PPTA Donor History Questionnaire

 

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The Full-Length PPTA Donor History Questionnaire and Abbreviated Questionnaire are designed to aid plasma sourcing organizations in evaluating a prospective donor’s history relative to current known safety risks, FDA regulations and recommendations, PPTA voluntary standards, and optionally, European requirements. The Full-Length PPTA DHQ is designed as a stand-alone questionnaire that may be used at each donation. It may also be used in conjunction with an abbreviated form for frequent donors.

The following documents are included as part of the PPTA Donor History Questionnaire:

Version 2.0 (July 2016)

The version 2.0 of the questionnaires and accompanying materials have been recognized by the FDA in a Guidance for Industry as an acceptable mechanism for collecting donor history information from Source Plasma donors. The materials are consistent with FDA's requirements and recommendations for collecting Source Plasma donor history information. 

Occasionally, PPTA (usually in consultation with AABB’s donor history task force) determines that a change to the FDA-recognized documents are needed. PPTA will post revisions, noted by the revision date, in the space below. Those documents may differ from the FDA-recognized documents if:

  • PPTA determines that the actions FDA has proposed in draft guidance are clear and important enough to warrant updating the DHQ before FDA issues the final guidance document recognizing the new PPTA DHQ version.
  • A change is made to the DHQ and/or materials related to donor eligibility issues for which FDA makes no requirement nor recommendation (e.g., history of cancer; previous organ, tissue, or bone marrow transplant and bone or skin graft).
  • The Medication Deferral List has been updated.

When a change is made, PPTA will notify membership via committee communications and the Leadership Briefing prior to posting the new version on the PPTA website.

Licensed blood establishments planning to implement a new version of the PPTA DHQ materials that has not been officially recognized by the FDA must submit a formal request to the FDA for approval. The facility should call its Consumer Safety Officer for the proper reporting category.

Documents changed since the FDA-acknowledgement of Version 2.0

1.   Medication List (Revised November 2017 - See Odomzo)

Revised April 2017 with Erivedge

2.  Ebola additions (May 2017)

Based on FDA’s Guidance for Industry: Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus, January 2017 PPTA is providing the following guidance:

Permanent addition to risk posters:

Do NOT donate if you...Ever

Temporary additions to questionnaires, flowcharts and risk posters:

To be used during periods with widespread transmission. This information applies following the CDC’s classification of one or more countries as having “widespread transmission or cases in urban areas with uncertain control measures.” The temporary additions should be added within 4 weeks of the date that CDC classifies one or more countries as having widespread transmission and should continue to be used until 4 weeks after the date CDC classifies the last affected country as a country with former widespread transmission.

Risk Posters:

Do NOT donate if you...In the last 8 weeks
  • Have lived in, or travelled to, a country with widespread Ebola virus disease or infection.
  • Have had sexual contact with a person has EVER had Ebola virus disease or infection, regardless of the length of time since recovery.
  • Have had direct exposure to the body fluids (such as blood, urine, stool, saliva, semen, vaginal fluids or vomit) of a person with Ebola virus disease or infection, including a person under investigation.
  • Have you been notified by a public health authority that you may have been exposed to a person with Ebola virus disease or infection.

PLEASE CONTACT THE CENTER, if you develop the following symptoms within the 8 week period following donation:

Fever                                                                                       Diarrhea
Severe Headache                      followed by:                   Vomiting
Muscle Pain and Weakness                                              Abdominal Pain
Fatigue                                                                                    hemorrhage (bleeding or bruising)

Full-length and Abbreviated Questionnaires and Directions for Use Flowcharts:

Until Ebola information can be incorporated into the FDA-acknowledged PPTA DHQ, the additional material intended for use during times of widespread transmission should be added at the end of the current Risk Posters, Full-length DHQ, Abbreviated DHQ and Directions for Use (flowcharts).

PPTA has worked with AABB’s Donor History Task Force in developing these additional tools. For more information, please visit AABB’s website.

**NEW!** PPTA’s DHQ Response to the COVID-19 Outbreak

These materials for optional use in plasma donor centers were developed in response to FDA’s Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak (FDA’s communication) and the 2019 novel coronavirus (COIVD-19) outbreaks identified by the CDC (Travel Health) Notices. The optional use materials provide examples of documents that align with FDA’s communication and could be used by plasma collection centers that elect to implement optional precautionary measures. These documents were developed with AABB’s Donor History Task Force and modified for use by PPTA’s Donor History Questionnaire Committee. Additional information on COVID-19 and blood and plasma donations is available on AABB’s and PPTA’s websites. 

Most importantly, during this time, plasma donations are needed more than ever.  Donors should be encouraged to donate and reassured that plasma centers employ universal precautions and general infection control on a daily basis. These precautions are taken to protect both donors and employees from contracting infections, including COVID-19. The continued health and safety of both donors and employees are a high priority as we work together to meet the needs of patients who depend on the plasma protein therapies prepared from plasma donations. Implementation of additional measures to protect the employees and donors from possible infection include deferring potential donors who may have traveled to risk areas, have been exposed to people with COVID-19 or are recovering from COVID-19 themselves.

COVID-19 additions (March 2020)

Optional Use Resources for Plasma Donor Management: 2019 Novel Coronavirus (SARS-CoV-2) and COVID-19 Infection (also noted below)

  1. Plasma donor arrives at donation center.
  2. Optional use of wall/poster signage/website messaging (ATTACHMENT 1) developed by the collection facility to inform the plasma donor of the option to self-defer.
  3. The donor is given the printed “Important Information on Plasma Donation and the 2019 Novel Coronavirus (COVID-19)” and asked to read. (ATTACHMENT 2)

    There is no requirement to implement ATTACHMENTS 1 or 2 presented here – this is intended as an example that can be easily modified. Plasma centers can elect to post signage or provide handouts when and where they deem necessary. Each center will determine which of the three criteria for deferral to use in messaging, noted below.

After reading the “Important Information” document:

Untitled 2  Donor self-defers and leaves prior to registration. 

Untitled 2  Donor does not self-defer but has questions about the risk for coronavirus exposure and/or infection.

  • If questions arise prior to donor screening, Flowcharts 1, 2, and 3 (ATTACHMENTS 3, 4 & 5) are available to assist the donor about the risk for COVID-19 and determine deferral if needed.
  • Donor center should follow current SOP regarding information shared by the donor outside of the screening process and any documentation of the conversation.
  • For the most up to date information regarding travel, refer to the CDC’s website.

Untitled 2  Donor does not self-defer and proceeds to registration.

  • If questions arise at the time of donor screening, Flowcharts 1, 2, and 3 (ATTACHMENTS 3, 4 & 5) are available to assist the donor about the risk for COVID-19 and determine if a deferral is needed.
  • Donor center should follow current SOP regarding information volunteered by the donor during the screening process and any documentation of the conversation.
  • For the most up to date information regarding travel, refer to the CDC’s website.

 

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