Nuclear panel finds firm here (Mallinckrodt) has inadequate safety controls

[GlennACarlson@aol.com]

Posted: Friday, June 23, 2000 | 7:18 a.m. 

Nuclear panel finds firm here has inadequate safety controls
By Virginia Baldwin Gilbert Of The Post-Dispatch
http://www.postnet.com/postnet/stories.nsf/ByDocID/A59B186F2547BEE586256907003
296CD?OpenDocument

The Nuclear Regulatory Commission said Thursday that Mallinckrodt Inc.'s 
plant in Maryland Heights has "inadequate controls" for safely using 
radioactive materials and can't find and fix safety problems on its own.

The commission ordered the company to hire an independent organization to 
evaluate its protection program and manufacturing processes for safety. It 
amended Mallinckrodt's license to use radioactive materials to include new 
requirements.

The order stems from an accident at the plant March 31 in which a worker was 
exposed to 40 times the annual cumulative radiation limit for workers. 
Investigators have since discovered numerous other cases of exposure.

The plant makes and ships radiopharmaceuticals -- radioactive materials used 
by hospitals and clinics for diagnostic medical tests.

Commission inspectors were at the plant, in two buildings at 2703 Wagner 
Place and 11480 Warnen Road, for several weeks last month and this month 
investigating workers' overexposure.

"Based on the team's findings, the (commission) staff has concluded there are 
deficiencies in the company's ability to evaluate the radiation safety 
aspects of its operations and to make accurate assessments of the causes of 
problems found," the commission said in a statement released Thursday.

Mallinckrodt responded Thursday in a statement, saying, "We continue to be 
committed to a plan of action for improving the safe handling of radioactive 
materials." The statement pointed out that management has been working on the 
actions in the order and agreed to them on June 16. It has waived its right 
to appeal the order.

The first worker discovered to be overexposed received a dose of 2,000 rems 
to his thumb and forefinger. The annual dose limit is 50 rems.

Further investigation turned up at least 14 other workers whose fingers or 
thumbs had been exposed to radiation above occupational limits - some for 
several years in a row.

According to the order issued by R.W. Borchardt, director of the commission's 
office of enforcement, the inspection teams found that:

* Company monitoring procedures failed to identify significant differences 
between actual doses on workers' fingertips and the doses measured by 
monitoring badges worn as rings.

* Operating procedures on the books did not reflect actual work practices.

* Supervisors overseeing laboratory activities did not recognize the 
potential radiological consequences of work habits in their area.

Barbara A. Abbett, spokeswoman for Mallinckrodt, said the company had hired 
the Delphi Groupe, a consulting firm based in Austin, Texas.

The order says the independent firm's evaluation must look at:

* Company committees on radiation safety and dose reduction.

* Staffing levels needed for effective radiation protection.

* The program for monitoring worker exposure.

* Resolution of previous radiation protection issues.

* The safety training program, including on-the-job training.

* Engineering controls related to radiation safety.

* Adherence to standard operating procedures affecting radiation safety.

* Processes for evaluating radiation safety issues in new and modified 
product lines.

The commission will release its findings at a public meeting at 9:30 a.m. 
today at the Maryland Heights Community Center, 2344 McKelvey Road.

The commission expects to consider possible penalties in the next several 
months.
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