CDC Guidelines for Laboratories

[tbostock]

Just released by the CDC on Jan 6,2012: "Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories", in the Blood Bank section:

Wipe outer surfaces of blood bags and components with a towel moistened with appropriate disinfectant before release for infusion, ensuring that the disinfectant will not compromise the plastic bag.

What??? Does anyone else have serious concerns about this? Also entertaining was their section on separating "clean" and "dirty" areas of the Lab. For the love...

[tbostock]

Here's the link: http://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm?s_cid=su6101a1_w

[Mabel Adams]

Wonder if they talked to the FDA about this?

[MAGNUM]

Wonder if they talked to the FDA about this?

What, and have two government entities talk with each other!!

[sdweaver29]

I agree with magnum, that would make too much sense.

[DPruden]

Seriously?? Since it was published as a recommedation, I think I will ignore this silliness.

[Cxm]

Hello everyone,

I contacted the AABB about this recommendation, see below:

AABB does not have recommend a disinfectant for the CDC recommendation. That particular recommendation actually was of concern to us, and we reached out to one bag manufacturer to get their thoughts on it before going back to the CDC. If you’d like to discuss this further, or if you have other comments regarding their guidelines document, feel free to give me a call at your convenience Thanks!

Eduardo Nunes

Senior Director of Policy, Standards, and Global Development

AABB

8101 Glenbrook Road

Bethesda, MD 20814-2749

tel: +1.301.215.6504

fax: +1.301.215.5704

[Cxm]

Hello all,

Just received this from the FDA,

"I apologize for any inconvenience a delayed response may cause. Your inquiry was forwarded within CBER to the Office of Blood Research and Review (OBRR) who provided the following:

FDA has participated in discussions with the authors of this recommendation. A modification of the recommendation was published as an “erratum” in the March 30, 2012, issue of the MMWR. The text of the modified recommendation follows:

In the MMWR supplement, "Guidelines for Safe Work Practices in Human and Animal Diagnostic Laboratories: Recommendations of a CDC-convened, Biosafety Blue Ribbon Panel," on page 72, the sixth bullet of paragraph 11.4.1 should read, "Gloves should be worn when spiking or otherwise entering blood bags. The blood banks should have written procedures to decontaminate or discard blood or component containers visibly soiled with potentially infectious materials (i.e., wiping with an alcohol pad or swab) (Buchta C, Blacky A, Leitner GC, et al. Surface disinfection of packed red blood cells with 70% ethanol. Int J Surg 2006;4:118–21)."

This revised recommendation is more consistent with safe work practices in a blood bank setting.

I hope this is helpful.

Sincerely,

Pauline

Manufacturers Assistance and Technical Training Branch

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Center for Biologics Evaluation and Research/FDA

301-827-2000 or 301-827-4081

800-835-4709

Industry.Biologics@fda.gov

Follow us on Twitter: FDA CBER"

Hope this will close this issue for us and inspectors.

[lwalton]

We are just finishing up a JC inspection today and may or may not be cited for our blood issuing practice. The concern has nothing to do with how we check the patient and unit identification, but rather on our infection control process. Our lab policy/procedures state that the Blood Bank, as part of the clinical lab, is a biohazardous work area, so therefore we wear lab coats and gloves. The inspector had an issue with the tech signing out a unit of blood while wearing gloves. Our practice is to put the units into plastic Biohazard bags, but because the tech did not remove his gloves, it was felt that now the Biohazard bag was contaminated and we were endangering the transporter and others down the chain as the blood is delivered to the nursing unit. Has anyone else been cited for this? What are your blood issuing practices, from an infection control point of view? We are thinking that we will have the transporter pick up and open the plastic Biohazard bags and then the Blood Banker can just drop the unit into the opened bag. Hopefully that will suffice. I'm very curious as to what others are doing. I've never been in a Blood Bank or any section of the Lab where we were cited for WEARING gloves, but I guess I can see the concern from an Infection Control aspect. Regardless, it looks like we need to come up with some sort of corrective action.

[EDibble]

Because our blood is thoroughly tested, and really, would you label anything as biohazard that you would infuse, our blood bags are considered "clean". The bags we use to transport blood seal completely, but are not labelled biohazard. We wear coats, but not gloves when signing out. We just had JC here last year, just had our CAP inspection a few weeks ago, and no problems.

[Mabel Adams]

OSHA does not consider tested blood biohazardous. Elizabeth's post points out the reasoning behind this. As for the hand-off and gloves, we have this problem in many ways in labs. Do the pens and paperwork handled at the bench never make their way to a clean area? How does one make a logical decision about all of these hand-offs and how much risk is there really?

[Mabel Adams]

And how is the outside of the unit not already contaminated because it was handled at the bench at the time of the crossmatch and tagging?

[Likewine99]

Our process to to not be wearing gloves when we sign out a unit of blood but we are still wearing our lab coats since we are working in the lab.

I just worked last evening, flying solo in our 400 bed Level II trauma center blood bank, and when someone came to the door to pick up a unit of blood I removed my gloves, washed my hands and went to the sign out bench to sign out the blood. The donor unit is placed in a bag that is marked biohazard. This procedure is done in case anything "leaks" on it's way to the floor and it was suggested by nsg that we do this.

Come to think about it, do RN's on the floor wear gloves when they spike a unit? This topic could go on and on and on and on. Since the majority of units issued from any blood bank are not visibily contaminated with blood I would think "no gloves" would be OK. But then what do I know????

[Mabel Adams]

Maybe the theory of immunomodulation is bunk and patients get more post-op infections if transfused because we send contaminated blood bags up to their rooms!

Seriously, what we really need is data on what processes actually make a difference. I have a feeling we could be missing a significant cause of infection whilst worrying about something else with no significant risk. It's tricky because it is easier to test for bacteria but we may be more worried about viruses.