Tuesday, May 25, 2010

BLOOD Supply

In the early days of FEMA's independent existence the Reorganization #1 of 1958 was often cited as a legal authority for agency programs, functions and activities. This was because due to the sloppiness of the legal analysis of the Presidential Reorganization TEAM that conducted the work for creation of Reorganization Plan No. 3 of 1978 leading to FEMA's formation by the plan and implementation by two Executive Orders, the REORG plan had a savings clause which attempted to save programs, functions, and activities overlooked by the new Executive Orders. It might be noted that the same situation exists in all reorganizations and even the Homeland Security Act of 2002 has a savings clause because it did not transfer legal authorities but so-called "functions"! This is a sloppy way to do business in federal reorganizations but none the less is often the shortcut taken by those conducting the reorganization.

So why is it important that functional transfers may in fact be a lazy way to do business but still a way to get the job done?

Okay let's back up a minute. First Reorganization Plan No. 1 of 1958 is still important but not because of its substance or context or impact today but because underlying that reorganization was a brilliant study by McKinsey and Co. consulting firm that studied the entire history of Presidential emergency management (sorry I left my copy in a now destroyed FEMA library)! That brilliant study concluded that emergency management authority should be vested solely in the President so that the President could design the approach and delegate appropriately his crisis management system. Anyone involved in Homeland Security or Emergency Management and watching a frustrated WH conduct crisis management operations today should have this document in hand as well as all Congressional committees. I think its recommendations are still sound.
Okay do the savings clauses in both the FEMA Reorganization Plan No. 3 of 1978 and the Homeland Security Act of 2002 save any functions not specifically identified? Well readers of this blog know I don't believe that Reorg Plan #1 of 1978 should be cited for any of FEMA's current programs,functions, or activities.
I have recently learned that the OCC (OFFICE OF THE CHIEF COUNSEL) of FEMA has concluded that the current publication of DMO's (Defense Mobilization Orders) in 44 CFR are legally incorrect and issued without current authority. First, only OLC (the Office of Legal Counsel) in DOJ probably has the resources, intellectual firepower, and analytical materials available to reach this conclusion but IMO these orders are issued by the President not FEMA but just happen to be published in Title 44 of the CFR. Some are still quite important and only OLC could rule accurately on their efficacy.

But it is a repealed DMO on the nation's blood supply that is of interest to me here. Why?
Recent MSM reports on the nation's blood supply have stories like this extracted portion of the WSJ as follows:

"Blood supply officials are urging the U.S. government to adopt so-called pathogen-reduction technology that can kill a wide range of contaminants in blood after it has been donated. One method already in use in about a dozen countries in Europe, Asia and elsewhere destroys most pathogens with a combination of chemicals and ultraviolet light. The Food and Drug Administration declined to approve the technology several years ago, citing possible side effects. But the agency is continuing to evaluate it."

The agency referred to is the FDA. Not sure if internal delegations from HHS or independent authority exists for the above conclusion that FDA is the lead but I do have some doubt.

Okay! The DMO on blood supply was revoked after the issuance of E.O. 12919 in June 1994, superseding a 1969 Executive Order. This clearly gave HHS new authority under the Defense Production Act of 1950 which is one legal authority for the DMO's but not the only one. Remember I believe these are the President's documents not just FEMA or DHS. The repeal of the blood supply DMO was premised on HHS producing a successor DMO which has never been done.

Guess what? In major catastrophes, blood and blood products are crucial to response. So how is this issue overlooked now by all administrations, all departments and agencies, and the entirety of the public health sector?

Some personal experience here. I was privy to the HHS promises to replace the blood DMO. Also within the last year I wrote a long letter to my Senator James Webb telling him about this issue and asking him to look into it? That has not happened. It does however impact DOD and its operations since during Desert Storm and other military events it has often been the case that blood supplies nationally were in a shortage situation and therefore needed a system of rationing and allocation. It turned out not to be needed for Desert Storm but in fact if blood and blood products had been needed then the President IMO had authority to shut off all non-emergency surgery requiring blood to allow its usage for military casualties.

Hey hoping someone knows what legal authority there is to prioritize and allocate blood and blood products in a national shortage because clearly this could be necessary. It is not FEMA or DHS or HHS or FDA that needs to know what to do if necessary but the President of the US.