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ONEBLOOD, INC
ORLANDO, FL, 32819
UnclaimedClaim this profile (free)
Prime contracting experience
37 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD | 36C24826D0015USAspending | $354,881 | Sep 30, 2026 | Mar 1, 2026 – Sep 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | WHOLE BLOOD (2-MO EXTENSION) | 36C24825D0048USAspending | $538,090 | Sep 16, 2026 | Jan 1, 2026 – Feb 28, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | DELIVERY ORDER FOR ORLANDO BLOOD AND WHOLE BLOOD PRODUCTS | 36C24826D0015USAspending | $619,287 | Sep 2, 2026 | Mar 1, 2026 – Sep 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | WHOLE BLOOD & BLOOD PRODUCTS | 36C24825D0048USAspending | $1,061,449 | Jul 7, 2026 | Jul 1, 2025 – Dec 31, 2025 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | WHOLE BLOOD AND BLOOD RELATED PRODUCTS FOR MIAMI VAMC | 36C24826D0015USAspending | $354,763 | May 28, 2026 | Mar 1, 2026 – Sep 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | BLOOD SUPPLY DELIVERY | 36C24626D0012USAspending | $492,004 | Mar 13, 2026 | Oct 1, 2025 – Sep 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR JAHVH (TAMPA, FL) | 36C24826D0015USAspending | $792,973 | Mar 6, 2026 | Mar 1, 2026 – Sep 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. | 36C24826D0015USAspending | $268,659 | Mar 1, 2026 | Mar 1, 2026 – Sep 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $502,697 | Jan 14, 2026 | Oct 1, 2024 – Sep 30, 2025 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $251,505 | Dec 5, 2025 | Jan 1, 2025 – Jun 30, 2025 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $343,724 | Nov 19, 2025 | Jan 1, 2025 – Jun 30, 2025 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | BLOOD COMPATIBILITY TESTING SERVICES | 36C24824D0008USAspending | $2,996,700 | Nov 18, 2025 | Dec 1, 2025 – Nov 30, 2026 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $707,159 | Oct 27, 2025 | Jan 1, 2025 – Jun 30, 2025 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $633,677 | Jul 9, 2025 | Oct 1, 2023 – Sep 30, 2024 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $1,187,310 | Mar 13, 2025 | Oct 1, 2023 – Sep 30, 2024 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | BLOOD COMPATIBILITY TESTING SERVICES | 36C24824D0008USAspending | $2,854,000 | Mar 4, 2025 | Dec 1, 2023 – Nov 30, 2024 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $264,909 | Mar 3, 2025 | Oct 1, 2023 – Sep 30, 2024 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD & RELATED PRODUCTS FOR BAY PINES | 36C24820D0014USAspending | $472,227 | Feb 27, 2025 | Oct 1, 2023 – Sep 30, 2024 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $471,589 | Jan 10, 2025 | Oct 1, 2023 – Sep 30, 2024 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | BLOOD COMPATIBILITY TESTING SERVICES | 36C24824D0008USAspending | $2,996,700 | Nov 13, 2024 | Dec 1, 2024 – Nov 30, 2025 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $1,296,671 | Aug 6, 2024 | Oct 1, 2022 – Sep 30, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | EO14042 | BLOOD COMPATIBILITY TESTING | 36C24818D0169USAspending | $423,365 | Aug 1, 2024 | Sep 1, 2023 – Dec 31, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $524,614 | May 21, 2024 | Oct 1, 2022 – Sep 30, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $278,710 | Mar 6, 2024 | Oct 1, 2022 – Sep 30, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $391,486 | Feb 15, 2024 | Oct 1, 2022 – Sep 30, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $410,165 | Feb 13, 2024 | Oct 1, 2022 – Sep 30, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $583,754 | May 17, 2023 | Oct 1, 2021 – Sep 30, 2022 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | WHOLE BLOOD AND RELATED PRODUCTS | 36C24820D0014USAspending | $571,086 | Mar 30, 2023 | Oct 1, 2021 – Sep 30, 2022 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $460,440 | Mar 7, 2023 | Oct 1, 2021 – Sep 30, 2022 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS DELIVERY ORDER FOR TAMPA VA | 36C24820D0014USAspending | $1,000,867 | Feb 28, 2023 | Oct 1, 2021 – Sep 30, 2022 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $330,570 | Feb 3, 2023 | Oct 1, 2021 – Sep 30, 2022 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | EO14042 | BLOOD COMPATIBILITY TESTING | 36C24818D0169USAspending | $1,693,459 | Sep 1, 2022 | Sep 1, 2022 – Aug 31, 2023 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | WHOLE BLOOD AND RELATED BLOOD PRODUCTS FOR TAMPA VA HOSPITAL | 36C24820D0014USAspending | $1,156,940 | Aug 9, 2022 | Oct 1, 2020 – Sep 30, 2021 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS ORLANDO | 36C24820D0014USAspending | $465,835 | Jul 19, 2022 | Oct 1, 2020 – Aug 11, 2022 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR BAY PINES, | 36C24820D0014USAspending | $654,725 | Mar 29, 2022 | Oct 1, 2020 – Sep 30, 2021 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | VISN 8 WHOLE BLOOD AND RELATED PRODUCTS FOR LOCATIONS BAY PINES, MIAMI, ORLANDO, TAMPA AND WEST PALM BEACH. FUNDING ARE BY INDIVIDUAL DELIVERY ORDERS. | 36C24820D0014USAspending | $293,859 | Feb 1, 2022 | Oct 1, 2020 – Sep 30, 2021 |
| Prime | Department of Veterans Affairs Department of Veterans Affairs | WHOLE BLOOD AND RELATED PRODUCTS ORDER | 36C24820D0014USAspending | $549,929 | Jan 11, 2022 | Oct 1, 2020 – Sep 30, 2021 |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Subcontracting experience
4 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | ONEBLOOD’S SCOPE OF WORK ON THIS PROJECT INCLUDES PROVISION OF DE-IDENTIFIED DONOR DEMOGRAPHIC AND HIV, HCV, HBV AND SYPHILIS INFECTIOUS DISEASE TESTING DATA TO THE AMERICAN RED CROSS WHICH WILL CONTINUE TO SERVE AS THE DATABASE COORDINATING CENTER FOR THE NEW TTIMS PROGRAM. PROVISION OF DONOR/DONATION DATA AND ADDITIONAL TESTING WILL BE CONDUCTED ON DE-IDENTIFIED SAMPLES MEETING THE EXPECTATIONS FOR PUBLIC HEALTH SURVEILLANCE. ONEBLOOD WILL NOT SORT OUT DONOR/DONATION DATA BASED ON WHETHER DONORS HAVE SIGNED A NEW COMMON RULE CONSENT.
PROVISION OF ADDITIONAL DONOR DEFERRAL DATA IS EXPECTED TO BE IN SCOPE FOR THE PROGRAM TO ADDRESS CHANGES BECAUSE OF THE IMPLEMENTATION OF INDIVIDUAL DONOR ASSESSMENT AND ADDITIONAL RESOURCES MAY BE PROVIDED AS NEEDED FOR THIS ADDITIONAL REQUIREMENT.
ONEBLOOD ALSO AGREES TO PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE STUDY DATABASE, RESPOND TO REQUESTS FROM TTIMS DATA COORDINATION GROUPS REGARDING DATA QUALITY ASSURANCE AND QC, REPORT SUMMARY LOOKBACK DATA FOR HIV AND HCV (NUMBER OF RECIPIENTS WHO RECEIVED COMPONENTS FROM PRIOR DONATIONS FROM DONORS WHO TESTED POSITIVE FOR HIV
AND HCV AND IF AVAILABLE, NUMBER OF RECIPIENTS WHO WERE FOUND TO HAVE TESTED POSITIVE FOR HIV AND HCV IN LOOKBACK INVESTIGATIONS), AND ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS.
FURTHER, AS IN PREVIOUS TTIMS PROGRAMS, ONEBLOOD WILL PROVIDE PLASMA UNITS AND SAMPLES (CODED BIOSPECIMENS) FOR THE TTIMS REPOSITORY AND THE ADDITIONAL TESTING THAT IS CONDUCTED AT VRI TO FURTHER CHARACTERIZE THE INFECTIONS IN TTIMSQUALIFYING
INFECTIONS. 12145OB181 Parent award context Parent award agency: Department of Health and Human Services · Food and Drug Administration Parent award NAICS: 621511 Parent award performance state: MD Parent award description: TRANSFUSION-TRANSMISSIBLE INFECTIONS MONITORING SYSTEM (TTIMS) BASE PLUS THREE OPTION YEAR CONTRACT View parent award on USAspending | — | $278,887 | Jan 14, 2026 | — – — |
| Subcontractor | Department of Health and Human Services | THE TTIMS LRCC PROJECT PURPOSE IS TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR SPECIFIC ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF HIV (INCIDENT AND PREVALENT INFECTIONS), HCV (INCIDENT) AND HBV (INCIDENT), AND SYPHILIS POSITIVE BLOOD DONORS. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO: €¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AND COMPARISON UNINFECTED (CONTROL) DONORS. €¢ COMPARE/ANALYZE RISK FACTOR DATA TO THAT OBTAINED IN THE EARLIER TTIMS STUDY PERIOD AND THE REDS-II TTVI MARKER PREVALENCE AND RISK FACTOR STUDY. €¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS. €¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV-POSITIVE AND INFECTION NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS. €¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES. €¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS. €¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT. IN SUPPORT OF THESE OBJECTIVES, ONEBLOOD WILL RECRUIT, ENROLL AND INTERVIEW ELIGIBLE PARTICIPANTS, PROVIDE DATA AS REQUIRED IN THE TTIMS LRCC STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. DR. RITA A. REIK, MD, WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT ONEBLOOD. SHE WILL OVERSEE ALL ASPECTS OF ONEBLOOD€„¢S PARTICIPATION IN THE LRCC PORTION OF TTIMS INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT. IN ADDITION, DR. TISHA FOSTER, MD, WILL SERVE AS THE CO-PRINCIPAL INVESTIGATOR AT ONEBLOOD. DR. FOSTER WILL ASSIST IN THE OVERSIGHT OF THE ACQUISITION OF DONOR DATA, AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT WHEN NECESSARY. ONEBLOOD WILL RECRUIT DONORS WITH QUALIFYING TEST RESULTS; ADMINISTER THE WEB-BASED QUESTIONNAIRE AND ENTER RISK FACTOR DATA INTO AN ELECTRONIC DATABASE; PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE DATABASE; RESPOND TO REQUESTS FROM THE LRCC REGARDING DATA QUALITY ASSURANCE AND QC; DEVELOP AND SUBMIT TO THE LOCAL IRB DOCUMENTS AND AMENDMENTS FOR APPROVAL. €¢ ONEBLOOD WILL ALSO MAINTAIN AND UPDATE THE STUDY MANAGEMENT SYSTEM (SMS) THAT SUPPORTS THESE ACTIVITIES AT ALL PARTICIPATING SITES, WORKING THE LRCC TO DEFINE TECHNICAL REQUIREMENTS AND RESOURCES NECESSARY TO SUPPORT THIS ACTIVITY. ONEBLOOD STAFF WILL FORWARD PLASMA BAGS AND/OR PILOT TUBES TO CREATIVE TESTING SOLUTIONS (CTS) SO THAT CTS CAN CREATE UP TO 5 X 2 ML PLASMA CYROVIALS AND A SINGLE 15 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT AND PREPARE ALIQUOTS FOR SHIPMENT TO THE REPOSITORY AND ADDITIONAL TESTING AT VRI FOR ALL INFECTIONS OF INTEREST AS DEFINED BY THE TTIMS STEERING COMMITTEE. IN COLLABORATION WITH THE LRCC, ONEBLOOD WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED CTS STAFF. IN ADDITION, ONEBLOOD WILL WORK WITH THE LRCC AND CTS TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING. ONEBLOOD WILL ALSO WORK THE LRCC TO FACILITATE SURVEYS AND QUALITATIVE INTERVIEWS OF ARV/PEP/PREP REACTIVE BLOOD DONORS. ONEBLOOD WILL NOT BE EXPECTED TO LEAD THE COLLECTION OF THESE SURVEY AND QUALITATIVE INTERVIEW DATA BUT WILL ASSIST IN IDENTIFYING AND RECRUITING PARTICIPANTS FOR THESE ACTIVITIES. ADDENDUMS TO THIS SOW WILL BE DEVELOPED AFTER THE RESEARCH PROTOCOLS TO SUPPORT EXPANDED ART/PEP/PREP STUDIES ARE FULLY DEFINE 11832OB159 Parent award context Parent award agency: Department of Health and Human Services · Food and Drug Administration Parent award NAICS: 541990 Parent award performance state: AZ Parent award description: TTIMS LRCC REQUIREMENT View parent award on USAspending | — | $327,069 | Feb 12, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THE TTIMS LRCC PROJECT PURPOSE IS TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR SPECIFIC ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF HIV (INCIDENT AND PREVALENT INFECTIONS), HCV (INCIDENT) AND HBV (INCIDENT), AND SYPHILIS POSITIVE BLOOD DONORS. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO:
€¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AND COMPARISON UNINFECTED (CONTROL) DONORS.
€¢ COMPARE/ANALYZE RISK FACTOR DATA TO THAT OBTAINED IN THE EARLIER TTIMS STUDY PERIOD AND THE REDS-II TTVI MARKER PREVALENCE AND RISK FACTOR STUDY.
€¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS.
€¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV-POSITIVE AND INFECTION NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS.
€¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES.
€¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS.
€¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT.
IN SUPPORT OF THESE OBJECTIVES, ONEBLOOD WILL RECRUIT, ENROLL AND INTERVIEW ELIGIBLE PARTICIPANTS, PROVIDE DATA AS REQUIRED IN THE TTIMS LRCC STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS.
DR. RITA A. REIK, MD, WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT ONEBLOOD. SHE WILL OVERSEE ALL ASPECTS OF ONEBLOOD€„¢S PARTICIPATION IN THE LRCC PORTION OF TTIMS INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT.
IN ADDITION, DR. TISHA FOSTER, MD, WILL SERVE AS THE CO-PRINCIPAL INVESTIGATOR AT ONEBLOOD. DR. FOSTER WILL ASSIST IN THE OVERSIGHT OF THE ACQUISITION OF DONOR DATA, AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT WHEN NECESSARY.
ONEBLOOD WILL RECRUIT DONORS WITH QUALIFYING TEST RESULTS; ADMINISTER THE WEB-BASED QUESTIONNAIRE AND ENTER RISK FACTOR DATA INTO AN ELECTRONIC DATABASE; PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE DATABASE; RESPOND TO REQUESTS FROM THE LRCC REGARDING DATA QUALITY ASSURANCE AND QC; DEVELOP AND SUBMIT TO THE LOCAL IRB DOCUMENTS AND AMENDMENTS FOR APPROVAL.
€¢ ONEBLOOD WILL ALSO MAINTAIN AND UPDATE THE STUDY MANAGEMENT SYSTEM (SMS) THAT SUPPORTS THESE ACTIVITIES AT ALL PARTICIPATING SITES, WORKING THE LRCC TO DEFINE TECHNICAL REQUIREMENTS AND RESOURCES NECESSARY TO SUPPORT THIS ACTIVITY.
ONEBLOOD STAFF WILL FORWARD PLASMA BAGS AND/OR PILOT TUBES TO CREATIVE TESTING SOLUTIONS (CTS) SO THAT CTS CAN CREATE UP TO 5 X 2 ML PLASMA CYROVIALS AND A SINGLE 15 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT AND PREPARE ALIQUOTS FOR SHIPMENT TO THE REPOSITORY AND ADDITIONAL TESTING AT VRI FOR ALL INFECTIONS OF INTEREST AS DEFINED BY THE TTIMS STEERING COMMITTEE. IN COLLABORATION WITH THE LRCC, ONEBLOOD WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED CTS STAFF.
IN ADDITION, ONEBLOOD WILL WORK WITH THE LRCC AND CTS TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING. ONEBLOOD WILL ALSO WORK THE LRCC TO FACILITATE SURVEYS AND QUALITATIVE INTERVIEWS OF ARV/PEP/PREP REACTIVE BLOOD DONORS. ONEBLOOD WILL NOT BE EXPECTED TO LEAD THE COLLECTION OF THESE SURVEY AND QUALITATIVE INTERVIEW DATA BUT WILL ASSIST IN IDENTIFYING AND RECRUITING PARTICIPANTS FOR THESE ACTIVITIES.
ADDENDUMS TO THIS SOW WILL BE DEVELOPED AFTER THE RESEARCH PROTOCOLS TO SUPPORT EXPANDED ART/PEP/PREP STUDIES ARE FULLY DEFINE 11832OB159 Parent award context Parent award agency: Department of Health and Human Services · Food and Drug Administration Parent award NAICS: 541990 Parent award performance state: AZ Parent award description: TTIMS LRCC REQUIREMENT View parent award on USAspending | — | $318,372 | Dec 7, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THE TTIMS LRCC PROJECT PURPOSE IS TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR SPECIFIC ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF HIV (INCIDENT AND PREVALENT INFECTIONS), HCV (INCIDENT) AND HBV (INCIDENT), AND SYPHILIS POSITIVE BLOOD DONORS. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO:
€¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AND COMPARISON UNINFECTED (CONTROL) DONORS.
€¢ COMPARE/ANALYZE RISK FACTOR DATA TO THAT OBTAINED IN THE EARLIER TTIMS STUDY PERIOD AND THE REDS-II TTVI MARKER PREVALENCE AND RISK FACTOR STUDY.
€¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS.
€¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV-POSITIVE AND INFECTION NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS.
€¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES.
€¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS.
€¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT.
IN SUPPORT OF THESE OBJECTIVES, ONEBLOOD WILL RECRUIT, ENROLL AND INTERVIEW ELIGIBLE PARTICIPANTS, PROVIDE DATA AS REQUIRED IN THE TTIMS LRCC STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS.
DR. RITA A. REIK, MD, WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT ONEBLOOD. SHE WILL OVERSEE ALL ASPECTS OF ONEBLOOD€„¢S PARTICIPATION IN THE LRCC PORTION OF TTIMS INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT.
IN ADDITION, DR. TISHA FOSTER, MD, WILL SERVE AS THE CO-PRINCIPAL INVESTIGATOR AT ONEBLOOD. DR. FOSTER WILL ASSIST IN THE OVERSIGHT OF THE ACQUISITION OF DONOR DATA, AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT WHEN NECESSARY.
ONEBLOOD WILL RECRUIT DONORS WITH QUALIFYING TEST RESULTS; ADMINISTER THE WEB-BASED QUESTIONNAIRE AND ENTER RISK FACTOR DATA INTO AN ELECTRONIC DATABASE; PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE DATABASE; RESPOND TO REQUESTS FROM THE LRCC REGARDING DATA QUALITY ASSURANCE AND QC; DEVELOP AND SUBMIT TO THE LOCAL IRB DOCUMENTS AND AMENDMENTS FOR APPROVAL.
€¢ ONEBLOOD WILL ALSO MAINTAIN AND UPDATE THE STUDY MANAGEMENT SYSTEM (SMS) THAT SUPPORTS THESE ACTIVITIES AT ALL PARTICIPATING SITES, WORKING THE LRCC TO DEFINE TECHNICAL REQUIREMENTS AND RESOURCES NECESSARY TO SUPPORT THIS ACTIVITY.
ONEBLOOD STAFF WILL FORWARD PLASMA BAGS AND/OR PILOT TUBES TO CREATIVE TESTING SOLUTIONS (CTS) SO THAT CTS CAN CREATE UP TO 5 X 2 ML PLASMA CYROVIALS AND A SINGLE 15 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT AND PREPARE ALIQUOTS FOR SHIPMENT TO THE REPOSITORY AND ADDITIONAL TESTING AT VRI FOR ALL INFECTIONS OF INTEREST AS DEFINED BY THE TTIMS STEERING COMMITTEE. IN COLLABORATION WITH THE LRCC, ONEBLOOD WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED CTS STAFF.
IN ADDITION, ONEBLOOD WILL WORK WITH THE LRCC AND CTS TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING. ONEBLOOD WILL ALSO WORK THE LRCC TO FACILITATE SURVEYS AND QUALITATIVE INTERVIEWS OF ARV/PEP/PREP REACTIVE BLOOD DONORS. ONEBLOOD WILL NOT BE EXPECTED TO LEAD THE COLLECTION OF THESE SURVEY AND QUALITATIVE INTERVIEW DATA BUT WILL ASSIST IN IDENTIFYING AND RECRUITING PARTICIPANTS FOR THESE ACTIVITIES. 11832OB159 Parent award context Parent award agency: Department of Health and Human Services · Food and Drug Administration Parent award NAICS: 541990 Parent award performance state: AZ Parent award description: TTIMS LRCC REQUIREMENT View parent award on USAspending | — | $309,820 | Jan 7, 2022 | — – — |
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Agencies supported
- Department of Veterans AffairsGov-sourced
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