In regard to the recent problem of 'white particulates' in blood, must the recommended inspection be performed at the time the blood is issued for transfusion, or can it be done earlier?

A transfusion medicine physician colleague at a hospital in Orange County, California reports that they received a letter from their main blood supplier requesting that their transfusion service perform an inspection on each unit of blood during the 10 minutes just prior to issuing each product. At that time they were advised to lay each product with the label facing down on a counter for 10 minutes. If no 'white particulate' is observed at the end of this time the product can then be dispensed to the patient care area. In the opinion of the Orange County physician, inspecting for 10 minutes each blood product just before it is issued for transfusion will 'grind his Blood Bank to a halt'. He wonders if it would be more practical to do the inspection process on the night shift or when his laboratory is at optimal staffing. Also, since his hospital has a significant number of emergency transfusions that need to be issued stat, there would be no time to do a pre-issue 10 minute inspection. The Orange County physician asks the e-Network Forum for suggestions.

The following responses have been received.

1. A blood banker in Newport Beach, California reports that his understanding is that the FDA states in their "Information Alert on Particulate Matter in Blood Bags" that the visual inspection being performed by the supplier (ARC) prior to leukoreduction and at the time of packing for distribution is an "appropriate interim precautionary measure." The Newport Beach blood banker is not aware of any mention about the need for an additional inspection prior to issue. He adds that he is unaware of any evidence presented to suggest that the risk of particulate matter increases during storage. Therefore, he asks "what is to be gained by an additional inspection done by the Transfusion Service prior to issue?"

ADDENDA Feb. 12, 2003

2. A transfusion medicine physician in Kentucky reports that his two Transfusion Service hospitals (trauma, children/adults) also determined that the 10-minute rest prior to "issue" would not be practical. They decided that in order to meet workflow demands, 5-10 minute rest/inspection could be performed at receipt from supplier or when unit is pulled for crossmatch. Discussion with their supplier did not reveal evidence that more particles have appeared with longer storage times.
   
   
3. A blood banker from the Sunbelt reports that at her hospital they have implemented the 10-minute inspection prior to issue as per request of their blood supplier. It is her understanding under the Code of Federal Regulations 640.5 (e) "Whole blood shall be inspected visually during storage and immediately prior to issue........." Therefore, it was her understanding that this would apply to the 10-minute inspection. She states, "We have started keeping our 'emergency units' laying flat so the inspection can be done when going to use the product. For others, we select our units for crossmatch, pull segments and lay them flat in the refrigerator. Then we start the indirect antiglobulin testing. By the time the crossmatching is done the unit is ready for issue and inspection. This is a precautionary measure so they just do the best that they can. The ultimate goal is to get a safe product to the patient". She adds "If someone is bleeding to death, you have to weigh the consequences in those situations and decide which is more important". At this time, they are also inspecting thawed FFP and Platelet Pheresis products ... as they have no guidance as to whether these products are affected or not.
   
   
4. A transfusion medicine physician in Michigan reports that his hospital has notified their blood product supplier that the direction to inspect blood products after a 10-minute observation period was unworkable and would not be implemented as written. It is his opinion and that of the technologists, supervisor and Quality Assurance Officer that the last minute inspections would be unnecessarily disruptive, cause increased wastage of blood products, and result in more errors. In addition, his hospital is a Level 1 Trauma Center, and they would have to deviate from policy routinely in order to provide blood to the trauma patients. This would also cause delays in transfusion for all the other patients in the hospital, very few of whom have "scheduled" transfusions. The hospital has placed the additional inspection step to when they accession the blood into their system, documenting the inspection on the invoice. They have had, and will continue, a mandatory visual inspection of components at the time of issue. This visual check takes a few seconds and does not result in a potentially critical delay in patient care.
   
   
5. A transfusion medicine physician in Cleveland reports that they, too, have received a letter from their blood product supplier, who is asking the hospital to hold units for 10 minutes in a flat position and then inspect them immediately prior to release. According to the Cleveland colleague, this is not possible for urgent blood use to OR, ER, etc. In addition, they have multiple off-site refrigerators in which blood is stored and released remotely. There is no way that this process can be followed when blood is issued at a remote site. The Cleveland physician would like clarification from the "powers that be" so that they can institute a process that is practical. She laments that as currently required/requested, such a procedure in her hospital would likely cause more harm than good by delaying the issuance of blood in critical cases.

ADDENDA Feb. 14, 2003

6. A blood banker in Boston reports that their major blood supplier also sent them a letter recommending that all units lie flat for 10 minutes and then be inspected prior to issue. According to the Bostonian, "for routine transfusions this can work alright. It is a little inconvenient to have the units lying flat after crossmatch, but we are managing. If the transfusion is urgent and the 10 minutes have not passed, we are issuing the blood anyway." The Bostonian is of the opinion that death by exsanguination is far more of a risk than death by white particulate matter.
   
   They are also taking these other precautions:
   • all blood received from outside sources is being inspected upon receipt
   • all red cell products collected on-site are being inspected prior to leukoreduction and again prior to labeling.

ADDENDA Feb. 27, 2003

7. Please refer to the FDA/CBER FAQ Update (Feb. 27)  In response to the question: 'Should transfusion services continue to visually inspect?' CBER states 'If transfusion services receive blood units from other blood collectors who have either leukoreduced the units and/or added an enhanced visual inspection, enhanced observation by the transfusion service prior to distribution probably does not add significant benefit. Implementation of the enhanced visual inspection is expected to have its greatest value during the manufacturing process of the blood component. FDA currently believes that routine visual inspections at the transfusion service prior to distribution are adequate.'

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