Daily Reagent QC

[Dawn]

How do you accomplish daily reagent QC?

[Shannon]

Sorry to sound dumb.......... but what kind of reagent? ALL of our reagents (We are a Reference lab in a blood center) get tested with pos. and neg. reactions. Everything. We use Hetero. cells when possible for the pos. rxns. Don't know if this helps.

[Dawn]

We also use heterozygous cells as positive controls for our reference lab antisera.

My question refers to QC on the basic type and screen reagents. I'm wondering about the specifics. Are all vials done daily? Or is every lot QC'd daily? Are new vials QC'd before using? Does each person QC their rack or does one person QC all of them? Do you use a kit?

[John C. Staley]

We have 2 racks and the reagents of both racks are tested each day of use. We use both racks M-F, just one on weekends. This is probably the only conservative stance I've ever taken where QC was concerned. I think the question that needs to be asked is "Why are you doing QC?" depending on how you answer that will determine whether or not you QC by the rack or by the lot.

[Cliff]

I think the question that needs to be asked is "Why are you doing QC?" depending on how you answer that will determine whether or not you QC by the rack or by the lot.

I used to think that too until we were cited by JCAHO for following the FDA rules for each lot each day of use. As a reminder here is the standard publshed in the 2005-2006 Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB) by JCAHO.

Standard QC.5.220

The laboratory tests for reactivity the potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compatibility determinations.

Elements of Performance for QC.5.220

• The laboratory defines its procedures for reactivity testing in writing.
• Each opened vial of antisera, reactive cells, and reagents is tested for reactivity on each day of use and when a new lot of reagents is first used.
• The laboratory confirms that each reagent reacts as expected.
• Results are documented.

[Shannon]

We work out of one rack and every vial is tested daily. If we open a new vial in the course of the day (even same lot#) it is also QC'd. We do not use a kit, but use different Ab examples for each new lot. (never the same twice in a row) The first person to use each reagent is responsible for doing it's QC. We are a blood center and do not answer to JCAHO. "Just" FDA.

[rdnewsom]

Regarding this issue, this throws in an interesting wrinkle with panel cells. At our facility we also QC panel cells with regards to the CAP regulation cited, are all reagent cells QC'd each day of use. I know that there are many other facilities that don't QC panel cells each day of use because the commentary of this question only addresses A Cell, B Cell, Check Cells and Screening Cells. I wonder if we are going overboard or are we accomplishing the intent of ensuring that reagent cells are functioning properly.

[Myella]

Panel cells are the only ones that we don't do QC on. We have four racks of reagents and we alternate performing daily reagent QC on 2 racks each day against a commercial RQC reagents. We parallel test all new lots before putting them into use.

[QDeb]

Our racks are stocked with reagents of the same lot numbers, so there is only one lot in use for any one particular reagent on any given day. We check each rack daily to ensure that the each rack has the same lot numbers in use, there is enough of that lot available to cover testing throughout the day (in storage or in the rack) and visually inspect the bottles. We only QC a single rack of reagents, thereby QCing the lot in use. If someone misjudges and a new lot of reagent needs to be opened, then it needs to be QC'd prior to use.

[MCPIOR]

We QC each rack in use once each day. A new vial is not QC'd when opened until the daily QC is done. We do a QC on each panel when it arrives and check one cell with anti-K and another cell with anti-M. Panels are visually checked for hemolysis before put into use. Heterozygous cells positive and a negative cell are run with other typing reagents once each day and again at the discretion of the tech, sometimes just a positive.

[mtheriault]

We do QC daily on all racks for routine reagents. On day of use, we QC special antisera.

[Claudia Higa]

We do Daily RGT QC like QDeb. We have 2 racks with the same lot #s and alternate rack testing 7 days/week.

Is Daily reagent QC recorded manually or do you enter results into the computer? If the computer is used, what software are you using?

[QDeb]

We document our QC manually. I am pretty sure that we have the capability to enter results of QC into our computer but opt not to. It was decided that it was easier to do it manually.

[Gloria Lucchese]

We have 7 stations and they all QC their rack everyday. Panels are parallel tested against a know antibody upon arrival.

[MicheleKay]

On the day shift there rare oughly 12 techs when fully staffed. Each tech QC's their own rack identified by a rack # each day and records it on a QC sheet and placed in a binder. When the next shift comes in, they acquire a rack QC'd from the the day shift, but they have to fill out their own sheet and compare with the previous tech's sheet. This eliminates opened vials with different lot numbers that can occur throughout the day. If a 2nd shift tech finds a new lot number from what was recorded in the morning he/she has to QC just that vial. All other information is written and a notation stating "QC'd by So-and So" is written on their QC sheet.

[luhubert]

Is CAP changing its requirements, too. I hate to disagree with JCAHO but isn't this overkill? At the present time, we have two racks and QC 1 of them each day, alternating days. The same lot number is on each rack. We QC new lot numbers before they're put into use. With the type and screen reagents I've never seen a QC failure in my 20 + years as a blood banker except a contaminated A and B cell when someone had switched the tops and those were still useable. This rule is going to be time and reagent consuming for those places which use 10 - 20 racks. I didn't know JCAHO went so in depth in the Blood Bank, I thought they left that up to CAP, CLIA and AABB. Lu

I used to think that too until we were cited by JCAHO for following the FDA rules for each lot each day of use. As a reminder here is the standard publshed in the 2005-2006 Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB) by JCAHO.

Standard QC.5.220

The laboratory tests for reactivity the potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compatibility determinations.

Elements of Performance for QC.5.220

• The laboratory defines its procedures for reactivity testing in writing.
• Each opened vial of antisera, reactive cells, and reagents is tested for reactivity on each day of use and when a new lot of reagents is first used.
• The laboratory confirms that each reagent reacts as expected.
• Results are documented.

[Cliff]

Hi Lu,

It's timely I re-read this today. I just finished photocopying for the last five hours. We need to send in four months worth of QC data as part of our follow-up to JCAHO.

We aren't a 20 rack facility, but we do have 6 routine racks, and it hurt a little. We also have a Rosys that we need to do QC on. Plus we were not following the manufacturers directions and testing with dilute anti-A and dilute anti-B. So in the past 6 months our QC has changed quite dramatically. My opinion, we didn't do a single thing to improve patient care. We are spending time and money needlessly to meet a foolish requirement.

Phew, I fell better now.

Is CAP changing its requirements, too. I hate to disagree with JCAHO but isn't this overkill? At the present time, we have two racks and QC 1 of them each day, alternating days. The same lot number is on each rack. We QC new lot numbers before they're put into use. With the type and screen reagents I've never seen a QC failure in my 20 + years as a blood banker except a contaminated A and B cell when someone had switched the tops and those were still useable. This rule is going to be time and reagent consuming for those places which use 10 - 20 racks. I didn't know JCAHO went so in depth in the Blood Bank, I thought they left that up to CAP, CLIA and AABB. Lu

[johna]

According to my interpretation of that JCAHO standard one should be QCing every vial of reagent opened. Since on any given day we wind up using multiple bottles of anti-IgG, LISS, Screening Cells, etc. this would require a separate QC on each bottle. If this isn't overkill I'm not sure what is. Fortunately we do not answer to JCAHO.