36C25623Q0208 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE

OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERE

D CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendmen t, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 520-23-1-119-0042 Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531 Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16 Veterans Avenue Biloxi MS 39531 To all Offerors/Bidders

36C25623Q0208 12-22-2022

X X X

12/28/2022; 12:00 PM CT

See CONTINUATION Page X The purpose of this amendment is to revise the Statement of Need, update the line items, and extend the closing date to reflect Wed., Dec. 28, 2022; 12:00 pm CT.

No other questions will be entertained at this time.

Danette Rene' Impey Contracting Officer

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Inpatient Vault Expired Narcotic Drugs Pick-up Room 2C115; Biloxi, MS Contract Period: Base POP Begin: 01-01-2023 POP End: 12-31-2023 PRINCIPAL NAICS CODE: 562119 - Other Waste Collection PRODUCT/SERVICE CODE: R499 - Support - Professional: Other

Outpatient Vault Expired Narcotic Drugs Pick-up, Room 2B102; Biloxi, MS

POP Begin: 01-01-2023 POP End: 12-31-2023

Cache expired Narcotic Drugs Pick-up Warehouse 26; Biloxi, MS

POP Begin: 01-01-2023 POP End: 12-31-2023

Vault Narcotic Drugs Pick-up monthly; Pensacola, FL

POP Begin: 01-01-2023 POP End: 12-31-2023

Vault Narcotic Drugs Pick-up quarterly; Clifford C. Sims State Veterans Nursing Home, Panama City, FL

POP Begin: 01-01-2023 POP End: 12-31-2023

Inpatient Vault Expired Narcotic Drugs Pick-up Room 2C115; Biloxi, MS Contract Period: Option 1 POP Begin: 01-01-2024 POP End: 12-31-2024

Outpatient Vault Expired Narcotic Drugs Pick-up, Room 2B102; Biloxi, MS

POP Begin: 01-01-2024 POP End: 12-31-2024

Cache expired Narcotic Drugs Pick-up Warehouse 26; Biloxi, MS

POP Begin: 01-01-2024 POP End: 12-31-2024

Vault Narcotic Drugs Pick-up monthly; Pensacola, FL

POP Begin: 01-01-2024 POP End: 12-31-2024

Vault Narcotic Drugs Pick-up quarterly; Clifford C. Sims State Veterans Nursing Home, Panama City, FL

POP Begin: 01-01-2024 POP End: 12-31-2024

Inpatient Vault Expired Narcotic Drugs Pick-up Room 2C115; Biloxi, MS Contract Period: Option 2 POP Begin: 01-01-2025 POP End: 12-31-2025

Outpatient Vault Expired Narcotic Drugs Pick-up, Room 2B102; Biloxi, MS

POP Begin: 01-01-2025 POP End: 12-31-2025

Cache expired Narcotic Drugs Pick-up Warehouse 26; Biloxi, MS

POP Begin: 01-01-2025 POP End: 12-31-2025

Vault Narcotic Drugs Pick-up monthly; Pensacola, FL

POP Begin: 01-01-2025 POP End: 12-31-2025

Vault Narcotic Drugs Pick-up quarterly; Clifford C. Sims State Veterans Nursing Home, Panama City, FL

POP Begin: 01-01-2025 POP End: 12-31-2025

Inpatient Vault Expired Narcotic Drugs Pick-up Room 2C115; Biloxi, MS Contract Period: Option 3 POP Begin: 01-01-2026 POP End: 12-31-2026

Outpatient Vault Expired Narcotic Drugs Pick-up, Room 2B102; Biloxi, MS

POP Begin: 01-01-2026 POP End: 12-31-2026

Cache expired Narcotic Drugs Pick-up Warehouse 26; Biloxi, MS

POP Begin: 01-01-2026 POP End: 12-31-2026

Vault Narcotic Drugs Pick-up monthly; Pensacola, FL

POP Begin: 01-01-2026 POP End: 12-31-2026

Vault Narcotic Drugs Pick-up quarterly; Clifford C. Sims State Veterans Nursing Home, Panama City, FL

POP Begin: 01-01-2026 POP End: 12-31-2026

Inpatient Vault Expired Narcotic Drugs Pick-up Room 2C115; Biloxi, MS Contract Period: Option 4 POP Begin: 01-01-2027 POP End: 12-31-2027

Outpatient Vault Expired Narcotic Drugs Pick-up, Room 2B102; Biloxi, MS

POP Begin: 01-01-2027 POP End: 12-31-2027

Cache expired Narcotic Drugs Pick-up Warehouse 26; Biloxi, MS

POP Begin: 01-01-2027 POP End: 12-31-2027

Vault Narcotic Drugs Pick-up monthly; Pensacola, FL

POP Begin: 01-01-2027 POP End: 12-31-2027

Vault Narcotic Drugs Pick-up quarterly; Clifford C. Sims State Veterans Nursing Home, Panama City, FL

POP Begin: 01-01-2027 POP End: 12-31-2027

Statement of Need

Background Information

The Gulf Coast Veterans Health Care System, Biloxi, MS, Pharmacy Services are required to dispose of expired or unusable DEA scheduled controlled substance both monthly and quarterly, depending on the location.

The proposed reverse distribution service fee shall be a firm fixed price per site visit and priced according to class of trade and frequency of site visit. The firm fixed price site visit service fee should cover all the contractor’s costs including, but not limited to, packaging, shipping, processing, software as a service application, waste disposal, and any other applicable costs or fees incurred in performance of reverse distribution and waste disposal services, to include travel, lodging, etc.

Scope

Pharmacy Service Inpatient Pharmacy, Outpatient Pharmacy, and Cache, Biloxi, MS; Pharmacy Service, Outpatient Clinic, Pensacola, FL; and Clifford C. Sims Nursing Home Pharmacy, Panama City, FL, has a need for DEA registered controlled substance retrieval and destruction from each site. This requirement will be for services provided once a month for the Biloxi Inpatient and Outpatient pharmacies, and Cache in Biloxi, MS, and the Pensacola Outpatient Clinic in Pensacola, FL, and once quarterly for Clifford C. Sims Nursing Home in Panama City, FL. All pharmacy locations of the Gulf Coast Veterans Health Care System, (Biloxi Inpatient and Outpatient, Cache; Pensacola Outpatient Clinic; and Clifford C. Sims Nursing Home) require on-site processing and collection of controlled substances to minimize the violation of laws and regulations, especially in pharmaceutical waste disposal. The contractor shall be compliant with all applicable regulations related to controlled substance handling and destruction (as required in 21CFR 1317). Returns to be processed will cover expired controlled substance pharmaceuticals, controlled substances due to expire in the future, or controlled substances that are otherwise unusable.

**NO CREDIT FOR RETURNS TO BE COLLECTED OR HELD FOR LATER DATE**

Reusable Medical Equipment: Not applicable.

Additional Technical Advisory Group Requirements: None.

Contractor Requirements

REGULATORY COMPLIANCE: The contractor shall be required to provide all plant, equipment, materials, and labor needed to process proper disposal of Schedule II-V controlled substance designated pharmaceuticals. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 40 Protection of the Environment, Title 49 Department of Transportation (DOT); U. S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), 41 U.S.C. chapter 67, Service Contract Labor Standards, and VA regulations. The Contractor shall also comply with applicable state/local regulations and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries. Accordingly, the Contractor shall arrange for, recommend, and/or advise the returning drug distribution point of the proper means of transporting the returned products to the Contractor's central processing facility.

LICENSES, PERMITS, REGISTRATION, INSURANCE: All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, etc., for individual Contractor staff as well as any required permits and licenses for interstate transport and storage/disposal of expired or unusable DEA scheduled II-V controlled substances. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA, and individual State regulations. The Contractor or designated sub- contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the contracting officer for retention in the contract file. The Contractor shall have proper insurance coverage, including environmental remediation and be prepared to list the VA, IHS, BOP, IHSC and other approved federal agencies as additional insured if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request.

CONTRACTOR AND SUBCONTRACTOR LICENSE QUALIFICATIONS REQUIREMENTS: The Contractor and any respective subcontractors shall maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, Occupational Safety and Health Administration, and all licenses and permits required by local agencies for destruction operations.

SHIPPING/PROCESSING ARRANGEMENTS: The Gulf Coast Veterans Health Care System, VA Medical Center, or outpatient clinic, will communicate with the Contractor directly to establish an agreed upon on-site service date once every calendar month. The Contractor shall provide all instructions, forms, labels, and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor's central processing facility. The Contractor will provide work on-site in all pharmacy locations:

Gulf Coast Veterans Health Care Center Pharmacy Service-Inpatient (119) 400 Veterans Avenue, Room 2C115 Biloxi, MS 39531-2410 (Hours of operation are 8:00 am to 4:30 pm, Monday through Friday)

Gulf Coast Veterans Health Care Center Pharmacy Service-Outpatient (119) 400 Veterans Avenue, Room 2B102 Biloxi, MS 39531-2410 (Hours of operation are 8:00 am to 4:30 pm, Monday through Friday)

Gulf Coast Veterans Health Care Center Pharmacy Service-Cache (119) 400 Veterans Avenue, Warehouse 26 Biloxi, MS 39531-2410 (Hours of operation are 8:00 am to 4:30 pm, Monday through Friday)

Joint Ambulatory Care Center (JACC) Pharmacy Service (119) 790 Veterans Way Pensacola, FL 32507 (Hours of operation are 8:00 am to 4:30 pm, Monday through Friday)

Clifford C. Sims State Veterans Nursing Home Pharmacy Service 4419 Tram Road Panama City, FL 32404 (Hours of operation are 8:00 am to 4:30 pm, Monday through Friday)

Contractor will provide a documented listing of controlled substance pharmaceuticals for return and prepare these for shipment to the processing facility. The returns will be processed using the Contractor’s on-site representative. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor’s facility. On-site service disposition shall be provided to each facility following completion of the services.

The Contractor shall prepare a list of controlled substance pharmaceuticals removed from the pharmacy and the facility must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The Contractor representative must sign the document listing the controlled substances transferred from VA to the destruction company and the appropriate DEA Forms (222, 41 etc.). The Contractor shall remove, or pick-up, controlled substance returns from the facility by close of business the same day as service is completed and boxed for return. Large or special pickups requiring separate removal shall be scheduled within 48 hours of service, and daily updates will be provided to the facility until pick-up is complete. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for shipment. The Contractor shall process all designated items through the disposal process in accordance with all applicable federal, state, and local regulations. The Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. All costs associated with gaining access to any customer facility shall be the responsibility of the Contractor.

CONTRACT ADMINISTRATION AUTHORITY

The Contracting Officer is the only person authorized to approve changes or modifications to the requirements under this contract on behalf of the Government.

In the event the Contractor makes any changes at the direction of any person other than the Contracting Officer, such changes shall be considered to have been made without authority and any adjustments in price involved as a result of unauthorized changes to the contract will not be ratified.

Each facility will have a designated Contracting Officer’s Representative (COR) who will serve as a point of contact for all matters pertaining to the technical aspects of the contract. At time of contract award, or upon appointment the Contractor will be furnished with a copy of the COR’s appointment letter. CORs have limited authority as delineated by the cognizant Contracting Officer in their appointment letter and cannot make any commitment obligating the Government.

In addition to designated CORs that will be responsible for all technical aspects of the contract, each facility will have a designated Ordering Officer or Contracting Officer. Only VA personnel officially designated as Ordering Officers under the Reverse Distribution contract or warranted contracting officers may place orders under this contract. Ordering Officers do not have the authority to negotiate, make any commitments or changes that will affect the terms and conditions of this contract. Ordering Officer Designations pertain only to the VAMC. Other Government Agencies will place orders in accordance with their facility policies and procedures.

FEDERAL GOVERNMENT HOLIDAYS

The following information is provided to assist the Contractor in scheduling returns when on-site service is required:

*If these holidays fall on a Saturday or Sunday, the contractor should contact the returning facility to determine on which day (Friday or Monday) they will be observed.

Questions to RFQ 36C25623Q0208

1. How many actual locations are there, Biloxi, Pensacola, Clifford C. Sims?

There are three separate locations in Biloxi, MS; one in Pensacola, FL (Joint Ambulatory Care Center); and one Panama City, FL (Clifford C. Sims) for a total of five locations. The locations and addresses are listed in the Statement of Need within the RFQ.

1. How many actual servicings per locations, per year?

Monthly for Inpatient Pharmacy, Outpatient Pharmacy, and Cache in the Warehouse, in Biloxi, MS; monthly for Pharmacy, Joint Ambulatory Care Center, Pensacola, FL; and Quarterly for Pharmacy, Panama City, FL (Clifford C. Sims).

1. I’m assuming 12.00 EA is monthly, 4.00 EA is quarterly, but what does 1,000.00 EA and the 50.00 EA stand for?

Yes, 12.00 EA is monthly; 4.00 EA is quarterly. The line items have been revised; therefore, the 1,000 EA and the 50 EA are no longer applicable.

1. The schedule also lists inpatient, outpatient and cache separately. Usually, they would all have the same DEA#, so they would be considered one account. Are they under the same DEA#?

No, the locations all have different DEA #’s.

1. “Pick-up” is included in the Clin for Drug Pick up and Processing/Handling Fee each invoice/pick up. How should the quote be itemized for the areas stating pick-up?

Quotes should be itemized as all-inclusive, i.e., to include invoicing, pick-up, travel, etc.

1. Please clarify what the Processing/Handling Fee each invoice/pickup.

Not applicable, the Statement of Need and line items have been revised.

1. Please clarify which travel you are pertaining for each location; POV mileage (round trip).

Not applicable, the Statement of Need and line items have been revised.

1. When was the account last serviced?

The prior pickup/service was in September 2020.

Questions to RFQ 36C25623Q0208

1. Please clarify what the quantity of 1,000.00 pertains to. Is this only for actual site visit?

Not applicable, the Statement of Need and line items have been revised.

1. Who is the incumbent?

The incumbent contract was a national contract with Returns ‘R’ Us, Inc., Pharma Logistics. However, this contract was not renewed.

RX Reverse Distribution pick-up