N6264518R0084_UPCH_Febrile_Respiratory.docx

N6264518R0084

Section SF 30 - BLOCK 14 CONTINUATION PAGE

NOTE

Proposals are not being accepted in response to this document.

This document is linked to Notice of Intent Posting ADVFY18RD00036. The Naval Medical Logistics Command (NMLC) intends to award a firm-fixed price (FFP) contract to La Universidad Peruana Cayetano Heredia (UPCH), Av. Honorio Delgado 430, San Martin de Porres 15102, Peru.

Section B - Supplies or Services and Prices

Research Studies

FFP

The vendor shall provide research activities to support the following studies: “Surveillance for Emerging Viral Respiratory Pathogens in South America� and “Characterization of the Infectious causes of Acute Febrile and Exanthematous illness in Latin America� FOB: Destination

PSC CD: AN42

NET AMT

FFP

The vendor shall provide research activities to support the following studies: “Surveillance for Emerging Viral Respiratory Pathogens in South America� and “Characterization of the Infectious causes of Acute Febrile and Exanthematous illness in Latin America�

PSC CD: AN42

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

- Research with human subjects may not begin until the contractor obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A copy of all IRB approval documentation shall be provided to the technical point of contact assigned to the contract, and to the IRB of the (Service) institution being supported, before any human subjects research begins.

- Health Insurance Portability and Accountability Act (HIPAA) of 1996 related guidance and requirements in accordance with BUMEDINST 7050.1B – Agreements with non-DoD entities: DoD commands are a Covered Entity as defined by the aforementioned BUMED instruction. However, in performance of its mission, the DoD command may and does contract out to non-DoD entities such that these non-DoD entities may have access to information covered under the HIPAA of 1996. When doing so, the DoD command must execute documentation in accordance with this instruction as it pertains to non-DoD entities by executing with the non-DoD entity a Business Associate Agreement (BAA, not to be confused with a Broad Agency Announcement).

I. INTRODUCTION

The Virology & Emerging Infections Department of the Naval Medical Research Unit No. 6 (NAMRU-6) carries out the studies: NAMRU6.2011.0012 “Surveillance for Emerging Viral Respiratory Pathogens in South America”; and, NMRCD.2010.0010 “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America”.

Both studies are funded by the Armed Forces Health Surveillance Center (AFHSC) - Global Emerging Infectious Surveillance and Response System (GEIS), and executed by U.S. Naval Medical Research Unit No. 6 (NAMRU-6) in collaboration with the Peruvian Ministry of Health (MoH), the National Institute of Health, the Peruvian Armed Forces, and other international collaborative institutions. Currently, the countries where the activities are carried out are Peru, Colombia, Honduras, and Paraguay.

II. BACKGROUND

AFHSB-GEIS provides direction, funding, and oversight to surveillance networks throughout many regions in the world. Working in conjunction with their host nations, these partners conduct disease surveillance and rapid outbreak response, encourage research and innovation, and build capacity.

Respiratory and Febrile & Vector-borne infections are two GEIS-surveillance priorities. The goal for these programs is to conduct studies that characterize diseases, develop risk assessments, generate disease risk maps for military-relevant geographic areas, provide timely, accurate, and actionable data for decision makers, identify changes in circulating influenza virus subtypes and genotype strains, and identify zoonotic transmission and risk factors for influenza and other viral infections.

Latin America possesses a wide spectrum of viral, bacterial, and parasitic agents that are as varied as its geography and people. These pathogens are among the leading causes of morbidity and mortality in human and domestic animal populations worldwide. The threat of infection continues to increase due to rapid population growth, expanding urbanization, extensive air travel, environmental changes, and lack of effective intervention strategies. Some of the more noteworthy re-emerging and emerging diseases include Influenza A (H1N1) pdm09, Dengue and Severe Dengue (SD), malaria, Yellow fever, Venezuelan Equine Encephalitis (VEE), Oropouche fever, Mayaro fever, leptospirosis, and rickettsiosis. Recently Zika virus infections are playing an important role in the causes of acute febrile illness in Latin America and are a major threat for deployed military troops.

Surveillance performed by NAMRU-6 over the past two decades has been instrumental in characterizing the burden of endemic tropical diseases throughout the region. The main objective is to determine the etiology of febrile disease and/or exanthematous syndromes and to conduct surveillance for emerging viral pathogens in Latin America.

III. GENERAL REQUIREMENTS

This PWS is for a one-year period of performance from 28 September 2018 to 27 September 2019, with a one-year option from 28 September 2019 to 27 September 2020.

UPCH shall perform the logistics for studies: NAMRU6.2011.0012 “Surveillance for Emerging Viral Respiratory Pathogens in South America”; and, NMRCD.2010.0010 “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America”; at the following study sites:

1. Peru:

a. Loreto (Iquitos and Yurimaguas)

b. Piura (Piura)

c. La Libertad (Trujillo)

d. Cusco (Cusco)

e. Amazonas (Bagua)

f. Junín (La Merced)

g. Lima (Lima)

h. Tumbes (Tumbes)

i. Madre de Dios (Puerto Maldonado)

2. Colombia:

a. Cartagena

b. Meta

c. Medellín

3. Honduras:

a. Tegucigalpa

4. Paraguay:

a. Asunción

b. Mariscal Estigarribia

Personnel working as part of the study team shall be trained on participant enrollment and confidentiality procedures, specimen collection, rapid diagnostic testing, molecular assays, and storage and transportation of specimens. Samples and epidemiological data will be obtained only from those individuals who provide informed consent and meet the inclusion criteria. Laboratory testing will be performed but not limited to NAMRU-6 installations.

Demographic, clinical, epidemiological, and laboratory test results will be entered into a database by a unique identification number. All forms with identifiers will be maintained in a locked office at each site and at NAMRU-6.

All databases used for data analysis include privately identifiable information and are kept under lock and key at NAMRU-6. Monthly reports will be sent to local co-investigators, NAMRU-6 PI, and to Ministry of Health.

IV. PERFORMANCE REQUIREMENTS

The Contractor shall perform the following activities:

A. HUMAN RESOURCES

The Contractor shall provide (unless stated all positions will be considered full-time employment):

1. For Bagua and La Merced, one Study Field Personnel (SFP) for each site.

2. For Yurimaguas, one SFP and one part-time Phlebotomist (P).

3. For Piura, one Consultant (CON) and one P.

4. For Trujillo, one CON and one Lab Technician (LT).

5. For Meta in Colombia, one Local PI (LP).

6. For Medellin in Colombia, one LP and one part-time LT.

7. For Lima, one Project Manager Professional (PMP) and one Nurse (N).

8. For Cusco, one part-time Molecular Biologist (MB) and one LT.

9. For Tumbes, one CON and one P.

10. For Puerto Maldonado, one CON and one P.

a. The SPF and CON shall be responsible for the following activities:

· To obtain local IRB approval

· To screen at least 300 potential study participants and perform clinical examinations of patients

· To perform the informed consent process as described in the protocol

· To collect study approved information and biological samples for acute and follow-up cases

· To label and keep samples in adequate cold-chain conditions at each site

· To prepare biological samples for shipping to Lima in adequate cold-chain conditions

· To follow-up enrolled cases as necessary

· To provide monthly reports to NAMRU-6 principal investigator (PI)

· To deliver results to the hospital/clinic where participants were enrolled

· To maintain and secure equipment loaned to site for satisfactory operating conditions and ensure security and shave the following professional profile:

· The SPF/CON must have an MD degree and experience participating and implementing epidemiological studies for a minimum of 3 years. Level IV language proficiency (fluent) in Spanish is required

· In addition, the CON is a full-time healthcare provider that works for the Peruvian Ministry of Health or Military Health System at the site

· Current ethical training (CITI) is required

b. The LP shall be responsible for the following activities:

· This person is responsible for supervising and ensuring all study activities are conducted according to the protocol; liaison between the site and NAMRU-6; liaison between the site and local health authorities (e.g. local IRB approval)

· This person must have experience in epidemiological studies or project management, and at least 10 years of experience working in a biomedical research. Fluent proficiency in Spanish and current ethical training (CITI) is required

c. The PMP shall be responsible for the following activities:

· To support NAMRU-6 (PI) in both studies

· To monitor and control the performance and executing of all the activities in both projects according to the protocol

· To assure all sites have everything necessary to enroll participants, to collect samples (following biosafety regulations), to keep and transport samples in adequate cold chain, and to manage and keep documents of the study in each site

· To verify all deliverables are completed on time and have the following professional profile:

· The PMP must have an MD degree, experience participating in and implementing epidemiological studies for a minimum of 3 years, project management training, level IV language proficiency (fluent) in Spanish and level II language proficiency in English

· Current ethical training (CITI) is required

d. The N will be responsible for the following activities:

· To perform quality control on all the documents and samples received by NAMRU-6

· To help data management of studies

· To enroll participants in sites located in Lima. To implement and review standard operating procedures and have the following professional profile:

· The Nurse shall have a Nursing degree or equivalent with experience in sample collection (i.e. blood draws, nasal swabs, etc.), biosafety and participating in epidemiological studies for a minimum of 3 years. Level IV language proficiency (fluent) in Spanish is required

· Current ethical training (CITI) is required

e. The P/LT shall be responsible for the following activities:

· To support the CON in enrolling participants in the study

· To support and complete questionnaires

· To perform quality control on informed consents/assents and epidemiological forms

· To collect samples from study participants, aliquot blood samples, store and maintain samples in adequate cold-chain conditions

· To perform rapid diagnostic testing, including but not limited to the BioFire FilmArray respiratory testing

· To manage and send samples from sites to NAMRU-6 – Lima for testing and storage

· Monitor freezer temperatures for sample storage and manage consumable/reagent inventory and have the following professional profile:

· The P/LT must be a medical technician with experience in sample collection (i.e. blood draws, nasal swabs, etc.), biosafety and participating in epidemiological studies for a minimum of 1 year

· Current ethical training (CITI) is required

· Level IV language proficiency (fluent) in Spanish is required

f. The MB shall be responsible for the following activities:

· Performing real-time RT-PCR assays for arboviruses and/or respiratory viruses

· Reports to the LP study activity results, issues, etc.

and shave the following professional profile:

· The MB must have a bachelor’s degree in biological sciences or equivalent, at least one year of experience working in a molecular laboratory, and intermediate level of computer knowledge.

· Current ethical training (CITI) is required

· Level IV language proficiency (fluent) in Spanish is required

UPCH shall to notify to NAMRU-6 PI in case of:

a) Personnel resignation.

b) New hires.

c) Personnel sick leave or vacations.

B. FIELD ACTIVITIES

The Contractor shall support minor expenses for the following field activities:

a) Transportation to participants’ houses to collect samples

b) Transportation from health facilities to the place where the freezer is located

c) Transportation reimbursement for participants to health facilities

d) Photocopies

e) Cabinet key replacements

C. MAINTENANCE

The contractor shall provide personnel to perform preventive maintenance for each equipment at each site stated above. Preventive maintenance is the care and servicing by qualified personnel for the purpose of maintaining equipment and facilities in satisfactory operating condition by providing for systematic inspection, detection, and correction of incipient failures either before they occur or before they develop into major defects. Maintenance, including tests, measurements, adjustments, and parts replacement, shall be performed specifically to prevent faults from occurring. The cost of preventive maintenance is a fixed cost. NAMRU-6 will cover the cost of equipment replacement, if necessary. If for any reason, the BioFire Film Array and/or accessory parts break down or must be serviced by the manufacturer, UPCH shall ship the equipment to NAMRU-6 Lima, Peru for replacement. Any sites with stabilizers or centrifuges must also be maintained by the contractor for satisfactory operating conditions (see below Section V for other equipment listed).

· Peru:

a) Yurimaguas:

1) Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Model UXF30086D, Serial number: 0160054601160910.

This equipment is located in: Hospital Santa Gema de Yurimaguas.

b) Piura:

1) Ultra-Low Temperature Freezer, So-Low Environmental Equipment, Model UXF30086D, Serial number: 0809261.

This equipment is located in: Centro de Salud I-4 Pachitea.

2) Biofire FilmArray + Laptop + Barcode Scanner + Accessories

S/N: 2FA02932, ECN#102892

c) Trujillo:

1) Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Model UXF30086D, Serial number: 0160054301160909.

This equipment is located in: Hospital Belén de Trujillo.

2) Biofire FilmArray + Laptop + Barcode Scanner + Accessories to be added.

d) Bagua:

1) Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Serial number: 83824321.

This equipment is located in: Laboratorio Referencial, Hospital de Apoyo de Bagua.

e) La Merced:

1) Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Serial number: 83824319.

This equipment is located in: Hospital Regional de Medicina Tropical "Dr. Julio César Demarini Caro".

f) Cusco:

1) Ultra-low Temperature Freezer, to be placed

g) Tumbes:

1) Ultra-low Temperature Freezer, to be placed

· Colombia:

a) Secretaria de Salud del Meta Laboratorio de Salud Publica – Meta:

1) Freezer, Thermo Forma 903, Serial number: 810281-100 This equipment is located in:

Calle 37 N°41-116, Barzal Villavicencio

b) Universidad de Antioquía.

1) Freezer, Thermo Forma 903, Serial number: 811778-101 This equipment is located in:

Carrera 53 No. 61-30, Torre 2, Laboratorio 535 Sede de Investigación Universitaria Medellín, Colombia

· Honduras:

a) National Autonomous University of Honduras

1) Freezer, Thermo Forma 903, Serial number: 811638-99 This equipment is located in:

Instituto Hondureño de Seguridad Social Barrio La Granja Comayaguela-Honduras

D. SHIPMENTS

1. Shipments of samples

· The Contractor shall execute the following number of shipments:

a) Piura, Trujillo, and Cusco: minimum of 3 from each site (9 total), no more than 5

b) Bagua, La Merced, Yurimaguas, Iquitos, Puerto Maldonado, and Tumbes: minimum of 6 from each site (36 total), no more than 8

c) Paraguay: minimum of 2 from Asunción (2 total), no more than 3

d) Colombia: minimum of 1 from Cartagena and 1 from Medellín/Bogotá (2 total), no more than 2

e) Honduras: minimum of 1 from Tegucigalpa (1 total), no more than 2

· The domestic delivery address is:

Dra. Sonia Ampuero

VEID – NAMRU-6

Av. Venezuela Cdra. 36 s/n – Bellavista – Callao

· The international delivery address is:

U.S. Embassy – NAMRU-6 Virology & Emerging Infections Department Av. Venezuela Cdra. 36 s/n – Bellavista - Callao

· The Contractor shall consider the following conditions for each shipment of samples:

a. Shipments shall be performed by air transportation preferably.

b. Each box must not exceed 25kg. Dry ice weight approximately 20kg.

c. All shipments start at and end in NAMRU-6 (Peruvian sites only).

d. The cold chain quality control will be done by NAMRU-6 laboratory personnel.

· The Contractor shall include the following in the shipments of samples:

a. All samples collected as part of the study.

b. Study documents are: Informed consents, assents and epidemiological forms.

The Contractor shall be responsible for delivering the biological samples and epidemiological forms from Medellin and Meta to Lima from either Bogota and/or Cartagena.

· The Contractor shall cancel the shipment of samples and communicate effectively with NAMRU-6 when the site does not have any samples to send or if bad weather conditions occur (even if the package is in transit).

2. Shipments of consumables

· The Contractor shall execute the following number of shipments:

a) Piura, Bagua, La Merced, Yurimaguas, Cusco, Trujillo, Iquitos, Puerto Maldonado, and Tumbes: minimum of 2 for each site (18 total), no more than 4

b) Colombia (Meta, Medellin, Cartagena), Paraguay (Asunción), and Honduras (Tegucigalpa): minimum of 1 for each site (5 in total), no more than 3

· The Contractor shall transport consumables (for collecting samples) estimated at 25Kg per site

The delivery addresses are:

a) Peru

1) Loreto:

Clínica Naval NAMRU-6 Consignee: Dr. Crystyan Siles y/o Lic. Regina Fenández Av. La Marina con Av. Trujillo Iquitos

Hospital Santa Gema de Yurimaguas Consignee: Dra. Yojani Aguilar Calle Progreso 305-307 Yurimaguas

2) Piura:

Centro de Salud I-4 Pachitea Consignee: Dr. Victor Ocaña Intersección de las Av. Francisco Eguiguren y Mártires de Uchuraccay. Pachitea. Piura

3) Trujillo:

Centro Médico Militar de la 32° Brigada de Infantería Consignee: Dr. Edward Chávez Av. América Norte S/N.

4) Cusco:

Laboratorio de Salud Publica Consignee: Blgo. Victor Zea Gutierrez Av. De la Cultura S/N, Wánchaq Cusco

5) Amazonas:

Laboratorio Referencial, Hospital de Apoyo de Bagua Consignee: Dr. César Sánchez Av. Héroes del Cenepa S/N Referencia: Esquina de la Plaza de Armas Bagua Capital

6) Junín:

Hospital Regional de Medicina Tropical "Dr. Julio César Demarini Caro" Consignee: Dr. Michel Valerio Av. Daniel A. Carrion s/n - Pampa El Carmen - Puerta 4 - Patología Chanchamayo La Merced

7) Tumbes:

Centro de Salud de Zarumilla Panamericana norte Km14, Tumbes

8) Puerto Maldonado:

Hospital Santa Rosa Cajamarca 232, Puerto Maldonado

b) Colombia:

1) Universidad de Cartagena Consignee: Dra. Doris Gómez Condominio Laguna Club Km.12 vía al mar, Almendros 3, apartamento 1A.

Cartagena, Colombia

2) Laboratorio de Salud Pública - Secretaría de Salud de Meta Consignee: Dra. Marina González Robayo Calle 37 # 41 – 116 Barrio Barzal Villavicencio, Meta, Colombia

3) Universidad de Antioquía Consignee: Dra. Ana Eugenia Arango Calle 62 52-59 Sede de Administración Universitaria Torre 2, Lab 532 Medellín, Colombia

c) Honduras:

1) Universidad Autónoma de Honduras Consignee: Dra. Ivette Lorenzana Edificio CB, 4to Piso Ciudad Universitaria. Tegucigalpa. Honduras

d) Paraguay:

1) ONG Rayos de Sol Consignee: Sr. Humberto Espinola Azara 2454, General Santos, Asunción. Paraguay

E. TRAVELS

· The PMP or Nurse shall travel to any site with a maximum of 4 trips within Peru for the period of this contract for supervision of the operational process. The CON or SFP shall travel to Lima, Peru once in the period of this contract for training purposes for the following sites: Piura, Bagua, La Merced, Yurimaguas, and Trujillo

· The contractor should consider 2-3 working days for SFP/CON and 3-5 days for PMP/Nurse, hotel and transportation for each one.

V. GOVERNMENT FURNISHED PROPERTY

A. EQUIPMENT

The following list of equipment is located (unless otherwise specified) at each participating site and is on loan to the local Principal Investigator.

Peru:

a) Yurimaguas:

· Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Model UXF30086D, Serial number: 0160054601160910

· Centrifuge, Tabletop, Eppendorf, Model 5415D, Serial number: 0077122

· Centrifuge, USA Scientific, Inc., Serial number: 056353

· Laboratory Hood, PCR Workstation, Air Clean System, Serial number: AC624LFUV-24311

· Centrifuge, mini, Labnet International, MPS 1000, Serial number: K1101171

· Laboratory shaker, IKA-Works, Inc., Lab Dancer, Serial number: 03426823

· Power supply, Powertronic, Serial number: 64113

· Thermocycler, RT-PCR, Abbott Molecular Diagnostic, 7500 Fast System, Serial number: 275015260

b) Piura:

· Ultra-Low Temperature Freezer, So-Low Environmental Equipment, Model UXF30086D, Serial number: 0809261

· Biofire FilmArray + Laptop + Barcode Scanner + Accessories

S/N: 2FA02932, ECN#102892

c) Trujillo:

· Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Model UXF30086D, Serial number: 0160054301160909

· Power supply, Powertronic, Serial number 64112

· Biofire FilmArray + Laptop + Barcode Scanner + Accessories to be added

d) Bagua:

· Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Serial number: 83824321

e) La Merced:

· Ultra-Low Temperature Freezer, Thermo Fisher Scientific, Serial number: 83824319

· Microscope, Light, Laboratory, Olympus, CX21, Serial number: 6D07395

f) Cusco:

· Ultra-low Temperature Freezer, to be placed

g) Tumbes:

· Ultra-low Temperature Freezer, to be placed

B. MATERIALS

Personal protective equipment:

a. N95 masks

b. Nitrile gloves

c. Laboratory coats Sampling consumables:

a. For collecting respiratory samples:

i. Universal transport media (UTM) with flocked swabs

ii. respiratory virus rapid test

iii. Biofire FilmArray respiratory kits

b. For collecting serum and blood samples:

i. BD Vacutainer® tubes for serum and whole blood collection

ii. Alcohol pads

iii. Alcohol gel

iv. Needles

v. Biohazard bags

vi. Waste disposal bins

c. For collecting other types of samples:

i. Body fluids’ containers

d. For local transportation of samples

i. Coolers

ii. Ice packs

e. For laboratory process;

i. Pipets and cryogenic-vials

ii. Zip-lock bags

iii. Labels Laboratory reagents (only for sites with RT-PCR platform):

a. Laboratory reagents to perform arboviral and respiratory RT-PCR Information technology equipment:

a. Laptop

b. Uninterruptible Power Supply (UPS)

c. Multifunctional printer

d. Toners for printer Paper based formats:

a. Informed consents/assents self-copied forms

b. Epidemiology self-copied forms

VI. DELIVERABLES: Refer to Stand Alone Document - Attachment 1 Deliverables Table

VII. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Objective: This Quality Assurance Surveillance Plan (QASP) serves as the principal basis for assessing overall performance quality by the Contractor. This document will be used by the Government to assess the effectiveness of the Contractor’s performance. This QASP provides the methodology by which the Contractor's performance will be monitored to determine compliance with established performance objectives and to establish performance benchmarks that ensure a quantifiable basis for measuring effectiveness. The plan is designed so that surveillance is limited to that which is necessary to verify the Contractor is performing satisfactorily and relates directly to performance objectives of the performance objectives delineated in the PWS.

Performance Objectives Summary Matrix:

TASK/

DELIVERABLE

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

1. does not cause a delay in schedule;

1. does not cause costs to increase;

1. involves minimal effort to fix; and

1. does not affect overall Contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Inspection

Are study reports complete and are they compliant with various government regulations?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements not met.

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

1. does not cause a delay in schedule;

1. does not cause costs to increase;

1. involves minimal effort to fix; and

1. does not affect overall Contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Inspection.

Is the Contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

1. does not cause a delay in schedule;

1. does not cause costs to increase;

1. involves minimal effort to fix; and

1. does not affect overall Contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Sampling.

Is the Contractor committed to high customer satisfaction? How Contractor proactive is to Contractor? Is the Contractor providing positive value to the government?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

1. does not cause a delay in schedule;

1. does not cause costs to increase;

1. involves minimal effort to fix; and

1. does not affect overall Contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Sampling.

What is the government’s overall satisfaction with the Contractor?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable

Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Section D - Packaging and Marking

DELIVERABLES

All deliverables required under this contract shall be packaged, marked, and shipped in accordance with study protocols and Section C, Performance Work Statement, of the resultant contract. All technical data in support of this contract (i.e., not developed exclusively at private expense) must be delivered to the Government before the Contractor submits and receives payment for its final invoice.

Section E - Inspection and Acceptance

COR

The Contracting Officer's duly authorized representative, the Contracting Officer’s Representative, will perform inspection and acceptance of services to be provided.

For the purposes of this clause, to be provided upon contract award is the authorized representative of the Contracting Officer.

Inspection and acceptance will be performed at the assigned locations according to the performance work statement

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

27-SEP-2019

AV. VENEZUELA CDRA 36 S/N BELLAVISTA

CALLAO CALLAO 02

511-614-4270

N44852

27-SEP-2020

N44852

Section G - Contract Administration Data

INVOICE SUBMISSION

Payment will be made within 30 days upon receipt and acceptance of goods or service and original proper Invoice.

The Contractor shall mail their invoice, indicating the contract award number, along with their complete EFT banking information to:

INFORMATION TO BE PROVIDED UPON CONTRACT AWARD

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

NOTE: THIS CLAUSE IS INCLUDED FOR INFORMATIONAL PURPOSES ONLY – THE CONTRACTOR SHALL REFER TO SECTION G, INVOICE SUBMISSION, FOR INVOICING INSTRUCTIONS.

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

2 IN 1 SERVICES ONLY

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

DESTINATION/DESTINATION

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table* Field Name in WAWF Data to be entered in WAWF

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

WAWF Additional Email Notifications: TBD

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

WAWF Help Desk: TBD

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

SPECIAL REQUIREMENTS

INVENTION DISCLOSURES AND REPORTS

(a) In accordance with the requirements of the Patent Rights clause (FAR 52.227-13)of this contract, the contractor shall submit “Report of Inventions and Subcontracts” (DD Form 882) along with written disclosure of inventions to the designated Contract Administrator.

(b) The Contract Administrator will forward such reports and disclosures directly to the appropriate Patent Counsel, designated below, for review and recommendations, after which the reports will be returned to the Contract Administrator.

Address of Patent Counsel:

Office of Legal and Technology Services Naval Medical Research Center (Code 1URO) 503 Robert Grant Avenue, Suite 1W/15 Silver Spring, MD 20910

(c) The above designated Patent Counsel will represent the Procurement Contracting Officer with regard to invention reporting matters arising under this contract.

(d) A copy of each report and disclosure shall be forwarded to the Procuring Contracting Officer.

(e) The contractor shall furnish the Contracting Officer a final report within three (3) months after completion of the contracted work listing all subject inventions or certifying that there were no such inventions, and listing all subcontracts at any tier containing a patent rights clause or certifying that there were no such subcontracts.

PATIENT CARE AND MEDICAL LIABILITY INSURANCE

The character of services for health care workers that are providing patient care in clinical or administrative tasks under this contract will be categorized as non-personal services as provided for by Federal Acquisition Regulation (FAR) Subpart 37.4. Patient care will be incidental to research activities or projects supported under this contract. Alleged acts of medical malpractice by non-personal health care workers are not covered under the Federal Tort Claims Act and the contractor shall indemnify the Government against legal action alleging malpractice by such workers by way of indemnification and medical liability insurance provided by the contractor. Insurance as prescribed by FAR clause 52.237-7 shall be required for those medical personnel such as physicians or nurses providing patient care in clinical or administrative tasks consistent with standard coverage prevailing within the local community as to the specific medical specialty.

NOTICE REGARDING THE DISSEMINATION OF EXPORT-CONTROLLED TECHNICAL DATA

(a) Export of information contained herein, which includes release to foreign nationals within the United States, without first obtaining approval or license from the Department of State for items controlled by the International Traffic in Arms Regulations (ITARS), or the Department of Commerce for items controlled by the Export Administration Regulations (EAR), may constitute a violation of law.

(b) For violation of export laws, the contractor, its employees, officials or agents are subject to:

(c) The Government shall not be liable for any unauthorized use or release of export-controlled information, technical data or specifications in this contract.

(d) The contractor shall include the provisions or paragraphs (a) through (c) above in any subcontracts awarded under this contract.

PROTECTION OF HUMAN SUBJECTS

(a) The performance of research involving human subjects shall be conducted in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.235-7004 “Protection of Human Subjects,” 32 CFR 219 “The Common Rule,” 10 USC 980 “Limitation on Use of Humans as Experimental Subjects,” Department of Defense (DoD) Instruction 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” and Secretary of the Navy Instruction 3900.39 (series) “Human Research Protection Program,” as well as other applicable federal and state law and regulations, and Department of the Navy guidance. The Contractor must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations, recruitment of military research subjects, and informed consent and surrogate consent and chemical and biological agent research. Food and Drug Administration regulation and policies may also apply. The Contractor shall rely on the local command’s designated Institutional Review Board (IRB) as the IRB of record for the research to be supported under the contract. The Contractor shall also comply with all research training requirements directed by the local command.

(b) The Contractor shall hold an active (i.e., not expired) Federalwide Assurance (FWA) appropriate for research to be supported under the contract. The FWA shall remain active for the duration of the contract. The FWA is issued by the Department of Health and Human Services.

(c) The following requirements must be completed prior to the Contractor’s performance of research involving human subjects or expenditure of funding on such effort, whichever occurs first:

(1) The Contractor shall enter into a DoD Institutional Agreement for Institutional Review Board (IRB) Review (IAIR) with the local command. The IAIR will apply to all human subject research supported under the contract. The IAIR shall be executed by the parties no later than 30 days after the effective date of the contract, or before commencement of performance of research involving human subjects or expenditure of funding, whichever occurs first.

(2) Contractor personnel providing support under the contract shall complete initial and ongoing research ethics and human subject protections training appropriate to each individual’s level of involvement, duties, and responsibilities. Specific training requirements will be provided by the COR.

(3) The Contractor shall obtain written notice from the local command that: (i) Contractor personnel identified as supporting human subject research under the contract have been added to the applicable research protocol; (ii) performance of the protocol has been approved by the Command’s Institutional Official and that performance may begin; (iii) a determination that the protocol meets exemption criteria including the exemption category or classification of research risk (e.g., minimal risk); (iv) confirmation of continuing acceptability of the Contractor’s assurances; and (v) Human Research Protection Official (HRPO) review of the protocol in accordance with DFARS clause 252.235-7004 has been completed. Contractor personnel shall not commence performance of research involving human subjects until stated notice is received.

(4) The Contractor shall notify the local command of personnel changes under the contract. New personnel that will perform research involving human subjects will be required to complete applicable training and will be added to the applicable research protocol(s) as discussed above.

(d) The Contractor shall support administrative efforts by the local command to ensure compliance with the terms of this requirement. This support includes identifying Contractor personnel that may support human subject research under the contract and maintaining records of training and other documentation to demonstrate compliance with human research protection requirements under the contract. The Contractor shall also assist with the continuing review of the human subject research that is supported under the contract.

(e) Failure of the Contractor to comply with the terms of this requirement will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 Alt. I to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

(f) The terms of this requirement are applicable to and shall be included in all subcontracts that may include the support of human subject research.

PRIVACY ACT AND HIPAA

The contractor shall ensure that all Protected Health Information (PHI) is protected in accordance with the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated safeguards to ensure confidentiality of health information. All contractor personnel are required to complete HIPAA training within one (1) year prior to the provision of services under this contract. Contractor personnel must complete HIPAA refresher training annually.

ENVIRONMENTAL STANDARDS

Note: This requirement applies to work performed at the contractor’s or subcontractor’s facility.

By accepting funds under this contract, the contractor assures that it will:

Comply with all applicable standards, orders, or regulations issued pursuant to the Clean Air Act (42 U.S.C. 7401, et seq.) and Federal Water Pollution Control Act (33 U.S.C. 1251, et.seq.), as implemented by Executive Order 11738 [3 CFR, 1971-1975 comp., p. 799] and Environmental Protection Agency (EPA) rules at 40 CFR Part 15. In accordance with the EPA rules, the contractor further agrees that it will:

Avoid use of any facility with a current compliance status of (1) violation, (2) non-compliance, (3) significant non-compliance, or (4) high priority violation in the EPA’s Enforcement and Compliance History Online (ECHO) website (http://echo.epa.gov/) in performing any contract that is nonexempt under 40 CFR 15.5 (contracts of less than $100,000, and certain other contracts, exempt from the EPA regulations), as long as the facility remains in one of the listed current compliance statuses.

Notify the awarding agency if it intends to use a facility in performing this contract that is in one of the listed EPA current compliance statuses or that the contractor knows has been recommended to be placed in one of the listed current compliance statuses.

Identify to the awarding agency any impact this contract may have on:

The quality of the human environment, and provide help the agency may need to comply with the National Environmental Policy Act (NEPA, at 42 U.S.C. 4321, et seq.) and to prepare Environmental Impact Statements or other required environmental documentation. In such cases, the contractor agrees to take no action that will have an adverse environmental impact (e.g., physical disturbance of a site such as breaking of ground) until the agency provides written notification of compliance with the environmental impact analysis process.

Coastal barriers, and provide help the agency may need to comply with the Coastal Barriers Resource Act (16 U.S.C. 3501, et seq.), concerning preservation of barrier resources.

Any existing or proposed component of the National Wild and Scenic Rivers system, and provide help the agency may need to comply with the Wild and Scenic Rivers Act of 1968 (16 U.S.C. 1271, et seq.).

AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor’s facilities or in any other manner communicates with contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

REVIEW OF PRESS RELEASES

The contractor agrees to accurately and factually represent the work conducted under the contract in all press releases. Misrepresenting contract results or releasing information that is injurious to the integrity of the Government may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer has received an advance copy of any press release related to the contract for review and comments at least five (5) working days prior to proposed issuance. After receipt of the Government’s comments, the contractor shall provide a copy to the Contracting Officer prior to issuance of the press release.

CONTRACTOR'S PROPOSAL

Performance of this contract by the contractor shall be conducted and performed in accordance with detailed obligations to which the contractor committed itself in its proposal dated (to be completed at contract award) in response to NMLC Solicitation No.N6264518R0084.

RESEARCH CONDUCT

Research provided under this contract must be conducted in accordance with all state, federal, Department of Defense, Department of the Navy, and command laws, regulations, policies, and procedures that govern the conduct of regulated research. Bureau of Medicine and Surgery (BUMED) Instruction 6500.3 (Series) “Research Integrity, Responsible Conduct of Research Education, and Research Misconduct” applies to research sponsored or funded by Navy Medicine. Federal regulations governing current Good Clinical Practice (cGCP) are found in 21CFR 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects protection are found in 45CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice are also standards governing the conduct of research trials. Reference for military regulations and policy governing regulated research may be found at http://www.med.navy.mil/bumed/humanresearch/Pages/default.aspx.

This is a non-personal services contract for research and development. The Federal Tort Claims Act does not apply.

REIMBURSEMENT OF TRAVEL, PER DIEM, AND SPECIAL MATERIAL COSTS

(a) Area of Travel. Performance under this contract may require travel by contractor personnel.