heathervaught

We started using weight-only RBC recovery whenever possible over the last 5 years. We started out with one filter type, and validated that any discrepancies betwen the hct method and the weight-only method was due to the variation in the analyzer. When validating a new filter (including the filter attached to the 832F kit), we prove that the filter does not preferrentially hold-up RBCs or plasma (statistically that the pre-hct = post-hct within the tolerance of the analyzer), then make the statement in the validation summary that the pre and post weights can be used to calculate RBC recovery.

We are implementing Lean initiatives in our Blood Center, and 5S is one of the topics covered in our training. We have contracted with Purdue University, who is our local NIST-MEP (Manufacturing Extension Partnership) affiliate. Unlike many Consulting groups that you will encounter, the NIST-MEP members teach your lab how to become lean, and then how to sustain it after the training is done (unlike what we have heard with "consultants" where they come in, tell you everything that is wrong, make life miserable, then walk out leaving you to pick up the pieces). I'm sure that your local NIST-MEP site can offer a course in just 5S. There were questions about the sustainability. The biggest step is going through everything the first time and geting rid of all of the stuff that you don't need, then making sure that the stuff that you DO need is in the right place. After that, it makes sustaining the changes a lot easier because there is less stuff to manage. It also makes a crowded lab seem a lot bigger when you take out all of the junk -- you'll find that the people who were once begging for a bigger lab are suddenly a lot happier.

I work in a Donor Center, and we monitor humidity in one area -- our computer server room. Acceptable range is 20 to 90%.

I am in a large blood center in the US. The original question asked if the FDA requirs temperature mapping to be carried out over 20 days...although I did not read every FDA document available, I did look for guidance documents related to Temperature Mapping and found none. I have been at our center for 9 years, and the first time we did any form of temperature mapping was due to an EMEA inspection almost 4 years ago (we ship plasma products to Austria for fractionation). We only map storage units for chambers that store plasma products at any stage of manufacture, test reagents, and supplies used to collect or process the plasma products. We let the probes sit in the storage chamber for at least 48 hours, and try to get a top-middle-bottom reading for each area of storage.

I think you are looking for an all-in-one stripper/crimper combo...but I thought that I would throw this out. Sarstedt makes an electronic tubing stripper that is WONDERFUL!!!!!!!! We process over 130,000 units per year, and each unit is stripped in our Component Lab. The cost of the device is $1800, but my techs would want it if it were $18,000. If you are high-volume, then you can justify the cost by examining the risk of an associate getting a repetative motion injury from manual stripping (we actually had a tech who developed tennis elbow and had to have surgery -- she has ended up with permanent nerve damage).

In the US, when leukoreduced Apheresis platelets are collected, leukoreduction does not occur by filtration -- rather, by the process of collection. The instruments are designed to detect instances that might cause WBC contamination of a leukoreduced product and alert the operator. I don't know what technology your supplying Blood Center uses Doug, but we use the Trimas at our facility. We test 36 random products per month for QC (we will be increasing that to 60 once we implement changes to be in-line with the 2007 Guidance Document) and 100% of the products that are flagged by the instrument. The rate of high WBCs in the randomly selected products is about once per year, which means that only about 0.2% of the products that we label as leukocyte reduced are not. Again, you can talk to your blood center to verify that the data applies to them as well. If that is the case, then giving the platelets through a leukoreduction filter is probably not necessary, and a standard infusion set would be appropriate.

Mary- We don't issue platelets to an OR, but we do use room temperature gel packs when we ship apheresis platelets to our hospital customers. We do the following: 1. Label the gel packs with a sticker that states ROOM TEMPERATURE ONLY 2. Store the gel packs in an old platelet environmental chamber with the shakers removed...even within our own temperature-controlled and monitored Distribution area, we know that there are certain areas that tend to get warmer or colder than we would like (i.e.right next to our external door). 3. Temp the gel packs prior to re-use so that we know that they are actually 20-24 degrees.

I plan on getting the flu vaccine this year, just as I have every year, as a parent with two young children at home.

We use a Corning Pinnacle device. It is a small table-top device. We have had the same one for YEARS (well before I arrived at our facility 9 years ago). The probe needs to be changed occasionally, but other than that, we haven't had any issues.

1 and 2: At least 24 hours from the STOP time of collection. 3. After 12 hours of incubation with a negative-to-date result.

If you want to define the scope of practice for a MT, then I would recommend contacting a university that offers a degree in Clinical Laboratory Science and getting a copy of their cirriculum. I know that the university that I attended has a lot of information online at http://pathology.iupui.edu/body.cfm?id=6360 ... but there seems to be a formatting issue, so some information has been lost. If you have a close relationship with a university, you may be able to get an official list of Course Objectives for each program, which would further reinforce that MTs are not trained in the three areas that you mentioned (accessing central lines, administering IV fluids and medications) My program director also had a breakdown of the scope of the ASCP exam, and what topics are covered. That would be further evidence that MT certification does not automatically qualify someone to perform therapeutic apheresis.

Our Reference Lab at the Indiana Blood Center also has the capability to perform genotyping using the BioArray. http://www.indianablood.org/labservices/Pages/Reference.aspx is the website for our reference lab; http://www.indianablood.org/labservices/Pages/Donor%20Testing.aspx has a link to contact the lab.

In the FDA Guidance for Industry for Collection of Platelets by Automated Methods, Page 8 of the PDF version states "we recommend that a pH meter or gas analyzer be routinely used rather than pH (nitrazine) paper." http://www.fda.gov/cber/gdlns/plateletauto.htm And yes, we all know that these guidance documents are "nonbiding recommendations" and not the law...

I think that this is a good article, based on the abstract: Transfus Med. 2006 Oct;16(5):313-9 Bern MM, Bierbaum BE, Katz JN, Losina E. Department of Medicine, New England Baptist Hospital, Boston, MA, USA. Murraybern@AOL.com Autologous blood donation is designed to avoid complications from allogeneic blood, leaving units of blood in the general blood supply. It is unclear how efficient these programmes are in accomplishing these goals. It is unclear if autologous donation provokes increased need for any transfusion following surgery and whether it can be avoided in low-risk surgeries. Of 430 patients undergoing unilateral primary knee replacement arthroplasty over 12 months in our hospital, 309 had autologous donations and 121 did not. Of the 121 patients who did not donate, 36% completed surgery without transfusion, whereas only 17% of those who had autologous donations did so (P < 0.05). Age less than 65 years, higher baseline and postoperative haemoglobin levels were associated with lower transfusion rates. Patients who had autologous donations were approximately four times more likely to be transfused. As the number of autologous units donated increased, transfusions following surgery increased. Autologous donation did reduce allogeneic blood transfusions. Therefore, autologous blood donation for unilateral total knee arthroplasty is associated with overall increased transfusion rates, but with reduced need for allogeneic blood, independent of other clinical factors associated with transfusion. Therefore, there is need for reconsideration of these programmes relative to specific surgeries. In doing a search, I thought that it would be good to find an article that was in a journal on orthopedic surgery...but most articles that I found recommended autologous donation to decrease the risk of allogeneic transfusion. The article above addresses the other side -- yes, you may be reducing the incidence of allogeneic transfusion, but are you increasing the risk of transfusion overall? Even autologous donation/transfusion is not without risk.

We have validated a washed apheresis platelet procedure on our Cobe 2991 Cell Processor, using 0.9% NaCl in the V2 position. The program is BASICALLY as follows: Super out Rate = 100 mL/min Agitate Time = 100 Sec Super Out Volume = 425 mL Cycle 1: Spin Time = 10 min, V2 Cycle 2: Spin Time = 5 Min, V2 Cycle 3: Spin Time = 5 min, change Super Out volume to 550 mL For the Cycle 1 spin timer, if you have a programmable board, you can just set the time to 10 minutes. If you have the old peg-board and dial model, then you have to set the timer to 5 minuts and start with the auto/manual switch set to "Manual". Set a timer for 5 minutes, then press Start/Spin. When your timer goes off, flip the auto/manual switch back to "Auto", and the program will start.

We also use SafeTrace. We have interfaced our electronic scales to SafeTrace using WinWedge. This has helped us to eliminate many errors.

Our reference lab SOP states that the AHG test must be read within 1 minute. The only indication for reading after a 5-minute incubation is to detect weakly-reacting complement. Our lab would interpret that your patient's DAT is positive for IgG only and negative for complement.

I agree with Ann and Mabel. There was not enough data early to conclude if this virus was like "normal flu" where 50,000 will die, or "pandemic flu" where 50,000,000 will die (i.e. 1918). When in doubt, most people are going to err on the side of extreme caution, especially when the lives of children are at stake. Once the CDC revised their recommendations, many schools in our area re-opened a full week earlier than they had originally planned.

The "explainible change" is also called Antigenic Shift. The following link from the CDC helps to explain it: http://www.cdc.gov/flu/about/viruses/change.htm.

Please review the below information from the FDA regarding swine influenza and the safety of blood products. This strain of influenza-A has never been detected before because the virus has undergone an explainable change that has happened many times in the human history. When a host becomes infected with multiple types of influenza viruses, then there is an opportunity for the genetic material of the viruses to recombine in such a way that it produces a new strain that the population has no previous immunity toward. This is how all pandemics have begun. Information about Newly Emerging 2009 H1N1 Influenza Virus and Blood Safety I. Background The ongoing outbreak of new emerging 2009 H1N1 Influenza Virus (H1N1 flu) infections in the United States has raised questions about whether this virus can be transmitted through blood transfusion. No case of transfusion transmitted seasonal influenza has ever been reported in the United States or elsewhere, and, to date, no cases of transfusion transmitted H1N1 flu have been reported. FDA is continuing to work with the Centers for Disease Control and Prevention (CDC) and is in close contact with the AABB Interorganizational Task Force on Pandemic Influenza and the Blood Supply to monitor this outbreak and its impact on blood safety and availability. At this time, it is important to remember that, when clinically indicated, the benefits of a transfusion far outweigh the risks, including any theoretical risk of H1N1 flu transmission through blood or blood products. II. Blood Safety Provisions Donor Deferral Under FDA regulations, individuals who are not in good health are not suitable to donate blood and blood establishments must defer these potential donors. (See FDA regulations at 21 CFR 640.3.) Blood donor screening procedures currently in place at blood establishments should identify persons with symptoms of H1N1 flu infection. The symptoms of H1N1 flu in people are similar to the symptoms of regular human influenza and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with H1N1 flu. Severe illness and deaths have been reported among infected individuals in Mexico and in the U.S. The donor screening procedures in place today are important measures in reducing the theoretical risk of transfusion transmitted H1N1 flu, particularly in areas where human cases are occurring. In addition, the continued standard practice of blood establishments in maintaining good hygiene and infection control practices will help to minimize possible spread of H1N1 flu in blood establishments. Staff member hand washing between contacts with different donors is especially important. Additional information on illness with H1N1 flu and general control strategies can be obtained at the Centers for Disease Control and Prevention (CDC) website at http://www.cdc.gov/swineflu/index.htm. Potential Component Quarantine and Retrieval Consistent with FDA’s October 2006 Guidance on Biologic Product Deviation Reporting for Blood and Plasma Establishments (see http://www.fda.gov/cber/gdlns/devbld.htm) Medical Directors of blood establishments should consider whether a post donation report of a flu-like illness in a donor indicates that the previously collected products are unsuitable and that the donor’s suitability for future donations should be assessed (e.g. deferral until well.) In addition to routine reporting of identified cases of H1N1 flu to state and local health departments, medical directors with any case raising concerns regarding potential transfusion transmission of influenza, may contact us at the Therapeutics and Blood Safety Branch of the CBER Office of Biostatistics and Epidemiology at 301-827-3974, as well as the CDC via state and local health departments, as appropriate. Safety of Plasma Derivatives The newly emerging 2009 H1N1 Influenza Virus is a large lipid-enveloped virus. Validation studies performed by the product manufacturers have shown that viruses with similar characteristics to this agent are effectively inactivated and/or removed by the manufacturing processes in place for these products.

The difference is that there is a much shorter incubation time in the human host, the symptoms are clear-cut with a rapid onset and are easily recognizable by the infected person, as opposed to HIV and hepatitis with a long incubation period where the individual is asymptomatic, and symptoms usually appear gradually. Donors are instructed to call and let us know if they experience any illness within 72 hours after donation...and they do call us. We don't test for other flu viruses during regular flu seasons. Even though this strain has new characteristics to which the population's immune system has never been exposed (which allows it to spread), it is still an influenza virus.

We are watching the AABB recommendations closely. At this point we have not taken any additional steps for donor qualifictation. If the AABB changes their recommendations, then we will change our criteria accordingly.

Helmer is our vendor of choice, too!!!

This would be an interesting case to send through Bio Array testing, given the recent transfusion history (much easier than typing retics!!!) I was also curious -- if a patient usually hemolyzes the 2nd unit (or whatever), then is there a possibility that the RBCs being hemolyzed are the patient's, in response to the acid levels present in the anticoagulant/additive? Perhaps an osmotic fragility study on the pre-transfusion sample would provide insight?

When we validate new boxes, we test worst case scenario: one unit in the box, placed in extreme temperatures. For example, we put a box in our plasma storage freezer (-20 C or below) with a temp-record device, then let it sit for a period of time. After the time is up, we remove the temperature recording device, download the graph, and determine how long it stayed within 20-24 degrees. We would repeat for a warm temperature...we find a nice warm boiler room in which to set the box for the desired period of time. These boxes are used to transport our finished product to any of our customers, some of which are sent on a Fed Ex plane overnight. We also use coolers for "short" "controlled" trips between our centers. These were validated by sending them on routine trips with the temperature recorder inside. We didn't think it was necessary to go to the same extent that we validate our boxes, since the coolers are only outside for short periods of time, and transported in comfortable conditions otherwise. We do check the temperature of each cooler upon arrival at our facility.