36C25024Q0834.docx

36C25024Q0834

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

36C25024Q0834 07-18-2024 Johnson, Jennifer A.

jennifer.johnson18@va.gov 07-23-2024 5:00pm

EDT

Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor

MI

48105 X X 562211 $47 Million N/A X Department of Veterans Affairs Saginaw VAMC 1500 Weiss St.

Saginaw

MI

48602 Y Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor

MI

48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin

TX

78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page The offeror shall provide a quote for Hazardous Waste services in accordance with the Statement of Work, the Price Schedule, and the provisions included in Section E.1 Instructions to Offerors.

The period of performance is one base year plus four (4) option years.

Wage Determination 2015-4865 Rev. 24 dated Apr 30, 2024 applies to this solicitation and forthcoming contract. The Offeror is responsible for determining the appropriate wage classification.

See CONTINUATION Page X X X Table of Contents

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: Company Name:

POC:

Email:

Phone:

b. GOVERNMENT: Contracting Officer 36C250 Jennifer Johnson Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Pick up and disposal of hazardous and universal waste for Saginaw VAMC. Base Year.

Contract Period: Base POP Begin: 08-01-2024 POP End: 07-31-2025

Pick up and disposal of hazardous and universal waste for Saginaw VAMC. Option Year I.

Contract Period: Option 1 POP Begin: 08-01-2025 POP End: 07-31-2026

Pick up and disposal of hazardous and universal waste for Saginaw VAMC. Option Year II.

Contract Period: Option 2 POP Begin: 08-01-2026 POP End: 07-31-2027

Pick up and disposal of hazardous and universal waste for Saginaw VAMC. Option Year III.

Contract Period: Option 3 POP Begin: 08-01-2027 POP End: 07-31-2028

Pick up and disposal of hazardous and universal waste for Saginaw VAMC. Option Year IV.

Contract Period: Option 4 POP Begin: 08-01-2028 POP End: 07-31-2029

Page 1 of Page 1 of

ALEDA E. LUTZ VA MEDICAL CENTER (SAGINAW, MI) 10

INDUSTRIAL WASTE SERVICE CONTRACT

1. BACKGROUND & SCOPE:

The Department of Veterans Affairs, Aleda E. Lutz VA Medical Center located at 1500 Weiss, Saginaw, MI generate industrial waste including but not limited to:

· hazardous waste;

· dual waste (hazardous waste and infectious waste);

· universal waste;

· Michigan Hazardous and Liquid Industrial By-Products;

· hazardous and non-hazardous waste pharmaceuticals

· various expired or spent research grade chemicals and non-regulated solid waste as listed in the schedule of “SUPPLIES OR SERVICES AND PRICES/COSTS.”

Industrial waste services include, but are not limited to:

· transportation preparation;

· transportation and treatment;

· disposal;

· destruction (i.e. incineration), or;

· recycling of industrial wastes.

Currently, the Aleda E. Lutz VA Medical Center is a Very Small Quantity Generators (VSQG) of Hazardous Waste.

Contractor is to follow the Veterans Administration environmental policy:

· To conduct our mission in a manner to protect human health and the environment; comply with all applicable Agency, Federal, State, and Local environmental laws, regulations and directives governing our activities.

The VA reserves the right to inspect contractor facilities before approving its use or at any time during or after contract period while VA wastes are present.

The Department of Veterans Affairs, Network Contracting Office (NCO) 10, intends to award a Firm Fixed Price Service Contract to a qualified firm with the capability and capacity to provide ALL industrial waste services listed in this Statement of Work (NO THIRD-PARTY BROKER FIRMS). All items listed in the schedule, regardless of their condition, are being discarded by the government and are industrial waste. The Contractor shall provide all industrial waste services necessary to execute this contract including, but not limited to:

· operational personnel;

· labor;

· equipment;

· packaging;

· transportation;

· treatment;

· disposal;

· destruction (i.e. incineration);

· recycling;

· reporting.

The Contractor shall comply with all federal, state and local municipal regulations including but not limited to:

· Title 40 Code of Federal Regulations Protection of Environment;

· Title 49 Code of Federal Regulations Transportation;

· Title 29 Code of Federal Regulations Labor; and Michigan Public Act 451 of 1994 as amended Natural Resource and Environmental Protection and Ohio Administrative Code 3745-3750.

· Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine December 11, 2018 The Contractor shall comply with amendments to applicable federal, state and local municipal regulations which occur during the term of this contract. The Contractor shall provide to the Contracting Officer’s Representatives (COR) any additional documentation which may be required because of such regulatory amendments.

The COR shall arrange with the Contractor for industrial waste services required for the Saginaw VAMC facility based upon rate of industrial waste generation. The Contractor shall possess the necessary technical expertise and resources required by this solicitation to be considered for contract award. The Contractor shall have a minimum of five (5) years working experience with healthcare and research laboratories in an industrial waste service capacity.

The contract requires one contractor to provide a “turnkey operation”, i.e., all industrial waste services necessary to execute this contract conducted by one single qualified firm. This includes, but is not limited to:

· operational personnel;

· labor;

· equipment;

· packaging;

· transportation;

· treatment, disposal, and recycling;

· and reporting.

The Contractor shall be a licensed Treatment, Storage, and Disposal Facility (TSDF) meeting 40 CFR 264/265 Subpart A-E). All industrial waste will be segregated, processed, and placed in temporary storage before being shipped off-site for final disposal.

Hazardous Waste Pharmaceuticals will be managed under Subpart P of Part 266 in Title 40 CFR.

2. TASKS:

a. Industrial waste shall be managed in the following preferred priority:

1. Reuse, reclamation, or recycling of industrial waste to another party for future use if economically feasible and practical (e.g. fuel blending, battery recycling).

2. Treatment of industrial waste at an appropriately state- or federally-permitted facility in a manner that renders it no longer a hazardous waste as defined by federal, state, and local regulations.

3. Long-term landfill burial internment in an appropriately state- or federally- permitted facility.

b. For the purposes of this contract, disposal includes:

1. The long-term landfill burial internment in an appropriately state- or federally- permitted facility.

2. Treatment of industrial waste, including but not limited to neutralization, detoxification, and incineration, in a manner that renders it no longer a hazardous waste as defined by federal, state, and local regulations at a facility appropriately permitted by a state or federal agency.

3. Reclamation, recycling, reprocessing and recovery.

4. Disposal does not include mere acceptance of the industrial waste at a properly permitted Treatment, Storage, and Disposal Facility and does not meet the definition of disposal under this contract.

c. Any shipments outside of the United States of America are strictly prohibited.

d. Routine collection of waste shall be scheduled within ten (10) workdays from time of request.

e. Emergency collection of waste shall be completed within) five (5) workdays from time of request.

f. The Contractor shall provide all materials, labor, and equipment necessary for moving industrial waste from storage areas to the designated loading and departure point. Use of government equipment or personnel for this activity is strictly prohibited.

g. Prior to transporting industrial waste from the facility, the Contractor:

1. Shall accurately prepare and supply proper DOT shipping papers for DOT hazardous materials, including bill of ladings, as well as, EPA Uniform Hazardous Waste Manifest for all hazardous waste and Michigan Hazardous and Liquid Industrial By-Product waste transportation services.

2. Shall accurately prepare and supply all other necessary documents related to industrial waste services including but not limited to Land Disposal Restriction forms and destination facility disposal profiles.

3. Shall provide the completed DOT shipping papers to the COR or his/ her designee for certification of DOT shipping papers.

4. Shall have the transporter certify DOT shipping papers as well as the following for EPA Hazardous Waste Manifest:

a) Ensure a legible signature on all copies.

b) Provide certified copies of the EPA Hazardous Waste Manifest Generator’s Initial Copy and Designated Facility to Generator State Copy to the COR or designee.

c) Other DOT shipping papers.

d) Obtain a legible signature.

e) Provide copies to the COR or designee.

5. Acknowledge and verify that DOT shipping papers are signed ONLY by the COR or his/her authorized designee.

6. Shall submit the EPA Hazardous Waste Manifest to the required regulatory agency within the timeline prescribed by state and federal regulations.

7. Within 35 calendar days of the initial transportation date, the Contractor shall provide to the COR and/or his/her designee the destination facility certified copy of the EPA Uniform Hazardous Waste Manifest.

8. Payment of services rendered under this contract will be made in arrears upon satisfactory completion of each service and receipt of a properly prepared invoice submitted by the Contractor to the payment address specified by the Contracting Officer. Invoices shall reference the Contract Number, Purchase Order Number, and DOT shipping paper number(s) as well as provide a complete and accurate description of services/supplies rendered/delivered, including dates of performance, amounts, unit prices, extended totals and any other data relevant for payment purposes.

9. The Government will not authorize payment until such time that the VA receives a properly prepared invoice, and all certified DOT transportation shipping papers, certificate of waste disposal, destruction (i.e., incineration) or recycling, and a completed industrial waste tracking form correlating to the industrial waste service.

10. The Contractor shall ensure that there is a clear audit trail for all industrial waste services including disposal, destruction or recycling of industrial waste. Any differences between the contract service and actual service shall be thoroughly described and documented and provided to the COR.

11. The Contractor shall obtain and maintain all necessary documentation to prove that the industrial waste service was accomplished in accordance with applicable federal, state and local regulations.

h. The contractor, with assistance of Aleda E. Lutz VAMC personal shall develop accurate waste analysis sheets (profiles) for waste as necessary.

3. CONTRACTOR FURNISHED MATERIALS AND EQUIPMENT:

Government will not furnish any equipment or assist the Contractor in the performance of the contract. The Contractor understands that any offers by Government personnel to use Government equipment for industrial services, including loading or packaging, are unauthorized, and the Contractor shall not accept such offers.

The contractor shall provide all necessary labor and all required materials to manifest, package, mark, label, placard, and load industrial wastes for transport.

The contractor shall use calibrated monitoring and measurement equipment. The equipment shall be calibrated in accordance with manufacturer’s specifications and the contractor shall maintain associated records of calibration.

4. CONTRACTOR FURNISHED TRANSPORTATION:

The Contractor shall:

a. Provide necessary personnel, materials and equipment to meet 49 Code of Federal Regulations, Transportation regulations, including packaging, labeling, marking and placarding.

b. Move industrial waste from storage area(s) to designated loading points.

c. Provide all labor, materials, and equipment to load containers onto the transport vehicle.

d. Properly secure the containers for transportation.

e. Equip vehicles with all necessary emergency equipment required by applicable state and federal regulations.

f. Stock vehicles with sufficient emergency supplies and equipment to manage actual and potential releases during loading, transporting or offloading of hazardous materials.

g. Provide properly licensed vehicles in states in which they operate. All vehicles shall be properly equipped in accordance with DOT regulations for the applicable states.

h. The Contractor shall be responsible for properly consolidating and containerizing all industrial wastes, including lab-packs.

5. SAFETY & SECURITY

a. The Contractor shall perform all operations in a prudent, conscientious, safe and professional manner. At a minimum, contractor personnel and equipment shall comply with all safety and environmental requirements set forth in applicable federal, state and local regulations and shall further ensure that its agents and employees perform work in a safe manner. Contractor shall ensure all safety measures to prevent harm or injury to VA patients, visitors, employees, contractor employees and the environment are adhered to.

b. The Contractor shall have an emergency contingency plan; establish, implement, and maintain procedures to identify potential emergency situations and potential accidents that can have impact(s) on the environment.

c. The Contractor shall ensure that all personnel involved in handling, packaging, and transporting industrial waste be trained at the level of expertise required for the proper performance of the task assigned. The contractor shall train personnel in the areas of chemical incompatibility, general first aid procedures, and release response.

d. Contractor employees present at the worksite shall have all current 29 CFR 1910.120 Hazardous Waste Operations and Emergency Response (HAZWOPER) and 49 CFR Hazardous Materials Regulations training. Required and appropriate safety training related to industrial services including but not limited to:

1. Proper handling, consolidation, and containerization of industrial waste.

2. Proper use of personal protective equipment while performing industrial waste services.

3. Contract employees that will work on VA premises shall have 40 hours of initial “HAZWOPER” training required by law as specified in 29 CFR 1910.120.

6. PERSONAL EXPOSURE AND RELEASE REPORTING REQUIREMENTS:

The Contractor shall be solely responsible for all leaks, spills, releases or personnel exposures, regardless of severity, related to or during the performance of contract related industrial waste services.

The Contractor shall cleanup leaks, spills or releases to the satisfaction of the COR in a manner which satisfies applicable state, federal and local regulations and at no cost to the Government.

The Contractor shall be solely responsible for immediately reporting by telephone to the COR and/or his/ her designee, all leaks, spills or releases, regardless of quantity. Reporting is not to exceed 15 minutes. If the COR or his/her designee is not available, the Contractor shall report the release to the facility (VAMC) Police.

The Contractor shall be solely responsible for “Immediately” reporting by telephone to the COR and/or his/her designee all personnel exposures, regardless of severity, within one hour of the event or upon medical treatment, whichever occurs first. If the COR is not available, the Contractor should report the personal exposure to the facility (VAMC) Police.

In the event of a regulatory reportable release the contractor shall provide to the COR and Contracting Officer a written report in accordance with the applicable release reporting regulations within three (3) calendar days.

7. PERFORMANCE

a. Places of Performance:

Aleda E. Lutz VA Medical Center 1500 Weiss Saginaw, MI 48602

b. Period of Performance:

Hours of work for pick-up of wastes (excluding emergency pick-up) are defined per the times specified in each facility’s Supplies or Services and Prices/Costs section.

c. Contractor Performance:

The Contractor shall without additional cost to the Government, provide and maintain all certifications, licenses, permits, etc. for operational personnel, trailers, containers, vehicles and other resources required for execution of the industrial waste service contract in accordance with all applicable federal, state, and local municipal regulations.

If appropriate certifications, licenses, permits, etc. are not maintained in accordance with all applicable federal, state, and local municipal regulations, the VA will terminate the contract effective immediately upon discovery.

The COR or his/her designee reserves the right to stop work if the COR determines work is being done in an unsafe/unhealthy manner or that could harm the environment. VA will not incur additional costs if work is stopped for good cause.

The CORs and coordinate with the Contracting Officer and Contractor if the Contractor is not performing within the scope of this contract.

8. AFFIRMATIVE PROCUREMENT:

The Contractor shall participate in an affirmative procurement program that requires preference for the following materials used at VA sites:

a. EPA designated items that are listed in EPA procurement guidelines at 40 CFR Part 247.

b. USDA designated items that are listed by USDA in the procurement guidelines found in 7 CFR Part 2902, Subpart B.

c. EPA designated items on EPA’s list at http://www.epa.gov/cpg/products;htm

9. DESIGNATION OF CONTRACTING OFFICER REPRESENTATIVE (COR):

The Contracting Officer will designate a Contracting Officer Representatives (CORs). The COR will provide the Contractor with a list of names indicating each location’s COR and his/her designee. A copy of the above designation memorandum(s) will be provided to the contractor and the appropriate VAMCs.

10. INDEMNIFICATION:

Upon receipt/removal of items from the Government installation, the contractor shall assume accountability, physical custody, and full responsibility for such items. The Government assumes no liability for any damage to any property belonging to the contractor, any person, or public property or for personal injuries, illness, disabilities or death to the contractor, contractor's employees, and any other person subject to the contractor's control of any other person, including members of the general public, arising from or incident to the processing, transporting, disposal, or any subsequent operation performed upon, exposure to or contact with any component, part, constituent or ingredient of this item, or substance or material whether intentional or accidental. The contractor agrees to hold the Government harmless and indemnify the Government for all costs, judgments, actions, debt, liability costs and attorney's fees or any other requests for monies or any other type of relief arising from or incident to the processing, transporting and disposal of any subsequent operation performed upon, exposure to or contact with any component part, constituent or ingredient of this item, material or substance, whether intentional or accidental.

11. CONTRACTOR:

Within 15 calendar days of award, the contractor shall provide a list of names, titles, telephone numbers (including cellular), pager/beeper numbers, facsimile numbers and e-mail addresses of key managers, supervisors, customer service and field service personnel performing under this contract to the VISN GEMS Consultant and Contracting Officer. Prior to commencement of work on this contract, the contractor shall provide the Contracting Officer the name and telephone number of at least one responsible individual who will respond to problems and/or emergencies on a 24-hour basis.

12. LABORATORY CLEAN-OUT:

This contract shall not include disposal costs for laboratory cleanout waste or other waste not included in the “SUPPLIES OR SERVICES AND PRICES/COSTS” section. Since it is impossible to ascertain the type or quantity of waste generated because of a laboratory cleanout, task orders will be generated as needed for transportation and disposal of these wastes. However, the “SUPPLIES OR SERVICES AND PRICES/COSTS” section requests a cost for inventory, regulatory assessment/documentation, and packaging on a per hour basis.

Transportation preparation (i.e. packaging materials, actual packaging) and disposal costs associated with laboratory cleanouts or waste not included in the “SUPPLIES OR SERVICES AND PRICES/COSTS” section will be performed under a separate task order. However, under the “SUPPLIES OR SERVICES AND PRICES/COSTS” section the contractor shall:

a. Properly and accurately characterize and classify hazardous materials and waste in accordance with Federal, State and location regulations.

b. Conduct field testing, as appropriate, to determine waste disposal requirements in accordance to Federal, State and Local regulations. In addition, contractor will complete the Laboratory Cleanout/Other Waste Inventory spreadsheet or other VA approved form and provide an electronic copy, along with other supporting data (i.e. SDS, technical data sheets, field test results) to the COR or facility representative. If a waste requires analytical testing beyond basic field testing, the contractor will inform the facility representative. The facility representative will manage the additional laboratory testing requirements outside of this contract.

c. Provide the documents listed above along with the cost for disposal at least ten

(10) calendar days before removing wastes from the site to allow for review for accuracy by the COR or his/ her designee.

The Contractor shall ensure that all personnel involved in handling, packaging, and transporting industrial waste be trained at the level of expertise required for the proper performance of the task assigned. The contractor shall train personnel in the areas of chemical incompatibility, general first aid procedures, and release response.

13. STANDARD OPERATING PROCEDURES (SOPs):

a. Contractor shall have Standard Operating Procedures (SOPs) that will be followed while conducting normal hazardous waste management activities. The SOPs shall include at a minimum the following:

· Characterization of unknowns

· Operational procedures and site management structure;

· Supplies and equipment practices;

· Material sampling procedures;

· Hazard assessment and categorization procedures;

· Packing procedures;

· Procedures for gaining waste acceptance into a transfer/ disposal facility.

· Quality assurance and quality control procedures to ensure materials are properly identified, categorized, and packaged, and paperwork is properly completed;

· Procedure for employee on the job-related injuries or conditions, as well as, a medical surveillance program for personnel involved in the direct handling and/or exposure to chemical waste;

· Site safety plan that will be used to ensure that workers and nearby population will be adequately protected during packaging and removal operations;

· A written plan for spill clean-up shall be included in their proposal;

· Highway Contingency Plan;

· And Hazardous Material Incident reporting (49 CFR 171.15 & 171.16)

14. DEFINITIONS:

DM# means abbreviation for the container and its capacity (e.g. DM55 = 55-gallon drum, DM30 = 30-gallon drum, DM5 = 5-gallon pail).

Dual waste means a waste stream that meets the definition of hazardous waste and infectious waste.

Episodic means a waste generated infrequently such as semi-annually or annually.

Incineration means waste that is to be burned and disposed at an EPA licensed incinerate for hazardous waste.

Minimum fee means the minimum disposal cost for a container which is priced on a per unit pound basis.

Pharmaceutical is defined as: any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials). This definition includes, but is not limited to, dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3(y); over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non-empty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals. This definition does not include dental amalgam or sharps.

Pharmaceutical waste containing RCRA Listed P/U or other waste for incineration: Segregated pharmaceuticals which meet the definition of RCRA Listed P-Waste or Listed U- Waste. As incineration is the most stringent form of disposal, it may also contain other pharmaceuticals in which the best management practice for disposal is incineration (i.e. non-regulated chemotherapy agents). Examples of P-listed pharmaceutical waste may include warfarin, nitroglycerin, physostigmine and any empty containers of those.

RCRA means Resource Conservation and Recovery Act.

Recycling means waste is sent to a facility where it will be processed into recyclable materials. Note: hazardous waste that is to be recycled normally does not involve a commodity rebate.

Recyclable Materials means hazardous waste that is recyclable.

Routine means a waste generated on a frequent basis such as monthly, bi-monthly, or quarterly.

Stabilization/Treatment means waste that is acceptable for RCRA Part B TSDF permit (i.e. does not contain waste which EPA requires incineration such as high mercury bearing, contains a listed P waste or listed U waste).

Waste Code means the EPA or MDEQ designated code describing the waste (i.e. D001 = ignitable, D002 Corrosive, 029L means other used oil, etc.).

Universal waste means any of the hazardous wastes that are identified in Rule 299.9228(1) of Michigan Public Act 451 of 1994, Part 111 Hazardous Waste Management, as amended.

B.3 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments.