Using IVF Samples Safety Alerts at a University Hospital

You may have seen the headlines about the crisis at Cleveland’s University Hospitals Fertility Center where there was an IVF safety breach due to lack of temperature monitoring. It is every safety manager’s nightmare. Between the overnight hours of March 3 and 4, one of the facility’s liquid nitrogen storage tanks began to warm up. Undetected by both the hospital staff and its monitoring system, more than 2,000 embryos and eggs have most likely been compromised during the excursion.

It’s the kind of safety and public relations disaster that should serve as a wake-up call for every clinic and hospital executive. Do you have an automated temperature monitoring system in place that provides 24/7 protection?

Remote Monitoring of Medical Refrigerator Assets

The University Hospitals Fertility Center is responsible for helping thousands of women create families, most of whom have had little hope. Tragically, this latest safety oversight has impacted more than 500 patients.  “It's absolutely devastating,” said Patti DePompei, President of University Hospital MacDonald Women’s Hospital and Rainbow Babies and Children’s Hospital.

Most unsettling is that the hospital’s freezing tanks should have set off alarms and sent alert notifications. Yet even days afterward, the hospital management did not know if the thaw was caused by technical or human error. Now, the affected eggs and embryos must be completely thawed to determine their viability, requiring all patients to contact their physicians for advice on next steps.

IVF Temperature Matters

The mystery about what exactly happened at the IVF medical facility was enough to spark a class action lawsuit filed on March 11. In a statement for the plaintiffs, attorney Mark DiCello said:

Let’s not forget those affected are grieving the loss of thousands of potential daughters and sons. They are in a state of confusion, anger and sorrow, with too many unanswered questions. With this lawsuit, we will get answers and stop this from happening again.

In yet another newspaper story where IVF temperatures were compromised, plaintiff Amber Michalak described her reaction when she got the shocking news: “It’s devastating just thinking the amount of struggle that everyone has to go through. And most of it is not covered by insurance. We paid out of pocket. It’s very expensive.”

 Fertility Treatment Safety Risks & Costs Are High Indeed

Expensive, yes, and not only for the patients. For the hospital, the costs are escalating:

•         Costs of fertility treatments to be reimbursed to more than 500 families affected (estimated at       
          $10,000 per treatment, that’s a hefty bill)
•         Costs of the class action lawsuit for additional damages awarded
•         Costs of an independent investigation into the causes of the excursion
•         Costs to repair or replace the temperature monitoring system
•         Costs to the clinic’s public reputation and patient trust moving forward

Encouraging Accountability for IVF Safety Managers

Perhaps the most important lesson to learn from this unfortunate incident is the importance of accountability in IVF clinics. The public wants to know why safety precautions fail. They also want to know how the problem will be corrected. They want answers NOW.

The executive team at University Hospitals has some soul-searching to do. If indeed the cause of the excursion was a system failure, they need to make some inquiries:

•         When was the last time the monitoring system was inspected?
•         How robust is the system? Is there adequate redundancy so that the failure of one piece of 
          equipment does not jeopardize the entire system?
•         How extensive is the remote notification network? Are there multiple platforms to receive alerts,
          including laptops, smartphones, and tablets?

If the cause of the excursion was human failure, a new set of questions arises:

•         How well-trained are the safety managers?
•         Is there a backup in case the primary manager is unable to respond?
•         How rigorously are temperatures checked during overnight hours?

That the executive staff could not provide a definitive cause several days after the incident is a sure sign of a faulty safety management plan. All the more reason to stay on top of your monitoring system to ensure its viability—and thus the viability of your practice.

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