A5 - PWS Updated - PR 51191.pdf

Section C - Description/Specification/Work Statement

Title of Project: Maintenance of Spark Holland Instruments

C.1 Background and Need

The Division of Laboratory Sciences (DLS) of the National Center for Environmental Health (NCEH), CDC, owns a significant number of Spark Holland Laboratory equipment which are used to perform critical chemical analyses in support of its public health mission. DLS utilizes instruments manufactured by Spark Holland Inc. to automatically exchange SPE cartridges in a way that is completely synchronized with the operation of the HPLC pump and mass spectrometer data collection. The exchange of cartridges is needed to ensure validity of the analytical results because of the complexity of the serum matrix. The equipment provides an on-line solid phase extraction. On-line SPE systems without the capability to automatically exchange SPE cartridges are not suitable for measuring chemicals in serum, due to the high protein and lipid content of serum.These instruments are used in analyses performed for chemical terrorism/emergency response, biomonitoring, tobacco, and research and development to establish new analytical methods for a broad variety of sample types on a wide range of mission critical projects.

DLS/NCEH/CDC is defined by Congress’ Federal Response Plan for Terrorism to be the single location for measuring chemical warfare agents or their metabolites in humans. The other primary responsibility of the Division is to provide measurements of environmental toxicants in humans, also known as biomonitoring. These instruments are highly complex and maintenance and repair requires a high degree of technical proficiency and training. In order to ensure readiness to respond in the event of a chemical/biological terrorist event or in the case of an environmental emergency, it is crucial that these instruments are functional and able to run 95% of the time.

C.2 Project Objective

This contract is for preventative and remedial maintenance of the Spark Holland Symbiosis SPE systems and autosamplers to keep all instruments running optimally while eliminating costly repairs due to damaged or malfunctioning equipment.

C.3 Scope of Work

The contractor shall provide maintenance and repair services to keep the covered instruments properly calibrated, services and maintained in accordance with or to exceed the Original Equipment Manufacturer

(OEM) recommendations throughout the contract period renewable for up to four additional option years.

The contractor shall provide telephone support, on-site maintenance and repairs by qualified, factory certified/authorized service engineers, priority response time, and coverage of any and all parts, travel to

CDC, labor costs, and software/firmware updates and support.

Maintenance service includes periodic preventative maintenance according to the specific needs of the instrument as determined by the manufacturer. This preventative maintenance may be performed during the course of remedial maintenance. Repair includes any action performed on instrumentation which restores the instrument to its originally designed working order. Certified replacement parts may be new or factory remanufactured and are furnished on an exchange basis (i.e., the replaced parts become the property of the contractor). Any software presented under the contract, whether transferred to CDC via portable media (CDs, thumb drives etc.), ftp sites, email or other means, must be scanned using CDC approved anti-virus program with up-to-date definitions prior to installation on CDC computers. In addition, portable media (except for required software downloads under the terms of the contract--see above) and mobile devices (laptops, PDAs, phones, MP3 players, cameras or similar equipment) will not be connected to CDC networks or computers. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above. A copy of CDC standards and procedures, including the “Mobile

Device/Portable Media Standard”, will be provided to the contractor with a properly executed non-disclosure agreement under CDC policy.

C.4 Technical Requirements – The Contractor shall perform the following tasks:

1. General Service Requirements - At the completion of work at each service location, the contractor service representative shall restore the work site to its original condition. Contractor site clean-up shall include disposal of any discarded parts, empty containers, packing materials, trash and debris. All chemical spills on equipment and/or surrounding floor shall be removed; and, these areas shall be cleaned to return to their original condition. The contractor shall not create or permit any safety or fire hazard to exist at the equipment site. Government-owned dumpsters may be used for disposal of waste materials except for metal parts and components, which shall be removed by the contractor. The general area of serviced equipment shall be left in a clean and orderly condition free of any trash or debris resulting from preventive maintenance and/or service activities. The contractor is responsible for all labor, parts, and travel costs associated with services rendered whether for repair or preventative maintenance. Warranty instruments will automatically be provided the same entitlements/response times as instruments under the program excluding PM’s which will be performed as the instruments comes out of warranty.

2. Repair Services - 24 hour response by service engineer; 5 workday’s timeframe to repair equipment. Routine repair services includes replacement or restoration of parts and all contractor services required to return installed CDC laboratory equipment to the operational and design specifications in accordance with OEM recommendations and requirements or exceeding them.

a. Initial confirmation of request shall be within four hours of formal service call placement.

b. The contractor shall respond within 24 hours to service call requests for instruments covered in the contract. Response (depending on the nature of the problem and as requested by CDC personnel) will be in one of the following forms:

(1) telephone call or email troubleshooting the problem and resulting in repair of the equipment by CDC personnel;

(2) dispatch of part(s) for problem resolution with instructions for replacement or repair by CDC personnel; and/or

(3) an on-site visit by service representative.

c. If the contractor service representative is unable to complete required service and return equipment to good working condition during the initial service call and within 5 working days the contractor shall provide a written timeline for repair agreed upon by both the end user, service technician and senior service representative by no later than 48 hours thereafter.

d. During situations where the CDC laboratory is responding to a national emergency, the

Contractor will provide repair services required as needed 24 hours per day, 7 days per week at no additional cost to the Government. The Contractor will provide a point of contact available to receive service requests in after-hour times. The Contractor shall respond within four (4) hours to notification of problems or equipment failure and shall perform repairs as necessary to put the system back into service.

e. Contractor workmanship shall be at or above industry quality standards; and, any government notice of non-acceptability shall be rectified by the contractor within 48 hours of notice, at no additional cost to the government.

f. Necessary replacement parts shall be “new” not “used” or “reconditioned” (unless mutually agreed to by the CDC program, in advance and replacement parts are Spark Holland Factory

Reconditioned). The cost of labor, travel, replacement materials, parts or supplies required to complete routine repair of CDC laboratory equipment and restore to OEM operational specifications shall be the sole responsibility of the contractor; and, shall be provided at no additional cost to the government.

g. For any loaner or mail in repair service the Contractor shall pay for all shipping charges for return, repair, loaner or replacement of equipment.

h. In the event that covered equipment is to be relocated to an alternate site, the Contractor shall provide appropriate service to ensure the safe transport, installation, and ensure the full operational condition of the equipment in the new location at no additional cost to the government.

i. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above.

j. The contractor shall guarantee that the service performed and the products and parts supplied to repair or replace the equipment conforms to standards of workmanship prevailing in the trade.

3. Software Upgrades – The Contractor shall provide software and firmware upgrades and support at no extra charge. Any software presented under the contract, whether transferred to CDC via portable media (CDs, thumb drives etc.), ftp sites, email or other means, must be scanned using CDC approved anti-virus program with up-to-date definitions prior to installation on CDC computers. In addition, portable media (except for required software downloads under the terms of the contract--see above) and mobile devices (laptops, PDAs, phones, MP3 players, cameras or similar equipment) shall not be connected to CDC networks or computers.

a. A copy of CDC standards and procedures, including the “OCISO Standard for Portable Media and Mobile Device Security,” will be provided to the contractor with a properly executed non-disclosure agreement under CDC policy.

b. The Contractor shall ensure currently supported versions of information technology products meet the latest FDCC major version and subsequent major versions.

c. The Contractor shall use Security Content Automation Protocol (SCAP)- validated tools with

FDCC Scanner capability to ensure its products operate correctly with FDCC configurations and do not alter FDCC settings--see http://nvd.nist.gov/validation.cfm. The Contractor shall test applicable product versions with all relevant and current updates and patches installed.

d. The Contractor shall ensure IT applications operated on behalf of CDC/DLS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements.

e. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above http://nvd.nist.gov/validation.cfm

f. The Contractor shall ensure IT applications designed for end users are fully functional and run in the standard user context without requiring elevated administrative privileges.

4. Preventative Maintenance - The contractor shall perform up to two annual electrical and mechanical preventive maintenance services on CDC laboratory equipment as specified by order in accordance with original equipment manufacturer (OEM) recommendations and requirements or exceeding them.

a. Preventive maintenance services include up to two annual periodic inspections and on-site service of installed equipment, in accordance with OEM recommendations or exceeding them; including, but not limited to cleaning, calibration, adjustments, replacement or restoration of parts, as necessary, and all services required to return equipment to OEM operational and design specifications.

b. Preventive maintenance services shall be performed, in accordance with a contractor proposed schedule; which shall be coordinated with CDC scientists

c. The contractor shall provide a copy of the preventative maintenance schedule to the COR within

2 months of contract award or new option year, to minimize disruption to planned laboratory experiments.

d. To the maximum extent possible individual equipment preventative maintenance services shall be coordinated to maximize efficiency and reduce preventative maintenance costs.

e. The contractor shall provide all consumables and reagents used for troubleshooting and performance verification testing both for preventative maintenance visits and repairs.

f. Provide no cost repairs to any nonoperational or defective instrumentation that result from normal operation and usage.

5. Service Engineers – Service engineers are considered visitors and must have proper approved access into CDC laboratories. Service engineers must follow all CDC policies and procedures and abide by all DLS laboratory safety requirements.

a. At CDC all non-U.S. citizen service engineers are required to register 10 days prior to a visit through the Non-U.S. Citizens Access Management System (NCAMS). Due to the time sensitivity of instrument repairs and maintenance it is required that field service engineers be a U.S. citizen or plan accordingly to ensure no delay to service.

b. On-site Contractor operations are subject to compliance with all applicable OSHA rules and regulations. All incidents and injuries to Contractor employees shall be promptly investigated by the

Contractor. A copy of the incident report shall be furnished to the COR and the Contracting Officer.

c. The service engineers shall provide CDC with Spark Holland certificate of trainings requisite for

DLS instrumentation in order to maintain records necessary for CDC equipment Clinical Laboratory

Improvement Amendments (CLIA) certification.

d. CDC badges may be given to service engineers that visit CDC/DLS regularly and considered essential by the Contracting Officer Representative.

(1) Service Engineers are required to take NCEH/DLS Safety Survival Skills I training in order to receive a badge.

(2) CDC Badges may be revoked at any time by the Contracting Officer Representative.

e. Service engineers should follow CDC standards of conduct and ethics.

6. Service Records – The Contractor shall provide a service invoice (field service report) to the instrument user and the COR/technical monitor detailing the work that was completed following remedial and preventative maintenance.

a. Provide to the user a printout and electronic copy of calibration verification performed during preventative maintenance to include in instrument logs.

b. Supply CDC with access to training records and certifications for all field service engineers who will be servicing CDC equipment in order to maintain records necessary for CDC equipment Clinical

Laboratory Improvement Amendments (CLIA) certification.

c. At a minimum, service tickets shall contain the following information: Contract Order #, Manufacturer, Model Number, Serial Number, CDC Property Number (if applicable), Program Contact, Location, Type of Service (preventive maintenance, routine repair, etc.), Date of Service and a Description of Service that was performed (i.e. calibration, parts replaced, etc.) for each instrument.

7. Inspection and Acceptance Criteria - The CDC COR and/or designee will monitor the contractor's performance; and, shall be responsible for documenting acceptance or rejection of contractor services..

8. Point of Contact - At a minimum the Contractor shall designate someone as the project manager to coordinate all activities including but not limited to contract administration, billing, ordering and shipping, and serve as the primary Point of Contact (POC) between the Contractor and CDC Contracting

Officer or designated CDC Contracting Officer’s Representative (COR).

9. Reporting Schedule – The contractor shall at a minimum provide the following:

a. Monthly Report: by the 10th day of each month, the contractor shall provide the Contracting

Officer’s Representative and the Contracting Officer with a Monthly Report of services provided during the preceding calendar month. Form, format and content of the report may be revised from time to time, but as a minimum shall provide the following information:

(1) A summary of the number of preventive service calls scheduled and comleted.

(2) A summary of the number and types of government requests for service, dates received and dates completed; individual turn- around time for each service; and, average turn-around times for each type of service.

(3) A brief description of any outstanding problems and/or issues for each type of service, with options and recommendations for resolution.

b. Annual Meeting: An annual onsite meeting visit initiated and lead by the contractor to discuss service issues/continuous improvement. The meeting should include contractor program manager, field service engineers, and CDC COR/Technical monitor and end users in the meeting.

C.5 Government Furnished Property: None

C.6 Deliverables:

Item Description

Quantity

Delivery Date

Deliver To

1. Preventive maintenance of instrument tickets.

Up to 2 annually per instrument

Throughout award period based on individual instrument service record.

NCEH/DLS

End User

2. Preventative Maintenance

Instrument Schedule

1 per year

Within 2 months of initial contract award or option year exercise.

NCEH/DLS

COR/Technical

Monitor

3. Repair documentation of instruments covered by the agreement.

1 per service request

Throughout award period based on need.

NCEH/DLS

End User

4. No cost software and firmware upgrades and support.

As needed

Throughout award period based on need and availability of updates.

End User

5. Service invoice/record (field service reports) provided following all remedial and preventative maintenance for inclusion in instrument logs.

1 per service request/ PM

Throughout award period due upon completion of PM or remedial service.

NCEH/DLS

End User and

COR/Technical

Monitor

6. Monthly report

Due once per month immediately upon award.

NCEH/DLS

7. Annual meeting to discuss service issues including account service manager, field service engineers, and

CDC users in the meeting.

Due within 12 months after award and within 12 months of each option period expiration.

Performance Requirements Summary:

Performance Objective Performance Standard (& AQL) Method of

Performance

Assessment

1. Preventive maintenance of instruments Performed for each qualifying instrument on or ahead of schedule at least 80% of time allowing flexibility if needed by end user.

Review contractor reports/COR survey/End user feedback

2. Preventative Maintenance

Instrument Schedule

Delivered within 2 months of contract award.

Review by COR/Technical

Monitor

3. Prompt confirmation of formal service request.

Within 4 hours of initial service request at least 95% of the time.

Review contractor reports/COR survey/End user feedback

4. Prompt response to formal call for service through telephone assistance, shipment of parts, and/or on-site repairs provided as necessary for remediation.

Within 24 hours of initial service request at least 95% of the time.

Review contractor reports/COR survey/End user feedback

5. Successful repair of instruments covered by the agreement.

Within 5 days as a general rule, if the repair requires additional time a written plan must be agreed upon.

Review contractor reports/COR survey/End user feedback

6. No cost software and firmware upgrades and support.

As needed/required by instruments.

Review contractor reports/COR survey/End user feedback

7. Service invoice/record (field service reports) provided following all remedial and preventative maintenance for inclusion in instrument logs.

1 per service call or PM included

100% of the time

Review contractor reports/COR survey/End user feedback

8. Monthly report 1 per month, on time at least 98% of time.

Review by COR/Technical

Monitor

9. Quarterly Conference Call with account service manager to discuss service and any issues.

1 per quarter, on time at least 98% of time.

Review by COR/Technical

Monitor

10. On-site visit by contractor to discuss service issues including account service manager, field service engineers, and

CDC users in the meeting.

1 per year, must demonstrate a commitment to continuous improvement of service delivery.

Review by COR/Technical

C.7 References

OCISO Standard for Portable Media and Mobile Device Security Quality Assurance Surveillance Plan

C.8 Special Considerations –

1. Terms and Conditions - The Government anticipates a fixed price contract. The contract will specify a list of equipment to be covered by the contract. The equipment list will be evaluated at least quarterly to determine if new equipment needs to be added or taken off the list. Changes to the equipment list will be done by modification to the contract. The Government does not guarantee any quantity of equipment for any of the services.

2. The contractor shall waive any re-certification/reinstatement fee for new equipment to be added to the contract for at least 90 days following the warranty period.

3. Removing Devices with CDC Information from CDC Premises

Contractor shall scan all media (CDC, DVD, portable hard drives, thumb drives, etc.) used for upgrading and installing the vendor’s software/firmware with antivirus software that has the latest virus signatures.

The scans shall occur before using the media in a CDC computer and when moving the media between

CDC computers.

4. If in the performance of this contract the contractor must replace an information storage device

(hard drive, non-volatile flash memory module, etc.) or service equipment offsite, the contractor must remove the information storage device(s) from the equipment and provide it to CDC to be either destroyed or erased. The contractor shall not bring off-site any part of the equipment they are servicing that contains CDC data.

C.9 IT Security and Privacy Requirements

Information Security and/or Physical Access Security

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical

(electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology”

(IT), the term as used in this section includes computers, ancillary equipment

(including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

Complete this section using the information obtained from the Security and Privacy

Checklist in Appendix A, parts A and B.

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information

Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National

Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume

II: Appendices to Guide for Mapping Types of Information and Information Systems to

Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the

Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [X] Low [ ] Moderate [ ] High

Integrity: [ ] Low [X] Moderate [ ] High

Availability: [X] Low [ ] Moderate [ ] High

Overall Risk Level: [ ] Low [X] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X] No PII [ ] Yes PII mailto:fisma@hhs.gov http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

4) Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be:

[ ] Low [ ] Moderate [ ] High [X] N/A

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 32 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as

CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy

Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-

171, Protecting Controlled Unclassified Information in Nonfederal Information

Systems and Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-

16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

7) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any

HHS records may be made available or disclosed shall be notified in writing by the

Contractor that information disclosed to such employee or subcontractor can be used

See Appendix D for baseline deliverables.

only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and [CDC] policies. Unauthorized disclosure of information will be subject to the HHS/[CDC] sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

8) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6). .

9) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable

HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume

HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

10) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

11) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the

Cryptographic Module Validation Program to confirm compliance with FIPS 140-2.

The Contractor shall provide a written copy of the validation documentation to the

COR.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys.

Encryption keys shall be provided to CDC Office of Chief Information Security http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf

See Appendix C for the Contractor Non-Disclosure Agreement.

Officer (OCISO).

12) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the CDC non-disclosure agreement, as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

13) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) –

The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract in accordance with HHS policy and OMB M-03-22, Guidance for

Implementing the Privacy Provisions of the E- Government Act of 2002.

a. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of

PII are collected that could introduce new or increased privacy risks), whichever comes first.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/CDC Contractor Information Security Awareness, Privacy, and

Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete CDC Security

Awareness Training (SAT), Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with

HHS training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant

Security Responsibilities Memorandum.

All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within

30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

D. Incident Response

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and

Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security

Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally

Identifiable Information” (03 January 2017) states:

Definition of an Incident:

An occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.

Definition of a Breach:

The loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment.

A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII for an other than authorized purpose.

The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC shall include the following requirements:

1) The contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage a suspected or confirmed breach.

2) All contractors and subcontractors shall properly encrypt PII in accordance with OMB

Circular A-130 and other applicable policies, including CDC- specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

3) All contractors and subcontractors shall participate in regular training on how to identify and report a breach.

4) All contractors and subcontractors shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC and incident management policy, and United States Computer Emergency Readiness Team (US-CERT) notification guidelines. To this end, the Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident

Response Center (CSIRC) or CDC Computer Incident Response Team (CSIRT) within

24 hours via email at csirt@cdc.gov or telephone at 866-655- 2245, whether the response is positive or negative.

5) All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

6) All contractors and subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

7) Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

8) Identify roles and responsibilities, in accordance with HHS/CDC Breach Response

Policy and the HHS/CDC Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with

HHS/CDC Breach Response Plan, and the Contractor shall then send CDC- approved notifications to affected individuals; and,

9) Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards mailto:csirt@cdc.gov

The requiring activity representative, in conjunction with Personnel Security, shall use the OPM Position Sensitivity Designation automated tool

(https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12) for PII.

E. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR).

F. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland

Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for

Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification

(PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order

13467, Part 1 §1.2.

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted immediately upon change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance

Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology and in accordance with the

HHS Contract https://www.opm.gov/investigations/ https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.dhs.gov/homeland-security-presidential-directive-12

HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html

CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.htm

Closeout Guide (2012).

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life

Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media

Sanitization.

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO before an employee stops working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non- government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR.

Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Out-Processing Checklist

(http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract. All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS policies and shall not dispose of any records unless authorized by HHS.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS policies.

https://www.hhs.gov/ocio/ea/documents/proplans.html https://www2a.cdc.gov/CDCup/library/other/eplc.htm http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf

Deliverables

Deliverable Title/Deliverable Type Description Due Date

Roster Roster Within 30 days of the effective date of this contract

Contractor Employee Non-

Disclosure Agreement (NDA)

Contractor Employee Non-

Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS

Privacy Threshold Analysis (PTA)/

Privacy Impact Assessment (PIA)

Assist in the completion of a

PTA/PIA form

Within 60-90 days after contract award

Training Records Copy of training records for all mandatory training In conjunction with contract award and annually thereafter or upon request

Rules of Behavior Signed ROB for all employees

Initiation of contract and at least annually thereafter

Incident Response Incident Report (as incidents or breaches occur) As soon as possible and without reasonable delay and no later than 1 hour of discovery

Personnel Security

Responsibilities

List of Personnel with defined roles and responsibilities

Within 7 days; that is before an employee begins working on this contract.

Personnel Security

Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

Within 5 days or less after the

Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Background Investigation Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

Certification of Sanitization of

Government and Government Activity-

Related Files, Information, and

Devices.

Form or deliverables required by

OpDiv.

At contract expiration.

Contract Initiation and

Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as

At contract expiration.

Disposition/Decommission Plan

Installation and Servicing of Equipment

Contractor shall scan all media (CDs, DVDs, portable hard drives, thumb drives, etc.) used for upgrading and installing the vendor’s software/firmware with antivirus software that has the latest virus signatures.

The scans shall occur before using the media in a CDC computer/device and when moving the media between CDC computers/devices.

If in the performance of this contract, the contractor must replace an information storage device (hard drive, non-volatile flash memory module, etc.) or service equipment offsite, the contractor must remove the information storage device(s) from the equipment and provide it to CDC to be either destroyed or erased. The contractor shall not bring off-site any part of the equipment they are servicing that contains

CDC data.

C.13 Section 508 Compliance

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