36C24120Q0180-003.docx

36C24120Q0180

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

650-20-1-104-2353 36C24120Q0180 04-17-2020 Gail Grundy 774-826-3358 04-27-2020 4pm Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301 X N 339113 750 Employees N/A X Department of Veterans Affairs VA Boston Healthcare System 940 Belmont Street Brockton MA 02301 Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

Payment will be made via Government purchase card on individually placed orders.

See CONTINUATION Page This solicitation is to obtain a contractor who can supply and offer a comprehensive "Veterans Lactation Package" to include all listed minimum items and service:

See attached Statement of Need and Specification This is a five-year contract, period of performance will be from May 11,2020 to May 10,2025 This IDIQ contract:

All individual task orders will be procured with a government purchase card.

This solicitation is for a commodity contract with a support service included.

See CONTINUATION Page To be identified on individual task orders and/or purchase card orders.

x X Clark Crandall 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: Gail Grundy

b. GOVERNMENT: Contracting Officer 36C241 Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

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.

Payment will be made via Government purchase card on individually placed orders.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Medela Advanced Breast Pump, Double Electric/2 Phase Technology

Nursing Bras, Set = 3 Total (2 regulars, 1 Sleep), B-G Cup size

Nursing Pads, Washable, Set = 12

Lanolin, Tender CareTM, 1 tube = 4 ounces

Premium Maternity Support Belt or Post-Partum Belt

Quick CleanTM Micro-SteamTM bags, or equivalent, Set = 5

Pump & SaveTM bags, or equivalent, Set = 40

OPTION – IF THE VA WERE TO REQUEST THIS PRODUCT WITH A CONTRACT MODIFICATION DURING THE CONTRACT - Portable, rechargeable battery-powered Breast Pump with backpack and accessories

(for information purposes only, please do no quote on this item)

OPTION – IF THE VA WERE TO REQUEST THIS PRODUCT WITH A CONTRACT MODIFICATION DURING THE CONTRACT - Nipple correction cups to assist with breastfeeding, Set = 2

OPTION – IF THE VA WERE TO REQUEST THIS PRODUCT WITH A CONTRACT MODIFICATION DURING THE CONTRACT - Disposable Bra Pads, Set = 30

B.3 DELIVERY SCHEDULE

180.00

180.00

180.00

180.00

180.00

180.00

180.00

0.00

0.00

0.00

B.4 STATEMENT OF WORK AND SPECIFICATION – Lactation Package PROJECT NAME: VISN 1 Maternity Care Coordination (MCC) Program

1. Purpose and Scope: The Maternity Care Coordination (MCC) Program Coordinator received feedback (both verbal & written) several years ago from Women Veteran mothers who reported that the previous breast pump offered through VISN 1 was awkward and did not function well. Additionally, Women Veterans were not receiving the supplemental supplies (e.g. nursing bras) that they were entitled to through the Program.

The contractor must offer a comprehensive “Veterans Lactation Package” which includes at minimum:

a) An Advanced Breast Pump with Double Electric/2 Phase Technology with an instructional DVD for operation of the pump.

b) Nursing Bras (All Sizes) 2 regular/1 sleep

c) The proper fitting of these nursing bras

d) Washable Nursing Pads (Qty. 12)

e) Tender CareTM Lanolin (Qty. 1 – 4 oz. tube)

f) Premium Maternity Support Belt or Post-Partum Belt

g) Lactation phone support from a Board-Certified Lactation Consultant available six days a week (including one weekend shift).

h) Breastmilk collection and storage bags

· Minimum of 5 Quick CleanTM Micro-SteamTM bags, or equivalent

· Minimum of 40 Pump & SaveTM bags, or equivalent

Optional – separate from the required package:

· Portable, rechargeable battery-powered Breast Pump options for Women Veterans to use outside of the home, when needed, with backpack and accessories.

· Nipple correction cups to assist with breastfeeding

· Disposable Bra Pads

The contractor shall work with the MCC Program Coordinator to provide and distribute a comprehensive Veterans’ Lactation Package throughout the Program. This package will provide Women Veterans with the supplemental supplies and equipment that are needed to ensure the successful breastfeeding of their newborns. The contractor shall support the full extent and purpose of this Veterans’ Lactation Package to ensure a successful VISN 1 MCC Program.

2. Each Woman Veteran (estimated, no more than 250 Veterans, annually) who is enrolled in the VISN 1 MCC Program will have the opportunity to receive the Veterans Lactation package up to 3 months prior to delivery and up to 6 weeks post-delivery. The Woman Veteran will initiate this process through the VISN 1 MCC Program Coordinator. The MCC Program Coordinator will act as the liaison between the Veteran and the contractor; the MCC Program Coordinator will be charged with directly notify the Veteran’s PCP/PACT to place an order for the Lactation Package to contractor for any Woman Veteran within the MCC Program who would like to receive the Veterans Lactation Package. Once the contractor receives this information from the MCC coordination, the company will ship the lactation package directly to the Veteran.

3. Specific tasks the contractor shall perform include:

A. The packaging of safe and efficient lactation supplies, including:

a) An Advanced Breast Pump with Double Electric/2 Phase Technology with an instructional DVD for operation of the pump.

b) Nursing Bras (All Sizes) 2 regular/1 sleep

c) The proper fitting of these nursing bras

d) Washable Nursing Pads (Qty. 12)

e) Tender CareTM Lanolin (Qty. 1 – 4 oz. tube)

f) Premium Maternity Support Belt or Post-partum Belt

g) Lactation phone support from a Board-Certified Lactation Consultant available six days a week (including one weekend shift).

h) Breastmilk collection and storage bags

· Minimum of 5 Quick CleanTM Micro-SteamTM bags, or equivalent

· Minimum of 40 Pump & SaveTM bags, or equivalent

If the contractor offers alternative supplies to those on the aforementioned list, the company is required to submit clear and convincing evidence that the product(s) offered is/are “equal” to the brand name. Substitution of a Veterans’ Lactation Package product may not be made without the approval of the VISN 1 MCC Program Coordinator. To this, the vendor may be required to submit samples at no cost to the government for review and approval.

B. Each Veteran’s Lactation Package will be delivered to the specified woman Veteran via the order authorization initiated by the Veteran’s Primary Care Provider/PACT and completed by the VAMC Prosthetics department. Products shall arrive at the Veteran’s residence or preferred address no later than 21 days following receipt of the VA order.

C. All defective and/or inferior products must be replaced within 48 hours at no cost to the VA New England Healthcare System, VISN 1 MCC Program, and the Women Veterans.

D. It is the vendor’s responsibility to provide the VISN1 MCC Program Coordinator, the Contracting Officer, the Contracting Officer Representative and the Women Veterans with a recall notice on any product that may be defective and has been delivered as part of this contract, including model and serial numbers of the device/product.

E. A company representative shall contact the VISN1 MCC Program Coordinator, Ms. Judith Kuzdeba (or designee) at cell: 413-265-1300, no less than once per quarter to review the account, provide product information, and answer questions or to handle any problems that may arise.

4. The contractor shall submit invoices in a timely manner to the ordering Purchasing agent and/or the Contracting Officer Representative (COR) for approval for services provided under this contract.

5. Performance under this contract is subject to all VA and VHA regulations and policy without limitation as to those now in effect or as may be established.

6. Performance under this contract is subject to the oversight of the COR, in consultation with the MCC Program Coordinator.

7. This contract will be effective and shall begin on May 12, 2020 and shall be based for a period of five years. The contractor shall be notified within 30 days of the contract anniversary date of the VISN 1 MCC’s Program intent to renew. If the option periods are exercised by the VA, the contract will expire on May 11, 2025.

8. Delivery Services in support of delineated requirements will be performed over the time period of approximately 12 months from contract award, at which time the contract with be up for renewal.

9. Progress and Compliance: Compliance shall be measured by the Contracting Officer, Contracting Officer Representative (COR) and the MCC Program Coordinator as to the timeliness, efficiency, and product satisfaction of the Veterans Lactation Package upon delivery in VISN1 Women Veterans, as noted in the QASP, Quality Assurance Surveillance Plan.

10. If directed by the COR, persons whom the contractor proposes to perform under this contract shall be VA WOC (Without Compensation) or shall be under an Intergovernmental Personnel Agreement (IPA).

11. The aforementioned quantities under this contact are estimated (EST) quantities.

12. PAYMENT: Payment to the vendor shall be made utilizing the Government wide Purchase Card (Purchase Card) primarily, however other methods (e.g. Purchase Orders) for payment may be used. Method of processing and acceptance may include the Government-wide Purchase Card, 1358 Obligation, and/or 2237 via a FORCE Contracting purchasing document.

Government Wide Purchase Card. Offeror shall accept the Government wide Purchase Card for payment in full of any payments made. The Purchase Card shall be accepted over the phone and/or in person. The Purchase Card shall be accepted regardless of dollar amount. Credit Card usage fees will not be added onto the contract prices for purchases made by Government wide Purchase Card.

13. Proof of Delivery. As a condition of payment, the offeror must provide with the initial invoice for equipment delivered, a receipt bearing the signature of the VA beneficiary, family member, or legal custodian and date of delivery, the Contract Number, and Purchase Order Number.

14. INVOICES: Invoices should be mailed (or e-mailed via encryption) to the addresses specified below:

VAMC Bedford, MA ATTN: Prosthetics Representative (518/121) 200 Springs Road Bedford, MA 01730

VA Boston Healthcare System ATTN: Prosthetics Manager (523/121) 150 South Huntington Avenue Boston, MA 02130

VA Central Western Massachusetts Healthcare System (VAMC Northampton, MA) ATTN: Prosthetics Representative (631/121) 421 North Main Street Leeds, MA 01053

VA Connecticut Healthcare System ATTN: Prosthetics Manager (689/121) 950 Campbell Avenue West Haven, CT 06516

VA Maine Healthcare System (VAMC Togus, ME) ATTN: Prosthetics Manager (402/121) 1 VA Center Togus, ME 04330

VAMC Manchester, NH ATTN: Prosthetics Manager (608/121) 718 Smyth Road Manchester, NH 03104

VAMC Providence, RI ATTN: Prosthetics Manager (650/121) 830 Chalkstone Avenue Providence, RI 02908

VAMC White River Junction, VT ATTN: Prosthetics Manager (405/121) 215 North Main Street White River Junction, VT 05009

17. CONTRACT CHANGES: - The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which shall affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof.

18. CONTRACT MODIFICATION: – The services specified in this solicitation may be changed by written modification to this contract. All modifications shall be in writing and, except for cancellation, have the written consent of both parties. The modification will be prepared by the VA Contracting Officer in consultation with the VISN 1 Prosthetics Service Line.

19. CONTRACTING OFFICER’S REPRESENTATIVES: - The Contracting Officer’s Representative (COR) shall be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority. Reviewing and certifying invoices to ensure that they reflect accurately the work completed in accordance with the requirements of the contract. Through information entered by the Contractor and available in VISTA, the COR shall also verify that services billed were indeed rendered.

20. FEDERAL HOLIDAYS: The ten holidays observed by the Federal Government are:

or any other day specifically declared by the President of the United States to be a national holiday. The Contractor shall not be responsible for providing services on Federal Holidays, unless there is an emergency order.

*** “When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by U.S. Government agencies.”

21. THE JOINT COMMISSION, CMS AND OTHER SPECIAL REQUIREMENTS

Where the contract does not require Joint Commission accreditation or other regulatory requirements regarding worker competency, the Contractor must perform the required work in accordance with Joint Commission and CMS standards. The Contractor must demonstrate that he/she has met or exceeded Joint Commission and CMS requirements. The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; includes knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this solicitation; and listing of relevant continuing education for the last two years. The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the VA Contracting Officer’s Technical Representative (COR), or upon request, for each Contractor employee working on the contract.

The Contractor will be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

The Contractor is required to maintain records that document competence/performance level of the Contractor employees who participate in this contract are in accordance with Joint Commission, CMS and other regulatory body requirements. The Contractor will provide a current copy of the competence assessment checklist and annual performance evaluation to the COR for each Contractor employee working on this contract.

When changes in Contractor personnel are approved in accordance with the “Key Personnel” clause of the contract, the Contractor must provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above.

Where the contract does not require Joint Commission accreditation or other regulatory body requirements, the Contractor must perform the required work in accordance with Joint Commission and CMS standards. A copy of these standards may be obtained from The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

The websites for Joint Commission and CMS are: https://www.jointcommission.org/standards_information/standards.aspx https://www.cms.gov/regulations-and-guidance/regulations-and-guidance.html

22. SPECIAL CONTRACT REQUIREMENTS

A. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS: The Contractor shall assign to this contract the following key personnel: all individuals providing supplies and services to VA Beneficiaries AND for whom information about education and training is required to be submitted as a part of the response to this Request for Proposal including, but not necessarily limited to, those individuals who must meet the training requirements set forth in the GENERAL REQUIREMENTS SECTION.

During the first one hundred (100) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment.

The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 100-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions.

The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel. If the VA does not agree with the proposed substitutes and their qualifications, then VA will terminate the contract and the Contractor will not get the minimum.

For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure stated in paragraph (b) above. In all cases, the Network COR should be informed of the situation immediately.

B. HHS/OIG: To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care Programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website: www.exclusions.oig.hhs.gov for each person providing services under this contract. Further the Contractor is required to certify in its proposal that all persons listed in the Contractor’s proposal have been compared against the OIG list and are NOT listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

C. CONFIDENTIALITY OF PATIENT RECORDS: The Contractor is a VA Contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. The Contractor is considered to be a VA Contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA Contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over the Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

The Contractor will have and maintain access to digital certificates for all key staff (includes all offices covering the VISN 1 contract both in New England and at headquarters of the vendor) for the safe electronic transmission of patient information via patient encryption (e.g. PKI). The VA can assist the Contractor in getting PKI access. Any initial or recurring costs that may be incurred are the responsibility of the Contractor.

D. PRIVACY POLICY TRAINING: All contractor and subcontractor employees performing work under this contract and having access to patient records and other privacy act information are required to complete the Veterans Health Administration (VHA)’s mandatory VHA Privacy-HIPAA and Privacy-Information Security training courses.

a) Completion of the VA Privacy-HIPAA and VA Privacy-Information Security Trainings.

b) All contractor employees performing work under this agreement and having access to patient records and other privacy act information are required to complete the Veterans Health Administration (VHA)’s mandatory “VHA Privacy Policy” and “HIPAA/Information Security” training courses. A list of these contractor employees must be provided to the COR immediately upon award and annually thereafter to ensure VA TMS (Talent Management System) access and complete the VA training requirements.

https://www.tms.va.gov/secureauth35/ Submittal: Training completion certificates or proof of training for all applicable contractor employees shall be forwarded as one submittal package to the Contracting Officer and Contracting Officer’s Representative within fifteen (15) calendar days of Award. NOTE: If the contractor employees require a VA TMS account be set-up, an additional 15 calendar days are authorized for training completion.

23. Business Hours: The administrative business hours for the VA are 8:00am - 5:00pm, Monday through Friday, with Federal Holidays and weekends excluded except for emergencies. The Contractor is responsible for providing service coverage and meeting the terms of the contract 24 hours per day, 7 days per week, including weekends and holidays for any emergencies.

24. ADMINISTRATIVE REQUIREMENTS FOR CONTRACTOR EMPLOYEE COMPETENCIES

A. The Contractor will be responsible to ensure that Contractor employees providing work on this contract is fully trained and meet all competence and state licensure requirements to perform the required work and meet the VA Privacy training requirements.

B. The Contractor is required to maintain records that document competence/state licensure/ performance level of Contractor employees working on this contract in accordance with The Joint Commission and other regulatory body requirements.

C. When changes in Contractor personnel occur, the Contractor must provide evidence of orientation, the current competence assessment, state licensure and certifications, and current performance evaluation.

D. The Contractor will provide an update on employee competencies and state licensure on an annual basis, upon arrival of a new employee and upon request by the COR.

25. PERSONNEL POLICY

The Contractor shall assume full responsibility for the protection of its personnel furnishing services under this contract, in accordance with the personnel policy of the Contractor, such as providing worker’s compensation, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that the Contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose.

26. POLICIES AND PROCEDURES

The Contractor will provide in written and/or electronic format a copy of its company’s policies and procedures in relation to all administrative, quality, data accuracy, information security, and clinical activities.

27. REQUIRED CONTRACTOR REPORTS

As outlined in the QASP – Quality Assurance Surveillance Plan for this contract, the Contractor will provide required reports with current data and statistics outlined to the VA Contracting Officer and VA COR.

ADDITIONAL REQUIREMENTS:

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA):

Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS). As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities. The covered entity component of the Department of Veterans Affairs is the Veterans Health Administration (VHA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.

Business Associates must follow VHA privacy policies and practices. All Contractors and business associates must receive privacy training annually. For Contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing the VHA National Policy Training, other VHA approved privacy training or Contractor furnished training that meets the requirement of the HHS Standards for Privacy of Individual Identifiable Health Information as determined by VHA. For Contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA Privacy Policy training. Proof of training is required.

Contractors shall require its employees who have access to patient information to take annual privacy training at the Dept. of Veterans Affairs web site. The web site is available at https://www.tms.va.gov/secureauth35/

REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS):

a. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $150,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

b. Each Contractor whose contract award is estimated to exceed $150,000 is required to register with CPARS database at the following web address: www.cpars.gov. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the Contractor’s registered representative.

c. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the Contracting Officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have thirty days to submit any comments and re-assign the report to the VA Contracting Officer.

d. Failure to have a current registration in the CPARS database, or to re-assign the report to the VA Contracting Officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond.

CONTRACTING WITH PARTIES LISTED ON THE OIG LIST OF EXCLUDED INDIVIDUALS/ENTITIES:

a. In accordance with The Health Insurance Portability and Accountability Act (HIPAA) and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care Programs. Specifically, the listed parties and entities may not receive Federal Health Care Program payments due to fraud and/or abuse of the Medicare and Medicaid Programs.

b. Therefore, all offerors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.exclusions.oig.hhs.gov to ensure that the proposed candidate(s) and/or firm(s) are not listed. Offerors should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care Program, or causes such a claim to be submitted, may be subject to a minimum and maximum Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against health care providers and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal Program beneficiaries.

By signing the offer, the Contractor certifies that he/she has reviewed the OIG List of Excluded Individuals/Entities and that the proposed candidate(s) and/or firm are not listed as of the date the offer was signed.

TORT CLAIMS:

Contractor employees are not covered by the Federal Tort Claims Act. When a Contractor employee has been identified as a provider in a tort claim, the Contractor employee is responsible for notifying the Contractor’s legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor employee’s action or non-action is the responsibility of the Contractor and/or insurance carrier.

CITIZENSHIP-RELATED REQUIREMENTS:

Each affected Contractor employee as described in paragraph shall be:

A United States (U.S.) citizen; or A national of the United States (see 8 U.S.C. 1408); or An alien lawfully admitted into the United States for permanent residence as evidenced by an Alien Registration Receipt Card Form I–151.

Contractor shall return a signed certification as found in this solicitation.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

CONFIDENTIALITY & SECURITY MEASUREMENTS:

Confidentiality: VA will provide the Contractor with access to pertinent medical information for the purposes of providing a service to the VA. The Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of breach of confidentiality. Contractor shall adhere to Health Insurance Portability and Accountability Act (HIPAA) standards when available. Any person who knowingly or willingly discloses confidential information from the VA may be subject to criminal penalties. Any and all documentation related to the patient’s records during the duration of this contract is the property of the VA and will be returned to the VA by the Contractor upon the termination of non-renewal of this contract.

Authorization to release Information: The Contractor shall be subject to the Privacy Act of 1974. Federal Acquisition Regulations 52.224-I, Privacy Act Notification, and 52.224-2 Privacy Act, are provided in full text in the Addendum, The Contractor is not authorized to release any information. The VA is the sole entity authorized to release any information upon written authorization from the patient.

Patient Medical Information: Contractor personnel who obtain access to medical records or access hardware/software that may store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for infection with HIV, medical quality assurance records, or any other sensitive information protected under 38 U.S.C. §4132 or §3305, as defined by VA, shall not have access to the records unless absolutely necessary to perform the requirement. Any Contractor employee required to access pertinent data shall not disclose to other Contractor employees that are not involved in the performance of this task. Any violation of these provisions may involve imposition of criminal penalties.

Patient Medical Records Handling, Storage, and Retention: The Contractor shall store all medical records in a locked/secured room during the performance period of this requirement. The Contractor shall retain the records in a secure storage area for a period of 60 days after final delivery. The Contractor shall dispose/destroy the medical records at the Contractors primary place of performance by means of shredding all documents so that none of the data is legible.

Property in Possession of Subcontractors: In accordance with FAR Sub-Part 45.510, the Contractor shall require any of its subcontractors possessing or controlling government property to adequately care for and maintain that property and assure that it is used only as authorized by the contract. The Contractors approved property control system shall include procedures necessary for accomplishing this responsibility.

The Contractor shall maintain a VA beneficiary account folder in compliance with the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). All beneficiary files are subject to review by designated VAMC officials and accreditation surveyors on behalf of the VAMC during accreditation surveys or consultation. At a minimum the VA beneficiary folder will adhere to current Joint Commission standards or equivalent for patient record keeping.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE:

GENERAL

All Contractors and Contractor personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA, and VA personnel, regarding information and information system security. Contractor must follow policies and procedures outlined in VA Directive 6500, Information Security Program and its handbooks to ensure appropriate security controls are in place.

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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE