Grand River Hospital, Psyche Systems, Siemens Healthcare, Bio-Rad, Home Test Direct


IT’S NOT OFTEN THAT A HOSPITAL LABORATORY needs to be closed and decontaminated following a lab accident. Yet that is what happened on April 2 at 495-bed Grand River Hospital in Kitchner, Ontario.

The problem was caused by the release of the soil fungus coccidioides when a specimen container broke in the laboratory during disposal. The spores of this fungus can cause a flu- or pneumonia-like illness when inhaled.

The problem was discovered within hours of the contamination. Workers in the laboratory were immediately evacuated and the facility was closed. Because the incident took place within the laboratory, no patients were exposed to the fungus.

The consequences of this contamination event were significant. Both the microbiology lab and the core lab were closed and sealed on April 2. The hospital decided to cancel elective surgeries for as many as 70 patients on the day following the accident in the laboratory.

The Waterloo Record newspaper reported that lab testing was switched to nearby St. Mary’s General Hospital. Lab specimens from Grand River Hospital were also being sent to Cambridge Memorial Hospital, Guelph General Hospital, and hospitals in Hamilton and London, Ontario.

Any laboratory equipment that could not be decontaminated is being replaced. Areas needing decontamination included the core laboratory. New ceiling panels, lights, and heat detectors were installed and, last week, parts of the lab reopened, including anatomic pathology for cancer testing, the newspaper said.

Another issue is the need to calibrate the new lab testing instruments and validate the tests to be run on these analyzers. For that reason, the Grand River Hospital laboratory has yet to return to normal operation with its full menu of lab tests.

The contamination of a large clinical laboratory by the accidental release of an infectious agent during the disposal of specimens is a rare event. This episode demonstrates how such a lab accident can disrupt normal operations of a large hospital and require substantial money to deal with the contamination, including replacing expensive lab analyzers and instrument systems.


SELF-SAMPLING FOR HPV TESTING is a concept that is becoming reality. Already, in the United Kingdom, one company sells an HPV test kit to consumers that allows a woman to collect her own specimen and send it away to a lab to be tested.

It was last fall when Home Test Direct Pty Limited introduced its TAMPAP test for detecting the HPV virus, which is associated with cervical cancer. The test is marketed on the company’s website ( It costs £19.95, plus £9.95 for postage (a total of US$47.79).

After purchasing the HPV test, the woman is sent a collection kit. She is told “You just take a sample of your cervical cells in the comfort of your own home (using an ordinary tampon) then dispatch it to our state-of-the-art laboratory in a specially supplied container.”

In February, 2011, the British Journal of Cancer published a study about the use of self-sample HPV test kits by consumers. In this study, 3,000 women were selected who had not responded to invitations to visit their physician for a cervical cancer screen.

Study authors wrote that “The women were randomized on a 1 : 1 basis to either receive an HPV self-sampling kit or a further invitation to attend for cervical cytology.” It was found that the HPV self-screening group responded at a rate of 10.2%. This was statistically higher than the 4.5% response rate by those women who visited their physician in response to a notice inviting them to come in for a cervical cancer screen.

Self-sampling for HPV testing has been the subject of several studies in Mexico. In November, 2011, the medical journal Lancet published a study conducted in “540 medically underserved, predominantly rural communities in Morelos, Guerrero, and the state of Mexico.” Researchers wrote that the goal was “to establish the relative sensitivity and positive predictive value for HPV screening of vaginal samples self-collected at home as compared with clinic-based cervical cytology.”

Approximately 12,000 women participated in the HPV self-sample group and 11,000 women participated in the cervical cytology group. The researchers determined that self-sampled HPV tests would be a useful option in “low-resource settings where restricted infrastructure reduces the effectiveness of cytology screening programs.”

Collectively, these examples provide evidence that advances in lab test technology make it feasible to involve the patient in self-sampling, at least for HPV testing. However, THE DARK REPORT is unaware of any laboratory in the United States that currently offers consumers an HPV test that utilizes a self-sampled specimen.


ON APRIL 10, 2012, IT WAS ANNOUNCED that Psyche Systems Corporation had inked a strategic alliance with Siemens Healthcare. The two companies intend to more closely integrate their respective laboratory information products.

Siemens’ flagship laboratory information system (LIS) is NOVIUS Lab. As part of the strategic alliance, WindoPath, the anatomic pathology information system sold by Psyche, will be offered “as the anatomic pathology component of NOVIUS Lab.”

This alliance of a laboratory information system (LIS) company with a pathology LIS company is a sign that laboratories recognize the need to deploy informatics solutions which offer more integration between the clinical lab’s LIS and the pathology information system used by the anatomic pathologists.

That goal was described in the press release about the strategic alliance. The two companies stated “By integrating Siemens’ Soarian, INVISION, and MedSeries4 health information systems with Psyche’s WindoPath AP system, the companies will provide AP capability for laboratories with bi-directional data, results, and demographic sharing and reporting to enhance laboratory workflow.”


BIG CHANGES MAY BE AHEAD for Bio-Rad Laboratories Inc., of Hercules, California. Following the death of its founder and Chairman, Howard Schwartz, on April 1, the business press is speculating that the company may be offered for sale.

Business Week magazine declared that Bio-Rad “is presenting potential buyers with the most affordable acquisition in the U.S. life-science equipment industry as investors bet the family-run company will now be open to a sale.”

Bio-Rad had sales of $2.1 billion last year. It is a respected provider of life science research and clinical diagnostic products test kits. The company was founded in 1952.


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