HIV_Industry_Day_Slides_11082017.0348.pdf

HIV Force Testing

Industry Day Kathleen D. Henderson, Contracting Officer

Kirk Wadsack, Contract Specialist

SECURITY CLASSIFICATION:

Unclassified/For Official Use Only

09 November 2017

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 2

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Agenda 7:15 – 8:00 Participant Registration

8:00 – 8:15 Administrative Announcements/Purpose Introduction of Government Personnel

8:15 – 9:30 Introduction of Industry Participants Educate and Engage HIV Testing Background/Objectives

9:30 – 9:45 Break

10:00 – 11:45 Draft PWS – Industry Feedback/Algorithms US Army HIV Testing Program IA and RMF Requirements Facilitated Discussion/Exchange of Ideas Summary/Questions and Answers

11:45 – 1:00 Lunch

1:00 – 4:00 One-On-One Meetings

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 3

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Administrative Announcements

• Please quiet all cell phones

• Location of restrooms and vending

• Food and drinks are not allowed in conference room

• Smoking is authorized outside of the complex only

• Lunch is available in the immediate area

• Slides of conference will be available afterwards, upon request

• Industry Day participants/attendees’ list will be posted in FedBizOpps

• Conference discussion will be scribed (but no audio/video recording)

• Audio/video recording of government personnel and photography of government buildings is prohibited

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 4

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Purpose

Purpose: The Government seeks to educate and engage Industry in the key elements and comprehensive requirements to provide HIV testing services to the United States (U.S.) Army and U.S.

Military Entrance Processing Command

(USMEPCOM).

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 5

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Introduction of Key Government Personnel

Dr. Sheila Peel – Chief, Department of Laboratory Diagnostics and Monitoring Laboratory Director, HIV Diagnostics and Reference Laboratory

Mr. Alan Daugherty – IA Compliance Manager, MEDCOM HQ G-6

LTC Robert Nace – HIV Laboratory Program Manager, Contracting Officer Representative (COR), Ms. Kathleen Henderson – Contracting Officer, Army Services Branch (ASB) Health Readiness Contracting Office (HRCO) Mr. Kirk Wadsack – Contract Specialist, ASB, HRCO Ms. Yvonne Camarce – Contract Specialist, ASB, HRCO Ms. Quina Garrett – Contract Specialist, ASB, HRCO Mr. Albert Solis – Contract Specialist, ASB, HRCO Mr. Darnell Greenfield – Contract Specialist, ASB, HRCO

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 6

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Educate and Engage Industry

Objectives of “Educate and Engage”:

• Decrease Ambiguity

• Decrease Vagueness

• Increase Understanding

• Increase Competition

• Decrease Cost

• Increase Quality

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 7

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Educate and Engage Industry

Industry Day 9 Nov 2017

One-on-One Meetings 9 Nov 2017

Submit Remaining PWS Questions 16 Nov 2017

Draft PWS Nov – Dec 2017

Solicitation (Request for Proposals) Jan 2018

Pre-proposal Conference Jan 2018

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 8

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Background/Objectives:

• The HIV Testing program is designed to provide 4th Generation HIV testing services for the U.S. Army to include the provision of collection supplies, specimen collection/preparation/shipment instructions and training, courier services, specimen testing (including required quality programs), result reporting, specimen storage/re-aliquot/final disposition services, required information management systems, and help desk customer support services.

• It is projected that the HIV Testing contractor may receive approximately 60,000 specimens monthly from U.S. Army MTFs and USAR RHRP sites; and 13,800 specimens from ARNG. Submitting activities for the U.S. Army MTFs/other sites, USAR, and ARNG sites. The HIV Testing contractor may also provide services as ordered to augment testing for the United States Military Entrance Processing Command

(USMEPCOM).

HIV Testing Background/Objectives

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 9

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Draft PWS – Industry Feedback

• PWS 1.2 Scope of Work: The contractor shall provide qualified personnel, services, materials, equipment supplies, information systems, and facilities, except as identified in Paragraph 3, Government-Furnished Equipment/Property, necessary to perform testing services for the detection of antibody against and/or antigens of HIV. The contractor shall employ Food and Drug Administration (FDA) approved tests, software, testing instruments, and methodologies. Approved testing protocols covered by this contract are established and updated by the HIV Diagnostics and Reference Laboratory (HDRL), Walter Reed Army Institute of Research (WRAIR), 9100 Brookville Rd., Bldg 508, Silver Spring, MD 20901.

• The contractor shall perform an initial HIV screening test on serum and/or plasma specimens submitted by U.S. Army Medical Treatment Facilities (MTFs) and/or other Submitting Activities (SA), (e.g., the U.S. Army Reserve (USAR) sites and U.S. Army National Guard (ARNG) sites (typically coordinated by the Reserve Health Readiness Program (RHRP)).

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 10

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Draft PWS – Industry Feedback

• The contractor shall forward all initial “Reactive” specimens to HDRL for additional testing. Initial “Reactive” specimens shall be aliquoted from original specimen tube, inventoried, frozen, packaged, and shipped frozen to HDRL by close of business on the next business day post initial receipt within the Laboratory. The contractor shall notify the SA on a daily basis of those specimens shipped to HDRL. HDRL will provide the final report for those specimens requiring repeat testing, confirmation and/or verification testing; and all additional testing will be reported by HDRL through the contractor LIMS to the submitting activities.

• The contractor shall, within four hours of the conclusion of all specimen testing, ensure transfer of the residual serum (approximately 2.5cc) into a tube (“parent tube”) suitable for permanent archival storage, and shall freeze the parent tube and the residual serum to a temperature of minus thirty degrees Celsius (-30ºC) or below and shall maintain the parent tubes at this temperature or lower during all subsequent operations to include shipment to the DoD Serum Repository.

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 11

CDC Algorithm

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 12

Army Algorithm

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 13

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• Commercial contract terms and conditions

– What are the commercial terms/definition for HIV Testing?

– What are the commercial standards for HIV Testing?

– What suggestions can Industry provide the government in identifying key/critical performance measures to evaluate success?

Facilitated Discussion/Exchange of Ideas

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 14

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Facilitated Discussion/Exchange of Ideas

• Industry best commercial practices and methods to improve quality. Please provide one (1) best commercial practice and/or method that would improve quality or lessen costs, or both.

• Cost saving efficiencies and initiatives. Please provide one

(1) cost saving efficiency and/or initiative

• Performance-based solutions. Please provide a performance-based solution to meet the PWS requirements.

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 15

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Summary

• Introduction of Government and Participants

• Educate and Engage Industry

• HIV Testing Background/Objectives

• Draft PWS – Industry Feedback

• Algorithms/Technical Points

• IA and RMF Elements

• Facilitated Discussion/Exchange of Ideas

• Posting of Attendee Roster

• Conference Slides May Be Made Available

Upon Request

Questions/General Comments?

14-Nov-17Name/Office Symbol/(703) XXX-XXX (DSN XXX) / email addressKathleen Henderson, kathleen.d.henderson2.civ@mail.mil 09 November 2017Slide 16

Guidance