W81XWH-18-R-0013-0001_Solicitation_Amendment.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

1. Release the Government's answ ers to the questions submitted prior to the closing date for receipt of questions on 1 June 2018.

2. Revise the Statement of Need, in Section C, as a result of the questions received.

3. Revise the Instructions to Offerors, in Section L, as a result of the questions received.

See Summary of Changes for full text description.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 22

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 21-Jun-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH-18-R-0013

X 9B. DATED (SEE ITEM 11)

16-May-2018

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

21-Jun-2018

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH-18-R-0013

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

STATEMENT OF NEED

Supply Statement of Need

U.S. Army Medical Materiel Agency (USAMMA)

Force Sustainment Directorate (FSD)

Sets, Kits and Outfits (SKOs)

Assemblies Requirement

STATEMENT OF NEED

Sets, Kits and Outfits (SKOs)

1. Purpose

The Defense Logistics Agency’s depots at Hill Air Force Base (AFB), Utah and Susquehanna, Pennsylvania have limited capacity and ability to meet many fiscal year procurement requirements of the U.S. Army Medical Materiel

Agency (USAMMA) Force Sustainment Directorate (FSD) Sets, Kits, and Outfits (SKOs). The Delivery Orders

(DOs) issued under this supply contract will serve to surge the capability of the Indefinite Delivery Indefinite

Quantity (IDIQ) contract to procure the low unit of measure and non-CLVIII items that are quite partial to all of the sets to achieve a higher percentage of fill for units. Some sets have significantly higher amounts of low unit of measure and non CLVIII items not currently supportable through DLA procurement and assembly, and surge requirements above DLAs capacity to provide. This contract for the USAMMA’s SKOs is to promote and enhance the Army Medical Department’s (AMEDD) ability to continue its global support to the U.S. Army Medical Force and America’s Warfighters at large.

2. Scope

2.1. The Government intends to award multiple (IDIQ) contracts to support USAMMA’s SKO requirement to supply medical, surgical, pharmaceutical, dental, laboratory, veterinary equipment, and material sets for the U.S.

Army medical units, nonmedical units and medical support programs with SKOs Supply requirement. These units and support programs include but are not limited to the U.S. Army Active, Reserve, National Guard Components;

Army Prepositioned Stocks program; and Foreign Military Sales program.

2.2. This supply Statement of Need (SON) has been reviewed and contains no supplies and services that are inherently governmental functions, as defined in Federal Acquisition Regulation (FAR) Part 2.1. The general services to assemble these SKOs are incidental to the overall supply requirements. The general scope of this requirement is to procure SKO components; label, assemble and pack these procured components into approved the

USAMMA SKO configurations.

3. Period and Place of Delivery Requirements

3.1. The period of delivery for this contract is proposed as follows:

Basic Year include Transition-in FY 2019/20 5 March 2019 – 4 March 2020

Option Year Period 1 FY 2020/21 5 March 2020 – 4 March 2021

Option Year Period 2 FY 2021/22 5 March 2021 – 4 March 2022

Option Year Period 3 FY 2022/23 5 March 2022 – 4 March 2023

Option Year Period 4 FY 2023/24 5 March 2023 – 4 March 2024

3.2. The place of delivery. Contractor shall deliver the assembled SKOs to various locations within the Continental

United States (CONUS) as Free-on-Board (FOB) Destination or mutually defined at time of Delivery Orders (DOs) issued under this contract.

4. Background

4.1. The USAMMA is a unique and multifaceted organization that serves as the Army Surgeon General’s central focal point and Executive Agent for strategic medical logistics programs and initiatives. The Agency’s mission is to develop, tailor, deliver, and sustain medical materiel capabilities and data in order to build and enable health readiness. Accordingly, the USAMMA’s principal skills and technologies focus on the medical logistician’s role in lifecycle management, sustaining and modernizing the medical force (Active, Guard, and Reserve), supporting exercises and contingency operations, and promoting medical logistics information and knowledge.

4.2. The USAMMA Production Assembly Management Division (PAMD) is organized under the USAMMA. The

FSD has principal responsibility for Army medical force management. Specifically, PAMD is responsible for planning and budgeting wholesale procurement, production, introduction, sustainment, and recovery of medical

SKOs and individual medical equipment items for the Army’s medical force, as well as nonmedical units with medical requirements (Active, Reserve, National Guard Components, and Army Prepositioned Stocks). This includes the full range of Planning, Programming, Budgeting and Execution (PPBE), procurement of SKO components and equipment, management of the SKO build process, distribution/fielding of medical SKOs, operational support of the Army medical units, and follow-on logistics support for medical systems and equipment to ensure combat ready forces in peacetime and during times of conflict. These actions are in direct support of the

USAMMA’s Core Competencies; Equip the Force and Sustain the Force.

4.3. USAMMA uses various acquisition vehicles to procure the items required within this document. The current

SKO IDIQ contracts for the USAMMA are as follows: W81XWH-14-D-0063 - TQM, LLC doing business as Two

Rivers Medical , W81XWH-14-D-0064 - The Lighthouse for the Blind doing business as LHB Industries, and

W81XWH-14-D-0065 - MSGI Corporation.

4.4. The terminologies of Medical Equipment Sets (MES), Medical Materiel Sets (MMS), Medical Unit

Assemblages (MUA), Unit Assemblages (UA), and SKO Assemblages are used interchangeably within the context of this SKOs contract Statement of Need (SON).

4.5. This contract will be available for use by all of the USAMMA directorates to include its worldwide activities supporting the U.S. Army Medical Research and Materiel Command (USAMRMC), the U.S. Army Medical

Command (MEDCOM), and the Department of Defense (DoD) Medical mission.

4.6. Due to the evolving nature of medicine practices, guidelines and doctrine, the subcomponents of the SKOs may be altered, updated or deleted.

5. Delivery Objectives

The Contractor shall use FOB Destination to ship SKOs to the Government’s authorized locations. The Contractor shall provide all necessary materials and labor to acquire FDA and DoD approved medical, surgical, dental, and pharmaceutical products in order to complete and build the medical SKOs that include, but are not limited to, the following:

5.1. Objective 1 – The Contractor shall possess product assembly capability for all SKOs (Section J: Attachment

01) to meet the USAMMA surge capacity requirements. The estimated order quantity for a 12 month period is in

(Section J: Attachment 13). Product assembly capability means that Contractor shall provide assembly services, space and warehouse shelf space when conducting procurement, sorting, assembly, packaging, storage (if required) and shipment of SKOs to military organizations, civilian organizations and Army Prepositioned Stock (APS) program.

5.1.1. The Contractor should possess a level of familiarity with the AMEDD process for developing, procuring, packing, marking, storing, and fielding SKOs; and familiarity with the DoD Medical Supply Chain and Logistics

Management infrastructure and systems.

5.1.2. The Contractor shall possess capability to assemble the SKOs in accordance with the provided listings of each

SKO and its components, sub-components with applicable quantities thereof, for all SKO requirements stated in each Delivery Order issued under the resultant IDIQ contract.

5.2. Objective 2 – The Contractor shall provide completed SKOs as specified in Delivery Orders issued under this contract. The completeness in building of medical unit SKOs is critical to the USAMMA’s Core Competencies in equipping and sustaining the U.S. Army Medical Force.

5.2.1. All SKOs shall be assembled with the accessories, supplies, and packed in whole as one complete unit prior to

Required Delivery Date (RDD) as specified in the Delivery Orders issued under this contract.

5.3. Objective 3 – The Contractor shall ensure that all SKOs will be shipped at 100% fill, unless otherwise approved by the USAMMA, within time and delivery requirements of the Delivery Order.

5.3.1. The fill rate is determined by those components identified on the Delivery Order. The Contractor shall provide medical SKOs with 100% fill rate of those components to meet the Government RDD.

5.3.2. At least bi-weekly the Contractor shall notify the appointed Contracting Officer’s Representative (COR) and the identified USAMMA Technical Advisors regarding the percent of fill for each SKO specified in Delivery Orders issued under this contract.

5.3.3. The Contractor shall provide a Certificate of Conformance (Deliverable 1, Section J: Attachment 02) for each Delivery Order with the invoices before the Government will accept and process payment requests in Wide

Area Workflow (WAWF).

5.3.4. In circumstances when the goal of the Delivery Order is not achievable, the Contractor shall notify the COR at least 45 days prior to the RDD. If the RDD is between 90 to 120 days after the Delivery Order award date, the

Contractor shall notify the COR at least 45 days prior to the RDD when the Delivery Order’s required delivery date is not achievable. If the RDD is less than 90 days after the Delivery Order award date, the Contractor shall notify the COR at least 15 days prior to the RDD when the Delivery Order’s required delivery date is not achievable.

5.3.5. In circumstances when the Contractor is unable to ship the SKOs at the required 100% fill rate and unable to meet the RDD, the Government will accept proposals or quotes with no less than 95% fill rate of the total components rolled up for each ordered SKO to meet the target RDD, or as otherwise specified at the Delivery Order level.

5.3.6. If the SKO configuration percentage fill rate is at least 95% but less than 100% of the Delivery Order, the

Contractor shall provide the COR a Certificate of Conformance with the exact percentage fill rate and listings of shortage items with invoice and payment request prior to submit to COR via Wide Area Workflow (WAWF).

5.3.7. If the SKO configuration percentage of fill is less than 95% at time of delivery, the Contractor shall provide a comprehensive Fill Rate Delivery Report (Deliverable 2, Section J: Attachment 03) in a Microsoft Excel spreadsheet format and shall submit this report to the COR and the identified USAMMA Technical Advisors. The

Contractor shall submit an update report every ten (10) business days thereafter until the Contractor can fulfill 100% of all component items for SKOs specified in the Delivery Order.

5.3.8. If the percentage of fill rate remains at least 95% but below 100% for more than 60 days after the RDD of initial delivery shipment, the Contractor shall not deliver the remaining items and shall not request for remaining payment without prior written approval obtained from the Contracting Officer.

5.3.9. The Contractor shall submit an Ad Hoc Report to both the COR and the Contract Technical Advisor (CTA)

(Deliverable 3), within 24 hours of request from the CTA, at any time after the Delivery Order is placed. The Ad

Hoc Report shall contain the working percentage of fill rate for each SKO ordered in the Delivery Order; contain working packing lists with all elements of data outlined in the Electronic Pack Data File Report (Deliverable 4, Section J: Attachment 04). Ad Hoc Reports will be submitted electronically, unless otherwise specified by the

COR. All electronic submissions must be compatible with the most current version of Microsoft Office Application.

5.4. Objective 4 – The Contractor shall comply and acquire healthcare products that have been approved by the

Food and Drug Administration (FDA), the Defense Health Agency (DHA), the DLA Medical Supply Chain, the

Defense Medical Materiel Office (DMMO), the AMEDD Directorate of Combat and Doctrine Development

(DCDD), the USAMMA and the USAMMA Project Management (PjM) Office.

5.4.1. The Contractor shall procure all necessary components for the SKOs. The Contractor shall comply with any and all required specialized licensing necessary in the acquisition of component requirements to the medical SKOs.

This includes but is not limited to clinical psychologist and veterinary licensing.

5.4.2. The Contractor shall conform and supply built SKOs with completed accessories and support components items as outlined within the Federal Logistics (WebFLIS) catalog file.

5.4.3. The Contractor shall have access to procure supply from the Government mandated federal supply schedules, Federal Catalogs, and DLA prime vendor program.

5.4.4. The Contractor shall be granted access to the Government’s Medical Services Information Logistics System

WebFLIS) http://www.webflis.us/database. This WebFLIS database supports the DoD Medical Logistics function and the Defense Medical Materiel Program Office (DMMPO). It is a central source for medical and nonmedical logistics data required to support the DoD’s health care missions. In order to meet the Minimum Essential

Characteristics (MECs) for each component item to build a complete SKO, the Contractor shall conduct an information search in WebFLIS for SKO components, relationships, consumable and support item report, hospital medical materiel sets, and Supply Catalogs for current SKOs. Procured components must be Non-Trade Agreement

Act (TAA) compliant.

5.4.5. The procurements of medical, surgical, dental, pharmaceutical, laboratory and veterinary component items for

SKOs are subject to the Buy American Act and the Berry Amendment Act.

5.5. Objective 5 – The Contractor shall mark individual components with the National Stock Number (NSN), short nomenclature, make, model, manufacturer, quantity and unit of issue. The Contractor shall ensure all SKOs are packed and labeled as specified for each Delivery Order issued under the contract. The accuracy of the information marked and labeled on components and each SKO is vital in the readiness and expedience of meeting surge requirements.

5.5.1. The Contractor shall assemble, label, pack, and mark the SKOs as required in individual Delivery Orders and

IAW applicable Federal and Army directives.

5.5.1.1 MIL-STD-129P (4), Department of Defense Standard Practice Military Marking for Shipment and Storage, 19 September 2007

5.5.2. The Contractor shall create an auditable record IAW the SKOs Delivery Orders issued under this contract.

5.5.3. The Contractor shall manage pharmaceutical component items; ensure availability of shelf life materiel at the date of delivery; and meet the requirements of the Delivery Orders.

5.5.4. The Contractor shall provide each box or container its own packing list, with all fields of information required in Section 5.5 reflecting each packed item in the SKOs container or box. The Contractor shall provide a packing list for each box or container to identify the component items contained therein.

5.5.5. The Contractor shall prepare and provide a Master Pack List (Deliverable 5, Section J: Attachment 05) for all SKOs. The Master Pack List shall be placed in the first container of the SKO. The packing list shall be, upon receipt of the equipment, readily available to the receiver at the shipping and destination point. This list will be used by the receiver as a checklist of items actually received and reported back to the COR.

5.5.6. The Contractor shall provide an Electronic Pack Data File Report no later than five (5) business days prior to the RDD, via electronic mail, as required for each Delivery Order. If any shortages are added after the Contractor submits the initial report, the Contractor shall provide a complete final report with updates only at the time of shipment. All electronic files must be compatible with the most current version of Microsoft Office Application.

5.5.7. The Contractor shall meet the standards of military packaging MIL-STD-2073-1D, Standard Practice for

Military Packaging in order to protect materiel against environmentally induced corrosion and deterioration, physical and mechanical damage, and other forms of degradation during storage, multiple handling, and shipment of materiel in the adverse operations environment.

5.5.8. The Contractor shall follow the DoD marking requirements for unique items IAW Defense Federal

Acquisition Regulation Supplement (DFARS) Clause 252.211-7003, Item Identification and Valuation and MIL-

STD-130, Identification Marking of U.S. Military Property as cited in each Delivery Orders issued under this

Contract.

5.6. Objective 6 – The Contractor shall meet standards in special handling, packaging, temperature sensitive medical products during shipment of the SKOs to delivery locations.

5.6.1. The Contractor shall ship each SKO IAW the RDD specified in each Delivery Order issued under this contract.

5.6.2. The Contractor shall promptly, properly pack and ship the SKOs to meet the critical medical support mission readiness. It is imperative the shipping containers are appropriate for safeguarding those assembled components to prevent damage during shipment. General container and shipping information can be found in DTR 4500.9-R, Defense Transportation Regulation (DTR), Part II, Cargo Movement, June 2008.

5.6.3. Shipments shall be delivered, as directed by the Government, to the Contiguous United States (CONUS) including Alaska, and Hawaii. This will include, but is not limited to, areas of extreme heat and cold. The

Contractor shall provide appropriate shipping containers so the product will not be compromised by heat or cold following the manufacturer’s storage recommendations.

5.6.4. The Contractor shall develop and implement a Quality Control Plan (QCP) (Deliverable 6). The QCP details the methods and procedures that the Contractor will employ to ensure compliance with contract requirements and specifications in the areas of inspection, identification of deficiencies, correction of deficiencies, and documentation and reports. The Government Quality Assurance Surveillance Plan (QASP) will be used to evaluate the Contractor’s ability to control quality and performance through the proper administration of the QCP.

5.6.5. Prior to shipment, the COR will have access to the Contractor’s facility and all SKOs purchased and packaged, as required by the Government.

5.6.6. Shipment shall take place as defined in the Delivery Order. The Contractor shall notify the COR of any deviation from delivery schedule, within 72 hours. The Contractor shall ensure the Packing List is readily available to the receiving facility and personnel, along with the equipment. The packing list will include all requirements as established in Objective 5 and as specified in individual DOs issued under this contract.

6. Constraints

6.1. Organizational Conflict of Interest (OCI). The U.S. Army Medical Research and Materiel Command

(USAMRMC) has categorized all supply procurements into one (1) of the following three (3) categories as defined below, for purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interest (OCIs) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1 - Program and/or Administrative Support. 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. 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.

Category 2 - Program Management Support. Services which assist in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business, process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate

Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3 - Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS Procurement and integration, internal development testing, deployment, installation, operations, and maintenance. 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.

6.1.1. OCI Certification (Deliverable 7, Section J: Attachment 06). USAMRMC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the USAISR organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan (See PWS Section 5.1). The Contractor shall complete the OCI

Certification at time of proposal submission.

6.2. This contract shall provide full support to the USAMMA SKOs and its activities located in CONUS and

Outside Contiguous United States (OCONUS). All specific delivery standards are identified in each DO with specific salient characteristics for each SKO and its components.

6.3. The components in each SKO are subject to change by the Government to fill the capability gap that are identified and validated by the USAMMA PjM Office. The SKOs for each service component with the U.S. Army and the DoD are different and depend on the unit’s type and its mission. The Service Component 1 known as Active

Duty units, normally require standard SKOs with Potency and Dated (P&D) medical and pharmaceutical products.

The SKOs for Service Component 2 known as Reserve Component and Component 3 known as National Guard may not require P&D products. On the other hand, regardless of service components, customized SKOs with specific

RDDs may be required for Special Forces and Civil Affair Units based on their unique mission, level of risk, operating environment and deployment timeline during surge operations in response to contingency operations such as natural disaster relief, humanitarian operations, conflicts and war time.

6.4. Each SKO has an assigned NSN approved by the DLA; however, there are components of SKOs which do not have an assigned NSN. Instead a UA (Unit Assemblage) number will be used to track the version of the SKOs managed by the USAMMA. Each component item in each SKO has its own NSN, but not all. In that case, the

Government will temporarily use the manufacture product number until a NSN is approved and updated in the

WebFLIS, and the Defense Medical Product Databank (MedPDB).

6.5. The Contractor shall contact the COR, and the Contracting Officer if there is a Delivery Order requirement in question or additional information and clarification is needed.

6.6. The Contractor shall not travel to the USAMMA SKO fielding location(s).

6.7. The Contractor shall not incur costs to perform work under any specific Delivery Order in excess of the price authorized for the Delivery Order. Only a written notice by the Contracting Officer may change any pricing or requirements under this contract or any Delivery Order issued hereunder.

6.8. The DoD Medical Standardization concepts are applicable to this supply contract.

6.9. The Occupational Safety and Health Act (OSHA) is applicable to this supply contract requirement.

6.10. The Anti-Terrorism (AT) by Fostering Effective Technologies Act of 2002 (SAFETY Act) (see Subpart 50.2) is applicable IAW the DoD AT/OPSEC Guidebook.

6.11. The Foreign Military Sales Program is applicable to this supply acquisition.

6.12. The Government will not furnish any equipment or facility during the life of this contract requirement.

6.13. The Government will provide complete information in the form of a requirements list for each SKO Delivery

Order issued under this contract. These SKOs will be configured as described in the Delivery Orders. Any exceptions will require pre-approval by the Contracting Officer.

7. Contract Administration

7.1. Government Purchase Card

The Contracting Officer and Government Purchase Card (GPC) Ordering Officer(s) are the only authorized buyers under this MA-IDIQ contract. The position titles of the appointed GPC Ordering Officers will be defined at the time of contract award. Delivery Orders issued by anyone other than the Contracting Officer and GPC Ordering

Officer(s) will not be honored without prior written approval from the Contracting Officer.

7.2. The Contract Administration Team will consist of the following members:

7.2.1. The Contracting Officer will have overall responsibility for administering this contract. The Contracting

Officer is the only person authorized to make changes to this Contract. A Contract Administration Plan (CAP) will be developed which identifies all functional positions, roles, responsibilities, coordination, and procedures to be performed in the contract administration and surveillance effort. The Contracting Officer will manage contract administration and quality assurance surveillance functions supported by contract administrators, the COR, quality assurance personnel, property administrators, cost and price analysts, and legal personnel, as applicable.

7.2.2. The Contracting Officer will be supported by the Chief of Contracts Management Division at the USAMMA and designated COR(s) who are required to properly administer the contract and ensure the Contractor is operating in accordance with the contract performance standards and all other contract requirements. The contract administrators must ensure all performance under this contract, and any required modifications comply with the contract requirements.

7.2.3. The COR will be appointed in writing via the COR Tracking Tool (CORT) and will be directly responsible to the Contracting Officer. The COR will monitor and document contract performance to ensure that the requirements of the contract are being satisfactorily executed by the Contractor. The COR may take actions, as delegated, which could lawfully be taken by the Contracting Officer except for changing the terms or conditions of the contract.

7.2.4. The COR will be assisted by the USAMMA Functional Unit’s Delivery Order Technical Advisors who also are known as Contract Technical Advisors (CTAs) will have the overall responsibility for surveillance of the

Contractor’s delivery to ensure controls are established and implemented pursuant to the Delivery Orders and

QASP. The CTA has duties and responsibilities as appointed by the USAMMA Commander in writing and will include the following:

7.2.4.1. Assist the appointed COR in conducting procedural reviews to determine if the Contractor’s methodical approach is complying with all technical aspects of the contract.

7.2.4.2. Assist the appointed COR in reviewing the Contractor’s Quality Control Plan (Deliverable 6) to ensure the

Contractor has adequately responded to the support requirements the Government enumerated in the supply SON.

7.2.4.3. Provide assistance to the COR in establishing contract surveillance procedures and methods.

7.2.4.4. Serve as the Assessing Official’s Representative by providing assessment of overall contract performance in

Contractor Performance Assessment Reporting System (CPARS).

7.2.5. The Contractor shall submit to the COR a SKO Quarterly Report (Deliverable 10) stating the percentage of fill versus the percentage of late fill and no fill of all required items on each Delivery Order. This Quarterly Report will be sent in both electronic and hard copy form.

8. Applicable Directives and References

The following directives and references are listed for support of this supply Statement of Need. Digital publications are available at the Army Publishing Directorate http://www.apd.army.mil/ .

- AR 40-61, Medical Logistics Policies and Procedures dated 08 January 2005

- AR 702-7-1, Reporting of Product Quality Deficiencies within the U.S. Army

- AR 702-18, Materiel Quality Storage Standards Policy for Shelf-Life Materiel

- AR 725-50, Requisition, Receipt, and Issue System

- DoD 4120.24-M, Defense Standardization Program (DSP) Policies and Procedures

- Federal Acquisition Regulation (FAR)

- Defense FAR Supplement (DFARS)

- Army FAR Supplement (AFARS)

- MIL-STD-129P, DoD Standard Practice Military Marking for Shipment and Storage

- MIL-STD-2073-1D, DoD Standard Practice for Military Packaging

- Technical Manual 38-470, Storage and Maintenance of Army Prepositioned Stock Materiel

- DTR 4500.9-R, Defense Transportation Regulation (DTR), Part II, Cargo Movement, June 2008

- DLM 4000.25, Defense Logistics Management System, Volume 2, Reporting of Supply Discrepancies, June 13,

9. Deliverables

The Contractor shall provide deliverables as described in the below table and subsequent Delivery Orders.

Deliverables shall be specified by the government.

E: Electronic H: Hard Copy TBD: To be determined

Item Reference Title Distribution E H Submission Requirement

SON 5.3.3,

SON 5.3.6

Certificate of

Conformance

COR

Contract

Technical

Advisor (CTA)

1 1 Each Delivery Order

2 SON 5.3.7

Fill Rate Delivery

Report

COR

CTA

1 0 IAW individual Delivery Order

3 SON 5.3.9 Ad Hoc Report

COR

CTA

1 0

Within 24 Hours after request from

CTA

SON 5.3.9,

SON 5.5.6

Electronic Pack

Data File Report

COR

CTA

1 0

Within 24 Hours after request from

CTA and NLT 5 business days prior to RDD

5 SON 5.5.5 Master Pack List

COR

CTA

1 1 Each Delivery Order

SON 5.6.4,

SON 7.2.4.2

Quality Control Plan COR 1 0

Initial submission with proposal.

Subsequent submission(s) as changes occur

7 SON 6.1.2 OCI Certification COR 1 1 Initial submission with proposal

9 SEC. H.1

Non-Disclosure

Statement

COR 1 1

The Contractor shall sign the Non-

Disclosure statement no later than

30 days after the contract is awarded.

10 SON 7.2.5 Quarterly Report COR 1 1 Quarterly

10. Related Documents – See Section J

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

http://www.apd.army.mil/

The following have been added by full text:

SETS, KITS, AND OUTFITS

U.S. ARMY MEDICAL MATERIEL AGENCY (USAMMA)

QUESTIONS AND ANSWERS

20 JUNE 2018

Question 1: Will being an 8A firm be a weighted factor in this solicitation?

Answer 1: No.

Question 2: Questions 40 and 51 from the pre-solicitation Q&A indicate that there will be 3 to 5 suppliers chosen for this and for each order, these suppliers will bid against each other. Can you please explain in more detail how this process works? In previous years, did this process result in one dominant supplier providing most of the materiel?

Answer 2: Reference Solicitation, Section B.3. ISSUANCE OF DELIVERY ORDERS; G.7. DELIVERY

ORDERS; and H.5 DELIVERY ORDER PROPOSALS.

Question 3: Will the USG please clarify if the Offeror shall be prepared to obtain proper documentation in the case of OCONUS deliveries, if applicable, or if all deliveries shall remain CONUS?

Answer 3: Requirements for Outside Continental United States (OCONUS) are coordinated and shipped through the Government Transportation Office(s).

Question 4: Will the USG please clarify which volume the Offeror is required to submit the executive summary in?

Answer 4: Executive Summaries are required in Volume II and Volume V.

Question 5: Is each awardee required to bid on all delivery orders? Section B.3.4 "Issuance of Delivery Orders", Solicitation page 2

Answer 5: No.

Question 6: Please define "Small Disadvantaged" as included in the bulleted list in M.2.4. Factor 4 - Small

Business Participation Plan. Section M.2.4 "Factor 4 - Small Business Participation Plan", Solicitation page 83

Answer 6: Reference Federal Acquisition Regulation (FAR) 2.1 “Small disadvantaged business concern, consistent with 13 Code of Federal Regulations (CFR) 124.1002.

Question 7: Section L.3.3.1.4 "Past Performance", Solicitation page 73. In reference to L.3.3.1.4 (solicitation page

73), if an Offeror's proposal includes the work of any number of subcontractors totaling over 30% of the contract, must the Offeror provide Past Performance information on all subcontractors? Or just those specific subcontractors performing over 30% of the contract?

Answer 7: Past Performance information is required for subcontractors performing thirty percent (30%) or more of the scope and objectives of this requirement.

Question 8: Section L.2.5 "The Proposal", Solicitation page 70. If an Offeror provides Past Performance information in Volume III for both themselves and a subcontractor(s), does the page limitation remain 15 pages?

Answer 8: Yes.

Question 9: Should the FFP price bid for each SKO in CLINs 0001, 1001, 2001, 3001, and 4001 be inclusive of shipping from suppliers to the contractor facility?

Answer 9: The Offeror shall propose a total price for each SKO under Contract Line Item Numbers (CLINs) 0001, 1001, 2001, 3001, 4001.

Question 10: Do the CLINs associated with Shipping and Handling include (a) shipping from suppliers to the contractor’s facility, (b) shipping from contractor’s facility to the end point location designated in the future delivery order, or (c) both shipping scenarios?

Answer 10: (b)

Question 11: It is our assumption that access to WebFLIS is free to contractors.

Question: Would the Government please confirm that contractor access to WebFLIS is free?

Question: If access to WebFLIS is not free, would the Government please provide a plug amount for this cost

(monthly or annual)?

Answer 11: The Public Search is free there is no requirement to subscribe. http://www.webflis.us/database

Question 12: The previous Q&A from the pre-solicitation conference indicates there is no requirement for cold chain management. Paragraph 5.6. 2 states, “The Contractor shall ensure the proper process of marking, preparing temperature sensitive medical and pharmaceutical products for safety, packaging, handling, shipment, and storage utilizing approved equipment, alarm systems and procedures so that required temperatures are maintained throughout the supply chain until the Government accepts the shipment.”

Will the Government please clarify the requirement for cold chain management and temperature control for the SKO components?

Answer 12: The Government has no requirement for cold chain management. Paragraph 5.6.2 of the Statement of

Need has been removed.

Question 13: Section D.2.1 states, “The Contractor shall ensure the proper process of marking, preparing temperature sensitive medical and pharmaceutical products for safety, packaging, handling, shipment, and storage utilizing approved equipment, alarm systems and procedures so that required temperatures are maintained throughout the supply chain until the Government accepts the shipment.”

What is the minimum size/volume of refrigeration the Government requires contractors to have for medical and pharmaceutical products that require controlled storage temperatures? Should any products require freezing, what is the minimum size/volume the Government requires for a freezer as a minimum capability?

Answer 13: Reference Question 12.

Question 14: Will the Government please clarify whether the Customized Kits will be awarded on a competitive delivery order or task order basis?

Answer 14: The SKO requirements will be competed among all awarded IDIQ Contractors on a Delivery Order basis.

http://www.webflis.us/database

Question 15: The RFP states, “Notwithstanding FAR 52.219-16, if, at the end of each contract period, the

Contracting Officer finds that the Contractor failed to make a good faith effort to comply with the incorporated

Small Business Participation Plan, the Contractor shall pay the Government the actual amount by which the

Contractor failed to achieve each proposed participation requirement.”

Specifically, how will liquidated damages be calculated? Please provide the formula that may be utilized.

Answer 15: Reference FAR 52.219-16(b)

Question 16: FAR 52.222-41 (Service Contract Act of 1965, as Amended) has not been incorporated into the solicitation.

Please confirm that the Government considers the contract resulting from the solicitation to be administratively or otherwise exempt from the requirements of the Service Contract Act (SCA).

Answer 16: FAR 52.222-41 does not apply to this acquisition.

Question 17: If the Government believes this solicitation is subject to SCA, please provide the applicable wage determination schedule.

Answer 17: Reference Question 16.

Question 18: The RFP states that all teaming arrangements must be presented in enough detail to allow the

Government to understand conceptually what type of technical work will be provided and performed by each subcontractor.

Does this requirement only apply to subcontractors or does it also apply to suppliers/vendors?

Answer 18: Subcontractors.

Question 19: Rather than providing a full Teaming Agreement for subcontractors, is a letter of intent sufficient proof of the type of arrangement entered into between the Prime and Subcontractor? Are letters of intent also required for suppliers/vendors? (L.1.2.1)

Answer 19: Reference FAR 9.6--Contractor Team Arrangements. The Government will accept a Letter of Intent in lieu of a full Teaming Agreement; however, in accordance with FAR 9.603, the team arrangements are clearly identified and company relationships are fully disclosed in the Offeror’s proposal. In addition, the Offeror shall provide the technical work to be performed by the Offeror and the work to be performed by the subcontractor. This is required for all proposed subcontractors. The Letter of Intent shall be signed by the subcontractor and the Offeror.

A Letter of Intent is not required for suppliers/vendors.

Question 20: Our company has an approved comprehensive Subcontracting Test Program with DCMA (FAR

252.219-7004). Our comprehensive small business subcontracting plan is authorized by and approved under the test program with the Department of Defense to utilize that plan for all new DoD solicitations and contracts.

The plan has been approved and is not able to be altered or shortened; however, the limit of pages for Volume IV is only 10 pages. Our comprehensive test plan in its entirety is 47 pages and as an offeror our company will also need additional pages to address the small business participation plan. Would the Government please increase the page count for this volume to N/A or at least up to 55?

Answer 20: No. If the Offeror's Small Business Subcontracting Plan exceeds the 10 pages, the Offeror is requested to include the Plan as an Attachment to Volume IV.

Question 21: The Government states, “The Table of Contents, Solicitation Compliance Matrix, Tabs and Index

Sheets, printed one side only, will not be counted towards the page limit.”

Will the Government please verify that the Cover Page and Cover Letter are also excluded from the page limitation?

Answer 21: The Cover Page and Cover Letter are also excluded from the page limitations.

Question 22: In Section L.3.2.2, the Government states, “The Offeror’s proposal shall cite specific examples of their technical approach to recent and relevant experience in packaging, marking, handling and providing medical equipment and material SKOs.”

Will the Government consider expanding this to include recent and relevant experience to include programs that incorporate the same processes of packaging, marking, handling and provisioning for other commodities?” This could provide the Government with advanced set building processes and technologies that are currently in effect for other commodities that can be adapted and applied to medical requirements.

Answer 22: L.3.2.2 has been modified to include recent and relevant experience that incorporates the same processes of packaging, marking, handling, and provisioning for other commodities.

Question 23: Will the Government please confirm that unit prices to be proposed within the Price Workbook are to be inclusive of all labor and Other Direct Costs (ODCs) necessary for the assembling, packaging, etc. of each SKO?

Answer 23: Reference Question #9. All unit prices are to be inclusive of all costs for each SKO.

Question 24: Since contractors are generally not the manufacturer of the items listed in Attachment 13, will awardees be afforded the opportunity to revise the proposed unit prices over the 5 years of the period of performance due to (1) fluctuations stemming from manufacturers adjusting their prices or (2) circumstances outside manufacturers control related to medical emergencies or outbreaks that impact supply and demand? If yes, would the Government consider a repricing on an annual or semi-annual basis?

Answer 24: No. Reference Attachment 13 - Pricing Sheet. The Government requests pricing for five (5) years.

Question 25: What process will the Government follow if there are product changes that necessitate a change to pricing such as (1) the product is no longer available, (2) there is a Government need to add a product, or (3) there is an upgrade to a product?

Answer 25: The Government manages the component requirements within the Sets, Kits, and Outfits. If a product is no longer available, the Combat Developers in conjunction with the Army Acquisition Project Managers will update the component lists.

Question 26: Reference Page 14/86: Pre-Solicitation Conference presentation and answers to questions are considered informational and not contractual. For official records please confirm that a clinical psychologist and licensed veterinarian are not required on staff nor required in order to participate in this solicitation. It is understood that some products may require a veterinary license or psychiatric license for procurement.

Answer 26: The Government does not require the Offeror to provide a Clinical Psychologist and licensed

Veterinarian to be employed by the Offeror or to respond to the solicitation.

Question 27: Reference Page 43/86: Small Business Subcontracting Plan states “(a) this clause does not apply to small business concerns.” Confirm that Small Businesses are not required to submit Volume IV “Small Business

Participation Plan and Subcontracting Plan.”

Answer 27: In accordance with FAR 19.702(b)(1), small businesses are not required to submit a Small Business

Subcontracting Plan, however all Offerors shall submit a Small Business Participation Plan.

Question 28: Reference Page 69/86: Confirm that five (5) Contracts will be awarded under this solicitation. Are any reserved for Small Business?

Answer 28: Up to five (5) IDIQ contracts will be awarded under this solicitation. The Government reserves the right to award more. No contracts are reserved for Small Businesses.

Question 29: General Question: Awardees who are both the manufacturer and the distributor will have a significant advantage over other awardees of this program. Recommend that awardee manufacturers of sole sourced products during the bidding process (RFO) be restricting from bidding by line item on the subject RFO. The manufacturer benefits because it is their product. The remaining non-manufacturer awardees will compete for the business and still provide the government a fair and reasonable price. Otherwise, there may be no incentive for the non-manufacturer awardee to provide a bid. This will be especially true in reverse auction competitions.

Answer 29: This acquisition is full and open in accordance with FAR 15. As a result, all interested Offerors may respond to the Request for Proposal (RFP).

Question 30: General Question: Requesting that the government provide a complete list of potential products that could be considered for this IDIQ based on recent ordering history (for example past 3 years)

Answer 30: Reference Attachment 1 – SKO Supply Requirement

The following have been modified:

INSTRUCTIONS TO OFFERORS

L.1. TYPE OF CONTRACT

L.1.1. CONTRACTS

The Government intends to award up to five (5) contracts to those Offerors who remain in the area of consideration as determined by the Government. These will be Indefinite Delivery Indefinite Quantity (IDIQ) contracts that utilize Firm Fixed Price (FFP) Delivery Orders. The Government reserves the right to make the final determination on the number of awards. The number of awards may be less or more than listed here.

L.1.2. SUBCONTRACTING AND TEAMING ARRANGEMENTS

L.1.2.1. Subcontractor and teaming arrangements are permitted and the Government encourages the “prime”

Contractor to further utilize small businesses through teaming arrangements. All teaming arrangements must be presented in enough detail to allow the Government to understand conceptually what type of technical work will be provided by the Offeror and what will be performed by each subcontractor. Since there is a direct relationship from the price proposal to the technical proposal, the Offeror shall cross-reference enough information on subcontracting and teaming arrangements to allow for a thorough proposal review. The overall percentage of work that will be subcontracted shall be clearly cross-mapped to the Government’s scope and objectives of performance requirements in accordance with the Statement of Need (SON).

L.1.2.1.1 The Government will accept a Letter of Intent in lieu of a full Teaming Agreement; however, in accordance with FAR 9.603, the team arrangements are clearly identified and company relationships are fully disclosed in the Offeror’s proposal. In addition, the Offeror shall provide the technical work to be performed by the

Offeror and the work to be performed by the subcontractor. This is required for all proposed subcontractors. The

Letter of Intent shall be signed by the subcontractor and the Offeror. A Letter of Intent is not required for suppliers/vendors.

L.1.2.2. The Government is looking for best value Contractor approaches to achieve the SKO supply requirements outlined in the Solicitation. Consistent with the Organizational Conflict of Interest clause, the FAR, the DFARS and

AFARS, the Government will require specific information about proposed Subcontractors and Consultants proposing for every Delivery Order under the USAMMA SKOs supply contract. Such information will include, at a minimum, the prior USAMMA contract and Delivery Orders, and Delivery Orders history of such firms and personnel. If the proposed use of such firms or personnel raises questions of potential, real, or apparent OCIs, the

Contractor will be required to note such questions…