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Answering your questions.

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?

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A 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 record-keeping tailored to its individual needs. Each regulatory agency, however, would like to sec 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 ease be dated to avoid confusion. In principle, it is not advisable to leave the blanks on the forms for the purpose of record-keeping. 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 dale 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

(1.) American Association of Blood Banks; Standards Program Committee. Standards for Blood Banks and Transfusion Services. 24th ed. Bethesda, MD: AABB;2006:68-33.

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 tips@mlo-online.com.

MLO's "Tips from the Clinical Experts" provides practical, up-to-date solutions to readers' technical and clinical issues from a panel of experts in various fields. Readers may send questions to Brad S. Karon, MD, PhD, by e-mail at tips@mlo-online.com.

Edited by Brad S. Karon, MD, PhD
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Title Annotation:Tips from the clinical experts
Author:Karon, Brad S.
Publication:Medical Laboratory Observer
Article Type:Column
Geographic Code:1USA
Date:Apr 1, 2010
Words:889
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