A colleague in North America reports that her laboratory uses the ImmucorGamma® Galileo for routine blood bank testing, but that they also perform occasional manual tube testing using 10x75 mm test tubes. Currently, each patient's blood specimen is labeled at the time of phlebotomy with the patient's first and last name, unique personal health identification number and an accession number. However, when performing manual tube testing, a small sample of the patient's plasma is transferred into 10x75 mm test tubes, which are labeled with a sequential number (i.e. 1,2,3) that is not unique to the patient specimen. The inquiring colleague wonders how other laboratories that are AABB accredited label 10x75 mm test tubes used in manual testing. She asks because her laboratory is preparing to apply for AABB accreditation. As part of their preparation they engaged an independent assessor to perform a mock audit. In this audit they were cited for not adhering to Standard 5.1.6.2 Traceability, which states: "The blood bank or transfusion service shall ensure that all 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". As a follow-up to the mock audit the inquiring colleague is gathering information on the practices used by other labs because it is hard to convince her staff to change a practice that has been done for many, many years without objective evidence.

The following comments have been received.

1. A physician at an academic medical center in New Hampshire reports that in his experience there are many variations of practice in labeling test tubes used in manual blood bank testing, but it is common practice (and a good idea!) to label these tubes with a patient identifier - such as a unique abbreviation of the patient's surname - in order to positively identify the tubes. In addition, his laboratory's SOPs stipulate that a technologist can only work on one patient's sample at a time, in order to minimize the possibility of a mixup from having more than one patient's sample in a rack at one time.

ADDENDA Dec. 8, 2006

2. Dr. Breanndan Moore (attribution used with permission) reports that at the Mayo Clinic in Minnesota, when they have to use a manual 'tube' method (such as PEG), they link each tube used in the test to the corresponding patient by labeling 12x75 mm tubes with TWO patient identifiers; a) Mayo Clinic number and b) Tech initials.

3. A transfusion medicine physician in Vermont reports that at his academic center when removing the plasma or serum and placing it into a separate tube, this new tube is labelled with the medical record number, complete name, date of collection, and unique accession number. However, he acknowledges variability of practice in his laboratory when it comes to the labelling of the test tubes actually used for testing and reading of results. A recent direct observation performed demonstrated compliance with traceability but with substantial variation. Some individuals used unique patient initials, others used accession numbers, one particular person uses color coding to mark and identify which patients he is testing in addition to initials and records his results in the corresponding color to limit the possibility of mixups.

ADDENDA Dec. 16, 2006

4. A Coordinator of Education and Quality Assurance at an academic medical center in Virginia reports that when her transfusion service laboratory receives a pre-transfusion specimen, it is accessioned into the computer with the date/time of receipt entered. The computer generates a bar-coded "accession label" which contains the patient's full name, medical record number, patient location, age, gender, accession number, date/time sample received, and test requested. This bar-coded label is placed on the paperwork, an empty 16 x 100mm "plasma tube" and also on the original patient specimen tube. The specimen is then centrifuged, and the plasma separated into the corresponding labeled 16 x 100mm tube.

For each individual test performed, the tech labels each 10 x 75 mm tube using the last TWO digits of the patient's accession number (or the last THREE digits if there is another specimen in the "batch" containing the same last two digits (Example: F12345 and F31945) -- followed by a code for the specific test being run.

As an example:

For the ABO Cell Typing: tubes would be labeled as 345-@A and 345-@B
For the ABO Serum Typing: tubes would be labeled as 345-A1 and 345-B
For the Rh Typing: tube is labeled as 345-D, (and if a control is needed, then it is labeled as 345-C)
For the antibody screen: tubes would be labeled as 345-I and 345-II.

For crossmatches: they label using the last 2 (or 3) digits of the patient's accession #, followed by a -1, -2, -3 (for each unit to be crossmatched). The donor unit #'s are listed on our computer screen in the same order the "segment tubes" are placed in the "crossmatch" rack.

Each of their SOPs list the appropriate and unique labeling codes for each tube used in that procedure. There is no duplication. Each test tube is always labeled with the last 2 (or 3) digits of the patient's accession number (and the patient specimen/plasma tube also contain the accession number label).

5. A medical technologist in Indianapolis, IN reports that in his laboratory if a tube used for testing lacked unique identification that permitted traceability back to the patient, the tube would be immediately discarded as improperly labeled, whether in the Blood Bank or in any other section of the lab. He asks us to imagine asking a Clinical Chemist to perform add-on testing to a tube that had no patient information on it other than "#2".

ADDENDA Dec. 26, 2006

5. A technologist who "worked the bench in the old days when everything was manual" reports that she performed the following procedure when testing samples in batches of 6-12. "When actually setting up the ABO Rh typing in test tubes, I would label my testing tubes with patient initials or assign a number that I would write on my worksheet, write on the specimen and write on all typing tubes with permanent marker such as a Sharpie®. For example, my typing tubes for patient Tom Smith would be labeled 1 on Tom Smith’s specimen, 1 on the worksheet, then my tubes are labeled 1A, 1B, 1D, for front type and for back type 1a,1b, 1SCI & 1SCII. Once my testing is completed and results are verified I throw all the typing tubes out. The 1 traces the identity from testing tubes back to the specimen. The important steps are to verify all samples and results with a linked identifier before discard."

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