A07_Attachment_1_Revised_PWS_Speciman_Shipping_IDIQ_8.28.18.docx

PERFORMANCE WORK STATEMENT

Walter Reed Army Institute of Research (WRAIR) Human Immunodeficiency Virus (HIV) Diagnostics and Reference Laboratory (HDRL) Specimen Shipping and Supply Management for Continental U.S. (CONUS) and Outside Continental U.S. (OCONUS) Sites

Title: Walter Reed Army Institute of Research (WRAIR), Human Immunodeficiency Virus (HIV) Diagnostics and Reference Laboratory (HDRL), Specimen Shipping and Supply Management for CONUS and OCONUS Sites

Requiring Activity Name: WRAIR, US Military HIV Research Program (MHRP), Department of Laboratory Diagnostics and Monitoring (DLDM)

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, Middle East, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

The first mission focus of DLDM was development, optimization, and deployment of Human Immunodeficiency Virus (HIV) screening, confirmation, clinical (viral load), and therapeutic (resistance genotyping) monitoring technologies for Soldiers and their Beneficiaries. DLDM has since evolved into a world class leader in the development of diagnostic countermeasures for HIV, Sexually Transmitted Infections (STIs), Bloodborne Infections (BBIs), Transmission Transmitted Infections (TTIs), Leishmania, and prevalent and emerging pathogens of US Military, US National, and Global Health interest, as well as the critical monitoring parameters utilized by the US Military, National, and Global Health Care Providers for clinical and therapeutic management of a wide variety of infectious diseases. This mission is currently executed through five laboratory sections: (1) HIV Diagnostics and Reference Laboratory (HDRL), (2) Leishmania Diagnostic Laboratory (LDL), (3) the Technology Assessment Laboratory (TAL), (4) Clinical Evaluation Unit (CEU), and, (5) the Processing Laboratory and Bio-Repository (SPL/Bio; not included in this solicitation).

The HDRL, a College of American Pathologist (CAP) and Department of Defense (DoD) Clinical Laboratory Information Program (CLIP) accredited diagnostic reference laboratory since 1987, is the designated US Army Medical Command (MEDCOM) reference laboratory for HIV clinical laboratory services. HDRL conducts state-of-art clinical HIV, STI, BBI, TTI screening and supplemental, confirmatory testing, clinical (viral load) and therapeutic (resistance genotype) monitoring services for US Service members and their Beneficiaries; and, provides diagnostic/consultative services to DoD Providers/Physicians for HIV and STI infection classification. Specifically HDRL currently provides technical oversight and final laboratory authority for HIV infection status for Army’s Active, Reserve, and National Guard units and for individuals applying for US Military service through U.S. Military Entrance Processing Command (USMEPCOM) Stations (MEPS). Currently HDRL directly performs HIV testing services for the U.S. Military European and Central Commands (65-100K tests per annum), USMEPCOM (300-350K tests per annum; 8 hour mandated turn-around-time (TAT) from receipt of specimen at HDRL), and conducts supplemental confirmatory testing/HIV infection classification of U.S Navy, and contract-vendor HIV repeat reactive screening tests. HDRL supports the U.S Air Force by request. In addition, the Laboratory performs HIV and STI quantitative viral load testing (~6K per annum) for all Army Medical Treatment Facilities (MTFs), the US Navy and the US Air Force (by request), and performs specialized testing to include HIV-1 genotypic resistance testing (600 -1,200 per annum)—for all Tri-Service (Army, Navy, and Air Force) HIV-infected Service members and their Beneficiaries; and, conducts HIV , STI and BBI infection screens for at risk US military populations. Currently, this laboratory operates six (6) days per week.

As the US Army’s low prevalence HIV rates reflect those of the general US population and its personnel are the largest repeatedly tested, low-prevalence population in the world, DLDM/HDRL clinical service delivery, clinical evaluations, and public/global health, diagnostic, clinical, prevention, intervention, and health systems studies, efforts directly impact DoD, US, and Global Health Communities. For example, DLDM was an important contributor to the formation of the 2014 updated US Centers for Disease Control HIV case surveillance definitions, including for the first time, a case definition for HIV-2 infection, recommendations for HIV diagnosis, and HIV result reporting. Current DLDM efforts in HIV encompass development of screening confirmation, and monitoring algorithms for HIV infection status in the era of HIV Treatment as Prevention (TasP), HIV Pre-exposure Prophylaxis (PreP), and HIV Post-exposure Prophylaxis (PEP). Each HIV Prevention strategy, TasP, PreP, and/or PEP, poses unique challenges to generation of laboratory evidence for determination of HIV infection status classification.

The LDL within DLDM is DoD’s best-in-class clinical screening, supplemental confirmatory, diagnostic parasitology laboratory and is the only U.S. CAP accredited clinical diagnostic laboratory providing a full spectrum of Leishmania test menu diagnostics inclusive of histology (smear, biopsy), serology, nucleic acid testing, parasite culture, parasite speciation, and xenodiagnoses. LDL staff also execute testing in support of therapeutic clinical trials for licensure of commercial and DoD sponsored products for medical management of Leishmania infected US Military Service members and their Beneficiaries. LDL will transition in 2017/2018 as a Parasitology Diagnostic Laboratory (PDL) under HDRL. This new initiative will transition LDL from a Leishmania focused diagnostic and clinical, public health unit to a broader based CAP accredited parasitology section within HDRL supporting clinical screening, supplemental confirmatory testing, vaccine, therapeutic, and cure initiatives of parasitic infections of critical importance to the WRAIR, MRMC, DoD and Global Health Communities. For example, PDL will design/develop, evaluate, validate, and deploy Laboratory Developed Assays (LDAs) for malaria screening, confirmation/diagnosis, specification, and/or clinical trial safety or diagnostic end points in support of WRAIR IRB approved malaria vaccine and therapeutic challenge studies.

Current total mean workload is ~400,000-450,000 assays per year; upper workload estimates are subject to change relative to mission requirements. The Government anticipates the scope of HDRL’s HIV testing requirement will continue to increase. Possible expansion of the mission will include a phased increase to accommodate U.S. National interests worldwide. The current annual requirement of specimens to be shipped is approximately 400,000. Once the anticipated phased approach is completed (Appendix D), HDRL could be responsible for testing up to 2,100,000 specimens per year.

2. PURPOSE AND BACKGROUND

The purpose of this requirement is to support the HDRL’s clinical test mission in support of U.S Military DoD soldiers and their beneficiaries (approximately 9.4 million), as well as other U.S. National interests worldwide. The Contractor shall provide medical consumables, logistical shipping support, and real-time on line shipping tracking to meet this requirement.

DLDM is a world class leader in the development of diagnostic countermeasures for HIV, Sexually Transmitted Infections (STIs), Bloodborne Infections (BBIs), Leishmania, and prevalent and emerging pathogens of US Military, US National, and Global Health interest, as well as the critical monitoring parameters utilized by the US Military, National, and Global Health Care Providers for clinical and therapeutic management of a wide variety of infectious diseases. This mission is currently executed through five laboratory sections: (1) HIV Diagnostics and Reference Laboratory (HDRL), (2) Leishmania Diagnostic Laboratory (LDL), (3) the Technology Assessment Laboratory (TAL), (4) Clinical Evaluation Unit, and (5) the Specimen Processing Laboratory and BioRepository (SPL/Bio).

3. SCOPE

The Contractor shall provide medical consumables globally for acquisition and routing of specimens to WRAIR for HIV testing. The contractor shall provide:

· Shipping of Biosafety Level 2 (BSL2) specimens in accordance with applicable Code of Federal Regulations (CFR) and International Air Transport Association (IATA) regulations

· Shipping Logistics and establishment and maintenance of a tracking methodology for specimen shipment, to include but not limited to on-line tracking and Customer Support assistance Shipment and tracking of material and specimens

· Electronic inventory management of packaging materials and medical consumables at each site, including alerts when inventory is low

· Shipping and management of specimens in accordance with Protected Health Information (PHI)/ Personally Identifiable Information (PII) / Health Insurance Portability and Accountability Act (HIPAA) regulations and requirements

The Contractor shall provide material and specimen shipping services identified in this contract for various organizations, including, but not limited to U.S. Military Operations (i.e. Army, Navy, Air Force), MEPS, U.S. Embassies, other international organizations such as North Atlantic Treaty Organization sites, and other U.S. National interests worldwide.

The Contractor shall support DoD Force screening for HIV throughout the 6 Geographical Combatant Commands (COCOMS):

· U.S. Central Command (CENTCOM) – Area of operations (AOR) covers 20 nations in the Middle East, Central and South Asia

· U.S. Africa Command (AFRICOM) – AOR covers African nations, the African Union and African regional security organizations

· U.S. European Command (EUCOM) - AOR covers in Europe and parts of the Middle East and Eurasia

· U.S. Northern Command (NORTHCOM) - AOR covers the continental United States, Alaska, Mexico, Canada, portions of the Caribbean and surrounding waters

· U.S. Pacific Command (PACOM) - AOR covers from the waters of the United States west coast to the western border of India, and from Antarctica to the North Pole, encompassing 36 diverse nations

· U.S. Southern Command (SOUTHCOM) - AOR covers 31 nations in Latin America south of Mexico, Central and South America, and the Caribbean Sea

Bangkok, Thailand; Tbilisi, Georgia; Nairobi, Kenya, and additional site(s) in Africa, the Middle East, Embassies, and international organizations as required.

4. PERIOD OF PERFORMANCE

The anticipated period of performance:

5. WORK SCHEDULE AND LOCATION

5.1. Work Schedule

The Contractor shall provide general support during normal work hours (6:30 a.m.-6:30 p.m. Eastern Standard Time[EST]); Monday through Friday, and shipping services (8:00 a.m. - 7:00 p.m. [EST]) Monday through Saturday, including Federal Holidays.

5.2. Work Location

No on-site work will be required at WRAIR. The Contractor shall support specimen shipping and supply management at its off-site location.

5.2.1. Telecommuting

Not Applicable for this requirement

5.3. Post Closure

The COR will instruct the Contractor on procedures for contract performance in the event of a post closure.

6. PERFORMANCE REQUIREMENTS

6.1. Specific Tasks / Requirements

6.1.1. Shipping Requirements:

6.1.1.1. Overall Shipping Requirements

6.1.1.1.1. The Contractor shall support global shipping of Biosafety Level 2 specimens in accordance with all applicable customs requirements, laws and regulations, inclusive of but not limited to, CFR, IATA regulations, PHI / PII / HIPAA regulations and requirements to support screening for HIV. This service shall include sending all materials (i.e. shipping materials, blood transfer kits, blood tubes etc..) to sites and meet all shipping requirements shipping to and from sites. This service shall follow shipping, consumable, and regulation specifications outlined in this PWS.

6.1.1.1.2. The Contractor shall provide disposable temperature monitoring devices, for both domestic and international shipping containers, capable of indicating if shipping containers have exceeded 30 degrees Celsius during transit and if the excessive temperature was exceeded for a brief or prolonged duration.

6.1.1.1.3. All domestic specimen shipments are to be at ambient temperature, 18-30° Celsius. All OCONUS specimen shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 ° Celsius using gel packs.

6.1.1.1.4. The Contractor shall, if applicable, require subcontractors to proactively respond in the event of a shipping delay, immediately refrigerate the affected specimen(s) and prioritize delivery.

6.1.1.1.5. In the event that HDRL is not available to conduct testing, the Contractor shall ship specimens for testing to a facility to be determined as per COR directive. Change in the ship-to address will not occur prior to notification and written approval from the KO and COR.

6.1.1.1.6. The Contractor shall provide expedited overnight or two-day shipping when requested. Shipment shall not occur prior to review/approval of the COR.

6.1.1.1.7. The Contractor shall be capable of providing each site a supply (quantity to be determine at the task order level) of blood tubes(10 ml Tiger Top SST, substitutions for blood tubes permitted with COR approval), and the appropriate shipping containers and shipping labels for delivery of collected specimens to the testing facility

6.1.1.1.8. Day before holiday specimens are to arrive at the testing laboratory no later than 0800 two days after the specimens are shipped.

6.1.1.1.9. Saturday specimens are to arrive at the testing laboratory no later than 0800 two days after the specimens are shipped.

6.1.1.1.10. All shipments, specimen collection kits as well as specimens will be sent in accordance with shipping regulations.

6.1.1.1.11. All shipping costs are to be included as part of the contract. There shall be no additional cost to the government.

6.1.1.2. Domestic Shipping Requirements

6.1.1.2.1. The Contractor shall provide CONUS shipping for up to twenty eight (28) Saturdays per year, locations will collect patient specimens that will be required to arrive at HDRL NLT 0800 on the subsequent Monday. These shipments shall be maintained at a temperature range of 2-8° Celsius during transport utilizing frozen gel packs and specimen shipping standards described in paragraph 6.1.2.

6.1.1.2.2. The contractor shall insure specimens arrive at HDRL no later than 2 days after shipping from OCONUS site.

6.1.1.3. International Shipping Requirements

6.1.1.3.1. Shipments must be maintained at a temperature range of 2-8° Celsius during transport utilizing at least 6 frozen gel packs. The package shall be shipped in accordance with IATA guidelines. Outbound shipment from vendor can be the most cost effective manner available while inbound must be expedited and arrive at HDRL within 5 calendar days.

6.1.1.3.2. The Contractor shall be responsible for all requirements to ensure OCONUS shipments clear customs.

6.1.1.3.3. The Contractor shall ensure shipments en route to HDRL that depart the day prior to a holiday are shipped using the international blood transfer kit to assist in maintaining 2-8° Celsius temperature for the extended duration in transit.

6.1.2. Management of Shipping Material

6.1.2.1. The Contractor shall provide blood tubes, shipping supplies and shipping labels to CONUS/OCONUS sites for transport of specimens to WRAIR, HDRL. Total annual requirement of specimens to be shipped will be a minimum of 200,000 and a maximum of 2,100,000.

6.1.2.2. Commercially available blood tube required is a Red/Grey conventional closer, 10mL Plastic, Serum Separator Tube (SST), brand name or equal to Becton Dickinson tube, Catalog number 367988. Any substitutions must be approved by the COR.

6.1.2.3. Shipping containers and blood collection tubes will be provided and delivered to the sites within 3 working days of the request by the site or HDRL.

6.1.2.4. Specimens that will be shipped from sites to WRAIR will adhere to Code for Federal Regulations (42 CFR Part 72 and 49 CFR Part 171 – 178), for all domestic as well as international shipping requirements. At a minimum, per WRAIR best practices, the specimens will be packed utilizing the following items; kit box with UN3373 Labeling ( The Contractor shall be responsible for creating mailing labels), foam with cavities for the blood tubes (Contractor shall provide a description of the foam cavities to ensure they are shipping to HDRL specifications (Appendix B), absorbent pad (Contractor shall provide a description of pad absorbency to ensure they are supplying a pad sufficient to handle the amount of liquid in each container), Kit content check list (Contractor shall provide a sample, should HDRL have certain scanning limitations/requirements), FedEx or equivalent UN3373 Labpak, FedEx or equivalent Remote Ship List (RSL) for overnight delivery. The contractor shall provide a variety of sizes of kits that hold anywhere from maximum of 5 – 40 specimens for shipping. Currently WRAIR uses kits that can ship up to 40 specimens. Delivery to HDRL shall be no later than 0800 the day after pick-up (including Saturday for Friday afternoon pick-up) for domestic shipment. International shipments are to arrive by 0800 two days following specimen pick-up.

6.1.2.5. Used Shipping containers that are in serviceable condition shall be recycled for restocking of sites. HDRL will return the containers to the Contractor for redistribution to the sites. The contractor shall credit this contract for all recycled shipping containers. The Government will only incur the shipping fee when recycled containers are reused. The Contractor shall include a report on the number of recycled containers reused per reporting period in the monthly report (Deliverable 2).

6.1.3. Shipment and Tracking of Material and Specimens

6.1.3.1. A “near real time,” electronic mechanism (including maintenance) to track and report; shipments of specimens and supplies, delivery of shipping supplies, to include blood tubes identified in section 6.1.3.2, for shipment of specimens, and subsequent shipment of specimens to WRAIR, HDRL

6.1.3.2. The Contractor shall provide a monthly accounting of all shipments of supplies and specimens to the COR as part of the Monthly Progress Report (MPR) (Deliverable 2).

6.1.3.3. The Contractor shall ensure that all shipments from sites to HDRL are tracked via an on-line management system (website) that is updated and accessible by HDRL before 0800 the day following domestic shipments from sites and before 0800 two days following international shipments from OCONUS sites.

6.1.3.4. The on-line management system (website) shall provide the following capabilities/information:

· Batch orders

· Client User access

· MEDCOM HQ Program Manager/User access

· Management of Client information pertaining to shipping address and primary POC for ordering

· Supply stocking tracking

· Specimen transport tracking

· Preprinted air bill

· Supply quantity reporting monthly to HDRL

· Contractor managed inventory with auto replenishment

· Client Inventory management for view and analysis of inventory

· Client users shall be able to generate shortage/out-of-cycle orders based on inventory levels and client par levels of supplies shall be maintained once established

· The system shall monitor shipments for delay. In the event of a delay, the system shall proactively send an immediate notification to designated contractor personnel

· The system shall allow the sender as well as receiver visibility of all shipments to and from their location

· Electronic inventory management of medical consumables at each site, including alerts when inventory is low. Each site shall have the ability to request additional blood tubes and shipping containers electronically; shipment will not occur prior to review/approval of the COR

· The Contractor shall provide help desk support for the system during normal business hours. If issues/help desk tickets are not resolved within 48 hours, the Contractor shall notify the COR

· Provide training on the tracking system for 2 HDRL and up to 2 staff and/or members at each site at no additional cost to the Government. Vendor will also provide additional on line training for end users as needed. All training will be online, training materials will be soft copy only.

6.1.4. PHI/PII/HIPAA

HIPAA. The contractor shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (P.L. 104-191) requirements, specifically the administrative simplification provisions of the law and the associated rules and regulations published by the Secretary, Health and Human Services (HHS) and the published DHA implementation directions. This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards. It is expected that the contractor shall comply with all HIPAA-related rules and regulations as they are published and as WRAIR requirements are defined. See Appendix C for more information.

6.1.5. Shipping Logistics and Customer Service

6.1.5.1. The Contractor shall provide customer support to HDRL on all days deliveries are expected at HDRL.

6.1.5.2. The contractor shall provide all material and logistics support for the OCONUS site to ship specimens.

6.1.5.3. The Contractor shall provide a customer service line during normal business hours to provide information to sites on the process and procedures for, “how to,” complete a shipment

6.1.6. Mission Essential Contractor Plan

Mission Essential Contractor Plan (Deliverable 1) - The Contractor shall prepare and submit a Mission Essential Contractor Plan for continuation of essential services. The Mission Essential Contractor Plan shall be due with the proposal and shall be updated on an annual basis. Services identified in section 6.1 are deemed essential services. The Mission Essential Contractor Plan shall address:

· A description of the Contractor’s emergency management procedures and policy as they apply to this award

· Identify provisions made for the acquisition of essential personnel and resources, if necessary, for continuity of operations for up to 30 days or until normal operations can be resumed in the event of a crisis situation

· Challenges associated with maintaining essential contractor services during an extended event, such as a pandemic that occurs in repeated waves

· The approach for communicating expectations to contractor employees regarding their roles and responsibilities during a crisis

· Plan to accommodate delayed delivery of specimens to HDRL during such emergencies as adverse weather conditions/power outages ensuring specimen integrity and temperature requirements are maintained

· How the Contractor shall communicate with WRAIR during a crisis situation

· A list of primary and alternate Contractor points of contact, each with primary and alternate telephone numbers and e-mail addresses

· Procedures for protecting Government furnished equipment (if any)

6.2. Management Reports and Plans

The Contractor shall ensure that a MPR (Deliverable 2) is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this contract. The MPR shall include but not be limited to:

· Activities completed in reporting period

· Activities anticipated for the next reporting period

· New and ongoing issues/ problems

· Identified risks and mitigation

· Any government action needed

· Funds expended, by shipment or material, for each task/sub-task

· Monthly Performance Metrics

· Lessons learned

· A separate section for optional Contract Line Item Numbers (CLINs) exercised for surge support with the same information as discussed above

· Report on the number of recycled containers used in the reporting period

· Monthly accounting of all shipments of supplies and specimens

· Monthly accounting of tracking system training participants

· Monthly Task Status Report

· Identification of milestones where Government information, activity, equipment, material, facilities, etc., is required and timeline dependencies for subsequent Contractor activities

· A Subcontract Expenditures Report that discloses actual subcontract expenditures by company name, business size standard (i.e. Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (i.e. Indian Incentive Program, Historically Black Colleges and Universities and Minority Institutions, etc.).

Quality Control Plan (Deliverable 4). The contractor shall provide a Quality Control Plan (QCP) no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract and materials to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. The QC approach, at a minimum, shall be evaluated for the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction; to include but not limited to a self-inspection plan that addresses medical consumables and packing consumables QC, i.e. monitoring for product recalls; tracking medical consumables expiration dates.

Contract Manpower Reporting Application (CMRA) (Deliverable 5).

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

7.1. Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter CORT system.

7.2. Method of Delivery

Electronic copies are to be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format), unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

7.3. Shipping:

The Contractor shall use the U.S. Postal Service standard delivery for delivery of deliverables, or required hardcopy documents. The COR must approve all exceptions to this requirement. The Contractor shall deliver all deliverables to the Contracting Officer’s Representative at 9100 Brookville Rd. Bldg. 508, Silver Spring, MD 20910-7500.

7.4. Government Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

The COR will have ten (10) workdays to review draft deliverables and make comments. The Contractor shall have five (5) workdays to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) work days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in thirty (30) calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted quote. In the event of a rejected deliverable, the Contractor shall be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

7.5. Delivery Schedule Abbreviations

7.6. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).

CS

The contractor shall complete and deliver the CMRA.

COR

CS

7.7. Reports and Documents

Contractor Performance Assessment Reporting System (CPARS). CPARS is the DoD mandatory system to electronically capture assessment data and manage the evaluation process. CPARS is used to assesses a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured on the CPAR form and together make a complete CPAR. Once the Assessing Official completes the proposed assessment for the period of performance, the CPARS is released to the appropriate Government Contractor Representative for their review and comments. User ID and password will be provided to the designated Government Contractor Representative upon issuance of a task order. The Contractor has 30 days after the Government's evaluation is completed to comment on the evaluation. The Government Contractor Representative must either concur or non-concur to each CPAR. If the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the CPAR, the Assessing Official may close out the CPAR. Otherwise, they must forward the CPAR to the Reviewing Official for them to review, enter comments if appropriate, and close out. The Reviewing Official may at their option direct the Assessing Official to forward every CPAR to them for review.

7.8. COR Information

The COR for the task order is a Government official who has been delegated specific technical, functional and oversight responsibilities for this task order. The COR is identified in the COR appointment letter, issued by the Contracting Officer, and will serve as the Government’s primary technical point of contact for all task order activities and issues. The COR will manage the task order on a day-to-day basis, will review Contractor performance and deliverables, and will receive and review all Contractor invoices.

8. Performance Requirements Summary Matrix

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP), Attachment 2, to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

the testing facility no later than 8:00 A.M. the day after Shipment from CONUS sites.

Specimens will arrive at the testing facility no later than 8:00 A.M NLT 95% of the time

domestic specimen shipments are to be at ambient temperature, 18-30° Celsius 99% of the time

OCONUS specimen shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 ° Celsius 99% of the time

and 2 site staff or members at each site at no additional cost to the Government. Vendor will also provide additional on line training for end users as needed

9. Transition Support

9.1. Incoming Transition Plan:

The Contractor shall provide a plan for 15 days of incoming transition. The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall develop and deliver a Transition-in Plan (Deliverable 6). This transition plan shall include, but is not limited to the following items as applicable:

· Coordination with Government representatives

· Review, evaluation and transition of current support services

· Transition of historic data to new Contractor system,

· Government-approved training and certification process, if required

· Transfer of hardware warranties and software licenses, if required

9.2. Outgoing Transition Plan:

The Contractor shall develop and deliver an outgoing transition plan (Deliverable 7) for 45 days of outgoing transition for transitioning work from an active award to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required documents, metrics and statistics. This transition plan shall include, but is not limited to:

· Coordination with Government representatives

· Review, evaluation and transition of current support services

· Transition of historic data to new Contractor system,

· Transfer of hardware warranties and software licenses (if applicable)

· Transfer of all necessary business and/or technical documentation

10. Key Personnel - NA

11. Travel/Temporary Duty (TDY) - NA

12. Government Furnished Equipment - NA

13. Compliance Documents

The services provided under this contract must be conducted in accordance with all Federal law, DoD, DA and USAMRMC laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

14.1. Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

14.2. A complete list of DoD compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

14.3. AR 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

14.4. AR 25-1, Information Technology. http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

14.5. AR 25-2, Information Assurance.

14.6. DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

14.7. DoD 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

14.8. DoD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

14.9. DoD Instruction 8500.01 Cybersecurity

14.10. DoD Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT DoD Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

14.11. AR 70-25: Use of Volunteers as Subjects of Research, Headquarters, DA, dated 25 January 1990 – currently under revision

14.12. Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

14.13. Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US DoD and Health and Human Services.

14.14. CAP Inspection Checklists. http://www.cap.org

14.15. Clinical Laboratory Standards Institute (CLSI). Standards and Guides for Laboratories: http://clsi.org/standards

14.16. Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

14.17. National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for GCLP Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

14.18. ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

14.19. Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

14.20. Title 21, CFR Part 50 Protection of Human Subjects https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1

14.21. Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

14.22. Title 21 CFR Part 56, Institutional Review Boards

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

14.23. Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

14.24. Title 32 CFR Part 219, National Defense, Protection of Human Subjects, http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title32/32cfr219_main_02.tpl

14.25. Title 45 CFR 46, Protection of Human Subjects, April 1, 2014, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#

14.26. Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910

14.27. Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

14.28. Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-199.pdf

14.29. Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

14.30. Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

14.31. DoD Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013. http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf

14.32. DoD Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

14.33. DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standard in D00D-Supported Research. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

14.34. AR 600-110, Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus, 22 April 2014. http://www.apd.army.mil/pdffiles/r600_110.pdf

14.35. AR 40-501, Standards of Medical Fitness

14.36. US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

14.37. US Medical Entrance Processing Command Regulation 40-8, DOD Human Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

14. Other Terms, Conditions, and Provisions

14.1. Severable / Non-Severable Services

This award identifies services that are severable in nature.

14.2. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

14.3. Acquisition Functions Closely Associated with Inherently Governmental Functions

NA

14.4. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States Medical Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities (solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official (contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors.