36C24419Q0088_1.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 NeuroStar Treatment Sessions 15215 36C24419Q0088 12-24-2018 N 334510 Department of Veterans Affairs Network Contracting Office 4 Caroline L. Robinette 1010 Delafield Road Pittsburgh, PA 15215 Caroline L. Robinette, Contract Specialist Caroline.Robinette@va.gov Lebanon VA Medical Center 1700 South Lincoln Avenue Lebanon, PA 17042

USA

Caroline.Robinette@va.gov Contract Specialist Email Address

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Contracting Office Address Department of Veterans Affairs Network Contracting Office (NCO) 4 1010 Delafield Road Pittsburgh, PA 15215 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-101 effective October 26, 2018, and the Veterans Affairs Acquisition Regulation (VAAR). The complete text of any of the clauses and provisions may be accessed in full text at www.acquisition.gov.

This solicitation is being competed with a 100% Small Business Set Aside. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing, with a small business size standard of 1250 Employees.

*Note: To be eligible to receive an award from this RFQ, SDVOSB and VOSB vendors must be registered and certified in the VIP database.

The Lebanon VA Medical Center; 1700 South Lincoln Avenue; Lebanon, PA 17042 has a brand name requirement for NeuroStar Treament Sessions. The specific item required and quantities is listed within the schedule. The Specific requirements for the treatment sessions are listed within Attachment 1, Statement of Need.

All interested companies shall provide quotations for the following:

Supplies

Services Vendor shall upload the required items onto the Lebanon VAMC’s NeuroStar Treatment System.

Delivery shall be provided no later than 30 days after receipt of order/award of contract. Delivery of the order shall be FOB destination. Uploading of the licenses shall be coordinated with VA’s COR following award of the purchase order.

Place of Performance

1700 South Lincoln Avenue Lebanon, PA

Offerors are requested to quote Firm Fixed Price for the line item on the Schedule of Supplies and Services attached to this solicitation. The Schedule of Supplies and Services is included as Attachment 2 to this solicitation.

Any award resulting from this solicitation will be issued on a Standard Form 1449.

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

Interested vendors are advised to monitor www.FBO.gov for any amendments to this solicitation that may be posted.

Vendors are advised that any questions concerning this solicitation must be sent in writing to the Contract Specialist at NCO 4, Pittsburgh, PA. Questions may be sent via email to Ms. Caroline L. Robinette at Caroline.Robinette@va.gov. No questions will be answered after 2:30 p.m. on Friday, December 21, 2018.

The following FAR and Veterans Affairs Acquisition Regulation (VAAR) provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” (OCT 2018) The following instructions are added as addenda:

a. Gray market items are Original Equipment Manufacturer’s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufacturers or gray market items will be acceptable.

b. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

c. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

Evaluation of this requirement will be based on PRICE ONLY.

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (OCT 2018)

The following provisions apply and are incorporated by reference and full text:

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://www.acquisition.gov

The Government intends to award a Firm-Fixed-Price Purchase Order as a result of this Request for Quote to the responsible offeror quotes the lowest price and meets the delivery schedule. Offerors must be determined responsible according to the standards of FAR Part 9 to be eligible for award.

The following FAR and VAAR contract clauses apply to this acquisition:

FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (OCT 2018)

VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2018)

(a) Definitions. As used in this clause-

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, e-mail, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the Contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the Contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A Contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI)

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances below, the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of clause)

VAAR 852.237-70 Contractor Responsibilities (APR 1984)

The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of [ ]. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from.

(End of Clause)

VAAR 852.246-71 Rejected Goods (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Clause)

VAAR 852.247-74, Advance Notice of Shipment (OCT 2018)

Three (3) work days prior to shipping item(s), the Contractor shall furnish the anticipated shipment date, bill of lading number (if applicable), and carrier identity to Dr. Daniel Weinstein and to the Contracting Specialist.

(End of Clause)

By-Reference: Attachment 3 – Records Management Obligations

By-Reference: Attachment 4 - VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

By- Reference: Attachment 5 – Contractor Rules of Behavior

FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (OCT 2018)

The following subparagraphs of FAR 52.212-5 are applicable:

52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) 52.219-28, Post Award Small Business Program Representation (Jul 2013) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50, Combating Trafficking in Persons (Mar 2015) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-1, Buy American-Supplies (May 2014) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018)

The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.

This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Offeror(s) shall list exception(s) and rationale for the exception(s).

Quote Submission Instructions:

Quotes shall be sent electronically via email to Caroline.Robinette@va.gov. All quotes are due by Noon on December 24, 2018. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

All Offerors shall submit the following: One (1) electronic copy of the quote. Quote should include pricing for each line item, total cost, and number of days for delivery.

Point of Contact Caroline L. Robinette, Contract Specialist Caroline.Robinette@va.gov

See attached document: Attachment 1 - SON-NeuroStar TMS Treatment Session Cards.

See attached document: Attachment 2 - Solicitation Schedule.

See attached document: Attachment 3 - RECORDS MANAGEMENT OBLIGATIONS.

See attached document: Attachment 4 - Appendix C Language.

See attached document: Attachment 5 - CONTRACTOR RULES OF BEHAVIOR.

See attached document: P03 JA BRAND NAME NEUROSTAR - 12-11-2018_01.

BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION, , AND Purpose. The purpose of this Business Associate Agreement (Agreement) is to establish requirements for the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) and in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH) Act, and the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), 45 C.F.R. Parts 160 and 164, for the Use and Disclosure of Protected Health Information (PHI) under the terms and conditions specified below.

Scope. Under this Agreement and other applicable contracts or agreements, will provide services to, for, or on behalf of .

In order for to provide such services, will disclose PHI to and will use or disclose PHI in accordance with this Agreement.

Definitions. Unless otherwise provided, the following terms used in this Agreement have the same meaning as defined by the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information (PHI), Required by Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

“Business Associate” shall have the same meaning as described at 45 C.F.R. § 160.103. For the purposes of this Agreement, Business Associate shall refer to , including its employees, officers, or any other agents that create, receive, maintain, or transmit PHI as described below.

“Covered Entity” shall have the same meaning as the term is defined at 45 C.F.R. § 160.103. For the purposes of this Agreement, Covered Entity shall refer to .

“Protected Health Information” or “PHI” shall have the same meaning as described at 45 C.F.R. § 160.103. “Protected Health Information” and “PHI” as used in this Agreement include “Electronic Protected Health Information” and “EPHI.” For the purposes of this Agreement and unless otherwise provided, the term shall also refer to PHI that Business Associate creates, receives, maintains, or transmits on behalf of Covered Entity or receives from Covered Entity or another Business Associate.

“Subcontractor” shall have the same meaning as the term is defined at 45 C.F.R. § 160.103. For the purposes of this Agreement, Subcontractor shall refer to a contractor of any person or entity, other than Covered Entity, that creates, receives, maintains, or transmits PHI under the terms of this Agreement.

Terms and Conditions. Covered Entity and Business Associate agree as follows:

1. Ownership of PHI. PHI is and remains the property of Covered Entity as long as Business Associate creates, receives, maintains, or transmits PHI, regardless of whether a compliant Business Associate agreement is in place.

2. Use and Disclosure of PHI by Business Associate. Unless otherwise provided, Business Associate:

A. May not use or disclose PHI other than as permitted or required by this Agreement, or in a manner that would violate the HIPAA Privacy Rule if done by Covered Entity, except that it may use or disclose PHI:

(1) As required by law or to carry out its legal responsibilities;

(2) For the proper management and administration of Business Associate; or

(3) To provide Data Aggregation services relating to the health care operations of Covered Entity.

B. Must use or disclose PHI in a manner that complies with Covered Entity’s minimum necessary policies and procedures.

C. May de-identify PHI created or received by Business Associate under this Agreement at the request of the Covered Entity, provided that the de-identification conforms to the requirements of the HIPAA Privacy Rule.

3. Obligations of Business Associate. In connection with any Use or Disclosure of PHI, Business Associate must:

A. Consult with Covered Entity before using or disclosing PHI whenever Business Associate is uncertain whether the Use or Disclosure is authorized under this Agreement.

B. Implement appropriate administrative, physical, and technical safeguards and controls to protect PHI and document applicable policies and procedures to prevent any Use or Disclosure of PHI other than as provided by this Agreement.

C. Provide satisfactory assurances that PHI created or received by Business Associate under this Agreement is protected to the greatest extent feasible.

D. Notify Covered Entity within twenty-four (24) hours of Business Associate’s discovery of any potential access, acquisition, use, disclosure, modification, or destruction of either secured or unsecured PHI in violation of this Agreement, including any Breach of PHI.

(1) Any incident as described above will be treated as discovered as of the first day on which such event is known to Business Associate or, by exercising reasonable diligence, would have been known to Business Associate.

(2) Notification shall be sent to and and to the VHA Health Information Access Office, Business Associate Program Manager by email at VHABAAIssues@va.gov.

(3) Business Associate shall not notify individuals or the Department of Health and Human Services directly unless Business Associate is not acting as an agent of Covered Entity but in its capacity as a Covered Entity itself.

E. Provide a written report to Covered Entity of any potential access, acquisition, use, disclosure, modification, or destruction of either secured or unsecured PHI in violation of this Agreement, including any Breach of PHI, within ten (10) business days of the initial notification.

(1) The written report of an incident as described above will document the following:

(a) The identity of each Individual whose PHI has been, or is reasonably believed by Business Associate to have been, accessed, acquired, used, disclosed, modified, or destroyed;

(b) A description of what occurred, including the date of the incident and the date of the discovery of the incident (if known);

(c) A description of the types of secured or unsecured PHI that was involved;

(d) A description of what is being done to investigate the incident, to mitigate further harm to Individuals, and to protect against future incidents; and

(e) Any other information as required by 45 C.F.R. §§ 164.404(c) and 164.410.

(2) The written report shall be addressed to:

and submitted by email to and to the VHA Health Information Access Office, Business Associate Program Manager at VHABAAIssues@va.gov F. To the greatest extent feasible, mitigate any harm due to a Use or Disclosure of PHI by Business Associate in violation of this Agreement that is known or, by exercising reasonable diligence, should have been known to Business Associate.

G. Use only contractors and Subcontractors that are physically located within a jurisdiction subject to the laws of the United States, and ensure that no contractor or Subcontractor maintains, processes, uses, or discloses PHI in any way that will remove the information from such jurisdiction. Any modification to this provision must be approved by Covered Entity in advance and in writing.

H. Enter into Business Associate Agreements with contractors and Subcontractors as appropriate under the HIPAA Rules and this Agreement. Business Associate:

(1) Must ensure that the terms of any Agreement between Business Associate and a contractor or Subcontractor are at least as restrictive as Business Associate Agreement between Business Associate and Covered Entity.

(2) Must ensure that contractors and Subcontractors agree to the same restrictions and conditions that apply to Business Associate and obtain satisfactory written assurances from them that they agree to those restrictions and conditions.

(3) May not amend any terms of such Agreement without Covered Entity’s prior written approval.

I. Within five (5) business days of a written request from Covered Entity:

(1) Make available information for Covered Entity to respond to an Individual’s request for access to PHI about him/her.

(2) Make available information for Covered Entity to respond to an Individual’s request for amendment of PHI about him/her and, as determined by and under the direction of Covered Entity, incorporate any amendment to the PHI.

(3) Make available PHI for Covered Entity to respond to an Individual’s request for an accounting of Disclosures of PHI about him/her.

J. Business Associate may not take any action concerning an individual’s request for access, amendment, or accounting other than as instructed by Covered Entity.

K. To the extent Business Associate is required to carry out Covered Entity's obligations under Subpart E of 45 CFR Part 164, comply with the provisions that apply to Covered Entity in the performance of such obligations.

L. Provide to the Secretary of Health and Human Services and to Covered Entity records related to Use or Disclosure of PHI, including its policies, procedures, and practices, for the purpose of determining Covered Entity’s, Business Associate’s, or a Subcontractor’s compliance with the HIPAA Rules.

M. Upon completion or termination of the applicable contract(s) or agreement(s), return or destroy, as determined by and under the direction of Covered Entity, all PHI and other VA data created or received by Business Associate during the performance of the contract(s) or agreement(s). No such information will be retained by Business Associate unless retention is required by law or specifically permitted by Covered Entity. If return or destruction is not feasible, Business Associate shall continue to protect the PHI in accordance with the Agreement and use or disclose the information only for the purpose of making the return or destruction feasible, or as required by law or specifically permitted by Covered Entity. Business Associate shall provide written assurance that either all PHI has been returned or destroyed, or any information retained will be safeguarded and used and disclosed only as permitted under this paragraph.

N. Be liable to Covered Entity for civil or criminal penalties imposed on Covered Entity, in accordance with 45 C.F.R. §§ 164.402 and 164.410, and with the HITECH Act, 42 U.S.C. §§ 17931(b), 17934(c), for any violation of the HIPAA Rules or this Agreement by Business Associate.

4. Obligations of Covered Entity. Covered Entity agrees that it:

A. Will not request Business Associate to make any Use or Disclosure of PHI in a manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if made by Covered Entity, except as permitted under Section 2 of this Agreement.

B. Will promptly notify Business Associate in writing of any restrictions on Covered Entity’s authority to use or disclose PHI that may limit Business Associate’s Use or Disclosure of PHI or otherwise affect its ability to fulfill its obligations under this Agreement.

C. Has obtained or will obtain from Individuals any authorization necessary for Business Associate to fulfill its obligations under this Agreement.

D. Will promptly notify Business Associate in writing of any change in Covered Entity’s Notice of Privacy Practices, or any modification or revocation of an Individual’s authorization to use or disclose PHI, if such change or revocation may limit Business Associate’s Use and Disclosure of PHI or otherwise affect its ability to perform its obligations under this Agreement.

5. Amendment. Business Associate and Covered Entity will take such action as is necessary to amend this Agreement for Covered Entity to comply with the requirements of the HIPAA Rules or other applicable law.

6. Termination.

A. Automatic Termination. This Agreement will automatically terminate upon completion of Business Associate’s duties under all underlying Agreements or by termination of such underlying Agreements.

B. Termination Upon Review. This Agreement may be terminated by Covered Entity, at its discretion, upon review as provided by Section 9 of this Agreement.

C. Termination for Cause. In the event of a material breach by Business Associate, Covered Entity:

(1) Will provide an opportunity for Business Associate to cure the breach or end the violation within the time specified by Covered Entity;

(2) May terminate this Agreement and underlying contract(s) if Business Associate does not cure the breach or end the violation within the time specified by Covered Entity.

D. Effect of Termination. Termination of this Agreement will result in cessation of activities by Business Associate involving PHI under this Agreement.

E. Survival. The obligations of Business Associate under this Section shall survive the termination of this Agreement as long as Business Associate creates, receives, maintains, or transmits PHI, regardless of whether a compliant Business Associate Agreement is in place.

7. No Third Party Beneficiaries. Nothing expressed or implied in this Agreement confers any rights, remedies, obligations, or liabilities whatsoever upon any person or entity other than Covered Entity and Business Associate, including their respective successors or assigns.

8. Other Applicable Law. This Agreement does not abrogate any responsibilities of the parties under any other applicable law.

9. Review Date. The provisions of this Agreement will be reviewed by Covered Entity every two years from Effective Date to determine the applicability and accuracy of the Agreement based on the circumstances that exist at the time of review.

10. Effective Date. This Agreement shall be effective on the last signature date below.

Department of Veterans Affairs Veterans Health Administration

By:

By:

Name:

Name:

Title:

Title:

Date:

Date:

End of Document