W9114F24R0003 Amendment 0003.pdf

W40M MRCO EUROPE

MEDICAL READINESS CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

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 publicize the follow ing:

The scheduled site visit w as cancelled due to increased security protocols. As a result, the Instructions to Offerors in the ADDENDUM TO 52.212-1 Paragraph 52.212-1(p) have been updated accordingly.

The time for submittal of questions is extended to now end on Wednesday, 10 July 2024, at 12:00 (noon) Central European Summer Time (CEST). As a result, the Proposal Submittal Instructions in the ADDENDUM TO 52.212-1 Paragraph f. for QUESTIONS have been updated accordingly.

Questions w ere received from industry w hich are provided along w ith the corresponding government responses.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 14

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

16C. DATE SIGNED

BY 02-Jul-2024

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 W9114F24R0003

X 9B. DATED (SEE ITEM 11)

20-Jun-2024

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.

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

02-Jul-2024

CODE

W40M MRCO EUROPE

MEDICAL READINESS CONTR OFC EUROPE

CMR 402

APO AE 09180-0402

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

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.

W9114F24R0003

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS AND ANSWERS

Page #/Section Reference Industry Question Government Answer

Page 3, Item Description

ITEM 0001

Ordering Period: 1 October 2024 through 31 August 2029

What is 1 October 2024 standing for? Starting point for installation? Starting point for shipments related to this contract?

1 October 2024 is the date that orders can be placed for item 0001.

Page 13, FAR Clause 52.216-18 Ordering

Such orders may be issued from 1 September 2024 through 31 August 2029.

Doesn't the Ordering Period start date of 1 October 2024 in the item 0001 description conflict with the ordering start date in the FAR Clause 52.216-18?

An order might be placed in September 2024 for item 0008.

Page 37, Performance Work Statement

Total Laboratory Automation 31 May 2024

Should this be 31 May 2025?

This date indicated the PWS version.

Page 40, Performance Work Statement Paragraph 1.5.1.

Quality Control Plan

(QCP):

(d) How the Contractor shall inventory and track maintenance of all Contractor Provided Equipment / Materials (Make, Model, Part # and Serial Number);

A serial number is assigned as soon as the devices are produced for a specific customer. Please confirm that the serial number can be submitted later upon receipt of the order.

Instrument serial numbers can be provided after contract award.

Page #/Section Reference Industry Question Government Answer

Page 53, Performance Work Statement Paragraph 5.2.1.2.7

Each analyzer shall provide at least 3 open channels to accommodate third party assays. These open channels shall be in excess of those required to fulfil PWS Paragraph

5.2.1.2.5 and PWS Paragraph 5.2.1.2.6.

Please explain in more detail which instruments are to be equipped with open channels. Open channels are common in the field of clinical chemistry. In immunochemistry, it is not standard and uncommon.

Please confirm our acceptance. In your case, all parameters in both areas can be mapped without open channels.

In order to add additional testing in the future the lab requires to have open channels on all the analyzers that perform clinical chemistry and immunochemistry testing.

Page 55 and Page 80, Performance Work Statement Paragraph 5.2.1.3.9, Table 3. Required hematology parameters at

LRMC.

AND

ATTACHMENT 3,

Historical annual reportable result volume for automated hematology parameters at

LRMC.

Annual Reportable Results 26,978.

The total number of blood counts is 26,978. This number includes reticulocytes. In order to be able to specify exact quantities of kits, a separate number of reticulocytes is necessary. Would you please provide the number of reticulocytes to us?

Historical annual reportable result volume for automated hematology parameters at LRMC include 300 reticulocytes.

Page 59, Performance Work Statement Paragraph 5.2.4.7

The Contractor shall provide an Inventory Program or System for continuous monitoring and management of all reagents, consumables and necessary supplies and their utilization.

Please describe in detail what you mean by Inventory Program. Do you want additional functionality that is not listed under PWS Paragraphs 5.2.4.1 through 5.2.4.6?

This does not have to be a computer program. An example is clear plastic shelves that hold reagent packs and make it easy for supply rotation and inventory monitoring. The lab requires a system to make supply inventory and management efficient.

Page 85, ADDENDUM TO

52.212-1 - Instructions to Offerors

Addenda to 52.212-1(m) Organizational Conflict of Interest. For those offerors planning to engage in a teaming arrangement or to use subcontractors, a conflict of interest may be created if a company is identified as a prime offeror, teaming partner/subcontractor, or as a member of a Joint Venture on more than one proposal. Each participating company shall only submit one proposal. If the contracting officer concludes during proposal evaluation that a potential conflict of interest exists because one or more companies have participated in more than one proposal as a prime offeror, teaming partner/subcontractor, or as a member of a Joint Venture, the contracting officer reserves the right to require a conflict-of-interest mitigation plan from the prime offerors of those proposals. If an offeror fails to submit a plan, or submits an inadequate plan, the offeror may not be considered.

We are planning to take part in this solicitation as sub-contractor.

At present we are planning to be subcontractor for two prime offerors.

Both companies requested an offer from us.

Regarding “Addenda to 52.212-1(m) Organizational Conflict of Interest”, we would like to know if we are allowed to subcontract with more than one prime-offeror.

The language of the paragraph indicated refers to the prime contractor's proposal and does not affect the proposed subcontractor.

Page 85, ADDENDUM TO

52.212-1 - Instructions to Offerors

Addenda to 52.212-1(m) Organizational Conflict of Interest. For those offerors planning to engage in a teaming arrangement or to use subcontractors, a conflict of interest may be created if a company is identified as a prime offeror, teaming partner/subcontractor, or as a member of a Joint Venture on more than one proposal. Each participating company shall only submit one proposal. If the contracting officer concludes during proposal evaluation that a potential conflict of interest exists because one or more companies have participated in more than one proposal as a prime offeror, teaming partner/subcontractor, or as a member of a Joint Venture, the contracting officer reserves the right to require a conflict-of-interest mitigation plan from the prime offerors of those proposals. If an offeror fails to submit a plan, or submits an inadequate plan, the offeror may not be considered.

Please describe in more detail what is meant by "Conflict-of-Interest Mitigation Plan". Is there a standard form existing and needs that form to signed – by whom?

Paragraph 209.571-4 of the DFARs describes the reasons and circumstances for the utilization of an Organizational Conflict of Interest Mitigation Plan, which states:

"(a) Mitigation is any action taken to minimize an organizational conflict of interest. Mitigation may require Government action, contractor action, or a combination of both.

(b) If the contracting officer and the contractor have agreed to mitigation of an organizational conflict of interest, a Government-approved Organizational Conflict of Interest Mitigation Plan, reflecting the actions a contractor has agreed to take to mitigate a conflict, shall be incorporated into the contract.

(c) If the contracting officer determines, after consultation with agency legal counsel, that the otherwise successful offeror is unable to effectively mitigate an organizational conflict of interest, then the contracting officer, taking into account both the instant contract and longer term Government needs, shall use another approach to resolve the organizational conflict of interest, select another offeror, or request a waiver in accordance with FAR 9.503 (but see statutory prohibition in 209.571-7 , which cannot be waived)."

Throughout solicitation

Reserved What is the significance of the term "Reserved" in the current solicitation phase?

The term "Reserved" means that this particular paragraph has been removed but retained to avoid renumbering the entire document.

(End of Questions and Answers)

The following have been modified:

CLAUSE(S) 52.212-1 - ADDENDUM TO 52.212-1

Instructions to Offerors - Commercial Items.

The following paragraphs are hereby amended to read as follows:

Paragraph 52.212-1(a), North American Industry Classification System (NAICS) code and small business size standard. The small business size standards and any resulting set asides or preferences do not apply to this acquisition.

Paragraph 52.212-1(c), Period for acceptance of proposals. The offeror agrees to hold the prices in its proposal firm for 90 calendar days from the date specified for receipt of proposals unless another time period is specified in an addendum to the solicitation.

Paragraph 52.212-1(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 FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

Paragraph 52.212-1(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. After evaluating proposals, if discussions are deemed necessary, the contracting officer may determine that the number of most highly rated proposals that might otherwise be included in the evaluation process exceeds the number at which an efficient competition can be conducted. In this event, the contracting officer may limit the number of proposals in the evaluation process to the greatest number that will permit an efficient competition among the most highly rated proposals.

Paragraph 52.212-1(h), Multiple awards. The Government will only award a single contract from this Request for Proposal (RFP). Award will be on an “ALL OR NONE” basis. Proposals for less than all of the minimum required tests will be rejected as nonconforming and unacceptable to the RFP.

The following paragraphs are hereby added:

Addenda to 52.212-1(m) Organizational Conflict of Interest. For those offerors planning to engage in a teaming arrangement or to use subcontractors, a conflict of interest may be created if a company is identified as a prime offeror, teaming partner/subcontractor, or as a member of a Joint Venture on more than one proposal. Each participating company shall only submit one proposal. If the contracting officer concludes during proposal evaluation that a potential conflict of interest exists because one or more companies have participated in more than one proposal as a prime offeror, teaming partner/subcontractor, or as a member of a Joint Venture, the contracting officer reserves the right to require a conflict-of-interest mitigation plan from the prime offerors of those proposals.

If an offeror fails to submit a plan, or submits an inadequate plan, the offeror may not be considered.

Paragraph 52.212-1(n) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found. All questions received will be answered officially through an amendment for distribution to all prospective vendors.

Paragraph 52.212-1(o) Offerors shall ensure that the original RFP's Standard Form (SF) 1449, Blocks 12, 17A (with offeror's name, address, telephone number and CAGE/NCAGE Code), and 30A through 30C, are completed in their entirety. Offerors shall also acknowledge each amendment by completing each SF 30, Blocks 8 and 15A through

15C, or submit the completed conformed document, if any amendments are issued. Documents shall be signed by corporate officer authorized to negotiation for the company.

Paragraph 52.212-1(p) Site Visit. The site visit scheduled for 1 July 2024 had to be cancelled due to increased security protocols at the Landstuhl Regional Medical Center. The Government is trying to reschedule the date as soon as the security situation allows. Please send an email to Mr. Henning Mayer-Goldstein at henningfalk.mayer-goldstein.ln@health.mil expressing your interest in a site visit and indicating the number of potential participants.

PROPOSAL SUBMISSION

1. INSTRUCTION

a. ELECTRONIC PROPOSAL. Each volume shall be submitted electronically through https://safe.apps.mil.

NOTE: The offeror, an unauthenticated user (guest), must request in writing to henningfalk.mayer-goldstein.ln@health.mil, matthew.r.elden.civ@health.mil and elena.m.raspitha.civ@health.mil access to “drop-off” their proposal in DoD Safe. Once requested, a 12 digits request code will be sent, which is required to upload proposal into DoD Safe. Uploaded data into DoD Safe expire 7 days after submission.

Once expired, the Drop-off files are automatically deleted from the system, so they can no longer be downloaded by the sender or recipients. There is no "undelete" option available. The maximum file size of a package is 8 GB. Guests (i.e., PIV holders, users with .com and .edu emails) can send files but only if solicited by individuals with a DoD Common Access Card (CAC). It is the Offerors responsibility to ensure they have allowed enough time between requesting access to DoD Safe and uploading files to ensure proposal submission by the due date on the proposal. Each volume should include a cover letter that identifies your company name or symbol once in the entire volume (does not count against maximum volume page limit). Any portion of the proposal that is changed (as a result of negotiations or proposal revisions) should be annotated and dated. Each volume shall be clearly labeled with its title and a copy number (e.g., copy 1 of 1).

b. It is the Offeror’s responsibility to request access to DoD Safe and confirm with the Government that the electronic submissions through, https://safe.apps.mil, are received by the Government before the due date and time.

c. To be considered for evaluation, proposals must be received no later than the date and time (Central

European Summer Time, CEST) specified in Block 8, SF 1449. Proposals shall be submitted in the format stated in the "FORMAT and SIZE" and “PAGE LIMITATIONS” below. Files shall not contain classified data.

d. FORMAT and SIZE: Each paragraph shall be separated by at least one blank line.

A standard, 12-point minimum font size applies.

Margins: Top, Bottom, Left, Right – 1” Page Size, Width – 8.5” Page Size, Height – 11” or DIN A4 size.

Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Page size 11x17 or DIN A3 size may be used where needed for readability, however, each printed side of an 11x17 or A3 size page will count as two (2) pages. Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the proposal and (for paper copies) will be returned to the offeror as soon as practical. The technical proposal shall address how you will comply with the requirements set forth in the line-item description and must clearly explain each of the technical subfactors (see paragraph 52.212-2 for details). The following is excluded from the page count: copies of certificates, price schedule, completed FAR 52.212-3 Offeror Representations and Certifications – Commercial Items, and acknowledgement of any amendments issued.

e. PAGE LIMITATIONS. Page limitations shall be treated as maximums. Pages in excess of the below limitations will be removed and disregarded during the evaluation. When both sides of a sheet display printed material, it shall be counted as two (2) 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 applicable to legible tables, charts, graphs and figures used wherever practical to depict organizations, implementation schedules, plans, etc.

The proposal shall consist of the following volumes and be limited by the maximum page limit.

Volume # Section Title Maximum Page Limit per Volume

VOL I

Business Proposal

- Cover Letter (2-page max.)

- Master Table of Contents

- Contract Administration Data, SF 1449/SF 30

- Representation and Certification

- Certified IRS Form W-14 (see FAR clause

52.229-12 and FAR provision 52.229-11) NOTE: Page 1 of the SF 1449 and all Amendments (SF 30) must be signed by an authorized representative who indicates agreement of a 90-day acceptance period. Offerors are not required to submit a complete copy of the solicitation in their Volume I, Business Proposal. Offers shall complete the SF1449 continuation pages as well as all other sections (e.g., FAR 52.204-24, FAR 52.209-5, etc.)

that require a response.

No Limit

VOL II Factor 1 – Technical Capability

50 pages, but no limit on ATO documentation regarding salient characteristics

VOL III Factor 2 – Present or Past Performance 1 page

VOL IV

Factor 3 – Prices

- CLINS on Standard Form (SF) 1449 No Limit

f. QUESTIONS. Prospective offerors may submit questions regarding this RFP no later than Wednesday, 10

July 2024, at 12:00 (noon) Central European Summer Time (CEST). Questions can be emailed to henningfalk.mayer-goldstein.ln@health.mil. All questions received will be answered officially through an amendment to the Request for Proposal for distribution to all prospective offerors.

g. SPECIAL NOTE. All vendors must be registered in the System for Award Management (SAM) at the time an offer is submitted, and lack of registration shall make a proposal ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.

2. PROPOSAL CONTENT

a. All information shall be confined to the appropriate volume/section. For example, only information included in the section labeled “Technical Capability” will be evaluated for Technical Capability. If Technical Capability information is included elsewhere in the proposal, it will not be evaluated as part of the Technical Capability subfactor. The offeror shall confine submission to essential matters, sufficient to define the proposal and provide adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each proposal. Proprietary information shall be clearly marked.

b. Cross-Referencing. Each volume shall be written on a standalone basis so that its contents may be evaluated with no requirement to cross-reference to other volumes of the proposal. Information required for proposal evaluation which is not found in its designated volume will be assumed to have been omitted from the proposal.

Offerors are responsible for the accuracy of its proposal and the Government will not search or hunt for information that is not provided in the required location. Information not found in a technical subfactor will be considered missing and may result in a deficiency.

VOLUME I - BUSINESS PROPOSAL

COVER LETTER

The cover letter shall be a no more than 2-page introduction identifying the offeror (name, address, telephone and fax numbers, email address, CAGE/NCAGE Code, Unique Entity ID (UEI), the solicitation, number, and the contents of the proposal).

TABLE OF CONTENTS

Business Proposal shall contain a Master Table of Contents referencing the contents in all volumes. The Master Table of Contents will not count against the page limitations for their respective volumes.

CONTRACT ADMINISTRATIVE DATA

The offeror shall provide with its proposal, Points of Contact (POC) for administration of any resulting contract should the offeror be selected. These POCs shall be available during normal business hours and other than normal business hours. The POC for other than normal business hours will be contacted only in the event of emergencies. Accordingly, the named individual(s) should possess sufficient corporate authority to effectively deal with emergency situations. The telephone number(s) provided should be functional at all times. If there are different POCs for different conditions, such as weekdays, weekends, holidays, etc., please furnish all and explain as follows:

Offeror’s normal business hours/days.

POCs during normal business hours.

POCs for other than normal business hours.

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS (SF 1449) AND AMENDMENTS (SF 30).

Page 1 SF 1449 with signature of a corporate officer authorized to negotiate for the company in Block 30a, acknowledgement of all amendments, (SF 30) with signature in Block 15B, and agreement of the acceptance period stated in the Addenda to 52.212-1(c).

REPRESENTATIONS AND CERTIFICATIONS

Offerors shall submit one completed copy of all representations and certifications. If the offeror has completed the Online Representations and Certifications at the System for Award Management (SAM) https://sam.gov, submit an electronic printout of the Representations and Certifications.

IRS FORM W-14

Offerors shall submit one completed and signed IRS Form W-14 if the offeror is a foreign person. Foreign person means any person other than United States person. See FAR clause 52.229-12 and FAR provision 52.229-11 for details. Information about IRS Form W-14 and its separate instructions is available via the internet at www.irs.gov/w14.

VOLUME II – TECHNICAL CAPABILITY PROPOSAL (Factor 1)

a) Submission of Technical Proposals (Volume II). Character spacing shall be set on the 'Normal' setting for Microsoft Word. Offeror’s technical volume shall include section, paragraph, and page number on each subfactor page. Page numbers shall be continuous and not restart at the beginning of each subfactor. Subfactors shall begin at the top of a new page.

b) Page count. Technical Proposal Subfactors are limited to 50 pages. Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the proposal. Pages with Tables and Exhibits are included in the page count. Pages not included are as follows:

ATO documentation regarding salient characteristics Table of Contents Glossaries of Abbreviations and Acronyms Dividers Blank pages

TABLE OF CONTENTS

Table of Contents shall be included as one document along with the offerors Subfactors. The Table of Contents shall contain details which delineate the pages, sections, paragraphs, and subparagraphs within that volume.

Technical Proposal must specifically address the subfactors.

TECHNICAL PROPOSAL INSTRUCTIONS

Volume II shall include the Technical Proposal and shall be specific and complete. All the requirements specified in the solicitation are mandatory and by your proposal submission, you are representing that your company will perform all the requirements specified in the solicitation. The Government will evaluate the offeror’s responses against the Technical Proposal subfactors defined in the Addendum to 52.212-2. The offeror shall use the instructions provided below, to provide as specifically and descriptively as possible the actual procedures, and capabilities your company would use to accomplish/satisfy ALL requirements specified in the subfactors listed below.

The offeror shall ensure that the Technical Proposal is legible, clear, concise, and cohesive. The offeror shall ensure that its proposal does not merely reiterate, restate, rephrase or reformulate the requirements specified herein. It is the offeror’s responsibility to provide a technical proposal that includes enough description and convincing rationale to substantiate the validity of its stated claims. The Government’s evaluation will not include assumptions or use of prior knowledge of the offeror and will base its evaluation ratings on the accuracy, detail, and merit of the offerors submitted proposal.

Note: Do not include company name, company symbol, names of employees, CAGE/NCAGE Code, Unique Entity ID (UEI), company website or company email addresses within the Technical Proposal.

SUBFACTOR CONTENT

Technical Proposal must specifically address the following subfactors:

SUBFACTOR 1A - TECHNICAL CAPABILITY. The offeror shall provide a description/plan that clearly communicates how your company intends to meet the solicitation requirements. The technical capability shall include specific narrative details and/or descriptions with sufficient detail of actual processes, procedures, etc. to demonstrate compliance and understanding of Performance Work Statement (PWS) requirements.

(1) Provide a management and organizational chart, which clearly demonstrates your company’s capability to meet the requirements of the PWS, specifically sections 1.5.1, 1.5.2 and 5.2-5.2.8.8. The chart must also be supported by a description of your company’s capability to provide qualified personnel to support the requirements of the PWS in section 5.2 - 5.2.8.8,

(2) Provide a narrative and assurance that your company can meet the scope of the services in section –5.2 of the PWS for all locations identified in PWS paragraph 5.2.8.7, and

(3) Provide technical data demonstrating that the analytical equipment to be delivered meets or exceeds the salient characteristics listed below:

Salient Characteristics LRMC Total Laboratory Automation System (TLAS): PWS paragraphs 5.2.1, 5.2.1.1, 5.2.1.1.1 through

5.2.1.1.11 LRMC Chemistry and Immunochemistry Analyzers: PWS paragraphs 5.2.1.2, 5.2.1.2.1 through 5.2.1.2.9 LRMC Hematology System: PWS paragraphs 5.2.1.3, 5.2.1.3.1 through 5.2.1.3.9 LRMC Coagulation Analyzers: PWS paragraphs 5.2.1.4, 5.2.1.4.1 through 5.2.1.4.9 LRMC Serology Analyzer: PWS paragraphs 5.2.1.5, 5.2.1.5.1 through 5.2.1.4.6 Grafenwoehr Chemistry Analyzer: PWS paragraphs 5.2.2, 5.2.2.1, 5.2.2.1.1 through 5.2.2.1.6 SHAPE Chemistry Analyzer: PWS paragraphs 5.2.3, 5.2.3.1, 5.2.3.1.1 through 5.2.2.1.6 All Analyzers: PWS paragraphs 1.3.1, 1.3.12, 5.2.4.1, 5.2.4.6 and 5.2.7.4 All Information Systems must possess or be able to obtain an ATO in accordance with PWS Section 9, demonstrated on the DHA Medical Cybersecurity form entitled Medical Device and Equipment Risk Assessment (MDERA)

Minimum shelf-life of reagents and quality control material: PWS paragraph 1.3.13

SUBFACTOR 1B - TRANSITION PLAN

The offeror shall provide a detailed transition implementation plan of action and milestones describing the required tasks and associated timeline in order to provide timely, effective and complete contract and task order transition in accordance with (IAW) PWS requirements to include paragraphs 5.2.6 - 5.2.8 of the PWS and include an outline of initial training to be provided to Government personnel. Provide a detail description of your company’s plans for providing timely, effective and complete phase-in transition in accordance with this requirement utilizing Attachment 8 entitled “TLA Estimated Project Timeline” as the basis.

(1) Provide a detailed description/plan, which clearly demonstrates your company’s in-depth understanding of the requirement to ensure successful deployment of the company’s bidirectional interface between all analyzers and the Government’s LIS. Describe in detail your plans and projected timelines for critical tasks and actions IAW PWS paragraph 5.2.7, and

(2) Provide current and proposed organization chart with roles and responsibilities terms of computer/IT support personnel and system security oversight. Describe in detail your company’s plan to ensure timely provision of qualified individuals in support of PWS paragraphs 5.2.6 - 5.2.8.

SUBFACTOR 1C CONTRACT QUALITY CONTROL PLAN.

The offeror shall provide a detailed Quality Control Plan describing the offeror’s quality control program and procedures for monitoring performance and describing how the offeror plans to identify, resolve, and prevent quality assurance problems, assure documentation, record maintenance, and reporting of quality related problems, and assure monitoring of overall contract performance with deficiencies identified before the level of services becomes unsatisfactory.

Provide a detailed Quality Control Plan, which

(1) Describes the offeror’s quality control program and procedures for monitoring performance, identifying trends/problems/issues, corrective actions and follow-up to determine resolution in relation to the requirements identified within the Performance Requirement Summary (PRS) in the solicitation (Exhibit A),

(2) Describes how the offeror plans to identify, resolve, and prevent quality assurance problems,

(3) Describes how the offeror plans to assure documentation, record maintenance, and reporting of quality related problems, and

(4) Describes how the offeror plans to assure monitoring of overall contract performance with deficiencies identified before the level of services becomes unsatisfactory.

VOLUME III – PRESENT OR PAST PERFORMANCE PROPOSAL (Factor 2)

List at least three (3) references, but not more than five (5), to include Point of Contact, Email address, Telephone Number, Nature of Work, Annual Dollar Value, Contract Number, Location and Time Period involved. Past performance information should be for work performed within the past three (3) years. Any/all references received beyond the maximum number will not be evaluated. Quoters submissions proposing the use of business partnerships or subcontractors shall also include at least three (3) references for the partnership or subcontractor.

VOLUME IV – PRICE PROPOSAL (Factor 3)

The Contracting Officer has determined there is a high probability of adequate competition on this acquisition. Upon examination of the initial proposals, the contracting officer will review this determination and if in the Contracting Officer’s opinion, adequate competition exists, no additional price information will be requested. However, if at any time during this competition the Contracting Officer determines that adequate competition no longer exists, offerors may be required to submit information to the extent necessary for the contracting officer to determine the reasonableness of offerors’ price proposals. Additionally, all information related to pricing shall be included in Volume IV of the proposal only. UNDER NO CIRCUMSTANCES should pricing information be included elsewhere in the proposal. A complete Volume IV shall include the information below:

(1) Offeror’s proposed prices shall be provided in electronic format on the Standard Form 1449. In the event of a discrepancy, the unit price on SF 1449 will prevail. If changes are anticipated or required, changes shall be annotated to include the reason the alteration on the SF 1449 or an additional page. Substantive changes that would impact the solicitation shall be submitted as a formal question to afford the Government a determination if an amendment to the solicitation is required.

(2) The offeror shall limit their prices to two (2) decimal places (example: $1.23 or €4.56).

(3) All information related to pricing shall only be included in this section of the proposal and identified as pricing data.

(4) CLIN pricing:

a) CLIN FOR POST AWARD CONFERENCE ATTENDANCE. (0008). This CLIN is to satisfy the guaranteed minimum for the resulting contract.

b) CLINS FOR REPORTABLE RESULTS (0001 through 0007). The proposed prices for these CLINS shall be on a Cost Per Reportable Result (CPRR) basis and the historical annual reportable result volume provided in Attachment 1 through 7.

(End of Addendum to 52.212-1)

(End of Summary of Changes)