Rhogam/rhophylac must be under pharmacy control

[BUGGIE]

In a recent Joint Commission (JC) review we were told that it is now mandated that RhoGam and RhoPhylac must be under the control of pharmacy as RhoGam/RhoPhylac is a blood derivative not a blood component such as blood, FFP, etc and as such is defined as a medication per the JC definition. Pharmacy will review orders and store product.

Is this something new? I remember a thread/poll about how labs deal with RhoGam and derivatives as to whether they were stored in Blood Bank or Pharmacy, but nothing that mandated one or the other.

I don't mind pharmacy dealing with this, but I worry about patients getting the appropritate testing (RH type/Fetal Bleed Screen, etc) before RhoGam is issued.

Too many times ER or OR has just called our Blood Bank for RhoGam without being aware of what test were needed.

I would like the order to go to pharmacey, and the product then be delivered to lab to dispence so we can assure proper testing and amount.

Any comments would be appreciated as this seems to be a done deal with pharmacey and the JC.

[David Saikin]

We stock and dispense RhIg from the blood bank . . . BUT we are not JCAHO regulated. I guess that regulation would cover albumin as well . . .?

[L106]

Many facilities (including ours) stock and dispense the Rh-Immune Globulin in the Pharmacy, but I have not hears that JCAHO was mandating this. What about other labs that are JCAHO accredited? Have you heard this?

[Susan.Sullivan]

I am curious if the is truly a "TJC mandate" or is it the opinion of a TJC surveryor. Years ago, we had such a surveyor, and three years later we had that opinion overturned. Don't believe everything a TJC surveyor says... do your home work! I am going to start digging now...

[Tonyd]

If it helps, we have a similar situation in the UK, where anti-D is defined as a medicine and should technically be under Pharmacy control. Because the transfusion laboratories have the expertise in dealing with the testing around anti-D issue (and more importantly are open 24/7, unlike most Pharmacy depts in the UK), we have found that Pharmacy are more than happy for the 'status quo' to continue, and in many hospitals have formally devolved responsibility to the transfusion laboratory via the medicines management committee of the Trust.

The MHRA police both the Blood Safety & Quality Regulations and also the Medicines Act in the UK, and seem at the moment quite happy to let the current arrangements continue, as laboratories are not "supplying" the medicine direct to a patient, but are "issuing" it on the order of a suitable person who will then supply or administer it to the patient (ie a medical officer or registered midwife).

Best wishes

Tony

[KarenJ]

We just had our JCHAO inspection and nothing was said about RhoGam. We handle it in the blood bank.

[rcollins]

Hi BUGGIE,

I'm not sure what the actual reg is either, but we just had JC through the doors at the end of last year and they seemed alright with our practice. Our pharmacy stocks the rhogam, the BB gets a small supply at a time. The BB is in charge of the requests for rhogam, as far as ensuring appropriateness of the order and performing the correct testing. Then, BB issues the product and faxes a sheet to the pharmacy with patient demographic info. The pharmacy then bills the patient for the medication. Of course, the pharmacy manager requested a meeting for next week about rhogam so we'll see what that will bring! But so far, it has worked for us. Good Luck.

Becky

[AMcCord]

We are JCHAO inspected and, at this point in time, RhoGAM is still in Blood Bank.

[mjshepherd]

We had our JC inspection just last month, the inspector spent quite a bit of time in the Blod bank and did not have a problem with us keeping rhogam in the blood bank.

[Ann Viernes]

I'm reviewing the proposed revisions to the TJC Standards for Blood Transfusion Service and Donor Center. There is no current standard addressing Rh Immune Globulin Administration. The new proposed standard is QSA.05.13.01 "The laboratory has written policies and procedures that address Rh Immune globulin (RhIG) administration."

"Elements of Performance for QSA.05.13.01:

1. The laboratory's written policies and procedures for the administration of Rh Immune globulin address: -Crieria to identify patients eligible for prophylaxis; -Procedure to determine dose of RhIG required; -Optimal timing of administration following exposure.

2. The laboratory follows its policies and procedures for RhIG administration."

This is a proposed standard, still in the comments phase.

There is no mention of pharmacy control.

[Rebecca Heichel]

We just finished our Joint Commission inspection in August. We handle all RhoGam orders and perform whatever testing is needed for the patient based on the situation. Pharmacy is not involved.

[velliott]

We also just had a Joint Commission and inspection and there was no mention about dispensing out of blood bank. Blood is a drug and it is dispensed from blood bank. Don't you think its a patient safety issue that it is dispensed from blood bank making sure the right dose and if the patient actually qualifies? My fight is that even though the OB floor has the process for ordering; blood bank is the czar. We had 3 occasions where it was an inappropriate order: the wrong dose was ordered, patient was 16 weeks and a physician wanted to give a mini dose (we don't stock anything but the full dose), ordered on a RH positive patient, ordered on a patient that developed an anti D previously - we had been titering throughout the pregnancy. The last 2 scenerios who not have hurt the patient but there was an added expense and the last patient was already confused as to why they couldn't get their Rhogam shot - because they had gotten it at 28 weeks in the doctors office. There's so much hoop-la in all the standards (AABB,CAP and Joint Commission) about making sure patients get the right dose, we type them correctly and we identify patients who need it why would someone make us move it out of the best control?

[KKidd]

We stock Otho Rhogam in the Blood Bank. I feel that we are the ones who understand who are the candiates and can make sure that all of the proper testing is done prior to the injection. I also feel like we are less likely to miss a dose since the postpartum criteria hinges on the cord blood type. If we used either WinRho or Phophylac I would want it to be dispensed from the pharmacy for thrombocytopenic patients. My oncologist called several weeks ago wanting to give a patient WinRho at 75 units/Kg. I'm not about to touch that. Fortunately, the pharmacy was able to get some from another hospital.

:work:

[Colin Barber]

As another UK based BBT member I echo Tonyd's comments and would add I want to know who has had prophylactic anti-D to help with deciding is it prophylactic or immune anti-D when you find anti-D in the antibody screen in a pregnant or recently delivered patient. Therefore I want to stock and issue from the Blood Transfusion department so we have control over who gets it and the records are on the lab computer system.

[macarton]

We've had a couple of very deligent JC inspectors and they haven't said anything about us keeping Rhogam in BB. When we do the cord blood and if appropriate fetal screen, we order the # of Rhogam needed in BB, get it ready & call the floor to pick up. I feel this eliminates a potential omission step in the process that might occur if the floor had to turn around & request from Pharmacy. We start our 6 month window with our inspection, so we'll see then. Mary

[JoyDenver]

As long as you have a policy/procedure in place that ensures the appripriate dispense of RhIg it doesn't matter which department controls the product. Absolutely the BB has the expertise in determining the quantity appropriate that a pharmacy doesn't have. Some places will send the RhIg workup to the BB who then relays the calculated dose to both the care givers and the Pharm for the Pharm to dipense, but you run the risk of missing doses, especially in the outpatient setting unless you have an effective hospital wide IS system that is effective in communicating to all departments. I have seen too many cases of HDN resulting in very expensive care because of this.

[Kimster]

I posed the question to JCAHO online and this is their response:

No, this is not a mandatory practice. Rho Immune Globulin is a "blood derivative". Our practice is to survey blood derivatives (albumin, Rhogam, factor concentrates, etc.) under either the Immunohematology or Medication Management standards, depending on which of the two hospital departments is overseeing it. Specifically, if managed by the blood bank, we would survey it under our Immunohematology standards in the laboratory manual. If managed by pharmacy, we would survey it under the Medication Management standards in the hospital manual . The former has stringent tracking requirements (see QSA.05.01.01 and AABB standards 5.1.6.1 & 6.2.3) ; the latter requires sufficient tracking to determine who may be impacted in the event of a recall (MM.05.01.17).

Note that full compliance with the intent of the standards can only be assessed during an onsite survey. Please feel free to contact me directly with any further questions or discussion for clarification purposes.Megan SawchukJoint Commission

[kmh76]

We had our Rhophylac stored in Pharmacy as we thought this was a JCAHO requirement. We had nothing but problems. The OB floor would bypass us and call the pharmacy for Rhophylac along with the ED department. It was causing havoc for us. After 3 years when a new pharmacy director came along we finally got our Rhophylac back in the blood bank. We just had AABB and JCAHO inspections and nothing was said about us stocking Rhophylac in our department.

[kmt]

We removed the Rh Immune Globulin a few years back due to a Joint Commission inspection. We removed all factors!!!!

[kmh76]

Why were you told to do this by joint commission? How do you handle the Rhogam ? How are you monitoring the patient is getting a work up and not just the drug?

[AMER]

our hospital AABB,CAP,JCIA

Rh-Immune Globulin in the Pharmacy

[kmh76]

our hospital AABB,CAP,JCIA

Rh-Immune Globulin in the Pharmacy

OUR HOSPITAL -AABB, JCAHO Rhophylac is kept in the Blood Bank

[kmt]

When Rh Immune globulin is ordered in our institution's campuses:

1. The order is placed as a TS order in our computer system and is sent to the TS.

2. We do the required testing that is necessary.

3. We send the completed RhIg control form to the pharmacy with the number of RhIg vials needed.

4. The pharmacy dispenses it.

The pharmacy's SOP is not fill any orders without a form from us and refers all floors to the Transfusion Service if there is an issue. We have been doing this for about 4-5 years now.

[seraph44]

We will be moving our RhIG to the pharmacy within six months. I find a bit confusing because of how I've handled RhIG in the past. This is what JC currently says:

QSA.05.13.01	1	The laboratory’s written policies and procedures for the administration of Rh immune globulin address:
		- Criteria to identify patients eligible for prophylaxis
		- Procedure to determine dose of RhIG required
		- Optimal timing of administration following exposure
QSA.05.13.01	2	The laboratory follows its policies and procedures for RhIG administration.

Once RhIG is moved out of the Laboratory, do we still monitor if the patients received RhIG appropriately? The part of "Criteria to identify patients eligible for prophylaxis" has me wondering. We will have doctors order a "Trauma KB" and a "Post Partum KB". This is easy to keep track off, but how do you keep track of a typical pregnant female with vaginal bleed and they order and an order for an ABO/Rh through the E.D.? Do the folks who no longer dispense RhIG have to pull any reports to and go through the trouble of making sure that all eligible patients received their RhIG? or is this something that pharmacy has to do?

Would you all agree that the criteria to identify patients for prophylaxis should not be applicable to the blood bank since we no longer dispense? I would assume our only responsibility should be to perform the testing and for the pharmacy to now have a checklist to determine eligibility.

Thanks,

 

[AMcCord]

We are wrestling with that one right now for the CAP checklist. We've got things pretty well locked down for everything else, but the ED and surgical patients remain problematic.