WA.09.03_W81K04-18-R-0004_Amendment_01.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 make changes to the PWS, POP for CLIN 0005, the Minimum Guarantee, and incorporate Exhibit T, B2B Phase 2 Gatew ay Questionniare. All changes in the PWS are highlighted.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 49

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

16C. DATE SIGNED

BY 04-May-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 W81K04-18-R-0004

X 9B. DATED (SEE ITEM 11)

18-Apr-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

04-May-2018

CODE

W40M USA HLTH CONTRACTING ACT

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

W81K04 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K04-18-R-0004

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

The contractor shall perform HIV-Ag/Ab Combo Screening tests for U.S. Army (Active Duty Army, Army Reserves, and Army National Guard) in accordance with the PWS 5.2.3. The ordering period is five years from date of award. Contractor prices will be incorporated into the contract as Exhibit T.

To:

The contractor shall perform HIV-Ag/Ab Combo Screening tests for U.S. Army (Active Duty Army, Army Reserves, and Army National Guard) in accordance with the PWS 5.2.3. Performance for testing will start upon Government approval of RMF certification IAW PWS 1.5.5.5. The ordering period is five years from date of award.

Contractor prices will be incorporated into the contract as Exhibit T.

CLIN 0005

The CLIN extended description has changed from:

The contractor shall perform testing phase-in requirements IAW PWS 1.7. The 6-month period of performance for testing phase-in period is 24 August 2018 - 27 February 2019.

The contractor shall perform testing phase-in requirements IAW PWS 1.7. The 6-month period of performance for testing phase-in period is 24 August 2018 - 25 February 2019.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for CLIN 0005 has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 24-AUG-2018 TO

28-FEB-2019

N/A W3VY USA MEDCOM

W3VY USA MEDCOM

2748 WORTH RD BLDG 2792

JBSA FT SAM HOUSTON TX 78234-6019

210-808-2837 FOB: Destination

W45RBK

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 24-AUG-2018 TO

25-FEB-2019

N/A W3VY USA MEDCOM

W3VY USA MEDCOM

2748 WORTH RD BLDG 2792

JBSA FT SAM HOUSTON TX 78234-6019

210-808-2837 FOB: Destination

W45RBK

The following have been added by full text:

EXHIBIT T B2B QUESTIONNAIRE

Under separate attachment.

The following have been modified:

52.212-1 ADDENDUM

In the following paragraphs, pursuant to FAR Subpart 12.302(a), FAR Provision 52.212-1, Instructions to Offerors – Commercial Items, is tailored. The basic provision paragraphs (a), (f), and (h) – (k) of FAR Addendum 52.212-1 are not replaced. The basic provision paragraph (e) is deleted for this solicitation. The following paragraphs of specific instructions to offerors for this solicitation replace the basic provision paragraphs (b) through (d), (g), and (l).

B. Instructions to Offerors – Commercial Items.

1. General Instructions.

a. This addendum prescribes the format for proposals and describes the approach for the development and presentation of proposal data. The offeror’s proposal shall include all data and information requested herein and shall be submitted in accordance with these instructions. Offerors are required to submit all documentation/information detailed herein, including terms and conditions, representations and certifications, and technical requirements. Failure to submit all required documentation/information may result in a proposal being ineligible for award. In submitting a proposal, offerors are agreeing to the terms and conditions as written in the entire solicitation.

b. These instructions are designed to ensure the submission of information essential to the understanding and comprehensive evaluation of proposals. The instructions permit the inclusion of any additional data or information an offeror deems pertinent within the stated page limitations. Offerors are cautioned to follow the detailed instructions fully and carefully, as the Government reserves the right to make an award based on initial proposals received, without discussion of such proposals. However, if deemed necessary, and at its sole discretion, the Government may request additional information from offerors.

c. All required elements of the RFP shall be submitted by the offeror with their proposal no later than the date/time shown in block 8 of the Standard Form (SF) 1449, Solicitation/Contract/Order for Commercial Items. The proposal shall be submitted to the address identified in block 9 of the SF 1449, Solicitation/Contract Order for

Commercial Items. Facsimile offers are unacceptable. Any offeror that submits an offer that is incomplete, does not comply with requirements stated in the PWS, or otherwise does not conform to the requirements specified herein may result in the offeror being removed from consideration for award.

d. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to meet these requirements. Offerors shall assume the Government has no prior knowledge of their facilities and experience, and will base its evaluation on the information presented in the offeror’s proposal. Any proposal that modifies or fails to conform to the essential requirements or specifications of the RFP may cause the proposal to be judged unacceptable resulting in the offer being removed from consideration for award. Any aspect of the proposal judged to be unacceptable may render the entire proposal unacceptable. If your proposal is determined to be unacceptable, upon completion of proposal evaluations you will be notified promptly of the basis of the determination.

e. In accordance with FAR Subpart 4.8, Government Contract Files, the Government will retain one copy of all unsuccessful proposals. Unless the offeror requests otherwise, the Government will destroy extra copies of such unsuccessful proposals.

f. Period for acceptance of offers. The offeror shall provide a statement that the offeror’s proposal and prices will remain in effect for 120 days after solicitation closing date.

g. Product samples. Elaborate brochures or documentation, binding, detailed artwork, or other embellishments are unnecessary and are not desired.

h. Questions, Clarifications, or Discrepancies. Address all questions, clarifications, or concerns regarding this solicitation in writing to the attention of Ms. Kathleen Henderson, Contracting Officer, via e-mail at kathleen.d.henderson2.civ@mail.mil or via fax at 210-221-5402 AND to Ms. Yvonne Camarce, Contract Specialist, via e-mail at yvonne.y.camarce.civ@mail.mil or via fax at 210-221-5402, referencing solicitation number W81K04- 18-R-0004. Contractors will be requested to submit questions in a Government provided format via email no later than seven days prior to the solicitation due date. However, the Government will continue to review questions prior to proposal submission date (Block 8, SF 1449) and reserves the right to respond and publicize responses based on the criticality of the question to the overall success of the solicitation. In the event of solicitation discrepancies (e.g., errors, omissions, or points otherwise unclear or unsound), offerors shall immediately notify the Contracting Officer in writing with supporting rationale. Be advised that all correspondence sent via e-mail shall contain a subject line that reads “W81K04-18-R-0004, Medical Laboratory Testing Services”. Note that e-mail filters at Fort Sam Houston are designed to filter e-mails without subject lines or with suspicious subject lines or contents (e.g., .exe or .zip files); therefore, if this subject line is not included, the e-mail may not get through the e-mail filters. Also be advised that .zip or .exe files are not allowable attachments and may be deleted by the e-mail filters at Fort Sam Houston. If sending packages via e-mail, ensure only .pdf, .doc, or .xls documents are sent. The e-mail filter may delete any other form of attachments.

i. Debriefings. The Contracting Officer (KO) will promptly notify unsuccessful offerors in accordance with procedures outlined in FAR Subpart 15.5, Pre-award, Award, and Post-award Notifications, Protests, and Mistakes. Unsuccessful offerors may request and receive a debriefing in accordance with FAR Subpart 15.5.

j. Electronic Offers. The offeror shall submit Volumes I through IV in electronic format on read-only CD-R CDs clearly labeled with the offeror’s name, Commercial and Government Entity (CAGE) code, volume number and volume title. Each volume shall be on a separate CD. For ease of locating proposal contents, each CD- R shall contain one file (do not use separate files) and shall include a file index with page numbers of proposal contents including factors, supplements, exhibits, annexes, and attachments, as applicable. If files are compressed, the necessary decompression program must be included. The offeror’s CDs shall be virus free. The electronic versions of the proposal shall be submitted in a format readable by, at a minimum, Microsoft (MS) Office Word 2007, MS Office Excel 2007, MS Office Project 2007, and MS Office Power Point 2007, as applicable. The Government will accept .pdf files for the electronic version with the exception of the price proposal (MS Office Excel 2007 or latest compatible version) which requires the formulas to be reviewed by the Government. The

Government will also accept Excel 2003 version as long as it is compatible with the Excel 2007 version. It will be the offeror's responsibility to ensure the Excel 2003 version is compatible with the Excel 2007 version.

k. Organization/Number of Copies/Page Limits. The offeror shall prepare the proposal as set forth in the Proposal Organization Table (Table 1.k. below). The titles and contents of the volumes shall be as defined in this table, all of which shall be within the required page limits and with the number of copies as specified in Table 1.k.

The contents of each proposal volume are described in the Instructions to Offerors (ITO) paragraph as noted in the table below.

Table 1.k. - Proposal Organization

Volume

ITO

Paragraph Number

Volume Title Copies Page Limit

I 2.a. Administrative 1 Un-sanitized CD-R 10* Section A 2.a.(1) Completed/signed SF1449 Section B 2.a.(2) Acknowledged/signed amendments **See Below Section C 2.a.(3) Completed Provisions **See Below Section D 2.a.(4) Statement of Offerors Section E 2.a.(5) Contractor Team Arrangement (if applicable) Section F 2.a.(6) Contractor Information Sheet (Attachment 2)

II 2.b. Factor 1 – Technical Approach 1 Un-sanitized CD-R 1 Sanitized CD-R 85***

Section A 2.b.(6)(a) General Requirements, PWS Section 1 25 Supplement A-1 2.b.(6)(a) Sample Quality Control Plan **See Below

Section B 2.b.(6)(b) Contractor-Furnished Items and Responsibilities, PWS Section 4 20

Section C 2.b.(6)(c) Specific Task Requirements, PWS Section 5 39 Supplement C-1 Current CLIA Certificate 1 Supplement C-2 CAP Laboratory Data (Attachment 6) No Limit Supplement C-3 CAP Analyte Scorecard (Attachment 7) No Limit Supplement C-4 Sample Testing Diagram and Layout No Limit Supplement C-5 HIV Testing Statistics No Limit

Supplement C-6 Medical Device Risk Assessment Questionnaire (Exhibit R) No Limit

Supplement C-7 B2B Phase 2 Gateway Questinnaire (Exhibit T) No Limit

III 2.c. Factor 2 – Past and/or Current Performance 1 Un-sanitized CD-R No Limit

IV 2.d. Factor 3 – Small Business Participation Plan (Attachment 4) 1 Un-sanitized CD-R No Limit

V 2.e. Factor 4 – Price (Attachment 3) 1 Un-sanitized CD-R No Limit *10 Page limitation for Volume I, Administrative includes completed/signed SF 1449, statements of offerors, contractor team arrangement (if applicable) and contractor information sheet.

**Page limitations are exclusive of acknowledged/signed amendments, completed provisions, Supplement A-1, Sample Quality Control Plan, Supplements C-1 thru C-5, and legible tables, charts, graphs, and figures (see 1.m.

below).

***85 page limitation for Volume II, Factor 1 - Technical Approach includes: General Requirements, PWS Section 1 (25 pages), Contractor-Furnished Items and Responsibilities, PWS Section 4 (20 pages); and Specific Task Requirements, PWS Section 5 (39 pages).

l. Page Limitations. Page limitations shall be treated as maximums. Pages in excess of the above limitations will be removed and disregarded during the evaluation. When both sides of a sheet display printed material, it shall be counted as two pages. Each page shall be counted except the following: Covers, tab dividers, title pages, glossaries, and table of contents/file index. Also, page limits are not applicable to legible tables, charts, graphs and figures used wherever practical to depict organizations, implementation schedules, plans, etc.

m. Page Size and Format.

(1) Page size shall be 8.5 x 11 inches, not including foldouts. Pages shall be single-spaced. Except for the reproduced sections of the solicitation document, the text shall be New Times Roman and shall be no less than font size 12. Use at least one inch margins on all four sides of the printed page. Pages shall be numbered sequentially by volume.

(2) Legible tables, charts, graphs and figures shall be used wherever practical to depict organizations, implementation schedules, plans, etc. These displays shall be uncomplicated, legible, and shall not exceed 11 by 17 inches in size.

2. Proposal Content.

a. Volume I – Administrative. Offerors shall submit one virus-free un-sanitized CD-R of the administrative proposal.

(1) Offerors shall include a copy of the completed SF 1449, with an original signature of a corporate officer authorized to negotiate for the company. Include proposed discount terms in Block 12 and the name of the company, address, phone and fax numbers in Block 17a.

(2) Offerors shall include acknowledged and original signed copies of amendments to the solicitation, if applicable.

(3) Offerors shall include COMPLETED provisions (FAR Provisions 52.209-2; 52.209-7; 52.209-11;

52.212-3; 52.222-22; 52.222-25; DFARS 252.237-7024). In accordance with DFARS 252.237-7024, the offeror shall provide with its offer a written plan describing how it will continue to perform the essential contractor services listed in Attachment 5, Mission Essential Contractor Services, dated 18 November 2009 (Attachment 5).

(4) Statements of Offeror. Offerors shall include a statement that the offeror and all subcontractors shall be in compliance with the Service Contract Act (SCA) of 1965, as amended. The Government is not making a predetermination of whether or not a particular labor category is SCA; or, if covered, which category from the Directory of Occupations applies.

For applicable SCA personnel, as the place of performance of a contract for services subject to the Act is unknown at the time of this solicitation, the solicitation does not initially contain wage determinations. The contracting agency, upon identification of firms participating in the procurement in response to an initial solicitation, shall obtain a wage determination for each location where the work may be performed as indicated by participating firms.

An applicable wage determination must be obtained for each firm participating in the bidding for the location in which it would perform the contract. The appropriate wage determination shall be incorporated in the resultant contract documents and shall be applicable to all work performed hereunder (regardless of whether the successful contractor subsequently changes the place(s) of contract performance).

Offeror shall also include a statement of the offeror’s appointed individual to make contractual decisions, and include the offeror’s CAGE code, Dun & Bradstreet (DUNS) Number, and Tax ID number, along with an email address, telephone and facsimile (FAX) number.

Note: Offerors who are a small business and fail to provide sufficient information for the Government to make an affirmative responsibility determination may be referred to the Small Business Administration (SBA) for Certificate of Competency. To be eligible for award of a contract, the offeror must receive an affirmative responsibility determination or a Certificate of Competency issued by the SBA.

(5) Contractor Team Arrangements. Offerors may propose under this solicitation through a contractor team arrangement as defined in FAR Subpart 9.601. As such, a contractor team arrangement means an arrangement in which –

(a) Two or more companies form a partnership or joint venture to act as a potential prime contractor;

or

(b) A potential prime contractor agrees with one or more other companies to have them act as its subcontractors under a specified Government contract or acquisition program. A major subcontractor is defined as a subcontractor performing more than 25% of the contract effort.

(c) Offerors proposing a contractor team arrangement shall include a statement that fully discloses the contractor team arrangement and company relationships pursuant to FAR Subpart 9.603, Policy.

(6) Contractor Information Sheet. Offerors are required to complete the Contractor Information Sheet (Attachment 2). The information must be completed for the prime and for any subcontractor performing at least 25% of the work.

b. Volume II, Factor 1 - Technical Approach. Offerors shall submit one virus-free sanitized CD-R and one virus-free un-sanitized CD-R of the technical proposal.

(1) The offeror shall sanitize one virus-free CD-R by excluding any information that would identify their company (i.e., name, address, telephone numbers, employees’ names, etc.). The sanitized Volume II proposal shall contain the offeror’s CAGE code on the top right corner of each page of each copy for identification purposes.

If the offeror does not have a CAGE code for any reason at the time proposals are due, a 5-character, alphanumeric, code created by the offeror shall be used. The codes used shall be identified in the Administrative section of the proposal.

(2) Volume II shall be organized according to the following outline. The intent of this outline is to give the offeror a general format to facilitate a timely evaluation by the Government.

Factor 1 – Technical Approach Section A General Requirements, PWS Section 1

Supplement A-1 Sample Quality Control Plan Section B Contractor-Furnished Items and Responsibilities, PWS Section 4 Section C Specific Task Requirements, PWS Section 5

Supplement C-1 Current CLIA Certificate Supplement C-2 CAP Laboratory Data (Attachment 6) Supplement C-3 CAP Analyte Scorecard (Attachment 7) Supplement C-4 Sample Testing Diagram and Layout (Contractor Format) Supplement C-5 HIV Testing Statistics (Contractor Format) Supplement C-6 Medical Device Risk Assessment Questionnairre (Exhibit R) Supplement C-7 B2B Phase 2 Questionnaire v10.3 (Exhibit T)

(3) All technical proposal information shall be confined to the appropriate volume and section. For example, only information included in the section labeled “Section A - General Requirements, PWS Section 1” will be evaluated for General Requirements, PWS Section 1. If General Requirements, PWS Section 1 information is included elsewhere in the proposal (e.g., different volume or section), it will not be evaluated as part of the Section A – General Requirements, PWS Section 1. The Government will not adapt their evaluation to comply with an offeror’s proposal submission or otherwise go in search of information that an offeror omitted or failed adequately to present. The offeror shall clearly mark any proprietary information as such.

(4) The technical proposal (Volume II) shall not make reference to price data. The technical proposal will be evaluated strictly on technical approach.

(5) As the technical proposal will primarily describe how your company clearly meets the minimum solicitation requirements, it shall be specific and complete in every detail. A positive statement to the effect that you will accomplish all requirements per the solicitation is not acceptable. The technical proposal shall not merely offer to perform work in accordance with the solicitation but shall outline the actual methods proposed as specifically as possible. It is the offeror’s responsibility to ensure the completeness of the technical proposal; hence, the Government technical review team will evaluate on the basis of the information provided in the technical proposal.

The Government will not assume that an offeror understands, complies, or clearly meets the minimum solicitation requirements unless described and specified in the technical proposal. All requirements specified in the solicitation are mandatory.

(6) Factor 1 - Technical Approach. The technical approach shall clearly demonstrate how the offeror intends to meet the minimum solicitation requirements. The offeror shall provide a technical approach of how it intends to meet the specific PWS Section 1 requirements; specific PWS Section 4 contractor-furnished items and responsibilities’ requirements; and, the specific PWS Section 5 requirements for the performance of Medical Laboratory Testing Services. The offeror shall provide specific narrative details and/or descriptions of its technical approach with actual methods, processes, and procedures that demonstrate the offeror’s compliance and understanding of PWS Section 1 requirements; specific PWS Section 4 contractor-furnished items and responsibilities’ requirements; and, the specific PWS Section 5 requirements for the performance of Medical Laboratory Testing Services. In addition to the technical approach, the offeror shall submit Supplement A-1, Sample Quality Control Plan (QCP), as a supporting document to the technical approach.

Note: Supplement A-1 does not replace the offeror’s technical approach to PWS 1.10, Quality Control as described in the following subparagraph 2.b.(6)(a). Supplement A-1 is a supporting document to the technical approach of PWS 1.10, Quality Control. An offeror who fails to separately provide Supplement A-1, Sample QCP, and provide a technical approach for PWS 1.10 in accordance with 2.b.(6)(a) may be considered non-compliant with the RFP and result in the offer being removed from consideration for award.

(a) Section A - General Requirements (PWS Section 1). The technical approach shall clearly demonstrate how the offeror intends to meet each of the following specific requirements in PWS Section 1. The offeror shall provide specific narrative details and/or descriptions of its technical approach with actual methods, processes, and procedures that demonstrate the offeror’s compliance and understanding of each of the following PWS Section 1 requirements:

PWS 1.2 Scope PWS 1.3 Workload Volume PWS 1.4 Safety Requirements PWS 1.5 Security Requirement PWS 1.7 Testing Phase-In Period PWS 1.9 Key Personnel PWS 1.10 Quality Control

In addition, the offeror shall submit the Supplement A-1, Sample QCP. The offeror shall provide a realistic, sample QCP that includes specific quality control procedures or methods that demonstrates the offeror’s compliance and understanding of the quality control requirements (PWS 1.10), PWS Exhibit A - Performance Requirements Summary (PRS), and PWS Attachment 1 - Quality Assurance Surveillance Plan (QASP), the sample QCP shall be sufficiently comprehensive as to demonstrate intensive knowledge of quality control procedures of medical laboratory testing services.

(b) Section B – Contractor-Furnished Items and Responsibilities (PWS Section 4). The technical approach shall clearly demonstrate how the offeror intends to meet each of the following specific contractor-furnished items and responsibilities in PWS Section 4. The offeror shall provide specific narrative details and/or descriptions of its technical approach with actual methods, processes, and procedures that demonstrate the offeror’s compliance and understanding of each of the following PWS Section 4 requirements:

PWS 4.1 Facilities

PWS 4.2 Laboratory Certification and Quality Management Program PWS 4.3 Materials PWS 4.4 Equipment PWS 4.5 Software PWS 4.6 Client Services Representatives

(c) Section C – Specific Task Requirements (PWS Section 5). The technical approach shall clearly demonstrate how the offeror intends to meet each of the following specific task requirements in PWS Section

5. The offeror shall provide specific narrative details and/or descriptions of its technical approach with actual methods, processes, and procedures that demonstrate the offeror’s compliance and understanding of each of the following PWS Section 5 requirements:

PWS 5.1 General PWS 5.2 Testing PWS 5.3 Contractor Laboratory Management Information System (LIMS)And Interface PWS 5.4 Handling of Specimen PWS 5.5 Reporting Test Results PWS 5.6 Management Reports PWS 5.7 Monthly Reports PWS 5.9 Contractor Performance Criteria for Proficiency Test panels PWS 5.10 Shipping Services

(1) In addition, the offeror shall submit Supplements C-1 thru C-5 as described in the following subparagraphs (appropriately sanitized/redacted):

(i) Supplement C-1. The offeror shall provide a copy of the current CLIA certificate (offeror's name redacted).

(ii) Supplement C-2. The offeror shall provide CAP Laboratory Data (See Attachment 6 for sample format);

(iii) Supplement C-3. The offeror shall provide CAP Analyte Scorecard (See Attachment 7 for sample format);

(iv) Supplement C-4. The offeror shall provide a realistic, sample Testing Diagram and Layout. At a minimum, the offeror shall include pre- to post-analytic activities describing/detailing all major pieces of equipment and testing platforms (including make/model/manufacturer). The sample Testing and Diagram Layout shall be sufficiently comprehensive as to demonstrate intensive knowledge of medical laboratory testing services specific to the FDA-approved 4th Generation HIV testing (contractor format).

(v) Supplement C-5. The offeror shall provide HIV testing statistics (contractor format) that include, at a minimum, the following information:

(A) Total workload unless accounted for within Supplement C-2. If offeror's total workload report is a total aggregate of all activity, the offeror shall provide HIV specific annual workload numbers;

(B) Annual rejection rates. Unless there is a significant difference between their HIV rejection rates and their overall rejection rates only the latter is required;

(C) Annual Indeterminate rates for HIV; and,

(D) HIV Confirmation Rate/False Positive Rates.

(vi) Supplement C-6. The offeror shall complete and submit the Medical Device Risk Assessment Questionnaire (See Exhibit R).

(vii) Supplement C-7. The offeror shall complete and submit the B2B Phase Gateway Questionnaire version 10.3 (See Exhibit T).

c. Volume III, Factor 2 – Past and/or Current Performance. Offerors shall submit one virus-free, un-sanitized CD-R. The offeror shall submit past and/or current performance information for up to three contracts the offeror considers recent (within the last three years) and relevant in demonstrating satisfactory past and/or current performance. The word “contract,” as defined herein, for the purpose of past and/or performance submissions under this solicitation, does not include individual delivery orders, task orders, or blanket purchase agreements or basic ordering agreements. If an offeror submits more than three contracts, the Government will evaluate only the first three listed contracts. The three contracts may include efforts performed by the prime and any major subcontractor(s) projected to perform on any resultant contract. Only those subcontractors that meet the definition of a major subcontractor, as defined as performing more than 25% of any resultant contract arising from this solicitation, will be used in the offeror’s past and/or current performance assessment. This volume shall be organized into the following sections:

(1) Section 1 – Contract Descriptions. This section shall include the following information in the following format.

(a) Contractor/Subcontractor place of performance, CAGE Code and DUNS Number. If the work was performed as a subcontractor, also provide the name of the prime contractor and Point of Contact (POC) within the prime contractor organization (name, and current address, e-mail address, and telephone and fax numbers).

(b) Government contracting activity, and current address, Contracting Officer’s name, e-mail address, telephone and fax numbers.

(c) Government’s technical representative/COR and current email address, telephone and fax numbers.

(d) Contract Number

(e) Contract Type (specific type such as Fixed-Price (FP), Cost Reimbursement (CR), Time & Material (T&M), etc.). In the case of Indefinite Delivery contracts, indicate specific type (Requirements, Definite Quantity, and Indefinite Quantity) and secondary contract type (FP, CR, T&M, etc.).

(f) Awarded price/cost.

(g) Final or projected final price/cost.

(h) Original delivery schedule, including dates of start and completion or work.

(2) Section 2 –Past and/or Current Performance. Offerors shall provide a specific narrative explanation of each contract listed in Section 1, Contract Descriptions, describing the objectives achieved and detailing how the effort is relevant to the requirement of this RFP. For any contracts that did not/do not meet original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination. Past and/or current performance information may include data on efforts performed by other divisions, corporate management, and critical subcontractors or teaming arrangements, if such performance is recent and relevant to the requirements of the solicitation. If a contractor teaming arrangement is contemplated, provide complete information as to the arrangement, including any relevant and recent past and/or current performance information on teaming arrangements with the same partner.

(a) Past and/or current performance shall meet the recency and relevancy definitions stated in the Addendum to FAR Provision 52.212-2, paragraphs A.5.d.1 and A.5.d.2 of the solicitation.

(b) Absent any recent and relevant past and/or current performance history or when the performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned, the offeror will be assigned a “neutral confidence rating” and its proposal will not be evaluated either favorably or unfavorably on past performance.

d. Volume IV, Factor 3 – Small Business Participation Plan. Offerors shall submit one virus-free, un-sanitized CD-R.

(1) The offeror shall submit a Small Business Participation Plan using the format at Attachment 4.

The format is designed to streamline and bring uniformity to responses and evaluations for Small Business Participation (FAR Subpart 15.304). The format provides clarity in that it is distinctly different than the Small Business Subcontracting Plan required for large businesses only (FAR Clause 52.219-9).

(2) The offeror shall submit a Small Business Participation plan that meets the minimum mandatory Total Small Business Participation goal of 33% (through collective small business participation from any type of small business or sub-category small business). The subcategory small business goals are NOT mandatory.

However, the Government will evaluate the proposals to determine which offeror(s) propose the best value in terms of meeting all the Small Business Participation goals listed in Table below. The work to be performed directly by a small business prime offeror will also be evaluated as Small Business Participation. The goals are:

Small Business Participation Goals Type of Business Target %

Small Business Concern 33% Small Disadvantaged Business 5% Woman-Owned Small Business 5% HUBZone Small Business 3% Service-Disabled Veteran-Owned Small Business 3%

(3) Separate from Small Business Participation Plan, other than U.S. small business (large business) offerors shall also submit a subcontracting plan meeting the requirements of FAR Clause 52.219-9 and DFARS Clause 252.219-7003 (or DFARS Clause 252.219-7004 if the offeror has a comprehensive subcontracting plan).

Other than U.S. small businesses (large businesses) shall submit acceptable subcontracting plans to be eligible for award. Subcontracting Plans shall reflect and be consistent with the commitments offered in the Small Business Participation Plan. In accordance with DFARS Subpart 215.305(c), when an evaluation assesses the extent that small businesses are specifically identified in proposals, the small businesses considered in the evaluation shall be listed in any subcontracting plan submitted.

e. Volume V, Factor 4 – Price. Offerors shall submit one virus-free, un-sanitized CD-R.

(1) Offerors are to complete the Pricing Spreadsheet (Attachment 3). Instructions are listed on the “Instruction” tab. Offerors are to enter pricing in the green areas only. Do NOT change the formulas or any other numbers. The determination of total evaluated price will be established by totaling the offeror’s proposed prices for CLINs 0001, 0002, and 0005 for the one 5-year ordering period.

(2) Pricing information shall be addressed ONLY in Volume V. A proposal will not be evaluated if it contains pricing information outside of Volume V.

(3) The offeror shall submit their unit prices up to two decimal places (example: $158.03). All dollar amounts provided in response to these instructions shall be stated in United States (U.S.) currency.

(4) The offeror shall verify the accuracy of its prices.

(5) An offeror’s Total Evaluated Price includes the sum of all prices for all CLINs for the one five-year ordering period with the exception of:

(a) Contractor Manpower Reporting (CMR), CLIN 0003. Offerors shall not provide separate pricing for annual CMR requirements. CMR appears as Not Separately Priced “NSP” in Schedule B.

(b) Post-Award Conference (Minimum Guarantee), CLIN 0004. Offerors shall not provide separate pricing for post-award conference (minimum guaranteed amount) as it is priced by the Government.

(6) The KO has determined there is a high probability of adequate competition on this acquisition.

Upon examination of the initial proposals, the KO will review this determination and if in the KO’s opinion, adequate competition exists no additional price information will be requested. However, if at any time during this competition the KO determines that adequate competition no longer exists; offerors may be required to submit information to the extent necessary for the KO to determine the reasonableness of price.

4. Discussions.

a. General Information. In accordance with FAR Subpart 15.306(d), discussion sessions with each offeror may be held.

b. Discussion Scheduling. If discussions are conducted, the KO will schedule the discussion sessions, and each offeror will be notified of the time and place at least three business days prior to their discussion session.

The KO will provide additional instructions with the notification. The discussion sessions will take place at a facility of the Government’s choosing in the Fort Sam Houston, TX area.

c. Discussions will be highly recommended for this source selection. The primary objective of discussions will be to maximize the Government’s ability to obtain best value, based on the requirement and the evaluation factors set forth in the solicitation.

d. If discussions are conducted, the KO will establish a competitive range based on the ratings of each proposal against all evaluation criteria (see FAR Subpart 15.306(c)). The establishment of the competitive range will be formally documented by the Government in a competitive range determination. The KO will only enter discussions, to include discussions to determine technical acceptability, with those offerors determined to be in the competitive range. If discussions are necessary to establish technical acceptability, the KO may conduct discussions with offerors whose proposal is determined to be reasonably capable of being corrected without a major rewrite of the proposal.

e. If discussions are deemed necessary, the KO may determine that the number of most highly rated proposals that might otherwise be included in the competitive range exceeds the number at which an efficient competition can be conducted. In this event, the KO may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals.

f. Discussions will be tailored to each offeror’s proposal and will be conducted by the KO with every offeror within the competitive range. The scope and extent of discussions will be a matter of KO’s judgment. As a minimum, during discussions, the KO will indicate to, or discuss with, each offeror in the competitive range the following: (a) significant weaknesses, and (b) any deficiencies that were identified during the evaluation. This will be accomplished through the release of Evaluation Notices (ENs). ENs will be prepared by the source selection evaluation board and reviewed by the KO and Legal Counsel. All ENs will clearly indicate the type of exchange being conducted (e.g. clarification, communication, etc.). Any EN addressing a proposal deficiency or significant weakness will clearly indicate that a deficiency/significant weakness exists. The KO will be encouraged to discuss other aspects of the offeror’s proposal that could in the opinion of the KO be altered or explained to enhance materially the proposal’s potential for award. However, the KO will not be required to discuss every area where the proposal could be improved as outlined at FAR Subpart 15.306(d) and (e). All discussions will be documented in writing.

MINIMUM GUARANTEE

Minimum and Maximum Guarantees

The minimum guarantee dollar amount is $1,500.00 for the post award conference.

The maximum test quantity amount is 5,853,600 for the one five-year ordering period.

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

Medical Laboratory Testing Services Human Immunodeficiency Virus(es) Screening

1. GENERAL. This is a non-personal services contract to provide medical laboratory testing services for the detection of antigen and antibodies of Human Immunodeficiency Virus(es) (HIV) in support of the United States (U.S.) Army (Active Duty Army, Army Reserves, and Army National Guard) and U.S. Military Entrance Processing Command (USMEPCOM). Medical laboratory testing services for include, but are not limited to, the provision of collection supplies, specimen collection/preparation/shipment instructions and training, courier services, specimen testing (including required quality programs), result reporting, specimen storage/re-aliquot/final disposition services, required information management systems, and help desk customer support services. The Government will not exercise any supervision or control over the contractor or any subcontracted service provider(s) performing the services herein. Such subcontract service provider(s) shall be accountable solely to the contractor who, in turn, is responsible to the Government.

IT IS THE GOVERNMENT’S INTENT TO TRANSITION TO GOVERNMENT PERFORMED TESTING OVER

THE COURSE OF THIS CONTRACT. TESTING WILL TRANSITION FROM CONTRACTOR PERFORMED

TO GOVERNMENT PERFORMED TESTING IN A PHASED MANNER FOLLOWING THE FIRST YEAR OF

PERFORMANCE. ANTICIPATED COMPLETION MAY BE AS EARLY AS THE THIRD YEAR OF

PERFORMANCE. THE TRANSITION TIMELINE IS CONTINGENT UPON THE DEVELOPMENT OF

GOVERNMENT CAPABILITIES AND CAPACITY.

1.1. PROGRAM AUTHORITY. The Assistant Secretary of Defense for Health Affairs (ASD (HA)) in coordination with the Under Secretary of Defense for Personnel and Readiness (USD (P&R), the General Counsel of the Department of Defense (DOD), and the ASD for Reserve Affairs are responsible for establishing policies, procedures, and standards for the identification, surveillance, and personnel management of military service members who have serologic or other evidence of HIV infection. The ASD (HA) and USD (P&R) also have purview over the screening and qualification policy for applicants into the Armed Forces.

1.2. SCOPE OF WORK. The contractor shall provide qualified personnel, services, materials, equipment supplies, information systems, and facilities, except as identified in Paragraph 3, Government-Furnished Equipment/Property, necessary to perform medical laboratory testing services for the detection of antibody against and/or antigens of HIV. The contractor shall employ Food and Drug Administration (FDA) approved tests, software, testing instruments, and methodologies. Approved testing protocols covered by this contract are established and updated by the HIV Diagnostics and Reference Laboratory (HDRL), Walter Reed Army Institute of Research (WRAIR), 9100 Brookville Rd., Bldg 508, Silver Spring, MD 20901. The contractor shall comply with all applicable laws, rules and regulations, including but not limited to those listed in paragraph 6 of the PWS.

1.2.1. The contractor shall perform initial HIV screening tests on serum and/or plasma specimens submitted by U.S.

Army Medical Treatment Facilities (MTFs) and/or other Submitting Activities (SA), (e.g., the U.S. Army Reserve (USAR) sites and U.S. Army National Guard (ARNG) sites (typically coordinated by the Reserve Health Readiness Program (RHRP)). The contractor shall also provide services as ordered to augment testing for the United States Military Entrance Processing Command (USMEPCOM). The contractor shall provide screening tests which employ state-of-art FDA-approved fourth generation technology for simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma. In the event that more sensitive and/or specific FDA approved screening tests become available, the contractor, upon the direction of the Government (HDRL) through the Contracting Officer (KO), shall employ the more sensitive/specific methodology.

1.3. WORKLOAD VOLUME. The contractor may receive approximately 60,000 specimens monthly from U.S.

Army MTFs and USAR RHRP sites; and 13,800 specimens from ARNG. Submitting activities for the U.S. Army MTFs/other sites, USAR, and ARNG sites are stated in Exhibit A.

1.3.1. The contractor may receive samples from USMEPCOM SAs for contingency testing. For planning purposes USMEPCOM currently submits approximately 24,000 specimens monthly to HDRL for testing. Submitting activities for the USMEPCOM are stated in Exhibit A.

1.3.2. The contractor may also receive approximately 5,000 specimens per month from the U.S. Army Clinical Laboratories from outside the continental United States (OCONUS) (includes Alaska and Hawaii) locations as a contingency – Germany (3), Italy (1), Japan (1), Saudi Arabia (1), South Korea (2), Turkey (1), Iraq (5), Kuwait (1), and Afghanistan (1).

1.4. SAFETY REQUIREMENTS. The contractor shall maintain safety and health standards compliant with requirements of the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC) and state and local requirements, if any.

1.5. SECURITY REQUIREMENTS. The contractor shall be responsible for the security of all patient information, testing results, specimens, supplies, materials, and equipment and shall ensure compliance with all applicable security requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), DOD regulations/guidance (including but not limited to Military Health System Automated Information Security; Privacy Act and data at rest policies), and this PWS.

1.5.1. The contractor shall ensure the protection of all sensitive, private, protected, and patient/applicant/source health information. Additionally, neither the contractor nor any of the contract service providers (CSPs) shall disclose or cause to disseminate any information concerning operations of military activities. Such action(s) could result in violation of the contract and possible legal actions. If there is a loss or compromise of any protected data, the contractor shall indemnify the Government and ensure that the Government bears no cost. The contractor shall comply with DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting.

1.5.2. All inquiries, comments, or complaints arising from any matter observed, experienced, or learned of as a result of or in connection with the performance of this contract, the resolution of which may require the dissemination of official information, shall be directed to the Contracting Officer’s Representative (COR) and the Contracting Officer (KO). The contractor shall not release such information, unless authorized by the KO.

1.5.3. The contractor shall only conduct business with designated Government personnel listed as points of contact (POCs). The COR (or KO) will provide the names of designated POCs within 30 calendar days of contract award and within 15 calendar days when any change occurs.

1.5.4. U.S. Government records, original results and reports and copies thereof, verified original data, corrected data, and corrected supporting final reports are maintained by the contractor, but remain the property of the U.S.

Government. These records, data, files, results and reports must be surrendered to the COR and the KO upon termination or completion of this contract.

1.5.5. INFORMATION SECURITY.

1.5.5.1. TELECOMMUNICATION.

1.5.5.1.1. All contractor systems that communicate with DOD systems shall interconnect through the established Military Health System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ).

1.5.5.1.2. The contractor shall follow Army Regulation (AR) 25-1, “Army Knowledge Management and Information Technology,” AR 25-2, “Information Assurance (IA)”, and DOD 6025.18-R, “DOD Health Information Privacy Regulation.”

1.5.5.1.3. Contractors shall connect to the B2B gateway via a contractor-furnished Internet Service Provider connection. The contractor shall establish and maintain connectivity to the B2B gateway. The contractor shall acquire and maintain the circuit to the B2B gateway and acquire a VPN device compatible with the MHS VPN device.

1.5.5.1.4. The contractor shall comply with DOD guidance regarding allowable ports, protocols and risk mitigation strategies. The contractor shall provide, maintain and configure a VPN concentrator that complies with DOD security standards.

1.5.5.1.5. The contractor shall provide VPN hardware and software.

1.5.5.2. GENERAL CYBERSECURITY REQUIREMENTS.

1.5.5.2.1. The contractor shall comply with DoDI 8582.01 "Security of Unclassified…