Blood Safety TA Services RFP.doc

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Blood Safety Technical Assistance Services Federal contract opportunity
Solicitation number
2010-N-11995
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

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RFP 2010-N-11995 Blood Safety Technical Assistance Services

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SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2010-N-11995

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

04/28/2010

6. REQUISITION/PURCHASE NO.

00HCVJG1-2010-78844

7. ISSUED BY
CODE
2543
8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 3 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in the mailroom, first floor until 2:00p local time 05/28/2010 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Sam Jamison

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-4787

C. E-MAIL ADDRESS

Esw2@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

PART I – THE SCHEDULE
PART II – CONTRACT CLAUSES
X
A
SOLICITATION/CONTRACT FORM
1
X
I
CONTRACT CLAUSES
34
X
B
SUPPLIES OR SERVICES AND PRICES/COSTS
2
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X
C
DESCRIPTION/SPECS./WORK STATEMENT
3
X
J
LIST OF ATTACHMENTS
42
X
D
PACKAGING AND MARKING
17
PART IV – REPRESENTATIONS AND INSTRUCTIONS

X

E
INSPECTION AND ACCEPTANCE
18

REPRESENTATIONS, CERTIFICATIONS, AND

X
F
DELIVERIES OR PERFORMANCE
19
X
K
OTHER STATEMENTS OF OFFERORS
43
X
G
CONTRACT ADMINISTRATION DATA
20
X
L
INSTRS., CONDS., AND NOTICES TO OFFERORS
51
X
H
SPECIAL CONTRACT REQUIREMENTS
30
X
M
EVALUATION FACTORS FOR AWARD
66

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO.
DATE
AMENDMENT NO.
DATE

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7)
CODE
2543
25. PAYMENT WILL BE MADE BY
CODE
434

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-498-4050

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

ITEM

SUPPLIES / SERVICES

QTY / UNIT

UNIT PRICE

EXTENDED PRICE

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
0001
Blood Safety Services

The objective of this acquisition is to provide a mechanism for USG missions in PEPFAR-supported countries to provide host governments with non-research-related technical assistance in the area of blood safety.

(2) Line Item shall not exceed $100,000,000.00. The Government intends to issue multiple-award contracts and the aggregate maximum value of all task order awards shall not to exceed $100,000,000.00.

B.1 Task Order Contract

This is an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract utilizing firm-fixed-pricing (FFP) and Cost Plus Fixed Fee type Task Orders in accordance with Federal Acquisition Regulation (FAR) Part 16.

If an individual task order is a Cost Plus Fixed Fee type task order the Contractor’s proposal for the individual task order shall specify the price for labor, other direct costs, indirect costs and fixed fee to perform the services required of that specific task order.

If an individual task order is a Firm Fixed Price (FFP) task order the Contractor’s proposal for the individual task order shall specify the price for labor, other direct/indirect costs, and profit to perform the services required of that specific task order.

Funds shall be obligated on each individual task order. The Contractor shall not exceed the amount negotiated for each individual task order without prior written approval of the Contracting Officer. The Government is not obligated to reimburse the Contractor for costs incurred in excess of the amount negotiated for each individual task order, or for costs that are specifically identified in this contract as being unallowable.

The Contractor shall not commence work until a task order or other notification for a specific assignment is issued by the Contracting Officer. If mailed, a task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or electronically.

The Contracting Officer is the only person authorized to request work plans or issue task orders under this contract. The Government is not obligated to reimburse the Contractor for cost incurred before issuance of a task order or other notification by the Contracting Officer.

B.2 Minimum Guarantee

The master ID/IQ contracts have a guaranteed minimum of $10,000.00. In the event the Contractor receives obligations of less than this minimum, the Government will reimburse the Contractor for the difference between the actual obligations and the guaranteed minimum.

B.3 Maximum Program Value

The maximum cumulative dollar value of all task order awards is $100,000,000.00. If the Government's requirements for services set forth in the solicitation do not result in orders in the amounts described as “maximum," the event shall not constitute the basis for an equitable price adjustment under this contract.

B.4 Ordering of Services

Orders for services shall be placed through the issuance of individually negotiated task orders in accordance with the clauses set forth in Section H.7 “Issuance of Task Orders”, I.2 “Ordering”, and I.3 “Ordering Limitations”.

Section C - Description/Specification/Work Statement Blood Safety Services for CDC Projects Supported by the U.S. President’s Emergency Plan for AIDS Relief

C.1 Background and Need CDC’s mission is to promote the health and quality of life of people by preventing and controlling disease, injury, and disability. CDC is in a position to bring its scientific expertise and credibility to the U.S. Global Health Initiative: “to protect the health of our people, while saving lives, reducing suffering, and supporting the health and dignity of people everywhere.” The key elements of CDC’s global health strategy are:

· Assist Ministries of Health to plan, effectively manage, and evaluate health programs;

· Achieve goals adopted by USG programs and international organizations to improve health, including disease eradication and elimination targets;

· Expand CDC’s global health programs that focus on the leading causes of mortality, morbidity and disability, especially chronic disease and injuries;

· Generate and apply new knowledge to achieve health goals; and

· Strengthen health systems and their impact.

As part of this mission, CDC is tasked with implementing programs in international settings, primarily in developing countries. To reach these goals HHS/CDC focuses on the following major program areas: HIV/AIDS, Malaria, Global Immunizations, Influenza, Global Disease Detection, Safe Water, Injury & Violence, Birth Defects & Developmental Disability, Field Epidemiology and Laboratory Training, Sustainable Management Development, Reproductive Health, Workforce and Career Development, and Global Preparedness & Program Coordination. To fulfill its mission CDC often necessitates seeking outside expertise and technical assistance. This contractor support and technical expertise is also critical to the achievement of the overall efforts and requirements of the CDC global health activities.

The World Health Organization (WHO) estimates that 5%-10% of incident HIV infections may be attributed to unsafe blood transfusions. To reduce the risk of transfusion-transmitted infections, WHO’s “Aide-Memoire for National Blood Programmes” encourages developing countries to pursue a strategy that focuses on:

· Availability of adequate supplies of blood and blood products and their accessibility to all patients requiring transfusion;

· Safety of blood and blood products; and

· Safe and appropriate clinical use of blood and blood products Since 2004, PEPFAR has supported blood safety programs based on the WHO guidance in 14 of the original PEPFAR focus countries. However, much work remains to be done worldwide. According to WHO, 177 countries responding to the 2001-2002 Global Database on Blood Safety questionnaire, 30% did not have a coordinated national blood service; 32% lacked national legislation to support blood transfusion regulations, policies and standard operating procedures; 84% lacked some or all of the recommended quality management components (e.g., external laboratory quality assurance); and 22% reported experiencing a stock out of test kits or supplies to ensure that 100% of all units collected are laboratory screened prior to transfusion.

In many developing countries, substantial problems have been documented in each of the following areas: (1) Assessment of demand for blood and determination of adequacy of the blood supply (assuring that a sufficient amount of safe blood is collected to meet the country’s annual demand); (2) Reliance on family identified replacement donors instead of voluntary, non-remunerated donors with a low behavioral risk profile for HIV; (3) Laboratory capacity at both processing and distribution sites; (4) Monitoring and evaluation to assure quality systems from vein to vein ( e.g. maintenance of cold chain, data management); (5) Commodities forecasting, procurement and distribution to avoid stock outs; (6) Management, training and supervision; (7) Adverse event monitoring; and (8) Policies and guidelines (nationally approved documents regarding the national blood transfusion service’s responsibility and authority to oversee, monitor and supervise the appropriate use of blood.

This task order contract will support Ministries of Health (MOH) and National Blood Transfusion Services (NBTS) in developing strong blood safety programs through the provision of technical assistance. This task order contract will support PEPFAR-funded blood safety initiative worldwide. Specific task orders may require the contractor to provide services for any or all of the key areas described above, as well as activities described in the nine (9) Technical Requirements listed below.

Services funded through this contract will include, but not be limited to, providing expert advice, training and mentoring in the areas of policy development, blood bank and laboratory infrastructure, blood collection, laboratory screening, clinical prescription strategies (i.e., appropriate use of blood), transfusion procedures and practices, and quality assurance. Additional activities may include advice on monitoring and evaluation, commodity management, waste management, and overall program management for blood services. This mechanism is not designed to support program implementation by contractors.

This statement of work and the resulting contracts and task orders are authorized under Sections 301(a) and 307 of the Public Health Service Act [42 U.S.C. Sections 241(a) and 242], as amended and under Public Law 110-293 (United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008) [22 USC 7601].

Successful applicants must be able to respond to task orders in any of 37 PEPFAR-supported countries listed in Attachment 1. Additional countries may be added by the Office of the Global AIDS Coordinator to the list of countries in Attachment 1.

Contractors shall have the capability to perform/deliver the services to meet the Government requirements. Contractors shall have the capability of expanding delivery capacity in order to meet fluctuating Government ordering periods. Contractors shall have the capability to simultaneously respond to multiple complex tasks at multiple geographically dispersed locations.

C.2 Project Objective The objective of this acquisition is to provide a mechanism for USG missions in PEPFAR-supported countries to provide host governments with non-research-related technical assistance in the area of blood safety. Assistance provided through this mechanism is described above and in detail below.

C.3 Scope of Work As an independent organization, and not as an agent of the Government, the Contractor(s) shall furnish all necessary personnel, facilities, supplies, travel and related costs, as well as equipment, as appropriate to provide CDC with required technical services within the general work parameters set forth in this Performance-Based Statement of Work (PBSOW) and outlined in the Technical Requirements.

C.4 Technical Requirements The following technical requirements are examples of activities which may be ordered through individual task orders under this contract. This listing provides a sampling of the types of tasks which may be conducted and is not represented as being complete or all inclusive. This statement of work shall function as a Performance-Based Statement of Work (PBSOW). Details regarding this Performance-Based acquisition, including details concerning measures of success indicators, standards-criteria for acceptance, methods of surveillance, and “incentives/de-incentives” can be found in the “Performance-Based Matrices” below. Note: This contract is for non-research activities only.

Technical Requirement (TR) #1

Policy Development and Advocacy: WHO recommends that an organized and managed blood programme should be an integral part of each country's national health care policy and health care infrastructure.

The national blood transfusion service (NBTS) should be established in accordance with an agreed national blood policy and plan within a legislative framework. It should be responsible for establishing and maintaining a national quality system, including the development of guidelines and standards, staff training, a data/ information management system and a system for monitoring and evaluation of all the blood transfusion activities.

To support these efforts the Contractor may be asked to assist with:

· An analysis of the demand for blood in the country

· An assessment of the status of blood transfusion and blood safety in the country

· Advocacy to secure continuous government commitment and support for the national blood program;

· Development and implementation of a national blood policy and plan, tailored to meet the needs of the health programme it serves;

· Formation of a National Blood Commission or equivalent;

· Formulation of an organization with responsibility and authority for the blood transfusion service;

· Development of job descriptions and mentoring plans for key personnel (medical director, a quality manager) and qualified and trained staff in each key aspect of the blood transfusion service with clear roles and responsibilities;

· Development of position descriptions and Terms of Reference for specialist blood transfusion service advisory groups, when necessary;

· Development and implementation of a budgeting and finance system to ensure a sustainable blood programme through cost recovery and/or annual budget allocation;

· Development of policies and standard operating procedures (SOPs) for specific activities (e.g., blood collection, laboratory screening algorithms, transfusion indications, risk assessment, and risk management).

· Establishment of a national quality system, including standards, guidelines, standard operating procedures (SOPs), accurate records, monitoring and evaluation;

Technical Requirement (TR) #2

Infrastructure Development: The Contractor may be asked to perform or assist with a situational assessment of the existing infrastructure in terms of needs for a national blood transfusion service, including analysis of blood demand, blood collection, screening, processing and blood banking facilities, capital and consumable needs (e.g., blood collection bags and tubes, laboratory devices and reagents, cold chain equipment, etc.), and information technology (IT) systems necessary to track data on blood donors, blood collections, laboratory results and, where available, hemovigilance. Contractor may provide technical recommendations or guidance on ways to strengthen blood collection sites. These sites may be integrated with larger healthcare facilities or exist as stand-alone, or mobile sites. Infrastructure recommendations must be site-specific, based on the location of the facility (e.g., urban or rural), and must include a review of the available or needed logistics systems to support each site. As noted above, guidance on the selection and procurement of standard laboratory equipment and reagents to test blood for TTI (e.g., HIV, Hepatitis B & C, and syphilis) and to perform blood grouping and cross matching will be included under the infrastructure technical area. Support for the assessment, development or strengthening of commodity and waste management policies and/or systems is also included in this technical requirement.

Technical Requirement (TR) #3 Blood Collection: Contractor may be asked to assist with development of generic and site-specific protocols for collecting, handling and storing, transporting, and distributing blood in and from fixed and mobile blood collection facilities. Provide support, as requested, in strengthening the capacity of blood donor recruiters and blood donor counselors at each blood collection site. Provide advice in developing and maintaining a system to recruit and retain low risk, voluntary, non-remunerated blood donors (VNRD). This may include, but not be limited to, guidance on the development of telephone or text message-based call-back systems and electronic data systems to manage donor lists. Contractors must also be able to provide guidance on effective quality assurance procedures for collecting and storing blood.

Technical Requirement (TR) #4 Blood Testing and Production of Blood Products: Under this technical requirement, Contractor may develop generic national and site-specific protocols for all required testing of blood: including for HIV and other relevant transfusion-transmissible pathogens; sero-typing and cross matching following Good Laboratory Practices. All testing algorithms should be based on internationally accepted standards, and include internal and external quality assurance components. Provide assistance to support the strengthening blood services’ capacity to manage blood testing laboratories and build capacity to fractionate blood products from collected units of whole blood. Activities in this area may include, but will not be limited to, assisting in the development or strengthening and implementation of laboratory Standard Operating Procedures (SOPs), testing algorithms, blood production guidelines and SOPs, cold chain systems, electronic record-keeping systems and policies to ensure good manufacturing practices. Contractors may also provide assistance to CDC and USG partners to support the development of external quality control agreements between host governments and internationally accredited laboratories.

Technical Requirement (TR) #5 Transfusion and Blood Utilization: Contractor may assist with the development and implementation of national guidelines for the appropriate use of blood and blood products. These guidelines may be developed through a series of national consensus conferences attended by transfusion practitioners and domestic and international transfusion experts. Guidance and advice may also be requested for the development of hospital-based transfusion committees and hemovigilance systems to monitor the use of blood, adverse transfusion events and overall patient outcomes.

Technical Requirement (TR) #6

Monitoring and Evaluation (M&E): Under this requirement, Contractor may provide recommendations and guidance on systems for collecting, managing and analyzing data on key programmatic indicators. This will extend to providing advice and guidance on methods and mechanisms for reviewing and adjusting program activities based on monitoring data. Examples of the use of M&E data may include, but will not be limited to, tracking the distribution of blood to evaluate hospitals’ use of blood collected and screened by the NBTS (vs. blood collected and screened by the hospital or a private entity); tracking trends in the prevalence of TTIs in donated blood to adjust donor recruitment practices and/or improve educational materials on ways donors can maintain a healthy lifestyle and reduce their risk of infection with HIV; tracking program costs to develop cost-recovery and other systems to ensure the program’s sustainability.

Technical Requirement (TR) #7

Training: Contractor may assist with development of a training plan for in-service, pre-service, continuing education, and/or short and long term career development along with assisting with identification of appropriate venues internally or externally. The Contractor may deliver on-site classroom training or on the job mentoring or a combination as determined by the country and the particular topic and target audience. Based on a training plan the Contractor shall submit, for Government approval, an appropriate lesson plan including outcomes, objectives and assessment of comprehension or competence, in the case of a procedure. The location of the training course(s) and/or on site mentoring will be determined in consultation with the Government. The Contractor shall provide all technical instructors, trainee guides, and all other training materials such as textbooks, workbooks, manuals, evaluation forms and other documentation tailored to the requested audience and subject matter. The training shall include, but not be limited to, a combination of classroom lectures, demonstration, hands-on experience, and manual/documentation familiarization for each trainee. Training should be interactive. Training may also take the form of in-situ mentoring in which on-site assistance is provided at an individual facility to incorporate information acquired in didactic settings into the workplace, e.g. a new technology such as Elisa or a new concept or system, such as introduction of quality management or hemovigilance. The Contractor shall ensure training is based on current information, conforms to internationally approved and accepted technical knowledge and approaches and is tailored to the location and local circumstances. The Contractor may also be asked to assist with development or adaptation of curricula and materials to be incorporated into other training scenarios such as pre-service training and continuing education programs.

Topics may include any aspect of blood safety from community mobilization and donor recruitment to blood processing and distribution; logistics; transfusion practices and hemovigilence; to management and supervision. Target audience(s) will depend on the subject matter and may include but not be limited to: health care professionals (e.g. physicians, nurses, physician assistants, community health aides, counselors, laboratory technicians, blood donor recruiters and blood service administrators.)

The use of train-the-trainer methods with appropriate assessment and supportive supervision to assure quality and sustainability is strongly encouraged.

Technical Requirement (TR) #8

Sustainability: Contractor may support the development or adaptation of organizational charts and other materials to support the strengthening of the blood service. This work may also include the development of career paths, including performance-based review and promotion systems, for MOH or NBTS staff; supporting CDC’s work to identify and diversify sources of external funding; and working with CDC and NBTS/MOH customers to develop cost-recovery schemes or to calculate the costs associated with producing a unit of blood or blood products.

Technical Requirement (TR) #9 Quality Assurance: The Contractor’s proposed work in this area includes supporting efforts to ensure the overall safety of the transfusion process, from the recruitment of blood donors to the transfusion of blood and blood products and follow-up of the recipients. The Contractor will provide technical assistance in the implementation of effective quality systems, covering all aspects of NBTS activities, including quality management, development and implementation of quality standards, effective documentation systems, training of staff and regular quality assessment.

Performance-Based Matrices

Performance-Based Matrices will be used to evaluate proposals for the awards. Contractors must respond to all nine (9) technical requirements in their proposals (see evaluation criteria). Contractors should use these matrices as they respond to the evaluation criteria in their proposals. These matrices will also be used by CDC to evaluate technical tasks included in individual task orders after the global contracts are awarded. Task order evaluations will only focus on the technical areas described in the task order.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#1
Policy Development and Advocacy
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include projects aimed at advising Ministries of Health on the development of national blood safety policies and guidelines. Experience providing advice on the development of national legislation to underpin and authorize blood service activities should also be described, if possible. Appropriate advocacy work should also be described. This description should include a short description of the nature of the advocacy and how the advocacy was requested by the host country MOH or NBTS.
Reports from past projects involving policy development and/or advocacy on behalf of an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1 .

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#2
Infrastructure Development
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include advice to MOH or NBTS customers in the area of infrastructure development. Specific projects should include: Work with architects on blood bank and laboratory design; experience with good manufacturing practices (GMP) in the area of laboratory design.
Reports from past projects involving advisory services related to infrastructure development provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#3
Blood Collection
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include, but not be limited to, advice to MOH or NBTS customers on strategies to recruit and retain voluntary, non-remunerated blood donors; to increase efficiencies in the collection of blood via mobile blood drives; to improve customer service among blood collection staff; to improve technical skills among blood collection staff, especially phlebotomists.
Reports from past projects involving advisory services related to blood collection activities provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#4
Blood Testing and Production of Blood Products
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include, but not be limited to, advice to MOH or NBTS customers on laboratory techniques and algorithms used to (1) screen blood for transfusion-transmissible infections (including, but not limited to, HIV, HBV, HCV, and syphilis); (2) produce blood products; and (3) ensure cold chain storage of screened and unscreened blood at fixed sites and in transit between sites.
Reports from past projects involving advisory services related to blood testing activities provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#5
Transfusion and Blood Utilization
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include, but not be limited to, advice to MOH or NBTS customers on the development of policies and guidelines to govern the appropriate clinical use of blood. Contractors should demonstrate experience working with NBTS and clinical healthcare providers to ensure that guidelines are based on consensus. Contractors may also show experience with the development or strengthening of hemovigilance systems to monitor and evaluate transfusion practices.
Reports from past projects involving advisory services related to services related to the appropriate clinical use of blood provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#6
Monitoring and Evaluation (M&E)
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include, but not be limited to, advice to MOH or NBTS customers on Monitoring and Evaluation (M&E) strategies and methods. Past experience may include, but should not be limited to, advice on the development of data collection tools and systems, assistance for the implementation of M&E methodologies, and support to countries to ensure that data captured by M&E systems is used to inform future programmatic and technical decisions. NOTE: Past experience in M&E must relate to blood safety activities.
Reports from past projects involving advisory services related to blood safety-specific M&E activities provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#7
Training
Demonstrate past experience as a provider of blood safety-related training in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). Experience with a wide-range of training subjects should be described. Specific subjects may include, but should not be limited to: Recruiting and retaining blood donors; blood collection strategies and techniques (to include phlebotomy); quality assured laboratory practices for the screening and storage of donated blood; blood banking; blood cold chain; blood service management; policy development; appropriate clinical use of blood; hemovigilance systems.
Reports from past training exercises. Reports should show the methods used to document student participation (e.g., attendance logs) and students’ grasp of the material (e.g., pre- and post-course tests.) Reports must include dates work was performed, and contacts at the MOH or NBTS who may corroborate the information.
100% of reports contain information relevant to the requirements described in Column 1.
Customer review and observation.
Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.
An organogram or staff list indicating subject matter experts currently on staff or on sub-contract.
Government is able to confirm names on staff list.
Customer review and observation.
Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.
Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#8
Sustainability
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia).This experience should include, but not be limited to, advice to MOH or NBTS customers on sustainability issues. These may include, but should not be limited to: (1) Cost recovery schemes, (2) Costing a unit of blood, (3) Developing sustainable staffing plans and devising performance-based promotion schedules, and (4) Diversifying sources of national and external funding to reduce the NBTS or MOH’s dependence on any single source.
Reports from past projects involving advisory services related to blood safety-specific M&E activities provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

Technical Requirement
Measures of

Success Indicators

Standards - Criteria for Acceptance
Method of Surveillance
"Incentives" Positive or Negative
TR#9
Quality Assurance
Demonstrate past experience working with Ministries of Health (MOH) and/or National Blood Transfusion Services (NBTS) in sub-Saharan Africa and at least one other geographical region (e.g., Southeast Asia, the Caribbean, and Central Asia). This experience should include, but not be limited to, advice to MOH or NBTS customers on quality assurance. Quality assurance components may include, but should not be limited to: (1) organizational management; (2) quality system standards; (3) documentation; (4) training; and (5) quality assessment.
Reports from past projects involving advisory services related to quality assurance activities provided to an MOH or NBTS customer. Reports must include dates work was performed, as well as contacts at the MOH or NBTS who may corroborate the information in the report.
100% of reports contain information relevant to the requirements described in Column 1.

Customer review and observation.

Evaluation of past performance reports will inform the Government’s decision to award the base contract or exercise future task order options.

C.5 Government Furnished Property The US Government will not provide contractors with any material or logistical support for the implementation of activities funded through these task orders.

C.6 References

For additional background information on PEPFAR or the WHO Aide Memoire, please see the following links:

www.pepfar.gov www.who.int/bloodsafety

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

FAR SOURCE
TITLE AND DATE
52.246-1
Contractor Inspection Requirements (Apr 1984)
52.246-5
Inspection of Services - Cost-Reimbursement (Apr 1984)

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Project Officer) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance

FAR SOURCE
TITLE AND DATE
52.242-15
Stop-Work Order (Aug 1989)
52.242-15 Alternate I
Stop-Work Order - Alternate I (Apr 1984)
52.242-17
Government Delay of Work (Apr 1984)

F.1 Period of Performance (Task/Delivery Order Contracts) (Jul 1999)

(a) Contract: The period of performance of this contract shall be a period of 5 years. The effective date of the contract is shown on the face page of the contract.

(b) Task Orders: The time for completion for each task or delivery order shall be determined under each individual task or delivery order through the mutual agreement of the parties involved. Task/delivery orders under this contract may be awarded by the Contracting Officer at any time within the contract period. The actual performance of the work may extend beyond the contract period.

(End of Clause)

F.2 Place(s) of Performance (Jul 1999)

It is anticipated that the Contractor shall perform all work under this contract at the foreign (non-US) locations specified in each task order: see list of potential countries in attachment J-1 immediately following section M.

(End of Clause)

Section G - Contract Administration Data

G.1 Reimbursement of Cost (Apr 2000)

(a) For the performance of this contract, the Government shall reimburse the Contractor the cost determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with the clause entitled Allowable Cost and Payment in Section I, Contract Clauses. Examples of allowable costs include, but are not limited to, the following:

(1) All direct materials and supplies which are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders.

(2) All direct labor, including supervisory , that is properly chargeable directly to the contract, plus fringe benefits.

(3) All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.

(4) Special expenditures which, upon request from the Contractor, the Contracting Officer approves as being an allowable cost under this contract, such as purchase or lease of office furniture or equipment, etc..

(5) All travel costs plus per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract. These costs will be in accordance with the Contractor’s policy and subject to the following:

(i) Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).

(ii) Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.

(iii) Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

(iv) Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.

(b) Except as stated herein, the Contractor shall not incur costs unless the prior written authorization of the Contracting Officer has been obtained. When costs are incurred without such prior authorization, with the intent of claiming reimbursement as direct costs, it shall be at the contractor’s risk.

(End of Clause)

G.2 Negotiated Indirect Cost Rates (Feb 2000)

(a) Notwithstanding the provisions of the clause entitled Allowable Cost and Payment in Section I, Contract Clauses, allowable indirect costs under this contract shall be determined by applying the following negotiated indirect rates to the bases specified below:

TYPE
RATE
LOCATION
APPLICABLE TO
BASE

Bases:

(1)

(b) The above rates are provisional billing rates only and shall apply from the date of award until such time as the contract is amended. Any modification to change the above rates will also state the effective period covered for the new rates.

G.3 Payment of Fixed Fee (Jan 2000)

The fixed fee for each performance period stated in the contract will be paid in equal monthly or bi-monthly amounts up to 85% of the fee for that period. In accordance with FAR 52.216-8, Fixed Fee, incorporated by reference in Section I, the Contracting Officer may withhold the final 15% of the fee for each period, or $100,000 whichever is less, until audited final rates are determined or until a closeout agreement is negotiated.

G.4 Evaluation of Contractor Performance (Service) (Jan 2000)

(a) Purpose

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the Project officer and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

G.5 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.6 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.7 Contracting Officers Technical Representative (COTR) Technical Guidance (Sep 2009)

Performance of the work hereunder shall be subject to the technical directions of the designated COTR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COTR is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the delegation memorandum for the COTR. Any changes in COTR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

G.8 Payment by Electronic Funds Transfer (Dec 2005)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by…

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