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By
LISA PRIEST
INVESTIGATIONS
UNIT
Monday,
July 8, 2002 - Page A1
Health
Canada's mandatory new inspection program has detected widespread problems
in sperm banks, including a failure to meet government testing requirements,
and donor semen that was erroneously released from
quarantine.
Documents
obtained under the Access to Information Act also found that one Toronto
clinic allowed an overage donor -- likely exposed to Hepatitis B--
to provide semen to a same-sex couple.
The
Whitehorse Medical Clinic flunked its June 12 inspection and is the only clinic
suspended from using its semen supply. With one exception, inspectors found
the clinic kept no records detailing which semen was used in
patients.
"They
can't operate until they can prove all the corrective measures have been
taken, they are in control of their establishment and they are compliant
with the semen regulations," Health Canada spokesman Andrew
Swift
said
in a telephone interview from Ottawa.
Sherillynne
Himmelsbach of the Whitehorse Medical Clinic said that she was not
made aware of the federal regulations but she is now and is working to comply
with them. She said she inseminated only one patient with donor sperm;
another physician in the clinic has probably inseminated two others.
"[Artificial
insemination] is something we wanted to provide for our patients
so they don't have to travel so far for it," Dr. Himmelsbach said from
Whitehorse. "But the bureaucracy involved in this is not worth it to us.
. . . It's been such an incredible hassle."
The
first raft of reports, completed after the national inspection program was
launched in 2001, reveal the latest problems to hit Canada's sperm banks,
which have a troubled history of unregulated clinics, quarantined
semen,
and in 1999, the chlamydia infection of an Ontario woman.
The
national inspection program, which started in November, 2001, imposed regulations
on all 98 establishments that distribute semen; 11 facilities that
process it and the 18 importers of it.
Canadian
Fertility and Andrology Society spokesman Roger Pierson called the regulations
the "most stringent in the world." But they are necessary, he said,
to ensure the safety of women who undergo fertility treatment and
the children
born as a result of it.
Access-to-Information
documents reveal that every distributor, importer and processor
of semen inspected over the past few months had deficiencies.
So far,
21 inspection reports have been obtained; the remaining 106 facilities either
have yet to be inspected or are in the midst of it.
"There
is always a risk in a biological product like semen," said Étienne Ouimette,
Health Canada's compliance co-ordinator for the semen inspection department.
"But the semen regulations in Canada require stringent
safety
measures
that reduce the risk."
Although
there were numerous deficiencies detailed in some of the inspection reports,
many processors, importers and distributors said most of the shortcomings
were of a niggling, administrative nature.
The
semen used in assisted conception by approximately 3,000 women each year is
safe, they stressed.
"The
bottom line is that sperm banks in Canada are conforming to the rules.
Nobody
has gotten hurt," said Calvin Greene, director of Calgary's Regional Fertility
Program, where five deficiencies were noted by inspectors.
The
"little picky things" identified by Health Canada inspectors in November
were
quickly rectified, Dr. Greene said.
One
problem was that inspectors could find no evidence that donors' written consent
for special-access semen was obtained by the clinic physician.
"Every
single treatment that we do has a consent signed prior to doing it
-- that
is a standard in medicine," said Dr. Greene.
He
described the deficiencies as "administrative issues that were easily resolved."
"We
have no problems here -- nor have we ever caused any health problems to our
patients in the 22 years we have had a donor program," he said.
Many
fertility clinics across the country have found Health Canada's semen-testing
requirements so onerous that they have dropped out of sperm-collection
altogether and gone to U.S. suppliers to meet their patients'
needs.
But
there have been problems there, as well.
Xytex
Corporation, a major U.S.-based provider of semen to Canadian clinics and
fertility doctors, was found to have seven deficiencies at its Toronto location,
Xytex Canada Inc.
The
problems included having a donor older than 40, which is against regulations,
who repeatedly tested positive for a Hepatitis B core antibody and
whose sperm was released without the approval of the medical director,
according
to inspection documents. In Canada, sperm donors cannot test positive
for that antibody, said Lolita Uy, the laboratory manager of Xytex Canada
Inc.
A
same-sex couple brought the man, who was in his mid-40s, to the Toronto clinic
to help make a baby. Further testing revealed the donor did not have Hepatitis
B, but likely had been exposed to it, Ms. Uy said.
Two
samples of that semen were used; a third is in quarantine, she said. But there
was no resulting pregnancy.
The
remaining deficiencies identified at Xytex stemmed from a misunderstanding
of when semen testing should take place, said spokesman David
Towles from Augusta, Ga. "All of the issues were fairly minor," he said.
Further
east, in Mont-Royal, Que., Procrea Centre de Cryoconservation Inc. mistakenly
released sperm samples from quarantine, but the samples were not used.
"The
mistake came from the way the date was recorded. To ensure that error does
not happen again, we have changed the way we put the date on them," said
Hélène Girard,
Procrea's director of communications and public
relations.
"That
semen was not distributed so it was a minor problem."
At
the McGill Reproductive Centre in Montreal, nine deficiencies were identified.
They included incomplete documentation on donors, an inspector said.
The report cited two donors' medical questionnaires that were not
signed
as required, and complete physical-examination results of donors were not
always recorded.
"We
didn't feel the safety of our patients was in any danger because of that,"
said Dr. Marinko Biljan, who was the general manager of the centre's sperm
bank in January when the inspection took place.
Five
deficiencies were found at ReproMed Ltd. in Etobicoke, Ont. including improper
investigation of two incidents involving donor semen that did not comply
with the rules.
Its
medical director, Alfonso Del Valle, was out of the country and could not
be reached. Assistant clinical director Cathy Ruberto did not return many
telephone calls made over several days.
While
some clinics were written up for such minor infractions as making corrections
on documents with whiteout fluid, others inherited problems from semen
suppliers who didn't follow Canadian testing regulations.
One
supplier provided semen that hadn't been tested within the 180-day limit to
the University of British Columbia Fertility Endocrine Clinic and IVF program.
Those samples have since been destroyed or returned to the
supplier.
"It
doesn't, in itself, pose a huge risk," said clinic co-ordinator Susan Wilson.
At
the Tennent Semen Bank, in St. John's, Nfld., there were no records of testing
dates or of test results for five donor samples in the inventory, according
to the reports.
"It
was just an administrative error, bookkeeping basically," said Dr. Donald
Tennent, a gynecologist who runs Newfoundland's only sperm bank. Those
problems have since been rectified.
At
Can-Am Cryo Services Corporation in Hamilton, four deficiencies were noted,
all administrative.
They
included missing donor signatures and incomplete procedures for the tracing
of semen -- all of which have since been rectified.
"I
know people say they are picky, but that's what you want as a patient," said
Haimant Bissessar, Can-Am's vice-president. "They do a very good job."
Investigations@globeandmail.ca
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