Rules violations found at Canada
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 ةtienne 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
"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."