Preadmit Specimens with positive antibody screens

[kmmoton]

Recent question from a colleague at another facility:

What is the rationale behind having a pre-admit specimen with a positive antibody screen recollected on the date of surgery?  Especially if the patient hasn't been transfused or pregnant within the last 3 months.  Is there a standard that supports having these specimens recollected?  Does it deal with the integrity of the specimen? 

[R1R2]

_{There is no rational for that.   You can crossmatch units when you do your other pretransfusion testing.  Just make sure they have good outdates.  We crossmatch 2 more units than requested, just in case}

[tbostock]

We redraw them on the day of surgery so that we have a specimen that will be in the 3 day window (we do not extend our presurgical specimens). As long as the antibody screen is comparable to the presurgical one (within 1 grade), we do not redo the panel.

[3cardmoe]

We extend our PAT samples no more than 14 days and we don't recollect unless the date of surgey is outside that range. Per protocol we set up two units for a T&S that is positive so personally for me I find it beneficial to find out ahead of time if a patient has a positive screen to avoid any surprises and delays when the patient is on the table.

[Malcolm Needs ☆]

The only thing that I would say is that not all antibodies develop at the same speed.

Just because there was, for example, an anti-D present when the pre-admission sample was taken, does not mean that another specificity, for example, an anti-Jka, may not have developed by the time the patient comes in for the surgery.

Personally, I would want a fresh sample to test upon admission.

[OxyApos]

Ours is like someone above, if they haven't been further exposed to antigens ( trans or preg ) then the specimen is valid to use.  We only allow 10 days.  People with antibodies are the whole point of PAT in BB...to not delay surgery because of the unexpected.  The billing from one account # to another is a nightmare so there has to be some advantage for us!! 

[AMcCord]

As I understand the Joint Commission requirement, (serologic) crossmatching must be performed using a specimen less than 72 hours old. If you have to crossmatch additional units, the PAT specimen meet that requirement.

 

Having said that......we are CAP inspected. Our PATs are extended for 7 days. We crossmatch long-date units using the PAT specimen. We do recollect a specimen at admission in case we would need to crossmatch additional units. Since it's a new specimen, we would repeat testing performed on the PAT sample, but only if additional units are ordered. The patients are almost always drawn for something else ordered by anesthesia, so they aren't usually stuck just for our specimen.

[cthherbal ☆]

We have the patient answer 4 Y/N questions on a form:

1. pregnant in the last 3 months (Females)

2. transfused in the last 3 months

3. Do you have Sickle Cell Disease

4. Have you had a Bone Marrow or solid organ transplant (or are you on a list for a future transplant).

 

They answer the Qs and sign this form when the Type and Screen (TAS) is drawn and submitted to BB with the sample. We do essentially the same as HillDi and keep the same sample until 3 days post-surgery (they can be drawn up to 10 days prior to surgery for the TAS). If the answer to Q 1 or 2 is Yes, the sample is only good for 3 days from draw, (which occasionally requires a new sample day of surgery). The pre-admit nurses are good in that they will not draw a patient if it's too soon (past 10 days out) or if the patient answers Yes (they will have the patient come back within 3 days of scheduled procedure).

 

We are CAP and AABB accredited. My understanding is that if you go past the 3-day AABB sample window you must validate that your results are the same on day X as they were on the day of original testing.

[AMcCord]

I like question 3 & 4. I think I'll add them to my form.

[ChrisH]

As I understand the Joint Commission requirement, (serologic) crossmatching must be performed using a specimen less than 72 hours old. If you have to crossmatch additional units, the PAT specimen meet that requirement.

 

Having said that......we are CAP inspected. Our PATs are extended for 7 days. We crossmatch long-date units using the PAT specimen. We do recollect a specimen at admission in case we would need to crossmatch additional units. Since it's a new specimen, we would repeat testing performed on the PAT sample, but only if additional units are ordered. The patients are almost always drawn for something else ordered by anesthesia, so they aren't usually stuck just for our specimen.

 

Where is this TJC requirement?

[SMILLER]

We are JCAHO (and FDA) certified, and we do pre-admit screens up to 7 days before a procedure, then start the three-day clock at that time. 

 

I am pretty sure there is no 72 hour requirement, except for patients who have been pregnant/transfused in the last 3 mos, etc.  I am not sure what re-testing the same specimen is supposed to accomplish.  Checking specimen stability maybe?

 

Scott

[AMcCord]

Quality System Assessment for Nonwaived Testing (CAMLAB / Laboratory Services)  

 

Retention Of Blood Bank Crossmatch Samples

Updated | November 24, 2008

 

"Q: How long do crossmatch samples need to be retained by the blood bank?

 

A: Blood banks must retain samples of both the transfused unit(s) and recipient blood for at least seven days following transfusion. Further, guidelines state patient samples for antibody screening and compatibility testing are acceptable to use for a maximum of three (3) days following the date of collection, at which time a new patient sample would be necessary*. As such, a transfusion may be given up to three days after the sample's original collection date.

In order to meet the requirement to retain samples for at least seven days after transfusion, samples would need to be retained for at least 10 days after the original collection date.

*If a patient's history is known and they have definitely not been transfused or pregnant in the preceding three months, protocols can be established for frozen retention of the patient's serum for a longer period."

 

©2013 The Joint Commission, All Rights Reserved

 

 

Note: underline added by me, not JC

Edited September 9, 2013 by AMcCord

[goodchild]

Thank you for the reference McCord.

[R1R2]

Quality System Assessment for Nonwaived Testing (CAMLAB / Laboratory Services)  

 

Retention Of Blood Bank Crossmatch Samples

Updated | November 24, 2008

 

"Q: How long do crossmatch samples need to be retained by the blood bank?

 

A: Blood banks must retain samples of both the transfused unit(s) and recipient blood for at least seven days following transfusion. Further, guidelines state patient samples for antibody screening and compatibility testing are acceptable to use for a maximum of three (3) days following the date of collection, at which time a new patient sample would be necessary*. As such, a transfusion may be given up to three days after the sample's original collection date.

In order to meet the requirement to retain samples for at least seven days after transfusion, samples would need to be retained for at least 10 days after the original collection date.

*If a patient's history is known and they have definitely not been transfused or pregnant in the preceding three months, protocols can be established for frozen retention of the patient's serum for a longer period."

 

©2013 The Joint Commission, All Rights Reserved

 

 

Note: underline added by me, not JC

Very interesting.  I am glad we are not JC accredited anymore. 

[SMILLER]

Quality System Assessment for Nonwaived Testing (CAMLAB / Laboratory Services)  

 

Retention Of Blood Bank Crossmatch Samples

Updated | November 24, 2008

 

"Q: How long do crossmatch samples need to be retained by the blood bank?

 

A: Blood banks must retain samples of both the transfused unit(s) and recipient blood for at least seven days following transfusion. Further, guidelines state patient samples for antibody screening and compatibility testing are acceptable to use for a maximum of three (3) days following the date of collection, at which time a new patient sample would be necessary*. As such, a transfusion may be given up to three days after the sample's original collection date.

In order to meet the requirement to retain samples for at least seven days after transfusion, samples would need to be retained for at least 10 days after the original collection date.

*If a patient's history is known and they have definitely not been transfused or pregnant in the preceding three months, protocols can be established for frozen retention of the patient's serum for a longer period."

 

©2013 The Joint Commission, All Rights Reserved

 

 

Note: underline added by me, not JC

 Thanks for the reference!  We will have to check the standard itself, as it appears that this is a response to a question about specimen retention, not specimen acceptability regarding age and testing. The last sentence seems to refer only to how long a specimen should and can be retained. 

 

There is no quoting of the complete JCAHO standard here, so I am wondering if the sense of the actual standards may say something else about specimens collected for Pre-admit testing.

 

Scott

[SMILLER]

Also, in the AABB tech manual, 17th ed, they suggest that the length of time for valid testing of a PAT specimen should be based on the maufacturer's recommendations (for patients with no recent history of TXN or preganancy).  It does not say anything special about what to do if the AB screen is positive.

 

Stil not sure what the relavent standard is for JCAHO, CAP or the FDA for that matter.  It may be more stringent.

 

Scott

[tbostock]

Check your package inserts for reagents; most of them specify 72 hours for testing.

[SMILLER]

I just checked mine (Ortho) -- they refer you to "applicable regulating agencies' requirements"!  LOL!

 

Scott

[ChrisH]

Scott did you find the TJC standard? 

 

 Thanks for the reference!  We will have to check the standard itself, as it appears that this is a response to a question about specimen retention, not specimen acceptability regarding age and testing. The last sentence seems to refer only to how long a specimen should and can be retained. 

 

There is no quoting of the complete JCAHO standard here, so I am wondering if the sense of the actual standards may say something else about specimens collected for Pre-admit testing.

 

Scott

[ChrisH]

Malcolm, let me ask you a question here.  If your patient is a 80 year old women with anti-D for her days of having kids (30 years or more ago), no other transfusions would you still require a sample just before surgery?

 

 

The only thing that I would say is that not all antibodies develop at the same speed.

Just because there was, for example, an anti-D present when the pre-admission sample was taken, does not mean that another specificity, for example, an anti-Jka, may not have developed by the time the patient comes in for the surgery.

Personally, I would want a fresh sample to test upon admission.

[SMILLER]

Waiting to get into my director's (locked) office to check those Chris...

 

Scott

[SMILLER]

OK, current (July 1st) JCAHO standard QSA.05.09.01 reads:

 

Policies and procedures for compatibility testing include the following:
- A determination of recipient ABO Group and Rh type
- A serologic and computer (if performed) crossmatch protocol
- An antibody screening protocol
- Actions to be taken in cases of positive antibody screens and direct antiglobulin tests
- Actions to be taken in cases of incompatible crossmatches
- A time frame during which a sample may be used for crossmatching before obtaining a new sample
- A time frame not to exceed three days for recipient serum or plasma samples if the recipient has been pregnant or transfused within the previous three months or if history is unknown or unavailable. The day the sample is drawn is day zero.

 

Nothing about "72 hour" time limits for positive screens that I can see.  (In fact, by starting counting the first day as "day 0" a specimen can be OK for crossmatching almost 96 hours -- if it is drawn right after midnight!   This is the same as far as AABB goes also -- JCAHO standards often refer back to AABB and FDA for blood banking stuff.)

 

Agian, if anybody finds something more on this, I would appreciate reading the citation.

 

Scott

 

Scott

[tbostock]

There is no reg that I can find. I looked at a few of my package inserts and they are all worded a little differently.

For the Tango, for the crossmatch test: Use of samples older than 7 days should be avoided since antibody reactivity has been shown to decrease in older samples.

From the Ortho gel card insert: Antibodies dependent for their detection upon the binding of complement may not be detected, if aged serum or plasma from an anticoagulated sample is used for antibody detection tests.

From tube testing, Anti-IgG: Recommends "fresh samples" then says: Use of samples older than ten days should be avoided.

So my advice is to review all of the package inserts for all of the reagents, etc, that you use for antibody screen and crossmatching for all of your methods and see what your time limit should be based on the one with the fewest days.

[Malcolm Needs ☆]

Probably not in such a case, but, having said that, if you have one rule for one, and another for another (females/males, older than X/younger than X) it can get very confusing and introduce the potential for errors.

[Eoin]

Fresh sample for us on admission. Over the years, I have seen too many patients answer NO to the standard questions and found they have recently been transfused in another hospital "Oh, I though you meant here in this hospital." I have never run a retrospective risk assessment on it though. Might be one for when I am short of work (LOL).

Cheers

Eoin