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One of our sister sites was recently cited by HFAP for not following their Anti-D package insert (BioRad Seraclone Anti-D blend for tube testing). Their procedure is to interpret any obstetrical RH type that reacts 1+ or less at immediate spin NEGATIVE until they refer the sample for genotyping. A chartable comment is added to the result stating that the reaction was discordant and that the sample was referred for genotyping.  If genotyping shows a Partial D, the interpretation stays as Negative. If the genotyping comes back as weak D 1, 2, 3, or D+ the interpretation is corrected to Positive and a corrected report sent. However, the BioRad package insert says "agglutination of red cells is a positive result". hence the citation. We realized that the "less than 2+" rule in the procedure refers to the FORMER Anti-D reagent (Immucor Series 4) and the SOP was left that way when they switched to BioRad. They aren't interested in changing the current process, because it has helped identify at least 3 partial D mothers who would not have received RhIG if the insert had been followed to a T. My question is, does anyone else follow a similar "less than 2+" rule, have you been cited, and what Anti-D reagent are you using? Do you result these patients at "Indeterminate", at least until genotyping is complete?

 

Thank you!

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I have NO idea who are HFAP, but I would say that, whoever they may be, they are complete idiots.

Your way of treating the patients as D Negative until proven otherwise (i.e. the patient is D Positive or is Weak D Type 1, 2 or 3) is EXACTLY what is suggested by people who actually know about the subject on both sides of the Atlantic (Daniels G.  Variants of RhD – current testing and clinical consequences.  British Journal of Haematology 2013; 161: 461-470, and Sandler SG, Flegel WA, Westhoff CM, Denomme GA, Delaney M, Keller MA, Johnson ST, Katz L, Queenan JT, Vassallo RR, Simon CD.  It’s time to phase in RHD genotyping for patients with a serological weak D phenotype.  Transfusion 2015; 55: 680-689).

I have, as I said above, no idea whether this was an HFAP ruling, or the ruling of a rogue inspector from HFAP, but, either way, I would be appealing against the citation, or changing the organisation who inspects my laboratory, if the appeal is rejected.  From my point-of-view (and I have a bit of experience) you have done no wrong, but the inspector/inspectors have not got a clue about the Rh Blood Group System, and, in particular, the vagaries of the RHD gene.

My own wife is D Negative, and if this lot forced her to be assigned as D Positive on such minimal reactions, I would be suing immediately.

Sorry about the rant!

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Healthcare Facility Accreditation Program (HFAP).  They serve a similar function as JCAHO in the United States.

I mentioned this issue to Malcolm and others in another thread regarding this same issue as to how facilities can justify interpreting the presence of agglutination in the Anti-D test ( with a negative Anti-D control test) as Rh Negative! 

Both ORTHO and BioRad state in their direction inserts for Anti-D that agglutination is a positive test result and must be interpreted as Rh Positive.  If the academic data is so compelling, why haven't the antisera manufacturers changed their directions for interpreting Anti-D test results?  Why haven't the accrediting agencies changed their inspection criteria?

The academic and accrediting communities are not in synch!  Which has priority in the United States?

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Fine, but I would ask, in that case, from where, or from whom, do the accrediting communities gather their information to make their rules, or do they make them up themselves?  Surely, they have to listen to the experts in the field, most of whom are the authors on these two papers?

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1 hour ago, Malcolm Needs said:

Fine, but I would ask, in that case, from where, or from whom, do the accrediting communities gather their information to make their rules, or do they make them up themselves?  Surely, they have to listen to the experts in the field, most of whom are the authors on these two papers?

In other words, who accredits the accrediting agencies?  There you go Malcolm living in that imaginary perfect world.  :rolleyes:

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Posted (edited)
5 hours ago, Malcolm Needs said:

Fine, but I would ask, in that case, from where, or from whom, do the accrediting communities gather their information to make their rules, or do they make them up themselves?  Surely, they have to listen to the experts in the field, most of whom are the authors on these two papers?

Please read the following from CAP (US accreditation program) announcing 2018 revisions to the Transfusion Medicine Checklist, "Also clarified in the 2018 checklist is that the use of molecular-based screening assays alone for ABO and Rh(D) blood type assignment is unacceptable for transfusion or transplantation. “We still do not know completely everything about ABO and Rh molecular typing,” Dr. Gandhi says, which is why TRM.40550, “Forward/Reverse Typing,” now says an FDA-cleared or -approved serological method must be used. ABO/Rh typing for transplant or transfusion has to be done “by an FDA-approved method, and right now that’s only serology,” Dr. Gandhi says.

“We use molecular-based testing for a lot of blood bank phenotyping now,” Dr. Park says, “but it is not acceptable and it’s just not the right testing and methodology for ABO and Rh.” ABO and Rh typing by molecular methods is complicated and not without risk, she says, adding, “Serology is very simple, so go with the simple one that works well.”

So, again I ask US Blood Bankers, "How do you justify interpreting the presence of agglutination in the Anti-D test as Rh Negative?"  Which scientific articles do you cite in your SOP?

Edited by Dansket
added sentence

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2 hours ago, John C. Staley said:

In other words, who accredits the accrediting agencies?  There you go Malcolm living in that imaginary perfect world.  :rolleyes:

At the risk of opening a can of worms; who does accredit the accrediting agencies WRT blood bank? It seems the higher up the government system you go the less serology they know (let alone the growing molecular implications) but they must ratify/audit each agency?! If the agencies are therefore effectively self regulatory how do they form agreements within itself, other agencies, define who the experts are, come to agreements and then implement the results?

I am familiar with the AABB technical manual revisions but have never thought through the process let alone the ramifications of integration with all the different agencies. Is there a pecking order? The ISBT meetings must be a whole other level of frustration!

From reading several threads it seems a hospital blood bank chooses (and pays for) the accrediting agency according to it’s requirements based on work volume and/or the complexity of testing done? Who within the hospital makes that decision?

I am trying to get an overview so I understand the process by which the OPs question could be resolved by each agency and how inspectors will audit individual hospital policy.

Thanks in advance for some enlightenment! 

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16 minutes ago, Ensis01 said:

At the risk of opening a can of worms; who does accredit the accrediting agencies WRT blood bank? It seems the higher up the government system you go the less serology they know (let alone the growing molecular implications) but they must ratify/audit each agency?! If the agencies are therefore effectively self regulatory how do they form agreements within itself, other agencies, define who the experts are, come to agreements and then implement the results?

I believe the FDA  is the ultimate authority in the US.   CAP, HFAP, Joint Commission and State regulators all act as surrogates for the FDA and are subservient to them.

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3 hours ago, Dansket said:

Please read the following from CAP (US accreditation program) announcing 2018 revisions to the Transfusion Medicine Checklist, "Also clarified in the 2018 checklist is that the use of molecular-based screening assays alone for ABO and Rh(D) blood type assignment is unacceptable for transfusion or transplantation. “We still do not know completely everything about ABO and Rh molecular typing,” Dr. Gandhi says, which is why TRM.40550, “Forward/Reverse Typing,” now says an FDA-cleared or -approved serological method must be used. ABO/Rh typing for transplant or transfusion has to be done “by an FDA-approved method, and right now that’s only serology,” Dr. Gandhi says.

“We use molecular-based testing for a lot of blood bank phenotyping now,” Dr. Park says, “but it is not acceptable and it’s just not the right testing and methodology for ABO and Rh.” ABO and Rh typing by molecular methods is complicated and not without risk, she says, adding, “Serology is very simple, so go with the simple one that works well.”

So, again I ask US Blood Bankers, "How do you justify interpreting the presence of agglutination in the Anti-D test as Rh Negative?"  Which scientific articles do you cite in your SOP?

I am sorry, but this rather proves to me that the FDA should take more advice, if they are going to claim to be the "be all and end all" in terms of ultimate authority.

I, and many people much more expert in the field than me (to name one, Dr Geoff Daniels), would agree with Dr Gandhi that serological ABO typing is far superior to molecular typing, BUT, the same cannot be said for RHD typing, where molecular typing is vastly superior to serological typing (not least because no blend of monoclonal anti-D reagent can detect all weak and partial D types, and no monoclonal anti-D has yet to be found that will not react with a Partial DIII).

It is also disappointing that Dr Gandhi is unable to use the internationally accepted terminology for the D antigen.  Many, many moons ago, Dr Patricia Tippett, who, you will recall, did the original work on partial D categorisation, which, to a large extent, is still used,not least by the International Society of Blood Transfusion.  Patricia pointed out that the correct terminology for the first of the Rh antigens was "D", and certainly not Rh(D).  Obviously, Dr Gandhi is one of those who feel they are above and beyond the reaches of those who really know.

Turning to Dr Park, I would again say that ABO typing is, almost universally, better done serologically (I doubt anyone would argue with that), but that the molecular testing of the RHD gene and, by inference, the fact that they are far more accurate than is D typing by serological techniques.  If this were not so, people with partial D types would not still be making allo-anti-D in the numbers that they are.

Similarly to the misuse of terminology by Dr Gandhi, I also note that Dr Park writes, "We use molecular-based testing for a lot of blood bank phenotyping now."  Since when has a "molecular technique" in the world of blood transfusion been "phenotyping", rather than "genotyping".  This is not just a mistake in terms of "blood grouping terminology", this is a very basic mistake in terms of biological science.

This brings me back to my question, do these "experts" make up their rules as they go along, or do they actually take any advice from the experts in the field, who wrote those two papers I cited in my earlier post?  I must say that they don't seem to be that "expert" to me.

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Posted (edited)
On 5/10/2019 at 1:56 PM, TRabs10 said:

One of our sister sites was recently cited by HFAP for not following their Anti-D package insert (BioRad Seraclone Anti-D blend for tube testing). Their procedure is to interpret any obstetrical RH type that reacts 1+ or less at immediate spin NEGATIVE until they refer the sample for genotyping. A chartable comment is added to the result stating that the reaction was discordant and that the sample was referred for genotyping.  If genotyping shows a Partial D, the interpretation stays as Negative. If the genotyping comes back as weak D 1, 2, 3, or D+ the interpretation is corrected to Positive and a corrected report sent. However, the BioRad package insert says "agglutination of red cells is a positive result". hence the citation. We realized that the "less than 2+" rule in the procedure refers to the FORMER Anti-D reagent (Immucor Series 4) and the SOP was left that way when they switched to BioRad. They aren't interested in changing the current process, because it has helped identify at least 3 partial D mothers who would not have received RhIG if the insert had been followed to a T. My question is, does anyone else follow a similar "less than 2+" rule, have you been cited, and what Anti-D reagent are you using? Do you result these patients at "Indeterminate", at least until genotyping is complete?

 

Thank you!

I am not sure about this, but just because the insert describes what a positive result looks like, I do not think that means they are trying to say the interpretation is necessarily positive.  That's what your facilities' P&P is for, approved by your pathologist and based on whatever data you want to cite.

Scott

Edited by SMILLER

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We use Ortho Anti-D and their insert says agglutination is interpreted as positive. It  also states one drop of 
Anti-D is used. But our procedure is add 1 drop of Anti-D and if the reaction is negative we add another drop of Anti-D and if the agglutination is 1+ or less the interpretation  is negative. We do not send for genomics testing unless the physician requests, which has happened in the past when the patient had a history of Rh positive from another institution. Never have we been cited from CAP or AABB  which are the accreditation agencies we use. Who is HFAP anyway?

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Posted (edited)
48 minutes ago, slsmith said:

We use Ortho Anti-D and their insert says agglutination is interpreted as positive. It  also states one drop of 
Anti-D is used. But our procedure is add 1 drop of Anti-D and if the reaction is negative we add another drop of Anti-D and if the agglutination is 1+ or less the interpretation  is negative. We do not send for genomics testing unless the physician requests, which has happened in the past when the patient had a history of Rh positive from another institution. Never have we been cited from CAP or AABB  which are the accreditation agencies we use. Who is HFAP anyway?

Which scientific paper(s) does your SOP cite to support your practice of adding a second drop of anti-D to a negative (no agglutination) Anti-D test?

Which scientific paper(s) does your SOP cite so support your practice of interpreting 1+ agglutination in the Anti-D test as Rh Negative?

HFAP in the Healthcare Facility Accreditation Program that has the same deemed status with CMMS as does Joint Commission.

Edited by Dansket
added statement

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My facility did the same as slsmith , adding a second drop of anti D to neg rxns.  We were cited by CAP for not following the reagent package insert, and discontinued the practice after our CAP inspection.  That was the only citation for Transfusion medicine during that CAP inspection.

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Would it be possible to interpret the 1+ reacton as Positive, but add a comment that the weak serological reaction (or molecular typing) indicate a probable Partial D and recommending the administration of Rh immune globulin during pregnancy?

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at our facility, if one drop of Anti-D and 1 drop of  patients 3-5% is negative, we proceed to the antiglobulin weak D procedure(incubate at 37 degrees for 15 min, wash 3 times, add 2 drops of monospecific IgG, if positive macroscopically patient is considered weak D positive,  AABB technical manual 19th edition  and orthoclinical  direction circular.

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29 minutes ago, Karen knight said:

at our facility, if one drop of Anti-D and 1 drop of  patients 3-5% is negative, we proceed to the antiglobulin weak D procedure(incubate at 37 degrees for 15 min, wash 3 times, add 2 drops of monospecific IgG, if positive macroscopically patient is considered weak D positive,  AABB technical manual 19th edition  and orthoclinical  direction circular.

I can see from where you are coming, BUT from where do you get your anti-Weak D?  The patient is a Weak D, NOT a Weak D Positive.

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5 hours ago, Karen knight said:

at our facility, if one drop of Anti-D and 1 drop of  patients 3-5% is negative, we proceed to the antiglobulin weak D procedure(incubate at 37 degrees for 15 min, wash 3 times, add 2 drops of monospecific IgG, if positive macroscopically patient is considered weak D positive,  AABB technical manual 19th edition  and orthoclinical  direction circular.

If your patient is negative at IS and positive using IAT what is recorded in the LIS and how do you deal with resulting questions?

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52 minutes ago, Ensis01 said:

If your patient is negative at IS and positive using IAT what is recorded in the LIS and how do you deal with resulting questions?

If the newborn rbcs are agglutinated in the Weak D test and are unagglutinated in the Weak D Control test, our computer interprets and reports these test results as Rh Positive.

 

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9 hours ago, Dansket said:

If the newborn rbcs are agglutinated in the Weak D test and are unagglutinated in the Weak D Control test, our computer interprets and reports these test results as Rh Positive.

 

Do you get many inquirys about about discrepant results from hospitals/Dr offices that only do IS?

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No, but we do find discrepancies in the computer database that goes back to 1999.

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2 minutes ago, Dansket said:

No, but we do find discrepancies in the computer database that goes back to 1999.

I am not at all surprised at that, as reagents have improved so much in the last two decades.

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11 hours ago, Dansket said:

No, but we do find discrepancies in the computer database that goes back to 1999.

So when you find the discrepancy, do you test for weak D and if that resolves the discrepancy add a comment and move on?

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The discrepancies found (typically Type and Screen requests) are not necessarily newborns but are usually adults who were reported to be Rh Negative or Rh Positive (years ago) who currently test differently.  We will request a second independent venipuncture, test that blood sample accordingly to resolve the discrepancy, and report the results with comments as appropriate.

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we report weak D as rh pos, use a 1+ in reporting field, and add internal comment. we would have to refer samples to our ref lab that have a positive DAT with a negative D test to be eluted. sample cannot be accurately tested for weak D positive. positive weak d test results are valid only if it can be demonstrated the red cells do not have a positive DAT. a DAT may be performed on weak d  positive red cells  or a saline control tube may be incubated with the D test tube.  I am not author of our procedure, but source is AABB technical manual 19th edition weak d pages 303-307, AABB standards for blood banks and transfusion services, 31st edition 2018pg 36 and ortho clinical diagnostics direction circular-AHG and direction circular blood grouping reagent anti D

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