36C24422Q0671 SAM.docx

36C24422Q0671

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

36C24422Q0671 05-10-2022 Shea Matthews 412-822-3765 05-20-2022 4pm

EDT

00244 Department of Veterans Affairs Network Contracting Office 4 shea.matthews@va.gov

X

562119 $41.5 Million

N/A

Department of Veterans Affairs VISN 4 VAMCs (See PWS for all locations)

00244

Austin Payment Center

PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429

See CONTINUATION Page This procurement is being competed in accordance with FAR

13.5. NCO 4 is seeking a VISN-Wide service contract for the

pickup and destruction of Drug Enforcement Agency (DEA) scheduled controlled substances (CS). NCO 4 intends to award a 5-Year Indefinite Quantity contract from this solicitation.

Prospective vendors shall adhere to the instructions to Offerors found in Section E of this solicitation.

Intended Effective Date: TBD

Intended Expiration Date: TBD not to exceed 60 months from

Effective Date

All questions pertaining to this solicitation shall be emailed to shea.matthews@va.gov no later than 5 days prior to the Close date.

Service Contract Labor Standards Act (SCLS) applies in

Accordance with FAR 52.222-41

Contractor shall comply with all applicable wage & hour laws and is responsible for the correct wage titles.

See CONTINUATION Page

Kevin Balser Contracting Officer

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:

b. GOVERNMENT: Contracting Officer 36C244 shea.matthews@va.gov

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 PERFORMANCE WORK STATEMENT

VISN 04 CONTROLLED SUBSTANCE DESTRUCTION - CONSOLIDATED CONTRACT

SECTION 1 - ACRONYMS AND DEFINITIONS

1.1 Acronyms. Following are acronyms which may be used in place of full text throughout this Performance Work Statement:

1.2 Definitions. Following are definitions for words or phrases used throughout this PWS.

1.2.1 Calendar Days. Every consecutive day on the calendar, including holidays and weekends.

1.2.2 Contractor. A supplier or vendor having a contract to provide specific supplies or service to the Government. The term used in this PWS refers to the prime Contractor.

1.2.3 Contracting Officer. A person with authority to enter, administer, and terminate contracts and make related determinations and findings on behalf of the Government. The only individual legally authorized to bind the Government.

1.2.4 Contracting Officers Representative (COR). An employee of the U.S. Government appointed by the CO to administer the contract. Such appointment must be in writing and must state the COR’s scope of authority and limitations. This individual has authority to provide direction to Contractor if within scope of the contract, does not constitute and change to the contract, and has no funding implications. This individual does not have authority to change the terms and conditions of the contract.

1.2.5 Controlled Substance. A drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of Title 21 USC - Controlled Substances Act. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

1.2.6 Facility COR. An employee of the U.S. Government to assist with contract administration at the facility level and to liaison between Contractor, CO, and COR. Each facility will have an appointed FCOR. This individual is a subject matter expert and has authority to provide direction to Contractor within scope of the contract. This individual does not have authority to change the terms and conditions of the contract.

1.2.7 Quality Assurance. The Government procedures to verify provided Contractor services are performed according to acceptable standards.

1.2.8 Quality Control. All measures taken by Contractor to assure the quality of services provided meets contract requirements.

1.2.9 QASP. A written document specifying the methodology to be used to surveil Contractor performance.

1.2.10 Task Order. An order for services placed against this established contract.

SECTION 2 – GENERAL INFORMATION

2.1 Background.

The Veteran Integrated Service Network 04 (VISN04) is comprised of nine Veteran Medical Centers. VISN 04 requires the removal and disposal of Drug Enforcement Administration (DEA) scheduled controlled substances and pharmaceutical products from Veterans Affairs Medical Centers (VAMCs) and Community Based Outpatient Clinics (CBOCs) within the VISN at regular intervals in accordance with all rules and applicable regulations.

2.2 Scope of Work.

VISN 04 requires Contractor to furnish all services, material, and equipment necessary for sorting and packaging of DEA scheduled controlled substances, to include providing appropriate containers and qualified personnel necessary for the preparation, labeling, manifesting, transporting, and disposal of materials specified in this contract. The Government will not provide any material handling equipment or packing supplies. All services provided shall be in accordance with all applicable local, state, and federal regulations.

2.3 Period of Performance.

2.4 Contractor Personnel.

2.4.1 Contractor Personnel. Contractor must not employ persons for work if such personnel considered by the CO or COR/FCOR coordinator to be a potential threat to the facility’s operational mission or the health, safety, security, general well-being of the VISN 04 VAMC’s facility population.

2.4.1.1 Contractor’s employees shall provide all labor; supervision; materials; equipment; sanitized, disinfected, and labeled containers; transportation; facilities; supplies; and waste manifests.

2.4.1.2 Contractor’s employees shall collect, analyze, prepare, package, label, remove, transport, store, treat, and dispose of DEA controlled substances under the resulting contract in accordance with the terms and conditions, specifications, and in accordance with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), in accordance with all federal, state, and local (U.S. Environmental Protection Agency – EPA and Department of Transportation – DOT) laws, policies, and guidelines, and VA Controlled Substance requirements.

2.4.2 Training. Contractor is responsible for providing personnel of an adequate skill and educational level. Personnel involved in the performance of this contract shall have received training regarding the handling of repackaged and controlled substances and emergency procedures to be followed.

2.4.2.1 Contractor must maintain their skill and education levels throughout contract life. Personnel selected by the Contractor must have the necessary education and training to perform the requirements of the contract prior to reporting for disposal under the contract. Contractor shall provide documentation of all necessary training, credentialing, and certifications to properly comply with federal and state regulations for DEA controlled substance disposal

2.5 Quality Assurance. According to Clause 52.246-4 (Inspection of Services – Fixed Price) incorporated into the contract, the Government will evaluate the Contractor’s performance under this contract. For those tasks, listed on the PRS in Section 5.1.1 of this PWS, the COR/FCOR will follow the methods of surveillance specified in the QASP. The COR/FCOR will record all surveillance observations and at times when defective performance is observed. Government surveillance of tasks not listed in the PRS or by methods other than those listed in the PRS, such as provided for by Clause 52.246-4 may occur during the performance period of the contract.

2.5.1 Contractor shall develop and maintain a quality program of unsure, refused, and repacking methods that are performed in accordance with commonly accepted commercial practices.

Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services.

2.6 Physical Security. Contractor is liable for any of Contractor’s personnel caused damage to Government property.

2.6.1 Contractor will be required to comply with physical security guidelines by either checking in with the VA Police each time the Contractor arrives on-site to perform contracted services or by obtaining a VA Contractor ID badge from the VA Police. The VA ID badge must be worn at all times while on VA property.

2.6.1.1 Contractor shall not have access to the VA network or any VA sensitive information under this contract.

2.6.1.2 Each facility will determine additional accessibility to the disposal pickups. Access to areas must be coordinated with the COR/FCOR and may require Government provided escort.

2.6.1.3 All Contractors must receive Privacy training annually using one of the following methods:

2.6.1.3.1 Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/SecureAuth35/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain.

2.6.1.3.2 Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the COR. Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR.

2.7 Hours of Operation.

2.7.1 Contractor must obtain from the COR/FCOR the site-specific hours of the disposal pickups. Contractor shall schedule pickups in advance by contacting the COR/FCOR coordinator.

2.7.1.1 Normal business hours are 8:00 AM to 4:00 PM, Monday through Friday.

2.7.1.2 Pickups outside of normal business hours will only be done with the preapproval of the COR/FCOR coordinator.

2.7.2 Multi-Site Complexes. Medical Centers may require substances to be picked up at multiple buildings or sites that are part of the medical center complex (i.e., 3 divisions/sites in Pittsburgh).

2.7.3 Weekends. Contractor services will not be required on weekends unless specified differently in subsequent sections of this PWS. Contractor may perform services on the weekends if approved by the COR/FCOR.

2.7.4 Federal Holidays. Contactor services will not be required on the following federal holidays:

New Year’s Day Martin Luther King Jr.’s Birthday President’s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

2.7.4.1 If a holiday falls on Sunday, the following Monday will be observed as the federal holiday. When a holiday falls on Saturday, the preceding Friday is observed as the federal holiday.

2.7.4.2 Any day specifically declared a holiday by the President of the United States is included.

2.8 Place of Performance. The following VISN4 locations shall be included under the terms of this contract. The Contractor shall be able to service all locations and addresses found below:

VISN 04 Medical Centers

Human Engineering Research Laboratories (HERL) 6425 Penn Avenue

See Section 6.3 for frequency of pickups at all above listed locations.

2.9 Records. Contractor is responsible for creating and maintaining federal, state, and local required records cited in this PWS, in other sections of the contract, or within incorporated contract clauses. See Section 10 for complete Records Management Language for Contracts.

2.9.1 Classification and packaging of controlled substances for transportation, labeling of containers, and providing a list of containers along with their assigned container numbers and classifications shall be performed by the Contractor's personnel in accordance with all applicable laws and regulations. In accordance with all applicable laws and regulations that becomes effective during the term of the contract.

2.9.2 Contractor shall provide all materials necessary for safe packaging in compliance with the applicable regulatory requirements. A detailed inventory of the contents of each container shall be prepared as the substances are packaged. A copy of this inventory shall be left with the VA Medical Centers.

2.9.3 Contractor shall maintain service records and submit them to COR/FCOR after each service.

2.9.3.1.1 The Contractor shall list all controlled substances designated for disposal on a disposal manifest (chain of custody paperwork) and a DEA form 222 (when appropriate) will be generated and a copy left within the pharmacy and the narcotic vault with facility validation for accuracy prior to the removal of medications from the facility. Any discrepancies shall be resolved prior to removal of the pharmaceuticals from the facility by the Contractor. The manifest list will include at a minimum product name, National Drug Code (NDC) or catalog number, strength, dosage form, and quantity. 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.).

2.9.4 Spill Report. When controlled substances are spilled by Contractor at any pickup or storage location during transport, Contractor shall submit Spill Report identifying the spills. Such incidents shall be reported to the COR/FCOR coordinator immediately, by telephone, and in writing no later than five business days after leaving the site.

2.9.4.1 The spill report shall list at a minimum the type of spill, amount of waste, and personnel exposed to the spilled waste.

2.10 Safety. Contractor must perform all work in a safe manner, ensuring the protection of Contractor personnel and facility population.

2.10.1 Contractor must comply with all applicable VA, VHA, VISN 04 VAMC, Federal, State, and Local Municipality directives, standards, ordinances, laws, and regulations to include but not limited to DOT, EPA, OSHA, and (JCAHO) Joint Commission on Accreditation of Healthcare Organizations directives, standards, laws, regulations, and guides.

2.10.1.1 Disposal shall be performed in such a manner as not to create conditions detrimental to public health or constitute a public nuisance.

2.10.2 Contractor must adhere to site-specific requirements (e.g. check-in and check-out procedures, pickup procedures, etcetera) provided by the COR/FCOR.

2.10.3 Contactor personnel performing controlled substance collection services must be certified and congruent with all laws and procedures. When requested by COR/FCOR, Contractor must provide personnel certification within three business days.

2.10.4 COR/FCOR reserves the right to stop work if unsafe practices are observed. Contractor must make corrections prior to work resumption at no cost to the Government.

2.10.4.1 The pickup area where containers are placed shall be maintained in a clean, orderly, and sanitary condition.

2.10.4.1.1 Particular attention shall be paid to the prompt cleanup of oil and/or grease spills, either generated from the vehicles used to haul containers or because of container leakage.

2.10.4.2 Contractor furnished containers shall be kept neat, in clean and sanitary appearance, and repaired or replaced as necessary.

SECTION 3 – GOVERNMENT FURNISHED AND SERVICES

3.1 Government Furnished Property. The Government will provide secure storage areas to store Contractor’s furnished containers. In some cases, the VA facility can package or consolidate their own substances and use Contractor provided packaging or consolidate the waste if it complies with Department of Transportation (DOT), DEA, and other regulations.

3.2 Government Furnished Materials. The Government will not provide GFM under this contract.

3.3 Government Furnished Services. The Government will not provide GFS under this contract.

SECTION 4 – CONTRACTOR FURNISHED PROPERTY, MATERIALS AND SERVICES

4.1 Contractor shall provide a price schedule to the Government that includes: Contractor’s prices for disposal of each classification of DEA scheduled controlled substances; pickup and delivery transportation fees; and prices for supplies and storage containers.

4.2 Contractor must provide all transportation, property, equipment, materials, supplies, safety equipment, and services required to ensure all contract terms are met.

4.3 Contractor shall provide all appropriate collection containers to the Government at a rate agreed upon in the Price Schedule. Containers, identifying labels, and markings shall meet applicable safety codes and regulatory requirements.

4.4 Contractor shall provide manufacture’s specification and descriptive literature for approval.

4.5 The Government reserves the right to have removed from the VAMC any Contractor equipment or not meeting standards expressed in this PWS.

SECTION 5 –CONTROLLED SUBSTANCE LAWS AND REGULATIONS.

5.2 Unidentified Waste Materials.

5.2.1. Characterizing Unknown Materials. Contractor shall identify or characterize unknown substance(s) and will identify and hold harmless the VAMC for all damages resulting from material(s) labeled as unknowns. No analytical work, other than on-site characterizations, will be performed without the consent of the COR/FCOR coordinator.

5.2.1.1. VAMC point of contact may elect to submit a sample of the unknown material(s) to Contractor in advance of the scheduled pickup for detailed classification. This material would then be included with the next scheduled pickup at the cost provided under the Price Schedule.

SECTION 6 – TASKS.

6.1 General Information. Contractor must provide all labor, material, equipment, maintenance, repair, supplies, transportation, management, expertise, and supervision necessary to perform the requirements of this service contract. In executing the requirements of this PWS, Contractor must satisfy the performance requirements included in this PWS and the requirements set forth in the Performance Requirements Summary located in Section 7 of this PWS.

6.1.1 The pharmacies at the VAMCs may accumulate repackaged items including medication processed into patient prescriptions, repackaged items for use within the facility, and other items removed from original packaging.

6.2 Standard Operating Procedures. Contractor shall provide a plan describing what will be followed while conducting normal controlled substance management activities.

6.2.1 Site safety and contingency procedures (e.g. spill management)

6.2.2 Operational procedures and site management structure.

6.2.3 Supplies and equipment practices.

6.2.4 Material sampling procedures.

6.2.5 Material assessment and categorization procedures.

6.2.6 Packing procedures.

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

6.2.8 Procedures for gaining substance acceptance into transfer/disposal facility.

6.2.9 Contractor and project management procedures.

6.3 Regular Pickup Situations. In non-emergency situations, Contractor shall coordinate with the designated facility COR/FCOR coordinator to schedule regular pickups with each VISN location listed in section 2.8 of this contract at least one (1) time per fiscal quarter, for a total minimum of four (4) times per year per location except for the Philadelphia and Pittsburgh locations. Both Philadelphia and Pittsburgh VAMCs require a total minimum of six (6) pickups per year. All CBOC locations will require scheduled pickups on a semi-annual basis only.

6.3.1 The Contractor shall initiate packaging of controlled substances for disposal within ten (10) business days of receiving telephonic notification from COR/FCOR coordinator that identifies waste disposal services.

6.3.1.1 The Contractor shall coordinate with the facility COR/FCOR to ensure that necessary packaging and storage supplies are available. If the facility is in need of additional containers or other supplies the facility shall be able to purchase supplies outlined in the price schedule referenced in section 4.1 of this contract and have them delivered as necessary for regular and irregular pickups. The Contractor may charge a supplies delivery fee as necessary based on the agreed upon delivery price.

6.3.2 Packaged wastes shall be removed from the facility and transported to a TSO (Temporary storage and disposal site) within five (5) business days after packaging.

6.3.3 If any substance requires a special permit to be issued before it can be transported to a TSO site, Contractor shall immediately notify the COR/FCOR or Contracting Officer that a special permit is required to move the substance. In addition, the approximate length of time that will be needed to obtain the necessary permit.

6.3.3.1 Contractor will be permitted to leave only the special permit substance at the medical center until the necessary permit can be obtained. It should not exceed past forty-five (45) calendar days.

6.3.3.2 Substances which require special permits for disposal, but not for transportation, shall be removed from VAMC within five (5) business days after packaging and taken to a TSO for holding until the necessary disposal permits can be obtained.

6.3.3.3 The facility COR/FCOR has the right to determine that a regular pickup is not needed. The COR/FCOR coordinator shall notify the Contractor of cancelation of a regular pickup before the pickup has been scheduled and the Contractor shall not be required to perform the pickup for that location within the fiscal quarter.

6.3.3.4 The Contractor shall not include any pickup fees for regularly scheduled pickups.

6.4 Emergency Situations. The COR/FCOR may require the Contractor to make unscheduled collections or disposals for emergencies, special events, or other unknown occasions. Contractor shall respond within 24 hours of the request and perform the emergency pickup within 72 hours of request. Unscheduled emergency services shall be ordered and billed in accordance with unit pricing limits established at the time this contract is signed.

6.4.1.1 The Contractor may include emergency rate pickup fees for emergency pickups. Transportation and pickup costs for emergency pickups shall be outlined in the price schedule.

6.5 Pickup Schedule. Contractor shall meet the pickup schedule specified by each VAMC (schedule and POCs will be provided upon award of contract). Depending on the type of waste, pickup schedules might vary. On an as needed basis the response time for disposal/removal will range from four (4) to five (5) business days.

6.6 Pickup Report. Contractor shall provide the COR a Pickup Report within 30 calendar days after each pickup is completed. Report shall reflect volume or weight of substances removed and disposed for each VAMC. Copies of this report shall be available to the COR/FCOR of each facility.

6.7 Billing and Payment. Invoices shall be submitted monthly, in arrears and shall include at a minimum:

6.7.1 Date of invoice

6.7.2 Contract number

6.7.3 Purchase order number

6.7.4 Vendor name

6.7.5 Invoice number

6.7.6 CLIN

6.7.7 Date of service

6.7.8 Volume and weight data for each type of substances collected

6.7.9 Any travel (including supporting documentation/receipts for all charges)

SECTION 7 – QUALITY ASSURANCE

SECTION 8 – PERFORMANCE REQUIREMENT SUMMARY

PERFORMANCE REQUIREMENTS SUMMARY

1st occurrence = written notice to the Contractor to correct the deficiency

2nd or more occurrence = Formal remedial meeting with the CO to discuss deficiencies and potential Cure Notice.

1st occurrence = written notice (CPR) to the Contractor to correct the deficiency

2nd occurrence = 2nd written notice (CPR) to the Contractor to correct the deficiency accompanied with CAP and document performance in CPARS

3rd or more occurrence =

1st occurrence = written notice (CPR) to the Contractor to correct the deficiency

2nd occurrence = 2nd written notice (CPR) to the Contractor to correct the deficiency accompanied with CAP and document performance in CPARS

1st occurrence = written notice (CPR) to the Contractor to correct the deficiency

2nd occurrence = 2nd written notice (CPR) to the Contractor to correct the deficiency accompanied with CAP and document performance in CPARS

1. Disposal manifest (chain of custody paperwork) and a DEA form 222

2. SOP

3. Insurance verification

4. Records of Inspections

2.10.3

6.2 2.6

7.1.1

1st occurrence = written notice (CPR) to the Contractor to correct the deficiency

1st occurrence = written notice (CPR) to the Contractor to correct the deficiency

SECTION 9- PRIVACY AND CONFIDENTIALITY

9.1 Privacy and Confidentiality. Contractors to the Department of Veteran Affairs may be unintentionally exposed to sensitive information that could potentially violate the privacy and confidentiality of our veterans, employees, volunteers and their families. Regulations such as, but not limited to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Freedom of Information Act (FOIA) and Privacy Act of 1974 have been enacted to protect sensitive information from being improperly disclosed. Information should not be divulged or released to anyone unless specifically authorized by this contract or its attached documents in accordance with the contracted services. Failure to comply with applicable statutes and regulation can result in the termination of this contract and civil and criminal penalties, including fines and imprisonment. All suspected or actual breaches of privacy and confidentiality should be reported immediately to the Contracting Officer, VISN 04 Contracting Officer's Representative (VCOR) or the Facility Privacy Officer. In the event that confidential information is incidentally disclosed in the performance of this contract, destruction of such material is required by an acceptable process such as incineration to ensure that any Protected Health Information (PHI) is fully destroyed making it unreadable and unable to be reconstructed. If there is reasonable cause to believe there has been incidental disclosure, Contractor will promptly investigate and report to the Contracting Officer the Contractor's determinations regarding any alleged or actual unauthorized use or disclosure, promptly resolve any problems identified by the investigation and if requested, submit a formal response to an allegation of unauthorized disclosure. Submission of a quote constitutes acknowledgement that controlled substance receptacle bags will not be opened in performance of contract and all Privacy and Confidentiality requirements will be enforced.

SECTION 10 – Records Management

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.

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.

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.

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.

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

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

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.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

SECTION 11 – ISO & PO Comments

The COR is responsible for ensuring that all Contractors comply with physical security policies. Contractor will be required to comply with physical security guidelines by either checking in with the VA Police each time they come on-site to perform contracted services or by obtaining a VA Contractor ID badge in accordance with VAPHS Policy. The VA ID badge must be worn at all times.

Contractor may not have access to the VA network or any VA sensitive information under this contract.

All Contractors must receive Privacy training annually using one of the following methods:

• Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/SecureAuth35/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain.

• Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the COR. Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR.

SECTION 12 – VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

1. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

B.3 PRICE/COST SCHEDULE

CLINS 0001-0056 –Year 1 CLINS 1001-1056 –Year 2 CLINS 2001-2056 – Year 3 CLINS 3001-3056 – Year 4 CLINS 4001-4056 – Year 5 IDIQ Minimum: TBD IDIQ Maximum: TBD Unit prices for each year of service at each location will be estimates only based on frequency of pickups. Volumes at all CBOC locations are not expected to be substantial. Vendors should consider the possibility of one, annual emergency pickup request at each VAMC when proposing prices.

ITEM INFORMATION

Altoona VAMC DEA Controlled Substance Disposal Services in accordnance with PWS PRINCIPAL NAICS CODE: 562119 - Other Waste Collection PRODUCT/SERVICE CODE: F108 - Environmental Systems Protection - Environmental Remediation

DuBois VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Huntingdon County VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Indiana County VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Johnstown VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

State College VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Butler VAMC DEA Controlled Substance Disposal Services in accordnance with PWS

Armstrong County VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Clarion County VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Cranberry Township VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Lawrence County VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

Michael A. Marzano CBOC DEA Controlled Substance Disposal Services in accordnance with PWS

Coatesville VAMC DEA Controlled Substance Disposal Services in accordnance with PWS

Delaware County VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS

West Norriton VA Clinic DEA Controlled Substance Disposal Services in accordnance with PWS