What is the correct procedure for decommissioning an outdated blood product irradiator?

A colleague in a sunbelt state is looking to replace their blood product irradiator. She reports that purchasing a replacement irradiator is "easy" (provided you have the money budgeted), but decommissioning an outdated unit is not so easy because of new laws in force since the attack of September 11, 2001. She has discovered that blood centers and hospital blood banks now have the option to turn over obsolete or excess irradiators to the government under a project called the Off-Site Source Recovery Project (OSRP). The program is managed by the National Nuclear Security Administration under the Radiological Threat Reduction Program, and aims to recover unused sources of radiation from the private sphere. OSRP encourages that those with sources of radiation register with OSRP, as well as request OSRP assistance in turning obsolete irradiators over to the government as part of homeland security and non-proliferation concerns. In the post-9/11 environment, the project was expanded to recover radioactive sealed sources for environmental concerns to help ensure national security. To register with OSRP, or for more information, call 877.676.1749, or email osrp@lanl.gov. The sunbelt colleague wonders what has been the experience of others in decommissioning outdated blood product irradiators.

The following comments have been received.

ADDENDA Nov. 23, 2005

1. The Director of Technical Services at a Community Blood Center/Community Tissue Services in Dayton, Ohio reports that they recently placed an order for a new blood product irradiator to be delivered in May of 2006. They are purchasing their new irradiator from the same manufacturer that provided their current irradiator. The director reports that part of the arrangement with the manufacturer was that when they deliver the new irradiator they "take back" the old irradiator, and then the manufacturer will be responsible for “decommissioning” the old irradiator. $6,600 of the cost of the new irradiator will be applied toward the old instrument’s disposal.

ADDENDA Jan. 22, 2006

2. A colleague in Illinois reports that he has learned of the government's concern over blood irradiators because they contain Cesium-137, which is of potential use in terrorism, such as making dirty bombs. The Nuclear Regulatory Commission issued new security requirements pertaining to blood irradiators in 2005. Documentation of this program was published as a new rule in the Federal Register 70:72128-32, 12/1/05. The requirements were effective immediately, and implementation by licensees is required by 5/13/06. The list of affected licensees (possessors of irradiators and other such items) was redacted for security reasons. The most relevant sections of the rule for blood irradiation facilities are IC1, access control; IC2, response to unauthorized access; and IC6, protection of security plan from public disclosure. Detailed background and technical information about these measures was recently posted on the NRC web site (121 page PDF file) Memo: PROTECTIVE MEASURES AND IMPLEMENTING GUIDANCE FOR GROUPS 1 THROUGH 4 MATERIALS LICENSEES. Attachment 1 on this memo contains guidance for implementation (see esp. pg 32-35 on access control and threat detection) and extensive Q&A about the requirement, beginning on pg 40.

ADDENDA Aug. 4, 2006

3. A Transfusion Service supervisor from a university medical center in northern California wonders if any facilities will be installing (or using existing) X-ray equipment for blood product irradiation, rather than radioactive material (such as Cesium) based blood product irradiators, given new security precautions that are mentioned above.

ADDENDA Aug. 31, 2006

4. A transfusion medicine physician at a University hospital in Southern California reports they have switched away from a Cesium-based to an X-Ray irradiator specifically because of the new security requirements. The new security requirements include controlled physical access to the site of the irradiator and extensive background checks on all employees with access. Since they did not have a site in which to adequately secure the irradiator without a substantial remodel (including re-engineering of the floor because of the weight of the irradiator), and the background checks were rather onerous, they elected to switch to an X-Ray based system. They report that the X-Ray based system is easy to use, accommodates multiple products at a time, and has a shorter irradiation cycle, so the switch has been advantageous to them. Changing to an X-Ray based system was faster and less expensive than a remodel and background checks would have been.

ADDENDA Nov. 9, 2006

5. A colleague in Jacksonville, FL reports that they are considering acquiring an irradiator and are wondering what others are doing to protect their irradiators in light of Homeland Security Requirements for protecting irradiation sources. They currently receive their irradiated products from a blood supplier and wonder if it will be more trouble than it's worth to attempt to irradiate products on site. They currently supply in the neighborhood of 400 irradiated red cells per month and all of their platelet pheresis products are irradiated.

ADDENDA Nov. 13, 2006

6. The colleague from the sunbelt state that initiated this discussion now has two hospitals with irradiators. For one, to prevent unauthorized access, they built a wall with a door (badge access by blood bank staff only) around the irradiator, put the entire lab in lockdown (but any hospital staff with an ID badge can get in) and put a camera pointed on the irradiator. The latter is to monitor who is accessing the irradiator room and to detect "intrusion". The camera displays in hospital security. They were just inspected by Sandia labs and had no improvement recommendations. As a side note, they use a 'baby monitor' to broadcast the irradiator alarm when it is finished irradiating.
   
   The other hospital is remodeling and will have the irradiator in a locked room just like the first hospital. The plan is to have an alarm on the door as well as badge access. The blood bank will be in a lockdown state (badge access) and hospital personnel who check out blood will be in an ante room with no access to the blood bank. They will have to issue large tissues (heart valves in liquid nitrogen) through a door.
   
   She concludes saying "Remember that you have to have means to do some sort of background check to determine the 'trustworthiness' of staff who access the irradiator". Her Human Resources policies cover this with their routine checks on potential employees (references, work history etc).

ADDENDA Dec. 8, 2006

7. The colleague in Ohio who submitted Addenda 1 on November 23, 2005, follows up with the steps they took after deciding to purchase a new blood product irradiator from a company in Ontario, Canada.

Sept. 2005: An order for a new blood product irradiator was submitted. They ordered the irradiator 7-9 months in advance of the anticipated completion of a remodeled Hospital Services area.

Oct. 2005: They submitted an application for a license amendment to the Ohio Department of Health. The amendment was issued 11/10/05 and allowed them to temporarily possess both the old and new irradiators, and allowed them to move the old irradiator to a temporary location.

Jan. 2006: An application was submitted to the Nuclear Regulatory Commission for an import/export license (NRC Form 7) as the irradiator manufacturer required a copy of the document prior to shipment of the new irradiator and return of the old irradiator. This application was sent to the NRC’s Deputy Director on January 13, 2006. On January 24th, an engineer from the irradiator manufacturer, with the assistance of a local rigging crew, moved the old irradiator to the 2nd floor temporary location of the Hospital Services department. A request for decommissioning of the previous irradiation room was sent to Ohio Dept. of Health.

Feb. 2006: They received the import/export license from NRC on 02/28/06 and sent a copy to the irradiator manufacturer.

June 2006: The new blood product irradiator was received at the blood donor center on 06/20/06. Increased security during delivery was accomplished through the recruitment of the Facilities staff at the blood donor center. An engineer from the blood manufacturer of the blood product irradiator prepared the old irradiator for return shipment using the same materials that housed the new irradiator. The old irradiator was returned to the manufacturer the same day. Because the blood product irradiator manufacturer is a manufacturer and distributor of radioactive material, they were responsible for compliance with the NRC’s Enhanced Security measures for domestic highway shipments. A representative from the Ohio Department of Health was on site during delivery of the unit. Installation, validation, and training on the new irradiator were accomplished by 06/22/06.

Oct. 2006: The local Homeland Security representative recently visited the blood donor center site to observe compliance measures pertaining to Increased Controls for Radioactive Materials.

ADDENDA June 22, 2007

8. A colleague in Missouri reports that his hospital administration has imposed a number of rules regarding the use and security of their blood product irradiator (Cesium source). These rules were issued by their 'Radiation Control' group to comply with perceived requirements of the Department of Homeland Security. The rules include the need to obtain finger prints and to do background checks of blood bank personnel who are using or working in the vicinity of the irradiator, the placement of a security guard at the irradiator when a maintenance person is working on the irradiator, and the prevention of non-screened personnel from being in the area of the irradiator without an escort. Rules also require the building of security devises (cage, locked doors, etc) in the area and around the irradiator. Being from the 'Show Me' state, the Missouri colleague wonders if other blood banks and transfusion services with irradiators (Cesium or Cobalt) have encountered these same issues and if so, what is the local practice. Is what is required at the Missouri hospital an extreme interpretation of the federal rules? How are others implementing compliance?

ADDENDA June 27, 2007

9. A Technical Supervisor of a Blood Bank in Arizona reports that the regulations from Homeland Security for isotope irradiators are quite stringent. In her experience, a written plan must include limiting access to the irradiator, deep background checks and fingerprinting of all staff who do have access, surveillance or physical barriers to prevent tampering, etc. The plan must be designed to prevent theft of isotope and tampering with the unit to cause contamination. Facilities are required to keep secret the measures they employ for isotope security. She concludes saying that "All of this makes an x-ray based irradiator very attractive."

ADDENDA July 11, 2007

10. The Sunbelt State colleague who initiated this discussion and who is affiliated with two hospitals with irradiators provides us with updated information. She reports that the Department of Energy (DOE) at Los Alamos National Lab (LANL) contracted with JL Shepherd to decommission one of her hospital's irradiators (at the expense of the DOE). In one hospital, the irradiator is kept in a 'badge access only' rooms, accessible only to the blood bank staff. In addition, the entire lab is badge access only (though the hospital staff have not been T&R'd (deemed trustworthy and reliable) by the employer as they are contract workers in these hospitals. In the other institution, the blood bank is badge-access only to blood bank staff and management; security will not permit housekeeping personnel access. In addition to badge access to the irradiator room, there is a pin pad where they input 4 digits unique to them. The pad has numbers that change location with each access so that patterns cannot be memorized. There is also a mechanism to alert if access is made under duress. At both hospital sites, baby monitors are in place to alert staff to the irradiator alarming when it is finished. One thing that the state inspector requests is a contract with local law enforcement about response to a call from the hospital for help. Their local law enforcement said they would respond but would not put it in writing. Given that they did not choose to show up when the irradiator was delivered, the sunbelt state colleague does not think this will be a priority for them.
    
    Regarding the use of x-ray machines in place of traditional blood product irradiators, the Sunbelt colleague suggests we check out the requirement for constant water cooling and the cost of $10,000 - $15,000 to replace an x-ray tube. In addition, she is unaware of any computer hook ups to capture all of the FDA required information. She suspects that in a few years this will change but she does not know about the x-ray tubes or the need for water cooling. She comments that they will give consideration to purchasing an x-ray machine when they must purchase another irradiator in the next few years. Another thing about the x-ray machine is that one does not have to pay a fee to import a radiation source from outside the US.
    
    
11. Editors' Note: The New York Times opinion article, Seize the Cesium, an editorial noting that Cesium-137 may be a favored isotope for a radiological terrorist attack, may be germane to this discussion. (Note: registration may be required to access article.)

ADDENDA October 11, 2007

12. Editors' Note: The Washington Post article, Experts Worried About Irradiation Machines: Replacement Urged to Thwart Terrorists is germane to the discussion. (Note: registration may be required to access article.)

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