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Unit Traceability Record


drwajiha
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Hello Everyone,

I would be much obliged if someone could share their protocol of maintaining unit traceabilty record.

I want to know how people are documenting it and the policy governing the process.

i have been working on it since two years and tried different experiments but  I have not been able to strike a simple protocol which would be easy for all technical staff (including the weak ones) to follow.

 

Thanks

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When I had my own little lab if the signed compatibility tag didn't get returned we telephoned the ward. If it still didn't arrive we sent a letter to the charge nurse/sister, if the letter didn't have a response we sent a letter to the ward manager, if that didn't have a response a letter got sent to the clinical director asking him to explain why his staff weren;t following policy...

 

In 3 years only 2 letters got send to the clinical director and we had 100% traceability. It does help having a clinical director that is on side though...

BSF_338_-_Traceability_Letter_1.doc

BSF_339_-_Traceability_Letter_2.doc

BSF_340_-_Traceability_Letter_3.doc

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I have a simple process:

 

1.  Units received are documented on the transfer form using a stamp - tech signs and dates; verifies unit integriy.

2.  Tech completes rbc retypes on the unit form with tech id and date.

3.  Final Disposition:  whether transfused, transfered or outdated documented on unit form with tech ID, date and time (and appearance when necessary).

4.  Night staff does daily/nightly inventory evaluation for appearance - documented with date and tech id.

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Echoing Dave's comment above, I'm assuming you have a paper system in place? Pre-computer, we had a 2 logbook sytem that worked well. The first was for incoming blood units, where we recorded unit data and retype results. The second was a crossmatch log where we recorded compatibility test results and issue data. After verifying transfusion as did Auntie-D, we recorded the appropriate page of the crossmatch logbook (or other disposition such as discarded, transfered etc.) next to the unit # in the blood logbook. We could then cross reference and find whatever data we needed in a few moments.

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Thanks to everyone for responding to my queries.

Dr Pepper you are absolutely right we still have paper system .

There are too many documentations in our  facility and i am to be blamed for it.

  • Step 1 component preparation section: we record the unit number in component preparation section and document the components prepared from it. If the unit is not fit to process it is also documented. This is documentation is carried out by component preparation section staff.
  • Step 2 Process of release blood products in circulation:There is another logbook which is used to record all serological tests of the donor and result of blood group confirmation. When blood components are released into circulation this process is recorded in this logbook with date and signature of two senior staff members releasing the product into circulation.any product discarded is also recorded in this logbook.
  • Step 3 cross match :We do serological cross match. The patient's data and the product used for x-match is recorded in this log book. This documentation is done and signed by the technical staff working on the immunohematology bench
  • Step 4 Issuing blood product to the clinical unit: The staff coming to collect the blood product checks all the data related to patient and blood product and record it in a separate logbook of issuing blood product to the clinical unit with  date,time and signature. 
  • Step 5 Expired / Wasted Blood products:  a separate logbook for documenting these.

 

My Problem: during one of the accreditation visits the inspector wanted to see the unit traceability record for each unit on a separate sheet assigned only for that unit. I tried to design a protocol but was not able to achieve consistency. I need help. Thanks

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  • 3 years later...

Can you (or your IT department) set up an Access data base? We've used Access for years to track final disposition of 1600-2000 units of red cells a year. When the unit comes in, you scan it into the data base and enter information such as invoice #, date ordered, date received, blood type, special attributes, expiration date, supplier information. There can be tables built into the data base so you can select blood type, attributes, etc. to speed up entry.  We can put 40 units of red cells into the data base in about 15 minutes. When the unit has been transfused, wasted, outdated, returned, transferred (in other words, final disposition), you pull up the information for that unit and enter recipient information (name, birthdate, ID #, account #, ordering provider, date transfused, status when released(emergency release? mass transfusion protocol, etc.) etc. - whatever you feel you need to include). If a patient didn't receive the product, you have fields for final disposition date (date outdated, date wasted, date returned to supplier, etc.) and you leave the patient info blank.  Again, you can have tables for drop down lists for the final disposition of the unit - Transfused, Wasted, Outdated, Transferred, etc. I also have a comment area for free text info so that I can enter details about why a unit was wasted, who the unit was transferred to, etc. That information takes about a minute or so to enter, maybe less if you type well. Testing information is not included in this record, but with the received date and the date of transfusion, it is very easy to find that information in the worklogs. We have only 2 paper logs - one for all patient and donor testing and one for unit/product checkout.

Our data base has separate files for each type of product - Red Cells, Platelets, FFP, Cryo, RhIG, Bone/Tissue, whatever you want. Once the data base is built, and someone who's good with Access can do in pretty quickly, ask for specific queries to be built so that you can pull reports for specific pieces of information. These queries can be downloaded into Excel spread sheets so you can sort data to your hearts content and build nice graphs and reports. If an inspector wants to track a unit, one of the queries allows me to pull up a page that has all the information for just that unit. With the date received and the date transfused, I can quickly find the appropriate pages in my 2 worklogs to show them the donor retest, patient testing and checkout. We were using this system when we drew autologous units and the FDA inspected us. They were always satisfied with our unit documentation. I've had no problems with CLIA, CAP or JC inspectors.

I am happy to report that we'll be retiring this system in about a year because we are getting a blood bank information system, but it's worked well for us over all the years we've used it.

 

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