Solicitation_Amendment_0001.pdf

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

1. Issue Date: Tuesday, 07 Aug 2018 Close Date: Thursday, 23 Aug 2018 1:00 PM EST

2. Solicitation Number: W81XWH-18-R-0061, See Amendment 0001 below

3. Requiring Activity: Armed Forces Research Institute of Medical Services (AFRIMS), Bangkok, Thailand

4. Contracting Office: US Army Medical Research Acquisition Activity (USAMRAA) 1504 Porter Chandler Street Fort Detrick, MD 21702

5. Point of Contact: Julie L. Burns julia.l.burns3.civ@mail.mil

6. Subject/Description:

This is a non-personal services contract to provide Clinical, Epidemiological, Administrative and Logistical Support Services for Armed Forces Research Institute of Medical Services (AFRIMS).

This combined synopsis/solicitation is issued as a request for proposal (RFP).

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-99, effective: 16 Jul 2018.

This an Unrestricted/Full and Open procurement. The relevant NAICS code is 541715 with a small business size standard of 1,000. The resulting contract is expected to be firm-fixed-price.

Questions shall be addressed to: Julie Burns via email at julia.l.burns3.civ@mail.mil no later than 1:00 p.m. EST on Monday, 13 August 2018. Answers will be posted via amendment. Questions will not be accepted by telephone.

Proposals shall be submitted electronically to julia.l.burns3.civ@mail.mil by Thursday, 23 Aug 2018 1:00pm EST. Please include your DUNS Number and CAGE Code with your offer.

Please refer to FAR 52.212-1 “Instructions to Offerors” (page: 12) & FAR 52.212-2 “Evaluation-Commercial Items” (page 20) for details on proposal evaluation and submission.

Solicitation No. W81XWH18R0061 Solicitation Amendment 0001

The purpose of this soliciation amendment is to:

1) Provide Government responses to vendor questions. See responses below in yellow.

2) Update Attachment 1 - Performance Work Statement (revised). See changes below in yellow.

3) Update FAR 52.212-1, "Instructions to Offerors" & 52.212-2 "Evaluation - Commerial Items." See changes below in yellow.

4) Change the proposal response date:

FROM: 1:00pm EST Tuesday, 21 August 2018

TO: 1:00pm EST Thursday, 23 August 2018

Vendor Questions/Government Respones

1) Is this a new requirement or is there an incumbent vendor? If available, can you please send along the incumbent contract number?

RESPONSE: This is new requirement.

2) If this requirement is already being fulfilled by a company, what is the name of that company and their contract number?

RESPONSE: See response to question one.

3) Are the Co-Investigators required to be a physician/doctor?

RESPONSE: Yes, the co-Investigators shall be current licensed physicians who have passed the National Physician Medical Licensure Examination.

4) Is this Principal Investigator (PI) required to be located in the Philippines? Many of the investigator meetings that we conduct only require the Principal Investigator's presence at kick-off, a halfway point check-in, and end results.

RESPONSE: Yes, the PI is required to be physically located in the Philippines. The PI shall oversee and ensures that the research project meets the required regulatory requirements.

5) If the offeror does not currently have a Contractor Performance Assessment Reporting System (CPARS) or Past Performance Information Retrieval System (PPIRS) rating, will the government allow a Past Performance Questionnaire to be submitted to substantiate previous performances?

RESPONSE: Yes, past performance questionnaire is acceptable if CPARS and PPIRS are not available.

6) Page 18 of the RFP provides the quantity of each Labor Category. Can the government specify how many of these positions are in Manila, and how many in Cebu? There is a cost difference between hiring personnel.

RESPONSE: All the “estimated” position will be located in Cebu.

LABOR CATEGORY EST HOURS PER YEAR QUANTITY

PI (Key Personnel) 672 1 Co-Investigator 576 3 Registered Nurse 1920 2 Registered Medical Technologist 1920 2 Admin Support Staff 1920 1 Health Care Support Staff 134 6

7) Is it expected for the offeror to provide an office for personnel? Or will the offeror's support personnel be co-located with USAMD-AFRIMS personnel?

RESPONSE: The PI and Co-Investigators will most likely have their own office/private clinics, which they may work out of for this requirement. If not, office space will need to be provided by the Offeror. NOTE: The PI and

Co-Investigators shall visit the PAVRU office as required/needed for regular meetings with the project staff, to check on the completeness of subjects’ medical records, and when preparing Annual Continuing Review Reports as may be required by Institutional Review Boards/Ethics Committees (IRBs/ECs).

In Cebu, the project staff (nurses and medical technologists) will be co-located with USAMD-AFRIMS personnel where the study-related clinical and laboratory documents will be placed throughout the entirety of the study. The healthcare support staff work in rural health units and they shall attend to patients seeking consultation at the health units.

In Manila, scope of the Febrile and Vector-Borne Illness (FVBI) surveillance project is only at Victorian Luna Medical Center (VLMC) Manila site and is estimated this work will be accomplished by Government AFRIMS Manila-based staff.

8) Are security clearances required for any of the personnel?

RESPONSE: There are basic pre-employment security clearances required to be submitted by personnel hired for employment such as the National Bureau of Investigation (NBI)/police clearance and/or barangay clearances. These are standard practice by almost all local employers regardless the job.

9) For the personnel working out of Cebu, are they required to speak Cebuano/Visayan? Or is Tagalog acceptable?

RESPONSE: For personnel working in Manila: Tagalog is the main language. For personnel working in Cebu: they are required to speak Cebuano/Visayan.

NOTE: Only proposed “Key Personnel” position(s) shall submit resume and letter of commitment with proposal submission. See “Instructions to Offerors” and PWS, Section 9 for details.

The following have been modified: (see items in yellow)

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JAN 2017)

See below Addendum to FAR 52.212-1, “Instructions to Offerors”

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation.

Each offer submitted will be evaluated separately. – NOT APPLICABLE

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers exceeding $3,500, and offers of $3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database.) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation ``Unique Entity Identifier'' followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this Solicitation. If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. Offerors may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

ADDENDUMN TO FAR 52.212-1 “Instructions to Offerors – Commercial Items”

1. SPECIFIC REQUIREMETS. This requirement will result in a Firm-Fixed Priced (FFP) commercial service contract. Performance requirements and objectives for this contract are provided in the Performance Work Statement of this solicitation.

2. PERIOD OF PERFORMANCE:

Base period 24 Sep 2018 – 23 Sep 2019 Option period 1 24 Sep 2019 – 23 Sep 2020 Option period 2 24 Sep 2020 – 23 Sep 2021 Option Period 3 24 Sep 2021 – 23 Sep 2022 Option Period 4 24 Sep 2022 – 23 Sep 2023

3. PROPOSAL SUBMISSION INSTRUCTIONS:

a. POINT OF CONTACT (POC): Questions and proposals shall be sent via E-mail to the POC for this requirement, TO: Julia L. Burns via email at julia.l.burns3.civ@mail.mil. The Offeror is responsible for ensuring receipt by the POC.

b. PROPOSAL QUESTIONS: Questions may be submitted to the POC via email No Later than Monday, 13 August 2018 1:00 PM Eastern Time. Follow-up/additional questions will not be accepted after this date.

Answers to Contractor submitted questions will be provided via solicitation amendment. Questions shall be submitted in MS Word (only) in the following format; Solicitation Section, page number, and question (e.g. PWS Section 4.1, page 38, question). No tables please.

c. PROPOSAL DUE DATE: No Later Than: Thursday, 23 Aug 2018 1:00 PM Eastern Time.

d. ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission should include two (2) separate parts: (1) Non-Cost/Price proposal (i.e. Technical Approach, Experience and Past Performance) and (2) Cost/Price proposal. A signed SF 1449 and your non-cost/price proposal shall be submitted in MS Word or searchable PDF format. The cost/price proposal shall include proposed pricing filled out for CLINs 0001, 1001, 2001, 3001, and 4001 as well as supplemental excel pricing sheet (Attachment #3).

4. PROPOSAL CONTENT & FORMAT INSTRUCTIONS.

a. ADMINISTRATIVE FORMAT INSTRUCTIONS:

(1) PAGE LIMITS: Proposals are limited to 8 single-sided pages. Pages should be numbered consecutively throughout the document and not by sections. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation.

The following sections are NOT subject to page limits:

(a) Cover/title Page

(b) Contractor POCs

(c) Excel Pricing Sheet (Attachment 3)

(d) Signed Proposal with pricing

(e) Fill out and submit the following:

- FAR 52.209-11

- FAR 52.212-3 and 52.212-3 Alt 1

- FAR 52.219-28

(f) Resume(s) and letter(s) of Intent/commitment for proposed Key Personnel (Deliverable 6)

The following sections are limited to 8 single-side pages:

(a) Technical Approach

(b) Experience

(c) Past Performance

(2) FORMATTING: Proposal content shall be no smaller than Arial font 12 pitch. Exhibits, graphics, charts, captions, etc., shall be no smaller than Arial font 10 pitch.

b. NON-COST/PRICE PROPOSAL CONTENT & INSTRUCTIONS The Offeror’s non-cost/price proposal shall clearly reflect the Offeror’s approach to execute and comply with the performance requirements identified in the PWS and is to be clear and concise. The level of effort proposed must be consistent with the proposed solution outlined in your non-cost/price proposal (i.e. Technical Approach). If you intend to use any labor categories that you feel are consistent in duties with the level of effort, but are titled differently, in accordance with your cost accounting procedures, you must cross map those labor categories to the Government’s PWS to ensure your proposal receives a proper evaluation. Any use of subject matter experts (SME) or other labor categories shall be explained in full as to why an existing labor category/rate is impractical to use or the proposal shall be deemed noncompliant.

Contract POC(s) The Offeror shall include on the cover page/title page of the proposal the proposed POCs. The Offeror shall provide a POC authorized to hold discussions/negotiations with the Government who has the full authority to bind the Offeror to a contract. The Offeror shall also provide a POC for the Contract Manager. Information required includes: First name, last name, title, e-mail address, phone number, mailing address, and level of authority.

(1) TECHNICAL APPROACH: The Offeror shall submit a written technical approach which effectively demonstrates:

Offeror’s clear understanding of the all the tasks and how the approach is likely to yield the required results within the required time frame

Offeror’s methodology that will be used in accomplishing any resultant award

Offeror’s overall ability to perform support services in the Philippines

Offeror’s approach to which the technical approach will yield success and to which manages or reduces (cost, technical or scheduled risk) to the Government

Offeror’s Management Plan, that describes the following:

* Management Approach - Management Approach that describes policies and procedures in accordance with industry practices for project management, administration, execution, and tracking as well as policies and procedures specific to conduct this type of support services in the Philippines as well as timely submission of deliverables.

* Staffing Plan – Staffing Plan that describes the staffing strategy that will be used to manage task completion, including the role of the Program/Contract Manager. The Offerors described staffing strategy for supporting this effort and a cross-reference of proposed position(s) to task(s).

(2) EXPERIENCE: The Offeror shall submit written Experience which effectively demonstrates the:

Demonstrated relevant corporate experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) identical to, similar to or related to performing services contained in the PWS. Offeror’s relevant experience shall support and substantiate that the organization (to include subcontractors and business partners, if applicable), have current capabilities for assuring successful task completion.

Demonstrated experience shall reflect (a) Appropriate mix and balance of education and training of team members AND proposed Key Personnel, (b) provide evidence that the organization has current capabilities for assuring performance with , and (c) Quality and effectiveness insofar as the allocation of personnel and resources. For any individual proposed to fill the Key Personnel position, you are to submit resume(s) and a letter(s) of intent/commitment (Deliverable 6). Resumes shall include a list of relevant training, education, and license/certifications.

Demonstrated experience for proposed Key Personnel is recommended have experience in human subjects protection and extensive clinical trial experience, and shall be a currently licensed Physician with the ability to practice medicine in Philippines.

Demonstrated experience for proposed co-Investigator(s) shall be a currently licensed Physician with the

(3) PAST PERFORMANCE REFERENCES: The Offeror shall submit no more than 2 references of relevant contracts within the past three years for its own performance. The contracts may be past or current as long as the performance did not end more than three years ago and the contracts may have been with Federal, State and/or City agencies and commercial customers.

(a) PAST PERFORMANCE REFERENCE CONTENT: It is the Offeror’s responsibility to provide valid, current and verifiable references. References must include:

Name of the Organization that will be providing the reference, Name of the POC, POC Telephone Number, POC Email address, Contract Number, Period of Performance, and Scope of Work

(b) INFORMATION FROM OTHER SOURCES: The Government may consider information obtained through other sources.

c. PRICE PROPOSAL CONTENT

Offerors’ price proposals shall include proposal price assumptions and include the following documents:

SF 1449

Labor - The Offer shall submit a signed SF 1449 and include proposed pricing for the following CLINs:

CLIN 0001

CLIN 1001

CLIN 2001

CLIN 3001

CLIN 4001

ODCs - The Offer shall propose Government estimated pricing for all Other Direct Costs (ODCs) as follows:

CLIN 0002 - $26,760.00

CLIN 1001 - $27,060.00

CLIN 2001 - $27,360.00

CLIN 3001 - $27,360.00

CLIN 4001 - $27,960.00

Excel Pricing Sheet (Attachment 3) The Offeror shall fill out and submit with proposal package. The Offeror shall indicate which labor categories will be performed by a subcontractor(s) along with the subcontractor company name, DUNS, Cage Code, and address.

Contractor shall ensure mathematical computations are correct.

The “estimated” labor category is as follows:

Labor Category Est Hours per Year Quantity Principal Investigator Physician (Key

672 1

Personnel) Co-Investigator 576 3 Registered Nurse 1920 2 Registered Medical Technologist

Administrative Support Staff

Health Care Support Staff

Estimated level of effort The contractor shall accomplish the required tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, experience, and/or overlapping capabilities.

The Government estimates this order requires an approximate level of effort, as outlined above, to accomplish the tasks identified in the PWS. Please note that the Government estimate is only put in place for Offerors to ascertain the approximate or estimated level of effort; however, this is not to be construed as either mandatory or necessarily the best technical approach. It is only in place as a reference to allow Offerors to better understand the general scope of this effort from the Government’s perspective. The Government is seeking the best solution for this performance based acquisition which uses the level of effort and labor mix your company has determined is appropriate to accomplish the tasks/objectives contained in this requirement. Offerors are not bound to propose these labor categories or quantities, rather offerors are expected to provide their best solution citing the labor mix and quantity required to accomplish the tasks. If Offerors have determined either the following labor categories or overall level of effort provided are not their best technical solution, Offerors are strongly encouraged and expected to submit a level of effort consistent with all of the cost/price and non-cost/price aspects of its approach.

Contractor Manpower Reporting shall be Not Separately Priced (NSP)

CLIN 0003 - NSP

CLIN 1003 - NSP

CLIN 2003 - NSP

CLIN 3003 - NSP

CLIN 4004 - NSP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the AFIRMS via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

https://cmra.army.mil. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2018.

Contractors may direct questions to the applicable help desk at: usarmy.pentagon.hqda-asa-mra.mbx.samr-fm-cmra@mail.mil.

d. ADDITIONAL INFORMATION

Alternate Proposals Alternate proposals will not be evaluated by the Government.

Prime and subcontractor An offeror shall NOT submit a proposal as a Prime contractor and also be proposed as a subcontractor on another prime contractor‘s proposal, responding to this RFP, UNLESS they are proposed as a subcontractor under multiple Offeror’s submitting a proposal to this RFP.

(End of provision)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Order of importance:

Factor 1: Technical Approach Factor 2: Experience Factor 3: Past Performance Factor 4: Price

Basis for Award: Award of this requirement will be made on the Lowest Price Technical Acceptable (LPTA) process. The Government intends to award a contract without discussions. However, the Government reserves the right to hold discussions if deemed necessary by the Contracting Officer. Offeror shall provide their best, complete proposal upon initial submission, including Government discounts. The non-cost/price evaluation factors numbered in descending order of importance are as follows:

Factor 1: Technical Approach (non-cost) Factor 2: Experience (non-cost) Factor 3: Past Performance (non-cost) Factor 4: Price

Government evaluators will not assume that the offeror possesses any capability or knowledge unless it is specified in the proposal.

After each of the above non-cost/price factors is rated individually, an overall rating will be assigned collectively to these factors. If any of the above non-cost/price evaluation factors receives an individual rating of “Unacceptable,” the collective overall rating will also be “Unacceptable.” Only proposals receiving an overall rating of “Acceptable” will be considered for award.

The non-cost/price factors are more important than cost/price. However, as Offeror’s non-cost/price factors are rated similar or equal, cost/price becomes more important.

The non-cost/price factors are more important than cost/price.

a. Non-Cost/Price Evaluation Criteria:

The following criteria will be used to evaluate the non-cost/price aspects of the proposal.

(1) Technical Approach: The technical approach will be evaluated that Offeror’s technical approach meets the minimum requirements:

Offeror’s clear understanding of the all the tasks and how the approach is likely to yield the required results within the required time frame

Offeror’s methodology that will be used in accomplishing any resultant award

Offeror’s overall ability to perform support services in the Philippines

Offeror’s approach to which the technical approach will yield success and to which manages or reduces

(cost, technical or scheduled risk) to the Government

Offeror’s Management Plan, that describes the following:

* Management Approach - Management Approach that describe policies and procedures in accordance with industry practices for project management, administration, execution, and tracking as well as policies and procedures specific to conduct this type of support services in Philippines as well as timely submission of deliverables.

* Staffing Plan – Staffing Plan that describes the staffing strategy that will be used to manage the support services, including the role of the Program/Contract Manager. The Offerors described staffing strategy for supporting this effort and a cross-reference of proposed position(s) to task(s).

(2) Experience: The Offeror’s proposal will be evaluated that the Offeror’s proposal meets the minimum requirements:

Demonstrated relevant corporate experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) identical to, similar to or related to performing services contained in the PWS. Offeror’s relevant experience shall support and substantiate that the organization (to include subcontractors and business partners, if applicable), have current capabilities for assuring successful task completion.

Demonstrated experience shall reflect (a) Appropriate mix and balance of education and training of team members AND proposed Key Personnel, (b) provide evidence that the organization has current capabilities for assuring performance, and (c) Quality and effectiveness insofar as the allocation of personnel and resources. NOTE: For all individual(s) proposed to fill Key Personnel, you are to submit resumes and a letter of intent. These resumes shall include a list of relevant training, education, and license/ certifications.

Demonstrated experience for proposed Key Personnel is recommended to have experience in human subject’s protection, extensive clinical trial experience, and shall be a current licensed Physician with the

Demonstrated experience for proposed co-Investigator shall be a currently licensed Physician with the

Rating Standards for the Technical Approach and Experience (excluding Past Performance)

Rating Description Acceptable Proposal clearly meets the minimum requirements of the solicitation Unacceptable

Proposal does not clearly meet the minimum requirements of the solicitation.

(3) Past Performance: The past performance evaluation is an assessment of the Offeror’s probability of meeting the minimum past performance solicitation requirements based on its record of relevant and recent past performance information that pertain to the services outlined in the solicitation requirements. The Government reserves the right to use other resources, such as Past Performance Information Retrieval System (PPIRS), Federal Awardee Performance and Integrity Information System (FAPIIS), and Contractor Performance Assessment Reporting System (CPARS), to conduct a past performance evaluation.

Rating Standards for Past Performance

Rating Description Acceptable Based on the offeror’s performance record, the

Government has a reasonable expectation that the offeror will successfully perform the required effort, or the offeror’s performance record is unknown.

Unacceptable Based on the offeror’s performance record, the Government has no reasonable expectation that the offeror will be able to successfully perform the required effort.

(4) Price

b. Cost/Price Evaluation Criteria:

Cost/price will be evaluated/analyzed separately from non-cost factors. Cost/Price will be evaluated/analyzed for fairness and reasonableness in terms of:

(1) Consistency with labor categories.

(2) Level of effort, in that the proposed labor mix and labor hours are based on reasonable assumptions.

(3) Consistency with the technical approach, in that the prices are consistent with and reflect the proposed staffing requirement for all years.

Option Pricing. The Government will evaluate cost/price for award purposes by adding the total price for all options to the total price for the base requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

Given that FAR 52.217-8 “Option to Extend Services” provides that the Government may exercise the Option to Extend Services at the rates specified in the contract (i.e., the rates in effect when the Extension of Services option is exercised), for purposes of evaluating the Option to Extend Services, the Contracting Officer will consider the prices submitted for the base year and each option year, since those are the binding prices should the FAR 52.217-8 “Option to Extend Services” be exercised.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, emailed, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

Attachment 1 – revised under Amendment 0001

PERFORMANCE WORK STATEMENT

for

Clinical, Epidemiological, Administrative and Logistical Support Services

Armed Forces Research Institute of Medical Sciences (AFRIMS) Bangkok, Thailand

INTRODUCTION & BACKGROUND

SCOPE

PERIOD OF PERFORMANCE

WORK SCHEDULE AND LOCATION…………………………………………………………..4

PERFORMANCE REQUIRMENTS

QUALITY CONTROL

DELIVERABLES

OTHER DIRECT COSTS (ODCs)

QUALITY ASSURANCE SURVELLIANCE PLAN (QASP)

KEY PERSONNEL

TRAVEL

GOVERNMENT FURNISHED ITEMS

COMPLIANCE DOCUMENTS

CONTRACT MANAGEMENT

OTHER TERMS, CONDDITIONS, AND PROVISION…………………………………………14

PERFORMANCE WORK STATEMENT (PWS)

Title: Clinical, Epidemiological, Administrative and Logistical support services

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Armed Forces Research Institute of Medical Sciences (AFRIMS).

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The mission of the Walter Reed Army Institute of Research (WRAIR) and its subordinate organization the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand is to conduct and support biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter. This is a requirement for research services in support of the AFRIMS division of WRAIR.

The United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD- AFRIMS) is an overseas laboratory of the WRAIR. USAMD-AFRIMS maintains field stations in both Manila and Cebu, Philippines, known collectively as the Philippines - AFRIMS Virology Research Unit (PAVRU) which conducts biomedical research and surveillance in support of the WRAIR mission. PAVRU executes biomedical surveillance and research projects focusing on emerging infectious diseases of importance to the U.S. Army. These diseases include but not limited to dengue, influenza and zika.

Projects conducted by PAVRU are done in conjunction with several institutions native to the Philippines, including, but not limited to Chong Hua Hospital in Cebu and the V. Luna Medical Center of the Armed Forces of the Philippines in Manila. Projects range from prospective investigations for drug resistance to epidemiology studies and seroprevalence studies related to diseases of interest to the U.S. military.

3. SCOPE

The contractor shall provide clinical, epidemiological, administrative and logistical support for biomedical surveillance and research projects for emerging infectious diseases being conducted by PAVRU in the Philippines.

Supported research projects include but are not limited to “Sentinel human surveillance for influenza in the Philippines,” “Surveillance for Influenza and Other Emerging Acute Respiratory Infections in Patients Seeking Admission in Chong Hua Hospital in Cebu, Philippines,” “Febrile and Vector-Borne Illness Surveillance (FVBI) in the Philippines and “Acute and Chronic Infectious Diarrhea: Etiology, Pathogenesis, and Correlates of Clinical Outcome.”

4. PERIOD OF PERFORMANCE

The ESTIMATED periods of performance for this contract are as follows:

Base period 24 Sep 2018 – 25 Sep 2019 Option period 1 24 Sep 2019 – 25 Sep 2020 Option period 2 24 Sep 2020 – 25 Sep 2021 Option period 3 24 Sep 2021 – 25 Sep 2022 Option period 4 24 Sep 2022 – 25 Sep 2023

OPTION: FAR 52.217-8 “Option to Extend Services” “The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed six (6) months. The Contracting Officer may exercise the option by written notice to the Contractor within thirty (30) calendar days.”

In accordance with FAR 52.217-8, the vendor shall have the ability to provide continuation of these support services for up to a period of six (6) months after the period of performance end date.

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

Services will be performed at the hospitals and/or city health centers in Manila or Cebu, Philippines where the projects are being implemented.

5.2. Federal Holidays

5.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander. In addition, PAVRU has their own set of approved holidays, and as such, the contractors will follow that holiday schedule in addition to the list of Federal Holidays that are designated by Federal Status.

5.2.1.1. The Philippine government often declares national holidays (not listed below) at the very last moment and the site must sometimes give up a day that might be in the schedule and exchange it for another, because Philippine national law dictates there cannot be more than twenty (20) national holidays in one (1) calendar year.

5.2.2. 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 be performed

The following are Federal Holidays from which the site selects no more than 20:

New Year’s Day Post New Year’s Day Chinese New Year Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Arawng Kagitingan/Day of Valor Eidul Fitr/End of Ramadan

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Christmas Eve Maundy Thursday Good Friday Independence Day

Ninoy Aquino Day National Heroes’ Day Pre-All Saint’s Day All Saint’s Day Bonifacio Day

Substitute for Quezon City Day (only in Manila)

Eidul Adha/Feast of Sacrifice

All Soul’s Day

5.3. Work Schedule

The contractor normal/core duty hours are 0800 to 1700 local time Monday through Friday. Normal duty contractor work-week shall be forty (40) hours per week, eight (8) hours per day, however staggered shifts, may be required for some positions. Dependent upon mission requirements, work for some positions may consist of overlapping shifts that exceed 8 hours in duration (e.g., 12-hour shifts) and may occur at any time around the clock. Evening and weekend work may also be required. However, total hours shall not exceed 80 hours biweekly per contract employee. The Contractor shall not work Federal Holidays unless necessitated by mission requirements. The Contractor shall not be designated as “essential” and will not be required to work during post closures unless authorized by the COR and or KO.

5.3.1. Telecommuting

In accordance with FAR 7.108, Telecommuting shall not be discouraged by the Government/Contractor.

However, it is not feasible for the services provided under this requirement to be performed by way of telecommuting and therefore, all contract support shall be performed on-site.

5.4 Working During Emergency Situations/Contingency Operations Plan

The Contractor shall prepare a Contingency Operations Plan for the Government. Contingency operation plans shall be activated immediately after determining that an emergency has occurred, and shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Manager to ascertain the status of any Contractor personnel who were located in the grounds affected by the emergency. When any disruption of normal, daily operations occurs, the Contractor Manager shall promptly open an effective means of communication with the COR. Contingency Operations Plan shall include the following:

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

b. A description of how the Contractor will account for their employees during an emergency

c. Planned temporary work locations or alternate facilities

d. How the Contractor will communicate with USAMRIID during emergencies

e. A list of primary and alternate Contractor points of contact, each with primary and alternate:

(1) Telephone/cell numbers

(2) E-mail addresses

f. Procedures for protecting Government furnished equipment (if any)

g. Procedures for safeguarding sensitive and/or classified Government information (if applicable)

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract.

Contractor shall not report to work on those days the Government controlled facility is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the WRAIR Commander or AFRIMS Director for any other reason. During these periods of closure, the contract employees who are not designated as “essential” in accordance with the contract, shall NOT report for work nor will they be compensated for those days. NO CONTRACT EMPLOYEE IS CONSIDERED “ESSENTIAL”

UNDER THIS CONTRACT.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives/Tasks

6.1.1. Contractor shall maintain files (electronic and hardcopy) for work products, associated reference material, and data for the duration of the contract. Develop, implement, and maintain a database of files accessible and reportable to the government (and government designees) relevant to PAVRU biomedical surveillance and research projects.

6.1.2. Contractor shall provide scientific/technical, administrative, logistical and laboratory support to PAVRU personnel in conducting biomedical surveillance and research projects. These activities include collection, processing, storage, and shipment of biological samples and data collected in the Philippines.

Scientific/Technical:

a. Projects shall be conducted in accordance with the prescribed protocol, current or amended as may be available and approved by international and local regulatory authorities. The conduct of the study shall be based on the applicable portions of the US Code of Federal Regulations (CFRs) for clinical studies, including but not limited to Good Clinical Practice Regulations (Title 21 CFR Parts 11, 50, 54, 56), the Health Insurance Portability and Accountability Act (HIPPA) of 1996 (Pub L.

104-191, 110 Stat. 1936, enacted August 21, 1996), and International Conference on Harmonisation Guidelines for Good Clinical Practices (GCPs) (ICH Guidelines for Good Clinical…