Solicitation W81K00-23-Q-0009 USP Software GLWACH 29 Nov 22.pdf

SEE ADDENDUM

(No Collect Calls)

W81K0023Q0009 29-Nov-2022

b. TELEPHONE NUMBER

254-288-4767

8. OFFER DUE DATE/LOCAL TIME

12:00 AM 19 Dec 2022

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81K009. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

FREDICINDA D. JONES

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0011808529

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0805 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

ACH LEONARD WOOD - PA

ACH LEONARD WOOD - PA

4430 MISSOURI AVE

BLDG 310A

FORT LEONARD WOOD MO 65473-8952

TEL: FAX:

FAX:

TEL: 210-221-1110 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$41,500,000

NAICS:

513210

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF49

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81K0023Q0009

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Months USP 797/800 Software

FFP

USP 797 Pharmaceutical Compounding Sterile Preparations and USP 800 Hazardous Drug Handling in Healthcare Compliance and Training Software FOB: Destination

PURCHASE REQUEST NUMBER: 0011808529

PSC CD: 7A21

NET AMT

0002 1 Job USP 797/800 Software Set up Fee

FFP

USP 797/800 Software Set up Fee- USP 797 Pharmaceutical Compounding Sterile Preparations and USP 800 Hazardous Drug Handling in Healthcare Compliance and Training Software FOB: Destination

1001 12 Months OPTION USP 797/800 Software

FFP

USP 797 Pharmaceutical Compounding Sterile Preparations and USP 800 Hazardous Drug Handling in Healthcare Compliance and Training Software FOB: Destination

2001 12 Months OPTION USP 797/800 Software

FFP

USP 797 Pharmaceutical Compounding Sterile Preparations and USP 800 Hazardous Drug Handling in Healthcare Compliance and Training Software FOB: Destination

3001 12 Months OPTION USP 797/800 Software

FFP

USP 797 Pharmaceutical Compounding Sterile Preparations and USP 800 Hazardous Drug Handling in Healthcare Compliance and Training Software FOB: Destination

4001 12 Months OPTION USP 797/800 Software

FFP

USP 797 Pharmaceutical Compounding Sterile Preparations and USP 800 Hazardous Drug Handling in Healthcare Compliance and Training Software FOB: Destination

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-JAN-2023 TO

31-DEC-2023

N/A ACH LEONARD WOOD - PA

ACH LEONARD WOOD - PA

4430 MISSOURI AVE

BLDG 310A

FORT LEONARD WOOD MO 65473-8952

FOB: Destination

HT0805

0002 POP 01-JAN-2023 TO

31-DEC-2023

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 01-JAN-2024 TO

31-DEC-2024

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-JAN-2025 TO

31-DEC-2025

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-JAN-2026 TO

31-DEC-2026

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-JAN-2027 TO

31-DEC-2027

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

NOV 2021

ADDENDUM TO FAR 52.212-4

(v) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

52.204-7 System for Award Management OCT 2018 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-17 Ownership or Control of Offeror AUG 2020 52.204-23 Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities

NOV 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.212-1 Instructions to Offerors--Commercial Products and Commercial Services

NOV 2021

52.212-1 ADDENDUM

Offer shall clearly identify each part of their quote, as described below.

Administrative: All offerors shall provide the following:

a. Completed SF 1449: Blocks 12, 17 (to include CAGE code), 30A – C.

b. Completed SF 30: Blocks 8, 15A - C (for all amendments issued, if any).

c. Provide Point of Contact Information for your company (Name, Telephone Number, Fax Number, and Email).

d. Provide Statement that the offeror will hold its quote firm for at least 60 calendar days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions (if applicable).

e. Completed provisions, as listed in the solicitation. Alternately, complete all provisions in SAM and provide confirmation of completion and accuracy with offer.

f. The offeror shall submit a completed copy of FAR 52.212-3, Representations and Certifications -Commercial Items. If the offeror has completed the Online Representations and Certifications Application (ORCA) at https://www.sam.gov the offeror shall indicate such on the FAR clause. DFARS 252.212- 7000, Offeror Representations and Certifications – Commercial Items. All offerors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make an offer ineligible for award.

g. Offers are due by the date and time identified on Page 1 Block 8 of the SF1449. Offers shall be submitted via e-mail to fredicinda.d.jones.civ@health.mil. Quotes received after the deadline will be considered untimely and will not be eligible for award. When submitting your offer via email please annotate the subject line as “Quote for W81K00-23-Q-0009”.

Technical: All offerors shall provide the following:

a. The technical quote shall be addressed in sufficient written detail for the Government to determine if the offeror’s product(s) adequately perform the specific salient characteristics as stated in 52.212-2. Offeror will be found technically acceptable if: They are able to provide all ofthe requested items and meet all of the Government specifications for the items as listed in the requirement. Offeror must submit any supporting documents showing the capability to provide the products listed in this synopsis/solicitation. These parts of the technical proposal shall be addressed in sufficient written detail for the Government to determine if the offeror possesses sufficient technical capability to provide the requested equipment in this solicitation.

b. Offeror must meet all of the salient physical, functional, or performance characteristics specified in this solicitation and clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

*Quote shall not exceed 20 pages*

c. Offeror must be able to ensure delivery and or service to General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood , MO, 65473.

Pricing: All offerors shall provide the following:

a. Pricing for Requirements. The offeror shall submit proposed pricing for all Contract Line Item umbers (CLINs) and subContract Line Item Numbers (subCLINs) (if applicable) identified in the Request for Quote, unless otherwise noted. Include the unit price and the total extended price for each CLIN.

Submitting Quote:

a. Contractors shall complete and return all information requested in Addendum to 52.212-1 listed above no later than the date and time stated in block 8 of the SF1449 to fredicinda.d.jones.civ@health.mil. Electronic (e-mail) is the only method of submission for quotes.

b. 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.

c. Contact POCs: The Contracting Officer and Contract Specialist are sole points of contact for this solicitation.

d. Questions regarding this solicitation are to be submitted electronically to the Contract Specialist by 5 December 2022 at 10:00 a.m. CST to fredicinda.d.jones.civ@health.mil; answers to all questions will be provided no later than 8 December 2022 3:00 PM CST.

Salient characteristics

All offerors shall provide a USP 797 and USP 800 Software that meets the below characteristics.

a. sterile compounding quality management system and staff education program in one software program

b. able to monitor record, and store information required by United States Pharmacopea Chapters 797 and Chapter 800 (USP 797/800) and the Joint Commission in regards to compounding sterile preparation medications

c. provides ongoing compliance of training, procedures and documentation essential to patent safety and risk mitigation

d. must be a web-based quality management system that delivers content, ongoing education and electronically logs staff’s activities and digitally documents them for reporting and operational trending

e. equips pharmacies with all of the tools and resources needed to comply with the complexities of USP 797/800

f. comprehensive quality management solution for enacting proper policies and procedures, elevating staff competencies, streamlining cleanroom operations and most importantly, protecting patients and staff from the risks of sterile and hazardous drug compounding

g. software will assist in recording and documenting training, developing and maintaining SOPs

h. provides a compounding tracker/mechanism that assists in documenting compliance necessary in the manufacture of sterile intravenous medications

i. provides environmental sampling and compounding logs

j. software updates with each new revision of USP 797/800 release

END OF ADDENDUM TO 52.212-1

52.222-3 Convict Labor JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies JAN 2022 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-50 Combating Trafficking in Persons NOV 2021 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

JUN 2020

52.225-13 Restrictions on Certain Foreign Purchases FEB 2021 52.225-25 Prohibition on Contracting with Entities Engaging in Certain

Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.232-18 Availability Of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

NOV 2021

52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7016 Covered Defense Telecommunications Equipment or Services

-- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services -- Representation

MAY 2021

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2021

252.225-7001 Buy American And Balance Of Payments Program-- Basic JUN 2022 252.225-7036 Buy American--Free Trade Agreements--Balance of

Payments Program--Basic

JUN 2022

252.225-7048 Export-Controlled Items JUN 2013 252.232-7010 Levies on Contract Payments DEC 2006

252.232-7017 Accelerating Payments to Small Business Subcontractors-- Prohibition on Fees and Consideration

APR 2020

252.243-7001 Pricing Of Contract Modifications DEC 1991

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of 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 paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) 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. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

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

(2) Section 889(a)(1)(B) 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, 2020, from entering into a contract or extending or renewing a contract with an entity that uses 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. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot 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) Representations. The Offeror represents that--

(1) 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. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

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

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) 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);

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

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

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

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

2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” and "reasonable inquiry" have 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) Representations.

(1) 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.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS--

REPRESENTATION (NOV 2015)

(a) Definitions. Inverted domestic corporation and subsidiary have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10).

(b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.

(c) Representation. The Offeror represents that--

(1) It [ ___ ] is, [ ___ ] is not an inverted domestic corporation; and

(2) It [ ___ ] is, [ ___ ] is not a subsidiary of an inverted domestic corporation.

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (NOV 2015)

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

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Subsidiary means an entity in which more than 50 percent of the entity is owned--

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

(b) If the contractor reorganizes as an inverted domestic corporation or becomes a subsidiary of an inverted domestic corporation at any time during the period of performance of this contract, the Government may be prohibited from paying for Contractor activities performed after the date when it becomes an inverted domestic corporation or subsidiary. The Government may seek any available remedies in the event the Contractor fails to perform in accordance with the terms and conditions of the contract as a result of Government action under this clause.

(c) Exceptions to this prohibition are located at 9.108-2.

(d) In the event the Contractor becomes either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation during contract performance, the Contractor shall give written notice to the Contracting Officer within five business days from the date of the inversion event.

(End of clause)

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A

FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that--

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See 52.212-2 Addendum.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(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.

52.212-2 ADDENDUM

The Government will award a Purchase Order resulting from this solicitation, to the responsible Request For Quote (RFQ) conforming to the solicitation, that is Best Value. Award will be on an all or none basis. 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.

EVALUATION PROCESS:

The following evaluation factors shall be used to evaluate offers:

Technical:

a. Offeror must meet all the salient physical, functional, or performances characteristic specified in this solicitation and clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

The factors of the technical proposal shall be addressed in sufficient written detail for the government to determine if the offeror possesses sufficient technical capability to adequately provide the requested supplies. This factor will be rated as either “acceptable” or “unacceptable”.

b. Offeror must be able to ensure delivery and or service to General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood, MO, 65473.

c. Salient characteristics

All offerors shall provide a USP 797 and USP 800 Software that meets the below characteristics.

1. sterile compounding quality management system and staff education program in one software program

2. able to monitor record, and store information required by United States Pharmacopea Chapters 797 and Chapter 800 (USP 797/800) and the Joint Commission in regards to compounding sterile preparation medications

3. provides ongoing compliance of training, procedures and documentation essential to patent safety and risk mitigation

4. must be a web-based quality management system that delivers content, ongoing education and electronically logs staff’s activities and digitally documents them for reporting and operational trending

5. equips pharmacies with all of the tools and resources needed to comply with the complexities of USP 797/800

6. comprehensive quality management solution for enacting proper policies and procedures, elevating staff competencies, streamlining cleanroom operations and most importantly, protecting patients and staff from the risks of sterile and hazardous drug compounding

7. software will assist in recording and documenting training, developing and maintaining SOPs

8. provides a compounding tracker/mechanism that assists in documenting compliance necessary in the manufacture of sterile intravenous medications

9. provides environmental sampling and compounding logs

10. software updates with each new revision of USP 797/800 release

Price:

a. Price will be evaluated using various price analysis techniques and procedures IAW FAR 13.5(a) including, but not limited to, comparison of proposed prices received in response to the solicitation. Evaluation of price will include a determination that the price is fair and reasonable.

The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. In addition, given that FAR Clause 52.217-9, Option to Extend the Term of the Contract, provides that the Government may require continued performance of any supplies within the limits and at the rates specified in the contract (i.e., the rates in effect when the Option to Extend the Term of the Contract clause is exercised), for purposes of evaluating this option, the contracting officer will consider the prices submitted for each CLIN, since those would be the binding prices should this option be exercised. Evaluation of this option shall not obligate the Government to exercise the option.

END OF ADDENDUM TO 52.212-2

CLAUSES INCORPORATED BY FULL TEXT

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (OCT 2022)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(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.

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Reasonable inquiry” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate--

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”--

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically--

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”--

(1) Means a small business concern--

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

"Small business concern"--

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13 CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned--

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Successor” means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term

“successor” does not include new offices/divisions of the same company or a company that only changes its name.

The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

“Veteran-owned small business concern” means a small business concern--

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

"Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern--

(1) That is at least 51 percent owned by one or more women or, in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; or

(2) Whose management and daily business operations are controlled by one or more women.

"Women-owned small business (WOSB) concern eligible under the WOSB Program" (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300.

(b) (1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM.

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications--Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ___

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that--

(i) It [ ___ ] is, [ ___ ] is not a small business concern; or

(ii) It [ ___ ] is, [ ___ ] is not a small business joint venture that complies with the requirements of 13 CFR 121.103(h) and 13 CFR 125.8(a) and (b). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ___ ]

Small business concern. The offeror represents as part of its offer that it [ ___ ] is, [ ___ ] is not a small business concern.

(2) Veteran-owned small business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents as part of its offer that it [ ___ ] is, [ ___ ] is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that--

(i) It [ ___ ] is, [ ___ ] is not a service-disabled veteran-owned small business concern; or

(ii) It [ ___ ] is, [ ___ ] is not a joint venture that complies with the requirements of 13 CFR 125.18(b)(1) and (2).

[The offeror shall enter the name and unique entity identifier of each party to the joint venture: ___ .] Each service-disabled veteran-owned small business concern participating in the joint venture shall provide representation of its service-disabled veteran-owned small business concern status.

(4) Small disadvantaged business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents that it [ ___ ] is, [ ___ ] is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents that it [ ___ ] is, [ ___ ] is not a women-owned small business concern.

(6) WOSB joint venture eligible under the WOSB Program. The offeror represents that it [ ___ ] is, [ ___ ] is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ___ .

(7) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The offeror represents that it [ ___ ] is, [ ___ ] is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c).

[The offeror shall enter the name and unique entity identifier of each party to the joint venture: ___ .]

(8) Women-owned business concern (other than small business concern). (Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents that it ( ___ ) is, a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that--

(i) It [ ___ ] is, [ ___ ] is not a HUBZone small business concern listed, on the date of this representation, as having been certified by SBA as a HUBZone small business concern in the Dynamic Small Business Search and SAM, and will attempt to maintain an employment rate of HUBZone residents of 35 percent of its employees during performance of a HUBZone contract (see 13 CFR 126.200(e)(1));

and

(ii) It [ ___ ] is, [ ___ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ___ .] Each HUBZone small business concern participating in the HUBZone joint venture shall provide representation of its HUBZone status.

(d) Certifications and representations required to implement provisions of Executive Order 11246--

(1) Previous Contracts and Compliance. The offeror represents that--

(i) It ( ___ ) has, ( ___ ) has not, participated in a previous contract or subcontract subject either to the Equal Opportunity clause of this solicitation, and

(ii) It ( ___ ) has, ( ___ ) has not, filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that--

(i) It ( ___ ) has developed and has on file, ( ___ ) has not developed and does not have on file, at each establishment, affirmative action programs required by rules and…