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BLOOD DONOR & TISSUE DONOR EDITIONS NOW AVAILABLE

April 13, 2020

Due to recent changes in the FDA’s vCJD screening recommendations for blood donors that do not yet apply to HCT/P donors, The Donor Screening GEO Guide has been adapted into new Blood Donor and Tissue Donor Editions with reference maps and lists that correspond with the differences in donor screening recommendations between blood and tissue donors.

 

As part of this change, Zika information has been removed from the Blood Donor editions and a Zika content section added to the Tissue Donor editions.

 

The Blood Donor and Tissue Donor Editions are both available in either the Screening Essentials Edition or the Enhanced Reference Edition. 

 

CAUTION TO PROGRAMS THAT SCREEN HCT/P DONORS: The Blood Donor edition should not be used to screen HCT/P donors due to recent changes in vCJD donor screening recommendations from FDA.      

UPDATE ISSUED FOR BLOOD DONOR SCREENING CHANGES

April 13, 2020

The Donor Screening GEO Guide update for the FDA’s revised donor screening recommendations has been completed and issued. Hard copy updates and digital file discs have been shipped to all subscription clients. Update files have also been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved digital version users.

 

IMPORTANT: Implementation of this update involves changes to the blood donor screening process that impact the donor history questionnaire and related processes and procedures. These changes are subject to reporting of changes to the FDA.

 

CAUTION TO PROGRAMS THAT SCREEN HCT/P DONORS: This update involves the creation of distinct Blood Donor and Tissue Donor editions of the GEO Guide (see new item above). The Blood Donor edition should not be used to screen HCT/P donors.     

FDA ISSUES REVISED BLOOD GUIDANCES FOR HIV, MALARIA & vCJD DONOR SCREENING

April 3, 2020

The FDA has published updated guidance for the blood industry reflecting revised donor eligibility recommendations for HIV and Malaria, and has finalized its draft guidance on CJD, and vCJD. The FDA blood guidance documents can be found here.

 

Implementation of these recommendations will warrant changes to blood programs' donor questionnaire and related SOPs, The AABB has already submitted revised Donor History Questionnaire and related documents to the FDA for review.

The Donor Screening GEO Guide will be updated to reflect the revised recommendations for vCJD risk and to reference the revised blood guidance documents for HIV and Malaria donor screening. The target release date for this update is April 8, 2020.

UPDATE ISSUED FOR COVID-19 WORLDWIDE

March 27, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify all countries worldwide with COVID-19 risk, in accordance with the CDC’s Level 3 Travel Notice for the Global COVID-19 Pandemic issued on March 27, 2020. The global notice supersedes all COVID-19 Travel Notices previously issued for specific regions or individual countries.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

PLEASE NOTE: The state where CreaTech Solutions is located is currently under a mandatory “Stay at home” order. As a result, requests for shipped updates may be subject to delays. Users of the COVID-19 updates are encouraged to obtain these updates by downloading the files from our ShareFile site (and printing the update pages if applicable). Hard copy subscribers have been granted permission to download and print the COVID-19 update files  (documented on the Update Notice).

UPDATE ISSUED FOR COVID-19 IN ARGENTINA & PANAMA

March 26, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify Argentina and Panama as countries with COVID-19 risk, in accordance with the CDC’s Level 3 Travel Notices for COVID-19 in Argentina and Panama issued on March 26, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

PLEASE NOTE: The state of Indiana where CreaTech Solutions is located is currently under a mandatory “Stay at home” order. As a result, requests for shipped printed or digital (provided on CD) updates may be subject to delay. Users of the COVID-19 updates are encouraged to obtain these updates by downloading the files from our ShareFile site (and printing the update pages if applicable). Hard copy subscribers have been granted permission to download and print the COVID-19 update files  (documented on the Update Notice).

UPDATE ISSUED FOR COVID-19 IN RUSSIA

March 25, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify Russia as a country with COVID-19 risk, in accordance with the CDC’s Level 3 Travel Notice for COVID-19 in Russia issued on March 25, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

PLEASE NOTE: The state of Indiana where CreaTech Solutions is located is currently under a mandatory “Stay at home” order. As a result, requests for shipped printed or digital (provided on CD) updates may be subject to delay. Users of the COVID-19 updates are encouraged to obtain these updates by downloading the files from our ShareFile site (and printing the update pages if applicable). Hard copy subscribers have been granted permission to download and print the COVID-19 update files  (documented on the Update Notice).

COVID-19 CASE CURVES FOR U.S. STATES & CANADIAN PROVINCES PROVIDED FOR PUBLIC USE
March 24, 2020

CreaTech Solutions has created a series of graphs of the total confirmed COVID-19 cases each day by U.S. states and Canadian provinces. This information is provided as a public service. The case curves are updated daily. Data is sourced from the Johns Hopkins CSSE COVID-19 Data Repository & interactive web map.

 

The case curves can be accessed from our public COVID-19 page here.

UPDATE ISSUED FOR COVID-19 IN ECUADOR, INDIA, INDONESIA, THE PHILIPPINES, ROMANIA, QATAR, SAUDI ARABIA, SINGAPORE, & SOUTH AFRICA

March 24, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify Ecuador, India, Indonesia, the Philippines, Qatar, Romania, Saudi Arabia, Singapore, & South Africa as countries with COVID-19 risk, in accordance with the CDC’s Level 3 Travel Notices for COVID-19 issued for these countries on March 24, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

PLEASE NOTE: The state of Indiana where CreaTech Solutions is located is currently under a mandatory “Stay at home” order. As a result, shipping of printed updates and CDs (by special request) may be delayed. Clients using the COVID-19 updates are encouraged to obtain this and future COVID-19 updates by downloading the files from our ShareFile site (and printing the update pages if applicable).  Our hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

UPDATE ISSUED FOR COVID-19 IN CHILE, PAKISTAN, THAILAND, & TURKEY

March 23, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify Chile, Pakistan, Thailand, & Turkey as countries with COVID-19 risk, in accordance with the CDC’s Level 3 Travel Notices for COVID-19 issued for these countries on March 23, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

Since many GEO Guide users are not currently utilizing the COVID-19 content, printed updates and CDs will only be provided to users that specifically request these materials. All current subscribers have access to view and download files from our ShareFile site and hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

COVID-19 CASE MAP OF CANADA & U.S. MADE AVAILABLE FOR PUBLIC USE
March 23, 2020

CreaTech Solutions has made its interactive COVID-19 web map of confirmed cases in the United States and Canada available to the public through this website. This interactive map details the total number of confirmed cases of COVID-19 by U.S. states and Canadian provinces.  This map will be updated at least once per day, and the data update day and time will be displayed on the entry screen when the map is accessed.

 

The map can be accessed on the COVID-19 page here.

WORLD COVID-19 INTERACTIVE WEB MAP PUBLISHED FOR GEO GUIDE SUBSCRIBERS
March 23, 2020

CreaTech Solutions has published a new interactive COVID-19 web map of the world that can be accessed by members of update subscription clients’ organizations through this website. This interactive map identifies countries with high travel risk for COVID-19. This map compliments the COVID-19 Risk List included in the GEO Guide. This map will be updated to identify all countries with CDC Level 3 Travel Notices as high risk for COVID-19. The last revision date will be shown on the entry screen for the interactive map and a full change history can be accessed by links provided on the Interactive Maps page as well as the entry screen for the interactive map.

 

To access the map, users must first sign up and receive approval as a CreaTech Solutions site member. Users must then log in to access the Interactive Maps page to access the map. Please note that access will be limited to members of current update subscription holders’ organizations.

 

Click here for instructions on how to sign up and get started.

UPDATE ISSUED FOR COVID-19 IN AUSTRALIA, BRAZIL, CANADA, ISRAEL, & JAPAN

March 22, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify Australia, Brazil, Canada, Israel, and Japan as countries with COVID-19 risk, in accordance with the CDC’s Level 3 Travel Notices for COVID-19 issued for these countries on March 21, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

Since many GEO Guide users are not currently utilizing the COVID-19 content, printed updates and CDs will only be provided to users that specifically request these materials. All current subscribers have access to view and download files from our ShareFile site and hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

UPDATE ISSUED FOR COVID-19 AND CRUISE SHIP TRAVEL AND COVID-19 IN MALAYSIA

March 18, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify travel on cruise ships and travel to Malaysia as COVID-19 risk, as described in the CDC’s Level 3 Travel Notice for COVID-19 and Cruise Ship Travel  issued on March 17, 2020 and the Level 3 Travel Notice for COVID-19 in Malaysia issued on March 18, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

Since many GEO Guide users are not currently utilizing the COVID-19 content, printed updates and CDs will only be provided to users that specifically request these materials. All current subscribers have access to view and download files from our ShareFile site and hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

UPDATE ISSUED FOR COVID-19 IN THE UNITED KINGDOM AND REPUBLIC OF IRELAND

March 16, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify the United Kingdom (England, Scotland, Wales, and Northern Ireland) and the Republic of Ireland as areas with COVID-19 risk, as described in the CDC’s Level 3 Travel Notice for COVID-19 in the United Kingdom and Ireland issued on March 15, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

Since many GEO Guide users are not currently utilizing the COVID-19 content, printed updates and CDs will only be provided to users that specifically request these materials. All current subscribers have access to view and download files from our ShareFile site and hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

UPDATE ISSUED FOR COVID-19 IN EUROPE & ZIKA IN KIRIBATI

March 13, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to identify the additional European countries of Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and Switzerland as areas with COVID-19 risk, as described in the CDC’s Level 3 Travel Notice for COVID-19 in Europe issued on March 11, 2020. This update also includes revised Zika transmission risk information specific to the nation of Kiribati.

Update files have been uploaded to the CreaTech Solutions ShareFile site and are available for download by approved users.

Since many GEO Guide users are not currently utilizing the COVID-19 content, printed updates and CDs will only be provided to users that specifically request these materials. All current subscribers have access to view and download files from our ShareFile site and hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

U.S. COVID-19 INTERACTIVE WEB MAP PUBLISHED FOR GEO GUIDE SUBSCRIBERS
March 5, 2020

CreaTech Solutions has published an interactive COVID-19 web map that can be accessed by members of update subscription clients’ organizations through this website. This interactive map details U.S. states and counties with reported confirmed cases of COVID-19. This map will be updated at least once per day, and will include an associated change history document indicating the date and time of updates.

 

To access the map, users must first sign up and receive approval as a CreaTech Solutions site member. Users must then log in to access the Interactive Maps page to access the map. Please note that access will be limited to members of current update subscription holders’ organizations.

 

Click here for instructions on how to sign up and get started.

COVID-19 UPDATE ISSUED FOR IRAN & ITALY

March 2, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to include Iran and Italy as COVID-19 risk areas.

Update files have been uploaded to the CreaTech Solutions ShareFile site and can be download by designated personnel of programs with an active Donor Screening GEO Guide subscription.

COVID-19 updates to the GEO Guide are being provided digitally at the current time. This temporary policy allows updates for COVID-19 to be issued as rapidly and efficiently as possible in the face of the frequent changes that are occurring. Hard copy subscribers are being given special permission to download and print the files for the COVID-19 updates (documented on the Update Notice). Printed updates and CDs will be provided to subscribers on a by request basis.

CDC ISSUES LEVEL 3 TRAVEL NOTICE FOR IRAN AND ITALY DUE TO CORONAVIRUS DISEASE 2019

February 29, 2020

On February 28, 2020, the CDC revised it's Travel Notices for Iran and Italy to Level 3 (Warning) due to a dramatic increase in community spread of Coronavirus Disease 2019 (COVID-19) in these countries. The CDC is currently recommending that travelers avoid all nonessential travel to Iran and Italy.

 

Here is a link to the Travel Notices on the CDC's website:

Level 3 Travel Notice for Coronavirus in Iran

Level 3 Travel Notice for Coronavirus in Italy

COVID-19 UPDATE ISSUED FOR SOUTH KOREA

February 26, 2020

In support of our users that have elected to implement voluntary travel screening for COVID-19, an update to the Donor Screening GEO Guide has been issued to include South Korea as a COVID-19 risk area. This update also revises the name of the novel coronavirus illness from the preliminary designation 2019-nCoV to the official name Coronavirus Disease 2019 (COVID-19) and updates references and information in the COVID-19 section to reflect new information issued since initial publication of the 2019-nCoV section in the GEO Guide on February 3, 2020.

Update files have been uploaded to the CreaTech Solutions ShareFile site.

Since many GEO Guide users are not currently utilizing the COVID-19 content, printed updates and CDs will only be provided to users that specifically request these materials. All current subscribers have access to view and download files from our ShareFile site and hard copy subscribers have been given permission to download and print the files for this update (documented on the Update Notice).

CDC ISSUES LEVEL 3 TRAVEL NOTICE FOR SOUTH KOREA DUE TO CORONAVIRUS DISEASE 2019

February 24, 2020

On February 24, 2020, the CDC revised it's Travel Notice for South Korea to a Level 3 Warning due to a dramatic increase in community spread of Coronavirus Disease 2019 (COVID-19). The CDC is currently recommending that travelers avoid all nonessential travel to South Korea.

 

Here is a link to the Travel Notice on the CDC's website:

Level 3 Travel Notice for Coronavirus in South Korea,

2020 UPDATE SUBSCRIPTION PRICING RELEASED

February 11, 2020

Donor Screening GEO Guide subscription pricing for the 2020 term (from April 1, 2020 through March 31, 2021) has been determined.

Hard Copy Update Subscriptions (per book):

Screening Editions (all versions): $170.00

Reference Editions (all versions): $220.00

Update projections for 2020 included consideration of the following factors:

  • Possible triggering of geographic donor screening for 2019-nCoV in 2020, based on uncertainties surrounding the current outbreak .

  • Possible changes in malaria-endemic areas in 29 countries (with an estimated 14 overlays impacted) based on analysis of the 2019 WHO World Malaria Report.

  • Possible publication of final revised FDA blood guidance on vCJD, based on the draft guidance published in January 2020 that includes revised geographic screening recommendations for vCJD.

  • Possible triggering of donor screening for Ebola Virus Disease in 2020 based on the sustained current outbreak in the Democratic Republic of the Congo.

Update subscription pricing for digital version clients will be provided individually based on each client’s reported 2019 annual collections.

CDC REVISES MALARIA INFORMATION FOR PANAMA: GEO GUIDE UPDATE TO BE ISSUED

February 10, 2020

At the end of last week, the CDC revised the malaria information for Panama in the online version of the 2020 Yellow Book to clarify that malaria is present in the indigenous region (comarca) of Emberá and anti-malarial chemoprophylaxis is recommended for travel to the area. As a result of this revised information, an update to the GEO Guide will be issued to include an updated malaria map of Panama.

 

Our GEO Guide subscribers can expect updated digital files to be available for download before the end of this week and shipped update packets should arrive early next week.

FDA ISSUES NOVEL CORONAVIRUS INFORMATION FOR BLOOD ESTABLISHMENTS

February 4, 2020

The U.S. Food and Drug Administration (FDA) issued an explanatory document on its' website for blood establishments regarding the current 2019-nCoV outbreak: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak. The document provides additional information and considerations for blood programs that are deciding whether to implement voluntary preventative measures in response to 2019-nCoV.

2019-nCoV UPDATE ISSUED

February 3, 2020

In support of our users that elect to implement voluntary preventative measures for 2019-nCoV at this time, an update to the Donor Screening GEO Guide has been issued to establish a new content section for 2019-nCoV geographic screening information. The new section includes a reference list and a reference map.

Update files have been uploaded to the CreaTech Solutions ShareFile site. Hard copy subscribers that want to implement this update immediately have been given special permission to download the update PDF files and print the pages required to update their hard copy books. All hard copy subscribers will subsequently receive shipment of the usual printed update packet(s), including new section dividers.

2019-nCoV OUTBREAK: SIGNIFICANT U.S. RESPONSE EVENTS

Updated January 31, 2020

January 30, 2020: The World Health Organization (WHO) declared the 2019-nCoV outbreak that originated in Wuhan, China now meets the criteria for a Public Health Emergency of International Concern (PHEIC).

January 31, 2020:

  • The U.S. Centers for Disease Control and Prevention (CDC) issued federal quarantine orders of 14 days duration to the 195 United States citizens that were evacuated from Wuhan, China and repatriated to the U.S. on January 29th.

  • The U.S. Department of Health and Human Services (HHS) declares 2019-nCoV to be a public health emergency in the U.S. beginning at 5 P.M ET on February 2nd.

  • AABB issues updated statement regarding 2019-nCov: Update: Impact of 2019 Novel Coronavirus and Blood Safety – January 31, 2020. No actions are being recommended by AABB, FDA, and CDC for blood establishments at the current time due to lack of data. The statement outlines several precautionary measures that could be voluntary implemented by individual blood establishments at the local level.

2019-nCoV ACTION PLAN

January 29, 2020

CreaTech Solutions is actively monitoring information from multiple sources regarding the current outbreak of novel coronavirus 2019-nCoV that originated in Wuhan, China. It is not currently known if geographic screening of potential blood donors will be recommended for U.S. blood banks, but preparations are underway in the event that geographic donor screening is recommended by the by FDA and/or AABB.

 

Scaffolding of all editions and formats of the Donor Screening GEO Guide is underway to ensure the most rapid addition, production, and distribution of 2019-nCoV information in the event that geographic screening of donors is triggered.

 

CreaTech Solutions is reviewing the 2003 FDA guidance document on SARS to provide insight into how the FDA's responded to a recent outbreak of a similar infectious agent. Here is a link to the FDA's blood guidance on SARS: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/revised-recommendations-assessment-donor-suitability-and-blood-product-safety-cases-suspected-severe

FDA ISSUES REVISED DRAFT BLOOD GUIDANCE FOR CJD & vCJD

January, 2020

The FDA has published revised draft guidance for the blood industry, entitled "Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry". The FDA has issued this draft guidance for comment.

 

In terms of geographic donor screening, the draft guidance proposes elimination of donor deferral for vCJD risk associated with time spent in Europe and on U.S. military bases in Europe (and Turkey). The proposed new recommendations retain deferral recommendations for time spent in the United Kingdom, France, and Ireland (Republic of); as well as having received a transfusion in the United Kingdom, France, and Ireland.

Additional changes are also proposed, regarding recommended questions for donors as well as acceptance of donors that have received hGH and bovine insulin.

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