36C25621Q0774.docx

Contract Opportunity Sources Sought Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Sources Sought Notice Q517 Source Sought Notice - Hazardous Sterile Compounding

(VA-22-00000455)

71306-9004 36C25621Q0774 04-26-2021

2:00 PM

CENTRAL TIME, CHICAGO, USA

N 446110

ALEXANDRIA VA HEALTH CARE SYSTEM

NETWORK CONTRACTING OFFICE 16

ALEXANDRIA VA HEALTH CARE SYSTEM

PO BOX 69004

ALEXANDRIA LA 71306-9004

Lonest Bonton Lonest Bonton Lonest.Bonton@va.gov 318-466-2234

DEPARTMENT OF VETERANS AFFAIRS

Overton Brook VA Medical Center Inpatient Pharmacy (119) RM 1 E95 510 East Stoner Ave.

Shreveport

Louisiana 71101

USA

lonest.bonton@va.gov See attached description of sources sought notice.

Contract Opportunity Sources Sought Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE

DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

Required Field Contract Opportunity Sources Sought Notice Q517 Source Sought Notice - Hazardous Sterile Compounding

(VA-22-00000455)

71306-9004 36C25621Q0774 04-26-2021

2:00 PM

CENTRAL TIME, CHICAGO, USA

N 446110

ALEXANDRIA VA HEALTH CARE SYSTEM

NETWORK CONTRACTING OFFICE 16

ALEXANDRIA VA HEALTH CARE SYSTEM

PO BOX 69004

ALEXANDRIA LA 71306-9004

Lonest Bonton

DEPARTMENT OF VETERANS AFFAIRS

Overton Brook VA Medical Center Inpatient Pharmacy (119) RM 1 E95 510 East Stoner Ave.

Shreveport Louisiana 71101

USA

lonest.bonton@va.gov lonest.bonton@va.gov See attached description of sources sought notice.

This is a SOURCES SOUGHT NOTICE ONLY This SOURCE SOUGHT NOTICE is for the purpose of Market Research. Response to this notice will be used for information and planning purposes. No proposals or quotes are being requested or accepted with this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS or QUOTES and NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. This notice shall NOT be construed as solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). Responses to this notice is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. The Network Contracting Office (NCO) 16 is seeking preferably Service-Disabled Veteran Owned Small Businesses, Veterans Owned Small Businesses, or Small Businesses (but will accept other than small business for market research purposes), capable of providing Sterile Compounding Services for the Overton Brook Veterans Administration Medical Center, 510 East Stoner Ave, Shreveport, LA 71101 per the DRAFT statement of work below. The NAICS code is 446110 Pharmacies and Drugs and the Size Standard is $30 million. Responses must be received by no later than 2:00 p.m. Central Standard Time, Monday, April 26, 2021. Responses shall be emailed to lonest.bonton@va.gov. Statements to include DUNS number. Facsimile or Telephonic responses will not be accepted. Note: All interested parties are reminded to be registered, active and verified in the following to be considered for Award (as applicable). SAM:

https://www.sam.gov/portal/public/SAM/ VETBIZ: https://www.vip.vetbiz.gov/Public/Search/Default.aspx (SDVOSB/VOSB) VETS 4212 (Veteran owned small Business are reminded of Reporting Requirements): https://www.dol.gov/vets/vets4212.htm DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

STATEMENT OF WORK BACKGROUND: The Overton Brooks VA Medical Center (OBVAMC) has a requirement for compounding hazardous chemotherapy agents for the Shreveport campus. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. OBVAMC has approximately 10‐12 patients on any given day Monday‐Friday for Chemotherapy Infusion. Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws.

Contract is an emergent request for a period of performance as follows:

Contract will be a firm-fixed price, Indefinite-Delivery-Indefinite-Quantity, contract. Period of performance will be as follows:

2. SCOPE OF WORK:

Services Non‐Personal; Contractor shall provide all chemotherapy agents, IV Tubing, closed system drug transfer devices, and any other items deemed necessary. All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders.

Orders will be submitted via a secure network or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email.

· Orders from OBVAMC will be submitted by 12:00pm CST.

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:

Orders for Shreveport, LA:

Overton Brooks VA Medical Center Inpatient Pharmacy (119) RM 1 E95 510 East Stoner Ave.

Shreveport, LA 71101

Items shall be delivered to the VA by 9:00am, the day after orders are submitted.

Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800 and Federal Law.

A list of the common chemotherapy agents will be provided directly to the Contractor.

All drugs are to be supplied by the Contractor. See Attachment 1 for common chemotherapy agents used. This list is not inclusive, and agents may be added or deleted as the mission needs change.

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

Contractor shall provide current and future 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.

Contractor shall update and provide the “VHA PBM Assessment Guide for Compounded Sterile Preparations within VAMCs and Outsourced Compounding Pharmacies” at time of solicitation response and annually (See Attachment 2)

Shipping is included with the order and there is no additional cost for any items delivered for the weekend. All shipments for weekend delivery will be arranged as needed to ensure delivery can be successfully completed.

Specifications below for compatibility needs:

Bag Spike Rule: All chemo and Mabs

Primary IV Set: BD Secondary Set (REF 11426965) or interchangeable set

Secondary IV Set: BD Secondary Set (REF 2204-0007) or interchangeable set

In‐line Filter: All necessary compounded materials per manufacture recommendation Filter Rules: Filter is required for Abatacept, Avelumab, Cabazitaxel, Cetuximab, Daratumumab, Durvalumab, Pembrolizumab, Ramucirumab, Siltuximab, and others as recommended by manufacturing guidelines.

Special Priming: Prime tubing with base fluid prior to adding medications

Total Volume Calculations – Overfills in IV Bags: Total volume only calculated when specified in order. No adjustments made for overfill.

Close System Device: Equashield

Pre‐meds: none

Other: Occasionally need 5‐FU in Homepump C-Series (REF C270050) or Elastomeric pumps

3. WORK HOURS:

OBVAMC pharmacy is open to receive medications 24/7.

4. 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.

5. COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS:

The Contractor shall ensure that services provided to the Government under this contract comply with all applicable laws, statutes, regulations, and guidelines. The Contractor shall also ensure that all services provided to the Government under this contract comply with all Government mandated procedures, standards, and requirements.

Information Systems Officer, Information Protection: The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non‐volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer: The contractor will have access to protected Patient Health Information (PHI) but it will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non‐volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de‐identified.

1. Records Manager:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. 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 by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

6. QUALITY ASSURANCE SURVEILLANCE PROGRAM:

The Government will monitor performance with the below performance objectives: