S02. 36C25625Q0103.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Simplifi 797 and Simplifi+ MedStorage or Equal G.V. (Sonny) Montgomery VA Medical Center

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25625Q0103

RESPONSE DATE/TIME/ZONE 11-05-2024 5:00 PM CENTRAL TIME, CHICAGO,

USA

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N/A

SET-ASIDE N/A

PRODUCT SERVICE CODE* DA10

NAICS CODE* 513210

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston, TX 77056-5643

POINT OF CONTACT*

Contract Specialist Caleb Parker caleb.parker@va.gov

PLACE OF PERFORMANCE

ADDRESS G.V. (Sonny) Montgomery VA Medical Center

1500 E Woodrow Wilson Avenue Jackson, MS 39216-5116 mailto:caleb.parker@va.gov

DESCRIPTION

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-07, dated 09/30/2024.

This acquisition is 100% Unrestricted.

The associated North American Industrial Classification System (NAICS) code for this procurement is 513210, with a small business size standard of $47.0 million. The Product/Service Code is DA10.

The Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) located at the Galleria Financial Center, 5075 Westheimer Road, Suite 750, Houston, TX 77056 is seeking to procure Simplifi 797 and Simplifi+ MedStorage or Equal in accordance with the Statement of Work (SOW).

The Pharmacy software solution listed below has been identified as meeting the minimum needs of the Government. All interested vendors shall provide Brand Name or Equal quotations for the following schedule:

Base Period: December 1, 2024 through November 30, 2025

Line Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Simplifi 797 and Simplifi+ MedStorage or Equal

1 YR

Base Period Total:

Option Period 1: December 1, 2025 through November 30, 2026

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Simplifi 797 and Simplifi+ MedStorage or Equal

Option Period 1 Total:

Option Period 2: December 1, 2026 through November 30, 2027

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Simplifi 797 and Simplifi+ MedStorage or Equal

Option Period 2 Total:

Option Period 3: December 1, 2027 through November 30, 2028

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Simplifi 797 and Simplifi+ MedStorage or Equal

Option Period 3 Total:

Option Period 4: December 1, 2028 through November 30, 2029

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Simplifi 797 and Simplifi+ MedStorage or Equal

Option Period 4 Total:

Grand Total (Including Option Periods): $

This acquisition is allowing vendors to submit quotes for alternate items, provided those items meet all of the salient physical, functional, or performance characteristics specified by this combined synopsis-solicitation. For 'equal' items, the vendor shall enter exactly what they are quoting (including make, model and description) for the quote to be considered. The VA will evaluate 'equal' items on the basis of information furnished by the vendor or identified in the quote. The VA is not responsible for locating or obtaining any information not identified in the quote.

Brand Name or Equal - Salient Characteristics:

The following are the salient characteristics that will be used to determine if other than the brand name is equal to the item that meets Government requirements:

USP 797/800/795 Compliance

1) Turnkey pharmacy compliance software that automates operations required with USP chapters 795, 797, and 800.

2) Web-based quality management solution for safe and efficient sterile compounding environment

3) ACPE approved training and competency assessments

4) Master formulation records

5) Customizable standard operating procedures

6) Electronic documentation of compliance metrics for all phases of USP compliance

7) Automated alerts of deviation of missed deadlines

Medication Storage

1) Customizable, mobile and scalable unit inspection management system

2) Data analytics to monitor and act on trends.

3) Ability to create online checklists to manage inventory and document procedures for the storage of medications.

4) Mobile‐responsive platform can be accessed on phones or tablet.

5) Is turnkey and customizable.

6) Web‐based solution that does not require maintenance or support from IT team.

The salient characteristics identified above are intended to be descriptive, not restrictive. It is the responsibility of the interested source to demonstrate to the Government that the interested parties can provide the Pharmacy software solution that fulfills the required specifications.

Invoicing:

In accordance with FAR Clause 52.212-4 (g)(2) Invoices will be handled in accordance with the

Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315. All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

FSC e-Invoice Payment at http://www.fsc.va.gov/fsc/einvoice.asp

Invoice Setup Information 1-877-489-6135 or va.registration@tungsten-network.com

The following solicitation provisions apply to this acquisition:

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

http://www.fsc.va.gov/fsc/einvoice.asp mailto:va.registration@tungsten-network.com

The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these addresses:

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT Oct 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING Aug 2020

52.211-6 BRAND NAME OR EQUAL Aug 1999

52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

Sep 2023

52.212-2 EVALUATION – COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

Nov 2021

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR

52.212-3, “Offerors Representations and Certifications–Commercial

Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

May 2024

Addendum to 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

The following provisions are incorporated into 52.212-1 as an addendum to this combined synopsis/solicitation:

Instructions for the Preparation of Quotes:

Offeror shall provide the following documentation for the quote to be considered:

1. A completed Price/Cost Schedule (to include pricing for all line items), located on pages 2-3 of this document. Insert legible proposed unit and total all-inclusive pricing using the table for each contract line item. No other format for the submission of the Price/Cost Schedule shall be accepted.

2. A completed Contractor Contract Administration Data Form, located on page 14 of this document.

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/ https://www.sam.gov/portal

3. The offeror shall provide an authorized distributor letter from Original Equipment Manufacturer (OME) which shows evidence of being an authorized OEM distributor or reseller for the quoted software subscription.

4. A completed Attachment D.2 Past Performance References Form.

5. For the purpose of evaluation of technical acceptability, the Contractor shall provide all of the salient physical, functional, or performance characteristics of the offered product(s), manufacturer sales literature or other product literature which clearly documents that the offered product(s) meet or exceed all of the requirements. The contractor may include any other information that is deemed necessary.

(End of Addendum to 52.212-1)

Addendum to 52.212-2 EVALUATION – COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

In accordance with FAR 13.106-2(b)(3), the Government will evaluate quotes based on the comparative evaluation process, by comparing one quote with another in a uniform and fair manner to determine which quote provides the best value to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation.

Salient Characteristics are located on page 4 of this document. Vendors offering items considered equal, shall include descriptive detail and product literature that fully demonstrates product equality. The Government will evaluate only that information that is provided with the quotes; any vendor that fails to provide sufficient technical detail regarding products considered equal runs the risk of having the quote rejected. See FAR 52.211-6 Brand Name or Equal for further details.

The following factors shall be used to evaluate offers: Technical, Past Performance, and Price.

The Government will award a single Firm-Fixed Price contract to the responsible vendor whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Quotes will be evaluated to determine compliance with the requirements of this combined synopsis/solicitation as follows:

1. Factor 1 – Technical

The quotation will be evaluated to the extent to which it can meet and/or exceed the

Government’s requirements as outlined in the brand name or equal combined synopsis/solicitation and based on the information requested in the instructions to quoters section of the solicitation to be eligible for award.

2. Factor 2 – Past Performance

Past performance information is one indicator on the ability to perform the contract successfully. The Government shall assess how well the offeror provided service to other customers in the past.

Generally, the Government shall rely upon the information provided by the offeror. The

Government shall consider this information as well as information obtained from any other sources, when evaluating the offeror’s past performance. Past performance will be rated as acceptable, unacceptable or neutral.

Determination Definition

Acceptable The offeror meets or exceeds the (acceptability) standard.

Unacceptable The offeror fails to meet the (acceptability) standard.

Neutral The offeror had no past performance.

a. The Offeror shall provide a minimum of three (3) past performance references of current contracts or contracts within the past five years of similar size, scope and/or complexity. Reference may include Federal, State, and local Government as well as private customers and shall include the following information:

i. Name and Address of the Contracting Activity (Medical Center, Company, etc).

ii. Name and Telephone Number of Point of Contact (Contracting Officer, Contracting Officer Representative, or Manager) who would have first-hand knowledge on contract performance and/or satisfaction.

iii. Contract Number and Dates of Contract Performance.

iv. List of Subcontracts (if applicable).

b. Offerors shall submit past performance references using attachment D.2. The

Government may use other sources including but not limited to Contractor

Performance Assessment Reporting System (CPARS) and System for Award

Management (SAM.gov) Responsibility/Qualification Records (formerly FAPIIS) for relevant past performance information. Offerors with no relevant performance history will receive a neutral rating.

3. Factor 3 – Price

Offerors' price quotes will be evaluated to determine the price is fair and reasonable in accordance with FAR 13.106-3 (a). In addition, the offeror’s price will be compared against competing quotes and the Independent Government Cost Estimate. Quotations should include a proposed unit price for each line item, as well as the extended amount

(unit price multiplied by quantity).

Offerors that are determined unacceptable based on Past Performance or Technical

Capability cannot be selected regardless of price. For offers that are considered essentially the same in Past Performance and Technical Capability, Price will be the determining factor to determine the offer that is most advantageous to the Government.

4. The Government intends to make its award decision with initial quote submitted by the contractor. However, the Government reserves the right to conduct communications with contractors if it is in its best interest of the Government to do so. Therefore, each offeror is encouraged to provide the Government with all of the information necessary to evaluate its initial quote under the evaluation factors stated above.

Offerors that fail to submit all the information necessary to evaluate their quote with their initial quote submission or do not conform with the solicitation requirements bears the risk that their quote may not be eligible for award.

5. For the purposes of the award of this contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time, and can be exercised in increments of one to six months, but for no more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under

FAR 52.217-8 will be at the same rates as those in effect under the contract at the time the option is exercised. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all quotes relative to each other, and will not affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the

Government to exercise any option under FAR 52.217-8.

6. The award will be made to the response most advantageous to the Government.

Responses should contain your best terms and conditions. Quotes shall be received on or before the date and time specified on page 1 of this document. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Contractor's quote submissions that do not comply/conform with the solicitation requirements and or determined not capable to meet the SOW requirements all factors considered may not be eligible for award.

(End of Addendum to 52.212-2)

The following contract clauses apply to this acquisition:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/ https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE Oct 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

Aug 2020

52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Nov 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS-

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

May 2024

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

Note: The specified rates under this clause will be those rates in effect under the contract each time an option is exercised under this clause.

(End of Clause)

FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the appointment letter shall be furnished to the Contractor.

(End of Clause)

VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor's products or services or considers the Contractor's products or services superior to other products or services.

(End of Clause)

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer

(ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

VAAR 852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (interim - OCT 2008)

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(End of Clause)

(End of Addendum to 52.212-4)

The following subparagraphs of FAR 52.212-5 are applicable:

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS Nov 2023

52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION Jun 2023

52.209-6 PROTECTING THE GOVERNMENT’S INTEREST WHEN

SUBCONTRACTING WITH CONTRACTORS DEBARRED,

SUSPENDED, OR PROPOSED FOR DEBARMENT

Nov 2021

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION Feb 2024

52.222-3 CONVICT LABOR Jun 2003

52.222-21 PROHIBITION OF SEGREGATED FACILITIES Apr 2015

52.222-26 EQUAL OPPORTUNITY Sep 2016

52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES Jun 2020

52.222-50 COMBATING TRAFFICKING IN PERSONS Nov 2021

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT

MESSAGING WHILE DRIVING

May 2024

52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—SYSTEM FOR

AWARD MANAGEMENT

Oct 2018

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Quote Content and Format: Offerors should review the combined synopsis/solicitation in its entirety. Offerors are responsible for ensuring that their quote fully complies with submission requirements outlined in the combined synopsis/solicitation. Failure to explain the offerors’ ability to meet all requirements will result in the proposing contractor to be removed from consideration for award. Clarity and completeness of quotes are of the utmost importance.

Therefore, quotes must be written in a practical, clear, and concise manner.

System for Award Management (SAM): Offerors are required to be registered in SAM at the time an offer or quotation is submitted per FAR Subpart 4.1102 (a). Keep in mind that the SAM registration process can take time to complete. Offerors are encouraged to go to the SAM database at www.sam.gov and start the registration process as soon as possible. If you are already registered in SAM, remember that your SAM registration must be renewed at least annually – and renewed whenever any part of your registration needs to be updated.

Technical Questions: All questions must be received in writing on or before October 31, 2024 at

2:00 PM CST. No phone inquiries will be accepted. All questions, comments, and requests for information regarding this acquisition shall be sent by email, cite the solicitation number in the subject line. The Government reserves the discretion not to respond to any inquiries submitted after October 31, 2024 at 2:00 PM CST. All inquiries regarding this combined synopsis-solicitation must be sent to the Contract Specialist email at caleb.parker@va.gov. All responses to questions will be incorporated into a written amendment.

Submission of Quotes: All quotes shall be sent electronically via email to Caleb Parker at caleb.parker@va.gov. Quotations shall be received no later than 5:00 PM CST, Tuesday, November 05, 2024.

All documents must be submitted and in the Government’s control by the date and time specified on page 1 of this document. It is offeror’s responsibility to ensure all documents are in the Government’s control by the set forth due date and time. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

(THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK)

CONTRACT ADMINISTRATION DATA

Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

Phone: ______________________

Email: _______________________

SAM UEI Number: ________________

TAX ID: ______________________

b. GOVERNMENT:

Marcos Madrazo-Jones, Contracting Officer Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston TX 77056-5643 Email: marcos.madrazo-jones@va.gov

Caleb Parker, Contract Specialist Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston TX 77056-5643 Email: caleb.parker@va.gov mailto:marcos.madrazo-jones@va.gov

Statement of Work (SOW)

1. General: The G.V. (Sonny) Montgomery VA Medical Center (GVSMVAMC) Pharmacy is seeking to procure a subscription for Simplifi 797 w/CriticalPoint, USP 800, USP 795, Compounding Module and Simplifi+MedStorage or Equal.

2. Background: The GVSMVAMC Pharmacy Department must comply with the U.S.

Pharmacopeial Convention (USP) 797 Pharmaceutical Compounding-Sterile Preparations standards. USP 797 is an enforceable federal guideline which provides comprehensive quality standards for the procedures used in sterile compounding areas. USP compounding standards help compounding practitioners adhere to widely acknowledged, scientifically sound procedures and practices, and facilitate the delivery of consistent and good-quality prepared medicines to patients. The failure to adhere to USP 797 standards increases preventable incidents that result in infections or death. The GVSMVAMC Pharmacy Department intends to utilize Simplifi 797 or Equal - a web-based quality management system, to ensure our sterile compounding programs are up to USP 797 standards. The system will assist with policies/procedures, training/competencies, environmental testing, documentation, etc. In addition, the GVSMVAMC Pharmacy Department must comply with medication storage requirements established by VHA and Joint Commission. The GVSMVAMC plans to use Simplifi+Medstorage or Equal to help ensure that clinic staff are following standardized protocols essential to storing and maintaining medications.

3. Objective: The goal of the contract is to acquire and implement Simplifi 797 or Equal product applications to assist with compliance to standards.

4. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this SOW, except as may otherwise be specified. The Contractor shall provide online access to the web-based application. Simplifi 797 or Equal must be user friendly and facilitate the ongoing compliance of training, procedures and documentation imperative to patient safety and risk minimization. The program will document and report on compliance and training to provide to pharmacy inspectors when necessary. The program will also provide needed continuing education to all pharmacy staff members via online ACPE- approved sterile compounding training. The product must provide ACPE accredited sterile compound training continuing education up to 33 hours for all pharmacy staff on both USP 797 and USP 800 standards, requires the most comprehensive sterile compounding training available online. The required product will specifically customize a quality assurance plan including policies and procedure for the GVSMVAMC Pharmacy Department. The product must provide real-time alerts on the facility and system level to assess compliance risks. The Contractor shall provide Simplifi+Medstorage or Equal, a single sign-on platform to help track all the tasks and documents required to pass unit inspections both inside and outside of pharmacy through the use of customizable automated checklists in a mobile friendly format.

5. Performance Period:

• Base Period: December 1, 2024 – November 30, 2025

• Option Period 1: December 1, 2025 – November 30, 2026

• Option Period 2: December 1, 2026 – November 30, 2027

• Option Period 3: December 1, 2027 – November 30, 2028

• Option Period 4: December 1, 2028 – November 30, 2029

6. Task: The contract will include the program providing product training and ongoing support.

As an online application, the product should not require any hardware investment or IT resources.

7. Contract Changes/Modifications: The Contracting Officer (CO) is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the COR on all matters pertaining to contract administration and technical direction. Only the CO is authorized to make commitments or issue changes that shall affect price, quantity, or quality of performance of this contract.

8. Final Invoicing Instructions: It is your firm’s responsibility to submit a completed and signed Final Invoice Memo (see attached template) in accordance with the terms and conditions of this contract. The Final Invoice Memo must be signed and attached to your firm’s submission of the final invoice for final payment or within seven (7) calendar days after the period of performance or contract expiration. If the CO or designated representative does not receive a signed copy of the Final Invoice Memo with your firm’s final invoice for final payment and/or if the Government does not hear from your firm via e-mail after seven

(7) calendar days, after the period of performance or contract expiration, the Government will accept that there is adequate evidence that all supplies and services have been delivered and accepted, all invoices have been paid, and that there are no outstanding invoices or issues concerning this contract; thus, the Government will continue with a unilateral de-obligation of any remaining funds and issue the signed modification to all parties. Further, failure to submit a signed Final Invoice Memo could result in a negative CPARS entry as a lack of business-like concern for the interest of the customer—which in this case is the VAMC. Notwithstanding the claim period stated in FAR 52.233-1, Disputes, and pursuant to FAR 33.206, Initiation of a Claim, the contractor agrees to submit any claim related to this contract within 12 months after accrual.

9. Records Management:

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a).

These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. The GVSMVAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of the VA or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the VA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate CO upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. Contractor personnel shall sign VA Form 10-0708 “Employee Clearance from Indebtedness” before resigning or termination from Contractor working for GVSMVAMC and Facility Records Officer must sign form. A copy of completed signed VA Form 10-0708 (Contractor personnel and Facility Records Officer signatures) shall be place in each competency folder. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to the VA control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract.

Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The Contractor is required to obtain the CO's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with GVSMVAMC policy.

h. The Contractor shall not create or maintain any records containing any non-public GVSMVAMC information that are not specifically tied to or authorized by the contract.

i. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

j. The GVSMVAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which GVSMVAC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VA provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. TMS (Talent Management System) course VA 4192704: “Records Management for Everyone” [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

l. Flow-down of requirements to subcontractors:

a. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same.

b. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

10. Contract Security: The Authorization & Accreditation (A&A) requirements do not apply, and that a Security Accreditation Package is not required.

(End of Statement of Work)

See attached document: Attachment D.1 Final Invoice Memo

See attached document: Attachment D.2 Past Performance References

ATTACHMENT D.1 FINAL INVOICE MEMO

IN REPLY

REFER TO: Contract/Order Number: ___________________________________

Purchase Order Number: ______________________

ATTN: Contracting Officer/Contracting Officer’s Representative/Ordering Officer

According to our records, this memo confirms that there are no outstanding invoices pending against the Contract & Purchase Order referenced above.

Sincerely, Vendor Representative Name: _________________________________________________

Vendor Representative Title: ___________________________________________________

Vendor Representative Contact Information: _______________________________________

Signature: Date:

ATTACHMENT D.2 PAST PERFORMANCE REFERENCES

REFERENCE 1:

Name of Government or Commercial Organization:

Address:

Contract Number:

Brief Description:

Contractor Performed as:

Prime Contractor

Sub-Contractor

Dates of Performance (if current include expiration):

Total Cost of Contract: Award/Incentive/Deduction Any terminations for cause or default? Circle YES or NO If yes, brief explanation:

Point Of Contact/COR:

Title:

Telephone Number:

Point of Contact’s email address:

Comments:

REFERENCE 2:

Prime Contractor

Sub-Contractor

Dates of Performance (if current include expiration):

Total Cost of Contract: Award/Incentive/Deduction Any terminations for cause or default? Circle YES or NO If yes, brief explanation:

Point Of Contact/COR:

Title:

Telephone Number:

REFERENCE 3:

Prime Contractor

Sub-Contractor

Dates of Performance (if current include expiration):

Total Cost of Contract: Award/Incentive/Deduction Any terminations for cause or default? Circle YES or NO If yes, brief explanation:

Point Of Contact/COR:

Title:

Telephone Number: