Avid123

We use HCLL and made the decision to not use "Emergency Issue (EI)" during the actual emergency. We use paper to issue the units and then after the emergency is over we use EI to perform the documentation in HCLL. We felt that it was too easy to make a mistake in EI during the emergency that would lock up the units in the nether void. We are a Level 2 trauma center, but our actual bleeding trauma numbers are low.

For all patients, we require a full ABORh on 2 different specimens-can be a specimen in the lab or a specifically drawn one. For Electronic XM (EC)-2 types and screens on different specimens performed by different techs-our Tango counts as a secondtech.

I have seen this with anti-M. The reverse typing cells are probably M+. M can be a cold reacting as well as a warm reacting antibody.

We stopped doing a type and screen on every OB patient on every admit years ago. We were not getting reimbursed for it. Now we just perfom T&S on an as ordered basis.

Big No-no. OSHA would certainly frown on any food or beverage in the lab. I do assume that your desk is in an area that testing is performed. You cannot even put lip balm on while in the lab according to OSHA. Do you really want to take the risk that some one would not accidently splash something dangerous into your water?

Why don't you get units from the supplier with pedibags attached, fill them, label them, and issue them in a bunch to the OR. you could do the sizes based on that the OR intends to use or by patient size or by max size of the syringe (Which we found out was 60 ccs). That way it is sterile. and expiration is life of unit. The OR could choose a pedibag and spike it with the syringe attachment. Include a second label for them to use.

It does not matter what you bill for on inpatients as reimbursement is based on the DRG code. Outpatients are a different story. Here is where you need to be concerned. You cannot bill for the second blood type nor antibody screen performed on the second specimen for electronic XM eligibility. You cannot charge for the second blood type performed on a second specimen for patient safety either. You cannot bill for CMV neg or Irradiated blood if the patients diagnosis code is not included on the approved list. j

The FDA has approved the medical devices for the purpose of concentrating the platelets. What you use those platelets for is still experimental and not approved therapies. Hence, insurance will not pay for it. I would suggest that the sports medicine clinic purchase the machine and learn to operate it since the procedure should be performed as close to the patient as possible. Janice

PS: insurance does not pay for this since it is "Experimental".

Why do they want you to prepare the PRP? This PRP injection is different than the stuff the BB prepares from donor platelets for infusion. You essentially would be preparing a drug. You would not need a FDA license? What would the FDA inspector do if he saw you prepare this product in your non-clean room blood bank? How would you label and store it? How would you assure that it gets back to the patient it came from? A really big deal when you think about it-patient A getting patient B's product. Would you perform the same tests as a we would for blood donors? How would you bill for it? You would want to get the $$ back that you invested in the machine you bought to make it. Think about tech training! This is best left in the doctors office as a point of care procedure. Our outside contractor perfusionists got involved in this and brought in the machine their group owns. The sports medicine program needs to invest their money andtake ownership of this non approved procedure and product. j

It is an autologous product. Would not use donor platelets. That is why point of care is preferred. Machines are manufactured that way. J PS: the product made from platelets years ago for wound healing was called "procuren".

Don't get involved with this! How are you going to label it? How are you going to manufacture it with out contaminating it? How do you assure it goes back to the correct patient? We used to store a product for our wound care center made out of platlets. Eventually the FDA closed down the lab that made it for precisely these reasons. There are machines that makes PRP. It is a closed system. Performed at the bedside. I was just talking to a perfusionist on monday about this. They are a contractor. They were asked to make PRP for a surgical case. They brought in a machine. There are several out there. http://www.perfusion.com/perfusion/prpdevicesummary.asp Point of care is the way to go! J

"Gel-o-bodies" or "Anti-Orthos" are a problem as are colds and warms. BUT not every method will detect every antibody when it is present. Each method has it's own selectivity and sensitivity. We found this out when we were doing our side-by-side for gel and Solid phase (Tango). Gel is really good at detecting Rh antibodies. We have kept Gel and still use tube and PEG when necessary. Gel is nice, our techs took to it when we first got it. The Provue is a very primitive instrument-I refer to it as an automated workstation. Echo and Tango are better-true instruments.

And you have to account for the Donor center "cherry picking" their antigen negative needs.

Again depends on your state. In Michigan we have ARC and MCBC. Is this facility affiliated with a group of hospitals or a stand alone? If affiliated, you might be able to get your supply from the main hospital and use their "buying power". J

You should check the regulations for your state.

Here is a copy of the question and the answer given by Penelope Meyers - Division of Laboratory Services, Survey & Certification Group, Center for Medicaid & State Operations at CMS: "Question 4: We perform all routine testing using gel technology. We also perform electronic crossmatches. For patients in whom clinically significant antibodies have been identified, is it sufficient to perform only a gel antiglobulin crossmatch? Does this satisfy the CLIA requirement to perform a test to detect ABO incompatibility? MS. MEYERS: For this question, before I start, I would like to just make the comment that the answers that I will be giving to the questions today are based on the CLIA regulations. However, I would like to remind the audience that many laboratories choose to obtain their CLIA certification through a CMS-approved accreditation organization, of which there are six. One of which is AABB. These laboratories must follow all the requirements of their chosen accreditation organization which may be more stringent than the CLIA requirements. Now back to the question. Actually, these CLIA requirements for crossmatching are based on the FDA requirements for crossmatching, and FDA and CMS have collaborated in preparing the answer to this question. The simple answer is that the IgG gel card does not fulfill the requirement to demonstrate ABO incompatibility. There are two issues involved here. First, the labeling clearly indicates that the IgG gel card is for direct and indirect antiglobulin tests. In other words, detection of cell-bound IgG antibodies. While the limitation section of the package insert states that some IgM antibodies may react, this limitation should not be interpreted to mean that the card is capable of detecting all IgM antibodies, particularly ABO antibodies. Secondly, the IgG gel card is a low ionic test system and there have been reports that ABO incompatibilities, due to IgM antibodies, can be missed when the antibodies are weak and the test is low ionic strength. While we acknowledge that there is continuing debate on this topic, but with the knowledge of these reports and in the absence of data from the reagent manufacturer to support the use of a low ionic strength system for detection of ABO incompatibility due to IgM antibodies, we believe it is not appropriate for users to omit some kind of test to detect these incompatibilities. And for eligible patients, an electronic crossmatch would fulfill the requirements. An immediate spin crossmatch, of course, is an acceptable method for all patients. MODERATOR: Thank you, Penny. Can I ask, because I could not hear everything that you just said, but did you respond to the part about sufficient to perform only the gel antiglobulin crossmatch, that first part? MS. MEYERS: No, it is not sufficient to perform only the gel antiglobulin crossmatch because that does not fulfill the requirement to detect ABO incompatibilities." There you have it. Straight from the horses mouth. The specific CFR is "21 CFR 606.151©- Procedures to demonstrate incompatibility between the donor's cell type and the recitpent's serum or plasma type." I wonder if we are in compliance? We have HCLL for our TSIS (Transfusion Service Information System). The compatibility truth tables are set up so that we can set up an allow, forbid, or allow with an over ride for product selection. Our system is set up so that an incompatible RBC donor type could never be allowed to be even chosen for a patient, much less crossmatched and issued. Does the cover the compliance issue? Or should we be doing IS crossmatches as well as gel crossmatches for patients with antibodies?

We issue platelets to OR in a room temperature cooler that is smaller than the coolers we use for RBCs. It has a sign saying it is a RT cooler with no ice. As for RBCs, we try not to issue multiple units in a cooler to the med/surg floor unless the patient is being dialyzed. OR, ER and ICUs can get multiple components in a cooler. We have a limited amount of coolers and OR has the priority for their use. We can refuse to send units in a cooler for areas other tha ER and OR.

Plavix affects the platelets when they are manufactured in the bone marrow. So it should not damage transfused platelets.

Could the patient have an antibody to an antigen that is not on your screening or panel cells? Might want to send specimen to a reference to test against cells with rare antigens. Just a thought.