Sources Sought 36C25723Q1075 LAB SERVICES 6 JULY 2023.docx

SUBJECT*

36C25723Q1075 | NEW - Lab services

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 17 1901 Veterans Memorial Dr. Building #171 Temple TX 76504

POINT OF CONTACT*

Contract Specialist Alison Schuman alison.schuman@va.gov 254-899-6023

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Special Notice Special Notice

DESCRIPTION

Special Notice

Page 1 of Page 1 of

The North Texas Veteran Affairs Health Care System (VANTHCS) is seeking Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or Small Business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12.

NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE.

The North American Industry Classification System (NAICS) is 621511 Medical Laboratories Any SDVOSB, VOSB, or Small Business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance, and delivery information by notifying the Contract Specialist no later than 1400 PM Central Time, 14 July 2023. Notification shall be e-mailed to Alison Schuman at alison.schuman@va.gov.

Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope.

DISCLAIMER

This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice.

SUPPLIES OR SERVICES

PRICES/COSTS

The purpose of this contract is to provide quality laboratory services to Veteran patients. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following laboratory procedures/tests within the current published turnaround times in support of the VA North Texas Health Care System (VANTHCS) in Dallas, Texas.

Pricing includes all labor, materials, equipment and supplies necessary to perform certain human laboratory procedures/tests. Total annual estimated test volume is less than 50. The following menu is required but not limited. VANTHCS is not limited only to these tests for utilization. Test requests are dependent on the ordering physicians at VANTHCS. Contractor shall perform and provide results for, the following tests:

WORK STATEMENT

1. Contractor shall provide laboratory services to the Pathology & Laboratory Medicine Service of the VA North Texas Health Care System, Department of Veterans Affairs Medical Center, located at 4500 S. Lancaster Road, Dallas, Texas. Tests will be performed as prescribed by the VA attending physician.

2. Contractor shall have the capabilities for non-tuberculous mycobacterial testing specifically:

Ability to perform susceptibility testing (even if laboratory developed test) for: Clofazimine, Bedaquiline, Omadacycline and Tedizolid in addition to standard panel of drugs.

For rapidly growing mycobacteria perform 14-day incubation for clarithromycin MIC and presence of inducible erm gene. Ability to sequence erm41 to more accurately determine presence of mutations associated with inducible macrolide resistance.

Broth microdilution for antimicrobial susceptibility testing including provision of individual MICs in report.

Capabilities of rpoB sequencing for rapidly growing mycobacteria for enhanced identification.

Ability to sequence entire 16S upon request if needed for identification of mycobacterial species.

3. VA North Texas Health Care System (VANTHCS) makes no guarantee as to what volume of tests, if any, the contractor may receive. VANTHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor will provide appropriate CPT and LOINC codes, pricing, and sample reports for the new tests. Contractor shall provide to the methodology and ranges for results on any tests that are requested by representatives of VANTHCS.

4. Only fully licensed/ CLIA-accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered.

5. Contractor shall provide laboratory services to include analysis, reporting of analytic results, and consultation regarding selection, collection, transportation, and result interpretation. These procedures/tests shall be performed to the satisfaction of VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service, Chief of Staff, and the Contracting Officer’s Representative (COR).

6. Contractor shall provide all labor, equipment, and materials required to perform procedures/tests as stated herein.

7. Contractor will consult with VANTHCS laboratory personnel on test results as needed.

8. Contractor shall provide to VANTHCS the methodology, ranges, and expected turnaround time for results on any tests that are requested.

9. Contractor shall maintain test catalog that contains the minimum information:

· Test Name

· Test Description

· Test Code

· Specimen Requirements to include:

· Collection instructions

· Storage and Shipping instructions

· Rejection Criteria

· Turnaround time

· Set up day(s)

10. The Contractor may add new tests to the base FSS contract over the course of the contract performance as test volumes increase or when new technology becomes available. Since not all tests may be listed on the contract, due to low volume testing or facility preferences, any test that appears on the Federal Supply Schedule (FSS) fee schedule shall be billed at the FSS fee schedule amount. The Contractor shall supply a list of all tests on the FSS with their associated costs. Tests ordered that do not appear on either schedule shall be offered by the Contractor and will be billed at the fair/open market rate.

11. Contract shall cover a period from October 1, 2023, through September 30, 2028. Contract will be renewable for (4) option years. Pricing will be provided for the base year and each option year.

Base October 1, 2023, through September 30, 2024

12. These procedures/tests shall be performed to the satisfaction of Quality Assurance Surveillance Plan (QASP) outlined in this document. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

13. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

14. The Contractor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

15. The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to (1) furnish phase-in training and (2) exercise its best efforts and cooperation to affect an orderly and efficient transition to a successor.

16. Security Requirements: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA. A patient’s consent is not required (1605.1P24). The vendor is required to secure the PHI as required by HIPAA. See below.

EVALUATION CRITERIA

SECTION A: REQUIRED DOCUMENTS

The Contractor shall provide the following documentation with their offer:

1. Response to solicitation including pricing

2. Proof of CLIA Accredited laboratory certification.

3. Catalog that includes test menu and turnaround times. Testing must be performed on-site at the laboratory.

4. Professional Staff Curricula Vitae.

5. CAP and/or any other Proficiency Exam Participation and Exception Reports for the past two (2) years.

6. Performance improvement monitor data for the previous 12 months that include and are not limited to demonstration of:

· Number of lost/damaged specimens

· Number of cancelled specimens

· Delays in turnaround times (including but not limited to lack of staffing, lack of availability of reagents, instrumentation issues, etc.),

· Resolution of complaints

· Number of corrected reports issued

· Errors in reporting patient results

7. Three (3) references of current or prior contracts, consisting of at least two (2) governmental, including one federal, who can attest to the duration of overall service and performance and of documentation of successful interfacing. References to include the facility address, telephone number, email address, and contact person’s name who can validate experience within the last two (2) years.

SECTION B: REQUIREMENTS/SPECIFICATIONS

1. ORDERING AND REPORTING OF LAB REPORTS RESULTS: All lab reports shall be reported via secured fax and a hard copy of all lab results shall be sent via mail.

2. LAB REPORTS: All lab reports shall contain at a minimum the following information:

· Patient's full name

· Patient’s identification number

· Specimen Identification Number

· Patient’s Date of Birth

· Physician's name (if supplied)

· Patient's location (clinic/ward) (if supplied)

· Test ordered

· Date/time of specimen collection

· Date/time test completed

· Test result

· Reference intervals

· Toxic and therapeutic ranges, if applicable

· Flagged abnormal test results

· Reference laboratory specimen number

· Name and address of testing laboratory

· Any other information the laboratory has that may indicate questionable validity of test results

· Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing A. Notification of a test result that has been identified in the commercial reference Contractor laboratory as a critical or alert value shall be communicated by telephone to VANTHCS. A hard copy result must follow any telephonic reporting either by fax or computer-generated report.

B. Contractor shall provide daily, a report listing all delayed results and an updated completion estimate.

C. The Contractor shall state their policy and any associated fees for repeat testing if requested by the provider.

3. TURNAROUND TIMES: The Contractor shall provide timely (defined by the minimum and maximum turnaround times detailed in the description of requirements) and appropriate testing of patient specimens as requested by VANTHCS.

A. The Contractor shall provide a list of the estimated turn-around time.

4. SPECIMEN IDENTIFICATION: VANTHCS will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests.

5. TRANSPORTATION SERVICES:

A. The contractor is available to receive specimen/isolates packed and shipped in accordance with all DOT and IATA regulations Monday to Friday from commercial carriers.

B. During the term of this contract, this program may need to be updated and/or revised to comply with regulatory requirements. This documentation shall be made to the VISN 17 facilities upon their request.

6. CUSTOMER SUPPORT: Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows: New Years’ Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day and any other day specifically designated as a national holiday by the President of the United States.

Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the VA minimum time expectation for meeting this service:

A. Specimen Collection

1) Routine inquiries where the reference laboratory performs the actual testing - if further clarification on the collection requirements is needed, shall be addressed at the time of the inquiry.

B. Testing

1) Status of Ordered Testing - inquiries regarding the status of pending orders shall be addressed at the time of the inquiry.

C. Technical Expertise

1) Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within 1 day of initial inquiry.

2) Result interpretation inquiries shall be addressed within an appropriate timeframe.

3) Consultative services where information is required regarding the clinical significance of test or inquiries by the provider into what is the best test to order for more effective patient care shall be addressed within an appropriate timeframe.

D. Account Follow-up

1) Account follow-up that requires information general in nature yet specific to the account, e.g. test pricing, courier service problems, specimen results discrepancy issues, equipment repair, supply ordering, etc. shall be addressed within four (4) hours of the initial inquiry.

7. TEST CONTRACTOR POINT OF CONTACT: Contractor shall assign a specific account representative to VANTHCS. The Contractor shall provide the following point (s) of contact when immediate inquiry regarding the status of a pending test (s) is required:

A) Person (s) name (s): ____________________________________________________ B) Telephone number: ____________________________________________________ C) Fax number: _________________________________________________________

8. LICENSING AND ACCREDITATION:

A) Contractor shall be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency [i.e., College of American Pathologists (CAP)] with deemed status from the Center for Medicare and Medicaid Services (CMS), the Nuclear Regulatory Commission, Center for Disease Control, Medicare and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the reference laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA).

B) Personnel assigned by the contractor to perform these services covered under this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia.

C) Laboratory Director shall be a licensed pathologist, physician, or biologist.

D) Copies of all relevant permits, licenses and certification of the Contractor and any subcontractor of the primary Contractor if tests and/or services are sent to another facility for testing, shall be supplied in response to this solicitation. In addition, as these documents for the Contractor and subcontracted facilities are reissued for accreditation, reworded, or renewed the awarded Contractor shall supply a copy to VANTHCS annually.

9. QUALITY CONTROLS: By the end of each month following the end of the quarter, the contractor shall provide to the Laboratory Manager and COR a cumulative (year-to-date) summary report by test. The report shall include at minimum the following

· Number of tests performed

· Number of test rejections with reason for rejection

· TAT for each test order during that quarter A) Contractor shall immediately advise the Laboratory Manager and COR of any changes in methodology, procedure, reference ranges and any new test introduced, including CPT code.

B) Contractor shall provide the following information annually during the life of the contract:

1. Indication of average monthly volume of specified tests listed in this contract.

2. Provide address of processing sites under contract.

3. Proficiency testing data shall include a list of tests outside of the -+2SD range for the past two (2) years.

4. Laboratory and clinical consultation in epidemiological studies involving mycobacteria and other actinomycetes.

5. Clinical consultations to physicians and other healthcare workers in the treatment od diseases and infections caused by mycobacteria and other aerobic actinomycetes.

C) Contractor agrees to maintain the satisfactory service, reporting systems and quality control as specified herein. Acceptable performance will be determined annually by the criteria listed below.

Scoring – Average score value per category:

· Exceptional – 4

· Very Good – 3

· Satisfactory – 2

· Marginal – 1

· Unsatisfactory <1

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

Result delays are minimal.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Problem records

· Sendout records

· TAT reports

Telephone Support is responsive.

Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85%

· Problem records

Exercise of Option Period

Invoices are itemized by service or product received.

Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80%

Contractor will provide proactive notification of changes.

· Quality Bulletins

· Customer Letters

· Customer Contact Exercise of Option Period

Timely recall notification of reagent and supplies.

· Customer Letters

· Customer Contact Exercise of Option Period

· Invoice records

· Customer communications

· Problem records

· Troubleshooting records Exercise of Option Period

Timely follow-up on complaints.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Order records

· Invoice records

· Customer communications

· Problem records

· Troubleshooting records Exercise of Option Period

D. The Government may evaluate the quality of the professional and administrative services provided but retains no control over the medical professional aspects of services rendered (e.g. professional judgments, diagnosis for specific medical treatment).

10. INVOICING: Invoices must contain at a minimum the following information. Contractor shall provide this information on one original invoice:

A) Invoice number B) Contract number C) Proper CPT and LOINC Code D) Unit Cost E) Total Cost F) Date of Service

11. CANCELLATION: The government may terminate this contract at any time upon at least 30 days written notice by the contracting officer to the contractor. The contractor, with written consent of the contracting officer, may terminate this contract upon at least 30 days written notice to the contracting officer.

12. GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law.

13. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VANTHCS without the VANTHCS’ consent.

14. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written.

15. RECORDS MANAGEMENT: All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VA North Texas Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA North Texas Health Care System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

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

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA North Texas Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VA North Texas Health Care System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA North Texas Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

PRIVACY

a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS).

b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.

c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually.

d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA.

e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request.

SECURITY REQUIREMENTS

1. 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/subcontractor 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 is 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. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. 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.

d. 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.

e. 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.

f. 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.

g. 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.

h. 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.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor / subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. 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.

l. 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 COTR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. 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 Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR 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.

c. 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.

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

e. 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.

f. 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.

g. The contractor/subcontractor agrees to:

(1) 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:

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

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

(2) 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

(3) 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.

h. 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.

(1) “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.

(2) “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.

(3) “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.

i. 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, hotfixes, 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.

j. 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_ days.

k. 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 _30_ days.

l. 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.

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

a. 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 COTR 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.

b. 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.

c. 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.

d. 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, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. 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 COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor / subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is…