Preventative Maintenance Volcano IVUS Systems

Added: Mar 22, 2018 1:35 pm Modified: Mar 26, 2018 2:37 pmTrack Changes The purpose of this Amendment A00001 is to add the following IT Clauses. A Business Associate Agreement (BAA) is required.



VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE



GENERAL

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



2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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



b. All contractors, subcontractors, and third-party servicers and associates working with

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



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



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



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



3. Section 3 is not applicable and has been intentionally omitted.

4. Section 4 is not applicable and has been intentionally omitted.

5. Section 5 is not applicable and has been intentionally omitted.



6. SECURITY INCIDENT INVESTIGATION

a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.



7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of the VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.



b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.



c. Each risk analysis shall address all relevant information concerning the data breach, including the following:



(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) Date of occurrence;

(b) Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.



d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $0 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:



(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.



8. Section 8 is not applicable and has been intentionally omitted.



9. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:



(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]



b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually hereafter, as required.



c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete

Added: Mar 22, 2018 1:35 pm (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 36C24118Q0258 and the solicitation is issued as a request for quotation (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97.

(iv) This requirement is being issued as a unrestricted. The associated NAICS code is 811219.

(v) The Government intends to award a firm-fixed priced award for 12 months (04/02/2018-04/01/2019) with four (4) twelve month options. The Contractor shall provide all labor, supervision, material, equipment, and travel to perform f preventative maintenance of seven Volcano IVUS units at the Boston VAMC, West Roxbury Campus. Please see the attached Statement of Work, Price Schedule and Evaluation below for full requirement details and pricing submission.



Item #

Description- Base Year 04/02/2018-04/01/2019



Qty

Unit

Price

Amount

0001

Preventative Maintenance of 7 Volcano IVUS in accordance with the attached Statement of Work.



1

YR







Item #

Description- Option 1

04/02/2019-04/01/2020



Qty

Unit

Price

Amount

1001

Preventative Maintenance of 7 Volcano IVUS in accordance with the attached Statement of Work.



1

YR







Item #

Description- Option 2 04/02/2020-04/01/2021



Qty

Unit

Price

Amount

2001

Preventative Maintenance of 7 Volcano IVUS in accordance with the attached Statement of Work.



1

YR







Item #

Description- Option 3 04/02/2021-04/01/2022



Qty

Unit

Price

Amount

3001

Preventative Maintenance of 7 Volcano IVUS in accordance with the attached Statement of Work.



1

YR







Item #

Description- Option 4 04/02/2022-04/01/2023



Qty

Unit

Price

Amount

4001

Preventative Maintenance of 7 Volcano IVUS in accordance with the attached Statement of Work.



1

YR









TOTAL _______________________





(vi) T The Contractor shall provide all labor, supervision, material, equipment, and travel to perform f preventative maintenance of seven Volcano IVUS units at the Boston VAMC, West Roxbury Campus. Please see the attached Statement of Work for a full description of the requirement.

(vii) The Place of Performance is the Boston VAMC, West Roxbury Campuses, 1400 VFW Parkway, West Roxbury, MA 02132 . The period of performance shall be 12 months with one four (4) twelve month options.

(viii) Provision at 52.212-1, Instructions to Offerors Commercial (JAN 2017), applies to this acquisition in addition to the following addenda s to the provision: 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998); 52.204-22 Alternative Line Item Proposal (JAN 2017); 52.209-7 Information Regarding Responsibility Matters (JUL 2013) ; 52.216-1 Type of Contract (APR 1984); 52.217-5 Evaluation of Options (JUL 1990); 52.233-2 Service of Protest (SEPT 2006); 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JUL 2016) (DEVIATION); 852.233-70 Protest Content/Alternative Dispute Resolution (JAN 2008); 852.233-71; Alternate Protest Procedure (JAN 1998); 852.270-1 Representatives of Contracting Officers (JAN 2008);

(ix) Provision at 52.212-2, Evaluation -- Commercial Items, applies to this requirement.

Submission of Quotes:

(1) Quotes shall be received on or before the date and time specified in Section (xv) of this solicitation. We will not consider any quote that we receive after the deadline unless we receive it before we issue a purchase order; it is in the best interest of the Government and it will not delay our purchase.

(2) Quotes shall be submitted electronically via email to Tammy.Davis6@va.gov.

(3) Quote Format: The submission should be clearly indexed and logically assembled in order of the evaluation criteria below. The Contractor shall include its company name, address, DUNS and Cage Code.

(5) Questions shall be submitted to the Contract Specialist in writing via e-mail. Oral questions are not acceptable due to the possibility of misunderstanding or misinterpretation. The cut-off date and time for receipt of questions is 03/26/2018 at 12:00 PM EST. Questions received after this date and time may not be answered. Questions will be answered in a formal amendment to the solicitation so all interested parties can see the answers.



(6) Evaluation Process:

Award will be made to the best value, as determined to be the most beneficial to the Government. Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall be considered non-compliant and your quote could be removed from the evaluation process.

Quotes shall be evaluated under FAR Part 13.106-2(b) -- Evaluation of Quotations or Offers. After the evaluation of quotes, the Contracting Officer may negotiate final terms with one or more quoters of the Government s choice before issuing a purchase order. The Contracting Officer will not negotiate with any quoters other than those that represent the best value to the Government and will not use the formal source selection procedures described in FAR Part 15. The Contracting Officer may issue a purchase order to other than the lowest priced quoter.

The Government will award a contract resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: 



Price: The Vendor shall complete the Price Schedule (attached) with proposed contract line item prices inserted in appropriate spaces.

Past Performance: Provide (2) references of work, similar in scope and size with the requirement detailed in the Performance Work Statement. References must include contact information; brief description of the work completed, and contract # (if relevant).  Please utilize Attachment 3 Past Performance Worksheet for your references and please submit as part of your quote submission. References may be checked by the Contracting Officer to ensure your company is capable of performing the Statement of Work.  The Government also reserves the right to obtain information for use in the evaluation of past performance from any and all sources to include PPIRS.

Technical: The vendor s quote shall be evaluated to determine if the organization has the experience and capabilities to provide the requested services in accordance with the Statement of Work in a timely efficient manner. 

The Contractor shall demonstrate how it will utilize OEM trained personnel to perform the work.





Options: Except when it is determined in accordance with FAR 17.206(b) not to be in the Government s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). The Government will evaluate prices for the option under FAR 52.217-8 by using the last year s option prices to calculate the price for six months of effort, and adding that amount to the base and other option years to arrive at the total.



(x) Please include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with your offer via the SAM.gov website or a written copy. Unless exempted by the Contracting Officer, you must register in SAM before we will issue a purchase order to you. If you do not register by the date set by the Contracting Officer, the Contracting Officer might issue the order to a different quoter. Once registered, you must remain registered throughout performance until final payment. Go to https://www.acquisition.gov for information on SAM registration and annual confirmation.

(xi) Clause 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition in addition to the following addenda s to the clause: 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (APR 2014); 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011); 52.228-5 Insurance-Work on a Government Installation (JAN 1997); 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013), 852.215-71 Evaluation Factor Commitments (DEC 2009); 852.203-70 Commercial Advertising (JAN 2008), 852.232-72 Electronic Submission of Payment Requests (NOV 2012); 852.237-70 Contractor Responsibilities (APR 1984).



SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.



52.217-8 -- Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days of contract expiration. (End of Clause)

52.217-9 --Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 3 Years and 6 Months.



Subcontracting Commitments - Monitoring and Compliance

This solicitation includes FAR 52.219-14 and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

(xii) Clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and in addition to the following FAR clauses cited, which are also applicable to the acquisition: 52.203-6, Restrictions on Subcontractor Sales to the Government (SEPT 2006); 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2016); 52.204-14, Service Contract Reporting Requirements (OCT 2016); 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015); 52.219-8, Utilization of Small Business Concerns (NOV 2016), 52.219-14 Limitations on Subcontracting (JAN 2017) ; 52.219-28 Post Award Small Business Program Representation (JUL 2013); 52.222-3, Convict Labor (JUNE 2003); 52.222-21, Prohibition of Segregated Facilities (APR 2015); 52.222-26, Equal Opportunity (SEPT 2016); 52.222-35, Equal Opportunity for Veterans (OCT 2015); 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014); 52.222-37, Employment Reports on Veterans (FEB 2016); 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010); 52.222-50, Combating Trafficking in Persons (MAR 2015); 52.222-54, Employment Eligibility Verification (OCT 2015); 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016); 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011); 52.225-13, Restrictions on Certain Foreign Purchases (JUNE 2008); 52.232-33, Payment by Electronic Funds Transfer System for Award Management (JUL 2013); 52.242-5, Payments to Small Business Subcontractors (JAN 2017); 52.222-41, Service Contract Labor Standards (MAY 2014); 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014); 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple Year and Option Contracts) (MAY 2014); 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015); 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017); (xiii) All contract requirement(s) and/or terms and conditions are stated above.

(xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this requirement.

(xv) RFQ responses are due 03/29/2018 at 12:00 PM. RFQ responses must be submitted via email to: Tammy.Davis6@va.gov. Hand deliveries will not be accepted. Submissions after the deadline may not be considered.

(xvi) The POC of this solicitation is Tammy Davis (Tammy.Davis6@va.gov).



STATEMENT OF WORK

PREVENTATIVE MAINTENANCE VOLCANO IVUS UNITS



1. Purpose

The purpose of this contract is to ensure the completion of preventative maintenance (PM) of seven (7) Volcano IVUS units to ensure safe operation and efficacy of the devices. This work shall include all parts, labor, and travel related to these services. The units are located at the Boston VAMC, West Roxbury, 1400 VFW Parkway, West Roxbury MA 02132. The serial numbers for the units are as follows: 103020095013; 103020084875; 121020084415; 103070029001; 106030404001; 103000597001; 103000596001.

2. Background

The Volcano IVUS Systems are highly complex medical devices used in invasive diagnostic imaging of cardiovascular patients in cardiovascular imaging areas of the West Roxbury VA Medical Center.

3. Contract Objectives

3.1.1 The contractor shall complete annual PM services including all operational specifications of the devices to ensure proper operation. The Contractor shall provide only original equipment manufacturer (OEM) technically qualified technicians who are formally trained on the above equipment. Service personnel shall have a good working knowledge of the equipment.



3.1.2 Complete this service in a timely manner as to not disrupt the flow of patient care beyond necessary and controllable limits.

3.1.3 Provide service documentation to Clinical Engineering upon completion of the PM service once completed.

4. Service Location

Services shall be completed on site at 1400 VFW Parkway, West Roxbury MA 02132 unless otherwise authorized by Clinical Engineering.



5. CONTRACTOR FURNISHED PROPERTY:

All materials required in the performance of this contract shall be furnished by the

Contractor. Availability of manufacturer's service literature needed in the performance of the contract

shall be Contractor's responsibility and will remain Contractor owned at the termination of the

contract.

The Government shall not be responsible for any damages or loss of Contractor supplies,

materials, or equipment.

The Government shall not be responsible for any damages or loss of the Contractor's

personal belongings, or those of the Contractor's employees, due to fire, theft, accidents or other

causes



6. SCOPE OF WORK

6.1 Qualified Technician shall report to the site as required. When departing, the technician

shall provide the service report with applicable information.

6.2 The performance of all services shall meet or exceed the specifications of the original

equipment manufacturer.

6.3 The Contractor is not responsible for the maintenance of equipment listed when damage

resulted from act of God, or Government neglect/misuse/abuse, or when services from other than

the Contractor's personnel have been performed.

6.4 The Contractor shall comply with applicable federal, state, and local laws and regulations.

6.5 The Contractor shall ensure that all maintenance services meet or exceed accreditation

requirements/standards of the Joint Commission on Accreditation of Healthcare Organizations.

7. CONTRACTOR PERSONNEL:

7.1 The Contractor shall provide technically qualified technicians to accomplish all

maintenance services required by the contract. Technician must have received formal

training presented by the original equipment manufacturer.

7.2 The Contractor shall designate a Point of Contact (POC) for the contract. The Contractor's

POC shall be authorized to discuss with the COR, any and all maintenance services required by

the contract and ensure response to requests for performance of the contract. The POC shall

have the authority to make decision for the Contractor. The Contracting Officer or the COR

shall be notified immediately whenever the POC changes. Contractor's POC shall be submitted

no later than 10 days after award of contract, and shall include as a minimum, name, title, and

telephone number.

7.3 The Contractor shall provide each employee an identification badge which shall be

displayed on their outer garment at all time when on duty. The badge shall include, as a

minimum, the employee's name, current picture, the Contractor's name, and title identification.

8. SAFETY:

8.1 When the Contractor leaves on-site location where maintenance services are being

performed, the site shall be lift in a clean, neat, and orderly condition ensuring the hospital staff

and patients are not subjected to any safety hazards, including but not limited to expose wiring,

open circuit panels, or tripping hazards.

9. Invoices shall be submitted monthly in arrears.