AABB 6.2.3.1

[R1R2]

Hi all,

 

How are addressing this standard:

 

Th record system shall ensure thte traceability of all of the following:

#8 Equipment used.

 

If you have more than one piece of the same type equipment that can be used in patient testing, for example a serofuge or incubator,  how are you tracking which one was used?

[David Saikin]

I don't think you need to track which equipment was used for each individual test.  You should be able to demonstrate that all equipment used on a particular day was in proper working order.

[kirkaw]

Our biomedical engineering department puts stickers with unique numbers, called asset tags, on all testing equipment. That's how we track ours.

[David Saikin]

Our biomedical engineering department puts stickers with unique numbers, called asset tags, on all testing equipment. That's how we track ours.

but how do you know they were used on a particular day?  I actually think there is more to this standard than I initially responded.  You should have a process dealing with the implementation/use of new equipment whether it be centrifuges, environmental storage, rotators - how to validate and studies, what happens if it goes down, etc, etc, etc until the equipement is no longer in use.

[R1R2]

This is the complete item: 

 

 

6.2.3   The record system shall make it possible to trace any unit of blood, blood component, tissue, or derivative from its source to final disposition; to review the records applying to the specific component; and to investigate adverse events manifested by the recipient.

 

 

• How does the record system make it possible to

• Trace any blood or blood component, product, or tissue from source to final disposition?

• Review the records applying to the specific component?

• Investigate adverse reactions manifested by the recipient?

• How are archived records accessed after the method/hardware used to archive them has been changed or updated?

6.2.3.1   The records system shall ensure the traceability of all of the following:

                  1)    Critical activities performed;

    2)   The individual who performed the activity;

                  3)    When the activity was performed;

                  4)    Results obtained;

                  5)    Method(s) used;

                  6)    Equipment used;

                  7)    Critical materials used; and

                  8)    The facility where the activity was performed.

 

 

• Review records (Assessor selected) and verify that the following elements are documented as applicable:

 

• Critical activities performed
• Staff performing the activity
• When the activity was performed
• Results obtained
• Methods used
• Equipment used
• Critical materials used
• Facility where the activity was performed

 

I don't think this is referring to putting biomed tags on equipment or having a list of all equipment in your department.  I think that this standard will require us to document what incubator, serofuge, pipette etc, was used for patient testing if there is more than one piece of the same equipment in use.  There is a similar requirement in a FACT checklist for cellular product processing.  I also think that this new item may go along with 5.1.3.2:

 

5.1.3.2   The validity of test results and methods and the acceptability of, products, or services provided shall be evaluated when quality control failures occur.

 

• What process for recall of products or services is undertaken when QC failures occur?  Please provide documentation to show this.

 

Perhaps I am over thinking this?

[SMILLER]

I would agree with David, above.  I think you may be overreading the use of the term "traceable".  In the FDA sense of where did a product come from, what happened to it, and where did it go, you do indeed have to have records documenting all that. 

 

But all you need for what equipment was used is to show that the centrifuge (for example) used for that particular unit or patient, was OK the day of use.  You would not need anything specific to link this to a unit or patient.

 

Scott

[R1R2]

Any AABB assessors out there?

[cthherbal]

Yes I am an AABB Assessor and I believe this is what most think it isn't. I know a reference lab and I worked in a Transfusion Service in a hospital where there were work stations and each station's equipment was ID'd with which reagent rack, heat block, cell washer, etc. being used. If you are a smaller lab and can get by with having 1 of everything in use then do that. Then when you have a problem and your backups are put into use, you have a mechanism to document this. I seem to remember this being more of an FDA thing but of all the agencies I think AABB is the most aligned with the FDA requirements.

[Eagle Eye]

I am an AABB Assessor Putting all the standards together, I agree with David, going and writing equipment for each test is overkill.

I am not an expert    

   But in my opinion you should be able to identify each equipment and be able to trace it. Eg. If your policy said that you will identify equipment by #1, #2 you should have a way to link this to an unique number(eg Serial number) and which should be unique just like donor number.

You should be able to trace it form purchase to disposal. (initial validation, routine QC & PMs, repairs, acceptability after repair etc.)

 

6.2.3.1   The records system shall ensure the traceability of all of the following:

              6)    Equipment used;

5.1.6.2  Traceability

              The blood bank or Transfusion service shall ensure that all blood, blood components, tissue, derivatives, and critical materials used in their processing, as well as laboratory samples and donor and patient records, are identified and traceable.

[SMW]

As initially noted and as stated in the Standards, the requirement IS that all the equipment, etc. can be traced to the indivdual test(s) performed using each particular piece of equipment/instrument.  The rationale is that when doing routine QC or PM and a particular instrument is found to be out of spec., the facility needs to be able to lookback at any tests that were performed using that particular instrument or piece of equipment when it may have been out of spec and evaluate the validity/invalidity of all results of testing performed using that instrument/equipment that may not have been performing as expected. As others have suggested, one way to accomplish this is to assign particular pieces of equipment, etc. to a workstation and then record which workstation was used for particular testing.  As compatibility testing is considered manufacturing, this is similar to requirements for component processing to know which particular centrifuge was used to separate a particular unit or which instruments, incubators. etc. were used to perform a particular infectious disease test.    

[David Saikin]

Having worked in large transfusion services (700+ beds), most techs had their "own" work station,i.e., they pretty much worked in a paticular space with always the same heat blockes and cell washers.  It seems excessively demanding, but not impossible, to precisely document each piece of equipment used for each test.  I was the night tech for a few years and would actually work at 2 work stations oppositve each other.  I guess you could make the work station a part of the report format in a BBIS and the reagent rack.  I too have been an AABB assessor (just retired from the I&A after 20+ years).  Has anyone contacted AABB and asked exactly what they require to satisfy this standard?  I think the way to go rather than listen to all our opinions. 

[Eagle Eye]

OK.

I got the bad news or good news......It may be overkill but I just spoke to someone at AABB.

 

The expectation is to make sure we are able to identify which equipment was used for the particular test.

 

In other words if you are large facility and have multiple incubators. Let's say the second shift noticed that the temperature was not correct (even though the QC was done by first shift and was acceptable) on particular incubator, you need to be able to identify all the tests performed using that incubator and repeat them or ensure that they were correct.

Same example was given to me.