Knowledge of food and drug administration reportable deviations

Rebecca Lam, Barbara Bryant

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

BACKGROUND: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations. STUDY DESIGN AND METHODS: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service. RESULTS: There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization. CONCLUSION: This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations.

Original languageEnglish (US)
Pages (from-to)1619-1623
Number of pages5
JournalTransfusion
Volume51
Issue number7 PART 2
DOIs
StatePublished - Jul 2011

Fingerprint

United States Food and Drug Administration
Blood Banks
Medical Laboratory Personnel
Biological Products
Quality Control
Hospitalization
Safety
Surveys and Questionnaires
Antibodies

ASJC Scopus subject areas

  • Hematology
  • Immunology
  • Immunology and Allergy

Cite this

Knowledge of food and drug administration reportable deviations. / Lam, Rebecca; Bryant, Barbara.

In: Transfusion, Vol. 51, No. 7 PART 2, 07.2011, p. 1619-1623.

Research output: Contribution to journalArticle

Lam, Rebecca ; Bryant, Barbara. / Knowledge of food and drug administration reportable deviations. In: Transfusion. 2011 ; Vol. 51, No. 7 PART 2. pp. 1619-1623.
@article{97a205357dd04e5798f21775ab659eae,
title = "Knowledge of food and drug administration reportable deviations",
abstract = "BACKGROUND: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6{\%} of hospitals reported blood product deviations. STUDY DESIGN AND METHODS: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service. RESULTS: There were 176 respondents to the survey. Only 5.7{\%} (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization. CONCLUSION: This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations.",
author = "Rebecca Lam and Barbara Bryant",
year = "2011",
month = "7",
doi = "10.1111/j.1537-2995.2011.03223.x",
language = "English (US)",
volume = "51",
pages = "1619--1623",
journal = "Transfusion",
issn = "0041-1132",
publisher = "Wiley-Blackwell",
number = "7 PART 2",

}

TY - JOUR

T1 - Knowledge of food and drug administration reportable deviations

AU - Lam, Rebecca

AU - Bryant, Barbara

PY - 2011/7

Y1 - 2011/7

N2 - BACKGROUND: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations. STUDY DESIGN AND METHODS: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service. RESULTS: There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization. CONCLUSION: This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations.

AB - BACKGROUND: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations. STUDY DESIGN AND METHODS: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service. RESULTS: There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization. CONCLUSION: This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations.

UR - http://www.scopus.com/inward/record.url?scp=79960267062&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79960267062&partnerID=8YFLogxK

U2 - 10.1111/j.1537-2995.2011.03223.x

DO - 10.1111/j.1537-2995.2011.03223.x

M3 - Article

C2 - 21736583

AN - SCOPUS:79960267062

VL - 51

SP - 1619

EP - 1623

JO - Transfusion

JF - Transfusion

SN - 0041-1132

IS - 7 PART 2

ER -