Attachment I -- Performance Work Statement.docx

Service: Blood Donor Testing

Location: NMC San Diego

Date: 9/1/2025

PART 1

PERFORMANCE WORK STATEMENT

IN ADDITION TO THE BASIC CONTRACT PWS, THE FOLLOWING TERMS AND CONDITIONS ARE REQUIRED:

1.4. Description of Services: Testing blood donors for blood type, transfusion transmissible infections (TTI), and screening for blood group antibodies is a key component of the process of providing safe, pure, and potent blood products for NMRTC San Diego, in addition to the Department of Defense (DOD) in support of service men and women conducting operational missions around the world, military retirees, and dependent communities. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform donor testing the Blood Donor Center at NMRTC San Diego as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.4.1. This TO is issued under the following arrangement:

This is a non-personal services contract to provide FDA-licensed donor testing for the Blood Donor Center at NMRTC San Diego.

1.4.2. Performance Location: The work shall be performed at the vendor’s FDA-licensed testing site.

1.5. General Information:

1.5.1. Key Government Personnel: The following personnel are considered key Government personnel at the TO level:

1.5.1.2. Contracting Officer’s Representative (COR): The following individual is designated as the COR for this TO and Vendor will be notified of any changes:

Name of COR:

Mr. Arman Jamuval Inventory Management Specialist Navy Medicine Readiness and Training Command Laboratory Department ☏ 619-532-5360 ✉️ arman.k.jamuval.civ@health.mil

1.5.6. Recognized Holidays: Contractor is not required to perform services on holidays.

Independence Day

PART 2

DEFINITIONS AND ACRONYMNS NOT FOUND IN BASE CONTRACT PWS

2.1. Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.1.7 Insert additional Definitions here

FDA-licensed blood donor testing – the list of mandatory tests to be completed on all blood or blood product donations. The list of tests and acceptable testing methodology is listed on the FDA website at: https://www.fda.gov/vaccines-blood-biologics/blood-donor-screening

2.2 Acronyms:

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. Government Furnished Items and Services:

3.1. General: The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below:

3.1.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below:

3.1.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

3.1.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Items and Responsibilities:

4.1. General: The following additions are made to the Contractor furnished items and services for this TO

4.1.1 Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below:

4.1.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.1.3 Secret Facility Clearance: Not applicable.

4.1.4 Materials: IATA/DOT-compliant shipping containers, external labels, and fillable shipping manifest documentation (as required by contractor).

4.1.5 Equipment: Not applicable.

4.1.6 Facilities: Not applicable.

PART 5

SPECIFIC TASKS

5.8. Requirements:

Specimen Testing:

a. Using Food and Drug Administration approved methodologies for testing volunteer blood donations, Vendor must provide accurate testing of received specimens in accordance with facility guidelines.

b. Vendor will deliver test results the NMCSD Blood Donor Center via email no later than 1300 the day following receipt of the donor specimens. In the event an email option is not functioning, the Vendor will fax test results in an easy to read format. Preferred method of test result reporting is a digital file which can be uploaded into the current Blood Establishment Computer System (BECS).

c. Vendor must maintain licensure by the Food and Drug Administration and ensure all test methods employed are approved by the FDA for use in blood donation testing.

d. Vendor will immediately notify the NMCSD Blood Donor Center of any delays or inability to transport donor specimens to the testing facility.

e. Vendor will provide all required facilities, personnel, services, equipment, and supplies to provide blood donor testing services to deliver interrupted performance of donor testing.

f. Vendor will maintain all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations. Current licensure and accreditations will be reported on an annual supplier qualification form sent by the NMCSD Blood Bank Quality Assurance Division.

g. Vendor will guarantee any subcontractors performing services hereunder shall meet the same requirements and any applicable State requirements. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be made available upon request.

f. Vendor will verify all employees perform duties in accordance with their level of license and certification. Vendor will ensure all testing staff complies with the minimum Federal, State, and local law qualifications/requirements.

g. Vendor will ensure each referral laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations.

h. Vendor will provide all necessary instructions for sample submission, paperwork required for sample submission, transport boxes, coolant devices, and packaging materials.

i. Vendor will ensure specimen transportation occurs in a timely fashion without reliance on FedEx.

j. Vendor will provide results for the following donor testing:

Anti-HIV-1/2, Anti-HTLV-I/II, Anti-HBsAg, Anti-HCV, Anti-HBc, HIV/HCV/HBV NAT (Multiplex, Pool, or Discriminatory), WNV (IDS or Pool), ABO/Rh, AB Screen, Syphilis, CMV

Anti-A, Anti-B Antibody Titers, ≤ 1:256 depending on methodology

HLA-1,2 for TRALI mitigation (when ordered)

West Nile Virus (IDS when indicated by local public health officials)

Babesia (IDT or Pooled)

T. cruzi antibody (Chagas)

Confirmatory testing as required

k. Vendor will ensure all confirmatory and/or supplemental testing is performed within 28 days upon receipt for the following tests:

Hepatitis B Surface Antigen (EIA) Hepatitis B Virus Core (EIA) Human T- Lymphotropic Viruses Type I & II (HTLV 1/11) (EIA) Human Immunodeficiency Virus (EIA/NAT) Hepatitis C Virus (EIA/NAT) Hepatitis B Virus (NAT) Treponema pallidum (Syphilis) T. cruzi antibody

l. Vendor will ensure the accurate and timely performance of laboratory testing services. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions as established by accrediting and licensing agencies.

m. Vendor will notify the NMCSD Blood Donor Center of improper specimen submission and rejection. Notification of rejected samples/shipments will be sent electronically to the current points of contacts provided by the customer.

n. Vendor will communicate testing errors or discrepancies to the attention of the representatives of the blood donor center immediately upon discovery.

4. Hours of Operation:

a. Vendor must be available by telephone every working day from Monday through Sunday during the business hours of 0730-1700 in accordance with the NMCSD BDC blood drive schedule.

5. Transportation of Specimens to Testing Facility:

a. NMCSD BDC will provide transportation of samples to San Diego International Airport Air Cargo facilities for transport by vendor’s contracted shipping partner. Vendor must provide specimen pick-up at the destination facility for transportation to the testing facility.

b. If offering door-to-door services, the Vendor’s Specimen Transport driver must contact the NMCSD BDC at (619) 532-6655 upon arrival at Naval Base San Diego to receive the specimen shipment. Cancellation of transport of specimens must be made by the NMCSD BDC no later than 1200 on the same day of the scheduled pick up.

c. Vendor must ensure cold chain requirements and integrity of the specimens is maintained from during the entirety of transport to the testing facility.

d. Shipment of specimens through FedEx is not acceptable. Vendor must have an agreement in place with commercial air cargo offering same-day delivery.

6. Technical Support:

a. Telephone support for technical and operational questions must be available every day of the week from Monday through Sunday during the business hours of 0730-1700.

b. The Vendor must have an information technology technician available to assist with maintaining, repairing, troubleshooting, and training on the testing computer information system.

5.8.1 Invoice for Services: The Contractor shall invoice for services as follows:

Through WAWF system.

PART 6

OTHER TERMS, CONDITIONS, AND PROVISIONS

N/A

PART 7

APPLICABLE PUBLICATIONS

7.1. Publications: The Contractor shall abide by these additional applicable service regulations, publications or manuals:

7.1.1 DODI 6480.04 – Armed Services Blood Program

7.1.2 OPNAVINST 6530.4B – Department of the Navy Blood Program

TECHNICAL EXHIBIT 1

PROGRAM PERFORMANCE SUMMARY (PPS)

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