36C25526R0023_VISN15 Compounding Services_final.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

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

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25526R0023 03-06-2026

Owen, Maria Riza/maria.owen2@va.gov 913-946-1965 1pm CST

36C255

Department of Veterans Affairs

Network Contracting Office (NCO) 15

3450 S 4th Street Trafficway

Leavenworth KS 66048

X

325412

1300 Employees

N/A

Department Of Veterans Affairs

VISN 15 Medical Centers

36C255

Department of Veterans Affairs

Network Contracting Office (NCO) 15

36C255

Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX

877-353-9791 512-460-5429

See CONTINUATION Page

This is a solicitation to establish a Requirements

Contract for Hazardous and Non-Hazardous Pharmacy Compounded

Sterile Preparation Services at the VISN 15 Pharmacies.

This will be a firm fixed-price 5-year Requirements contract with annual ordering periods.

All questions are due NLT March 20, 2026, at 1pm CST and shall be emailed to Maria Riza Owen @ maria.owen2@va.gov.

All responses are due NLT April 7, 2026, at 1pm CST and shall be emailed to Maria Riza Owen @ maria.owen2@va.gov.

See CONTINUATION Page

X X

Jeanine Wallace

Contracting Officer

36C25526R0023

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-21 REQUIREMENTS (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.7 52.240-93 BASIC SAFEGAURDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (DEVIATION) (NOV 2025)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 45

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.216-1 TYPE OF CONTRACT (DEVIATION) (NOV 2025)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (NOV 2020)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C255 Jeanine Wallace

Network Contracting Office (NCO) 15

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Other [X] Upon delivery of services

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

Financial Services Center http://www.fsc.va.gov/einvoice.asp

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1 YR ________________ ______________

VISN 15 Hazardous and Non-Hazardous Pharmacy

Compounded Sterile Preparation

Contract Period: Ordering Period One

POP Begin: 06-01-2026

POP End: 05-31-2027

0001AA

Hazardous and Non-Hazardous Pharmacy Compounded Sterile

Preparation -

Columbia VA Medical Center

0001AB

Eastern Kansas Health Care System

0001AC

Kansas City VA Medical Center

0001AD

1 YR _______________ ______________

Marion VA Medical Center

0001AE

Poplar Bluff VA Medical Center

0001AF

St. Louis VA Medical Center

0001AG

Wichita VA Medical Center

Ordering Period One Total ______________

Compounded Sterile Preparation

Contract Period: Ordering Period Two POP Begin: 06-01-2027 POP End: 05-31-2028

0002AA

0002AB

0002AC

0002AD

0002AE

Poplar Bluff VA Medical center

0002AF

Hazardous and Non-Hazardous Pharmacy Compounded Sterile

0002AG

Ordering Period Two Total ______________

Compounded Sterile Preparation

Contract Period: Ordering Period Three

POP Begin: 06-01-2028

POP End: 05-31-2029

0003AA

Preparation

0003AB

0003AC

0003AD

0003AE

0003AF

0003AG

Ordering Period Three Total ______________

Compounded Sterile Preparation

Contract Period: Ordering Period Four

POP Begin: 06-01-2029

POP End: 05-31-2030

0004AA

0004AB

0004AC

0004AD

Hazardous and Non-Hazardous Pharmacy Compounded Sterile

0004AE

0004AF

0004AG

Ordering Period Four Total ______________

Compounded Sterile Preparation

Contract Period: Ordering Period Five

POP Begin: 06-01-2030

POP End: 05-31-2031

0005AA

0005AB

0005AC

0005AD

0005AE

0005AF

0005AG

1 YR ______________ ______________

Ordering Period Five Total ______________

GRAND TOTAL ______________

B.3 DELIVERY SCHEDULE

SHIPPING INFORMATION QUANTITY DELIVERY DATE

Ship to:

Kansas City VAMC

Room V2-710

4801 E. Linwood Blvd.

Kansas City, MO 64128

See attachment D.1 for estimated quantity

06/01/2026 to

Mark for:

Name:

Contact Information:

05/31/2031

Ship to:

Columbia VAMC

Room E001

800 Hospital Drive, Columbia, MO 65201

See attachment D.1

Mark for: Name:

Contact Information:

Topeka VAMC

Room 1- A10

2200 SW Gage Blvd.

Topeka, KS 66622

See attachment D.1

Mark for: Name:

Contact Information

Leavenworth VAMC

Room B237

4101 4th St. Trafficway

Leavenworth, KS 66048

See attachment D.1

Mark for: Name:

Wichita VAMC

Room 101-3

5500 E. Kellogg Drive

Wichita, KS 67218

See attachment D.1

Mark for:

Name:

St. Louis VAMC (J. Cochran)

Bldg 1, 4th Floor B405

915 N. Grand Blvd.

St. Louis, MO 63106

See attachment D.1

Mark for: Name:

St. Louis VAMC (J. Barracks)

JB 55 1st Floor,1c100

1 Jefferson Barracks Dr.

St. Louis, MO 63125

See attachment D.1

Mark for: Name:

Poplar Bluff VAMC

Bldg 1 Ground Floor, GB-007

1500 N. Westwood Blvd.

Poplar Bluff, MO 63901

See attachment D.1

Mark for: Name:

Cape Girardeau VAMC

Room 1106

711 S. Mount Auburn Rd.

Cape Girardeau, MO 63701

See attachment D.1

Mark for: Name:

Marion VAMC

Room D109

2401 West Main Street

Marion, IL 62959

See attachment D.1

Mark for: Name:

Contact Information

Evansville VAMC

Room 1110.1

6211 East Waterford Blvd.

Evansville, IN 47715

See attachment D.1

Mark for: Name:

Contact Information

B.4 PERFORMANCE WORK STATEMENT

VISN 15 Hazardous and Non-Hazardous Pharmacy Compounded Sterile Preparation

1. REQUIREMENT:

The VA Heartland Health Care Network (VISN15) VAMC facilities listed below require compounding hazardous and nonhazardous sterile compounded intravenous products. (see

Attachment D. 1 Summary of Services). These compounding services are necessary to provide intravenous therapy treatments to Veterans diagnosed with specific medical conditions.

Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws.

This contract would be utilized primarily as a contingency plan. A Pharmacy Compounding

Services Contingency Plan is designed to prepare a pharmacy for unexpected events that could disrupt normal compounding operations. The plan is to ensure continuity of patient care and safety, minimize downtime, and maintain compliance with regulatory requirements. The government anticipates awarding a Firm-Fixed Price, Requirements Contract for this service.

2. BACKGROUND:

VA pharmacy compounding practices are governed by VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparation. This directive requires adherence to industry standards outlined in USP <797>, <800>, and <795>, including certification requirements, compliance with Controlled Environment Testing Association (CETA) standards, and delivery protocols.

In addition to VA policy, compounding practices must comply with federal law established under the Drug Quality and Security Act (DQSA) following the 2012 national fungal outbreak. This law sets operational requirements for compounding medications. VA facilities are categorized as

503A compounding pharmacies and must comply with 21 U.S. Code § 353a - Pharmacy compounding.

VISN 15 facilities are currently upgrading or planning the construction of compounding spaces to ensure ongoing compliance with the standards outlined above. When possible, facilities utilize other VHA resources to maintain operations during these transitions. However, when such resources are unavailable, VISN 15 requires a Requirements contract to supply hazardous and non-hazardous compounded intravenous products. This contract will cover periods of planned or unplanned downtime in VA pharmacy sterile compounding areas due to upgrades, construction, or other disruptions.

3. PERIOD OF PERFORMANCE

This procurement is for a five (5) year contract with annual ordering periods, period of performance is from 06/01/2026 – 05/31/2031.

4. FACILITIES TO BE SERVED

Facility Name Address

VISN 15 589 Kansas City, MO 4801 E. Linwood Blvd.

Kansas City, MO 64128

VISN 15 589A4 Columbia, MO 800 Hospital Drive

Columbia, MO 65201

VISN 15 589A5 Topeka, KS 2200 SW Gage Blvd.

Topeka, KS 66622

VISN 15 589A6 Leavenworth, KS 4101 4th St. Trafficway

Leavenworth, KS 66048

VISN 15 589A7 Wichita, KS 5500 E. Kellogg Drive

Wichita, KS 67218

VISN 15 657 St. Louis, MO J.

Cochran

915 N. Grand Blvd.

St. Louis, MO 63106

VISN 15 657A0 St. Louis, MO J.

Barracks

1 Jefferson Barracks Dr.

St. Louis, MO 63125

VISN 15 657A4 Poplar Bluff, MO 1500 N. Westwood Blvd.

Poplar Bluff, MO 63901

VISN 15 657GH Cape Girardeau, MO 711 S. Mount Auburn Rd.

Cape Girardeau, MO 63701

VISN 15 657A5 Marion, IL 2401 West Main Street

Marion, IL 62959

VISN 15 657GJ Evansville IN 6211 East Waterford Blvd.

Evansville, IN 47715

4. PERFORMANCE REQUIREMENTS

The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contingency IDIQ

Requirements contract for all medications, diluents, fluids, IV Tubing, closed system drug transfer devices and any other compounding and administration supplies items deemed necessary for the provision of hazardous and non-hazardous compounded intravenous products. (Attachment D. 1) The quantities reflected in Attachment D.1 is estimated annual requirements provided for pricing and planning purposes. These figures do not represent guaranteed purchase commitments. Actual quantities ordered under this VISN-wide contingency Requirements contract will vary based on patient-specific needs and operational requirements throughout the contract term. The government reserves the right to order more or fewer quantities than estimated. All sterile products will be aseptically compounded based on patient specific orders, in accordance with federal, state and local laws and any regulatory or accrediting bodies. Additionally, the vendor shall provide all deliveries and handling of materials and supplies to ensure appropriate storage conditions are maintained during shipment, to include segregated shipment and labeling for hazardous versus non-hazardous sterile compounds. Pricing in B.2 Price/Cost Schedule is all inclusive.

Contractor shall provide and update the “VHA Pharmacy Benefits Management (PBM)

Assessment Guide for Compounded Sterile Preparations within VAMCs and Outsourced

Compounding Pharmacies” at time of solicitation response and annually thereafter (See

Attachment D. 2 VHA PBM)

a. PRESCRIPTION ORDERS:

i. Orders will be submitted via secure network or fax.

ii. Once submitted, VA staff will confirm receipt of order with vendor by phone or email.

iii. Each prescription will include the following:

1. Patient name

2. Patient address (with first order for each patient)

3. Patient phone number (with first order for each patient)

4. Gender

5. Date of birth

6. Height

7. Weight

8. Allergies

9. Drug dosage

10. Diluent and volume

11. Rate

12. Administration/procedure date

13. Prescribing physician/signature

b. DELIVERY

i. Orders submitted by the facilities by 2:00pm CST will be delivered by the vendor by 9:00am CST the following day.

ii. The vendor will ensure appropriate storage conditions are maintained during shipment for all materials and supplies.

iii. Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time to the following locations.

Inpatient Pharmacy

Room # Address

VISN 15 589 Kansas City, MO V2-710 4801 E. Linwood Blvd.

Kansas City, MO 64128

VISN 15 589A4 Columbia, MO E001 800 Hospital Drive

Columbia, MO 65201

VISN 15 589A5 Topeka, KS 1- A10 2200 SW Gage Blvd.

Topeka, KS 66622

VISN 15 589A6 Leavenworth, KS B237 4101 4th St. Trafficway

Leavenworth, KS 66048

VISN 15 589A7 Wichita, KS 101-3 5500 E. Kellogg Drive

6.

DESCRIPTION OF WORK

The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contingency ID/IQ

Requirements contract for all medications, diluents, fluids, IV Tubing, closed system drug transfer devices and any other compounding and administration supplies items deemed necessary for the provision of hazardous and non-hazardous compounded intravenous products. All sterile products will be aseptically compounded based on patient specific orders, in accordance with federal, state and local laws and any regulatory or accrediting bodies, to include VA PBM evaluation of Outsourced 503B Compounding Pharmacy regulatory requirements and all required documents. The vendor will prevent risk of contamination, ensuring the safety and efficacy of compounded medications provided to Veterans.

Additionally, the vendor shall provide all deliveries and handling of materials and supplies to ensure appropriate storage conditions are maintained during shipment. This contingency contract will allow VISN 15 pharmacies to continue to deliver essential compounded medications to patients without interruptions in the event of planned or unplanned downtime of

VA pharmacies sterile compounding areas and when other VHA resources are unavailable.

7. DELIVERABLES

The contractor shall furnish all necessary materials, supplies, equipment, and personnel to complete required tasks.

a. CONTRACTOR FURNISHED MATERIALS.

i. Compounding, labeling, delivery and beyond use dating/expiration dating will be based on USP 797, USP 800, Drug Supply Chain Security Act (DSCSA) and federal law.

ii. All drugs and supplies are to be supplied by the Contractor. (see Attachment D.1) This list is not inclusive, and agents may be added or deleted as the mission needs change.

Wichita, KS 67218

VISN 15 657 St. Louis, MO J. Cochran Bldg 1, 4th Floor

B405

915 N. Grand Blvd.

St. Louis, MO 63106

VISN 15 657A0 St. Louis, MO J.

Barracks

JB 55 1st

Floor,1c100

1 Jefferson Barracks Dr.

St. Louis, MO 63125

VISN 15 657A4 Poplar Bluff, MO Bldg 1 Ground

Floor, GB-007

1500 N. Westwood Blvd.

Poplar Bluff, MO 63901

VISN 15 657GH Cape Girardeau, MO Rm 1106 711 S. Mount Auburn Rd.

Cape Girardeau, MO

63701

VISN 15 657A5 Marion, IL Rm D109 2401 West Main Street

Marion, IL 62959

VISN 15 657GJ Evansville IN Rm 1110.1 6211 East Waterford Blvd.

Evansville, IN 47715

iii. Contractor shall invoice for billable units for the amount of medication utilized for each individual patient.

iv. Contractor shall provide current and past certification reports for the sterile compounding areas and compounding hoods. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected. All reports shall be submitted to facilities within 5 days of result/receipt. Reports will be submitted to V15CSPPharmacists@va.gov.

v. Contractor shall provide monthly viability results. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected. All reports shall be submitted to facilities within 5 business days or result/receipt. Reports will be submitted to V15CSPPharmacists@va.gov.

vi. All shipping fees are included in the unit prices reflected in the pricing schedule;

there will be no additional charges for shipping, including deliveries scheduled for weekends. The contractor shall arrange weekend deliveries as needed to ensure timely and successful completion.

b. GOVERNMENT FURNISHED MATERIALS AND SERVICES.

i. The Government has included a list of the common infusion medications to be provided by the contractor, see attachment D.1 Summary of Services. This list is not all inclusive, and agents may be added or deleted as the mission needs change.

ii. The Government will include all patient information listed above with each order.

iii. The Government will submit all orders via secure network or fax.

iv. The Government will confirm receipt of order with vendor by phone or email.

c. SPECIFICATIONS FOR COMPATIBILITY NEEDS:

i. Bag Spike Rule: All chemotherapy, monoclonal antibody agents and protein kinase inhibitors.

ii. Primary IV Sets: BD Primary Set (REF 2426-0007) or interchangeable set. BD Low Sorbing Primary Set (REF 2260-0500) or interchangeable set. BD Lo Sorbing 1.2 micron Primary set (REF 10010453) or interchangeable set. BD Lo Sorbing 1.2 micron Primary set (REF 10010453)

iii. Secondary IV Set: BD Secondary Set (REF 10014881) or interchangeable set.

iv. In-line Filter: All necessary compounded materials per manufacturer recommendation.

v. Filter Rules: Filter is required for Abatacept, Avelumab, Cabazitaxel, Cetuximab, Daratumumab, Durvalumab, Pembrolizumab, Ramucirumab, Siltuximab, and others as recommend by manufacturing guidelines.

vi. Special Priming: Prime tubing with non-hazardous base fluid prior to the addition of medication to the bag. Then transfer primed tubing to final bag prior to adding medications.

vii. Total Volume Calculations – Overfills in IV Bags: Total volume included on the pharmacy label must include all additive volume, the base solution volume and overfill volume in the container (including the manufacturer’s overfill of premixed base solution.) HD chemotherapies and monoclonal antibody agents will have volume adjusted to stated diluent volume (removing calculated overfill and volume of medication.)

viii. Close System Device: Equashield

ix. Pre-meds: None mailto:V15CSPPharmacists@va.gov

x. Other: Occasionally need fluoroucil 5-FU in WalkMed bags and in CADD

Medication Cassette (REF 21-7002-24), Avanos C-series Homepumps (REF

C270050, C100020, and C270020) interchangeable cassette and Routine 5-FU

SMARTeZ Elastometric Pump (PMI Item# SE0002-100C, SE0005-270C, SE0002-

270C).

d. WORK HOURS

Facility Name Work Hours

VISN 15 589 Kansas City, MO Rm V2-710 is open to receive medications 24/7

VISN 15 589A4 Columbia, MO Rm E001 is open to receive medications 24/7

VISN 15 589A5 Topeka, KS Rm 1, Basement A10 is open to receive medications

24/7

VISN 15 589A6 Leavenworth, KS Bldg 89, Floor 2, B237 is open to receive medications 24/7

VISN 15 589A7 Wichita, KS Rm 101-3 is open to receive medications 24/7

VISN 15 657 St. Louis, MO J.

Cochran

Bldg 1, 4th Floor, Rm. B405 is open to receive medications 24/7

VISN 15 657A0 St. Louis, MO J.

Barracks

JB 55, 1st Floor, Rm 1c-100 is open to receive medications 24/7 (however, the building has restricted access after business hours)

VISN 15 657A4 Poplar Bluff, MO Bldg 1, Ground Floor, Rm GB-007 is open to receive medications M-F 0800-1800 and

Sat, Sun & holidays – 0800-1630

VISN 15 657GH Cape Girardeau, MO

Rm. 1106 is open to receive medications

M-F 0730-1630

VISN 15 657A5 Marion, IL Bldg 42, Room D109 is open to receive medications

24/7

VISN 15 657GJ Evansville IN 1st Floor – Pharmacy Room 1110.1 is open to receive medications M-F 0800-1630

e. CONTINGENCY PLANNING

The Contractor shall have a contingency backup plan in the event that compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must meet the same criteria as stated herein. VISN 15 facilities must be notified prior to dispensing any medications from contingency location. Notification shall be, and daily until contingency is no longer required.

f. COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS

i. The contractor shall ensure that services and materials provided and delivered to the Government under this contract comply with USP 797, USP 800 and all other applicable laws, statutes, regulations and guidelines for manufacture and handling of hazardous and non-hazardous sterile compounding products.

ii. The contractor shall also ensure that all services provided under this contract comply with all Government mandated procedures, standards and requirements.

g. QUALITY ASSURANCE SURVEILLANCE PROGRAM The Government will monitor the Contractor’s performance under this contract with these performance objectives. Certificates and Assessments will be submitted to

V15CSPPharmacists@va.gov.

Task ID Indicator Standard Acceptable

Quality Level

Method of Surveillance

General

Orders processed accurately

Contractor shall ensure all orders are processed per prescription order

100% Labeling

Orders received prior to infusion date/time

Timely delivery and contractor shall comply with all safety requirements

100% Validated receipt of order

Contractor maintains certifications required for compounding

Contractor shall furnish copies of certificates and complete VHA

PBM Assessment Annually

100%

Validated receipt of certificates and/or assessment

1. Contract Performance Monitoring.

The COR and Subject Matter Experts (SMEs) may perform surveillance of services by any of the methods listed below:

i. the Government shall periodically evaluate the Contractor performance by appointing local POC’s to monitor performance to ensure services are properly received. These appointed SME’s will be Government representative(s) who will act as points of contact (POC’s) and serve to evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. Evaluations from the POC’s will be provided to the COR, who will likewise advise the Contracting Officer of any issues encountered. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

ii. Observing actual performance

iii. Inspecting the services to determine whether the performance meets the performance standards

iv. Review of any other appropriate records

v. When unacceptable performance occurs, the POC shall inform the Contractor and the COR and Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

vi. If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount.

When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

vii. The Contractor shall take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

8. SECURITY REQUIREMENTS

a. INFORMATION SYSTEMS OFFICER, INFORMATION PROTECTION

i. The contractor will not have access to VA desktops or laptop computers, nor will they have access to online resources belonging to the government while conducting services or providing products.

b. PRIVACY OFFICER

i. The contractor will have access to protected Patient Health Information (PHI) provided to it by VA, but it will not have the capability of accessing patient information during the services provided to the VA.

ii. Any questions from either party about the medication that will be compounded will use two patient identifiers to confirm the correct patient for that medication prior to any conversation taking place.

iii. All research data available for Contractor analyses are de-identified.

9. GENERAL ADMINISTRATION

a) POINTS OF CONTACT (POCs).

The contractor will contact the respective facility POC to schedule product delivery.

Upon arrival, the contractor will contact the POC.

Facility Name

CSP POC

E-Mail Address

VISN 15 589 Kansas City, MO TBD

VISN 15 589A4 Columbia, MO TBD

VISN 15 589A5 Topeka, KS TBD

VISN 15 589A6 Leavenworth, KS TBD

VISN 15 589A7 Wichita, KS TBD

VISN 15 657 St. Louis, MO

(J. Cochran and J. Barracks)

TBD

VISN 15 657A4 Poplar Bluff, MO TBD

VISN 15 657GH Cape Girardeau, MO TBD

VISN 15 657A5 Marion, IL TBD

VISN 15 657GJ Evansville IN TBD

b) CONTRACT ADMINISTRATION DATA.

All contract administration functions will be retained by the Department of Veterans

Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the

Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

c) NON-PERSONAL SERVICES.

This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

d) HOURS OF OPERATIONS.

i. Business hours: Monday through Friday, 8:00 a.m. – 4:30 p.m.

ii. National Holidays: The holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Juneteenth National Independence Day;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and

Any other observed Federal holiday.

10. BUY AMERICAN ACT (BAA)

The BAA applies to the acquisition of supplies, not services. Since this procurement is for compounding services, BAA does not apply to the primary requirement.

However, the requirement is to furnish incidental supplies such as IV tubing, closed system drug transfer devices, diluents, and fluids. These items are considered end products under FAR

25.003 and therefore must comply with BAA requirements unless an exception applies.

Contractors shall be required to certify compliance under FAR 52.225-2 (Buy American Certificate) and ensure that incidental supplies are domestic end products or disclose foreign origin for evaluation.

11. RECORDS MANAGEMENT:

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle

Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. 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.

2. 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.

3. 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.

4. VA 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 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 VA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer 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. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to 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 Contracting Officer or address prescribed in the contract.

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

6. The Contractor is required to obtain the Contracting Officer'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.

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

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

9. 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.

10. The VA 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 VA 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.

11. 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.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to subcontractors

1. 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.

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

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The

Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims

Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the

Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the

Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the

Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by

Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(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.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-

5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting

Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the

Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the

Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The

Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the

Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain

Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C.