SOW_01142022_jt.docx

1. Introduction The National Institutes of Health (NIH) Clinical Center is a 200-inpatient bed biomedical research hospital with an active outpatient component. The Department of Transfusion Medicine (DTM) operates an FDA-licensed, hospital-based blood bank that collects and processes blood components for transfusion and for laboratory research use. In addition, it collects and processes (Human Cell, tissue and cellular and tissue-based product (HCT/P) for cellular therapy and laboratory research use. Laboratory tests required for lot release of these products are performed according to FDA regulations and AABB Accreditation Standards. Products are collected 6 days/week, Monday - Saturday.

The DTM collects and tests approximately 12,000 products each year as well as processes pre-assessment samples for screening on unrelated donors for bone marrow and cellular transplant as follows:

1.1 Scope

The contractor shall provide all required facilities, personnel, services, transportation, materials equipment, and supplies required to provide blood donor testing services in support of the National Institute of Health, Department of Transfusion Medicine. All test shall be executed at the contractor’s premises or within the contractor’s network of the laboratories. Contractor shall have a Plan to ensure no delay or stoppage of services.

1.2 Testing Requirements

STATEMENT OF WORK – Laboratory Specimen Testing for Transfusion Medicine

DTM requires testing panels to be performed on each specimen with supplemental and/or confirmatory testing as needed based on FDA regulations and agreed upon test algorithms. These may change based on new FDA guidance or AABB recommendations. The standard test panel shall include as follows. Pooled testing for routine NAT testing is acceptable, Individual NAT testing must be performed on all HCT/P donor products:

(Note: T.cruzi, Babesia and HLA only performed on select collections)

Additional testing will be requested and added ad-hoc on specific samples due to sample storage issues, sample type, Non ISBT label type and special requests. These samples will consist of the following but not inclusive,

The Contractor Shall:

· Perform all testing in accordance with the Food and Drug Administration (FDA) regulations for the manufacturing of blood products and for blood bank reference lab testing.

· Must be certified by Centers for Medicaid and Medicare Services for performance of the laboratory tests The Contractor must agree to scheduled audits by NIH Clinical Center DTM QA Officers of the testing laboratory's quality management system as needed.

· Be capable of testing and reporting results for approximately 12,000 specimens per year for the test panels. The contractor must be capable of providing testing services seven days/week on multiple shifts for testing panels.

· Perform testing (initial donor screen) within 12 hours of receipt and results within 24 hours of receipt or as an agreed upon timeframe by the NIH

· Must provide assurance that it has alternate testing sites or arrangement in the event that one testing location is not operational (e. g , if a Nucleic acid Amplification Testing (NAT) lab is temporarily decommissioned due to contamination issues).

· Ensure each laboratory possesses all legally-required licenses, certifications and accreditations in accordance with Federal statute and implementing regulations well as those of the state in which laboratory is located.

ISBT LABELED

Line item #

Additional Samples: May be NON ISBT LABELED and/or ISBT labeled. NON ISBT labels will be code 128

HIV, HCV, HBV, HTLV or T.cruzi Reentry. Confirmatory/ Supplemental samples, as well as various donor profiles. Zika, Babesia Toxoplasma Gondii, Anti –CMV (Cytomegalovirus Antibody), HLA, Malaria, EBV (Epstein Barr virus), Dengue and Toxoplasma sp.

Note: This list is not inclusive, subject to change based on new or revised FDA guidance or AABB recommendations

1.3 Testing Methods

Testing methods must be FDA approved/cleared for use in blood donor screening and meet minimum sensitivity standards as determined by the FDA. Test algorithms must be performed according to current FDA regulation and published guidance, and shall be agreed upon with DTM. HCT/P specimens shall be tested in accordance with FDA requirements. Testing methods used for supplemental and confirmatory testing shall be FDA approved/cleared when an FDA approved method exists.

Specific requirements for blood donor screening and supplemental or confirmatory tests include (these requirements may be revised based on current knowledge from FDA guidance or other recommendations, i.e. - AABB):

Volumetric Limitations of Donor samples.

The Contractor must perform all required tests for the routine transfusion donors and the HCTP donors, including the combination of required tests and special/ad-hoc requested tests (including but not limited to: Chagas, , Babesia, Cytomegalovirus (CMV), and Human Leukocyte Antigen (HLA) testing); using a maximum volume of 24 mL of whole blood from each donor [i.e. (4) 6mL vacutainer tubes or a combination of vacutainer tubes not to exceed a total maximum volume of 24mL or another volume as agreed upon by the Department of Transfusion Medicine (DTM)].

Compatibility of Donor Testing resultant with Blood Bank Computer Systems, Inc. (BBCS) Software.

The contractor has the capability of submitting the test results electronically that will interface with BBCS successfully and accurately [i.e. the use of SSH File Transfer Protocol or Secure File Transfer Protocol (SFTP)]

Anti-HBcore HBV NAT (TMA is preferred method, multiplex pooled assay acceptable as initial screening test, Individual testing required for HCT/P donors) Secondary HBsAg test and/or HBsAg neutralization or acceptable equivalent Discriminatory HBV NAT

HIV-1/2

Anti-HIV-1/HIV-2 EIA HIV-l NAT (TMA is preferred method, multiplex pooled assay acceptable as screening test, individual testing required for HCT/P donors) HIV-1/2 Supplemental Assay HIV-1 IFA or acceptable equivalent tests that meet FDA guidelines for confirmatory/supplemental testing.

For donor eligibility for re-entry or reinstatement such as HIV-1 IFA, HIV-2 EIA HIV-2 Western blot Anti-HIV-1 Whole Virus Lysate Discriminatory HIV-1 NAT

If pooled, must trigger to ID NAT based on current triggering policies by FDA/AABB (contractor trigger and/or NIH trigger) WNV IgM WNV IgG (not required) Alternate WNV PCR/NAT method upon request

Immunohematology tests:

1.4 Shipping Requirement

All deliverables under this contract shall be packaged, monitored, shipped in accordance with IATA standards or regulations and method/process shall be described by the contractor. The Contractor shall guarantee that all required materials shall be delivered in immediate, usable and acceptable condition.

Describe alternative packaging and shipping requirements for extreme weather conditions or “Acts of GOD.” The testing laboratory must be able to receive same day or overnight shipments seven days/week.

1.5 Performance Requirements /Tasks

The Contractor shall report upon completion of the testing and verification of results for accuracy within 24 hours period via electronic submission, email or fax. Electronic Submission of results must be compatible with BBCS (blood bank computer systems) or computer donor system that NIH has implemented. Observed and/or numerical results (e.g., OD values, cutoff value or equivalent) shall be available for all reactive, borderline, or indeterminate specimens if requested. The Contractor shall provide reports via FAX, secure email or via a validated electronic interface. Follow-up Antibody ID results shall be reported within 24-48 hours of observation of discrepancy. Follow-up confirmatory and supplemental test results shall be reported within 3-5 business days, or acceptable time frame agreed upon by DTM after reporting of the repeat reactive screening test.

The Contractor is responsible for the following:

· Additional testing ad-hoc (this list is not inclusive, subject to change based on updated guidance by FDA or AABB and requested upon implementation of guidance)

· Specimen management

· Providing description of specimen suitability requirements for the laboratory tests listed in 1.2

· Providing description of specimen suitability requirements for the laboratory tests listed in 1.2 for extreme conditions (hot or cold).

· Providing request forms for submission for ad hoc testing and ad hoc panels. These forms will be updated and revised by the contractor.

· Providing the government with adequate notification and time for implementing any changes, revisions or updates to test changes, form revisions, computer updates etc.

1.6 Result Reporting

The contractor shall provide reports of donor testing to the Department of Transfusion Medicine within a 24 hour turn-around time of receipt. Blood donor testing reports shall be electronically transmitted or faxed in a portable document format. Electronic submission must be compatible with BBCS or computer donor system implemented within DTM.

2. Security Requirements Baseline Security Requirements

A Non- Disclosure Agreement (NDA) is necessary for contractors who will require access/inadvertent access to sensitive and/or personally identifiable information in the course of their assigned task(s). (See attached Contractor Non-Disclosure Agreement form.)

3.1 Non-Personal Services

The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer immediately.

3.2 Business Relations

The Contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

3.3. Contract Management

The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor must maintain continuity between the support operations on-site at NIH and the Contractor's corporate offices.

3.4 Training Requirements

The Contractor shall ensure that each contract employee successfully completes all training programs, Competency Assessment programs and Quality Assurance programs which ensures staff are capable of performing the testing and affiliated tasks.

3.5 Contract Administration

The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to Government requests for contractual actions in a timely fashion. The Contractor shall have a single point of contact between the Government and Contractor personnel assigned to support contracts or task orders. The Contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement.

3.6 PERIOD OF PERFORMANCE

The period of Performance for the Base year and Four (4) option periods is anticipated to be as follows: