26 Mar 2018

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

Type of document: Contract Notice
Country: United States

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

Agency:
Department of the Army

Official Address:
Attn: MCMR-AAA
820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014

Zip Code:
21702-5014

Contact:
Flodean Billings, Phone 3016192648, Email flodean.p.billings.civ@mail.mil

Link:

Date Posted:
23/03/2018

Classification:
99

Contract Description:
Title: Walter Reed Army Institute of Research (WRAIR), Human Immunodeficiency Virus (HIV) Diagnostics and Reference Laboratory (HDRL), Specimen Shipping and Supply Management for CONUS MEPS and OCONUS Sites
Solicitation: W81XWH-18-R-0050
Notice Type: Sources Sought
Response Date: 03 April 2018
Classification Code:
NAICS: 492110 – Couriers and Express Delivery Services
Synopsis: The Government requires non-personal support services to successfully perform the projects, tasks, and subtasks outlined below designed to support the Walter Reed Army Institute of Research (WRAIR) in their Human Immunodeficiency Virus (HIV) Diagnostics and Reference Laboratory (HDRL), Specimen Shipping and Supply Management for CONUS MEPS and OCONUS Sites

 

 

 

 

DRAFT – 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) Military Entrance Processing Station (MEPS) 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 MEPS 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 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.

2. PURPOSE AND BACKGROUND

The purpose of this requirement is to support the HDRL’s clinical test mission in support of U.S Military Entrance Processing Command as well as other U.S. Army and DoD entities. Specifically, test of specimens from Military Entrance Processing Station (MEPS) applicants, specimens from OCONUS sites, and other sources for the presence of Human Immunodeficiency Virus (HIV). The Contractor will provide medical consumables and logistical shipping support 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 will provide medical consumables to CONUS MEPS and OCONUS Sites, for acquisition and routing of specimens to WRAIR for HIV testing. For both CONUS and OCONUS sites, the contractor shall provide:

• Medical consumables
• Temperature controlled shipping services in accordance with International Air Transport Association IATA regulations
• Shipping material
• A, “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 paragraph 2, for shipment of specimens, and subsequent shipment of specimens to WRAIR, HDRL
• Electronic inventory management at each site, including alerts when inventory is low

4. PERIOD OF PERFORMANCE:
One 12 months Base year and four 12 months option years

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. The Contractor shall not work Federal Holidays. The Contractor shall not be designated as Essential; and, will not be required to work during U.S. Military Base Post closures unless authorized by the COR and/or KO.
5.2. Work Location

No on-site work will be required at WRAIR. The Contractor shall support specimen shipping and supply management for CONUS MEPS and OCONUS Sites.

5.2.1. Telecommuting

Not Applicable for this requirement
5.2.2. Working During Emergency Situations

Not Applicable for this requirement
5.3. Federal Holidays

5.3.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

5.4. Post Closure

The Contracting Officer (KO) 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. Consumables

6.1.1.1. The Contractor will provide a 45 day supply of blood tubes, shipping supplies and shipping labels to MEPS for transport of blood specimens to WRAIR, HDRL. Approximately 66 MEPS Processing Sites (CONUS and OCONUS See Attachment 3) will receive the first shipment of supplies no later than 10 Days after Contract Award (DACA). Contractor will not ship blood collection tubes in quantities greater than that which would be utilized within a 120 day period as determined by historical data per each shipping site, nor ship blood collection tubes that will expire in less than 180 days after the day of shipment. Total annual requirement of blood specimens to be shipped will be a minimum of 200,000 and a maximum of 400,000.

6.1.1.2. 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. (If using equivalent please provide product specifications).

6.1.1.3. Contractor will provide disposable temperature monitoring cards, 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.

6.1.2. Shipping Services

6.1.2.1. Blood specimens that will be shipped from MEPS 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 the blood specimens will be packed utilizing the following items; kit box with UN3373 Labeling, foam with cavities for the blood tubes (contractor will provide a description of the foam cavities to ensure they are shipping to HDRL specifications (Appendix B), absorbent pad (contractor will 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 will 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. Kits are to hold up to 40 specimens for shipping. Delivery to HDRL is to 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.

6.1.2.2. Used Shipping containers that are in serviceable condition shall be recycled for restocking of CONUS and OCONUS sites. HDRL will return the containers to the Contractor for redistribution to the CONUS and OCONUS sites. HDRL will receive credit for all recycled shipping containers and 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).

6.1.2.3. The Contractor shall provide shipping for up to twenty eight (28) Saturdays per year, CONUS MEPS locations will collect patient specimens that will be required to arrive at HDRL NLT 0800 on the subsequent Monday. These shipments will 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.

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

6.1.2.5. The Contractor shall develop and implement an inclement weather plan (Deliverable 4) to accommodate delayed delivery of specimens to HDRL during adverse weather conditions/outages ensuring specimen integrity and temperature requirements are maintained.

6.1.2.6. The Contractor shall provide shipping for OCONUS sites to support DoD Force screening for HIV. This service shall include sending all materials to OCONUS sites and meeting all international shipping requirements shipping to and from OCONUS sites. Shipping of testing supplies and return shipping container will be one time per site, per quarter, with the possibility for 4 additional shipping requests in the quarter from any of the locations. Sites include, Bangkok, Thailand; Tbilisi, Georgia; Nairobi, Kenya, and additional site(s) in Africa and the Middle East. OCONUS locations will collect patient specimens that the vendor shall be required to ship to and have arrive at HDRL no later than 2 days after shipping from the site.

Shipments will 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 WRAIR/HDRL within 5 calendar days.

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

6.1.2.8. 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.

6.1.2.9. The Contractor shall ensure that all shipments from MEPS 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 MEPS sites and before 0800 two days following international shipments from OCONUS sites.

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

6.1.2.11. (Optional) The Contractor shall provide shipping for OCONUS sites to support DoD Force screening for HIV. This service shall include sending all materials to OCONUS sites (Embassies and other US Government sites) and meeting all international shipping requirements shipping to and from OCONUS sites. Shipping of testing supplies and return shipping container will be one time per site, per quarter, with the possibility for 4 additional shipping requests in the quarter from any of the locations. Sites to be supported are located throughout Africa and the Middle East.

6.1.2.12. 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).

6.1.2.13. In the event that HDRL is not available to conduct testing, the Contractor shall ship specimens for testing from CONUS/OCONUS sites to the Center for Disease Detection (CDD), 11603 Crosswinds Way #100, San Antonio, TX 78233. Change in the ship-to address will not occur prior to notification and written approval from the KO.

6.1.3. Tracking/Inventory System

6.1.3.1. Contractor shall provide an on-line management system (website) for on-line ordering from Military Entrance Processing Command (MEPCOM) and Medical Command (MEDCOM) to HDRL. The following system capabilities/information shall also be provided:

• 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 personnel at HDRL
• The system shall allow the sender as well as receiver visibility of all shipments to and from their location
• 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 2 MEPCOM staff and members at each MEPS 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. Minimum Requirements:

The Shipping Supplies, blood tubes, supply management as well as supply and blood shipment tracking must meet the following requirements:

• The Contractor shall be capable of providing each site a 45 day supply (to be determine by each site) of blood tubes(10 ml Tiger Top SST), and the appropriate shipping containers and shipping labels for delivery of collected specimens to the testing facility
• Total required blood tubes, for all sites, will be a minimum of 200,000 and a maximum of 400,000 annually
• All domestic specimen shipments are to be at ambient temperature, 18-30° Celsius. All OCONUS blood shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 ° Celsius using gel packs.
• Domestic specimens are to arrive at the testing laboratory no later than 0800 the day after the blood samples are shipped.
• International specimens are to arrive at the testing laboratory no later than 0800 two days after the specimens are shipped.
• Day before holiday specimens are to arrive at the testing laboratory no later than 0800 two days after the blood samples are shipped.
• Saturday specimens are to arrive at the testing laboratory no later than 0800 two days after the blood samples are shipped.
• 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.
• All shipments, specimen collection kits as well as specimens will be sent in accordance with shipping regulations.
• All shipping costs are to be included as part of the contract. There shall be no additional cost to the government.

6.1.5. Expedited Shipping

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

6.1.6. Mission Essential Contractor Plan

Mission Essential Contractor Plan (Deliverable 9) – The Contractor shall prepare and submit a Mission Essential Contractor Plan for continuation of essential services. A draft of the Mission Essential Contractor Plan shall be due with the proposal and final copy 30 calendar days after the award of the order, and shall be updated on an annual basis. Services identified in paragraphs 6.1.1, 6.1.2, 6.1.3, 6.1.4, and 6.1.5, are deemed essential services. The Mission Essential Contractor Plan shall address:

• A description of the Contractor’s emergency management procedures and policy
• 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

• 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
• A description of how the Contractor will account for their employees during an emergency
• How the Contractor will communicate with WRAIR during emergencies
• 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 task. 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

Quality Control Plan (Deliverable 5). The contractor shall provide a draft 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 to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

Contract Manpower Reporting Application (CMRA) (Deliverable 6).

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:

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:

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

Subcontractor Expenditure Plan (Deliverable 3)

The Contractor shall prepare and deliver a Subcontract Expenditures Report (Deliverable 3) 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.).

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 will use the U.S. Postal Service standard delivery for delivery of materials, equipment, 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 will 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

Abbreviation Definition
COR Contracting Officer’s Representative for the Task order
CS Contract Specialist
DA Days after
DACA Days after contract award (award of this order)
DAEOM Days after the end of the month
Days Calendar Days unless otherwise specified
DID Data Item Description
E Electronic Copy
H Hard Copy
NLT Not Later Than
PWS Ref Performance Work Statement Reference (paragraph number)
WDA Working Days After

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).
Deliverable Number PWS Ref Title Dist. E H Initial Subsequent
Deliverable 1 Attachment 1 Non-Disclosure Agreement COR
CS 1
1 1
1 Signed statements are due, from each employee assigned, prior to performing ANY work on this task.
Deliverable 2 6.1.2.2, 6.1.2.12, 6.2 Monthly Progress Report COR 1
NLT 45 DACA NLT 15th of each month
Deliverable 3 6.2 Subcontractor Expenditure Plan COR
CS 1
1 NLT 45 DACA Monthly with MPR
Deliverable 4 6.1.2.5 Inclement Weather Plan COR
CS 1
1 1
1 Draft with Proposal As required
Deliverable 5 6.2 QCP COR 1
1
With Proposal As required
Deliverable 6 6.2 Contract Manpower Reporting Application
The contractor shall complete and deliver the CMRA. COR
CS 1 By October 31 or on the last day of contract performance – whichever is first As required
Deliverable 7 9.1 Incoming Transition Plan COR 1
1
Draft due with proposal As required
Deliverable 8 9.2 Outgoing Transition Plan COR 1
1
Draft due 90 days prior to contract end As required
Deliverable 9 6.1.6 Mission Essential Contractor Plan COR 1
1
Draft due with proposal As required

7.7. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

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

# PWS Ref. Performance Objective Acceptable Quality Level Method of Surveillance Incentive
1 6.1.2.10 Provide online tracking of subcontracted carrier sample delivery from MEPS sites accessible via on-line management system (website) by 0800 the day following shipment and by 0800 two days following OCONUS shipments 100% of deliveries are represented on on-line management system (website) by 0800 the day following shipment. HDRL will print incoming MEPS site tracking report daily and OCONUS tracking when shipments are expected and compare to actual shipments received. Positive CPARS review, renewal of option period(s)
2 6.1.1.1 Delivery of a 45 day supply of blood tubes and shipping containers to the MEPCOM sites by 10 August 2018. Supplies delivered NLT 10 August 2018 Observation/MEPCOM site feedback/ Monitoring supply/shipment tracker Positive CPARS review, renewal of option period(s)
3 6.1.3.1 Technical Support for supply/shipment tracking system Issues/help desk tickets will be resolved within 48 hours Observation/ Feedback from CONUS and OCONUS users Positive CPARS review, renewal of option period(s)
4 6.1.4 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. All MEPCOM sites will be stocked with sufficient supplies to maintain a 45 supply for their site 95% of the time Vendor will provide electronic records of all shipments, supplies, and specimen samples, to HDRL Positive CPARS review, renewal of option period(s)
5 6.1.2 Specimens will arrive at
the testing facility no later
than 8:00 A.M. the day after
shipment from CONUS MEPCOM sites. Specimens will arrive at
the testing facility no later
than 8:00 A.M NLT 95% of the time Observation/MEPCOM site feedback/ Monitoring supply/shipment tracker Positive CPARS review, renewal of option period(s)
6 6.1.4 All domestic specimen shipments are to be at ambient temperature, 18-30° Celsius. All OCONUS blood shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 °
domestic specimen shipments are to be at ambient temperature, 18-30° Celsius 99% of the time

OCONUS blood shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 ° Celsius 99% of the time Review of temperature monitoring cards Positive CPARS review, renewal of option period(s)
7 6.1.3.1 Provide user training on the tracking system for 2 HDRL
and 2 MEPCOM staff and
members at each MEPS site at no additional cost to the
Government. Vendor
will also provide additional on line training for end users as needed Online user training available 95% of the time Observation/MEPCOM site feedback/ Positive CPARS review, renewal of option period(s)

 

 

 

 

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 7). 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
• Transfer of hardware warranties and software licenses
• Transfer of all System/Tool documentation to include: user manuals, system administration manuals, training materials, disaster recovery manual, requirements traceability matrix, and all other documents required to operate, maintain and administer systems and tools
• Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches
• Orientation phase and program to introduce Government personnel, programs, and users to the Contractor’s team, tools, methodologies, and business processes
• Applicable WRAIR briefing and personnel in-processing procedures
• Coordinate with the Government to account for government keys, ID/access cards, and security codes (if necessary)

9.2. Outgoing Transition Plan:

The Contractor shall develop and deliver an outgoing transition plan (Deliverable 8) 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
• Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches (if applicable)
• Orientation phase and program to introduce Government personnel, programs, and users to the Contractor’s team, tools, methodologies, and business processes
• Applicable WRAIR debriefing and personnel out-processing procedures
• Turn-in of all government keys, ID/access cards, and security codes (if necessary)

10. KEY PERSONNEL – NA

11. TRAVEL/TEMPORY DUTY (TDY) – NA

12. GOVERNMENT FURNISHED EQUIPMENT – NA

13. CONTRACT MANAGEMENT

13.1. Government Management
The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

13.2. Contractor Management
The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

13.3. Contractor Organization
The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

13.4. Subcontract management

13.4.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.
13.4.2. The contractor is responsible and accountable for subcontractor performance on this contract
13.4.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations
13.4.4. Contractor my add subcontractors to their team after notification and written approval from the KO.
13.4.5. Privy of contract is with the contractor and the subcontractor…..

13.5. Foreign Nationals
A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. A background investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access will not be approved until a background check is done in accordance with para 18.9. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

14. COMPLIANCE DOCUMENTS

14.1. General Compliance

14.1.1. Federal Law
The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

14.1.2. DoD Compliance Documents
A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at

• Army Regulation 340-21, Army Privacy Program.

• Army Regulation 25-1, Information Technology.

• Army Regulation 25-2, Information Assurance.

• Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

• Department of Defense (DOD) Instruction 8500.01 Cybersecurity

• Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program

14.1.3. Other
• International Air Transport Association IATA regulations

15. REFERENCE DOCUMENTS

a) Department of Defense Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013.

b) US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations ;sort=pubNo

c) US Medical Entrance Processing Command Regulation 40-8, Department of Defense (DOD) Human Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program ;sort=pubNo

d) Defense Federal Acquisition Regulation Supplement 252.237-7024 – Notice of Continuation of Essential Contractor Services

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

16.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor’s responsibility to notify the Contractor Officer (KO) immediately.

16.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

16.3. Inherently Governmental Functions

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

16.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

NA

16.5. 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. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

16.6. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and other costs. Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for other costs shall list all elements of costs, such as shipping breakout backup, including, dates of shipping, description, and cost shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

16.7. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

16.8. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

16.9. Attendance at Meetings – NA

16.10. Data Rights
The Government will retain rights to all data generated in the course of developing, deploying, training, using and supporting WRAIR or other federal agencies that utilize this contract.
16.11. Anti-Terrorism and Operational Security

16.11.1. AT Level I Training.
All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website:

16.11.2. AT Awareness Training for Contractor Personnel Traveling Overseas.
Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

a) For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

b) For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

16.12. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.
The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g. Public Affairs clearance and Operational Security clearance for dissemination).

16.13. Personally Identifiable Information (PII) and Protected Health Information (PHI)
The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C. (Reference (ae)).

16.14. Public Key Infrastructure Authentication – NA

16.15. Network Security – NA

16.16. Workplace Safety – NA

17. Appendix

Appendix A – Acronyms List

 

Appendix A – ACRONYM LIST

Acronym Definition
AFARS Army Federal Acquisition Regulation Supplement
AFRIMS Armed Forces Research Institute of Medical Sciences
AKO Army Knowledge Online
AOR Area Of Responsibility
AT OPSEC Antiterrorism and Operational Security
ATCTS Army Training Certification Tracking System
CAC Common Access Card
CFR Code of Federal Regulations
CONUS Continental United States
COR Contracting Officer Representative
DFARS Defense Federal Acquisition Regulation Supplement
DoD Department of Defense
EIT Electronic and Information Technology
FAR Federal Acquisition Regulation
FBI Federal Bureau of Information
FPCON Force Protection Condition
FSC Federal Supply Code
FSS Federal Supply Schedule
GFE Government Furnished Equipment
GFI Government Furnished Information
GSA General Services Administration
IA Information Assurance
ID Identification
ID/IQ Indefinite Delivery / Indefinite Quantity
IPT Integrated Product/Process Team
IT Information Technology
NAC National Agency Check
NACI National Agency Check with Inquiries
NCIC-III National Crime Information Center Interstate Identification Index
NLT No Later Thank
OCI Organizational Conflict of Interest
OCONUS Outside Continental United States
OPSEC Operational Security
PMO Project Management Office
PRS Performance Requirements Summary
PWS Performance Work Statement
QASP Quality Assurance and Surveillance Plan
QCP Quality Control Plan
SHARP Sexual Assault Prevention and Response Program
SOP Standing Operating Procedure
TARP Threat Awareness and Reporting Program
U.S.C. United States Code
UIC Unit Identification Code
US United States
USAMRAA United States Army Medical Research Acquisitions Activity
USAMRD-G United States Medical Research Directorate – Georgia
USAMRD-K United States Medical Research Directorate – Kenya
WAWF Wide Area Work Flow
WRAIR Walter Reed Army Institute of Research

 

Appendix B – HDRL Shipping Container Specifications

HDRL Specimen Packing Specifications:

A. Wrap all vials individually to avoid contact

B. Surround individually wrapped specimens with enough absorbent material to contain spillage (preferred method is use of a foam separator that tubes insert into)

C. Package specimen in a watertight primary and secondary container.

D. Additional information can be found on the HDRL website at:

 

 

 

 

Response Date:
040318

Sol Number:
W81XWH-18-R-0050