Request for Information -WRAIR Specimen Shipping.docx

Request for Information (RFI)

Specimen Shipping: Walter Reed Army Institute of Research

This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI.

RFI Response and due date: 30 October 2023 no later than 10:00AM ET

Instructions to Responders:

Responses from all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF.

2. Cover Page (1page)

· Title

· Organization

· Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

· Topic area(s) addressed

3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the DRAFT Performance Work Statement.

Please note that responses are due no later than 30 October 2023 @ 10:00AM ET. The preferred method of submission is via email. The point of contact for this action is Ms. Flodean Billings, Contract Specialist flodean.p.billings.civ@health.mil . Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation.

DRAFT PERFORMANCE WORK STATEMENT (PWS)

Specimen Shipping and Supply Management

Part 1

General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide medical consumables globally for acquisition and routing of specimens to Walter Reed Army Institute of Research (WRAIR) Fort Detrick, MD, for Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV)/ Hepatitis B Virus (HBV) and Leishmania testing.

1.2 Background: Since 1893, the WRAIR has been a leader in solving the most significant threats to Soldier readiness and lethality such as disease and battle injury. WRAIR’s broad research capabilities at its Washington, D.C., area, and expeditionary laboratories function in concert to afford Soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR’s research is focused on Soldier health, its products have important civilian applications, saving countless lives around the world.

The Diagnostics and Countermeasures Branch (DCB), formerly the Department of Laboratory Diagnostics and Monitoring, works to provide effective, state-of-art diagnostic countermeasures to ensure force health and readiness. Branch efforts include the development of new diagnostic assays, and identification of optimal diagnostic testing platforms, assays and algorithms using evidenced based approaches.

DCB evaluates the performance characteristics and cross-comparison of current and emerging diagnostic and surveillance methodologies for evidenced-based down-selection of the most appropriate countermeasures for disease detection, screening, confirmation, and monitoring for enhanced patient management. DCB boasts standout accomplishments in their work related to leishmaniasis, HIV, and COVID-19. They have evaluated 63% of HIV diagnostics in use today.

1.3 Scope: 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), Military Entrance Processing Stations (MEPS), U.S. Embassies, other international organizations such as North Atlantic Treaty Organization sites, and other U.S. National interests worldwide.

1.3.1 Period of Performance: The period of performance shall be as follows:

1.4 Objectives:

The Contractor shall provide medical consumables globally for acquisition and routing of specimens to WRAIR for HIV/HCV/HBV, Leishmania, and any other applicable diagnostics testing. All shipping costs are to be included as part of the contract. There shall be no additional cost to the Government. The contractor shall provide:

· Shipping of Biosafety Level 2 (BSL2) specimens in accordance with (IAW) 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 IAW Protected Health Information (PHI), Personally Identifiable Information (PII), and Health Insurance Portability and Accountability Act (HIPAA) regulations and requirements.

The Contractor shall support Department of Defense (DoD) Force screening for HIV/HCV/HBV, Leishmania, and other applicable diagnostics specimens throughout the six geographical Combatant Commands (COCOMS), the Intelligence and Security Command (INSCOM), and other U.S. organizations as directed.

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

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

· U.S. INSCOM – Alice Springs, Australia

1.5 General Information:

Contracting Officer Representative (COR):

TBD

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed IAW this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within ten days after date of contract award (A.001).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 30 days. If the Government has provided comments, the Contractor shall then have 30 days to submit a Final QCP. After receipt of the Final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than 30 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team.

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals).

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses.

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including DoD Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance.

(e) How the Contractor will ensure all keys issued will remain controlled items, if applicable (Paragraph 1.7 Key Control).

(f) How the Contractor will inventory and track maintenance of all Government Provided Equipment / Materials, if applicable.

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future.

(h) How the Contractor will file and save all Quality Control related documents for the life of the contract plus 5 years.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract IAW the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the KO. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in January Presidents’ Day 3rd Monday in February Memorial Day last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

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 HIV Diagnostics and Reference Laboratory (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)

(FAR) Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the KO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.12.2 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). The Contractor (to include subcontractors) shall provide each of their employees an easily readable identification badge. The badge must include the employee’s name, the contractor’s company name, the functional area of assignment, and a recent color photograph of the employee. Companies with U.S. Government contracts will require their employees to wear these badges visibly when performing work at Government workplaces unless this would be impractical because of mission or safety considerations. The Contractor shall collect all ID Badges upon completion of the contract or termination of employee. A listing of issued ID cards shall be furnished to the KO prior to the contract performance date and updated as needed to reflect Contractor personnel changes (A.007).

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice (A.008).

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 ODCs.

Backup information for ODCs shall list all elements of costs. All ODCs exceeding $3,000 requires the contractor to conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The WAWF – Receipt and Acceptance application is the required method of submission.

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

The requirements under FAR 52.236-13 and specifically of the EM 385-1-1 include, but are not limited to the following:

(a) Before initiation of work at the job site, an Accident Prevention Plan, written by the Contractor for the specific work and hazards of the contract and implementing in detail the pertinent requirements of EM 385-1-1; will be reviewed for acceptance by designated on-site Government safety personnel (A.011). Specific requirements for development of the Accident Prevention Plan are found in 01.A and Appendix A of EM 385-1-1. EM 385-1-1 is available online at www.usace.army.mil.

(b) Before beginning each activity involving a type of work presenting hazards not experienced in previous project operations or where a new work crew or subcontractor is to perform work, Activity Hazard Analysis (AHA) shall be prepared by the Contractor performing the work activity (See paragraph 01.a.09 of EM 385-1-1) (A.011).

(c) The Contractor shall require subcontractors to submit their plan of operations showing methods they propose to use in accomplishing major phases of work

(d) The Contractor shall discuss the plans in conferences convened by the KO prior to starting work on each major phase of operation. Plans shall include all pertinent information such as layout of haul roads, access roads, storage areas, electrical distribution lines, methods of providing minimum exposure to overhead loads, and methods of access to work areas. The plan for accomplishing the initial work phase shall be submitted within 15 calendar days after award of the contract. Plans for subsequent major phases of work shall be submitted no later than 15 calendar days prior to initiation of work on each major phase; and

(e) In all areas where construction, demolition, alteration, building, or similar related activities take place, the Contractor shall have the following minimum personal protective clothing and equipment requirements in place for any person working on or visiting the site: short sleeve shirt, long trousers, steel-toed safety boots, and hard hat.

If training cannot be conducted on the website, the Contractor shall coordinate with the COR who will contact the local AT Officer at their assigned location for classroom training. Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the AT Officer. Verification of the training shall be provided to the COR within 15 days after completion of the training (A.012).

1.23.2 OPSEC Training: All Contractor employees, including subcontractors, shall complete Level I OPSEC training within 15 days of employment under this contract Verification of the training shall be provided to the COR within 15 days after completion of the training OPSEC Level I training is available at http://www.cdse.edu/catalog/elearning/GS130.html. Contractor personnel must complete refresher training every 12 months Verification of the training shall be provided to the COR within 15 days after completion of the training (A.013).

If training cannot be conducted on the website, the Contractor shall coordinate with the COR, who will contact the local OPSEC Officer at their assigned location for classroom training. Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the OPSEC Officer. Verification of the training shall be provided to the COR within 15 days after completion of the training (A.013).

PART 2

DEFINITIONS & ACRONYMS

Contracting Officer (KO) – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in Defense Federal Acquisition Regulation Supplement (DFARS 202.101), means an individual designated and authorized in writing by the KO to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified IAW this instruction. For example, local terminology can be COR, KO’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation (AR)70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the KO as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract.

Government Property - means all property owned or leased by the Government. Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the KO appointed IAW agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are like Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of a product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are like Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Workday - The number of hours per day the Contractor provides services IAW the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

PART 5

SPECIFIC TASKS

· The commercially available blood tube required is a red/grey conventional closer, 10mL plastic, SST, brand name or equal to Becton Dickinson tube, catalog number 367988. Any substitutions must be approved by the COR.

· 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 (the Contractor shall provide a description of the foam cavities to ensure they are shipping to HDRL specifications (see 1.4 (A)), absorbent pad (the 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 (the 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.

· Shipping containers and blood collection tubes shall be provided and delivered to the sites within three working days of the request by the site or HDRL.

· 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 as described in section 5.2.4.4 below.

· All domestic specimen shipments are to be at ambient temperature of 18-30° Celsius.

· Delivery to HDRL shall be no later than 0800 the day after pick-up (including Saturday for Friday afternoon pick-up) for domestic shipments.

· The Contractor shall provide CONUS shipping for up to 28 Saturdays per year; locations will collect patient specimens that will be required to arrive at HDRL No Later Than (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.

· Specimens collected the day before a holiday are to arrive at the testing laboratory at no later than 0800 two days after the specimens are shipped.

5.2.3.7 OCONUS/International Shipping Requirements:

· International shipments are to arrive at HDRL by 0800 two days following specimen pick-up at the OCONUS site.

· All Outside Continental United States (OCONUS) specimen shipments and day before holiday shipments are to be maintained at a temperature range of 2-8 ° Celsius using utilizing at least six frozen gel packs. 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.

· The package shall be shipped IAW IATA guidelines.

· Outbound shipment from the Contractor can be the most cost effective manner available while inbound must be expedited and arrive at HDRL within five calendar days.

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

5.2.4 Tracking of Material and Specimens: