W9114F24R0003 Amendment 0005.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 do the follow ing:

a. Publicize the questions received from industry and the corresponding government responses.

b. Change the solicitation response date/time to 25 July 2024 at 14:00 Central European Summer Time (CEST).

c. Add FAR Provision 52.204-22 Alternative Line Item Proposal.

d. Updated Quality Control Plan language in PWS, Deliverables, 52.212-1 and 52.212-2.

e. Updated testing parameters in the PWS as addressed in the Final Questions and Answ ers.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 53

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

16C. DATE SIGNED

BY 11-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 X is extended, 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

11-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:

W9114F24R0003

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 22-Jul-2024 04:00 PM to 25-Jul-2024 02:00 PM.

The following have been added by full text:

FINAL Q&A

Page #/ Section

Reference Industry Question Government Answer

Page 1, Standard Form 1449, Block 8

Offer Due Date/Local Time 04:00 PM 22 Jul 2024

Due to limited availability of personnel resources because of increased workload due to tendering projects, we kindly ask for an extension of the offer deadline by at least 2 weeks.

The Offer Due Date/Local Time was extended to 02:00 PM 25 Jul 2024.

As the solicitation is written it appears to be source limiting vs.

full and open competition, as such, changes are requested to open up competition. One example is that the industry does not offer reselling methods of modalities that are not in a single companies capabilities, chemistry, immunoassay, urinalysis, etc. refer to the question below.

We see that many modalities are included in this tender. We ask that the requirement to connect all portions of Clinical Chemistry, Immunochemistry, Hematology, Coagulation and Serology be relaxed to allow for open competition.

The requirements for this acquisition were generated under the general auspices of throughput, efficiency, and quality. Successful total laboratory automation systems array multiple testing modalities.

Removal of any portion of the requirement would diminish the opportunity to maximize throughput, efficiency and quality.

Which country of original registrations are required? Will you consider changing the requirement from that of requiring FDA approvals and change to CE mark, since these are locations in Germany/Belgium?

The US DoD-operated laboratories in Germany and Belgium operate under the regulatory framework of the US Clinical Laboratory Improvement Program (CLIP; ref. DODI 6400.02). Accordingly, requirements are developed under the appropriate US regulations.

Must be FDA approved.

Reference Industry Question Government Answer

Do the site LRMC in Landstuhl have 400V power capabilities?

LRMC has the capability of 400V power connection in Bldg 3711.

We request the opportunity to engage with the local customer to conduct product demonstrations, learn more of their needs, to best create an offer that meets the needs of the laboratories. For example, webinars or office days in order to illustrate our capabilities to meet your needs.

A request for information was published on 7 June 2023, which led to this solicitation. To ensure that industry understands the requirements of the solicitation, a site visit was conducted on 8 July 2024.

Is shipping via a U.S. depo or directly within Europe?

Per the Solicitation, all shipments are to be FOB (Free on Board) Destination. The methodology for shipment/logistical processes proposed is up to each potential Offeror.

Reference Industry Question Government Answer

Page 85, ADDEND

UM 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.

From Company A: Concerning the Addenda to 52.212-1(m) and the amendment 0003 from 2 July 2024 we are still in doubt how to interpret.

As mentioned, 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 and we would like to deliver.

Therefore, we still like to know if we are allowed to subcontract with more than one prime-offeror.

From Company B: To have an unequivocal clearness for us as the prime offeror an to companies that will act as a teaming partner/subcontractor for more than one prime offeror, we have to repeat our question.

We please need to have the confirmation, that the teaming partner/subcontractor will not create a conflict of interest if they will submit more than one proposal with different prime offeror.

From Company C: Does the occurrence of a company, participating as a subcontractor for two prime contractors, have the potential to create an OCI for the prime vendor submitting a proposal?

This Organizational Conflict of Interest (OCI) paragraph merely reserves the right of the U.S.

Government to require additional information from the proposing offerors (prime offerors) when additional information is required to determine whether an OCI will exist.

In the event that a company/offeror is included in more than one Prime Offeror's proposal, this does NOT automatically constitute an OCI, neither for the prime offeror nor the sub-contractor/teaming partner. In plain language: YES, a specific company can be included in more than one Prime Offeror's proposal without an issue.

The Federal Acquisition Regulation at subpart 9.508 provides examples to illustrate situations in which OCI's may arise.

https://www.acquisition.gov/far/9 .508

If none of the situations apply in your particular case, then there should not be an issue.

Page 37/38, Performanc e Work Statement Paragraph 1.1 and Page 84, FAR

Clause 52.212-1(e)

Services (DPALS) at the Landstuhl Regional Medical Center (LRMC) and to provide clinical chemistry testing capabilities for the laboratories at the SHAPE Army Health Clinic and the Grafenwoehr Army Health Clinic. The full delivery addresses are specified in PWS paragraph 5.2.8.7. Prices shall be fixed prices based on a Cost Per Reportable Result (CPRR) agreement, which shall include instrumentation, reagent packs, ancillary equipment, inventory management system (for all required supplies), water systems, middleware (hardware and software) including consulting and services required in developing, validating, and implementing features, maintenance, service, repairs, parts, labor, and materials required in order to keep the systems in optimum operating condition. Installation and removal of equipment at all locations listed in the PWS shall also be included.

FAR 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

We understand LRMC will accept alternative business option models based on page 84 Clause/Paragraph 52.212-1(e) provides the flexibility needed to provide alternative pricing models.

The CLIN structure for Solicitation W9114F24R0003 is based upon the Defense Health Agency Procedures Manual

4000.02 (dated 18 Oct 2021) referencing Medical Devices and Equipment (MDE) Requirements Management. Within this document the Defense Health Agency documents Cost Per Reportable Result (CPRR) as one of only two preferred structures for MDE Contracts.

Added FAR provision 52.204-22 Alternative Line Item Proposal to provide additional information.

Reference Industry Question Government Answer solicitation. Each offer submitted will be evaluated separately.

Page 54, Table 2 Required immunoche mistry parameters at LRMC

Brain natriuretic peptide Troponin I (incl. high sensitivity)

Would NT-ProBNP and Troponin T Hs be a suitable replacement? If so, we kindly request these tests to be listed as options.

Changed the PWS entries as follows:

From "Brain natriuretic peptide" To "BNP or NT-proBNP"

From: "Troponin I (incl. high sensitivity)" To: "Troponin (high sensitivity)"

Page 54, Table 2.

Required immunoche mistry parameters at LRMC.

If the mentioned parameters can only be offered by one provider in the market, we understand that the laboratory also accepts adequate and qualitatively equivalent alternatives. Please verify.

All tests listed in the tables are required to be performed. If the tests are performed on an alternative platform within the system, they must still meet the requirements of the specific test(s) as documented in the PWS.

Page 51, Performanc e Work Statement Paragraph 5.2.1.1.4

100mm x 16mm and 100mm x 13mm tubes

Where are these types of tubes used and why?

These are standard blood collection tubes that the LRMC Laboratory is currently using to collect blood from patients.

100mm x 16mm are tiger top tubes, 100mm x 13mm are Gold, Pink and Red top tubes.

Pages 3 through Page 9, Item Description

ITEM 0001

- 0007, Page 83, Attachment

8, TLA

Estimated Project Timeline

Page 13, FAR clause 52.216-18

Ordering Period: 1 October 2024 through 31 August 2029

CLIN periods of performance state 1 October 2024 through 31 August 2029 but there is an estimated start date in Attachment 8, TLA Estimated Project Timeline, stating the start date of 1 November.

Additionally, FAR clause 52.216-18 shows a period of performance starting 1 September 2024. Please clarify.

Line Item Description: 1 October 2024 is the date that orders can be placed for item 0001 through 0007.

Attachment 8, TLA Estimated Project Timeline start date of 1 November 2024 is the estimated project timeline to start the on-site implementation process.

FAR clause 52.216-18 start date of 1 September 2024 covers any order placed for CLIN 0008 in September 2024.

Reference Industry Question Government Answer

Page 39, Performanc e Work Statement Paragraph 1.5.1.

Quality Control Plan (QCP)

Page 76, Exhibit B, Deliverable s Schedule, Deliverable A.001 Contractor’ s QCP

Page 91, SUBFACT

OR 1C

CONTRA

CT

QUALITY

CONTROL

PLAN

The PWS in paragraph 1.5.1 states the quality control plan (QCP) is to be submitted within 30 days of contract award; this is reiterated in Exhibit B, Deliverables. However, Subfactor 1C requires submission of a QCP as part of the proposal. Are there two versions of the QCP that will be required - one with the proposal and another within 30 days of contract award?

Updated PWS with final QCP information.

Updated Deliverables to reflect final QCP.

Updated 52.212-1 and 52.212-2 to reflect initial QCP.

Attachment 2 Historical annual reportable result volume for immunoche mistry parameters at LRMC.

Attachment 5 Historical annual reportable result volume for serology parameters at LRMC.

Is there a reason for the double listing of several parameters, e.g.

Rubella?

The tests are not double listed.

Rubella IgG and Rubella IgM are looking at chronic vs acute disease states.

There are two types of measles in the world. Rubeola is the common measles and Rubella is German measles. The lab needs to be able to test for both.

Reference Industry Question Government Answer

Page 81, Attachment 5 Historical annual reportable result volume for serology parameters at LRMC.

TPLA seems to be an outdated manual method, is there a reason for this listing?

Corrected typographical error in PWS from TPLA to TPPA.

Page 81, Attachment 5 Historical annual reportable result volume for serology parameters at LRMC.

How many smears, body fluids and PLT-F's are made per year in hematology? That would be important for the calculation.

Smears are 10% of CBC count.

PLT-Fs are 1% of CBC count.

Body Fluids are 130 per year.

Please provide the maximum floor load capacity in kilograms per square meter for the room area in which the Total Laboratory Automation System is to be installed.

The Maximum Live Load of the LRMC Laboratory floor is 350 kilograms per square meter.

Please provide a room plan for the room area in which the Total Laboratory Automation System is to be installed.

Room plan will be provided to interested sources upon request via email to henningfalk.mayer-goldstein.ln@health.mil and matthew.r.elden.civ@health.mil.

Requests must be arrived in the email inbox not later than Monday 15 July 2024 at 16:00 Central European Summer Time

(CEST).

Please provide a room plan with the analyzer marked on it for the room area in which the Grafenwoehr chemistry analyzer is to be installed.

Room plan will be provided to interested sources upon request via email to henningfalk.mayer-goldstein.ln@health.mil and matthew.r.elden.civ@health.mil.

Requests must be arrived in the email inbox not later than Monday 15 July 2024 at 16:00 Central European Summer Time

(CEST).

Please provide the percentages of reruns for clinical chemistry and immunochemistry.

The percentage of reruns for addressed analyzers is less than 1% at all locations.

Reference Industry Question Government Answer

Page 52, Performanc e Work Statement Paragraph 5.2.1.1.7

In PWS Paragraph 5.2.1.1.7 of the solicitation, for the post-analytical storage refrigeration unit, a temperature of between 2 and 8 degrees Celsius is specified. Would a storage temperature between 4 and 8 degrees Celsius also be acceptable?

The laboratory and CAP requires a temperature between 2 and 8 degrees Celsius. Since the range of 4 to 8 degrees Celsius falls within the range of 2 to 8 degrees Celsius, the requested range is acceptable.

(End of Final Questions and Answers)

52.204-22 ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)

(a) The Government recognizes that the line items established in this solicitation may not conform to the Offeror's practices. Failure to correct these issues can result in difficulties in acceptance of deliverables and processing payments. Therefore, the Offeror is invited to propose alternative line items for which bids, proposals, or quotes are requested in this solicitation to ensure that the resulting contract is economically and administratively advantageous to the Government and the Offeror.

(b) The Offeror may submit one or more additional proposals with alternative line items, provided that alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation. However, acceptance of an alternative proposal is a unilateral decision made solely at the discretion of the Government. Offers that do not comply with the line items specified in this solicitation may be determined to be nonresponsive or unacceptable.

(End of provision)

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 cancelled for 1 July 2024 is rescheduled to take place at the Landstuhl Regional Medical Center on Monday, 8 July 2024 from 10:00 a.m. to 12:00 a.m. Central European Summer Time (CEST). Please send an email to Mr. Henning Mayer-Goldstein at henningfalk.mayergoldstein.ln@health.mil expressing your interest in the site visit and indicating the number of potential participants. Please note that all participants will need two (2) forms of photo identification (e.g. passport (Personalausweis), driver’s license, etc.) and are encouraged to arrive early due to increased security measures.

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,

(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 INITIAL QUALITY CONTROL PLAN.

The offeror shall provide a detailed initial 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 initial 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,

(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)

CLAUSE(S) 52.212-2 - ADDENDUM TO 52.212-2

A. BASIS OF AWARD

Award will be made using the Lowest Price Technically Acceptable (LPTA) source selection process. The Government intends to award a Single Indefinite Delivery / Indefinite Quantity (ID/IQ) contract to the Offeror deemed responsible in accordance with (IAW) the Federal Acquisition Regulation (FAR), whose proposal provides the lowest price with acceptable technical and past and present performance. The Government will evaluate Factor

(1) “Technical Capability” to determine acceptability, Factor (2) “Present or Past Performance” to determine acceptability, and Factor (3) “Price” to determine the successful awardee.

B. FACTORS AND SUBFACTORS TO BE EVALUATED

Factor 1 Technical Capability: Each of the technical subfactors will be evaluated individually and each subfactor must receive an acceptable rating in order to receive an overall acceptable Technical Capability rating.

Subfactor 1A Technical Capability.

Subfactor 1B Transition Plan, and bidirectional LIS Interface Subfactor 1C Quality Control Plan

Factor 2 Past and Present Performance

Factor 3 Price

C. EVALUATION

All proposals will be subject to evaluation by a team of Government personnel. Offerors must ensure all information pertaining to the factor or subfactor is addressed in that particular portion of the proposal. Offerors are cautioned that only the information included for each factor/subfactor will be evaluated. 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.

TECHNICAL CAPABILITY EVALUATION (Factor 1).

Each of the technical subfactors will be assessed individually. The evaluation process will consider the following:

Subfactor 1A Technical Capability: The technical capability will be evaluated to measure the offeror’s understanding of the requirements and to ensure that the capability meets the capability standards outlined in the

PWS.

This subfactor is met when:

(1) The offeror provides 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 offeror provided chart must also be supported by a description of the offeror’s capability to provide qualified personnel to support the requirements of the PWS in section 5.2 - 5.2.8.8,

(2) The offeror provides a narrative and assurance that your company can meet the scope of the services in section 5.2 for all locations addressed in PWS paragraph 5.2.8.7, and

(3) The offeror provides 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 and Laboratory Information Systems (LIS) and Interface. 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 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 strategy for providing timely, effective and complete phase-in transition in accordance with this requirement.

(1) The offeror provides a detailed description/plan, which clearly demonstrates the offeror’s in-depth understanding of the requirement to ensure successful deployment of the offeror’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,

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

Subfactor 1C Initial Quality Control Plan: The offeror shall provide a detailed initial 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.

The offeror provides 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.

The following Technical Acceptable/Unacceptable Rating Method apply:

Adjectival Rating Description

Acceptable Proposal meets the requirements of the solicitation.

Unacceptable Proposal does not meet the requirements of the solicitation.

PAST AND PRESENT PERFORMANCE EVALUATION (Factor 2).

(a) The Contracting Officer will evaluate relevant present or past performance information of all Offerors based on (1) the past and present effort provided by the Offeror and (2) data independently obtained from Government and commercial sources. Relevant performance includes performance of efforts involving laboratory automation testing that are similar or greater in scope, magnitude and complexity to the effort described in this solicitation. The assessment process will result in an overall performance rating of Acceptable or Unacceptable as defined in the table below. Present or past performance of subcontractors will be rated individually. A present or past performance rating of either the offeror or its subcontractor of “Unacceptable” will result in the overall present or past performance rating being “Unacceptable” and therewith ineligible for award.

Note: In the case of an…