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Health and Community Services
November 2, 2007

Health Minister Provides Update on Work of Secretary to Cabinet (Health
Issues) on ER/PR RE-testing Process

The Honourable Ross Wiseman, Minister of Health and Community Services, today provided an update on the work being undertaken by the Secretary to Cabinet (Health Issues), in collaboration with regional health authorities, to prepare for the Commission of Inquiry on Hormone Receptor Testing.

"On May 22 of this year, the Provincial Government announced that it would undertake a Commission of Inquiry as an important and necessary measure to ensure a thorough review and understanding of what exactly happened with respect to the problems encountered with ER/PR testing for breast cancer patients," said Minister Wiseman. "In addition, we created a task force to examine how the health care system responds to adverse health events. As a result of these measures we have identified inadequacies within Eastern Health's record-keeping system."

As part of the preparation for the commission process, the Newfoundland and Labrador Centre for Health Information (NLCHI) was asked by the Provincial Government to develop a comprehensive database to ensure a thorough understanding and documentation of key dates and results. The database is designed to include the total number of ER/PR tests sent to Mount Sinai for re-testing; determine whether or not any breast cancer patients tested between May 1997 and August 2005 need re-testing at Mount Sinai but were not included in the initial round of re-testing; and confirm that all patients who were re-tested in 2005-06 were contacted. NLCHI is the crown corporation charged with developing and maintaining a wide range of health statistics and information systems and offers a wealth of expertise regarding database management in the health system.

"While the database is not yet complete, there are emerging results which I feel are important to be shared with patients and the public,"

said Minister Wiseman.

In December 2006, Eastern Health reported that 939 patients with original ER/PR tests between 1997 and 2005 had been re-tested at Mount Sinai Hospital. The main criterion for being selected for re-testing was that the original test result was negative for estrogen and progesterone receptivity. The work thus far on the new database shows that approximately 1000 cases were sent to Mount Sinai Hospital for re-testing. Despite the increase in the total number of cases, and with the exception of the 15 cases noted below, almost all the extra cases were retested in the original 2005-06 period and assessed when the results came back from Mount Sinai.

 

There are 15 new cases which were sent for re-testing in the last three months. Three of these patients have been confirmed negative, meaning no requirement for a change in their treatment. Results have not yet been returned for the other 12 cases, however, in 10 of these cases, the patients' physicians determined they should be treated as positive and they received Tamoxifen or another adjuvant therapy, meaning their course of treatment will not change. Further information is being pursued on the patient records of the remaining two cases.

"Contact with these patients and their physicians has begun," said Minister Wiseman. "One of the key learnings is that record keeping at Eastern Health is clearly inadequate in this area and I have made it clear to them that this situation must be addressed immediately. As a result of problems identified with record keeping through our review, it is possible that the total number of cases may change as the database exercise is completed. We are committed to ensuring that the patients, the public and the commission continue to receive information as it becomes available so that public confidence is restored in the system."

"It is important to note that the ER/PR testing protocols in place today are on par with the best processes in the country, and patients should have confidence that they are receiving quality of treatment today," added Minister Wiseman.

The database development process has also been used to ensure that all re-tested patients have been contacted with their final results. To date, six patients have been identified for which there is no documentation of contact. Eastern Health is calling these patients to confirm the earlier contact or, if necessary, to provide the re-test results.

"Our government will remain diligent in ensuring the ER/PR re-testing process is satisfactorily completed," said Minister Wiseman. "Furthermore, we will keep the Centre for Health Information engaged with Eastern Health to ensure high-quality and effective management of their health data."

"The Commission of Inquiry on Hormone Receptor Testing was briefed yesterday on the results to date from the new database," said Minister Wiseman. "We anticipate that these matters will be studied by the commission and will contribute to a thorough examination of the events related to ER/PR testing."

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Media contact:
Glenda Power
Director of Communications
Department of Health and Community Services 709-729-1377, 685-1741
glendapower@gov.nl.ca

2007 11 02                                                  12:45 p.m.


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