Art

At our blood center, we can assess what is an acceptable temperature/humidity range for an area by asking a few questions. 1) Are blood products going to be stored or processed in that area? What is their acceptable storage/resting/processing range (refer to FDA, AABB, manufacturer ect...) 2) Are there any critical supplies or materials to be stored in the area? What is their storage range (manufacturer inserts)? 3) What are the acceptable ranges for instruments operating in the area (manufacturer operator manuals)? 4) Does the area need 24hr monitoring coverage (draw location only/blood, supplies stored there)? What then is the appropriate monitoring system (automated-Mack/Rees/manual-eye readable/chart recorder)? Does it need it immediate response (blood product moved immediately)? Your range (and time requirements) is now established! Once your needs are addressed, the hard part of vendor/system evaluation and cost analysis starts--from the physical plant improvements to monitoring and response requirements. Have fun and good luck.

At our blood center, we perform temperature mapping for refrigerators and freezers (large and small) at validation to ensure that all points in that unit are performing within specification. After validation, we go to one point continuous monitoring with a commercial system. I don’t believe there is a regulation for temperature mapping, but our European plasma buyer requires mapping every two years and I believe it will become a de facto standard soon.

Hi Angela, Congratulations on the new position. Process improvement seems to be the hot topic at blood centers. We're undergoing that now too. We have process improvement team (all the managers) in place, 2 dedicated process improvement specialist and are receiving training on Lean and Six Sigma. Funny how the thought processes have paralleled! Have fun! Art @ BBSBRC

I work at a medium-size blood center and it is my understanding that HIPAA reinforces/enhances the donor confidentiality already in place.

The baseline from the 21 CFR 640.25 is four collections/month. I believe that was refined into (from the FDA Guideline for the Collection Platelet Pheresis 10/88 and other) 4 collections per machine type, per collection site and per product type. I work at a Blood Center and both the FDA and AABB looked at our QC practice and were satisfied with them.

We are currently using the Mack Lablink System (Mack Information Systems, Inc.) in our blood center. We use it for monitoring refrigerators, freezers, platelet incubator/doors, production room temps, IS server room temps and even have an adapter (Mack's) for our BacT/ALERT Bacterial Detection system. The equipment has proven very reliable and the vendor support is excellent (tech support and repairs). We are moving to their Plexxium System in the near future and that system looks very promising. Quality control monitoring (calibration verification) is also fairly easy to perform. Good luck in your search.

Lcsmrz Well written. Your definitions and commentary are right on. A validation assures me that the process in my lab functions properly and meets my lab’s acceptance criteria under my conditions. Validation by a manufacturer does not negate my responsibility of ensuring that changes will not affect my process. Validations also enable me to tap the knowledge of others in the facility that may see the process from a different perspective. Risk assessments (clinical/programming/security and regulatory) will dictate the extent and complexity of the validation. Section 5.0 of the AABB Standards also addresses this issue as Process Control.

We are running a bioMerieux BacT/ALERT 3D Signature system for bacterial testing of apheresis platelets. During the past three weeks we've had a couple false positives that have ID'd out as a Bacillius species. Repeat cultures of the positive units have been negative. Our false positive rate prior to this group of positives was low. Is anyone else experiencing this problem?

Here you go. This the link to their home page: www.metro.com Here are specific links to the specifications of what we purchased: www.metro.com/ftp/pdf/9.30.pdf & www.metro.com/ftp/pdf/9.35.pdf. I don’t recall if we purchased direct or through a vendor.

At our blood center, our components laboratory uses MetroMaxQ carts by Metro. You can order the pieces(size) that meet your needs. They ordered frames, posts, casters, snap-on hooks (for hanging bags), a grid shelf and dividers. It was very easy for them to put together and has held up well in a production environment (we draw approx. 120,000/yr). A single small cart that meets your needs should be very reasonable.

Root cause analysis of the error should occur before any decision is made. Procedures, training, quality control, communications, human engineering and management of those systems should be addressed prior to assigning fault. If the tech is dismissed, are you setting up the next one for failure? Why aren't the rest of the techs making this error? After the Root cause has been addressed, corrective action and an effectiveness check(of the corrective action) should follow. The system is only as good as the weakest link in the chain--unfortunately, the tech is the most visible when errors occur. If the tech is at fault, disciplinary action should occur according your written policies in the department or with HR involvement(keep the lawyers out of it!).

We are sampling the mother bag after the 24hr hold period and hold the unit for at least another 12 hrs before release. Positive units are resampled/cultured on the BacT/ALERT and a sample from the bag is sent out for culture/ID. Product is discarded after investigation is completed. AABB Association Bulletin #04-07 and #05-02 and Bacterial Contamination of Platelets: Summary for Clinicians.....dated 02/23/05 may help you with some of your questions.

Has anyone had any problems with the update B.12. Any problems with validation? Art

You are meeting the AABB Standard. The reference in the 22nd edition is 5.7.5.1. QC units that do not met this standard are remixed, resampled and tested one time. QC failures are not released. An investigation of the failure is also started. I don't have a reference for the 90%. Hope that helps. Art

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