Blood-bank recordkeeping
Q I work in a small hospital laboratory in which the
blood-bank supervisor requires us not
to fill out the blood-bank
transfusion log completely. We use a standard Ortho Clinical Diagnostic
transfusion log. If a type and screen (T&S) and two units are ordered on
a patient, we write the patient's name and medical record number; in the
donor column, we put the blood-bank ID number and T&S. On the next line
of the log, we leave the name column blank then place the unit number in
the donor column. This line contains the compatibility testing. The date
column is filled out once per day and left blank for subsequent entries.
Must all columns on a line be filled in? Is there a regulation requiring
the transfusion log to be completed in a certain manner?
The Standard for Blood Banks and Transfusion Services
has described the essentials of recordkeeping requirements in detail.
Following are the some of the important standards which pertain directly
to the question:1
- Standard 6.2.1: Records shall be complete,
retrievable in a time appropriate to the circumstances, and
protected from accidental or unauthorized destruction or
modification. - Standard 6.2.3: The record system shall
make it possible to trace any unit of 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. - Standard 6.2.4: The actual results of each
test observed shall be recorded immediately, and the final
interpretation shall be recorded upon completion of testing.
Regulatory agencies do not describe a standard form
or format for recording transfusion information, so each facility has
the freedom to design forms or a system for manual or computer
recordkeeping tailored to its individual needs. Each regulatory agency,
however, would like to see that the records are complete, indelible,
legible, and made concurrently with the performance of test or activity.
Also, these records must be able to answer for each significant step in
the process: Who? What? When? Where? Why? How?
The standard Ortho Clinical Diagnostic transfusion
log is a commercially designed, large multicolumn and multi-row log that
includes major columns with subdivisions for the date, patient
identification, donor identification, blood type and screen, antibody
identification, direct antiglobulin test, compatibility testing,
component issuance and disposal and with a column for the technologist
involved in testing, as well as a column for additional information.
This form is designed to manually record most of the essential functions
of the transfusion services as required by the regulatory agencies, but
it is not tailored for every individual institution's requirements.
Thus, in every case, all the columns or rows may not be required to be
filled in and may be left blank (e.g., when only T&S is ordered with
screen results being negative for presence of antibodies, there will not
be a need to fill the columns for antibody identification, direct
antiglobulin test, and compatibility test). As long as complete
information is recorded for each case, blank spaces may not be
questioned by an inspector or reviewer if clearly defined and understood
in the policy that blanks mean either test “not ordered” or “not
performed.”
As long as a new form is used every day, recording the
date once a day also may not raise an objection if so defined by the policy.
If the same form is used for multiple days or a date range, then it is
strongly advised that each case be dated to avoid confusion. In principle,
it is not advisable to leave the blanks on the forms for the purpose of
recordkeeping. These records are important to the traceability of the blood
component from donor to recipient for the purpose of recall, errors, adverse
reactions, look backs, and manufacturing defects, so it is a good idea to
record the date for each case or event.
The following solutions can help:
- Create a form tailored to the facility's specific
needs. - If a commercial form is used, clearly define in the
SOP how the form will be completed and if blank spaces are permitted. - Make a policy to fill the blanks with a line or “NA”
comment as appropriate to avoid confusion. - The method of recording the date should be defined in
the policy.
—Krishna Oza, MD
Hematopathology
US LABS
Brentwood, TN
Reference
- American Association of Blood Banks; Standards
Program Committee. Standards for Blood Banks and Transfusion Services.
24th ed. Bethesda, MD: AABB;2006:68-83.
Despite the exceptional value that clinical laboratories provide (producing much of the objective information necessary to diagnose and treat patients with very little relative resource required), labs will continue to come under pressure to do more with less. I am happy to learn that so many of our labs are up to the challenge.
—Brad S. Karon, MD, PhD,
Assistant Professor
Laboratory Medicine and Pathology,
Director of Hospital Clinical
Laboratories,
point-of-care testing,
and phlebotomy services
Mayo Clinic,
Rochester, MN
Contact him at [email protected].
