The Paul-Ehrlich-Institut has made fully accessible versions of the sample donor questionnaires available since 16 December 2024, in order to support blind and visually impaired persons in establishing their eligibility for blood and plasma donation. These documents are subject to the requirements for accessibility laid out in the Equal Opportunities for People with Disabilities Act (Behindertengleichstellungsgesetz) and the Barrier-Free Information Technology Regulation (Barrierefreie-Informationstechnik-Verordnung, BITV) 2.0.

 The content or language used in the questions themselves has not changed.

 Some key adjustments include:

• The questionnaires now have a table of contents.
• The headings for each question set are above the tables.
• Each question within a question set is placed in its own row. The question numbers from the original donor questionnaire were carried over in this process.
• Colour-coded notes on completing the donor questionnaire have been replaced by numbered notes throughout the document.

Due to the revision of the guideline hemotherapy published on 4 September 2023, which was developed including the amendments to the Transfusion Act (§§ 12a and 18) of March 2023, there are adjustments in the requirements for persons willing to donate, in particular to the deferral criteria after exposure to the risk of acquiring a transmissible infection.

The evaluation of a risk due to sexual behavior that leads to a deferral from donation must now be based on the respective individual sexual behavior of the person willing to donate. The sexual orientation and gender identity of the person willing to donate or his or her sexual partners, as well as transsexuality, are not taken into account when assessing the risk leading to deferral from donation. This approach is intended to help prevent discrimination in donor selection.

To reflect these changes, an adaptation of the uniform blood and plasma donor questionnaire is required in question 16 (standard version) and question 13 (short version), respectively. In addition, editorial changes have been made to further improve the readability and comprehensibility of the questions.

Due to the circumscribed update of the guideline hemotherapy adopted on 16 September 2021 - based on the consultation result of the joint working group "Blood donation of persons with sexual risk behavior" - there are changes in the requirements for donors, in particular regarding the deferral criteria after exposure to the risk of acquiring a transmissible infection. To reflect these changes, it was necessary to adapt question 16 (standard version) and question 13 (short version) in the uniform blood and plasma donor questionnaire.

In addition, some editorial changes were made to improve the readability and thus the comprehensibility of the questions, and attention was paid to gender-appropriate wording.

In order to use the uniform blood and plasma donor questionnaire (standard and short version) as an online version, the responsible working group has made the necessary changes to the wording. This should enable the donor to fill out the donor questionnaire before the donation and away from the donation facility with the help of an electronic tool (donor app, web browser, etc.), e.g. to avoid waiting times on the donation dates.

The time-critical questions 1, 7 and 25 (or 1, 6 and 19 in the short version) were affected by this adjustment. The changes prevent important information required for assessing donor suitability from being lost or not taken into account when answering the questions "online" before the donation date. (Note: The procedure for "online" use of the donor questionnaire should be coordinated with the regional competent authority and must be notified to the Paul-Ehrlich-Institut.

In 2019, multiple cases of a West Nile virus (WNV) infection acquired within Germany emerged. Presumably, the virus will be endemic all over Germany within the next years. Therefore, from 1st of June 2020 onwards, the Paul-Ehrlich-Institut will issue an obligation to test certain blood, plasma and stem cell donations for West Nile Virus. Alternatively, individuals who spent at least two consecutive days in a region within Germany affected by WNV can be temporarily excluded from donating.

Blood establishments, which want to take advantage of this option, are obliged to use the supplement WNV, which contains the additional question about stays and a German map, which highlights affected regions ("Landkreise" and "kreisfreie Städte"). The current map is available to the blood establishments in the protected area ‘Donor reserve database’.

Further Information

Donor reserve database - current map of Germany with districts and cities affected by WNV (German only)

At the request of many donor centres, the working party "Uniform questionnaire for donating blood and plasma" has prepared a short version of the questionnaire, in addition to the standard version, which can be used for persons donating blood frequently. The idea behind this is to increase the acceptance of the questionnaire, and thus the preparedness to donate blood, by markedly reducing the number of questions.

The short version of the uniform questionnaire may be used instead of the standard version only in the following cases:

• The person willing to donate blood has already provided two donations or eligibility checks within two years using the standard version of the uniform questionnaire,
• the last donation was provided not more than 200 days ago, and
• the standard version was used again, once each time if the last use of the questionnaire was more than two years ago. After that, the short version of the uniform questionnaire can be used again for a follow-up period of two years, if the intervals between the donations do not exceed a period of 200 days.

Due to new requirements laid down in the overall amendment of the guideline for the collection of blood and blood components and the application of blood products (haemotherapy guideline) from 2017, the uniform blood donor questionnaire introduced since 2015 has been revised.

The update

• considers the modified donor selection criteria of the amended haemotherapy guideline,
• lays down deadlines that take into account current knowledge on the retention time of drugs toxic to human reproduction in donor plasma,
• is better understood thanks to linguistic and formal changes and
• ensures that the questionnaire can be used without restriction by institutions that only produce plasma for fractionation.

The blood and plasma donor questionnaire is part of the marketing authorisation documents. Blood donation institutions that have already indicated the use of the current standard blood and plasma donor questionnaire can use the respective current version without submitting a new variation notification. Blood donation institutions that use the single blood and plasma donor questionnaire for the first time will indicate this in relation to their medicines or the donation master file with a declaration that they will track any future changes and implement them within a reasonable time.

The development of the questionnaire began in 2004. Until its completion, it was up to each blood donation facility to translate the donor selection criteria from the haemotherapy guideline into appropriate questions to be included in the donor questionnaire. The correct implementation was checked for the marketing authorisations of each individual institution.

The effectiveness of a questionnaire for the detection of unsuited donors can only be checked under conditions in the day-to-day practice. For this purpose, a new uniform questionnaire was developed in a subgroup of the AK Blut (Working Party ‘Blood’; version 1), which takes into account findings gained in the field of sociology for the questionnaire design as well as the specific needs of the donor situation and the situation in the donation institutions. In a multicenter study (2006-2007), this questionnaire was successfully tested on several thousand new donors. As a result, donor acceptance and suitability for the daily practice were very high. In addition, acute illnesses and risk donors were detected significantly better than with the usual questionnaires.

In its Opinion No. 41 on 07 June 2010 The Arbeitskreis Blut (Working Party ‘Blood’) recommended that a nationwide donor questionnaire be introduced.

However, experts expressed their fear that the directly addressing sexual risk behavior as newly introduced in the version of the multicenter study could lead to unacceptably high donor losses.

For this reason, in a follow-up field study (2011-2012), data on donor provisions were collected as part of the routine blood bank operation to assess the suitability of the questionnaire regarding its effects on the blood supply prior to mandatory use. The result of this follow-up field study was a questionnaire (Version 2) revised in some points compared to the version of the Multicenter study, which was developed by the Working Party Blood with representatives of the German Society for Transfusion Medicine and Immune Hematology and the Association of German Transfusion Medicine.

This resulted in the updated Single Blood and Plasma Donor Questionnaire, which takes into account the amended requirements of the amended haemotherapy guideline for donor selection, new findings on the half-life and thus deferral periods for medicinal products. This questionnaire can also be used without restriction for the exclusive extraction of plasma for fractionation.

This update has been developed by a working group of representatives of blood and plasma donation agencies and the Robert Koch-Institut under the auspices of the Paul-Ehrlich-Institut.

The questions of the unified blood and plasma donor questionnaire cover the donor selection criteria set out in the haemotherapy guideline. They are grouped by topic. Donors will be able to derive information on why these questions are asked, simply by reading the headings.

According to the haemotherapy guidelne, the health status and relevant pre-existing conditions of the donor must be determined before each donation by means of a questionnaire and a personal survey. This may contribute to the identification and permanent exclusion or temporary deferral of persons whose donation may pose a health risk to themselves or a risk of disease transmission to others.

The use of a standard sample questionnaire provided by the Paul-Ehrlich-Institut is recommended in the amended Haemotherapyguideline.

Deferral Periods Changed After the Use of Reproduction Toxic Medicines Three Years Instead of Permanent Exclusion from the Donation (Question 26 Standard Version)

According to the BfarM (Bundesinstitut für Arzneimittel und Medizinprodukte, Federal Institute for Drugs and Medical Devices), the retinoids Isotretinoin and Alitretinoin (e.g. Akennormin, Toctino) for the treatment of serious forms of acne and hand eczema have half-lives which would permit a blood donation already one month after the administration of the product has been discontinued. Solely for products with the active ingredient Acitretin, the use of which includes the treatment of serious disorders of keratinisation or psoriasis (e.g. Neotigason), and which, due to their potential formation of etretinate can have a relatively long half-life of 120 days, a deferral from a donation of three years is considered as required. The marketing authorisation for Tigason (etretinate) expired more than 20 years ago.

As we can never assume that all donors can remember exactly which product they took, and when they took it, the question above refers to the treatment, and, to ensure the safety of the blood donations, the longest deferral period of three years was chosen.

Deferral Periods Changed After the Use of Growth Hormones before 1996 Instead of before 1986 (Question 29 Standard Version)

In the mid-1980s there was some evidence of possible prion-mediated diseases after the use of human Somatotropin. According to the BfArM as the competent regulatory authority, however, there is no official information when this product was last used in Germany or in other countries. In 1985, manufacturers of the human products had to include a warning into the package leaflet. In the same year, they discontinued the sale of this product entirely and renounced the marketing authorisation in 1989. In spite of this, the product was still marketable from the pharmaceutical law point of view until 1992. In the mid-1980s there was some evidence of possible prion-mediated diseases after the use of human Somatotropin. According to the BfArM as the competent regulatory authority, however, there is no official information when this product was last used in Germany or in other countries. In 1985, manufacturers of the human products had to include a warning into the package leaflet. In the same year, they discontinued the sale of this product entirely and renounced the marketing authorisation in 1989. In spite of this, the product was still marketable from the pharmaceutical law point of view until 1992.

Although, two products manufactured by genetic engineering have been available since 1986, there is no official information on which countries have already access to these products, either.

The new wording of the questionnaire both takes into account the unclear data situation in Germany and includes persons willing to donate blood who, during the period in question, possibly received treatment with grow factors of human origin.

This information was previously not available to this extent so that the changed deferral periods regarding treatment with growth factors could only now be in included into the new version of the questionnaire.