what is your blood bank doing to validate anti-sera; what is regulation being sited?

[Barbpump]

I heard a blood bank was recenlty sited by CAP for not validating their antisera (tube testing) when switching manufacturers. What are sites doing to validate current vendor against old with tube tesitng (AB0, RH, rare). Has anyone heard of this? If so, what is standard and/or CAP requirement they are siting.

[Justina]

I haven't heard of validating phenotype antisera (Duffy, Kidd,etc), but we do validate antisera used for ABO/Rh (A, B, D, A,B )when switching manufacturers.

 

I am curious to hear if anyone has been sited for this as well.

Edited March 14, 2014 by Justina

[Barbpump]

How many samples do you run, and do you have a citing for the standards or CAP checklist that requires this?

[Eagle Eye]

We performed validation for each and every reagent from new manufacturer before putting into use. We compared the results. For ABORH and IgG etc at least 20 specimens. For antisera controls and few specimens. As long as your medical director signed off on some kind of validation it would have been OK.

[tbostock]

Yes, we also validate any new reagent/manufacturer.  Since the FDA beats up on reagents before they get to us, you really don't need to do an extensive validation.  So for an antisera, we would do parallel testing with the old and new reagent with pos and neg controls, and a known pos and neg unit (segment).  We write up a document that it is acceptable for use, FDA approved, etc, and have the Medical Director sign.

[Barbpump]

_{Hi Terri,- Are you perfroming this proceudre on just ABO/RH anti-sera, or also your rares?}

[tricore]

CAP  TRM.31241

Reagent QC

Phase II

 

All new lots of reagents and critical materials (e.g. blood collection sets) are inspected and tested, as applicable, before use, with documentation of acceptance.

 

 

 

CAP  TRM.31400

Antisera/Reagent Red Cell QC

Phase II

 

Records document acceptable reactivity and specificity of typing sera and reagent cells on each day of use, including a check against known positive and negative cells or antisera, or manufacturer's directions for daily quality control are followed.

NOTE:  Unless manufacturer instructions state otherwise, the following apply:

 

• Each cell used for antibody detection must be checked each day of use for reactivity of at least one antigen using antisera of 1+ or greater avidity.

• Typing reagents such as anti-D, anti-K, anti-Fy(a), etc. must be checked each day of use.

• Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening and crossmatching.

• Typing sera and reagent cells must be checked for reactivity and specificity on each day of use, including a check against known positive and negative cells or antisera.

This checklist requirement can be satisfied by testing one vial of each reagent lot each day of testing.

 

REFERENCES

1)

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7171 [42CFR493.1217]

Edited March 14, 2014 by tricore

[tricore]

Joint Commission

Elements of Performance for QSA.02.03.01

The laboratory has a written procedure for calibration verification that includes the following, at a minimum: A

- The requirements established by the instrument manufacturer

- The number of calibration verification levels

- The type of calibration verification materials used

- The concentration of the calibration verification materials

- The frequency of calibration verification

- The acceptable performance limits for the calibration verification

1.

The laboratory tests the reportable range of results during the calibration verification process, including a minimal value, a A

midpoint value, and a maximum value based on the manufacturer‘s directions and instrument history.

Note: The Joint Commission does not require the purchase of commercial linearity kits to meet this requirement. Quality control

materials, previously tested proficiency testing samples with known results, and calibration materials are acceptable to use for

calibration verification.

2.

Calibration verification is performed every six months. A

Note: Semiannual calibration verification is not required when the laboratory performs calibration at least once every six months

using three or more levels of calibration materials that include a low, mid, and high value.

3.

Calibration verification is performed whenever the following events occur: A

- A complete change of reagents for a procedure is introduced, unless it is demonstrated that changing reagent lot numbers does

not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number

changes.

- Major preventive maintenance is performed, or critical parts are replaced that may influence test performance.

- Quality control results indicate that there may be a problem with the test system.

- An environmental change occurs, including instrument relocation.

- An instrument has been replaced.

- Quality control materials reflect an unusual trend or shift or are outside the laboratory‘s acceptable limits, and other means of

assessing and correcting unacceptable quality control values fail to identify and correct the problem.

[tricore]

AABB 29th

5.1.3 Quality Control

A program of quality control shall

be established that is sufficiently

comprehensive to ensure that

reagents, equipment, and methods

perform as expected. Chapter 9,

Process Improvement Through

Corrective and Preventive Action,

applies.

[Malcolm Needs ☆]

We do this for each and every reagent we use. This includes everything from grouping reagents to elution kits, phosphate buffered saline, AHG, Low Ionic Strength Solution. EVERYTHING! THE LOT!

In fact, this even includes human-derived reagents that we use diluted as far as we can dilute them and get a positive result in our rare donor screening programme.

I don't suppose you really wanted to hear this!!!!!!!!!!!!!!!!!

[tricore]

Malcolm, 

After you do all of the QA/QC do you have any reagent left to use to test patient samples ?    

[Malcolm Needs ☆]

Just!!!!!!!!!!!!!!

[Justina]

How many samples do you run, and do you have a citing for the standards or CAP checklist that requires this?

Tricore did a great job of citing all the regulations.

We test 20 samples in parallel with the old manuf. and QC both each day of use during the validation. We also run it for 20 days....so a sample a day.

[tbostock]

_{Hi Terri,- Are you perfroming this proceudre on just ABO/RH anti-sera, or also your rares?}

On all new reagents.  These are the only antisera that we carry in-house: C,E,c,e,K,Jka,Jkb,Fya,M.

[kate murphy]

For rare reagent validation, when changing manufacturers, we do a couple of patients and/or segments with controls in tandem.

For changing lots only from the same manufacturer, we do controls in tandem.

[salman]

We do this for each and every reagent we use. This includes everything from grouping reagents to elution kits, phosphate buffered saline, AHG, Low Ionic Strength Solution. EVERYTHING! THE LOT!

In fact, this even includes human-derived reagents that we use diluted as far as we can dilute them and get a positive result in our rare donor screening programme.

I don't suppose you really wanted to hear this!!!!!!!!!!!!!!!!!

Malcolm Sir,

Do you perform  validation of blood grouping reagents for other parameters like Titration, potency, Intensity, avidity, prozone, rouleaux, 

as well or  reactivity and specificity only ?

 

salman

SBBT

 

[Malcolm Needs ☆]

Hi Salman,

 

When we (as in, the NHSBT) first get a new reagent, we perform titration, potency, intensity/reactivity, prozone, rouleaux and specificity.  We do not specifically test for avidity (other than to use the reagent by the technique as instructed by the manufacturer).

 

Once we receive the reagents into our own laboratory, we will perform acceptance testing, but will regularly test to ensure that the reagents have not "gone off".

 

Malcolm

[David Saikin]

_{I run new ABORh reagents through my routine QC process.  These reagents are beat up by the FDA and must have a minimum potency . . . rares from a new vendor I test to see if they work in gel or not, otherwise I just qc them with cells demonstrating heterozygous,homozygous, and negative expressions of the ag being tested.  Even most rares have FDA minimum potency requirements.  I believe you just have to prove the reagent works in the manner in which you intend to use it.}