Blood Supply Services - Solicitation FINAL 4.16.2020.pdf

Blood Supply Services – Navajo Area Indian Health Services Solicitation No.: 75H71020R00004

SECTION B – CONTINUATION OF SF-1449

B – 1 PURPOSE OF CONTRACT:

The Navajo Area Indian Health Service (NAIHS), and the medical facilities located in Arizona and New Mexico, requires blood supplies, blood products, and blood testing services as noted in Section B-2 (Fee Schedule). Vendors shall be capable of providing whole blood, blood bi-products and blood type testing supplies, reagents, and controls on an as needed basis for diagnostic testing and treatment of patients treated. The following are facilities needing this service:

Chinle Comprehensive Healthcare Facility in Chinle, Arizona

Crownpoint Comprehensive Healthcare Facility in Crownpoint, New Mexico

Gallup Indian Medical Center in Gallup, New Mexico

Kayenta Health Center in Kayenta, Arizona

Northern Navajo Medical Center in Shiprock, New Mexico

The sole purpose of this contract is to furnish human blood supply and blood bi-products, as well as, to provide blood-testing services to the U.S. Public Health Service, Navajo Area Indian Health Services (NAIHS) to meet direct patient care.

The Indian Health Service (IHS), an agency within the Department of Health and Human Services, is responsible for providing federal healthcare services to American Indians and Alaska Natives. The provision of healthcare services to members of federally recognized tribes grew out of the special government-to-government relationship between the federal government and Indian tribes. The Indian Health Service (IHS) is the principal federal health care provider and health advocate for Indian people and its goal is to raise their health status to the highest possible level. The IHS provides a comprehensive health service delivery system for approximately 1.9 million American Indians and Alaska Natives who belong to 564 federally recognized tribes in 35 states.

B – 2 FEE SCHEDULE:

The Contractor will be compensated a firm fixed amount for the Blood Supply and will be implemented according to the schedule of completion for each phase identified below.

Interested Proposers shall provide a summary breakdown of each subcomponent cost to the deliverable specified in proposal. An initial assessment will conducted during solicitation phase.

BASE YEAR: Date of Award to December 31, 2020:

State of Arizona Service Units:

NAIHS-FEE SCHEDULE: Chinle Comprehensive Healthcare Facility

Item Product Description Estimated Quantity

Unit Unit Price

Total

1 RBC (Leukoreduced) 331 EA

2 Fresh Frozen Plasma 64 EA

3 Platelets (Leukoreduced) 10 EA

4 Cryoprecipitated AHF Pooled 13 EA

5 ANTIGEN TYPING, PATIENT (PER

ANTIGEN)

EA

6 TYPE & SCREEN 1 EA

7 ANTIBODY IDENTIFICATION PANEL 1 EA

8 TITRATION STUDIES (PER

TITRATION)

9 CMV-Test 1 EA

10 STAT Delivery Charge 1 EA

Estimated Cost per year

NAIHS-FEE SCHEDULE: Kayenta Health Center

Unit Unit Price

Total

1 RBC (Leukoreduced) 150 EA

2 Fresh Frozen Plasma 40 EA

3 Platelets (Leukoreduced) 2 EA

4 Cryoprecipitated AHF Pooled 2 EA

5 PLAMSA PEDIATRIC UNIT 2 EA

6 ABO/RH TYPING-DONOR 60 EA

7 ABO GROUPING 20 EA

8 RH(D) TYPING 20 EA

9 TYPE & SCREEN 20 EA

10 ANTIBODY SCREEN 20 EA

11 CROSSMATCH: IMMEDIATE SPIN

(IS)

20 EA

12 STAT Processing Fee 20 EA

13 Compatibility Testing 20 EA

State of New Mexico Service Units:

NAIHS-FEE SCHEDULE: Crownpoint Healthcare Facility

Unit Unit Price

Total

1 RBC (Leukoreduced) 54 EA

2 Fresh Frozen Plasma 9 EA

3 ABO/RH TYPING-DONOR 69 EA

4 STAT CHARGE-DELIVERY 1 EA

5 ABO GROUPING 6 EA

6 RH(D) TYPING 6 EA

7 ABO/RH 2 EA

8 ANTIBODY SCREEN 8 EA

9 CROSSMATCH: IMMEDIATE SPIN

(IS)

10 EA

10 ON-CALL PATIENT TESTING FEE 4 EA

NAIHS-FEE SCHEDULE: Gallup Indian Medical Center

Unit Unit Price

Total

1 RBC (Leukoreduced) 562 EA

2 Fresh Frozen Plasma 261 EA

3 Platelets (Leukoreduced) 21 EA

4 Cryoprecipitated AHF Pooled 24 EA

5 ANTIGEN TYPING CLASS I-DONOR 2 EA

6 ANTIGEN CONFIRMATION-DONOR 1 EA

7 CMV TEST-DONOR 2 EA

8 STAT PROCESSING FEE 1 EA

9 ABO GROUPING 2 EA

10 RH(D) TYPING 2 EA

11 RH PHENOTYPE 1 EA

12 EXTENDED PHENOTYPE 1 EA

13 DIRECT ANTIGLOBULIN TEST 4 EA

14 ANTIBODY SCREEN 5 EA

15 ANTIBODY IDENTIFICATION PANEL 1 EA

16 ELUTION 2 EA

17 RED CELL SEPARATION 1 EA

NAIHS-FEE SCHEDULE: Northern Navajo Health Center

Unit Unit Price

Total

1 RBC (Leukoreduced) 420 EA

2 Fresh Frozen Plasma 60 EA

3 Platelets (Leukoreduced) 25 EA

4 Cryoprecipitated AHF Pooled 30 EA

5 STAT CHARGE-DELIVERY 20 EA

6 Antibody Identification Panel 20 EA

7 Antigen Typing 20 EA

8 Rh Phenotype 20 EA

9 Rh(D) typing 20 EA

10 Antibody screen 20 EA

OPTION YEAR ONE: January 1, 2021 to December 31, 2021:

Unit Unit Price

Total

1 RBC (Leukoreduced) 331 EA

2 Fresh Frozen Plasma 64 EA

3 Platelets (Leukoreduced) 10 EA

4 Cryoprecipitated AHF Pooled 13 EA

5 ANTIGEN TYPING, PATIENT (PER

ANTIGEN)

8 TITRATION STUDIES (PER

TITRATION)

Unit Unit

3 Platelets (Leukoreduced) 2 EA

4 Cryoprecipitated AHF Pooled 2 EA

5 PLAMSA PEDIATRIC UNIT 2 EA

6 ABO/RH TYPING-DONOR 60 EA

7 ABO GROUPING 20 EA

8 RH(D) TYPING 20 EA

9 TYPE & SCREEN 20 EA

10 ANTIBODY SCREEN 20 EA

11 CROSSMATCH: IMMEDIATE SPIN

(IS)

20 EA

12 STAT Processing Fee 20 EA

Unit Unit Price

Total

5 ABO GROUPING 6 EA

6 RH(D) TYPING 6 EA

7 ABO/RH 2 EA

8 ANTIBODY SCREEN 8 EA

9 CROSSMATCH: IMMEDIATE SPIN

(IS)

10 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 562 EA

2 Fresh Frozen Plasma 261 EA

3 Platelets (Leukoreduced) 21 EA

4 Cryoprecipitated AHF Pooled 24 EA

5 ANTIGEN TYPING CLASS I-DONOR 2 EA

6 ANTIGEN CONFIRMATION-DONOR 1 EA

7 CMV TEST-DONOR 2 EA

8 STAT PROCESSING FEE 1 EA

9 ABO GROUPING 2 EA

14 ANTIBODY SCREEN 5 EA

15 ANTIBODY IDENTIFICATION PANEL 1 EA

16 ELUTION 2 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 420 EA

2 Fresh Frozen Plasma 60 EA

3 Platelets (Leukoreduced) 25 EA

4 Cryoprecipitated AHF Pooled 30 EA

5 STAT CHARGE-DELIVERY 20 EA

6 Antibody Identification Panel 20 EA

7 Antigen Typing 20 EA

8 Rh Phenotype 20 EA

9 Rh(D) typing 20 EA

OPTION YEAR TWO: January 1, 2022 to December 31, 2022:

Unit Unit Price

Total

1 RBC (Leukoreduced) 331 EA

2 Fresh Frozen Plasma 64 EA

3 Platelets (Leukoreduced) 10 EA

4 Cryoprecipitated AHF Pooled 13 EA

5 ANTIGEN TYPING, PATIENT (PER

ANTIGEN)

8 TITRATION STUDIES (PER

TITRATION)

Unit Unit

3 Platelets (Leukoreduced) 2 EA

4 Cryoprecipitated AHF Pooled 2 EA

5 PLAMSA PEDIATRIC UNIT 2 EA

6 ABO/RH TYPING-DONOR 60 EA

7 ABO GROUPING 20 EA

8 RH(D) TYPING 20 EA

9 TYPE & SCREEN 20 EA

10 ANTIBODY SCREEN 20 EA

11 CROSSMATCH: IMMEDIATE SPIN

(IS)

20 EA

12 STAT Processing Fee 20 EA

Unit Unit Price

Total

5 ABO GROUPING 6 EA

6 RH(D) TYPING 6 EA

7 ABO/RH 2 EA

8 ANTIBODY SCREEN 8 EA

9 CROSSMATCH: IMMEDIATE SPIN

(IS)

10 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 562 EA

2 Fresh Frozen Plasma 261 EA

3 Platelets (Leukoreduced) 21 EA

4 Cryoprecipitated AHF Pooled 24 EA

5 ANTIGEN TYPING CLASS I-DONOR 2 EA

6 ANTIGEN CONFIRMATION-DONOR 1 EA

7 CMV TEST-DONOR 2 EA

8 STAT PROCESSING FEE 1 EA

9 ABO GROUPING 2 EA

14 ANTIBODY SCREEN 5 EA

15 ANTIBODY IDENTIFICATION PANEL 1 EA

16 ELUTION 2 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 420 EA

2 Fresh Frozen Plasma 60 EA

3 Platelets (Leukoreduced) 25 EA

4 Cryoprecipitated AHF Pooled 30 EA

5 STAT CHARGE-DELIVERY 20 EA

6 Antibody Identification Panel 20 EA

7 Antigen Typing 20 EA

8 Rh Phenotype 20 EA

9 Rh(D) typing 20 EA

OPTION YEAR THREE: January 1, 2023 to December 31, 2023

Unit Unit Price

Total

1 RBC (Leukoreduced) 331 EA

2 Fresh Frozen Plasma 64 EA

3 Platelets (Leukoreduced) 10 EA

4 Cryoprecipitated AHF Pooled 13 EA

5 ANTIGEN TYPING, PATIENT (PER

ANTIGEN)

8 TITRATION STUDIES (PER

TITRATION)

Unit Unit

3 Platelets (Leukoreduced) 2 EA

4 Cryoprecipitated AHF Pooled 2 EA

5 PLAMSA PEDIATRIC UNIT 2 EA

6 ABO/RH TYPING-DONOR 60 EA

7 ABO GROUPING 20 EA

8 RH(D) TYPING 20 EA

9 TYPE & SCREEN 20 EA

10 ANTIBODY SCREEN 20 EA

11 CROSSMATCH: IMMEDIATE SPIN

(IS)

20 EA

12 STAT Processing Fee 20 EA

Unit Unit Price

Total

5 ABO GROUPING 6 EA

6 RH(D) TYPING 6 EA

7 ABO/RH 2 EA

8 ANTIBODY SCREEN 8 EA

9 CROSSMATCH: IMMEDIATE SPIN

(IS)

10 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 562 EA

2 Fresh Frozen Plasma 261 EA

3 Platelets (Leukoreduced) 21 EA

4 Cryoprecipitated AHF Pooled 24 EA

5 ANTIGEN TYPING CLASS I-DONOR 2 EA

6 ANTIGEN CONFIRMATION-DONOR 1 EA

7 CMV TEST-DONOR 2 EA

8 STAT PROCESSING FEE 1 EA

9 ABO GROUPING 2 EA

14 ANTIBODY SCREEN 5 EA

15 ANTIBODY IDENTIFICATION PANEL 1 EA

16 ELUTION 2 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 420 EA

2 Fresh Frozen Plasma 60 EA

3 Platelets (Leukoreduced) 25 EA

4 Cryoprecipitated AHF Pooled 30 EA

5 STAT CHARGE-DELIVERY 20 EA

6 Antibody Identification Panel 20 EA

7 Antigen Typing 20 EA

8 Rh Phenotype 20 EA

9 Rh(D) typing 20 EA

OPTION YEAR FOUR: January 1, 2024 to December 31, 2024

Unit Unit Price

Total

1 RBC (Leukoreduced) 331 EA

2 Fresh Frozen Plasma 64 EA

3 Platelets (Leukoreduced) 10 EA

4 Cryoprecipitated AHF Pooled 13 EA

5 ANTIGEN TYPING, PATIENT (PER

ANTIGEN)

8 TITRATION STUDIES (PER

TITRATION)

Unit Unit

3 Platelets (Leukoreduced) 2 EA

4 Cryoprecipitated AHF Pooled 2 EA

5 PLAMSA PEDIATRIC UNIT 2 EA

6 ABO/RH TYPING-DONOR 60 EA

7 ABO GROUPING 20 EA

8 RH(D) TYPING 20 EA

9 TYPE & SCREEN 20 EA

10 ANTIBODY SCREEN 20 EA

11 CROSSMATCH: IMMEDIATE SPIN

(IS)

20 EA

12 STAT Processing Fee 20 EA

Unit Unit Price

Total

5 ABO GROUPING 6 EA

6 RH(D) TYPING 6 EA

7 ABO/RH 2 EA

8 ANTIBODY SCREEN 8 EA

9 CROSSMATCH: IMMEDIATE SPIN

(IS)

10 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 562 EA

2 Fresh Frozen Plasma 261 EA

3 Platelets (Leukoreduced) 21 EA

4 Cryoprecipitated AHF Pooled 24 EA

5 ANTIGEN TYPING CLASS I-DONOR 2 EA

6 ANTIGEN CONFIRMATION-DONOR 1 EA

7 CMV TEST-DONOR 2 EA

8 STAT PROCESSING FEE 1 EA

9 ABO GROUPING 2 EA

14 ANTIBODY SCREEN 5 EA

15 ANTIBODY IDENTIFICATION PANEL 1 EA

16 ELUTION 2 EA

Unit Unit Price

Total

1 RBC (Leukoreduced) 420 EA

2 Fresh Frozen Plasma 60 EA

3 Platelets (Leukoreduced) 25 EA

4 Cryoprecipitated AHF Pooled 30 EA

5 STAT CHARGE-DELIVERY 20 EA

6 Antibody Identification Panel 20 EA

7 Antigen Typing 20 EA

8 Rh Phenotype 20 EA

9 Rh(D) typing 20 EA

B – 3 DEFINITIONS:

1. Acceptance: An authorized representative of the Government has inspected and agreed that the work meets all requirements of this contract, to include documentation requirements.

2. Approval: The Government has reviewed submittals, deliverables, or administrative documents (e.g.: insurance certificates, installation schedules, planned utility interruptions, etc.)

and has determined the documents conform to contract or contract requirements. Government Approval shall not relieve the Contractor from responsibility for complying with contract requirements.

3. Regular Business Hours: Monday through Friday, 8:00am to 4:30pm.

4. Contracting Officer (CO): A Government employee with warranted delegated authority to enter into, administer, and/or terminate contracts.

5. Contracting Officer’s Representative (COR): A Government individual responsible for administration of this contract. The COR closely monitors the contract for contractor compliance and provides feedback to the Contracting Officer.

6. Contractor: The individual or firm awarded a legal binding contract to provide supplies and/or services.

7. Federal Acquisition Regulation (FAR): The FAR is the primary regulation for use by all Federal Executive agencies in their acquisition of supplies and services with appropriated funds.

8. Ordering Activity: An authorized user of IHS that may issue a task or delivery order to obtain required services under this contract.

9. Point of Contact (POC): An employee designated (by the Contracting Officer) to be the primary contact at a facility for the Contractor and Contracting Officer Representative. The Point of Contact is authorized to contact the Contractor regarding facility requirements serviced by this contract.

10. Service Unit: The local administration unit of the Indian Health Service (IHS).

11. Delivery/Task Order: In order activity issued in accordance with the terms of the contract and ordering activities’ specific requirements using the Standard Form 1449. An ordering activities written to obtain services, at a minimum will include the following where applicable:

description of services, skill categories, hours, price, period of performance, contract number, and the ordering activities task or delivery order number.

B – 4 STATEMENT OF WORK:

1. Introduction/Background. Acquisition is for blood, blood bi-products and, esoteric compatibility testing to support direct patient care in treating blood disorders or, as prophylaxis for surgical or obstetrical events.

The products obtained are utilized in transfusion services located throughout the Navajo Area to treat bleeding disorders or, as prophylaxis for trauma, surgical or obstetrical events. Service units that utilize these products and services are typically remote from metropolitan areas and, sometimes lack the technical resources to perform all of the requisite testing required by law. Consequently, the selected vendor is often relied on to perform this testing and, to supply adequate bloodstock in a timely manner.

2. Contractor is required to supply whole blood, blood bi-products and blood type testing supplies, reagents, and controls on an as-needed basis for diagnostic testing and treatment of patients treated through the U.S. Public Health Service, Indian Health Service, Navajo Area. Additional specialty blood type testing services are also required on an intermittent basis. Under very unusual circumstances (transfusion related death, very rare blood type, patients with irregular antibodies) specialized laboratory testing services of the contractor may also be required. All blood and blood bi-products must conform to the U.S. Food and Drug Administration standards where applicable and, these products and services shall be approved by the Navajo Area Clinical Director. Products, supplies and services will also conform to requirements of the Joint Commission, The College of American Pathologists and, the Center for Medicare & Medicaid Services/CLIA 1988.

(a) Contractor shall supply blood and blood bi-products for transfusion and associated testing supplies and, testing services to the Gallup, Chinle, Shiprock, Kayenta, and Crownpoint Service Units of the Navajo Area Indian Health Service as needed.

(b) Services shall be available on a 24/7 basis. Most items shall be supplied through routine shipments. However, emergent situations will require the vendor to make available product after-hours and on weekends. The Contractor shall be responsible for transportation logistics and costs related to blood and blood bi-product shipments. Navajo Area Service Units will be responsible for transportation and costs relative to specimens transported to the vendor’s reference laboratory via use of Federal Express or other transport vendors. Contractor shall provide requisitions, transport and shipping containers to the respective service unit transfusion services for the term of this acquisition.

(c) Contractor shall perform screening on all blood donors relative to their health, lifestyle and disease transmission risk factors. The contractor shall maintain permanent files on all blood donors with complete results of screening and testing.

(d) Contractor shall complete a health assessment on all blood donors that includes a questionnaire on past and present illnesses, and that assessment must satisfy minimum physiologic criteria. In addition, the contractor’s questionnaire process must attempt to identify serologically undetectable risk factors for transmissible infectious agents [ex. Viruses, bacteria, parasites and variant disease agents such as Creutzfeldt-Jakob disease], as well as other risk factors associated with lifestyle, use of narcotics, travel abroad and immigration.

(e) Contractor shall perform the following tests on all blood donated:

• ABO Typing

• Rh Factor Determination

• Blood Group Antibodies (unexpected)

• Hepatitis B Surface Antigen

• Antibody to Hepatitis B Core

• Antibody to Hepatitis C Virus

• Antibody to HTLV 1 and 2

• Antibody to HIV 1 and 2

• Serologic Test for Syphilis

• Any other test screen for transmissible disease mandated by the Food & Drug Administration as applicable to the respective blood product.

(f) Contractor shall maintain in quarantine all blood and blood bi-products that test positive for infectious agents AND, shall promptly notify the applicable Navajo Area transfusion service, or applicable patient provider, of all such testing in event shipments are received prior to test completion AND, shall offer no-cost return of all products potentially infected with all screened for infectious agents.

(g) Contractor shall ship supplies and product prepaid the most economical way.

(h) Contractor shall be responsible for providing an itemized monthly invoice for all products and supplies and for the testing rendered.

(i) Contractor shall continue to provide state-of-the art technology necessary to perform the required testing.

(j) Contractor shall supply necessary transport materials, supplies and containers sufficient to comply with National, State and Local regulations that effect transport of potentially bio-hazardous materials.

(k) Contracted Laboratory shall maintain registration with the U.S. Food & Drug Administration.

This registration will be sufficient to permit pre-analytic, analytic and post-analytic test processes necessary to report and apply interpretation of testing results, as well as bill for it.

(l) Contractor shall be required to offer cost-free return privileges for packed red blood cells that are in date i.e., are not expired.

B – 5 DELIVERABLES:

Individual facilities in the Navajo Area will arrange for routine and emergent stock supply deliveries of blood and blood products. Deliveries shall be made to the respective facilities located as follows:

Medical Facility: Address: Telephone: Fax:

Chinle Health Care Facility Off Hwy 191 Hospital Dr.

Chinle, AZ 86503

928-674-7001 928-674-7372

Crownpoint Service Unit Hwy Junction 57, Rt. 9 Crownpoint, NM 87313

505-786-5291 505-786-5840

Gallup Indian Medical Center

516 E. Nizhoni Blvd.

Gallup, NM 87301

505-722-1000 505-722-1397

Northern Navajo Medical Center

U.S. Hwy 491 N.

Shiprock, NM 87420

505-368-6001 505-368-6260

Kayenta Health Center Off Hwy 160, MP 394.3 Kayenta, AZ 86033

928-697-4000 928-697-4145

(a) Unused blood and blood products will be rotated out on a regular schedule to ensure in-date blood products are always available to NAIHS facilities. Each NAIHS facility will arrange the schedule according to their needs with the contractor for these shipments.

All deliverables of blood products must be accompanied by an itemized packing slip. Blood products used by the NAIHS facility(s) or, that expire while in the custody of the facility(s) will be billed to the respective facility. Returned products will be credited to the facility’s account. Contractor shall submit an itemized invoice for all billed deliverables for payment to be received. Shipping and packaging of blood and blood products shall be done in conformance with established law and regulations in adherence to the transport of blood and blood product regulations of the U.S. Food and Drug Administration and, the U.S. Department of Transportation. The contractor shall use a recognized shipping agent to deliver supplies to each facility. The shipping agent must utilize a shipment tracking system to ensure timely delivery of supplies. Shipping charges for routine shipments shall be borne by the contractor.

B – 6 QUALIFICATION REQUIREMENTS:

The Contractor shall meet the following requirements throughout the term of the contract:

a. Maintain registration with the U.S. Food and Drug Administration.

B – 7 APPLICABLE DOCUMENTS

a. American Association of Blood Banks: Standards for Blood Banks and Transfusion Services: http://www.aabb.org/sa/standards/Pages/bbts.aspx http://www.aabb.org/sa/standards/Pages/bbts.aspx

b. Food and Drug Administration: CFR – Code of Federal Regulations Title 21:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=6 40&showFR=1

B – 8 CUSTOMER SERVICE ASSISTANCE:

Contractor shall provide contacts for NAIHS and referring facilities for assistance for clinical, technical, and business related issues as follows.

a. Contractor shall provide a point of contact to assist NAIHS and referring facilities staff with business questions during regular business hours Monday through Friday, 0800

– 1700, Mountain Time (MST).

Name and Title:

Phone No.:

Email Address:

B – 9 PERIOD OF PERFORMANCE

a. Performance of this contract shall begin on Date of Award to December 31, 2020, unless the period is changed by written modification of the contract. This contract will be effective for one (1) base contract year and four (4) one (1) year option periods.

b. If the Government exercises its option pursuance to 52.217-9: Option to Extend the term of the Contract, the period of performance will be extended in accordance with the following schedule:

Year: Option Period:

BASE YEAR Date of Award through December 31, 2020

FIRST YEAR OPTION January 1, 2021 through December 31, 2021

SECOND YEAR OPTION January 1, 2022 through December 31, 2022

THIRD YEAR OPTION January 1, 2023 through December 31, 2023

FOURTH YEAR OPTION January 1, 2024 through December 31, 2024

B – 10 CONTRACTING OFFICER RESPONSIBILITIES:

Authority to negotiate changes in terms, conditions, or amounts cited in this contract are reserved to the Contracting Officer. Responsibilities http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=640&showFR=1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=640&showFR=1

B – 11 CONTRACTING OFFICER REPRESENTATIVE (COR):

The COR will be responsible for the following:

1. Monitoring the Contractor’s technical progress to include the surveillance and assessment of performance;

2. Interpreting the Statement of Work;

3. Technical inspections and acceptances required by this contract; and

4. Assisting the Contractor in resolution of technical problems encountered during performance of this contract.

The COR for this requirement is:

Name: Colleen A. Ben, MT

Title: Supervisory Clinical Laboratory Scientist

Phone No.: (928) 674-7101

Email Address: colleen.ben@ihs.gov

B – 12 INDIVIDUAL DELIVERY/TASK ORDERS

a. Individual delivery orders by each medical facility under this contract will be issued in accordance with the Schedule of Prices utilizing Standard Form (SF) -1449, which will set the scope of services and costs.

b. Individual (s) authorized to sign and place delivery/task orders against this contract are as follows:

Navajo Area IHS Medical Facilities Contracting Officers

Navajo Area Office Saint Michaels, AZ 86511

Margaret Shirley-Damon, Contract Specialist Priscilla Duncan, Contract Specialist DeeAndra Salabye, Contract Specialist Thomasina Willie, Business Specialist Michelle James, Contract Specialist

Chinle Comprehensive Healthcare Facility Chinle, AZ 86503

Tanya Begay, Supervisory Contract Specialist DeeAndra Salabye, Contract Specialist

Kayenta Health Center Kayenta, AZ 86033

Roxanne Franklin, Contract Specialist Kerri Gilmore, Contract Specialist

Northern Navajo Medical Center Margaret Shirley-Damon, Contract Specialist mailto:colleen.ben@ihs.gov

Shiprock, NM 87420 Priscilla Duncan, Contract Specialist

Crownpoint Healthcare Facility Crownpoint, NM 87313

Margaret Shirley-Damon, Contract Specialist Priscilla Duncan, Contract Specialist DeeAndra Salabye, Contract Specialist

Gallup Indian Medical Center Gallup, NM 87301

DeeAndra Salabye, Contract Specialist Natasha Bitsoi, Contract Specialist Misty Billy, Contract Specialist

SECTION C – CONTRACT CLAUSES

C.1 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov/browsefar

FAR Clause No. Title Date

52.202-1 Definitions NOV 2013

52.204-7 System for Award Management OCT 2018

52.232-40 Providing Accelerated Payments to Small Business Sub-Contractors DEC 2013

C.2 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011)

(a) The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24 and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

(b) The Contractor shall account for all forms of Government-provided identification issued to the Contractor employees in connection with performance under this contract. The Contractor shall return such identification to the issuing agency at the earliest of any of the following, unless otherwise determined by the Government:

(1) When no longer needed for contract performance.

(2) Upon completion of the Contractor employee’s employment.

(3) Upon contract completion or termination.

(c) The Contracting Officer may delay final payment under a contract if the Contractor fails to comply with these requirements.

(d) The Contractor shall insert the substance of this clause, including this paragraph (d), in all subcontracts when the subcontractor’s employees are required to have routine physical access to a Federally-controlled facility and/or routine access to a Federally-controlled information system. It shall be the responsibility of the prime Contractor to return such identification to the issuing agency in accordance with the terms set forth in paragraph (b) of this section, unless otherwise approved in writing by the Contracting Officer.

https://acquisition.gov/browsefar

C.3 52.212-4 Contract Terms & Conditions-Commercial Items (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C.

3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference.

The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232- 33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-

5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the— https://acquisition.gov/sites/default/files/current/far/html/52_232.html#wp1153351 https://acquisition.gov/sites/default/files/current/far/html/52_232.html#wp1153351 https://acquisition.gov/sites/default/files/current/far/html/52_232.html#wp1153375 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1203358

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109 , which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or http://uscode.house.gov/ https://acquisition.gov/sites/default/files/current/far/html/Subpart%2033_2.html#wp1079912 https://acquisition.gov/sites/default/files/current/far/html/Subpart%2032_6.html#wp1031290 https://acquisition.gov/sites/default/files/current/far/html/Subpart%2032_6.html#wp1031326

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C.

2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with

Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

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(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

https://www.gsa.gov/forms-library/solicitationcontractorder-commercial-items

C.4 52.212-5 Contract Terms & Conditions Required to Implement Statutes or Executive Orders

– Commercial Items (MAR 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115- 91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)(Public Laws 108-77 and

108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting

Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(Oct 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C.

657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

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__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020).

__ (iii) Alternate II (Nov 2011).

X (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Mar 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Mar 2020) of 52.219-9.

__ (v) Alternate IV (Aug 2018) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar

2020) (15 U.S.C. 657f).

__ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Mar 2020) (15

U.S.C. 632(a)(2)).

(ii) Alternate I (Mar 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).

(25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C.

644(r)).

(26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15 U.S.C. 637(a)(17)).

X (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020)

(E.O.13126).

X (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(30)(i) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26.

(31)(i) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35.

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