36C24918R0178-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Q Mobile Lithotripsy 37129 36C24918R0178 01-19-2018 N 621999 Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129 Pretial Caston, Contract Specialist pretial.caston@va.gov Robley Rex VA Medical Center Medical Services 800 Zorn Avenue Louisville, KY 40206 United States pretial.caston@va.gov pretial.caston@va.gov

COMBINED SYNOPSIS/SOLICITATION

Mobile Lithotripsy Services

This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6, and is being conducted under Simplified Acquisition Procedures of FAR Part 13; VA will conduct the procurement in accordance with a combination of FAR Part 12, Acquisition of Commercial Items and Part 13, Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Proposals are being requested and a written solicitation will not be issued.

(ii) This solicitation is issued as a request for proposal (RFP). Submit a written proposal on RFP 36C24918R0178. The Government requires that all Contractors doing business with this office be registered with System for Award Management (SAM). No award can be made to a company not registered in SAM. For additional information and to register in SAM, please access the following web site: https://www.sam.gov/. Please ensure that the representations and certifications are completed to allow Contracting Officers to determine your business size and any additional socio-economic categories, if applicable.

In order to register, all firms must have a Dun & Bradstreet Number. A Dun & Bradstreet number may be acquired free of charge by accessing the Dun & Bradstreet website at https://iupdate.dnb.com/iUpdate/viewiUpdateHome.htm;jsessionid=55B24DAB2EC255669C07D65FA0B98930.app1 or by phone at (800) 234-3867.

(iii) The provisions and clauses incorporated in this solicitation document are those put into effect through Federal Acquisition Circular 2005-95, January 13, 2017. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) can be found at http://www.arnet.gov/far (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) at http://vaww.appc1.va.gov/oamm/vaar.

(iv) This solicitation is issued as a set aside for Small Business. The North American Industry Classification System (NAICS) code is 621999 and the size standard is $11M.

(v) This combined synopsis/solicitation is for the following commercial service:

This is a non-personal services contract for Mobile Lithotripsy Services for the Robley Rex VA Medical Center in Louisville, Kentucky. The Contractor shall furnish certified and trained employees to provide Mobile Lithotripsy Services and operation of the equipment in accordance with the specifications listed below to meet the customers need:

· Providing portable, state-of-the-art digital Mobile Lithotripsy equipment;

· Assisting in a timely manner the Attending Urologist(s) and other physicians in providing Mobile Lithotripsy services;

· Operating the Mobile Lithotripsy equipment;

· Maintaining the equipment to ensure it is in the highest level of functioning condition; obtaining all licenses, approvals, permits and be in compliance with all Federal, state and local laws and regulations applicable to the equipment and delivery of Mobile Lithotripsy related services;

· Completing all applicable annual mandatory VA training; and

· Delivery of all reports, digital film and file records of all procedures performed with the equipment to the Contracting Officer’s Representative (COR) on the same day services are performed.

(vi) The period of performance is indicated below:

Base Period – March 1, 2018 through February 28, 2019

· CLIN 0001- Mobile Lithotripsy cases. The estimation is that there will be three (3) cases per month and a total thirty-six (36) for the base year period.

Option Year 1 - Period of Performance: March 1, 2019 through February 29, 2020

· CLIN 1001- Mobile Lithotripsy cases. The estimation is that there will be three (3) cases per month and a total thirty-six (36) for options year one (1).

Option Year 2- Period of Performance: March 1, 2020 through February 28, 2021

· CLIN 2001- Mobile Lithotripsy cases. The estimation is that there will be three (3) cases per month and a total thirty-six (36) for option year two (2).

Option Year 3- Period of Performance: March 1, 2021 through February 28, 2022

· CLIN 3001- Mobile Lithotripsy cases. The estimation is that there will be three (3) cases per month and a total thirty-six (36) for option year three (3).

Option Year 4- Period of Performance: March 1, 2022 through February 28, 2023

· CLIN 4001- Mobile Lithotripsy cases. The estimation is that there will be three (3) cases per month and a total thirty-six (36) for option year four (4)

The Government anticipates making a single firm, fixed price contract award. The Robley Rex VA Medical Center in Louisville, Kentucky, has a need for the provision of Mobile Lithotripsy services per the following Performance Work Statement:

(vii) PERFORMANCE WORK STATEMENT

MOBILE LITHOTRIPSY SERVICES COVERAGE

PERFORMANCE WORK STATEMENT

I. STATEMENT OF OBJECTIVES

The Contractor shall furnish certified and trained employees to provide Mobile Lithotripsy Services and operation of the equipment in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Robley Rex VA Medical Center (603), 800 Zorn Avenue, Louisville, KY 40206. Mobile Lithotripsy services would include, but not limited to:

· Providing portable, state-of-the-art digital Mobile Lithotripsy equipment;

· Assisting in a timely manner the Attending Urologist(s) and other physicians in providing Mobile Lithotripsy services;

· Operating the Mobile Lithotripsy equipment;

· Maintaining the equipment to ensure it is in the highest level of functioning condition; obtaining all licenses, approvals, permits and be in compliance with all Federal, state and local laws and regulations applicable to the equipment and delivery of Mobile Lithotripsy related services;

· Completing all applicable annual mandatory VA training; and

· Delivery of all reports, digital film and file records of all procedures performed with the equipment to the Contracting Officer’s Representative (COR) on the same day services are performed.

It is understood that the quantities presented for bid are in good faith estimates and that the actual numbers may be greater or less than those stated.

The Authority for this procurement extends from Public Law 104-262 and Title 38 U.S.C., Section 8151-8153. The solicitation is for a contract for a base period of one year with four one-year option to renew. Mobile Lithotripsy services will be paid at an established rate per procedure. All Mobile Lithotripsy procedures will be done at the Robley Rex VA Medical Center.

A. SERVICES

1. The Contractor is to provide Mobile Lithotripsy equipment and related technical personnel and support to and at the Robley Rex VA Medical Center (VAMC), Louisville, Kentucky, in accordance with a regularly scheduled day per month to be mutually agreed upon between the parties. This monthly schedule will be coordinated with the VA Urology Advanced Practice Registered Nurse to ensure the patients are scheduled and the Contractor is available to provide Mobile Lithotripsy services. This schedule is subject to increase by mutual agreement between the VAMC and Contractor. The VA anticipates that an average of three (3) Veterans will be treated monthly per regularly scheduled list. The per-procedure pricing shall include single stone and multiple stone procedures per unilateral or bilateral episode. The equipment must be prepared to perform the first procedure of the day at a mutually agreed upon time and continue to perform procedures until the VAMC’s schedule for the day is completed.

2. The Contractor’s technical personnel shall be certified and trained in Mobile Lithotripsy services and operation of the equipment. The Technologist will assist the Attending Urologist and other physicians in the operation of the equipment. The Technologist may be required to operate the equipment and any related imaging equipment during procedures.

3. The Contractor shall be responsible for providing the following:

a. Provide portable, state of the art, digital equipment that can be easily moved into the Operating Room Suite at the Louisville VAMC. Equipment must meet or exceed the following criteria:

b. Such additional materials and supplies, including consumables (i.e., electrodes), as are necessary to conduct Mobile Lithotripsy procedures with the equipment.

c. Maintenance of the equipment to include service and preventative maintenance to ensure that the equipment is in the highest level of functioning condition.

d. Assist in the education of medical center personnel as it relates to Mobile Lithotripsy.

e. Be responsible for obtaining all necessary licenses, approval permits and be in compliance with all Federal, state and local laws and regulations applicable to the equipment and delivery of Mobile Lithotripsy related services provided for under the terms of this contract.

f. Delivery of all reports, digital, film and file records of all procedures performed with the equipment to the contracting Officer’s Representative (COR) located in the Surgical Service Administrative Office, Room A453, on the day the services are provided. These medical records shall be the property of the Robley Rex VA Medical Center, Louisville, Kentucky.

g. Contractor shall perform all services under this agreement in accordance with any and all regulatory and accreditation standards applicable to the facility, including without limitations, those requirements imposed by the Joint Commission (JC). Contractor shall provide consultation, if requested, in the development of protocols utilization review, peer review and risk management as required by JC and other regulatory bodies.

h. Contractor will perform services within the policies, procedures and regulations (such as the medical staff by-laws and professional standards board) governing the Robley Rex VA Medical Center, Louisville, Kentucky.

i. Timeliness: Timeliness is essential component of this contract and the Contractor must adhere to established timeframes for vision of service. Failure to provide the documentation required by this agreement or to provide documentation to support the charges being assessed will be seen as incomplete services and will result in delayed processing of invoices.

4. The VA Medical Center, Louisville, Kentucky, will provide the following:

a. Suitable electric service to operate the equipment;

b. Provide a secure room for the equipment while located on the premises;

c. Physician(s) to perform the procedure and appropriate personnel to administer any required anesthesia;

d. Scheduling of patient for Lithotripsy procedures and coordinating the scheduling of in-service relating to the equipment for facility staff;

e. Provide the pre-operative preparation of patients for Lithotripsy, obtain written patient consent forms and provide patients with the necessary services relating to post-procedure recovery. Facility shall be responsible for providing emergency service personnel, physicians, facilities and supplies necessary to provide patients with emergency medical care as may be required, as well as physicians, facilities and supplies necessary to provide patients with inpatient or outpatient post-procedure care.

f. Any pharmaceuticals required for the procedures;

g. Take all actions reasonably necessary to assist Contractor in achieving compliance with Federal, state and local laws and regulations.

h. Shall be responsible for the collection and disposal of infectious waste and sharps related to the Mobile Lithotripsy procedures.

B. INSPECTION: The VA Biomedical Engineering staff will inspect the Mobile Lithotripsy equipment upon each set up in the Operating Room Suite, prior to the first procedure.

C. RETREATMENT: If a Veteran must undergo an additional treatment within 90 days from their initial procedure due to continued problems with the stone(s); i.e., stone(s) was not broken down small enough to pass or fragments of the stone(s) remain; the Contractor will provide the treatment at 50% of the contract cost.

D. MEDICAL EQUIPMENT

1. The Contractor will maintain a system of notification of equipment hazards, defects and recalls and will maintain an effective, written recall plan.

2. The Contractor will have written equipment preventive maintenance policies and procedures and will maintain a system for tracking all preventive maintenance by serial number. All preventive maintenance will be performed by trained personnel and in accordance with manufacturer’s guidelines.

3. The Contractor is required to maintain medical equipment records that document the following:

II. SCHEDULE OF SERVICES

BASE PERIOD, March 1, 2018 – February 28, 2019

CLIN

Description

Unit

Est. Qty.

(Estimated 3 per month)

OPTION YEAR 1, March 1, 2019 – February 29, 2020

CLIN

Description

Unit

Est. Qty.

(Estimated 3 per month)

OPTION YEAR 2, March 1, 2020 – February 28, 2021

Description

Unit

Est. Qty.

(Estimated 3 per month)

OPTION YEAR 3, March 1, 2021 – February 28, 2022

Description

Unit

Est. Qty.

(Estimated 3 per month)

OPTION YEAR 4, March 1, 2022 – February 28, 2023

Description

Unit

Est. Qty.

(Estimated 3 per month)

TOTAL ESTIMATED CONTRACT VALUE (BASE, PLUS 4 OPTION YEARS)

NOTE: 52.217-8 Option to Extend Services is included as part of the solicitation and contract. The six-month extension must be evaluated as a part of the government's initial negotiation. Offerors are not required to submit pricing for clause 52.217-8. The prices offered for the last year’s option prices will be used for any extension exercised under FAR Clause 52.217-8.

III. TERM OF CONTRACT

This contract is effective for the period March 1, 2018 through February 28, 2019, with four (4) one (1) year options to renew. The option to extend for additional periods (if required) will be at the discretion of the Government. This contract is subject to the availability of VA funds.

IV. DEFINITIONS

Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter into, administer contracts, and make related determinations and findings.

Contracting Officer’s Representative (COR) - A person appointed by the CO to take necessary action to ensure the contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

Credentialing – is the systematic process of screening and evaluation qualification and other credentials, including licensure, required education, relevant training and experience, and current competence and health status

Privileging (Clinical Privileging) – Is the process by which a practitioner, licensed for independent practice; i.e., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training, and licensure. Clinical privileges must be facility-specific and provider- specific.

Veterans Health Administration (VHA) -- The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, DC

Veterans Integrated Services Network (VISN) – The regional oversight for the VA Medical Centers in Memphis, TN, Tennessee Valley Healthcare System (Murfreesboro and Nashville), Louisville, KY, Lexington, KY, Huntington, West Virginia and Mt. Home, TN. The VISN office is located at 1801 West End Avenue, Suite 1100, Nashville, TN 37203.

Veterans Integrated Systems Technology Architecture (VISTA) – A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

Computerized Patient Record System (CPRS) – Electronic patient charting system that houses all pertinent healthcare records; i.e., laboratory and radiology results, doctor’s orders, progress notes, surgery reports, etc.

V. QUALITY & QUALIFICATION REQUIREMENTS

A. If the providers are not employees of the Contractor, they must be regarded as sub-contractors. When this is the case, the Contractor will be responsible for all care rendered by any sub-contractor(s) and must ensure the sub-contractors meet all aspects of this contract.

VI. KEY PERSONNEL

A. The Contractor shall prepare and forward a listing of all Contractor personnel who will be performing services under this contract. The Contractor shall inform the contract employee that when filling out Standard Form 85, Questionnaire for Non-Sensitive Program, that there should be no gaps in employment history. Any gaps in employment history on Standard Form 85 may result in the Office of Personnel Management (OPM) rejecting the documentation for investigation. Vendor will provide a current list of all providers who will provide services upon the contract award date.

B. Contractor shall provide as to the contract:

1. During the first ninety (90) 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 3 below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph 3 to the Contracting Officer at least 15 days prior to making any permanent substitutions.

2. 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 CO. Proposed substitutes shall have comparable qualifications to those of the person(s) being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contractor will be modified to reflect any approved changes of key personnel. It is critical the COR and Contractor ensure the contract is amended to include any new key personnel to include salary lines for payment of invoices.

3. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days 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 procedures stated in A. above.

4. Key personnel as identified by the Robley Rex VA Medical Center are as follows*:

*VAMC Key Personnel will be provided upon Contract Award.

C. The Contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following for these personnel:

D. The parties agree that the Contractor, its employees, agents and Sub-Contractors shall not be considered VA employees for any purpose. The payment for any leave, including holiday pay, sick leave or annual leave is the responsibility of the Contractor and is included in the contract price.

VII. PATIENT RIGHTS AND SAFETY

A. The Robley Rex VAMC is not responsible or liable for any unsafe condition caused by the Contractor or Veteran.

B. The Contractor will have evidence of implementation of the Joint Commission National Patient Safety Goals as applicable.

Patient’s Rights and Responsibilities

1. Respect and Nondiscrimination:

· You will be treated with dignity, compassion, and respect as an individual. Your privacy will be protected. You will receive care in a safe environment. We will seek to honor your personal and religious values.

· Treatment will respect your personal freedoms.

· In order to provide a safe treatment environment for all patients or residents and staff, you are expected to respect other patients, residents and staff and to follow the facility's rules. Avoid unsafe acts that place others at risk for accidents or injuries. Please immediately report any condition you believe to be unsafe.

2. Information Disclosure and Confidentiality:

· You will be given information about the health benefits you can receive. The information will be provided in a way you can understand.

· You will receive information about the costs of your care, if any, before you are treated. You are responsible for paying your portion of any costs associated with your care.

· Your medical record will be kept confidential. Information about you will not be released without your consent unless authorized by law (an example of this is State public health reporting). You have the right to information in your medical record and may request a copy of your medical records. This will be provided except in rare situations when your VA physician feels the information will be harmful to you. In that case, you have the right to have this discussed with you by your VA provider.

· You will be informed of all outcomes of care, including any potential injuries. You will be informed about how to request compensation for any injuries.

3. Participation in Treatment Decisions

· You, and any persons you choose, will be involved in all decisions about your care. You will be given information you can understand about the benefits and risks of treatment. You will be given other options. You can agree to or refuse treatment. You will be told what is likely to happen to you if you refuse treatment. Refusing treatment will not affect your rights to future care but you take responsibility for the possible results to your health.

· Tell your provider about your current condition, medicines (including over-the-counter and herbals), and medical history. Also, share any other information that affects your health. You should ask questions when you do not understand something about your care. Being involved is very important for you to get the best possible results.

· You will be given, in writing, the name and title of the provider in charge of your care. As our partner in healthcare, you have the right to be involved in choosing your provider. You also have the right to know the names and titles of those who provide you care. This includes students, residents and trainees. Providers will properly introduce themselves when they take part in your care.

· You will be educated about your role and responsibilities as a patient or resident. This includes your participation in decision making and care at the end of life.

· If you believe you cannot follow the treatment plan, you have a responsibility to notify your provider or treatment team.

· You have the right to have your pain assessed and to receive treatment to manage your pain. You and your treatment team will develop a pain management plan together. You are expected to help the treatment team by telling them if you have pain and if the treatment is working.

· As an inpatient, you will be provided any transportation necessary for your treatment plan. You have the right to choose whether you will participate in any research project. Any research will be clearly identified. Potential risks of the research will be identified and there will be no pressure on you to participate. You will be included in resolving any ethical issues about your care. You may consult with the Medical Center's Ethics Consultation Service and/or other staff knowledgeable about healthcare ethics.

· If you or the Medical Center believes that you have been neglected, abused or exploited, you will receive help.

VIII. CONTINUUM OF CARE

All medical records pertaining to VA beneficiaries are and shall remain the property of the Department of Veterans Affairs and the Contractor IS PROHIBITED to release any information contained in the VA system of records. Any use or disclosure of information contained in these records must be in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act, and all other applicable state and federal statutes governing the use or disclosure of individually identifiable health information. Neither the Contractor nor anyone working on his/her behalf may use, disclose, or otherwise release any information on VA beneficiaries without the express, written consent of the patient or his/her legal guardian. At no time will the Contractor access or permit access to the electronic medical record of any VA beneficiary under the terms of this agreement. Inappropriate access to VA patient data will result in termination of access privileges and may result in criminal charges, penalties, fines or any combination thereof, and will be considered grounds for immediate termination of this agreement.

IX. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

A. The government will monitor the Contractor’s performance under this contract using the quality assessment and improvement procedures established by the VAMC and pursuant to the Inspection of Services Clause. Additionally, the Contractor’s performance is subject to scheduled and unscheduled review by quality assessment personnel as defined by the VAMC QASP Plan.

B. The VAMC shall monitor specific data to ensure Contractor compliance (see QASP).

C. The Contractor will provide statistical, quality assurance, and performance data in accordance with schedules established by VAMC. On a quarterly basis, the Contractor will provide the following:

1. Report with date of service, number of cases, name of Technician and whether services started on time;

D. This data will be provided to the COR/Administrative Officer, Surgical Service, through the Chief, Surgical Service on a quarterly basis, by the seventh (7th) workday of the month following the end of the quarter; i.e., 1st Quarter (October, November and December) submit by 7th workday in January; 2nd Quarter (January, February and March) submit by 7th workday in April; 3rd Quarter (April, May and June) submit by 7th workday in July; and 4th Quarter (July, August and September) submit by 7th workday in October. This information will be used for contract audit review documentation conducted at the VAMC on a quarterly basis.

E. In the event of non-receipt or delay in receipt of monthly quality improvement data, the morbidity and mortality reports and the on-call listing, the Contractor’s monthly invoice shall be reduced $1,000.00 per instance of non-compliance.

X. ENVIRONMENT OF CARE:

A. The Government will schedule and provide an initial orientation which all Contract staff shall attend prior to working in the VAMC.

B. The VAMC will provide all other ancillary personnel services required for performing services, including but not limited to nursing personnel, x-ray technologists, medical assistants and laboratory technicians.

C. The Government will provide an identification badge to each Contract personnel during facility orientation. The Contract personnel shall wear the identification badge on the front of the outer clothing at all times when providing services under this contract.

D. The Government shall provide space for consultations, conferences, study, telephone conversations and privacy.

XI. INFORMATION MANAGEMENT SECURITY VA HANDBOOK 6500.6, APPENDIX A

A. 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.

B. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

C. VA INFORMATION CUSTODIAL LANGUAGE

1. 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).

2. 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 onsite 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.

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

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

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

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

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

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

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

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

D. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

7. The Contractor/subcontractor agrees to:

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

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

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

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

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

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

a. “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

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

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

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

10. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 working days.

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

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

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

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

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

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

4. The Contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The Contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with Contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

5. The Contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another Contractor/subcontractor.