W81K04-20-R-0017-0001 Reference Lab Amendment.pdf

W81K0420R0017

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

A. The purpose of this amendment is to revise the Performance Work Statement, Addendum to FAR 52.212-1, and Period of Performance, add Attachment 11 "Workload by MTF FY2018", update Exhibit B "Summary by Facility Name" and Exhibit C "Schedule of Required Tests", add Exhibit J " DHA B2B Gatew ay Questionnaire", and provide answ ers to all questions received from industry. Offerors are cautioned to read the entire amendment for changes.

B. Attachment 11, Exhibits B, C, and J, and Questions and Answ ers are separately attached.

C. The solicitation due date is extended from 4:00 pm, 2 March 2020 to 4:00 pm (Central Standard Time), 12 March 2020.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 59

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

16C. DATE SIGNED

BY 27-Feb-2020

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 W81K0420R0017

X 9B. DATED (SEE ITEM 11)

30-Jan-2020

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

27-Feb-2020

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:

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 02-Mar-2020 04:00 PM to 12-Mar-2020 04:00 PM.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Transition Period: 1 October 2020 to 30 March 2021 Note: Transition period shall be rendered Not Separately Priced (NSP)

To:

Transition Period: 1 October 2020 to 31 March 2021 Note: Transition period shall be rendered Not Separately Priced (NSP)

CLIN 0002

Ordering Period: 31 March 2021 through 30 September 2025. The contractor shall provide Clinical Reference Laboratory Testing Services through placement of task orders for all laboratory tests specified in the Schedule of Required Tests (Exhibit C).

Ordering Period: 1 April 2021 through 30 September 2025. The contractor shall provide Clinical Reference Laboratory Testing Services through placement of task orders for all laboratory tests specified in the Schedule of Required Tests (Exhibit C).

CLIN 0003

Ordering Period: 31 March 2021 - 30 September 2025

Ordering Period: 1 April 2021 - 30 September 2025

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for CLIN 0001 has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2020 TO

30-MAR-2021

N/A W40M USA HLTH CONTRACTING ACT

SEE TASK ORDERS

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

FOB: Destination

W81K04

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2020 TO

31-MAR-2021

N/A W40M USA HLTH CONTRACTING ACT

SEE TASK ORDERS

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

The following Delivery Schedule item for CLIN 0002 has been changed from:

CAGE

POP 31-MAR-2021 TO

30-SEP-2025

N/A W40M USA HLTH CONTRACTING ACT

SEE TASK ORDERS

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

CAGE

POP 01-APR-2021 TO

30-SEP-2025

N/A W40M USA HLTH CONTRACTING ACT

SEE TASK ORDERS

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

The following Delivery Schedule item for CLIN 0003 has been changed from:

CAGE

POP 31-MAR-2021 TO

30-SEP-2025

N/A W40M USA HLTH CONTRACTING ACT

SEE TASK ORDERS

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

CAGE

POP 01-APR-2021 TO

30-SEP-2025

N/A W40M USA HLTH CONTRACTING ACT

SEE TASK ORDERS

CTR FOR HEALTH CARE CONTR

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

The following have been added by full text:

ATTACHMENT 11

Workload by MTF (FY 2018) -- Separately Attached

EXHIBIT J

B2B Gateway Questionnaire – Separately Attached

252.204-7012 SAFEGUARDING COVERED DEFENSE INFORMATION AND CYBER INCIDENT

REPORTING (DEC 2019)

(a) Definitions. As used in this clause--

Adequate security means protective measures that are commensurate with the consequences and probability of loss, misuse, or unauthorized access to, or modification of information.

Compromise means disclosure of information to unauthorized persons, or a violation of the security policy of a system, in which unauthorized intentional or unintentional disclosure, modification, destruction, or loss of an object, or the copying of information to unauthorized media may have occurred.

Contractor attributional/proprietary information means information that identifies the contractor(s), whether directly or indirectly, by the grouping of information that can be traced back to the contractor(s) (e.g., program description, facility locations), personally identifiable information, as well as trade secrets, commercial or financial information, or other commercially sensitive information that is not customarily shared outside of the company.

Controlled technical information means technical information with military or space application that is subject to controls on the access, use, reproduction, modification, performance, display, release, disclosure, or dissemination.

Controlled technical information would meet the criteria, if disseminated, for distribution statements B through F using the criteria set forth in DoD Instruction 5230.24, Distribution Statements on Technical Documents. The term does not include information that is lawfully publicly available without restrictions.

Covered contractor information system means an unclassified information system that is owned, or operated by or for, a contractor and that processes, stores, or transmits covered defense information.

Covered defense information means unclassified controlled technical information or other information, as described in the Controlled Unclassified Information (CUI) Registry at http://www.archives.gov/cui/registry/category-list.html, that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations, and Governmentwide policies, and is--

(1) Marked or otherwise identified in the contract, task order, or delivery order and provided to the contractor by or on behalf of DoD in support of the performance of the contract; or

(2) Collected, developed, received, transmitted, used, or stored by or on behalf of the contractor in support of the performance of the contract.

Cyber incident means actions taken through the use of computer networks that result in a compromise or an actual or potentially adverse effect on an information system and/or the information residing therein.

Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information.

Malicious software means computer software or firmware intended to perform an unauthorized process that will have adverse impact on the confidentiality, integrity, or availability of an information system. This definition includes a virus, worm, Trojan horse, or other code-based entity that infects a host, as well as spyware and some forms of adware.

Media means physical devices or writing surfaces including, but is not limited to, magnetic tapes, optical disks, magnetic disks, large-scale integration memory chips, and printouts onto which covered defense information is recorded, stored, or printed within a covered contractor information system.

Operationally critical support means supplies or services designated by the Government as critical for airlift, sealift, intermodal transportation services, or logistical support that is essential to the mobilization, deployment, or sustainment of the Armed Forces in a contingency operation.

Rapidly report means within 72 hours of discovery of any cyber incident.

Technical information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data--Noncommercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering http://www.archives.gov/cui/registry/category-list.html http://www.archives.gov/cui/registry/category-list.html data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code.

(b) Adequate security. The Contractor shall provide adequate security on all covered contractor information systems.

To provide adequate security, the Contractor shall implement, at a minimum, the following information security protections:

(1) For covered contractor information systems that are part of an information technology (IT) service or system operated on behalf of the Government, the following security requirements apply:

(i) Cloud computing services shall be subject to the security requirements specified in the clause 252.239-7010, Cloud Computing Services, of this contract.

(ii) Any other such IT service or system (i.e., other than cloud computing) shall be subject to the security requirements specified elsewhere in this contract.

(2) For covered contractor information systems that are not part of an IT service or system operated on behalf of the Government and therefore are not subject to the security requirement specified at paragraph (b)(1) of this clause, the following security requirements apply:

(i) Except as provided in paragraph (b)(2)(ii) of this clause, the covered contractor information system shall be subject to the security requirements in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations” (available via the internet at http://dx.doi.org/10.6028/NIST.SP.800-171) in effect at the time the solicitation is issued or as authorized by the Contracting Officer.

(ii)(A) The Contractor shall implement NIST SP 800-171, as soon as practical, but not later than December 31, 2017. For all contracts awarded prior to October 1, 2017, the Contractor shall notify the DoD Chief Information Officer (CIO), via email at osd.dibcsia@mail.mil, within 30 days of contract award, of any security requirements specified by NIST SP 800-171 not implemented at the time of contract award.

(B) The Contractor shall submit requests to vary from NIST SP 800-171 in writing to the Contracting Officer, for consideration by the DoD CIO. The Contractor need not implement any security requirement adjudicated by an authorized representative of the DoD CIO to be nonapplicable or to have an alternative, but equally effective, security measure that may be implemented in its place.

(C) If the DoD CIO has previously adjudicated the contractor's requests indicating that a requirement is not applicable or that an alternative security measure is equally effective, a copy of that approval shall be provided to the Contracting Officer when requesting its recognition under this contract.

(D) If the Contractor intends to use an external cloud service provider to store, process, or transmit any covered defense information in performance of this contract, the Contractor shall require and ensure that the cloud service provider meets security requirements equivalent to those established by the Government for the Federal Risk and Authorization Management Program (FedRAMP) Moderate baseline (https://www.fedramp.gov/resources/documents/) and that the cloud service provider complies with requirements in paragraphs (c) through (g) of this clause for cyber incident reporting, malicious software, media preservation and protection, access to additional information and equipment necessary for forensic analysis, and cyber incident damage assessment.

(3) Apply other information systems security measures when the Contractor reasonably determines that information systems security measures, in addition to those identified in paragraphs (b)(1) and (2) of this clause, may be required to provide adequate security in a dynamic environment or to accommodate special circumstances (e.g., medical devices) and any individual, isolated, or temporary deficiencies based on an assessed risk or vulnerability. These measures may be addressed in a system security plan.

http://dx.doi.org/10.6028/NIST.SP.800-171 mailto:osd.dibcsia@mail.mil https://www.fedramp.gov/resources/documents/

(c) Cyber incident reporting requirement.

(1) When the Contractor discovers a cyber incident that affects a covered contractor information system or the covered defense information residing therein, or that affects the contractor's ability to perform the requirements of the contract that are designated as operationally critical support and identified in the contract, the Contractor shall--

(i) Conduct a review for evidence of compromise of covered defense information, including, but not limited to, identifying compromised computers, servers, specific data, and user accounts. This review shall also include analyzing covered contractor information system(s) that were part of the cyber incident, as well as other information systems on the Contractor's network(s), that may have been accessed as a result of the incident in order to identify compromised covered defense information, or that affect the Contractor's ability to provide operationally critical support; and

(ii) Rapidly report cyber incidents to DoD at https://dibnet.dod.mil.

(2) Cyber incident report. The cyber incident report shall be treated as information created by or for DoD and shall include, at a minimum, the required elements at https://dibnet.dod.mil.

(3) Medium assurance certificate requirement. In order to report cyber incidents in accordance with this clause, the Contractor or subcontractor shall have or acquire a DoD-approved medium assurance certificate to report cyber incidents. For information on obtaining a DoD-approved medium assurance certificate, see https://public.cyber.mil/eca/.

(d) Malicious software. When the Contractor or subcontractors discover and isolate malicious software in connection with a reported cyber incident, submit the malicious software to DoD Cyber Crime Center (DC3) in accordance with instructions provided by DC3 or the Contracting Officer. Do not send the malicious software to the Contracting Officer.

(e) Media preservation and protection. When a Contractor discovers a cyber incident has occurred, the Contractor shall preserve and protect images of all known affected information systems identified in paragraph (c)(1)(i) of this clause and all relevant monitoring/packet capture data for at least 90 days from the submission of the cyber incident report to allow DoD to request the media or decline interest.

(f) Access to additional information or equipment necessary for forensic analysis. Upon request by DoD, the Contractor shall provide DoD with access to additional information or equipment that is necessary to conduct a forensic analysis.

(g) Cyber incident damage assessment activities. If DoD elects to conduct a damage assessment, the Contracting Officer will request that the Contractor provide all of the damage assessment information gathered in accordance with paragraph (e) of this clause.

(h) DoD safeguarding and use of contractor attributional/proprietary information. The Government shall protect against the unauthorized use or release of information obtained from the contractor (or derived from information obtained from the contractor) under this clause that includes contractor attributional/proprietary information, including such information submitted in accordance with paragraph (c). To the maximum extent practicable, the Contractor shall identify and mark attributional/proprietary information. In making an authorized release of such information, the Government will implement appropriate procedures to minimize the contractor attributional/proprietary information that is included in such authorized release, seeking to include only that information that is necessary for the authorized purpose(s) for which the information is being released.

(i) Use and release of contractor attributional/proprietary information not created by or for DoD. Information that is obtained from the contractor (or derived from information obtained from the contractor) under this clause that is not created by or for DoD is authorized to be released outside of DoD--

(1) To entities with missions that may be affected by such information;

http://dibnet.dod.mil/ http://dibnet.dod.mil/ https://public.cyber.mil/eca/

(2) To entities that may be called upon to assist in the diagnosis, detection, or mitigation of cyber incidents;

(3) To Government entities that conduct counterintelligence or law enforcement investigations;

(4) For national security purposes, including cyber situational awareness and defense purposes (including with Defense Industrial Base (DIB) participants in the program at 32 CFR part 236); or

(5) To a support services contractor (“recipient”) that is directly supporting Government activities under a contract that includes the clause at 252.204-7009, Limitations on the Use or Disclosure of Third-Party Contractor Reported Cyber Incident Information.

(j) Use and release of contractor attributional/proprietary information created by or for DoD. Information that is obtained from the contractor (or derived from information obtained from the contractor) under this clause that is created by or for DoD (including the information submitted pursuant to paragraph (c) of this clause) is authorized to be used and released outside of DoD for purposes and activities authorized by paragraph (i) of this clause, and for any other lawful Government purpose or activity, subject to all applicable statutory, regulatory, and policy based restrictions on the Government's use and release of such information.

(k) The Contractor shall conduct activities under this clause in accordance with applicable laws and regulations on the interception, monitoring, access, use, and disclosure of electronic communications and data.

(l) Other safeguarding or reporting requirements. The safeguarding and cyber incident reporting required by this clause in no way abrogates the Contractor's responsibility for other safeguarding or cyber incident reporting pertaining to its unclassified information systems as required by other applicable clauses of this contract, or as a result of other applicable U.S. Government statutory or regulatory requirements.

(m) Subcontracts. The Contractor shall--

(1) Include this clause, including this paragraph (m), in subcontracts, or similar contractual instruments, for operationally critical support, or for which subcontract performance will involve covered defense information, including subcontracts for commercial items, without alteration, except to identify the parties. The Contractor shall determine if the information required for subcontractor performance retains its identity as covered defense information and will require protection under this clause, and, if necessary, consult with the Contracting Officer; and

(2) Require subcontractors to--

(i) Notify the prime Contractor (or next higher-tier subcontractor) when submitting a request to vary from a NIST SP 800-171 security requirement to the Contracting Officer, in accordance with paragraph (b)(2)(ii)(B) of this clause; and

(ii) Provide the incident report number, automatically assigned by DoD, to the prime Contractor (or next higher-tier subcontractor) as soon as practicable, when reporting a cyber incident to DoD as required in paragraph (c) of this clause.

(End of clause)

The following have been modified:

ADDENDUM TO 52.212-1

Addenda to 52.212-1(b), Submission of Proposals. The paragraph is tailored as follows:

Paragraph (b), the second sentence is deleted and replaced with the following: “Proposals must be submitted on the SF 1449 and accompanied by all requested items elsewhere specified in the solicitation.

Paragraph (b) (10) is deleted and replaced by information required to be submitted in Volume III of the proposal.

Addenda to 52.212-1(c), Period for Acceptance of Proposals. The paragraph is tailored as follows: “The offeror agrees to hold the prices in its offer firm for 180 calendar days from the date specified for receipt of proposals.”

Addenda to 52.212-1(e), Multiple Proposals. This paragraph is deleted in its entirety.

Addenda to 52.212-1(g), the following paragraph is added to the end of the current paragraph as follows: "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 competitive range 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 competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals."

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.

PROPOSAL SUBMISSION

1. INTRODUCTION.

a. The offeror shall submit its proposal to the office indicated in block 9 of the Standard Form (SF) 1449, Solicitation/Contract Award. To be considered for evaluation, proposals must be received no later than the date and time (Central Standard Time) specified in Block 8, SF 1449. The offeror shall mark the exterior of their package and each CD-R with the solicitation number specified in Block 5, SF 1449 (See Proposal Table of Contents for further instructions). Proposals shall be submitted in the format stated in the “Proposal Table of Contents” listed below in Section 2 “Proposal Files”. Each volume of the offeror’s proposal shall be submitted in electronic form on a separate CD-R as specified in the table below entitled, “Proposal Table of Contents.” Telegraphic, electronic mail, and facsimile proposals will not be accepted. Files shall not contain classified data. 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”. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Page size 11x17 may be used where needed for readability, however, each printed side of an 11x17 page will count as two pages.

b. Electronic Files (CD-Rs). Offerors shall submit their proposal on CD-Rs that are clearly labeled with the offeror’s name, cage code, volume number and volume title. Electronic files shall not contain classified data.

Each CD-R shall be made read only and “burned” at a minimum 8x speed. In addition, each CD-R must be made “final.” “Final” is a recording option that renders the CD totally used so that no other data tracks can be added. Do not use compressed file formats. Submissions shall be virus free. Electronic files shall be submitted in a format that is compatible with Microsoft Office 2007 applications. Use of .xlsx, .docx, and Adobe pdf file types are acceptable.

Each CD-R shall be submitted in a separate CD package (i.e. die-cut jacket, plastic case, CD sleeve, CD bag) clearly marked with the volume number and volume title and shall be submitted as a set.

c. Each volume of the offeror’s proposal (Business proposal, Technical Quality proposal, Performance Risk proposal (Past & Present Performance), and Price proposal) shall be submitted on a separate CD-R.

d. Additional Restrictions.

(1) Technical Quality Proposal (Volume II) is limited to 100 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.

If there are more than 45 lines of text on any page, the additional lines will not be evaluated. Headers, footers and page numbers are not included in the line count.

(2) Each page shall be counted except the following:

• Master Table of Contents

• Volume Cover Pages

• Table of Contents

• Summary Section

• Glossaries of Abbreviations and Acronyms

• Dividers

• Blank pages

• Online Representation and Certifications

• Consent Letters/Client Authorization Letters

• Past Performance Risk Assessment Questionnaires

• Points of contacts list completing past performance questionnaires

(3) Questions and Answers. Offerors may submit questions regarding this solicitation to the attention of Mr. Anthony J. Smith, at e-mail: anthony.j.smith138.civ@mail.mil no later than 10 calendar days after issuance of this solicitation in the format at Attachment 1 entitled “Question and Answer Template.”

(4) Glossary of Abbreviations and Acronyms. Each volume shall contain a glossary of all abbreviations and acronyms used, and with an explanation for each. Glossaries do not count against the page limitations for their respective volumes.

(5) E-mail correspondence. Offeror’s shall ensure that all e-mails identify in the subject the solicitation number referenced and specific title of reference i.e. “W81K04-20-R-0017- Questions”

Offerors shall use the “Proposal Table of Contents” below to organize their electronic proposal files. Each volume of the offeror’s proposal shall be submitted in electronic form on a separate CD-R as specified in the table. Each document shall be saved to the appropriate CD-R as a separate electronic file using the document titles provided in Solicitation Attachment 2 entitled, “Proposal File Naming Convention.”

PROPOSAL TABLE OF CONTENTS

Vol. Document Title Copies Page Limits mailto:anthony.j.smith138.civ@mail.mil

I Business Proposal:

Cover Letter Master Table of Contents Contract Administrative Data 4. SF 1449/SF 30 Representation and Certifications Responsibility Determination Glossary of Abbreviations and Acronyms NOTE:

Page 1 of the SF 1449 and all Amendments (SF

30) must be signed by an authorized representative who indicates agreement of a 180-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 52.219-28, FAR 52.209-2, etc.) that require a response.

1 CD-R and 1 Paper Copy containing the Offeror’s complete Volume I, Business Proposal

No Limit

II Technical Quality Proposal

1. Table of Contents

2. Technical Approach

3. Transition Plan and Lab Information, LIS, and

Interface

4. Contract Quality Control Plan

5. Quality Assurance Plan

6. Management Capability and Experience

7. Glossary of Abbreviations and Acronyms

4 CD-Rs total and 1 Paper Copy containing the offeror’s complete Volume II, Technical Proposal

NOTE: 1 CD-R must be unsanitized.

3 CD-Rs and Paper Copy must be sanitized to include the label/cover of the CD-R which should reference Volume II, the solicitation number, and Technical Quality Proposal (See Attachment 2). Note: For the sanitized copies, do not include Company name or CAGE Code on the CD-R Label cover or within the Technical Quality Proposal

III Performance Risk Proposal:

1. Table of Contents

2. Subcontractor Teaming Partner Consent Letter

3. Subcontractor Teaming Partner Table

4. (Performance Assessment Submission 1)

5. (Performance Assessment Submission 2)

6. (Performance Assessment Submission 3)

7. Glossary of Abbreviations and Acronyms

1 CD-R and 1 Paper Copy containing the offeror’s complete Volume III, Performance Risk Proposal

2 pages per reference

IV Price Proposal Exhibit C

1 CD-R and 1 Paper Copy containing the offeror’s complete Volume IV, Price Proposal

No limit

V Small Business Participation 1 CD-R and 1 Paper Copy containing the offeror’s complete Volume V, Small Business Participation

5 pages

VI Small Business Subcontracting Plan 1 CD-R and 1 Paper Copy containing the offeror’s complete Volume VI, Small Business Subcontracting

10 pages

2. PROPOSAL CONTENT

a. All information shall be confined to the appropriate volume/section. For example, only information included in the section labeled “Technical Approach” will be evaluated for Technical Approach. If Technical Approach information is included elsewhere in the proposal, it will not be evaluated as part of the Technical Approach 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 code, DUNS number, 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://www.sam.gov/portal/public/SAM, submit an electronic printout of the Representations and Certifications.

RESPONSIBILITY DETERMINATION

To assist in determining offeror/Contractor responsibility IAW FAR Part 9, the offeror shall explain how they plan to have or obtain adequate financial resources to support any awarded contract. If the offeror intends to rely on internally available working/operation capital, evidence of availability must be submitted. If the offeror plans to rely on financial support from other sources, evidence of availability and the maximum lines of credit that may be available must be submitted. Evidence of external funding must be provided in the form of a dated letter from the external source. Documentation to support the amounts must also be included.

Offerors who fail to provide sufficient information for the USG to make an affirmative responsibility determination may be referred to the Small Business Administration (SBA) for Certificate of Competency consideration USG FAR Part 19.6. 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.

a) GLOSSARY OF ABREVIATIONS AND ACRONYMS.

Include a glossary of abbreviations and acronyms used throughout the volume.

VOLUME II – TECHNICAL QUALITY PROPOSAL (Factor 1)

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

b) Page count. Technical Quality Proposal Subfactors are limited to 100 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:

• 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 Quality Proposal must specifically address the sub-factors.

TECHNICAL QUALITY PROPOSAL INSTRUCTIONS

Volume II shall include the Technical Quality 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 https://www.sam.gov/portal/public/SAM will perform all the requirements specified in the solicitation. The USG will evaluate the offeror’s responses against the Technical Proposal sub-factors 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 methodologies, procedures, and approaches your company would use to accomplish/satisfy ALL requirements specified in the sub-factors listed below.

The offeror shall ensure that the Technical Quality 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: As referenced in Attachment 2 and the Proposal Table of Contents, for the sanitized copies do not include Company name or CAGE Code on the CD-R Label cover or within the Technical Quality Proposal.

SUBFACTOR CONTENT

Technical Quality Proposal must specifically address the following sub-factors:

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

(1) Provide a detailed description of how your company will provide qualified contract personnel in accordance with the PWS to include paragraphs 1.8 and 8.3 – 8.5. Provide proposed locations and distribution of specimen processing/data entry technicians in support of PWS paragraph 1.8.3. Include placement criteria such as submitting activity type, location, workload, volume thresholds and test complexity. Include how this supports the efficient and effective provision of support at the local submitting activity and at the enterprise level. Include the organizational structure, management roles and responsibilities of contractor personnel as required in paragraph 1.8 of the PWS.

(2) Provide a detailed description of how your company will provide the full scope of services In

Accordance With (IAW) PWS paragraph 1.4. to locations that are within the Contiguous/Continental United States (CONUS) and locations that are Outside the Contiguous/Continental United States (OCONUS). Provide specific management techniques, reports, tools and practices to ensure appropriate management and oversight necessary to provide quality and timely services IAW PWS paragraph 1.7.

(3) Provide a detailed description of how your company will meet the full testing requirements of PWS paragraph 8.0 and the Contractor’s Price List (Exhibit C) inclusive of internal “in-house” and external reference lab support. Description shall include a list of current external reference labs for which your company has established agreements with as well as specific criteria for evaluating (minimum testing volume, same or comparable testing), selecting and establishing agreements with new laboratories in support of PWS paragraph

8.15. Describe how your company will manage reference testing support from “cradle to grave” from sub-contractors to include electronic transmission of tests requests and results back into the government's EHR IAW PWS paragraph 8.15. Describe business management practices and procedures to ensure the accurate and timely billing will occur.

(4) Provide detailed description of your company’s plan to handle emergency situations which may arise during performance of this requirement to ensure continuity of reference testing services. Provide a detailed description of how your company will accomplish and redirect testing in case of acts of God, natural disaster, reagent shortages, manufacturer recalls, or temporary shutdown of your facility, during performance of this contract.

(5) Provide a detailed description of your company’s policies and procedures for communication of test results that are critical, amended, or rejected IAW PWS paragraphs 8.11 and 8.13; and how your company will monitor performance to ensure compliance with contract requirements. Provide a detailed description of how your company will effectively manage changes in methodology, reference range, etc. in support of PWS paragraph 7.1.2. and a description of systems and processes that will support timely notification and requisite changes to the Government’s LIS in support of PWS paragraph 1.8.6.

(6) Provide a detailed plan for customer service support in accordance with PWS paragraph 8.4. Plans shall include specific policies and procedures as to how your company will monitor and ensure responsive and effective communication between your company and government personnel to ensure timely provision of services and specific metrics or indicators your company will use to monitor and ensure effective customer service and satisfaction in meeting the needs Government (e.g., call/email response times, resolution times, etc.).

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 paragraph 8.16 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) Provide a comprehensive description of the methodology to be employed to demonstrate the in-depth understanding required to ensure successful deployment of the contractor’s LIS and interface with the government’s network. Describe in detail your plans and projected timelines for critical tasks and actions IAW PWS paragraph 8.8 in support of minimally obtaining an initial ATO-C IAW PWS paragraph 8.16 and a full ATO IAW PWS paragraph 8.7.1.3.

(2) Provide a completed DHA B2B Phase 2 Gateway Questionnaire with as much current information as possible; document shall include current network diagram, hardware and software list. Current NESSUS scan of system. Offerors shall submit the DHA B2B Phase 2 Gateway questionnaires as an appendix to the Technical Proposal. This document is excluded from the 100 page limitation. The DHA B2B Gateway Questionnaire is added as Exhibit J to the Solicitation.

(3) 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 1.8.7 and 4.

SUBFACTOR 1C CONTRACT QUALITY CONTROL PLAN. Describe your company’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). Explain your methodology for identifying, resolving, and preventing quality assurance problems. Discuss how your quality control plan will assure documentation, record maintenance, and reporting of quality related problems, and how your quality control plan will monitor overall contract performance with deficiencies identified before the level of services becomes unsatisfactory.

SUBFACTOR 1D QUALITY ASSURANCE PLAN. Describe your company’s laboratory quality assurance plan as required by PWS paragraphs 5.1.22., and how it supports the monitoring and evaluation of the ongoing and overall quality of all of the total testing processes (both internal and external) in support of the Government’s requirements. Provide all of your company’s unsatisfactory/unsuccessful testing performance summary reports of CAP (or equivalent) proficiency testing surveys for the last 24 months for all testing identified within the Contractor’s Price List (Exhibit C) in accordance with PWS paragraph 8.2. Annotate any instances where testing ceased due to repeat unsuccessful PT performance. If applicable provide an example of the investigation and documentation of either an unsuccessful or repeat unsuccessful PT performance.

SUBFACTOR 1E MANAGEMENT CAPABILITY AND EXPERIENCE. Describe your company’s overall management organizational structure, roles and responsibilities that demonstrates the company’s ability to meet the requirements within the solicitation. Provide a list of proposed key corporate and management positions and the qualifications that will be required to occupy those positions in support of PWS paragraphs 1.8. If those positions are currently filled, provide a list of the personnel who currently hold those positions, include their credentials, roles and responsibilities and experience with management and oversight of requisite support services at the appropriate scope and current estimated volumes per month.

(1) Describe in detail your company’s plans, policies and procedures to facilitate utilization management and periodic evaluation/re-evaluation of pricing on current and new tests to be added to the Contractor’s Price List (Exhibit C). Plan shall include proposed frequency of reviews and specific details on how proposed new test pricing will be established (e.g., flat % discount off of an established commercial price list or established based upon actual test utilization at the individual test level) as well as procedures for management of new tests in the interim until formal inclusion in the Contractor’s Price List.

(2) If partnering with another contractor, state the capacity (to include roles and responsibilities) in which this partner will serve in the management and oversight of this contract. Provide an organizational chart that demonstrates any partnering that will affect this requirement and how that partnering will be utilized during the life of the requirement.

VOLUME III – PERFORMANCE RISK PROPOSAL (Past and Present Performance) (Factor 2)

Volume III includes documentation that illustrates the offeror’s performance on current or past USG or commercial contracts. Volume III may include no more than three Performance Assessment Submissions (PASs). Each PAS shall describe work performed under one contract (see contract definition below). Each PAS shall meet the relevancy definition in Addendum to 52.212-2 and performance must have occurred within the last three years of the issuance date on the solicitation. The three PASs may include work performed by the prime offeror and major subcontractor(s) stated in the offeror’s technical proposal to perform on any resultant contract. A complete Volume III shall include all files described below:

TABLE OF CONTENTS. The Table of Contents shall contain details which delineate the subparagraphs and sections within that volume.

SUBCONTRACTOR/TEAMING PARTNER CONSENT LETTERS. Performance Risk information concerning subcontractors and teaming partners cannot be disclosed to a private party without the subcontractor’s or teaming partner’s consent. Because a prime offeror/contractor is a private party, the USG will need that consent before disclosing subcontractor/teaming partner past and present performance information to the prime offeror during discussions or negotiations. In an effort to assist the USG in assessing your performance risk, offerors must have each of their subcontractors and teaming partners complete Attachment 3 entitled “Subcontractor/Teaming Partner Consent letter”. A completed consent form should be submitted as part of your Performance Risk (Past and Present Performance) Volume for each Subcontractor/Teaming Partner identified in your Volume III.

(1) Teaming Arrangements. If a teaming arrangement is contemplated, provide complete information as to the arrangement, including any relevant and recent past performance information on previous teaming arrangements with same partner.