistakes. samples from the order.” lated errors that occur in their own blood
NEWSDAY, TUESDAY, APRIL 9, 2002

NEWSDAY, TUESDAY, APRIL 9, 2002

ing out transfusion errors in its outpatient Dr. James AuBuchon, a transfusion ex- hospital’s blood But the wristband doesn’t guarantee banks such as giving the wrong blood to a
transfusion unit. While other hospitals do pert and pathology chairman at Dart- bank, where Al safety. nurse for a patient.
have computerized transfusion systems, mouth-Hitchcock Medical Center in Leba- Langeberg works, “Sometimes in the operating room, the But most hospital transfusion errors
Georgetown believes its system is the most non, N.H., finds blood locks effective. left, to the wristband is removed,” Linden said. tend to occur on the floor and not in the
comprehensive one in use in U.S. hospitals. “It prevents a human error that may patient’s bedside Hospital staffing shortages also pose a blood bank, experts say. The government
Georgetown uses handheld computers have happened in the chain from causing for the transfusion, huge problem: Harried technicians and doesn’t require reports of errors that occur
a disaster,” AuBuchon said. prepared by nurses may cut corners under pressure in hospitals but outside their blood labs.
Patients have three-letter codes on their registered nurse and make fatal mistakes. Hospitals must report all transfusion-re-
wristbands. When a blood sample is Jennifer Jay, Preventing errors isn’t the only problem lated fatalities, no matter where they
drawn to be tested, the patient code is writ- right. associated with transfusion deaths. Incom- occur, to the FDA.
To read the entire ten on the tube of blood. When the hospi- plete reporting of transfusion errors Richard Lewis, deputy director of the
blood transfusion tal blood bank sends out a unit of blood for masks the full extent of the problem. FDA’s Office of Blood Research and Re-
safety series, log on transfusion into a specific patient, it em- The problem is so urgent that the view, says that although more errors have
to www.newsday.com. beds the patient’s code into a small plastic Health and Human Services blood safety
lock at the top of a plastic bag resembling Photos by Michael Geissinger committee suggested more than a year 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

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

biomedical communications professor, committee that urged the government to

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

FDA Plasma Warning

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

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

Andersen Trial to ‘Drive Stake Deeper’

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

ners and severe damage to its reputation. cago headquarters. Rusty Hardin, Andersen’s lead ment of Justice. Since then, nearly $1 billion in reve-
Unless attorneys reach a last-minute settlement, lawyer in the criminal case, argued March 20 for a nue has vanished as more than 300 publicly traded
jury selection will begin today in the first criminal speedy trial to expose what he called flimsy evidence clients, such as United Airlines and Merck & Co.,
trial to emerge from Enron Corp.’s collapse last year. from prosecutors. Top Andersen officials had turned dumped the smallest of the Big Five auditing firms
“All the trial will do is allow the Justice Depart- over documents to prosecutors and had testified be- — most after the indictment was unsealed March 14.
ment to bring a lot more dirt out on Andersen and fore Congress that they knew nothing of intentional Meanwhile, Andersen’s international network
drive the stake deeper into its heart,” said Arthur shredding to thwart Enron investigations. has been dissipating as partners in more than
Bowman, editor of Atlanta-based Bowman’s Account- U.S. District Judge Melinda Harmon agreed and two dozen countries moved to join competitors.
ing Report, an industry publication. set today’s trial date. She also has ruled that jury se- The firm has laid off thousands of workers.
Members of the accounting firm are accused of lection would last no longer than a day and attorneys “Even an acquittal doesn’t reverse all the damage of
shredding documents and deleting computer would give opening statements tomorrow. the past three to four months,” Bowman said. “But this
records related to Enron audits as the Securities Negotiations to settle the criminal case broke is a firm that truly believes in its innocence as a firm,
and Exchange Commission began examining En- down in mid-April. If convicted, Arthur Andersen and apparently is willing to go to its death to prove it.”
A28

A Blood Transfusion Mistake

VICTIM from A6 due to clerical errors that occurred in the blood E-mail correspon-
bank. Had [standard operating procedures] cover- dence between two
State Sen. Kemp Hannon (R-Garden City), has intro- ing identification of specimens been followed, the FDA officials — ob-
duced a bill to provide for development of computer- error would have been avoided.” tained by Newsday as
ized hospital systems designed to avoid transfusion Carol Bohdan, a hospital spokeswoman, said of- part of a Freedom of In-
errors. The bill would empower the state health com- ficials had no comment regarding the incident formation Act request
missioner to require such computerized systems in since the case is in litigation. — states: “The labeling
hospitals and would provide for appropriating funds. Mitchell Drach, the attorney handling the case for error occurred in the
It was added as a provision to a bill aimed at prevent- the law firm of Popick, Rutman & Jaw, said that de- lab when the bar codes
ing other medical errors. spite Wong’s health problems, he believes it was the were generated and
Medical experts have expressed increasing concern transfusions that caused her death. the wrong label was
over deaths associated with transfusion errors, fearing “She was able to live at home with her husband,” placed on this [pa-
that the real number of such deaths is vastly under- Drach said. “She didn’t have a life-threatening condi- tient’s] tube.”
counted because some hospitals fail to report them. tion. If she didn’t have the bad transfusions — based on As a result of the er-
Wong entered NYU Downtown in lower Manhattan my discussion with experts and a review of the records rors, on April 5, 2000, Newsday Photo / Mayita Mendez
on April 4, 2000, suffering from gastrointestinal bleed- Wong received a trans-
— I don’t think she would have died.” Mary Wong, granddaughter of
fusion of two units of
ing. She also had diabetes and coronary heart disease. According to FDA records, a technologist apparently Type B positive red Ying Lung Chiu Wong.
An FDA inspection report concerning Wong’s confused Wong’s blood sample with that of another pa- blood cells instead of
death states: “The inspection confirmed that the tient. A second technologist failed to perform checks the Type A positive she required. In the days that fol-
transfusion reaction and subsequent fatality were that would have revealed the initial error. lowed, Wong became lethargic and developed breath-
ing difficulties. After testing, she was diagnosed with
sepsis, a serious blood infection. The records do not

Blood Plasma Linked to Deaths 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 from A6 there was some concern that the technique, which plasma. After receiving just one unit, Wong devel-
eliminates dangerous viruses, might miss some oped breathing problems and cardiac arrest.
earlier Oct. 20, 2000, notice to doctors, advising pathogens that can cause disease. Hospital employees resuscitated Wong but didn’t
them of a cluster of deaths in liver transplant pa- In 1999, V.I. Technologies recalled 37 lots, stop the transfusion at first. Family members say the
tients who received SD plasma and suggesting which amounted to 90,000 units of SD plasma, be- transfusion took place roughly between 10 and 11 p.m.
that the use of the plasma be carefully monitored. cause tests revealed the presence of the parvovi- During the transfusion, a technologist discovered
That notice also suggested that improper storage rus B19 that can seriously affect pregnant women that Wong’s blood type was really Type A positive and
and handling of SD plasma could result in prob- and people with compromised immune systems. called a doctor, who then halted the transfusion.
lems. Shortly after that, Wong again required resusci-
The FDA apparently did not receive any reports
tation. At 12:22 a.m. on April 11, she was pro-
V.I. Technologies, which is now located in Wa- of serious adverse events associated with the re- nounced dead.
tertown, Mass., divested itself of its Melville plas- called plasma. Various documents cite different causes for
ma operation in 2001, less than a year after the At one point, the Justice Department investigat- Wong’s death. A hospital death note says the cause
deaths. A V.I. Technologies spokeswoman de- ed the arrangement the Red Cross had with V.I. of death was cardiac arrest. An autopsy report by
clined several requests for comment. Technologies, also known as Vitex, and Novation, the medical examiner’s office stated the cause of
SD plasma has been controversial for some a company which distributes medical supplies to death was bacteria in the blood due to a urinary
time. The plasma costs more than twice the hospitals, to manufacture and sell SD plasma. tract infection complicating diabetes.
amount of ordinary plasma — $125 a unit. The antitrust investigation raised concerns that An FDA document states: “Cause of death de-
Traditionally, doctors have preferred to trans- the plasma arrangement created a monopoly but layed hemolytic reaction, ABO incompatibility.” A
fuse plasma taken from just one donor. Using the the probe was eventually dropped. hemolytic reaction refers to a patient’s response
SD method, donated plasma from about 2,000 peo- V.I. Technologies sold its plasma business to to receiving the wrong blood; ABO incompatibility
ple is pooled — ordinarily risky because the pool Precision Pharma, also in Melville, in 2001. Preci- means a mismatch in blood type.
Mary Wong, Wong’s granddaughter, said in an
may contain many different viruses from the vari- sion has not manufactured SD plasma, but Marge interview that hospital officials met with family
ous donors. The solvent detergent process then Gandolfi, a marketing executive for the New York members about three weeks after she died, admit-
dissolves the fatty protective coating of viruses Blood Center, said the center is in discussions ted that mistakes had occurred and apologized. “I
like HIV and hepatitis C and cleanses the viruses with Precision about manufacturing a “second gen- feel that we’re all very angry and shocked at what
from the plasma. eration” plasma that would combine the solvent happened,” Wong said. “She should have been
When the FDA approved SD plasma in 1998, detergent method and another technique. 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.
NEWSDAY, MONDAY, MAY 6, 2002

AP Photo
A36

MDs Warned on Ebola Potential

THE ASSOCIATED PRESS nal of the American Medical Associa- under the skin or from body orifices. lines are useful for doctors like him
Chicago — A bioterrorist attack tion, aim to help doctors recognize bio- The guidelines note that these virus- who would be on the front line in such
using Ebola or other so-called bleeding logical warfare agents that most have es already have been turned into weap- an attack, but the advice needs to be ac-
viruses could be especially insidious be- only read about in medical books but ons by the former Soviet Union and the companied by federal money for train-
cause the early symptoms seem so ordi- that seem more menacing after last United States and could cause wide- ing and equipment.
nary and there is no vaccine or ap- fall’s anthrax-by-mail attacks. spread illness and death. “It’s one thing to have the masks and
proved drug treatment, experts say in The recommendations deal with Dr. Neal Shipley, head of the emer- suits sitting in someone’s office. It’s an-
new guidelines for doctors. hemorrhagic fever viruses, whose gency department at North General other thing to have personnel on every
The guidelines, in this week’s Jour- most severe symptom is bleeding, Hospital in Manhattan, said the guide- 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 guidelines were created by the Working
Group on Civilian Biodefense, which is
comprised of doctors and public health ex-
By Tom Brune Driving the reorganization, Muel- some criminal enforcement responsi- perts from the military, civilian govern-
WASHINGTON BUREAU ler said, is the FBI’s realization that bilities and increasing the number of ment agencies and universities.
Washington — Despite the most mas- Sept. 11 plotters had taken the abili- analysts, he said. This is the sixth set of bioterrorism
sive probe in history, the FBI has found ty to blend into America, below the It must improve its technologies, he guidelines from the group, which has
no paper containing information about radar of law enforcement, to a new said. Already, he noted, the FBI will be published recommendations in JAMA
the plot for the Sept. 11 attacks, a fact level of sophistication. spending $600 million to upgrade and for anthrax, smallpox and plague.
that spurs the bureau on to a greater “Eight months after the attacks — boost its technological capabilities. “We know that mortality can be di-
sense of urgency, FBI Director Robert even after all the information we’ve Over the past decade, the FBI has minished with good, meticulous medi-
Mueller said yesterday. turned up, as one reporter put it, from steadily improved in its fight against ter- cal care,” said Dr. Luciana Borio of the
“Our mission is clear: to stop acts of ‘caves to credit cards’ — we have yet to rorism, preventing more than 40 at- Johns Hopkins Center for Civilian Bio-
find a single piece of paper outlining any tacks in recent years, Mueller said. But defense Strategies and lead author of
terror from ever getting off the ground,”
element of the attack,” Mueller said. the FBI has more to do. the guidelines. That would include
Mueller told the Anti-Defamation Mueller said terrorists are “willing As he admitted in an April 19 speech steps to reduce fever and blood pres-
League yesterday in remarks that fore- to go to great lengths to destroy to the Cosmopolitan Club of California sure, and the use of ventilators and
shadow his testimony today at a hear- America. We must be willing to go to in San Francisco, the FBI had shortcom- anti-seizure drugs if needed.
ing before the Senate Judiciary Commit- even greater lengths to stop them.” ings that it had “made problems worse Victims of Ebola and other hemorrhag-
tee on the reorganization of the FBI. To stop them, the FBI must broad- by ignoring or denying them” instead of ic viruses, such as Marburg, yellow fever
As he has in other speeches in recent en its reach internationally with embracing constructive criticism. and Rift Valley fever, can show early,
weeks, Mueller touted his efforts to reor- more legal attaches, now in 44 coun- “We have to acknowledge prob- flu-like symptoms within two to 21 days
ganize the widely criticized FBI while ac- tries, and secure better cooperation lems and be ahead of the curve in fix- that can include fevers, facial redness,
knowledging the bureau’s inability to with local law enforcement at home. ing them,” he said. “That has been lethargy and headaches. The more seri-
come up with a smoking gun on the The FBI must devote more of its our approach in recent months, and ous, telltale symptoms such as bleeding
Sept. 11 hijackings or anthrax attacks. resources to prevention, shedding it will remain our approach.” may take longer to develop.

Flaws at Old Reactors Raise Concerns

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

Families Never Told of Link in Plasma Deaths

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

troversial product had been linked to their deaths the FDA and the Centers for Disease Control and monitored for bleeding problems. The FDA has taken
nor were they informed of the government investi- Prevention to report the deaths, but never shared its no action to remove SD plasma from the market, al-
gation that followed. concerns with relatives.“We do not want to alarm our though it currently is not in production.
Now, the deaths of four more hospital patients, patients’ families,” she said. “We don’t know that The warning came more than two years after
which federal officials say took place around the there’s a direct cause and effect. It appears there the Los Angeles deaths and more than a month
same time as the Los Angeles deaths, have been may be some correlation.” after Newsday began investigating them.
linked to the plasma, which the American Red When Newsday asked whether the government is The plasma’s manufacturer, V.I. Technologies,
Cross sold to thousands of hospitals, Newsday has currently investigating any other deaths that may be is located in Watertown, Mass., but had a
learned. But the Food and Drug Administration linked to the use of SD plasma, FDA spokesman Melville plasma operation until 2001, when it di-
refused yesterday to say where the four addition- Jason Brodsky said: “I am not in a position to discuss vested itself of the operation. The company has re-
al patients — three with liver transplants and a any talks we may be having. I can’t confirm or deny.” peatedly refused to comment.
fourth with liver disease — died. The controversial SD plasma is created by pooling As part of a contractual arrangement with the
Newsday reported Monday the links between the plasma from about 2,000 donors and then cleansing Red Cross, V.I. Technologies manufactured the
Los Angeles deaths and the plasma, formerly manu- it of dangerous viruses like HIV and hepatitis. Some plasma using a cleansing method that was patent-
factured by V.I. Technologies on Long Island. The medical experts, however, have raised concerns that 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 structing doctors not to use the plasma in liver trans-
STAFF WRITER plant patients and those with liver disease. The
The death of a pregnant 17-year-old on an operat- warning came after the 10 deaths and about a month
ing table in Los Angeles three years ago sounded the after Newsday began asking federal officials ques-
NEWSDAY, SUNDAY, JUNE 2, 2002

first alarm about a high-tech blood plasma processed tions about the deaths.
on Long Island. SD, or solvent detergent plasma, approved by the
Ultimately, the deaths of five other liver trans- FDA in 1998 and received by the Cedars-Sinai pa-
plant patients at the Cedars-Sinai Medical Center in tients, had promised to make transfusions safer. A
Los Angeles would be linked to the plasma, along scrubbing technique was used to rid pooled batches
with the deaths of four other people around the coun- of plasma from up to 2,500 donors of dangerous virus-
try. Internal Food and Drug Administration e-mail es such as HIV and hepatitis B and C. Some scien-
messages and memos obtained by Newsday reveal tists liken the process to pasteurization of milk: The
that after Cedars-Sinai notified the agency about the technology used to cleanse the plasma could be used
1999 deaths at the hospital, investigators quickly only on large batches. The New York Blood Center in
began focusing on the role the blood plasma played. Manhattan patented the method and licensed it to Newsday Photo / Daniel Goodrich
In March 2002, the FDA issued a “black box” warn- SD plasma was expected to make transfusions safer, but
ing — the agency’s most serious labeling alert — in- See PLASMA on A34 has been linked to 10 deaths around the country.
A34
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company with a Melville plasma facili- With each new death, Silverman
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grew more impatient, expressing mis-
givings in e-mail messages about SD
At Frank & Camille’s! The Red Cross had agreed to pay V.I.
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plasma..
“The additional 3 cases concern me
Ask about our special introductory lesson plans! Sept. 30, 2000, to make SD plasma greatly and must be resolved soon,” Sil-
• For the very young (from 3-1/2 to 11 years old) over a period of several years. The Red verman wrote at one point to col-
• For adults & children (from 12 years old & up) Cross then sold it — $125 per unit com- leagues. “If we do not come to resolu-
pared with $45 for regular plasma — tion tomorrow . . . or if, based on the
• For the not so young (senior citizens welcome) to thousands of hospitals. information we hear tomorrow, we be-
At Cedars-Sinai, the 17-year-old lieve the product to be implicated, we
girl, pregnant and suffering from liver should act to stop distribution.”
disease, required a liver transplant. Meanwhile, Cedars-Sinai officials
During surgery, she was transfused who reported the deaths to the FDA be-
FREE 1 Month Lessons!** with more than 16 units of SD plasma, came skittish — but ultimately cooper-
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died in early 1999.
ated — when federal investigators
asked to examine their records, the
All rental fees apply towards Confronted with a mysterious death, e-mail messages indicate. The hospital
purchase price. Cedars-Sinai contacted the FDA. Soon had stopped using SD plasma once it
**Lessons available only at Melville and Westbury locations. Cedars-Sinai had reported the deaths became aware of the problem.
of five more transplant patients be- “Dr. Dennis Goldfinger, director of
tween April and December 1999: a Transfusion Medicine Service is very
Frank & Camille’s
K E Y B O A R D C E N T E R S
man, 61; a woman, 58; a woman, 54; a
man, 43; and a woman, 48. All had
nervous about FDA coming,” FDA em-
ployee Jonetta Collins notes in one
some form of liver disease. All had re- e-mail message.
MELVILLE
Established 1976 www.frankcamilles.com
WESTBURY
ceived SD plasma. And another e-mail message from
In early 2000, e-mail messages FDA employee Tania Hall states: “Dr.
482 Route 110
(2 Miles North of L.I.E.)
(631) 385-0606 1(800) 660-PIANO 15 Old Country Rd.
(1 Blk. East of Fortunoff’s)
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buzzed back and forth between FDA of-
ficials as they struggled to solve the
Goldfinger stated that he has already
invited an investigation. However, he
VALLEY STREAM MANHATTAN WESTCHESTER PARAMUS, NJ
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(516) 561-9400 (914) 285-9524 (201) 291-1212
Melville plant be linked to the deaths A hospital spokeswoman said Gold-
Most major credit cards accepted. *Delivery and pickup not included. at Cedars-Sinai 3,000 miles away? finger was not available for comment.
Dozens of internal FDA memos and Silverman expressed her concern in
e-mail messages obtained by Newsday another e-mail message. “This is very
FREE IN-HOME CONSULTATION under the Freedom of Information Act
reveal details about the deaths and the
troubling and I would not wait very
long for an answer from the company,”
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FDA spokesman Jason Brodsky
Silverman messaged colleagues, al-
though it is unclear whether she was
CUSTOM DRAPERIES & TOP TREATMENTS said the fact that it took the agency
about three years from the time of
referring to Cedars-Sinai or the plas-
ma manufacturer. “The product does
FROM OUR DESIGNER’S CHOICE COLLECTION the first death to issue its recent no harm when it is not being used.”
black box warning about SD plasma Silverman, in one e-mail message, re-
does not mean the agency dawdled. ferred to previous scientific research
Brodsky pointed to an interim warn- that had found low levels of certain pro-
ing issued in 2000 and said a March teins in SD plasma could adversely af-
2001 death of a patient with liver fect the blood’s clotting ability.
disease who received SD plasma but The deaths continued to confound
did not have a transplant prompted FDA investigators who wondered
the agency to issue the black box whether the SD technique had missed
warning on March 29. a dangerous virus. Or was there some-
“Each of these situations are decid- thing wrong with the equipment Ce-
ed on a case-by-case basis,” Brodsky dars-Sinai used to transfuse the plas-
said. “The agency acts and when it ma? Could the hospital be thawing the
receives additional information, it frozen blood product the wrong way so
considers what action might be nec- as to cause unusual clotting and bleed-
essary. In this specific case, when it ing?
became clearer that not just patients While first suspecting transfusion
undergoing liver transplants were at equipment at the hospital, investiga-
risk but [also] those with liver dis- tors later discounted that as a cause of
ease, the FDA decided a stronger the deaths.
warning was necessary.” During the initial phase of its investi-
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FDA officials who sent and received gation, the FDA knew of only one other
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NEWSDAY, SUNDAY, JUNE 2, 2002

CALL TODAY FOR YOUR FREE IN-HOME CONSULTATION The FDA correspondence states that tee that approved SD plasma, referred
1-800-543-5436 Cedars-Sinai officials said their liver
transplant program started using the
FDA colleagues to a summary of the
deaths prepared by Silverman and a ra-
Sale price includes fabric, lining, labor and installation. Verticals, blinds, shutters and shades have an installation charge. SD plasma in 1999, and it was only tionale for not issuing a widespread
Percentages off represent savings on regular prices. Does not include Every Day Low Price items. Sales may or may not have
been made at regular price. Major purchase plan available. Custom Decorating available at most larger JCPenney stores. after that patients began developing alert: “Broad notification of the medi-
Sale prices effective through June 29, 2002. blood clots and dying mysteriously. cal community that there is a potential
As the investigation unfolded, Dr. risk associated with the use of SD plas-
Toby Silverman, medical officer at the ma would inevitably curtail the use of
FDA’s Center for Biologicals Evalua- this product, including its use under
tion and Research, e-mailed co-work- circumstances where the product ap-
ers, saying: “I believe it is too early to pears to be beneficial.”
decide whether the product is to be im- On Oct. 20, 2000, about 18 months
www.jcpenney.com/customdecorating ® plicated in this fatal event although I after the first reported death, the FDA