Guidance for Industry 

 
 
Recommendations for Blood 

Establishments:  Training of Back-Up 

Personnel, Assessment of Blood Donor 

Suitability and Reporting Certain 

Changes to an Approved Application 

 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the 
Internet at  
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida 
nces/default.htm. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers listed above. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
November 2010  Contains Nonbinding Recommendations 

 
 
Table of Contents 

 
I.   INTRODUCTION............................................................................................................. 2 
 
II.   BACKGROUND ............................................................................................................... 2 
 
III.   RECOMMENDATIONS.................................................................................................. 3 
 
A.   Training of Back-Up Personnel ........................................................................... 3
  
B.   Blood Donor Suitability........................................................................................ 3
  
C.   Changes to an Approved Application ................................................................. 4 
 
IV.   IMPLEMENTATION ...................................................................................................... 5
  
V.   REFERENCES.................................................................................................................. 5 
 
 
i  Contains Nonbinding Recommendations 
 
 
Guidance for Industry 

 
Recommendations for Blood Establishments: 

Training of Back-Up Personnel, Assessment of Blood Donor 
 
Suitability and Reporting Certain Changes to an Approved 

Application 

 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic. It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public. You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, 
call the appropriate number listed on the title page of this guidance. 
 
 
I.   INTRODUCTION 
 
In November 2009, we, FDA, issued a draft guidance entitled Recommendations for the 
Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood 
Supply in Response to Pandemic (H1N1) 2009 Virus, dated November 2009 (Pandemic 
(H1N1) 2009 Virus Draft Guidance) (November 19, 2009, 74 FR 59982).  This guidance 
finalizes that draft guidance. Note that while the recommendations that FDA is finalizing were 
proposed in the Pandemic (H1N1) 2009 Virus Draft Guidance, the finalized recommendations 
are applicable regardless of the existence of a pandemic or other emergency situation.   
 
This guidance is intended for establishments that manufacture Whole Blood and blood 
components intended for use in transfusion and for further manufacture, including recovered 
plasma, Source Plasma, and Source Leukocytes.  Within this document, you refers to blood 
establishments; we refers to FDA. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDAs guidance means that something is suggested or 
recommended, but not required. 
 
 
II.   BACKGROUND 
 
As discussed above, the Pandemic (H1N1) 2009 Virus Draft Guidance was issued in November 
2009. At that time, we anticipated that the rapid spread of pandemic (H1N1) 2009 virus had the 
potential to cause disruptions in the blood supply.  In addition, at that time, there was limited 
2 
 Contains Nonbinding Recommendations 
 
 
information available on pandemic (H1N1) 2009 virus viremia and the potential for transmission 
of the virus through blood transfusion.  Furthermore, as explained in the Pandemic (H1N1) 2009 
Virus Draft Guidance, it was anticipated that the usual practices for ensuring blood availability in 
response to local disasters (i.e., hurricanes) would not be applicable or sufficient under a severe 
pandemic scenario.   
 
Since we issued the Pandemic (H1N1) 2009 Virus Draft Guidance, the H1N1 influenza 
pandemic has waned in the United States and disruptions in the blood supply have not been 
observed. The April 26, 2009 declaration of a public health emergency by the Department of 
Health and Human Services in response to H1N1 influenza expired on June 23, 2010.1   
Therefore, we are not finalizing those recommendations set forth in the draft guidance that 
referred to blood donor deferral and blood product management specific to the pandemic (H1N1) 
2009 virus. 
 
Instead, in this document, we are finalizing those recommendations contained in the Pandemic 
(H1N1) 2009 Virus Draft Guidance that are of general applicability (i.e., regardless of the 
existence of a pandemic or other emergency situation) as to training of back-up personnel, 
assessing blood donor suitability and reporting certain changes to an approved application for 
licensed blood establishments under Section 601.12 of Title 21, Code of Federal Regulations (21 
CFR 601.12). 
 
 
III.   RECOMMENDATIONS 
 
A.   Training of Back-Up Personnel 
 
Under 21 CFR 211.25 and 21 CFR 606.20, personnel performing critical functions in  
blood establishments must be adequate in number, educational background, training and 
experience, including professional training as necessary, or combination thereof, to 
assure competent performance of their assigned functions.  We recommend that you have 
adequate back-up personnel in the event of personnel shortages which could occur during 
incidents such as influenza pandemics, local natural disasters or as a result of 
bioterrorism. To assure continued operations, we further recommend that you train more 
than one back-up person for each critical function where appropriate.  Any such back-up 
personnel should be trained pursuant to your existing training program.  We also 
recommend that as provided in your training program, you document this training and/or 
re-training. 
 
B.   Blood Donor Suitability  
 
In general, a donors medical history is obtained at the time of blood collection.  
However, under 21 CFR 640.3(a) and 21 CFR 640.63(a), the suitability of a donor as a 
source of Whole Blood or Source Plasma, must be made on the day of collection from the 
donor. These regulations do not explicitly define the term  day of collection. 
                                                 
1  http://www.flu.gov/news/h1n1pheexpiration.html, accessed November 16, 2010. 
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 Contains Nonbinding Recommendations 
 
 
Occasionally, a donors responses to the donor questions presented before collection are 
found to be incomplete upon review by the blood establishment.  In such instances, you 
may clarify a donors response to the donor history questionnaire or obtain omitted 
responses to questions within 24 hours of the time of collection. 
 
Licensed blood establishments that currently have approved standard operating 
procedures (SOPs) for clarifying or obtaining a donors response to the donor history 
questionnaire after the donor has left the collection establishment do not have to report 
this change to FDA under 21 CFR 601.12.  However, if you are a licensed blood 
establishment that lacks such SOPs, and you now wish to implement such procedures, 
you must submit a supplement and receive our approval before making this change in 
accordance with 21 CFR 601.12(b) (See FDAs Guidance for Industry:  Changes to an 
Approved Application: Biological Products:  Human Blood and Blood Components 
Intended for Transfusion or for Further Manufacture, (July 2001) (July 2001 
Guidance), section III.A.2, (Ref. 1)). 
 
C.   Changes to an Approved Application   
 
As provided under 21 CFR 601.12(c)(5), we have determined that the following changes 
to an approved application for licensed blood establishments may be submitted as a 
Supplement-Changes Being Effected (CBE). 
 
	   Use of a different outside test lab, provided the test lab is registered with FDA and 
has been performing donor testing.2       
 	  Implementation of a written or audio/visual presentation of a self-administered, pre-
donation donor history questionnaire with respect to the high-risk behavior questions, 
provided you are using your currently approved questionnaire and you follow the 
critical control points described in FDAs Guidance for Industry:  Streamlining the 
Donor Interview Process: Recommendations for Self-Administered Questionnaires 
(July 2003) (July 2003 Guidance)(Ref. 2)), and the submission contains the content 
recommended for these self-administered procedures as outlined in the July 2003 
Guidance.3  Note that if you change your donor interview process to include a self-
administered, computer-assisted interactive interview procedure with respect to the 
high-risk behavior questions, as described in section IV of the July 2003 Guidance, 
you must report this change to us as a Supplement-Changes Being Effected in 30 
Days (CBE-30) under 21 CFR 601.12(c), as recommended in the July 2003 
Guidance. 4     
 
                                                 
2 Note that the temporary use of a previously approved alternate or  back-up contractor to  perform a manufacturing 

step should continue to  be described in an annual  report.   See section VI.C.2 in Ref.  1. 

3 As discussed in section II of the July 2003 Guidance, in an  audio/visual presentation, the donor reviews the 

questions by listening to a recording or watching a video and documents the answers on a printed questionnaire. 

4 As discussed in section II of the July 2003 Guidance, in a computer-assisted interactive interview, the donor 

reviews the questions on a computer screen  and enters the  answers electronically.   

 
4 
 Contains Nonbinding Recommendations 
 
 
Note that the recommendations set forth above supersede the recommendations set forth 
in FDAs July 2001 Guidance at section IV.C.1 and the July 2003 Guidance at section 
IV.A, respectively (in both of these guidances, we previously had determined that these 
changes would require a CBE-30). 
 
 
 
IV.   IMPLEMENTATION 
 
This guidance is for immediate implementation  
 
 
V.   REFERENCES 
 
1. Guidance for Industry: Changes to an Approved Application:  Biological Products:  Human 
Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001). 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida 
nces/Blood/ucm076729.htm, accessed November 16, 2010. 
 
2.  Guidance for Industry: Streamlining the Donor Interview Process:  Recommendations for 
Self-Administered Questionnaires (July 2003). 
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInform 
ation/Guidances/Blood/ucm062910.pdf, accessed November 16, 2010. 
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