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President Signs Executive Order for Regulatory Overhaul

Published March 19, 2011 10:52 PM by Glen McDaniel
 

In January, President Obama signed an executive order aimed at eliminating administrative obstacles to business and industry, saying he wanted to balance the need for regulation (to protect the public, for example)  against the interests of economic growth. This review clearly includes regulations that affect clinical laboratories so when I first read this, I was very optimistic.

The executive order requires federal agencies to revisit their regulations to make sure

  • The benefits justify the cost of ensuring compliance
  • The least burden is imposed on society
  • Regulations specify goals and objectives when possible, versus actual behavior (there is more than one way of getting to a goal and a company might find a more cost-effective way)
  • Alternatives have been considered e.g. is it better to offer economic incentives to get desired behavior rather than issue a regulatory mandate?
  • Regulations are not redundant or in conflict with other regulations.  One example cited is that there is an ongoing dispute over the artificial sweetener saccharin. The Environmental Protection Agency listed saccharin as a hazardous material while the Food and Drug Administration considered it absolutely safe for human consumption

This list sounded almost too logical to be true, especially coming from the government. However, in my head I still I went down a list of lab regulations I would gladly say goodbye to. Sure enough word from the Office of Management and Budget (OMB) is that this mandate will be applied to the most archaic and conflicting regulations. So while it will address some doozies, it will not touch more recent regulations or mandates such as those formulated in the last 5 years.

If you could give input on redundant or onerous laboratory regulations, which ones would you eliminate?

3 comments

I say repeal CLIA and start over. This is one of those things that is not any good for anyone. For us in New York state our licence and state law is much stronger than CLIA. Even for states without licences they  would do better without CLIA. It makes our lives hard because of all the documentation  but at the same time it allows unqualified people to work in labs. That is why I said it is no good for anyone. We who are professionals and want to do a good job dont need CLIA and the greedy people who want to hire unqualified people can still get away with dangerous  lab practice under CLIA. Go figure.

Ronson L MT, Clinical Scientist March 26, 2011 12:31 PM
New York NY

I think we need licensure. Some rules exist to make sure that assorted people like OJT are doing the right thing. If we had trained licensed MLTs and MTs they would all know to do teh right thing. That's what i think.

Marilyn MLT March 22, 2011 6:45 PM
Kansas City KS

I wish we did not have to do so many correlations and verrification. I think verifying linearity for sophisticated instruments is stupid. These companies have the staff, equipment and resources to verify their linearity and we should not have to re-do all that work.

Jonas K MT (AMT) March 21, 2011 3:52 PM
Patterson NJ

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