Donor Recruitment Collection and Apheresis Services -(SOW - 6M) KW 08022023.pdf

07/29/2023

SOW for Donor Recruitment; Plt Apheresis, and Blood Products for Research, and Donor Safety Page 1

ATTACHMENT I

STATEMENT OF WORK

I. Background

To meet the needs of a 200-bed inpatient service, including a combined NHLBI/NCI/NIAID 26-bed allogeneic hematopoietic stem cell transplant unit and a busy outpatient transfusion service, the DTM will require approximately 5,000 units of red cells, 3,200 plateletpheresis concentrates containing approximately 32,000 units of platelets, 1,500 units of plasma, 500 units of cryoprecipitate, and 50 units of white cell concentrates each year. In addition to these standard blood components, a variety of more complicated, large-volume apheresis procedures from healthy volunteer donors are required to supply highly specialized products for investigator-initiated research.

II. Objectives

A. To administer a donor recruitment and collection program involving:

1. Voluntary whole blood, red cell apheresis, plateletpheresis, plasmapheresis, and leukapheresis donations for transfusion purposes.

2. Whole blood and apheresis donations in support of Institute research.

3. Maintenance of a computerized file of 2,500 active HLA-typed donors available for apheresis donations on an emergency basis.

B. To schedule donors for whole blood and apheresis procedures sufficient to meet the transfusion needs of Clinical Center patients and the research needs of NIH investigators.

C. To perform red cell apheresis, plateletpheresis, plasmapheresis, and leukapheresis procedures sufficient to meet the transfusion needs of Clinical Center patients. Due to the usual absence of a physician at the Fishers lane facility, an RN should be present at all times in the event of an adverse reaction.

D. To perform whole blood collections and automated apheresis procedures to supplement research and transfusion needs that cannot be met by the CCND.

E. To provide information technology support needed by the contractor to manage its functions.

F. To provide blood donor advocacy, safety and support services, including activities related to health maintenance, notification of positive infectious disease markers and follow-up epidemiological studies and re-entry testing related to such positive markers, donor counseling, and hemovigilance services in documenting donor and recipient adverse events.

G. To provide donor-related research support and protocol navigation services, including data management and analysis, and quality assurance oversight functions.

Successful performance will assure that the transfusion needs of Clinical Center patients can be met in a timely fashion, and that all component requests in support of investigator-initiated research can be supplied. All activities must be performed in compliance with applicable FDA regulations, AABB accreditation standards and DTM Policies and Procedures.

III. Work to be Performed

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed

SOW for Donor Recruitment; Plt Apheresis, and Blood Products for Research, and Donor Safety Page 2 to perform the statement of work below:

Maintain a Government-provided facility and program for whole blood and apheresis collections from a donor pool for use by the National Institutes of Health

Specifically, the contractor shall provide the following:

A. Donor Program

1. Recruit for and maintain registries of active, eligible donors from the NIH, government and contract employees working in the area around the main campus in Bethesda and satellite collection facility in Rockville, MD, and residents of the surrounding communities as follows:

Category Blood group Minimum number active, eligible donors*

Volunteer blood donors who donate primarily whole blood for transfusion purposes

O 3,000

A 2,000

B 700

AB 200

Individuals who donate primarily apheresis products for transfusion purposes (HLA typed)

O 1,000

A 1,000

B 400

AB 100

Paid blood donors who donate primarily apheresis products for laboratory research purposes all blood types 1,000

*Active eligible donors are those who meet FDA, AABB and DTM criteria for blood donation, have donated at NIH within the last three years, and are not permanently deferred.

2. Schedule whole blood and apheresis donations at the NIH Department of Transfusion Medicine in Bethesda, MD and satellite collection facility in Rockville, MD, sufficient to meet the transfusion needs of Clinical Center patients and the research blood product needs of the NIH Institutes.

Schedule donations each day according to hourly collection capacity as follows:

Category Schedule (approximate)

Average Daily Collections

Volunteer blood donors who donate primarily whole blood for transfusion purposes, with 60% of those scheduled being group “O” donors

Monday - Friday, 7:30 am - 6:00 pm*

25**

Individuals who donate primarily apheresis products for transfusion purposes

Monday - Friday, 7:30 am - 8:00 pm

Sat., 8:00 am - 4:00 pm 6

Volunteer or paid blood donors who donate primarily whole blood and apheresis products for laboratory research purposes

Monday - Thursday, 7:00 am - 3:00 pm

*with ability to expand hours up to 9:00 pm and on Saturdays if needed to meet unusual demand **collections may need to surge to higher numbers to meet occasional unusual demand.

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3. Provide donor advocacy, safety and support services.

• Notify and counsel donors who have abnormal screening results

• Schedule follow-up visits for donors eligible for re-entry

• Trace and follow-up with donors and recipients involved in possible transfusion related disease transmission

• Manage and conduct hemovigilance and donor safety programs

• Document, record, analyze and report donor adverse events

• Assist donors seeking copies of their donor records

• Educate donors needing clarification regarding informed consent issues

• Administer informed consent and provide nursing care for donors enrolled in DTM clinical Protocols

• Provide protocol navigation support for donors enrolled in DTM clinical protocols related to platelet and granulocyte product development, and protocol coordination for long term whole blood, platelet and granulocyte donor and transfusion safety studies.

• Manage donor complaints and special needs

4. Provide Information Systems expertise as required to manage and support the contractor’s functions.

B. Apheresis program

1. Perform donor screening health history and mini-physical to qualify potential donors prior to apheresis.

2. Arrange for and forward specimens for high-resolution HLA typing on new donors.

3. Draw whole blood samples from all prospective donors at the time of each apheresis donation for the performance of laboratory testing as required by FDA, AABB and DTM. Ensure that pre-donation samples are delivered to DTM, and/or shipped under appropriate temperature control in accordance with DTM SOPs.

4. Prepare summary reports of pre-donation CBC results to be reviewed monthly, quarterly or as requested by the Chief, Blood Services Section. All CBCs that fall outside of the acceptable range as listed in the relevant DTM Standard Operating Procedures (SOPs) shall be brought to the attention of the Chief, Blood Services Section. The BSS Chief shall be responsible for temporarily or permanently deferring potential donors based on pre-donation CBC criteria for eligibility as detailed in the Donor Area SOP and may delegate this task to Donor Safety Officer.

5. Supply licensed, qualified nursing personnel to administer medications to the donor that are designed to maximize granulocyte yields, as directed by the Chief, Blood Services Section. These medications shall include filgrastim (rhG-CSF, Neupogen) and dexamethasone, which will be supplied by the Clinical Center Pharmacy Department.

6. Perform automated apheresis as follows:

Category Anticipated # collections per year

Schedule (approximate)

Average Daily Collections

Plateletpheresis for transfusion purposes1, with approximately 25-30 % HLA matched donors, minimum 3 x 1011 platelets per collection

3,200

M - F, 7:30 am - 8:00 pm

Sat, 8:00 am - 4:00 pm

Granulocytapheresis for transfusion purposes, minimum 1 x 1010

Up to 50 M - F, 7:30 am - 2:00 pm up to 2

SOW for Donor Recruitment; Plt Apheresis, and Blood Products for Research, and Donor Safety Page 4 granulocytes/unit2 Sat, 8:00 am - 2:00 pm up to 2

Apheresis products for laboratory research purposes, including lymphocyte, monocyte, granulocyte, platelet, and plasma collections.

M - Th, 7:00 am

- 3:00 pm up to 4

1 Performance of apheresis procedures on holidays will not occur on a routine basis, but may be scheduled with advance notice by the Chief, Blood Services Section, depending on clinical needs.

On holidays, a maximum of 8 procedures may be scheduled between 8:00 am through 4:00 pm.

2Incident reports will be generated for any granulocyte product for transfusion < 1.0 x 1010 neutrophils, e.g. for pediatric recipients, etc.

7. Prepare samples for quality control testing and distribute to DTM laboratories.

8. Store and distribute apheresis components to DTM.

o Arrange for and assure that plateletpheresis concentrates are stored at room temperature and delivered to DTM by 3:00 pm daily.

o Arrange for and assure that plasma components and leukocyte concentrates are stored at room temperature and delivered within two hours of donation.

9. Create and maintain standard operating procedures (SOPs) pertinent to donor recruitment, scheduling, and apheresis donation, consistent with the policies, requirements and standards of the DTM, AABB, and FDA.

10. Maintain Government-provided facility of approximately 4,000 square feet in size on space supplied by the Government. All utilities, equipment, furnishings, parking spaces and housekeeping services will be provided by the Government.

11. All products for transfusion must meet FDA and AABB requirements concerning donor screening and testing for agents of transfusion-transmissible disease.

C. Research Blood Products Program

1. Develop, administer and manage a program for Principal Investigator (PI) and proxy registration, product ordering, donor recruitment and scheduling, collection of blood products by donor phlebotomy or apheresis, preparation of blood products as specified by the requester, issue of the research blood products, and accounting for products issued.

D. Create and maintain blood manufacturing records

1. Organize and maintain complete records according to the requirements of the Center for Biologics Evaluation and Research as outlined in the Code of Federal Regulations, Title 21, Parts 211, 606, 640, and 1271 as applicable. These records shall be available for review/audit by the Chief, Blood Services Section and DTM Quality Assurance Officer at any time.

2. All records related to donor recruiting, scheduling, screening, collection and product manufacture will be the property of the U.S. Government.

3. Maintain electronic records of all donor screening interviews, including donor health history questionnaire and physical examination. Scan paper documents into digital system for archiving donor screening interviews in electronic form.

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4. Maintain computerized records of all apheresis donations, including pre- and post-apheresis CBCs where applicable, product CBCs, and trends in product yields by various apheresis machines.

5. Adhere to and abide by the Standard Operating Procedure manuals for the DTM. Establish and adhere to a schedule for ongoing training, reeducation and review of the principles of quality control, quality assurance, and continuous process improvement, as described in the DTM’s Quality Plan.

E. The Contractor shall meet the following minimum conditions:

1. The contractor shall be prepared to perform recruitment, sampling, whole blood collections and apheresis during the hours of 7:30 am through 8:00 pm, 5 days a week, Monday through Friday, and to perform whole blood collections and apheresis on Saturdays, 8:00 am through 4:00 pm as may be needed to maintain specified PAR levels.

2. The Contractor is responsible for scheduling personnel and potential donors to meet the transfusion needs of all Clinical Center patients, as specified by DTM inventory targets.

3. Physician coverage for whole blood collections and apheresis procedures will be provided by the Government. No costs or risks associated with donor reactions or medical care arising from the blood or apheresis donations are reimbursable under this contract.

4. The recruitment of donors at the National Institutes of Health or in the community is to occur under plans acceptable to the Chief, Blood Services Section who shall give his/her written approval to such plans.

5. All donor eligibility determinations, whole blood collection and apheresis procedures shall proceed in accordance with FDA regulations and guidelines and AABB accreditation requirements.

6. In addition, platelet and white cell counts in apheresis donors shall be followed serially, as specified by the Chief, Blood Services Section and detailed in the DTM SOP.

7. The Contractor shall bear full responsibility for the performance of all work and services involving the use of donors under this contract and shall act in a proper manner and as safely as feasible.

8. Whole blood and apheresis donor visit and eligibility records will be integrated into a computerized DTM donor database as directed by the Chief, Blood Services Section.

9. Staff shall be qualified, trained and competent to perform assigned duties in compliance with DTM

SOPs and regulatory requirements. Records of qualification, training and competence shall be available for review by the Chief, Blood Services Section and DTM Quality Systems Officer at all times.

10. The Contractor shall operate under the NIH Clinical Center registration and license for FDA regulated blood and cellular therapy product manufacturing activities.

F. Special Conditions

1. Donors in existing NIH apheresis donor files as well as newly recruited donors may not be referred for donations at any other facility or institution without permission of the Chief, Blood Services Section.

2. Donors may not undergo apheresis for any recipient other than those at the Clinical Center. In special cases, individuals designated as suitable recipients outside of the NIH must be approved by the Chief, Blood Services Section.

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G. Estimated Requirements for Apheresis Program

1. Capability to collect an average of twelve (12) six-unit plateletpheresis concentrates, 5 days/week (Monday through Friday), and an average of six (6) six-unit plateletpheresis concentrates per day on Saturdays and holidays as needed to maintain specified minimum PAR levels.

2. Capability to perform granulocytapheresis on a maximum of two donors daily, 6 days/week, including Saturdays and holidays when necessary.

3. Capability to schedule and collect cellular and plasma apheresis donations to support Clinical Center and Institute research needs. The total number of research apheresis procedures scheduled and collected daily shall not exceed 10 per day, four days per week, Monday through Thursday.

4. Capability to perform a maximum of 4 cytapheresis or plasmapheresis procedures daily, four (4) days per week, Monday through Thursday, in support of institute research needs.

5. Capability to schedule sufficient whole blood donors such that an average of 25 whole blood donor phlebotomies are performed daily, 5 days per week, Monday through Friday, and up to 10 when needed on Saturdays and holidays.

6. Capability to maintain an HLA-typed apheresis donor file of a minimum of 2,500 active and available donors. Donors with specific HLA types for specific recipients must be recruited to the satisfaction of the Chief, Blood Services Section.

7. Capability to maintain, upgrade and enhance whole blood, and apheresis donor databases. Includes management of validation, documentation and regulatory compliance issues.

H. Reporting Requirements

1. Technical Progress Reports In addition to the required reports set forth elsewhere in this schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods.

The frequency and specific content of these reports will be determined during negotiations, but are to include at a minimum:

Specific Content of Reports:

a. Donor Recruitment Activity

i. Number of new donors

ii. Number of whole blood collections

iii. Size and blood group distribution of the active blood donor registry

b. Platelet and Granulocyte Apheresis Procedures

i. Numbers of donors presenting, numbers and reasons for deferrals

ii. Numbers of procedures

iii. Cellular yields, means, ranges, and efficiencies

iv. Volumes of products

v. Trends, particularly when machine modifications/upgrades are made

vi. Donor pre- and post-apheresis counts (mean, range, outliers)

vii. Quality Control monitoring data (both in aggregate and by machine type)

c. Research Blood Products Program

i. Numbers of donors presenting, numbers and reasons for deferrals

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ii. Numbers of procedures

iii. Cellular yields, means, ranges, and efficiencies

iv. Volumes of products

v. Trends, particularly when machine modifications/upgrades are made

vi. Donor pre- and post-apheresis counts (mean, range, outliers)

vii. Number of investigator requests for research blood products that are filled

Frequency of Reports:

For proposal preparation purposes only, it is estimated that electronic copies of these reports will be required as follows:

Monthly Quarterly Annually Final upon final completion of the contract

2. Summary of Salient Results The contractor will be required to prepare and submit, with the final report, a summary (not to exceed

200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

3. Other Reports Monthly Financial Statements/ Invoices

Direct Labor Fringe Benefits Materials and Supplies Travel & Training G & A