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Posts posted by PSanai
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The vendors of apheresis equipment have sample validations available that you could use as a starting point. You'd need to revise them to fit within your validation process.
The validations performed on new apheresis equipment at my blood center consists of (shortened version) IQ= installation of the machine by the vendor. OQ = writing, approving and training the procedures for the process and finally PQ= collecting X amount of products and checking to see if the products are suitable for transfusion. In the case of plasmapheresis the PQ would check to see if the actual volume of the product is within 10% of the tageted volume.
Good Luck!
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Currently we are tracking red cell/plasma loss manually on paper. In about 2 months we will be implementing the Vista Information System. Vista will track red cell/plasma loss as well as number of donations in a rolling 12 month period.
Our supervisors perform a review of donor charts with each donation and will notify the Medical Director if any abnormal results are seen.
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10 yrs ago I worked at the ARC in special donations. At that time we would defer an autologous donor for at least 72 hrs if they had a procedure performed with any dye. The concern was that if a unit is collected within 72 hrs after a procedure then that unit would contain the dye. Even though the pt didn't react to the first exposure they might have an allergic reaction to the second exposure to the dye when transfused with the unit.
I'm not sure if that is still the policy, but it was something we took seriously when scheduling donations for autologous pts.
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Here at the Indiana Blood Center we don't track double sticks or hematomas as quality indicators. We see this as more of a cutomer service issue and have minimum phlebotomy standards in place. We require anyone not meeting the minimum phlebotomy standards to be retrained in phlebotomy.
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The blood center I work at will allow a donor to donate for most cancers one year after treatment and as long as the donor remains cancer free.
Childhood leukemia (onset 18 years or younger) is a 5 year deferral post treatment.
Lymphomas and adult leukemia (19 years and older) are indefinate deferrals.
Like many others, we allow autologous donors with cancer to donate but place a deferral on them as outlined by our criteria listed above.
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For the most part, we try to obtain as much information as possible from the donor, i.e., type of apheresis equiptmet, if red cells were returned, number of donations and last date of donation. From that, we can determine a estimate of what red cell/plasma loss the donor has experienced in their time away. When in doubt we can use default values that are pretty conservative.
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Since jaundice is a sysmpton not a disease, it all depends on the cause of the jaundice. For example, if the jaundice is caused by alcohol, gall bladder disease, Gilbert's Disease, hemochromatosis, nutritional deficiency, poison or other non-viral causes then, the donor is acceptable as long as they are sympton free on the day of donation. If the jaundice was due viruses like CMV, Epstein-Barr or Hepatitis A, B, C, D, E, or if the jaundice happened after the age of 10 then, we defer the donor indefinitely.
Hope that helps!
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Yes, we test samples from each donor each time they donate as if it were their first donation. Not to do so would be a very difficult thing for us to track.
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Is it possible for you to provide more information? We are looking installing VISTA with our Trima Accels and I'm interested in learing more about the problems you have experienced.
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Based on the Code of Federal Regulations 21 640.3, we screen donors each time they come in to donate. It does not matter whether the donor is donating whole blood, plateletapheresis, plasmapheresis or red cell apheresis.
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Also, keep in mind the sofware in the apheresis instruments used in blood centers in the US is different than the software in the apheresis instruments used in EU. My understanding is that the EU software for the MCS+ is much better than the software approved for use here in the US.
Good Luck!
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I currently work with Trima Accels and are very happy with them. A few years ago we had both the MCS+LN 9000 and Cobe Spectra instruments in use at our blood center. There were donors who could use either instument and donors who couldn't tolerate one machine or the other for whatever reason (usually citrate issues). Both Haemonetics and Caridian BCT are very supportive and have good training programs.
There are pros and cons to all apheresis instruments and you need to decide what platform will work best for your facility.
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Not all donors will take two hours. The actual machine time varies based on the donor's plt count. As with all apheresis technology today, donors with higher plt counts have the shorter machine times.
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I"ve used both the CS-3000 and the MCS+ to collect platelet products. I found the MCS+ to be easy to use. Most donors did well on the MCS+ and liked the one arm donation process. I have found the Haemonetics company to be very helpful with training and troubleshooting problems.
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One of the methods we use to get new plt donors in the door is to collect one 4 mL purple top tube from qualified whole blood donors (males with at least one good vein and not on anti-platelet medications, etc.). We will do this on mobiles that are within 1 hour drive time of our plt collection sites. Once the precount is done and it is detemined that the donor is a suitable canadate for plt apheresis then a recruiter will call to educate and recruit the donor for plts.
We have used this approach in the past with good success. Several other blood centers that done similar programs.
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Our SOP states that moderate reactions include fainting, incontinence and irregular pulse or any light (slight reaction) which lasts over 15 minutes. Severe reactions include chest pain, involuntary movements and cardiac arrest.
Ten years ago I was employed by the ARC and this was the same classification in use then.
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Here at our blood collection facility we provide transportation for our collection staff with passenger vans for inside set-ups or the staff ride in the mobile buses.
Our policies for reimbursement for mileage are pretty strict. Basically if it is the stafff member's choice to not ride in the van or bus then no mileage is paid.
Hope that helps.
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Yes, we implemented a program from eDonor at the end of March. This program allows donors to schedule online at a designated website. This is a bit of a culture change for us as we have not focused on sheduling donors in the past. Since the our program is new the number of donors scheduling themselves is small but growing daily.
Another part we are using is the donor loyality program. Donors receive "points" for their donations and can obtain extra points for scheduling online and keeping their appointments. The donor then can spend their points at the online store.
Of course Autos, Directeds, and Therapeutic donors still need to go through the Special Donations folks.
Plasmapheresis Validations
in Donor Services and Donor Recruitment
Posted
That is a very good question with no easy answer. Typically at my blood center, this decision is made in conjunction with QA. We'd consider the number of machines being installed. Another factor is if this is a new process or just adding machines to an exsisting process. Obviously, we'd require a larger number for the validation if process is new. Your vendor rep could tell you what other blood centers have done. You might consider selecting a number and contacting your CSO at the FDA and asking if they consider the number adequate for this validaton.
My guess is that we would require at least 10 procedures per machine. Any procedure stopped early due to VP problems or donor reactions would not count in the 10 (or whatever number you select.)
Hope that helps!