W81XWH-21-R-0071.pdf

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94 - 99 X H 100 - 105 jennifer.s.bassett.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 105

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W81XWH 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

JENNIFER S. BASSETT 301-619-2268

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

1 - 2 3 - 16

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

17 - 46

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

49 - 50 X K REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 51 - 54 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 55 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIO NS AND INSTRUCTIO NS

PART III - LIST O F DO CUMENTS, EXHIBITS AND O THER ATTACHMENTS

56 - 70

PART II - CO NTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

10 Aug 2021

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH21R0071

Section A - Solicitation/Contract Form

CLAUSES INCORPORATED BY REFERENCE

52.203-19 Prohibition on Requiring Certain Internal Confidentiality

Agreements or Statements

JAN 2017

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Job

NHP SIMULATOR - TECHNICAL REQ.

FFP

The Contractor shall develop a NHP Training Simulator with the following

TECHNICAL REQUIREMENTS:

**A 4-10k full body model with state of the art skills trainer designed to replicate Macaca Fasicularis animal with training sights designed to replicate look, feel and function of medical procedures performed.

**A system with an anatomically accurate airway. The system must permit realistic endotracheal intubation with a 4mm endotracheal tube. A closed airway system will support use with ventilator.

**A system with a durable, washable, replaceable coat. The system shall be designed in a way that allows USAMRIID to replace the fur, wash, and clean external elements, and durable enough to withstand repeated use in training under industry average conditions for a minimum of three (3) years, and, will support repeatability, reuse and minimal instructor re-set time.

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination ADDITIONAL MARKINGS: POC: Ms. Jennifer Audet, #301-619-0370

PSC CD: 6515

NET AMT

0002 12 Job

NHP SIMULATOR - FUNCTIONAL REQ.

FFP

The Contractor shall develop a NHP Training Simulator with the following

FUNCTIONAL REQUIREMENTS:

**The system must allow phlebotomy training (femoral/saphenous/cephalic) to include incorporation of a “flash” cue.

**The system must allow intravenous catheter placement (cephalic) to include incorporation of a “flash” cue.

**The system must allow for intubation with chest rise and fall. This will allow users the ability to train on intubation procedures to include bag valve mask (BVM) ventilation. The chest must rise and fall with accurate placement (stomach rise and fall if incorrectly placed in esophagus).

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

0003 2 Job

NHP SIMULATOR TRAINING

FFP

TRAINING

In accordance with Section 3.1.3. of the Performance Work Statement, the Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon by both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering.

These trainings/meetings can occur virtual or in-person; as preferred.

FOB: Destination

0004 4 Job

CONSUMABLES & OPERATING MANUAL

FFP

CONSUMABLES & OPERATING MANUAL

In accordance with Section 3.1.4. of the Performance Work Statement, the Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution. These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

**The Contractor shall provide three (3) printed and an electronic Operating Manuals to allow a user to operate the system in the absence of the Contractor. The Operating Manual shall include the following:

**Comprehensive instructions for unpacking, setup, calibration (if required), power up, operating instructions (covering all features), power down, storage, maintenance, troubleshooting of the system and system part numbers.

**The Operating Manual shall also outline safety guidelines for operating the system, quick start guide, and service instructions (covering all services to maintain the system in the field).

**Three (3) and One (1) Electronic Operating Manual FOB: Destination

0005 1 Job

WARRANTY

FFP

WARRANTY - 3 YEARS TOTAL (YEAR #1)

In accordance with Section 3.1.5. of the Performance Work Statement, the Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

FOB: Destination

1001 12 Job

OPTION DEVELOPMENT OF A 2ND NHP SIMULATOR

FFP

The Contractor shall develop a NHP Training Simulator with the following

TECHNICAL REQUIREMENTS:

**A 4-10k full body model with state of the art skills trainer designed to replicate Macaca Fasicularis animal with training sights designed to replicate look, feel and function of medical procedures performed.

**A system with an anatomically accurate airway. The system must permit realistic endotracheal intubation with a 4mm endotracheal tube. A closed airway system will support use with ventilator.

**A system with a durable, washable, replaceable coat. The system shall be designed in a way that allows USAMRIID to replace the fur, wash, and clean external elements, and durable enough to withstand repeated use in training under industry average conditions for a minimum of three (3) years, and, will support repeatability, reuse and minimal instructor re-set time.

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

1002 12 Job

OPTION *OPTIONAL* CLIN - RADIOPAQUE LIMBS

FFP

The Contractor shall develop a NHP Training Simulator with the following

TECHNICAL REQUIREMENTS:

**A 4-10k full body model with state of the art skills trainer designed to replicate Macaca Fasicularis animal with training sights designed to replicate look, feel and function of medical procedures performed.

**A system with an anatomically accurate airway. The system must permit realistic endotracheal intubation with a 4mm endotracheal tube. A closed airway system will support use with ventilator.

**A system with a durable, washable, replaceable coat. The system shall be designed in a way that allows USAMRIID to replace the fur, wash, and clean external elements, and durable enough to withstand repeated use in training under industry average conditions for a minimum of three (3) years, and, will support repeatability, reuse and minimal instructor re-set time.

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

1003 12 Job

OPTION *OPTIONAL* CLIN - BONE MARROW EXTRACTION

FFP

The Contractor shall develop a NHP Training Simulator with the following

FUNCTIONAL REQUIREMENTS:

**The system must allow phlebotomy training (femoral/saphenous/cephalic) to include incorporation of a “flash” cue.

**The system must allow intravenous catheter placement (cephalic) to include incorporation of a “flash” cue.

**The system must allow for intubation with chest rise and fall. This will allow users the ability to train on intubation procedures to include bag valve mask (BVM) ventilation. The chest must rise and fall with accurate placement (stomach rise and fall if incorrectly placed in esophagus).

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

1004 12 Job

OPTION *OPTIONAL* CONSUMABLES

FFP

CONSUMABLES - OPTION YEAR #1

The Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution. These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

FOB: Destination

1005 2 Job

OPTION *OPTIONAL* NHP SIMULATOR TRAINING

FFP

TRAINING

In accordance with Section 3.1.3. of the Performance Work Statement, the Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon by both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering.

These trainings/meetings can occur virtual or in-person; as preferred.

FOB: Destination

1006 1 Job

OPTION WARRANTY

FFP

WARRANTY - 3 YEARS TOTAL (YEAR #2)

In accordance with Section 3.1.5. of the Performance Work Statement, the Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

FOB: Destination

2001 12 Job

OPTION *OPTIONAL* CLIN - IC INJECTION

FFP

The Contractor shall develop a NHP Training Simulator with the following

TECHNICAL REQUIREMENTS:

**A 4-10k full body model with state of the art skills trainer designed to replicate Macaca Fasicularis animal with training sights designed to replicate look, feel and function of medical procedures performed.

**A system with an anatomically accurate airway. The system must permit realistic endotracheal intubation with a 4mm endotracheal tube. A closed airway system will support use with ventilator.

**A system with a durable, washable, replaceable coat. The system shall be designed in a way that allows USAMRIID to replace the fur, wash, and clean external elements, and durable enough to withstand repeated use in training under industry average conditions for a minimum of three (3) years, and, will support repeatability, reuse and minimal instructor re-set time.

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

2002 12 Job OPTION *OPTIONAL* CLIN - Tethered Inf. System

FFP

The Contractor shall develop a NHP Training Simulator with the following

FUNCTIONAL REQUIREMENTS:

**The system must allow phlebotomy training (femoral/saphenous/cephalic) to include incorporation of a “flash” cue.

**The system must allow intravenous catheter placement (cephalic) to include incorporation of a “flash” cue.

**The system must allow for intubation with chest rise and fall. This will allow users the ability to train on intubation procedures to include bag valve mask (BVM) ventilation. The chest must rise and fall with accurate placement (stomach rise and fall if incorrectly placed in esophagus).

THIS CLIN WILL BE BILLED ON A MONTHLY BASIS FOR THE FULL

PERIOD OF PERFORMANCE = 12 MONTHS.

***PAYMENT MAY BE WITHHELD DEPENDING ON THE LEVEL OF

PROGRESS WITH THE SIMULATOR DEVELOPMENT***

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

2003 12 Job

OPTION *OPTIONAL* CONSUMABLES

FFP

CONSUMABLES & OPERATING MANUAL

In accordance with Section 3.1.4. of the Performance Work Statement, the Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution. These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

**The Contractor shall provide three (3) printed and an electronic Operating Manuals to allow a user to operate the system in the absence of the Contractor. The Operating Manual shall include the following:

**Comprehensive instructions for unpacking, setup, calibration (if required), power up, operating instructions (covering all features), power down, storage, maintenance, troubleshooting of the system and system part numbers.

**The Operating Manual shall also outline safety guidelines for operating the system, quick start guide, and service instructions (covering all services to maintain the system in the field).

**Three (3) and One (1) Electronic Operating Manual FOB: Destination

2004 2 Job

OPTION *OPTIONAL* NHP SIMULATOR TRAINING

FFP

TRAINING

In accordance with Section 3.1.3. of the Performance Work Statement, the Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon by both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering.

These trainings/meetings can occur virtual or in-person; as preferred.

FOB: Destination

2005 1 Job

OPTION WARRANTY

FFP

WARRANTY - 3 YEARS TOTAL (YEAR #3)

In accordance with Section 3.1.5. of the Performance Work Statement, the Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

FOB: Destination

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

FOR

NON-HUMAN PRIMATE (NHP) TRAINING SIMULATOR DEVELOPMENT

FOR THE

U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES (USAMRIID)

SECTION 1 PURPOSE

1.1. INTRODUCTION

1.1.1. The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is the Department of Defense’s (DoD) lead laboratory for medical biological defense research. USAMRIID’s core mission is to protect the warfighter from biological threats; USAMRIID also investigates disease outbreaks and threat to the public health. The research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information that benefit both the military personnel and civilians. USAMRIID has a mission to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.2. MISSION

1.2.1. The USAMRIID mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.3. BACKGROUND

1.3.1. The Guide for the Care of Use of Laboratory Animals, 8th edition further clarifies required training and education by stating that the institution is responsible for providing personnel with resources needed to ensure that staff involved with animal care and use have “experience, training, and expertise” required. VMD sustains a robust training program to meet federal requirements and ensure that USAMRIID’s animal program maintains continued AAALAC accreditation (a DOD requirement). VMD is comprised of civilian and military personnel with varying degrees of technical experience in laboratory animal species; personnel are required to undergo extensive species-specific training prior to animal care and use. Species specific skills that are routinely employed are incorporated into the current training program and must be mastered prior to working with the identified animal species.

1.3.2. In addition to introductory training, refresher training is provided to maintain skillset and to support approved protocols as needed. Animal species skill training extends beyond VMD personnel. The Institutional Animal Care and Use Committee (IACUC) evaluates personnel training, experience, and credentials during protocol and addenda review as well as during the semi-annual program review. Additionally, training is reviewed during the Pre- Protocol Planning Meeting (PPM) and when a protocol undergoes Post Approval Monitoring (PAM). Principal Investigators (PIs) and their staff are required to be adequately trained in procedures performed. Trained VMD staff provide species specific training.

1.4. SCOPE

1.4.1. The USAMRIID VMD requires the procurement of a NHP Training Simulator, which may be referenced as a NHP Trainer, NHP skills Trainer, or NHP Simulator, which will provide a comprehensive, timely solution to improve upon the VMD training program and ensure that federal regulatory requirements are maintained. The enterprise solution must support a variety of end users to include veterinarians, veterinary technicians, caretakers, PIs, and research staff. The NHP Training Simulator acquisition directly supports not only laboratory animal regulatory requirements, but also continued growth and development of the animal care technicians’ skillsets and supports the Army’s Laboratory Animal Medicine Residency Program.

1.4.2. Section 3 of the PWS describes the full Technical Requirements, Functional Requirements, Optional Technical and Functional Requirements, and Deliverables associated with this requirement for a NHP Training Simulator.

1.5. ORGANIZATIONAL CONFLICT OF INTEREST (OCI) STATEMENT

1.5.1. Organizational Conflict of Interest (OCI), Deliverable #1, Attachment #1. This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category Three (3) – Product Support, which falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. In additions, the contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1. Place of Performance.

2.1.1.1. Primary On-Site Government Location. 1425 Porter Street, Fort Detrick, Frederick, Maryland 21702 for training on use and sustainment of the NHP Training Simulator and any service requirements on the NHP Training Simulator.

2.1.1.2. Primary On-Site Contractor Location. Development of the NHP Training Simulator will be conducted at the Contractor Location.

2.1.1.3. Period of Performance. This contract is for one (1) twelve (12) month Base Period, and three (3) twelve

(12) month Option Periods. The periods of performance for this contract are as follows:

Base 15 September 2021 – 14 September 2022 Option Year 1 15 September 2022 – 14 September 2023 Option Year 2 15 September 2024 – 14 September 2024

See Section 3 of the PWS for additional information regarding the deliverables and how they tie in with the Period of Performance.

2.2. NON-PERSONAL SERVICES

2.2.1. 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.

2.2.2. Contract personnel performing services under this contract shall be controlled, directed and supervised by contract management personnel only. The contractor’s management shall ensure that personnel properly comply with the performance standards outlined in the Quality Assurance Surveillance Plan (QASP). Contractor personnel will perform independent of and without the supervision of any Government official. Actions of contractor personnel may not be interpreted or implemented in any manner that results in any contractor personnel creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal personnel, providing direct personal services to any Federal personnel or otherwise violating the prohibitions set forth in FAR 7.5 entitled, “Inherently Government Functions” as well as in FAR 37.1, entitled, “Service Contracting.”

The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3. CONTRACT MANAGEMENT

2.3.1. 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. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2. 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. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

2.3.2.1. 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.

2.3.2.2. Quality Control Plan (QCP) (Deliverable #2). The Contractor shall provide a DRAFT QCP with their proposal and a FINAL QCP no later than Fifteen (15) days after contract award. The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contracts to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.4. REPORTS

2.4.1. 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.

2.4.1.1. Monthly Status Reports (Deliverable #3). The contractor shall provide monthly reports detailing all work completed. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next two (2) months, those items which required Government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency.

2.4.1.2. Quarterly Reports (Deliverable #4). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the Contract Specialist, Contracting Officer, and COR no later than fifteen (15) calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.4.1.3. Final Report (Deliverable #5). The Contractor shall provide a Final Report to the KO and COR. The Contractor shall prepare the Final Report that shall include, but not be limited to, the results of the work performed and completed throughout the life of the contract and list of deliverables provided by the Contractor as part of the requirement.

2.5. PERSONNEL TRAINING REQUIREMENTS

2.5.1. Completion of All Training Requirements (Deliverable #6). The contractor shall track and complete all initial and refresher trainings to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each contractor and subcontractor personnel working under this contract to the COR within five

(5) calendar days after completion of training.

2.5.1.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, or 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 applies. 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) with 5 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil.

2.5.1.2. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training (Deliverable #7). This paragraph is added to incorporate reporting and training requirements and to reference the Office of the Surgeon General (OTSG)/Medical Command (MEDCOM) Policy Memo 16-033, dated 29 March 2016 as an attachment to the contract, Sexual Harassment Assault Response Prevention (SHARP) AKO ALMS instructions. This training is in accordance with USAMRAA Policy 17-01, SHARP FINAL DATED 19OCT2016 with attachments, and is applicable to all on-site contractors and contractor personnel supporting all Services type Contracts over the Simplified Acquisition Threshold (SAT), that are awarded by USAMRAA, and who are performing those services on-site in a Government facility or work space, leased or owned. Training may be obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or it can be taken in person. If the personnel has an AKO account, they can access training online at Army AKO https://www.us.army.mil/.

2.5.1.2.1. In addition, All contractor personnel shall comply with OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program which states that All allegations of sexual harassment and sexual assault shall be immediately addressed, no matter where they occur or who are involved. This includes all personnel working in Government facilities in support of contracts awarded by United States Army Medical Research Acquisition Activity (USAMRAA). Department of Defense and Department of the Army (DoDDA) civilian complaints of sexual harassment or sexual assault will be investigated and processed in accordance with the Equal Employment Opportunity (EEO) Program and AR 690-600. Contract personnel with knowledge of an incident of sexual harassment or assault will immediately report the incident to their employer and their employer will immediately report the incident to the Government’s Contracting Officer Representative (COR) or Contracting Officer.

2.6. DUTY HOURS

2.6.1. Contractor personnel shall perform services during regular duty hours; Monday through Friday. For purposes of when the Contractor has to schedule training and maintenance, the core hours of operation for USAMRIID are 9:00am – 3:00 pm; however, times may be changed with little to no notice.

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

2.6.3. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

2.6.3.1. New Year’s Day, 1 January

2.6.3.2. Martin Luther King’s Birthday, 3rd Monday in January

2.6.3.3. President’s Day, 3rd Monday in February

https://www.us.army.mil/

2.6.3.4. Memorial Day, last Monday in May

2.6.3.5. Juneteenth, 19 June

2.6.3.6. Independence Day, 4 July

2.6.3.7. Labor Day, 1st Monday in September

2.6.3.8. Columbus Day, 2nd Monday in October

2.6.3.9. Veteran’s Day, 11 November

2.6.3.10. Thanksgiving Day, 4th Thursday in November

2.6.3.11. Christmas Day, 25 December

2.6.4. Contractor Personnel shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, or energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel shall not report for work nor shall they be compensated for those days.

2.7. TRAVEL / TEMPORARY DUTY (TDY).

The COR is the CONUS travel order approval authority as designated in writing by the KO. Travel to other Government facilities or other Contractor facilities may be required and will be specified in the PWS. All CONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures.

2.7.1. Travel Arrangements.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to scheduled CONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of Identification before the Contractor is authorized to travel CONUS.

2.7.2. Travel Claim Procedures, Approval, and Reimbursement

Travel to be performed issued under this contract shall be reimbursed after the KO has determined fair and reasonable cost reimbursement IAW the JTR and FAR Part 31.205-46. The Contractor shall submit an estimate for travel to COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost.

The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS. The Contractor shall provide a trip report to include costs associated with the travel to the COR within ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 The contractor shall provide all necessary services and supplies in the development of a NHP Training Simulator. The following section specifies the Performance Objectives and Performance Elements for the contract.

The NHP Training Simulator shall have a three (3) year extended warranty for defects and repairs as a result of normal industry usage with any repairs and/or updates shall be performed on-site.

3.1.1. TECHNICAL REQUIREMENTS – CLIN 0001

3.1.1.1. The Contractor shall provide a NHP Training Simulator with the following technical requirements:

3.1.1.1.1. A 4-10k full body model with state of the art skills trainer designed to replicate Macaca Fasicularis animal with training sights designed to replicate look, feel and function of medical procedures performed.

3.1.1.1.2. A system with an anatomically accurate airway. The system must permit realistic endotracheal intubation with a 4mm endotracheal tube. A closed airway system will support use with ventilator.

3.1.1.1.3. A system with a durable, washable, replaceable coat. The system shall be designed in a way that allows USAMRIID to replace the fur, wash, and clean external elements, and durable enough to withstand repeated use in training under industry average conditions for a minimum of three (3) years, and, will support repeatability, reuse and minimal instructor re-set time.

3.1.2. FUNCTIONAL REQUIREMENTS – CLIN 0002

3.1.2.1. The Contractor shall provide a NHP Training Simulator with the following functional requirements:

3.1.2.1.1. The system must allow phlebotomy training (femoral/saphenous/cephalic) to include incorporation of a “flash” cue.

3.1.2.1.2. The system must allow intravenous catheter placement (cephalic) to include incorporation of a “flash” cue.

3.1.2.1.3. The system must allow for intubation with chest rise and fall. This will allow users the ability to train on intubation procedures to include bag valve mask (BVM) ventilation. The chest must rise and fall with accurate placement (stomach rise and fall if incorrectly placed in esophagus).

3.1.2.1.4. The system will permit advanced artificial ventilation training to include use of a ventilator using a closed airway system.

3.1.2.1.5. The system will allow for cerebrospinal fluid (CSF) collection. The system must include anatomically correct landmarks. It should have the ability to perform lumbar (L4-5, L5-6) and cisterna magna puncture (placement confirmed by positive response) with reusable puncture inserts, followed by subsequent CSF collection training.

3.1.3. NHP SIMULATOR TRAINING – CLIN 0003

3.1.3.1. The Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering. These trainings/meetings can occur virtual or in-person; as preferred by the Government.

3.1.4. CONSUMABLES AND OPERATING MANUAL – CLIN 0004

3.1.4.1. The Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution. These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

3.1.4.2. The Contractor shall provide three (3) printed and an electronic Operating Manuals to allow a user to operate the system in the absence of the Contractor. The Operating Manual shall include the following:

3.1.4.2.1. Comprehensive instructions for unpacking, setup, calibration (if required), power up, operating instructions (covering all features), power down, storage, maintenance, troubleshooting of the system and system part numbers.

3.1.4.2.2. The Operating Manual shall also outline safety guidelines for operating the system, quick start guide, and service instructions (covering all services to maintain the system in the field).

3.1.5. WARRANTY (YEAR #1) – CLIN 0005

3.1.5.1. The Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

3.1.6. OPTIONAL TECHNICAL AND FUNCTIONAL REQUIREMENTS (IF EXERCISED)

3.1.6.1. Each Option is considered as a stand-alone optional requirement. For example, the Government may require a NHP Training Simulator, which has the technical requirements listed under PWS 3.1.1 and functional requirements listed under PWS 3.1.2., with OPTION 2: Radiopaque limbs to support positioning for radiographs and verification of positioning/exposure of the radiopaque limbs. Likewise, the government may require a NHP Training Simulator, which has the technical requirements listed under PWS 3.1.1 and the functional requirements listed under PWS 3.1.2., with multiple Options that include between two (2) – five (5), or, all of the below Options.

3.1.7. DEVELOPMENT OF A SECOND NHP TRAINING SIMULATOR – CLIN 1001

3.1.7.1. If it is determined to exercise Option Year 1, an additional NHP Training Simulator will be required. The Contractor shall develop a SECOND NHP Training Simulator with all of the TECHNICAL and FUNCTIONAL Requirements as the NHP Simulator developed in the Base Year.

3.1.8. *OPTIONAL* DEVELOPMENT OF RADIOPAQUE LIMBS – CLIN 1002

3.1.8.1. The System shall have radiopaque limbs to support positioning for radiographs and verification of positioning/exposure with radiopaque limbs.

3.1.9. *OPTIONAL* DEVELOPMENT OF THE ABILITY TO EXTRACT BONE MARROW – CLIN 1003

3.1.9.1. The NHP Training Simulator, which has the technical and functional requirements from the Base Year, will also include the ability to extract simulated bone marrow samples from the iliac crest.

3.1.10. *OPTIONAL* CONSUMABLES – CLIN 1004

3.1.10.1. The Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution. These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

3.1.11. *OPTIONAL* TRAINING – CLIN 1005

3.1.11.1. The Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering. These trainings/meetings can occur virtual or in-person; as preferred.

3.1.12. WARRANTY (YEAR #2) – CLIN 1006

3.1.12.1. The Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

3.1.13. *OPTIONAL* INTRACARDIAC (IC) INJECTION – CLIN 2001

3.1.13.1. The NHP Simulator will be modified to support IC injection procedures to include administration of fluid substances IC via simple form heart collection chamber.

3.1.14. *OPTIONAL* TETHERED INFUSION SYSTEM – CLIN 2002

3.1.14.1. The NHP Simulator will be modified to support connection to a tethered infusion system.

3.1.15. *OPTIONAL* CONSUMABLES – CLIN 2003

3.1.15.1. The Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution. These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

3.1.16. *OPTIONAL* TRAINING – CLIN 2004

3.1.16.1. The Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering. These trainings/meetings can occur virtual or in-person; as preferred.

3.1.17. WARRANTY (YEAR #3) – CLIN 2005

3.1.17.1. The Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

3.2. PERFORMANCE REQUIREMENT SUMMARY MATRIX

Performance Requirement

PWS

Para.

Ref.

PERFORMANCE STANDARD

Acceptable Quality Level

(AQL)

Surveillance Method

Technical Requirements

– CLIN 0001

3.1.1.

3.1.1.1. The Contractor shall provide a NHP Training Simulator with the following technical requirements:

3.1.1.1.1. A 4-10k full body model with state of the art skills trainer designed to replicate Macaca Fasicularis animal with training sights designed to replicate look, feel and function of medical procedures performed.

3.1.1.1.2. A system with an anatomically accurate airway. The system must permit realistic endotracheal intubation with a 4mm endotracheal tube. A closed airway system will support use with ventilator.

3.1.1.1.3. A system with a durable, washable, replaceable coat. The system shall be designed in a way that allows USAMRIID to replace the fur, wash, and clean external elements, and durable enough to

98% Complete

Observation, Validated User/Customer Complaints, and 100% Inspection by the COR and Technical Representative.

withstand repeated use in training under industry average conditions for a minimum of three (3) years, and, will support repeatability, reuse and minimal instructor re-set time.

Functional Requirements

– CLIN 0002

3.1.2.

3.1.2.1. The Contractor shall provide a NHP Training Simulator with the following functional requirements:

3.1.2.1.1. The system must allow phlebotomy training

(femoral/saphenous/cephalic) to include incorporation of a “flash” cue.

3.1.2.1.2. The system must allow intravenous catheter placement (cephalic) to include incorporation of a “flash” cue.

3.1.2.1.3. The system must allow for intubation with chest rise and fall. This will allow users the ability to train on intubation procedures to include bag valve mask (BVM) ventilation. The chest must rise and fall with accurate placement (stomach rise and fall if incorrectly placed in esophagus).

3.1.2.1.4. The system will permit advanced artificial ventilation training to include use of a ventilator using a closed airway system.

3.1.2.1.5. The system will allow for cerebrospinal fluid (CSF) collection. The system must include anatomically correct landmarks.

It should have the ability to perform lumbar (L4-5, L5-6) and cisterna magna puncture (placement confirmed by positive response) with reusable puncture inserts, followed by subsequent CSF collection training.

98% Complete

Observation, Validated User/Customer Complaints, and 100% Inspection by the COR and Technical Representative.

NHP

Simulator Training –

CLIN 0003

3.1.3.

The Contractor shall provide training on the NHP Training Simulator use and sustainment. The training dates and times will be agreed upon both the Government and the Contractor after the NHP Training Simulator has been given to and reviewed by USAMRIID’s Property Book Office and Clinical Engineering.

These trainings/meetings can occur virtual or in-person; as preferred.

100% Inspection

Observation, Validated User/Customer Complaints, and 100% Inspection by the COR and Technical Representative

Consumables and Operating Manual –

CLIN 0004

3.1.4.

3.1.4.1. The Contractor shall supply a basic set of consumables used during normal operation of the NHP Training Simulator upon initial delivery as determined by the final prototype design and solution.

These basic set of consumables shall support repeatability, reuse and minimal instructor re-set time.

3.1.4.2. The Contractor shall provide three (3) printed and an electronic Operating Manuals to allow a user to operate the system in the absence of the Contractor. The Operating Manual shall include the following:

3.1.4.2.1. Comprehensive instructions for unpacking, setup, calibration (if required), power up, operating instructions (covering all features), power down, storage, maintenance, troubleshooting of the system and system part numbers.

3.1.4.2.2. The Operating Manual shall also outline safety guidelines for operating the system, quick start guide, and service instructions (covering all services to maintain the system in the field).

100% Inspection

Observation, Validated User/Customer Complaints, and 100% Inspection by the COR and Technical Representative.

Warranty (Year #1) –

CLIN 0005

3.1.5. The Contractor shall include a three (3) year warranty that covers any defects and repairs (as required) as a result of normal usage.

98% Complete

Observation, Validated User/Customer Complaints, and 100%

Inspection by the COR and Technical Representative.

Development of a Second

NHP

Training Simulator –

CLIN 1001

3.1.7.

If it is determined to exercise Option Year 1, an additional NHP Training Simulator will be required. The Contractor shall develop a SECOND NHP Training Simulator with all of the TECHNICAL and FUNCTIONAL Requirements as the NHP Simulator developed in the Base Year.

98% Complete

Observation, Validated User/Customer Complaints, and 100% Inspection by the COR and Technical Representative.

*Optional* Development of Radiopaque Limbs –

CLIN 1002

3.1.8.

3.1.8.1. The System shall have radiopaque limbs to support

positioning for radiographs and verification of positioning/exposure with radiopaque limbs.

98% Complete

Observation, Validated User/Customer Complaints, and 100% Inspection by the COR and Technical Representative

*Optional* Development of The Ability to Extract Bone Marrow

– CLIN 1003

3.1.9.

3.1.9.1. The NHP Training Simulator, which has the technical and functional requirements from the Base Year, will also include the ability to…