The facility here in Pomona has lots of neat pictures on the walls and in the halls, some dealing with the history of transfusion medicine and some just history in general. Here’s the first I’ll share, an old poster from the 1950’s. Ahh, the good old days.
Lena M Napolitano, MD and colleagues with the Eastern Association for the Surgery of Trauma Practice Management Workgroup and The American College of Critical Care Medicine Taskforce of the Society of Critical Care Medicine reviewed English language publications from the period 1980 to July 2008 to determine best transfusion practices in the management of adult trauma and critical care. Their findings were published in the December 2009 issue of The Journal of Trauma. This is the first time such guidelines have been addressed specifically in critically ill and injured adults.
For the complete article see:
Clinical practice guideline: red blood cell transfusion in adult trauma and critical care. Napolitano LM – Crit Care Med – 01-DEC-2009; 37(12): 3124-57.
There is also a “synopsized” version available in:
Napolitano, LM, et. al. The Journal of Trauma. 2009 Dec; 67(6): 1439-42.
So, Stanford University Medical Center and all it’s various sub-entities are being sued by a blood donor who believes an infection he suffered was the result of giving blood. The details are scarce, but allow me to discuss some problems with the scenario. First, let me just say that I in no way intend to make light of Mr. Bui’s (the plaintiff) plight or the suffering he’s gone through, or to suggest that Stanford handled the situation in the right way because, honestly, they probably suck as much at providing compassionate care as any other Administrator-helmed, for-profit facility. Before anyone jumps down my throat, “not for profit” on paper doesn’t mean the CEO doesn’t make $500,000+ a year. But America’s health care system is not the topic of this post.
I’m assuming it was a Staph infection that Mr. Bui contracted, resulting ultimately in the removal of his collarbone. How he came to the conclusion that donating blood was the cause would probably be best answered by his attorney, Joseph Carcione, Jr.. I’m not aware of any pathogen associated with sterile blood collection devices, possibly Mr. Carcione’s vast medical training as a lawyer leads him to think otherwise. Staph, however, lives just about everywhere else. Especially your skin. As a blood donor’s arm is vigorously sterilized (as in killing everything) with a chemical called povidone-iodine before that equally sterile needle goes into it, it seems much more likely to me that Mr. Bui picked up the infection shaving that morning, or from a hangnail, or any other break in his skin that hadn’t been sterilized. In any case, the source of Mr. Bui’s infection was environmental, most likely the bug was growing on his own skin, and not the needle.
There are ways of checking to see if it is likely that Mr. Bui’s donation caused the infection.
Most obviously, did that unit of blood cause an infection or reaction in the person who received it? If it grew in Mr. Bui, it would most likely grow in the blood that came out of him also. If so, the FDA would be made aware, as it is required that all such events be reported. If random platelets were manufactured from Mr. Bui’s donation, this would be the most likely product contaminated, so start there. Platelets are stored at room temperature (as opposed to red blood cells, which are stored at 4-6 C) and bugs love to grow in them. It would be very serendipitous if Mr. Bui’s unit of platelets were further selected for quality control testing (a certain number of this product must be tested monthly for bacterial growth, among other checks, as mandated by the FDA). Of course, if the recipient were taking antibiotics this check wouldn’t be much help.
Locate the source of Mr. Bui’s infection. I’ll give 10 to 1 odds that it is still growing somewhere on Mr. Bui, like behind his ears. Bacteria have “fingerprints” just like people, and molecular techniques can identify bugs to that degree of specificity. If the bacteria were resistant to the -cillins (i.e. MRSA), so much the better. It will most assuredly still be growing on Mr. Bui, once you’re colonized with MRSA you’ve pretty much got it for good.
Does the Stanford Donor Center have a record of problems infecting donors or drawing blood contaminated with bacteria? The literature reports 1 in 225,000 blood donors experience local infection (incidence of septic infection not reported but likely much much lower) following their donation (see also Roback JD, ed. AABB technical manual. 16th ed. Bethesda, MD: American Association of Blood Banks Press; 2008: p195). Is Stanford’s record worse than this, indicating a local problem with the staff not properly sterilizing the site prior to phlebotomy?
I could go on and on and none of this will prove one way or another where Mr. Bui’s infection came from, but the point is there are many, many more or equally likely sources of the infection than his blood donation. Donors and potential donors need not fear that donating blood will make them sick and (again not excusing Stanford for their treatment of Mr. Bui and not suggesting their asses shouldn’t be sued) such media pandering on the part of his attorney can only cause harm to the very community Mr. Bui so generously donated of himself to help. Any benefit from his previous blood donations has now been negated, and then some, by the loss of future donations that will result from Mr. Carcione’s sensationalism.
Posted in Blood Bank, blood bank regulations, blood donation, blood donor, blood products, clinical laboratory improvement amendments, college of american pathologists, food and drug administration, joint commission, platelets, red blood cells | Tags: Bui, Carcione, MRSA, Stanford Medical, Staph
I’m hoping someone out there stumbles onto this and would be willing to provide a review for the Kindle Edition of Dr. Marion Reid’s Blood Group Antigen Facts Book (no, I’m not being paid for diverting traffic to Amazon.com via the previous link).
Even better, I’d love to hear from someone who has accessed the Kindle version using the Kindle application for iPhone. My iPhone has become an indispensable tool at work (I’ll get around to posting about some of the apps that come in handy in the lab eventually), and to have access to this resource with me everywhere in my pocket without having to actually lug around the book would be a huge bonus. The Kindle version costs just as much as the printed version, though, so if it’s a bust using the Kindle app for iPhone I’d rather know before shelling out the $60 to buy it.
If you aren’t familiar with the resource yourself, it’s absolutely fantastic and no transfusion service or blood bank should be without it. With the exception of the Technical Manual, it’s the resource I use more than any other.
In as much as no news is good news, here’s some bad news.
In a brief interview with a well-informed representative of a well known national blood supplier, “universal” ISBT implementation is still further off than most of us have been hoping. The issue is implementation of an ISBT-compliant computer system, which is projected to happen sometime in 2011 (no, I have nothing more specific than a year). With recent experience, on a smaller scale, working with software implementation in a blood bank, I can understand why this organization is years past deadline and way over budget.
Strides are being made, however, and implementation of the new LIS/Donor registry/data management system/distribution management system, etc. (i.e. it’s a big project) is high priority and running full speed ahead.
So, for anyone looking forward to receiving ISBT-128 labeled units from their favorite blood supplier by “February 2010”, or whatever arbitrary date was thrown your way, I have it from a reliable source that you’ll be waiting at least another year.
I finally got around to checking out the August 2009 version of the Circular of Information for the Use of Human Blood and Blood Components, published periodically by (jointly) the AABB, American Red Cross, America’s Blood Centers, and the Armed Services Blood Program. Link is in my Links section in .pdf format if you haven’t yet received your high-speed pamphlets.
The FFP (and Plasma Frozen Within 24 Hours of Collection – I’ll just use “FFP” in the post) expiration issue still hasn’t been resolved. For anyone unfamiliar – The Circular states “FFP should be infused immediately after thawing or stored at 1 to 6 C for up to 24 hours”. The FDA says FFP expires in 6 hours unless a variance is granted per 21 CFR 640.120. So, 3 years after the FDA promised clarification is coming (FDA Liaison meeting, 4/11/07), people are still confused about when exactly FFP expires due to the fact that the Circular is approved by the FDA.
The CFR is still the Law of the Land, as far as the FDA Inspector with the power to shut you down is concerned, so unless you’ve been granted a variance 6 hours is it. If your blood bank doesn’t have a variance and you’re tired of waiting for the FDA to catch up with themselves, find a sample variance request template via this link.
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