36C24718Q0194-004.docx

FedBizOpps Amendment to a Previous Combined Solicitation

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* = Required Field FedBizOpps Amendment to a Previous Combined Solicitation Rev. March 2010 R

STERILE PROCESSING TECHNICIANS FBO POSTING

30084 36C24718Q0194 01-29-2018 N 561320 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084 Darlene.Chase@va.gov Darlene.Chase@va.gov The purpose of this amendment is to post RFQ# 36C24718Q0194 due to previous system errors. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items", as supplemented with additional information included on this notice. This announcement constitutes the only solicitation; this is a Request for Quotation (RFQ), and a written solicitation document will not be issued. The solicitation number is 36C24718Q0194.

The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular FAC 2005-96 effective November 6th, 2017. The associated North American Industrial Classification System (NAICS) code for this procurement is 561320 and the Small Business Size standard is $27.5 Million. This combined/synopsis solicitation is set aside for Veteran Owned Small Businesses (VOSB’s) in accordance with VAAR 852.219-11. Only VA verified VOSB’s in the VIP at the time of contract award will be considered. All non-VIP verified firms will be considered non-responsive and ineligible for award. The acquisition will be made pursuant to the authority in FAR 13 to use simplified procedures for commercial items.

This RFQ is set-aside for 100% Service Disabled Veteran Owned Small Businesses and Veteran Owned Small Businesses.

The Atlanta VA Medical Center (AVAMC), Decatur, GA requires a contractor to provide labor of up to (16) Medical Supply Technicians with Central Sterile/Sterile Processing Services/ Sterile Processing Department (CS /SPS/ SPD) experience that have and maintain national central service certifications from a national body such as IAHCSMM or CBSPD, to support the Nursing Services, Sterile Processing Services (SPS), Nursing & Patient Care Service Line, in accordance with this statement of work.

GENERAL INFORMATION

Description: MEDICAL SUPPLY TECHNICIAN (Sterile Processing Services (SPS))

1. Purchase of Contract.

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Contractor shall provide minimum specifications contained herein. Work shall meet all applicable codes and regulations and is subject to the terms and conditions of the contract.

Background: The Atlanta VA Medical Center (AVAMC), Decatur, GA requires a contractor to provide labor of up to (16) Medical Supply Technicians with Central Sterile/Sterile Processing Services/ Sterile Processing Department (CS /SPS/ SPD) experience that have and maintain national central service certifications from a national body such as IAHCSMM or CBSPD, to support the Nursing Services, Sterile Processing Services (SPS), Nursing & Patient Care Service Line, in accordance with this statement of work. The contract will provide SPS/CS/SPD Technician staff to supplement on board staffing while recruitment efforts to fill vacant positions continue. Contract CS/SPS/SPD Technicians are required to assist in meeting staffing needs in multiple circumstances: (a) during recruitment of permanent staff because of identified areas of short staffing and additional shifts to support operating room and clinical procedures.

1. Performance Period:

BASE YEAR, PERIOD OF PERFORMANCE: MARCH 1, 2018 THROUGH 30 SEPTEMBER 2018:

OPTION YEAR ONE, PERIOD OF PERFORMANCE WILL BEGIN 1 OCTOBER 2018 THROUGH 30 SEPTEMBER 2019:

OPTION YEAR TWO, PERIOD OF PERFORMANCE WILL BEGIN 1 OCTOBER 2019 THROUGH 30 SEPTEMBER 2020:

In the event a contractor other than the incumbent is selected, the awardee shall give first opportunity to fill available positions to the personnel currently performing under the former contract. This precautionary measure is to ensure the personnel already in place will have the opportunity to support the contract while the awardee prepares to provide this service and ensure continuity of staffing services to the Atlanta VA Medical Center, without interruption.

DAYS AND HOURS OF OPERATION:

The sterile processing services department operates 24 hours per day, 7 days a week, Sunday through Saturday, subject to rotating shifts

Day Shift: 7:30am to 4:00pm Midday Shift: 10:30am to 7:00pm Evening Shift: 3:30pm to 12:00pm

a) Overtime shifts would be limited but could be utilized dependent upon the needs of the medical center and specific work areas.

b) The Contractor must notify the Atlanta VAMC COR in advance of proposed employee for the performance of the contract. The Contractor shall submit a resume of qualifications to the COR. All contractor employees will be approved by the COR prior to bringing on duty. If, at any time from the date of award to the end of the contract, specific Contractor employee is no longer available, the Atlanta VAMC will approve the qualifications of proposed replacement employee. The Contractor must inform the COR when employee is removed from the contract for any reason. The Contractor shall remove any employee member from the performance of this contract within 48 hours (2) workdays of receiving notice from the Contracting Officer that the employee’s performance is unsatisfactory. All contract employees are subject to immediate removal from the performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons.

Equivalent 2080 hours’ usage per for up to 16 technicians; Coverage equates to the full 2080 hours to ensure that in the event of employee vacation time or call in, services will continue to be rendered and there will be no interruption. The VA will not be responsible for paying contractor employee vacation or call-in.

a. PRINCIPLE DUTIES AND RESPONSIBILITIES:

The contractor employee shall rotate assignments among various Sterile Processing Services as specified under the terms of the contract. Assignments may include decontamination, instrument and surgical tray assembly, sterilization, and case cart preparation in a continually changing medical and surgical facility. Contractor shall staff sixteen (16) Sterile Processing (Central Sterile) positions for day, midday, evening shift or any shift on Saturdays and Sundays; totaling sixteen (16) positions each not more than 40 hours per weekend as determined by facility work requirements.

During each period of performance, contract personnel may be allowed to work overtime hours if a need arises within the department.

The contractor employee shall operate decontamination, high level disinfection, duties in reprocessing or monitoring critical and semi-critical Reusable Medical Equipment (RME) sterilization equipment as well as desktop computer systems under the supervision of VA employees.

b. DECONTAMINATION:

(1) The contractor employee shall retrieve and return contaminated RME to decontamination for reprocessing.

(2) The contractor employee shall identify and receive contaminated surgical instruments, trays, surgical sets, suction equipment, various specialty carts, endoscopes, powered drills and saws, respiratory equipment, and a variety of other patient care items and devices from all areas in the medical center and remote locations; and prioritize instruments required for surgical procedures in the Operating Room.

(3) The contractor employee shall select proper methods based on manufacturer’s guidelines, experience, current SOPs, and training for pre-cleaning, decontamination and sterilization of all patient care items.

(4) The contractor employee shall disassemble and inspect items for damage or missing components; operate equipment and instruments to ensure proper functioning prior to sterilization or redistribution. The contract employee will document any identified damage or missing instruments and report the occurrence to SPS leadership.

(5) The contractor employee shall inspect, disassemble, clean, and perform user preventive maintenance of sophisticated surgical devices such as bronchoscopes, endoscopes, colonoscopes, ENT scopes, sigmoidoscopes, cystoscopes, laparoscopic cameras, drills, saws, reamers, and a wide variety of lumened devices. Procedures will be in accordance with manufacturer’s guidelines, experience, current SOPs, and training.

(6) The contractor employee shall inspect, disassemble instrumentation from Community Based Outpatient Centers (CBOC’s) including dental, GYN, ENT and other instrumentation prior to preparation.

c. ASSEMBLY AND PREPARATION:

(1) The contractor employee shall assemble instruments, complex instrument sets, and other surgical items and kits by selecting the appropriate items, trays, instruments, and arrange them in the correct manner permitting effective sterilization using existing SOPs and instrument count sheets.

(2) The contractor employee shall assemble complex instrument sets containing a variety of instruments which must be inspected for damage such as pitting, rust, cracks, bends, sharpness, proper locking ability, jaw alignment, and residual blood bio-burden, etc.

(3) The contractor employee shall can process complicated procedural sets such as Open heart sets, ENT, General Surgery, Urology, Gynecology, Vascular, Orthopedic, Orthopedic (Spine), Ophthalmology, Dental, Podiatry, Plastic Surgery and Dermatology instruments and sets and other sets containing very specific and complex instrumentation.

(4) The contractor employee shall have extensive knowledge of aseptic technique and proper wrapping methods to allow the surgical or procedure user to open the product in an aseptic manner. The contractor employee shall produce an aesthetically organized, compact, logically arrange package, which is within the proper weight limits and is appropriate for assured sterilization.

(5) The contractor employee shall:

· Inspect and select the appropriate wrapping materials and sterilization packaging.

· Use external and internal chemical indicators.

· Label all packages correctly.

· Initial all products in accordance with VA regulations and SPS policy and procedures manuals.

· Be watchful to ensure single-use items are NOT reused.

(6) The contractor employee shall inspect instruments for proper functioning, scissors for sharpness, box locks for tightness, towel clamps and hemostats for proper functioning jaws, rough edges on ring handles, jaws, ratchets and shanks (burrs or nicks). The contractor shall inspect for cleanliness and corrosion.

(7) The contractor employee shall adhere to SPS dress attire and SOP including enforcement of wearing hair covers and inside clothes (scrub attire or gown) always, wash hands frequently, and following proper work and people flow.

(8) The contractor employee shall maintain an inventory of all items required for packaging and indicate any items missing or not working appropriately and replace them prior to submitting trays or instrument sets for sterilization.

(9) The contractor employee shall inspect, instrumentation from other specialty areas including dental, GYN, ENT and instrumentation prior to sterilization utilizing appropriate packaging methods.

d. STERILIZATION:

(1) The contractor employee shall efficiently schedule operation of sterilizers to permit cooling of sterilized items prior to use by units, clinics and the Operating Room.

(2) The contractor employee shall select the correct sterilizing method (steam, gas plasma, peracetic acid, Cidex OPA) per the SOP’s and IFU.

(3) The contractor employee shall prepare test packs and run biological indicators in accordance with The Joint Commission (TJC), AORN Standards and Recommended Practices, IAHCSMM, and manufacturer’s instructions for biological indicator products used.

(4) The contractor employee shall identify items to be processed with a gaseous sterilant and adjust temperature and timing mechanisms in a manner that would allow circulation and permeation by sterilizing medium.

(5) The contractor employee shall label all sterilized items with load control number and expiration date. The contractor shall inspect chemical integrators in each package for indication of exposure to the sterilant and inspect all products for package integrity and residual moisture. External indicator tapes will be initialed prior to submitting for sterilization to identify the preparer if necessary.

(6) The contractor employee shall review and sign all sterilizer printouts to verify the proper sterilization time, temperature, pressure, humidity, and sterilant exposure. The contractor shall record all items sterilized for VA maintenance records. Records will be maintained for three years.

(7) The contractor employee shall assemble and load operating room surgical instruments on case carts per schedules and sterilization guidelines. The contractor employee shall fill special emergency requests for sterile instrumentation. The contractor employee shall monitor performance of sterilizers and aerators with prescribed tests.

(8) The contractor employee shall record biological spore test results, and, in the event of a positive culture, initiate the recall of instruments, notifies supervisor and appropriate individuals in the medical center per policy.

(9) The contractor employee shall sterilize instrumentation from Community Based Outpatient Centers (CBOC’s) including dental, GYN, ENT utilizing appropriate sterilization methods.

e. CASE CART PREPARATION AREA:

(1) The contractor employee shall accurately assemble case carts with the instruments required on different surgical procedures.

(2) The contractor employee shall utilize basic computer skills to maintain print service preference cards for surgical procedures.

f. EQUIPMENT:

(1) The contractor employee shall use, clean, and maintain a wide variety of equipment. The Contractor employee shall clean the interior and exterior of all reprocessing equipment in decontamination, prep and assembly and case cart/sterile storage areas. Examples of equipment to be cleaned are sterilizers and aerators, loading carts, specialty carts, work areas and storage shelves, using chemical solutions, detergents and alcohol per written frequency procedures and manufacturer instructions, or as needed, to prevent cross contamination.

6. QUALIFICATIONS:

a. Contractor employee shall have extensive knowledge of the complete range of surgical implementation, surgical tray assembly, manufacturer’s maintenance requirements, disposable and reusable medical equipment and instrumentation.

b. Contractor employee shall be aware of changing guidelines and regulations as they apply to the decontamination and sterile supply operation.

c. Contractor employee shall be aware of and comply with Occupational Safety and Health Administration (OSHA) regulations, Centers for Disease Control (CDC) guidelines, VA SPS Procedures and infection control standards.

d. Contractor employee shall be skilled in individual recognition of thousands of instruments and can logically arrange trays that permit effective penetration of the sterilizing medium, aseptic retrieval and arrangements which allow for surgical use per the sequence of events during surgical procedures.

e. Contractor employee shall understand the basic principles of aseptic technique, microbiology and infection control as they apply to medical supply operation, knowledge of prevention of cross contamination and the critical contamination and the critical nature of nosocomial infection related to the importance of clean and sterile supplies to the treatment and care of patients.

f. Contractor employee shall have a thorough knowledge of aseptic principles and techniques, including cleaning techniques, sterilization mediums, sterilizer operation, proper packaging to assure sterility, tests to determine the effectiveness of sterilization, storage, and stock rotation, inspection, and shelf-life characteristics.

g. Contractor employee shall have a good working knowledge of the availability, economics, use, operation, maintenance, assembly, and disassembly of the full range of medical supplies, surgical instruments and sets, medical equipment, sophisticated decontamination and sterilization equipment and procedures and the specific disinfection, sterilization, storage and handling requirements of each.

h. Contractor employee shall have a basic understanding of medical and surgical terminology, therapeutic procedures and of human anatomy and physiology.

i. Contractor employee shall understand basic computer terminology and be capable of operating computer systems and microprocessors.

7. ORIENTATION AND TRAINING:

All medical supply technicians providing services under this contract shall attend mandatory orientation and training specified by the government specific to the facility and department where they will be working.

· Knowledge of VHA Directive 1116(2) is a plus

· Candidates must have prior Central Sterile/Sterile Processing Services/ Sterile Processing Department (CS /SPS/ SPD) experience

· Candidates must have current IAHCSMM or CBSPD certification and ability to maintain these certifications

· Candidates must have experience utilizing instrument tracking system

· VSC Form #1 Security Request Form

· VSC Form #2 Fingerprinting Request Form

· VSC Form #3 PIV Form

· SAC Fingerprint Form

· OF 306 Form

· VA Form 710

· Self-Certification of Continuous Service Form

· Quick Reference e-QIP Form

· Contractor employee will be required to create an account in the Talent Management System (TMS) and take the Privacy course before being given access and required to complete annually thereafter.

8. INFORMATION TECHNOLOGY SKILLS:

The contractor employs shall be required to use the Atlanta VA Medical Center computer system in accomplishment of their work. Evidence of a current background investigation, web privacy and cyber security training shall be presented at the time of employment.

a. A contractor/sub-contractor shall request logical (technical) or physical access to Atlanta 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, contractor employees 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. The contractor or subcontractor must notify the COR and 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.

d. 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).

e. 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.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access.

1. Position Sensitivity – The position sensitivity has been designated as Low Risk

2. Background Investigation – The level of background investigation commensurate with the required level of access is Minimum background investigation.

3. Contractor Responsibilities

a. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and can read, write, speak and understand the English language.

The contractor shall submit or have their employees submit the required forms listed below:

· VSC Form #1 Security Request Form

· VSC Form #2 Fingerprinting Request Form

· VSC Form #3 PIV Form

· SAC Fingerprint Form

· OF 306 Form

· VA Form 710

· Self-Certification of Continuous Service Form

· Quick Reference e-QIP Form

c. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract within 48 hours.

d. Failure to comply with contractor personnel security requirements may result in termination of the contract for default.

e. Contractor employee will not have access to VA Network, provide software upgrades or other VA sharing or disclosure of PHI or PII.

Government Responsibilities

a. The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor, or to the contractor’s employees, after receiving a list of names and addresses.

b. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy, and forward the forms to the office of Personnel Management (OPM) to conduct background investigations.

c. The VA Office of Security and Law Enforcement will notify the CO, and contractor, of adjudication results received from OMB.

d. Upon being notified about a favorable determination, the COR may issue a notice to proceed to the contractor.

PROCEDURES FOR ACCESS

Access requirements to VA information systems by contractors and contractor personnel shall meet or exceed those requirements established for personnel as described in VHA directives. A written and signed request for user access by VHA management, or designee(s), constitutes management approval (sponsorship) to initiate a request for access to any sensitive automated information system. Access shall be granted to non-VA users only if the purpose for access meets criteria of the Privacy Act and VA Confidentiality Regulations and Transfer.

a. Contractor's personnel shall be required to sign-in before starting work under this contract and abide by the VA Computer Access Security Agreement and Confidentiality Agreement.

b. In the performance of official duties, the contractor's personnel may regular access to printed and electronic files containing sensitive information, which must be protected under the provisions of the Privacy Act of 1974, HIPAA and other applicable Federal laws and regulations. The employee is responsible for (1) protecting that information from unauthorized release or from loss, alternation or unauthorized deletion, and (2) following applicable regulations and instructions regarding access to computerized files, release of access codes, etc. as set out in a computer access agreement which the employee signs.

9. CONTRACT PERFORMANCE MONITORING:

The government will evaluate the quality of the services being performed to ensure payment is made for only those services received and accepted by the government.

- In the event a contractor employee is replaced for any reason; the contractor shall provide a resume or curriculum vitae for all applicants meeting qualification requirements for employment consideration and;

- The Contractor shall provide certified Sterile Processing Technicians as discussed in the Education and Training section of this document. Offeror must provide a copy of the employee’s certification certificate from their accreditation agency to the facility annually and prior to the employee’s current certificate expiration date.

- Contractor shall have a policy or plan to address performance and/or conduct issues regarding employees working in our facility.

- If an employee needs to be removed from our facility, the Contractor shall be able to complete the action the same day.

- Contractor shall be able to provide two (2) qualified replacement Sterile Processing Technicians for our facility to select from within 48 hours (2 days) of the loss of a current employee.

- Contractor shall provide employees that can function independently while properly completing all Sterile Processing functions upon entry into our facility.

-Employee will receive input from the end-users and supervision as input is valuable to the quality of product we would like to produce and expect.

-Contractor will ensure that any additional price outside of the IGCE is discussed before service is rendered

Quality Assurance Surveillance Plan (QASP) – Sterile Processing Services Performance Objective Inspection of Instruments and Sets

Quality Level (AQL) Monitoring Method Disincentive for not meeting AQL

Customer Satisfaction

10. ADMINISTRATIVE:

RECORD KEEPING:

The contractor shall establish a record keeping system to ensure accuracy of reporting and recording time and attendance of contract employees. The contractor shall provide a properly prepared invoice accompanied by certified time sheets to the Contracting Officer’s Representative (COR) for validation on a bi-weekly basis. The COR or the government is not the timekeeper of the contractor’s employees.

INVOICE:

Payment will be made upon receipt of a properly prepared invoice validated by the COR, and submitted to VA FSC, P. O. Box 149971, Austin, TX 78714.

(1) A properly prepared invoice will contain:

o Invoice number and date o Contractor’s name and address o Accurate purchase order number o Name of contract employee o Copy of submitted timecards per invoice for each employee to include o Hours worked o Hourly rate o Total amount due

TERMINATION FOR CONVENIENCE:

Subject to a 72-hour notice, the government reserves the right to reduce the required hours or number of employees or terminate this contract for convenience if the need for this service changes or is no longer required. The government reserves the right to terminate individuals as needed if the individual does not adhere to safe patient practices or department policies without a 72-hour advanced notice.

(End of Clause)

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 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 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 follow 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 during 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

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 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 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 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 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 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 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.

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 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 COR. 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 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 used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the…