36C25021Q0106_1.docx

36C25021Q0106

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

506-21-1-1040-0002 36C25021Q0106 11-10-2020 Bartelt, Michele R.

734.845.5623 11-16-2020

12:00 PM

EST

Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105 X X 541380 $16.5 Million N/A X Department of Veterans Affair Ann Arbor VA Medical Center

WAREHOUSE

2215 Fuller Road Ann Arbor MI 48105 Y Department of Veterans Affair Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page The Contractor shall provide Preventative Maintenance and Services for the Clean Air Testing located at the Ann Arbor VA Medical Center in Accordance with Statement Work (SOW), Clauses, and Provisions Contained Herein.

All questions and requests for information must be submitted in writing to: Michele.Bartelt@va.gov by November 12, 2020 at 12:00 pm Eastern Standard Time.

See CONTINUATION Page X X Poole, Kelly J.

Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C25021Q0106

Page 1 of Page 1 of Statement of Work for Pharmacy Primary Engineering Control Certification, Testing, Preventative Maintence Service

B.2 STATEMENT OF WORK

A.1 INTRODUCTION: This requirement is for testing and certification of all the VA Ann Arbor Healthcare System Pharmacy and Nuclear Medicine facility’s primary engineering controls (PECs) and ISO classified clean rooms used for preparation of Compounded Sterile Preparations (CSPs) for human administration. PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), compounding aseptic isolators (CAI) and Isolators used to create an ISO Class 5 area for aseptic processing. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797>, or current guidelines for identified equipment every 6 months or earlier as noted.

A.2 BACKGROUND: The VAAAHS Pharmacy Service and Nuclear Medicine Service wishes to establish a contract for initial equipment certification, recertification and maintenance using standardized testing criteria appropriate for all PECs used pursuant to current USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although USP <797> states that certification procedures “such as” those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other “such as” procedures that may exist. Depending on the period of performance and option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) also has the authority to inspect VA medical facility sterile compounding facilities.

Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

A.3 SCOPE OF WORK:

This contract will include the following Services, facilities and equipment. Replacement equipment or new equipment added by the covered service(s) will be included within this service contract.

1. Pharmacy Service

a. Inpatient Pharmacy IV Room DB21, Investigational Drug Room DB15, Research G05.

b. Equipment: (total 6)

i. BSC1 Baker

ii. BSC2 Baker

iii. BSC3 Forma

iv. LAFW1 Baker

v. LAFW2 Baker

vi. LAFW3 Germfree

2. Nuclear Medicine

a. CapCell Isolator BSC Room D734

b. Equipment: (total 1)

i. BSC- Nuaire Model NU-SNR797-400 Serial# 143430032911 A.3.1 PEC Testing and Certification The contractor shall test and certify each PEC according to USP <797> and USP <800> using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006). Other applicable standards may be requested by the services, such as USP <825>. All PECs must:

· be certified to meet ISO Class 5 or better

· maintain unidirectional airflow

· be supplied by HEPA filtered air The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

· Viable and non-viable air particle counts

· Airflow testing

· HEPA filter leak test

· Induction leak/back-streaming test

· Cabinet leak test

· In-flow velocity test to include exhaust airflow volume rate

· Surface sampling

· Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs). Any media files must be provided in a format consistent with VHA media guidance.

A3.1.1 Laminar Flow Hoods (Laminar Airflow Workbench (LAWF), Integrated Vertical Laminar Flow Zone (IVLFW), and Class II Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test.

Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POCs upon request.

The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site point of contact(s) (POC see A.3.2.6) as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified POC as soon as practicable.

A3.1.2 Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

A3.1.3 Hazardous Compounding PECs Hazardous compounding PEC certification is required for:

· Negative Pressure Hoods

· Isolators

· PECs where robotic enclosure is used inside of the PEC The contractor shall test and certify each hazardous PEC to the manufacturer’s specifications. Tests shall include face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the hazardous PEC has an air flow monitor or controller, the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

· Company name, address and phone number

· Unit make, model and serial number

· Report number reflecting the room certification

· Location (room number)

· Certification date

· Recertification date

· Sash height (only for fume hoods)

· Technician signature A.3.2 All CSP Facilities must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019). Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

· Non-Viable Particle Counting under dynamic operating conditions

· Viable / Microbial Air Testing

· Viable / Microbial Surface Testing

· Airflow Volume Measurements

· Air Velocity Profile

· Room Air Exchange Rates

· Room Pressure Measurement

· In-Place Leak Testing of HEPA Filters

· Temperature, Relative Humidity Measurements

· Lighting Measurement

· Sound Level Measurement

· Airflow visualization test (Smoke study)

· Electrical leakage and ground circuit resistance and polarity tests

· Pass-through chamber air quality

A3.2.1 Viable and Non-viable Particle Counts For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> and USP <800> A.3.2.2 Air Changes per Hour The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. In the event that a room does not meet USP<797> and USP <800> requirements for ACPH the identified site POC(s) shall be informed immediately.

A.3.2.3 Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> (or USP <800> when applicable). The contractor shall report all pressures to an accuracy of 0.001” water column (3 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

A.3.2.4 Viable Environmental Sampling The contractor shall perform viable environmental (air) sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. In addition, semi-annual viable environmental surface sampling of classified areas will be performed.

· The interior of the PEC and any equipment contained in it (i.e. automated compounding devices, pumps or IV workflow system components)

· Staging or work area(s) near the PEC

· Frequently touched surfaces (as determined by department subject matter expert(s))

· Pass-through chamber(s)

· Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

· Surface Sampling: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates as directed by USP <797>. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Media used for viable surface tests must contain additives that neutralize disinfectant residues.

A.3.2.5 Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

· ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

· ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

· ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.

Report Requirements: All of the following information should be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable.

Reports to include at a minimum:

· Date and time of testing on each page of report. Page numbers should be in the following format “Page X of Y”

· Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the genus or species grown (reference USP <797> and USP <1116>).

· The identification of highly pathogenic microorganisms will be highlighted in the report.

· Action level for ISO area tested

· Executive summary or summary of findings.

· Room number and/or location

· Room type (e.g. oncology prep room)

· Type of PEC certified

· Serial number of the PEC certified

· Date and time samples collected and particle counts tested

· Technician collecting the samples

· Date of next required certification

· Standards used to test room

· Comments indicating when dynamic operating conditions were used

· Notes (comments, observations and findings as documented by field technician(s))

· Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

· Sketch identifying location of each sample obtained

· Total room area and volume

· Room humidity and temp

· Room air changes per hour

· Pressure differentials

· Nonviable particle counts (cfu’s), action level for target ISO level

· Viable particle count analysis

· Sketch of viable particle test location in room

· Viable sample results (cfu’s), action level

· Certificates of analysis of media used

· Comments indicating when dynamic operating conditions were used including number of personnel present, brief activity description.

A.3.2.7 Report Distribution The contractor will immediately notify identified points of contact with any results indicating failure prior to departing the VA facility. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

All completed reports will be provided via email to adam.pugacz@va.gov. In addition, facility specific reports will be provided to the following points of contact:

Kastriot.Shaska@va.gov (Pharmacy) Russell.Cutino@va.gov (Nuclear Pharmacy)

Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis.

A3.2.8 Testing Frequency:

· Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

· Environmental sampling (air and surface) will be completed quarterly (every 6 months), or more frequently by facility request if required to assess corrective actions associated with prior negative results. More frequent testing may be required should USP standards change during the performance period or option year(s).

· Room HEPA filter testing will be completed at least once yearly, or more frequently, if required, to assess corrective actions associated with prior positive results. More frequent testing may be required should USP standards change during the performance period or option year(s).

A3.2.9 Testing Schedule:

· Testing will be performed on a set rotation to assure that certification remains current and valid. This includes four (4) scheduled contractor visits every 12 months.

Base Year: Period of December 1, 2020 through November 30, 2021

Total Base Year

Option Year 1: Period of December 1, 2021 through November 30, 2022

Total Option Yr. 1 Renewal

Option Year 2: Period of December 1, 2022 through November 30, 2023

Total Option Yr. 2 Renewal

Option Year 3: Period of December 1, 2023 through November 30, 2024

Total Option Yr. 3 Renewal

Option Year 4: Period of December 1, 2024 through November 30, 2025

Total Option Yr. 4 Renewal

Grand Total (Base Year and Option Years I, II, III, and IV): $_________________ A.3.3 Personnel Training Contractor will provide a written documentation and credentials of technicians performing testing, service, certification or quality review. A resume or curriculum vitae will be provided along with copies of current certifications.

A.3.4 Specific Contractor Requirements

1. CETA certified technicians

2. Certify equipment and facility per USP Chapter 797/800 requirements

3. Environmental Monitoring

a. Obtain viable (air and surface) and non-viable air particulate samples

b. Offers training for government personnel on environmental monitoring sampling

c. Can support environmental monitoring sampling performed by Pharmacy service personnel by providing sampling media B.1 Place of Performance:

B.1.a Required Services Per Facility:

Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment.

B.2 Period of Performance: Contract period is base year (12 months) with the option to renew annually for a total of five year contract period.

B.3 Special Considerations:

B.3.1 Contractor Furnished Materials:

· All materials and tools to complete the work identified.

· Contractor to ensure all staff that perform on-site testing arrive in clean apparel. Contractors will follow facility and service hand hygiene and gowning procedures for testing areas.

· All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments. Equipment must be visibly clean and in good repair. Government may request new equipment be obtained by the contractor for use within the cleanroom environment.

B.3.2 Government Furnished Materials and Services:

· The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

· The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

· The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

· May also provide desk phone service as needed.

B.3.3 Qualifications/References: VA Ann Arbor Healthcare System is seeking a qualified contractor that meets the following specifications:

· Technicians are CETA National Board of Testing (CNBT) certified. Certification status is presented by the contractor or readily available online for review.

· If a technician does not have a CETA certification (or a lapse occurs) a CETA certified technician must be a reviewer and signatory on certification reports.

· Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include: Hospital/Medical Center name, POC name, email address and phone number.

· Provide copy of clean room certification report for evaluation.

· If required, contractor (employees performing services at the facility) will attain VA clearance (i.e. attend VA training, identification card, etc.)

· Contractor is based within a 50 mile radius of Ann Arbor, MI or has available service technicians that meet that requirement.

· Contractor should be able to respond to emergency requests for service within a timely manner.

B.3.4 Security Requirements: There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return. Contractor will not require access to VA information technology systems or handle patient identifiable information (PII).

B.3.5 Additional Considerations The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.

Local facility POC(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Eastern Standard Time (CST), Monday through Friday, excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM EST (CST) to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

B.3.6 Liable Insurance Requirements Contractor must provide proof of liability insurance.

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

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

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

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

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

3. 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 COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT (NOT APPLICABLE)

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 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.

b. 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.

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;

(1) 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

(2) 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 7 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.