B.09_Amendment 001.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: ROLAND JASSO

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011452582

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

1. This amendment is issued to incorporate the follow ing clauses and provision into this solicitation:

FAR 52.204-24, FAR 52.204-25, and FAR 52.204-26.

2. Please complete the fill-in for FAR 52.204-26 of the attached and return now or please address this clause (FAR 52.204-26) in your Reps and Certs (FAR 52.212-3)."

If this clause "does" apply to your firm then you shall also complete FAR 52.204-25 and include w ith your quote or proposal.

3. All else remains unchanged and the closing date has been extended to 12:00PM CST-19 August 2020.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 9

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

16C. DATE SIGNED

BY 11-Aug-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 W81K0020Q0173

X 9B. DATED (SEE ITEM 11)

31-Jul-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

11-Aug-2020

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0020Q0173

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

The Offeror shall not complete the representation in this provision if the Offeror has represented that it “does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument” in the provision at 52.204-26, Covered Telecommunications Equipment or Services--Representation, or in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications--Commercial Items.

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

Covered telecommunications equipment or services, critical technology, and substantial or essential component have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Contractors are not prohibited from providing--

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services”.

(d) Representation. The Offeror represents that it [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation.

(e) Disclosures. If the Offeror has represented in paragraph (d) of this provision that it “will'' provide covered telecommunications equipment or services”, the Offeror shall provide the following information as part of the offer-

(1) A description of all covered telecommunications equipment and services offered (include brand; model number, such as original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);

(2) Explanation of the proposed use of covered telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b) of this provision;

(3) For services, the entity providing the covered telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known); and

(4) For equipment, the entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(End of provision)

52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

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

Covered foreign country means The People's Republic of China.

Covered telecommunications equipment or services means--

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means--

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled--

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. The Contractor is prohibited from providing to the Government any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in Federal Acquisition Regulation 4.2104.

(c) Exceptions. This clause does not prohibit contractors from providing--

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(d) Reporting requirement.

(1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at https://dibnet.dod.mil.

(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause:

(i) Within one business day from the date of such identification or notification: The contract number; the order number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.

(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: Any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.

(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.

(End of clause)

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (DEC

2019)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services”.

(c) Representation. The Offeror represents that it [ ___ ] does, [ ___ ] does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(End of provision)

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

52.212-2 ADDENDUM

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

(a) Evaluation Process.

The Government anticipates awarding multiple blanket purchasing agreements to responsible vendor(s) whose offer meets or exceeds the minimum technical requirements of the solicitation and provides fair and reasonable pricing. Awards will be made based on the Radiopharmaceuticals supply categories listed in sub-factors and in attachement 1. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Note Section C of 52.204-26 must be returned or verify 52.204-26 has been completed with online Reps and Certs to be eligible for award.

Factor 1 - Technical Capability - Technical capability ratings reflect the Government’s confidence in the offeror’s ability, as demonstrated in its written technical quote, to meet the requirements stated in the solicitation. The Government will make an independent judgment of each sub-factor and of the technical acceptability on offered products. Each sub factor, and the overall factor, will be evaluated using Table 1 below:

Sub-factor 1A – Specific Requirements – Offeror must meet, or exceed, each listed Salient Characteristics

Acceptability will be determined by whether or not the offeror has provided an adequate response or explanation for each requirement listed.

Sub-factor 1B – The vendor shall deliver Isotopes between 6:00 a.m. and 5:00 p.m., CST, Monday thru Friday for the life of this BPA until otherwise specified.

Sub-factor 1C – Isotopes must be produced locally due to shelf-life not exceeding 24 hours. If the local area is malfunctioning, FDG-18 from outside the local area shall be available for use.

Sub-factor 1D – . Reagents / Radiopharmaceuticals must be approved be approved by the FDA.

Sub-factor: 1E - Reagents / Radiopharmaceuticals must be compatible with exisiting Mo99/Tc99m Generator within the hospital.

Sub-factor: 1F - The vendor shall deliver TWO (2) Indium 111 Oxyquiline 1mCi / Vial every Monday for the life of this BPA until otherwise specified.

Technical Evaluation Criteria:

Offerors must be deemed acceptable in each sub-factor in order to receive an acceptable rating for “Factor 1, Technical Capability”. Each sub-factor will be assigned an adjectival rating. An unacceptable rating in any technical sub-factor will render the offeror’s entire “Technical Capability” unacceptable and therefore ineligible for award. If found Technically Unacceptable, the Government will not evaluate Price.

The following adjectival ratings will be used in evaluating the offeror’s written technical capability:

Table

Table A-1. Technical Acceptable/Unacceptable Ratings Rating Description Acceptable Quote/Offer clearly meets the minimum requirements of the Salient Characteristics and RFQ.

Unacceptable Qoute/Offer does not clearly meet the minimum requirements of the Salient

Characteristics RFQ.

Factor 2 – Price.

(a) Price will be evaluated using various price analysis techniques and procedures in accordance with Federal Acquisition Regulation (FAR) 15.404-1(b) including, but not limited to, comparison with competitive published price lists, published market prices, Independent Government Cost Estimate (IGCE), and /or prices obtained through market research for the same or similar type services. Price must be determined to be fair and reasonable.

Comparing the items listed in the Cross Reference Product Matrix;

(b) Options. None.

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

ADDENDUM 52.212-1

(m) Offeror shall adhere to and submit the following:

Vendors shall submit their offers in three separate volumes. Volume I shall consist of the TECHNICAL CAPABILITY submittal. Volume II shall consist of the PRODUCT AND PRICING data. Volume III shall consist of the ADMINISTRATIVE submission. There shall be no pricing data included in Volume I or III. The response for Volume I shall not exceed 20 pages. Proposals shall be submitted on standard 8 ½” by 11” paper, using no smaller than 10pt. font, front-side only. Each volume shall also have a title page identifying the offeror, the full physical address, e-mail address, phone and facsimile numbers, points of contact (POCs) of the offeror, the solicitation number, and the proposal’s contents. A statement that the offer is firm for at least 120 days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions (if applicable) shall be included. Offerors shall mark and prepare each volume submitted in accordance with these instructions.

Note Section C of 52.204-26 must be returned or verify 52.204-26 has been completed with online Reps and Certs to be eligible for award.

The following Factor(s) and Sub-factor(s) will be used for evaluation purposes:

Volume I – TECHNICAL CAPABILITY

Factor 1 - Technical Capability - The technical offer shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical aspects of the Government’s requirement.

Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications or parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. Insufficient explanations may result in your offer receiving an UNACCEPTABLE rating.

Sub-factor 1A – Specific Requirements – Offerors shall provide a detailed explanation as to how their products meet each listed, “SALIENT CHARACTERISTICS” below brochures and/or product information containing illustrations of proposed products, not exceeding 100 pages, may be included as supplemental information to their technical proposal submission.

Sub-factor 1B – The vendor shall deliver Isotopes between 6:00 a.m. and 5:00 p.m., CST, Monday thru Friday for the life of this BPA until otherwise specified.

Sub-factor 1C – Isotopes must be produced locally due to shelf-life not exceeding 24 hours. If the local area is malfunctioning, FDG-18 from outside the local area shall be available for use.

Sub-factor 1D –Reagents / Radiopharmaceuticals must be approved be approved by the FDA.

Sub-factor: 1E- Reagents / Radiopharmaceuticals must be compatible with exisiting Mo99/Tc99m Generator within the hospital.

Sub-factor: 1F - The vendor shall deliver TWO (2) Indium 111 Oxyquiline 1mCi / Vial every Monday for the life of this BPA until otherwise specified.

SALIENTS CHARACTERISTERICS FOR RADIOPHARMACEUTICALS

The vendor shall deliver Isotopes between 6:00 a.m. and 5:00 p.m., CST, Monday thru Friday for the duration of any resultant contract until otherwise specified.

The vendor shall have after hour and STAT delivery as needed for expedited delivery of radiopharmaceuticals and on-call request.

Isotopes must be produced locally due to shelf-life not exceeding 24 hours. If the local area is malfunctioning, FDG-18 from outside the local area shall be available for use.

Reagents / Radiopharmaceuticals must be approved be approved by the FDA.

Reagents / Radiopharmaceuticals must be compatible with existing Mo99/Tc99m Generator within the hospital.

SALIENTS CHARACTERISTERICS FOR Indium-111 oxyquinoline:

Indium in 111 oxyquinoline (oxine) must be a diagnostic radiopharmaceutical intended for radiolabeling autologous leukocytes.

It must be supplied as a sterile, non-pyrogenic, isotonic aqueous solution with a pH range of 6.5 to 7.5.

Each ml of the solution must contain 37 MBq, 1 mCi of indium in 111 no carrier added,>1.85 GBq/mg indium (>50 mCi/mg indium) at calibration time, 50 mg oxyquinoline, 100 mg polysorbate 80,and a 6 mg of HEPES (N-2-hydroxyethyl-piperazine-N¢-2-ethane sulfonic acid) buffer in 0.75% sodium chloride solution.

The drug must be intended for single use only and contains no bacteriostatic agent.

The radionuclidic impurity limit for indium 114m must be not greater than 37kBq, 1 mCi of indium 114m per 37 MBq, 1 mCi of indium In 111 at the time of calibration.

The radionuclidic composition at expiration time must not be less than 99.75% of indium In 111 and not more than 0.25% of indium In 114m/114.

Chemical name must equal Indium In 111 oxyquinoline (oxine).

Volume II – PRODUCT AND PRICE LIST

Factor 2 – Each offeror shall review Attachment 1 and provide pricing on all items capable of delivery and which meet the required salient(s) if applicable. Offerors shall submit a price list for all offered products and supplies using Attachment I, or similar format, to include any discounts offered to the Government. Offerors that do not provide Government discounts shall provide an explanation as to why they are not providing a discount. Offeror’s shall certify that their price list establishes prices equal to or lower than pricing found on their current Federal Supply Schedule (GSA/VA) contract. Should an offeror not hold such contract, a certification shall be included that they are offering to the Government prices equal to or lower than those offered to their most favorable customers.

Volume III – ADMINISTRATIVE

Offerors shall submit the following in response to the solicitation:

1. Completed SF1449, and acknowledged solicitation amendments, if issued;

2. Cover page including company name, CAGE code, DUNS number, and the solicitation responses’ point of contact information;

3. Completed provisions listed herein to include FAR 52.212-3 Alt I, Offeror Representations and Certification – Commercial Items (OCT 2018) and FAR 52.209-7, Information Regarding Responsibility Matters (OCT 2018).

4. Affirmation the offeror’s System for Award Management (SAM) registration is current, complete and accurate on the date offers are due. Registration in SAM can meet the requirement for FAR 52.212-3 Alt I submission should the Representations and Certifications be available in SAM and are current. The SAM website is http://www.sam.gov. The offeror shall not have any Active Exclusion Record in SAM which may make them ineligible for consideration for being awarded a contract or issued an agreement.

5. Volume I Technical Capability, Volume II Product and Price List, Volume III, Administrative;

86. Offers shall be submitted via electronic mail to roland.jasso.civ@mail.mil. Due by 14 August 2020, 12:00PM

CST.

(n) Protests received at a level higher than the Contracting Officer will be referred to the Contracting Officer.

Protestor may request a review by the Contracting Officer or an independent review at a level higher that the Contracting Officer. Requests for appeals or independent review will be addressed to the Contracting Officer for referral to the review authority. Questions on this process will be referred to the cognizant Contracting Officer identified in the solicitation.

(o) The non-FAR Part 12 discretionary FAR and DFARS 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.

(end of addendum)

(End of Summary of Changes)