36C24821Q0221 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) 06-11-2021 675-21-1-2231-0008 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827 To all Offerors/Bidders

36C24821Q0221 06-10-2021

X X

X The purpose of this amendment is to:

A. Provide responses to Contractor's Inquiries. See A.1 Government's Response to Contractor's Inquiries.

B. Revise the Performance Work Statement. See A.2 Performance Work Statement Rev.01.

Rohan McKenzie Contracting Officer A.1 GOVERNMENT’S RESPONSE to CONTRACTOR’S INQUIRIES

(PWS, SOW,

CLIN Structure, etc.)

General Would it be possible to receive historical volume data and frequency for each waste type? This would allow for more accurate and insightful quoting.

Refer to Amendment 0001, Performance Work Statement Rev.01 Section 3. j) and Table 2.

c) Shipping

Please confirm that no credit processing is required for noncontrolled substances and controlled substances due to expire in the future that are otherwise unusable. How will we handle products that are eligible for credit?

Refer to the response to question number 8.

There are 4 quarterly scheduled collection services per site, however we estimated 8 additional collection services per site per performance period.

Is there an incumbent performing these services, if similar services have been performed in the past, or if this is a new requirement?

If this is a follow-on requirement, could you please provide the previous contract or task order number?

There is no incumbent performing the scope of work described in the Performance Work Statement, this is a new requirement. Previously we had a reverse distribution/credits contract. That contract is no longer active.

This is not a follow-on requirement; scope of work has changed from the previous contract.

A.2 PERFORMANCE WORK STATEMENT Rev.01

PHARMACEUTICAL WASTE COLLECTION & DESTRUCTION SERVICES FOR THE ORLANDO VA HEALTHCARE SYSTEM (OVAHCS).

1. INTRODUCTION:

The OVAHCS is seeking a distributor licensed by Drug Enforcement Agency (DEA) to collect, transport, and destroy controlled and non-controlled medications. See table 1 for list of OVAHCS locations.

2. BACKGROUND:

OVAHCS is required to remove all controlled substance expired or otherwise determined to be unusable from active stock and stored separately until destroyed or turned over to a distributor for destruction per the requirements of 21 CFR Part 1317 Electronic Code of Federal Regulations (eCFR) . Controlled substances held for destruction must be destroyed on-site or turned over to a DEA-licensed destruction company at least quarterly.

3. SCOPE OF WORK:

a) The Contractor shall provide onsite processing of schedule II-V controlled substances and non-controlled substances to minimize the violation of laws and regulations in the area of pharmaceutical waste disposal. The Contractor shall be compliant with all applicable regulations related to hazardous waste and controlled substance handling and destruction (as required in 21 CFR 1317). Processing shall include noncontrolled substances and controlled substances due to expire in the future that are otherwise unusable.

b) Processing Arrangements: The Contractor shall anticipate, at a minimum, 4 on-site visits within a calendar year per facility, however there may be need for additional on-site visits.

The Contracting Officer Representative (COR) will contact the Contractor directly to arrange for on-site services. The Contractor shall provide on-site servicing within ten (10) business days from the date of the COR request.

c) Shipping: The Contractor shall provide all shipping instructions, forms, labels, postage, DEA approved tamper-proof pouches and boxes needed to ship the controlled and noncontrolled substances to the Contractor's central processing facility. After packaging, labeling, sealing, and applying postage to the boxes by the Contractor, Pharmacist and AO, OVAHCS will be responsible for mailing the boxes to the Contractor’s central processing facility. The Contractor shall submit to Pharmacist and AO prior to departing OVAHCS facilities an Inventory list that includes all collected outdated/waste controlled and non-controlled substances for shipment. Any discrepancies shall be resolved prior to the collection of controlled and noncontrolled substances from OVAHCS by the Contractor. The Pharmacist, Accountable Officer (AO), and Contractor shall sign the document listing the controlled substances transferred from OVAHCS to the Contractor’s central processing facility and the DEA Form 41. The AO, Pharmacist, and Contractor must be present to witness and verify counts of the controlled substances turned-in to the Contractor. Contractor shall provide on-site service disposition report for each facility following completion of the waste collection.

d) The Contractor shall package and ready for shipping controlled and noncontrolled substances from OVAHCS facilities by close of business the same day as service is completed. 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 pickup is complete.

e) Place of Performance: The Contractor shall provide services at the fees awarded herein for the facilities below.

Table 1.

f) Service Request Ordering System: The Contractor shall provide a telephone number for work order placement by customers.

g) Substance Collection Plan: Offerors shall submit a written proposed plan detailing implementation of the controlled and non-controlled substance destruction plan. The plan shall demonstrate step by step procedure for collection, transportation, and destruction of controlled and non-controlled substances. The plan shall be submitted with your offer.

h) Substance Contingency Plan: The Contractor shall submit and maintain a plan for contingency operations, which identifies the ability to provide uninterrupted support of the requirements outlined herein. This plan shall be submitted with your offer.

i) Reports: An inventory report shall be provided after each onsite service prior to departure from the site. The report shall be provided for all medications collected from the facility for destruction. This report shall include at a minimum drug name, formulation, strength, National Drug Code (NDC), quantity, manufacturer, facility name, address, city, state, zip code, contact name, phone number, E-mail, and DEA number. The Contractor shall provide an initial orientation, and training on the various reports and any web-based systems that contains functionality of reports available to assist the facilities.

j) Historical Collection Data Frequency: Historically, controlled, and non-controlled substances were packaged, labeled, and sealed in DEA approved tamper-proof pouches and placed in 18-inches by 18-inches boxes for shipping. Pounds per shipment are not available, however each site had approximately 4-12 collection visits per year. Non-controlled substances are being stored at the facilities in glass vials, tamper evident bags, and vendor totes. Hazardous and non-hazardous pharmaceuticals were not being segregated. Lake Baldwin SVNH is not open; therefore, the historical data is unknown, but we anticipate the same frequency and approximate hours for collection to be the same as Emory L Bennett SVNH.

Table 2.

Orlando, FL 32827

Orlando, FL 32827

Orlando, FL 32803

Daytona Beach, FL 32114

Viera, FL 32940

Daytona Beach, FL 32117

Orlando, FL 32803

4. PERFORMANCE PERIOD: The period of performance is one (1) twelve-month base period, plus four (4) twelve-month ordering periods.

5. HOURS OF OPERATION: The Contractor shall perform all required services between the hours of 8:00 AM and 4:00 PM, Monday through Friday excluding federal holidays except services requested by the COR.

6. DELIVERABLES:

Table 3.

The Contractor shall provide a telephone number

7. FEDERAL GOVERNMENT HOLIDAYS:

The contractor will not perform services on federal holidays, or when the government facility closes due to local or national emergencies, administrative closings, or similar government directed facility closings. government shutdowns occur when the government refuses passage of key bills, resulting in the cession of some or all operations by the government. If Veterans Affairs (VA) is affected by a government shutdown during the period of performance, the contractor shall not provide services or submit claims against the government during and after the shutdown. The following Federal Holidays are observed by the government.

Table 4.

8. REGULATORY COMPLIANCE: Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, 21 CFR Parts 1300, 1301, 1304, 1305, 1307, and 1317, Title 40 Protection of the Environment Electronic Code of Federal Regulations (eCFR) , Title 49 Department of Transportation Electronic Code of Federal Regulations (eCFR); U.S. Environmental Protection Agency (EPA) United States Environmental Protection Agency | US EPA, Occupational Safety and Health Administration (OSHA) Home | Occupational Safety and Health Administration (osha.gov), Food and Drug Administration (FDA) U.S. Food and Drug Administration (fda.gov), Drug Enforcement Administration (DEA) DEA Diversion Control Division (usdoj.gov), VA regulations VHA 1108.01 and 1108.7 VHA Forms and Publications - Publications - Brochures (va.gov). The Contractor shall also comply with applicable state/local regulations and consult with regional offices of the federal and state regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations.

9. PERMITS: All necessary permits required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes any required permits for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to Drug Enforcement Administration (DEA), Department of Transportation (DOT), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA) and individual State regulations.

10. LICENSES: All necessary licenses and permits required by Federal, state, and local authorities shall be acquired and maintained by the Contractor and any Sub-Contractor for the life of the contract. This includes required licenses individual Contractor’s staff as well as any required licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to Drug Enforcement Administration (DEA), Department of Transportation (DOT), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA) and individual State regulations. The Contractor shall be a licensed DEA registrant to handle and destroy Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the Contracting Officer for retention in the contract file.

11. CONTRACTOR PERSONNEL SECURITY AND SUITABILITY:

a) The Contractor shall comply with OVAHCS security requirements and procedures for access to facilities. All costs associated with gaining access to OVAHCS facilities shall be the responsibility of the Contractor.

b) Contractor personnel shall be subject to a tier 1 low risk National Agency Check with Inquiries (NACI). Prior to contract performance, the Contractor shall submit all information required to perform NACI. This information shall be provided continuously throughout contract performance for each person providing service under this contract.

12. INSURANCE: The Contractor shall have proper insurance coverage, including environmental remediation. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request.

13. PERFORMANCE REQUIREMENT SUMMARY (PRS):

a) The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Table 5.

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