Crea
Tech Solutions
2014 News Archives
UPDATE: REVISED CDC MALARIA RECOMMENDATIONS
November 17, 2014
On October 31, 2014, the CDC updated their online 2014 Yellow Book with revised malaria travel information and recommendations for the countries of Algeria, Argentina, Costa Rica, Ecuador, Egypt, Guatemala, Mexico, and Sri Lanka.
The changes in the CDC's stated areas with malaria and chemoprophylaxis recommendations has resulted in reduced malaria-endemic areas in Argentina, Mexico, and Sri Lanka. No new areas or countries meet the definition of malaria-endemic as per the FDA's recent guidance on malaria.
On November 17, 2014, CreaTech Solutions published an update to the Malaria Risk Maps Reference Collection to incorporate the CDC's October 31st changes to online 2014 Yellow Book. Updates will be shipped automatically to subscription clients.
Non-Subscription Pricing for this update is as follows:
All Hard Copy Editions: $55.00 per book
Electronic format pricing is client-specific and will be provided individually
Update pricing and ordering information has been provided to non-subscription clients that are up to date at least through the 2013 FDA Guidance update.
Non-subscription clients that are interested in this update and have not yet obtained the 2013 FDA Guidance update are advised to contact us for composite update pricing.
GOOD NEWS: MALARIA RISK MAPS PRICING REDUCTION!
September 24, 2014
Due to a reduction in the number of maps in our collection following implementation of the FDA's Guidance on malaria, we have reviewed our pricing structure and are happy to announce a reduction in our prices. Each edition of our hard copy books have been reduced in price by $25.00 per book. Electronic version pricing has also been reduced - by 13% for Screening Editions and 18% on Reference Editions.
Our website and order form has been updated to reflect this new pricing.
Reductions in our pricing scale will also be applied to future updates and update subscriptions for all clients.
AVAILABLE NOW:
MALARIA-ENDEMIC RESIDENT EVALUATION TOOL
September 24, 2014
The FDA’s new recommendations for assessing donors for residence in malaria-endemic countries is somewhat complex, so our users group asked us to develop a tool to assist screeners in making this determination. That tool is now available for purchase.
Description of the tool:
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Overview of Content: Consists of a 2-sided flowchart. Side 1 provides step-by step instructions for determining whether a donor meets the FDA’s definition of a prior resident of a malaria-endemic country (or countries). Side 2 details the steps for evaluating whether a prior resident of a malaria-endemic country has cleared the 3-year deferral requirements and determining the appropriate deferral period of either 12 months or 3 years.
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Content Highlights: Flowchart addresses each critical decision point, includes specific references to our Malaria Risk Maps reference content, provides documentation prompts to remind screeners to capture critical information in the screening record. Color coding is incorporated to organize content and reinforce the text and symbols.
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Construction Details: The flowchart is printed on both sides of white card stock and is then heat laminated using the thickest available material. This produces a sturdy, rigid page that can be cleaned or disinfected as needed. This also provides a surface that can be repeatedly marked on and erased using either dry-erase or wet-erase (Vis-à-Vis®) markers.
PLEASE NOTE: This tool is intended as a supplement to the AABB DHQ flowchart, not as a replacement for any aspect of the AABB DHQ. This tool can also be used to supplement other donor history questionnaires. This tool is designed to be used in conjunction with our Malaria Risk Maps Reference Collection. Specific references are made to content that was introduced with the FDA Guidance update, therefore we do not recommend use of this tool until you have implemented this update.
AABB DHQ ALIGNMENT UPDATE RELEASED
August 11, 2014
This update aligns our FDA Guidance update materials with the revisions to the AABB DHQ flowcharts that were accepted by the FDA on August 1, 2014.
Non-Subscription Pricing for the AABB DHQ Alignment update is as follows:
All Hard Copy Editions: $35.00 per book
Electronic format pricing is client-specific and will be provided individually
Update pricing and ordering information has been provided to clients that are up to date at least through the 2014 Yellow Book update.
Clients that are interested in this update and have not yet obtained the 2014 Yellow Book update are advised to contact us for composite update pricing.
FDA ACCEPTS REVISIONS TO AABB DHQ FLOWCHARTS
August 1, 2014
Today the FDA published an update their “Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria” dated August 2013, to include the following:
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Recognition of revisions to certain flow charts contained in the accompanying materials for the Full-Length Donor History Questionnaire (v.1.3 dated May 2008) and Abbreviated Donor History Questionnaire (v.1.3 dated December 2012) prepared by the AABB Donor History Task Force, as acceptable for use in screening donors of blood and blood components for risk of malaria (see new section VI).
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Revised recommendations in section VII on how licensed establishments must report the implementation of the recommendations contained in the guidance to FDA.
EGYPT INTERIM UPDATE RELEASED ON JULY 18, 2014
July 21, 2014
This update is not applicable for blood banks that have implemented the FDA’s guidance on malaria in full or have implemented the definition of malaria-endemic areas contained in the guidance.
Non-Subscription Pricing for the Egypt interim update is as follows:
Hard Copy Screening Editions: $45.00 per book
Hard Copy Reference Editions: $55.00 per book
Electronic format pricing is client-specific and will be provided individually
Due to low client demand for the Oman interim update, order forms for this update will be provided on request to non-subscription clients. Contact us to request an order form or electronic format pricing.
Update materials have been sent out to all clients with 2014 update subscriptions that did not elect to OPT OUT of the Oman interim update.
AABB POSTS REVISED MALARIA FLOWCHARTS ONLINE
June 13 , 2014
AABB has updated information on their website regarding the process as well as drafts of the revised DHQ flowcharts submitted to FDA. Here is the link: http://www.aabb.org/tm/questionnaires/Pages/dhqaabb.aspx
IMPORTANT CAVEATS FROM AABB: " AABB made the flowcharts available prior to official recognition by FDA – via a guidance document – to provide enough time for facilities to prepare for the Aug. 19, 2014 implementation deadline".
"Facilities that implement use of these flowcharts prior to publication of the guidance document officially recognizing them must file a prior approval supplement, or PAS. Once the FDA publishes a guidance recognizing these flowcharts as an acceptable tool for meeting the recommendations within the 2013 malaria guidance, facilities may report use of these tools in their annual report to the FDA".
CDC ISSUES MALARIA OUTBREAK INFORMATION FOR EGYPT
June 13 , 2014
The CDC has issued malaria outbreak information for the country of Egypt.
The CDC has issued a notification regarding an outbreak of malaria in the Aswan Governorate in Egypt. Egypt was previously identified as having no malaria in the country. The CDC is not currently recommending malaria prophylaxis for travel to the outbreak area in Egypt, therefore this area does not meet the FDA’s definition of malaria-endemic areas as defined in the August 2013 guidance.
Since many of our map users are still waiting on FDA acceptance of the revisions to the AABB Uniform Donor History Questionnaire flowcharts before implementing the FDA’s guidance, the current change to Egypt appears to warrant another interim update. At this point in time the change to Egypt has been made to the CDC’s “Red Pages” and the CDC Malaria Map Application, but the change has not yet been implemented in the CDC’s online 2014 Yellow Book.
OMAN INTERIM UPDATE TO BE RELEASED ON MAY 23, 2014
May 20, 2014
This update is not applicable for blood banks that have implemented the FDA’s guidance on malaria in full or have implemented the definition of malaria-endemic areas contained in the guidance.
Non-Subscription Pricing for Oman interim update is as follows:
Hard Copy Screening Editions: $45.00 per book
Hard Copy Reference Editions: $55.00 per book
Electronic format pricing is client-specific and will be provided individually
Update pricing and ordering information has been provided to clients that are up to date at least through the 2014 Yellow Book update.
Clients that are interested in the Oman interim update and have not yet obtained the 2014 Yellow Book update are advised to contact us for composite update pricing.
Clients with 2014 update subscriptions may OPT OUT of this update. Subscription clients that elect to opt out will receive a credit toward their 2015 update subscription.
CDC ISSUES UPDATED MALARIA INFORMATION FOR OMAN
May 1, 2014
The CDC has issued updated malaria information for the country of Oman.
Oman was previously identified as having no malaria in the country. The CDC is not currently recommending malaria prophylaxis for the areas now identified with malaria in Oman, therefore these areas do not meet the FDA’s definition of malaria-endemic areas as defined in the August 2013 guidance.
Since many of our map users are still waiting on FDA acceptance of the revisions to the AABB Uniform Donor History Questionnaire flowcharts before implementing the FDA’s guidance, an interim update will be issued for Oman to accommodate screening programs that have not yet adopted the FDA's clarified definition of malaria-endemic areas.
2014 UPDATE SUBSCRIPTION PRICING RELEASED
February 14, 2014
Update pricing for the 2014 subscription year has been determined.
Hard Copy Update Subscriptions (per book):
Screening Editions (all versions): $90.00
Reference Editions (all versions): $115.00
This pricing applies to the 12 month period from April 1, 2014 through March 31, 2015.
Update subscription pricing for electronic version clients will be provided individually based on each client’s reported 2013 annual collections. If you are an electronic version user, please ensure that your annual reporting form has been completed and submitted.
Clients with existing subscriptions do not need to have a new contract signed.
Clients that wish to obtain update subscriptions for the first time, please contact us for information.