Combined Synop RFP WebEHRS.pdf

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INDIAN HEALTH SERVICES (IHS) WEB-BASED ENVIRONMENTAL HEALTH REPORTING SYSTEM
Solicitation number
75H70121R00039
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This is a combined synopsis/solicitation for a web-based environmental health reporting system. The Indian Health Service seeks proposals by September 21, 2021 to develop and maintain a commercial off-the-shelf database and web application. The system must support environmental health programs across 250 users at national, regional, and local levels. Key functions include documenting facility information, work records, inspections, referrals, and attaching files. Modifications are required to add custom inspection forms, calculate workload metrics, and integrate IHS coding systems. The base period of performance is one year with four one-year option periods. This opportunity is set aside for small businesses under NAICS code 511210. Matthew Phelps of IHS is the point of contact for any inquiries.

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Amendment 3 WebEHRS.pdf PDF
Example environmental health and management report.pdf PDF
Amendment 2 WebEHRS.pdf PDF
Example DEHS RRM.pdf PDF
Example tribal code and ordinance report.pdf PDF
Example inspection violation trend reports.pdf PDF
Example RRM Summary.pdf PDF
Example Calendar.png PNG image
Amendment 1 WebEHRS.pdf PDF
Att 1 RRM_CalculationFlowChart.pdf PDF
B01 RFP Attachment 2 - PPQ.docx DOCX document
B01 RFP Attachment 1- QASP.docx DOCX document
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INDIAN HEALTH SERVICE

DIVISION OF ENGINEERING SERVICES

INDIAN HEALTH SERVICES (IHS) WEB-BASED ENVIRONMENTAL HEALTH REPORTING

SYSTEM

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Request for Proposal (RFP) 75H70121R00039

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06.

This is a total small business set-aside under NAICS Code 511210 with a size standard of $41.5 million.

Issue Date: 12 August 2021

Proposal Due Date: 21 September 2021 at 2:00 P.M. PDT or earlier due to matthew.phelps@ihs.gov.

The provision at 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition with addenda.

The provision at 52.212-2, Evaluation-Commercial Items is included with addendum in Section M.

The Contracting Officer and primary point of contact for this RFP and resulting award is Matthew Phelps.

He can be reached at (206) 613-2153 and matthew.phelps@ihs.gov.

The table of contents and the rest of this document represent the combined synopsis/solicitation.

Request for Proposal 75H70121R00039 Web-based Environmental Health Reporting System

TABLE OF CONTENTS:

Section Taxonomy Section B Schedule of Items Section C Description and Specification (Statement of Work) Section D Packaging and Markings Section E Inspection and Acceptance Section F Deliveries or Performance Section G Contract Administration Data Section H Special Contract Requirements Section I Contract Clauses Section J List of Documents, Exhibits Section K Representations and Certifications Section L Instruction, Conditions and Notices Section M Evaluation Factors for Award

Proposals shall set forth full, accurate, and complete information as required by this request for proposal (including attachments). The penalty for making false statements in proposals is prescribed in 18 U.S.C. 1001.

SECTION B – SCHEDULE OF ITEMS

Base Year Nov 7, 2021 Through Nov 6, 2022 Fixed Monthly License Per User Costs including Development Work

Cost Users Months TOTAL

0001 $ 250 12 $

0002 Travel (for Training) NTE $5,000.00

TOTAL PRICE $_________

Option Year 1

Nov 7, 2022 Through Nov 6, 2023 Fixed Monthly License Per User Costs including Development Work

Cost Users Months TOTAL

1001 $ 250 12 $

Option Year 2

Nov 7, 2023 Through Nov 6, 2024 Fixed Monthly License Per User Costs including Development Work

Cost Users Months TOTAL

2001 $ 250 12 $

2002 Travel (for Training) NTE $5,000.00

Option Year 3

Nov 7, 2024 Through Nov 6, 2025 Fixed Monthly License Per User Costs including Development Work

Cost Users Months TOTAL

3001 $ 250 12 $

Option Year 4

Nov 7, 2025 Through Nov 6, 2026 Fixed Monthly License Per User Costs including Development Work

Cost Users Months TOTAL

4001 $ 250 12 $

NOTES:

1. Offerors shall submit pricing for each line item in Section B. Failure to propose in this manner may result in proposal rejection. Each price shall be a fully burdened (billable rates inclusive of all costs) to cover, all direct and indirect charges, burdened to include, but not limited to the following: Direct labor, fringe benefits, materials, subcontracts, overhead, general and administrative, quality control, supervision, support functions, facilities capital, cost of money and profit. These rates shall apply on all resulting task orders issued against this contract.

SECTION C – Statement of Work

This is a request for a commercial-off-the-shelf (COTS) database driven, web-based environmental health inspection and management system that will support a nationwide environmental health program. The system will be modified as described in section 2. The system will be utilized at the national, regional, and field levels by approximately 250 environmental health specialists. The contractor shall have technical experience or competency in the fields of environmental and public health.

1. The COTS System shall

a. Document establishment and operator information where environmental health services are provided by IHS. Users can add or modify establishment information. Managers can verify and approve changes.

b. Allow users to document, track and report on 1) work including inspections and other activities related to establishments and 2) work that may not be related to establishments such as referrals, complaints, investigations, projects, and training.

c. Allow users to attach pictures, PDFs, spreadsheets and other common electronic files to any work record.

d. Allow users to email completed reports, with selected electronic attachments (photos spreadsheets, etc.), directly from the system.

e. Referrals, complaints, investigations, and projects should permit multiple related activities to be entered under a single overarching RCIP referral, complaint, investigation, or project.

System should allow users to associate individual activities with an establishment of their choosing.

f. Provide electronic inspection data collection capability to be used by environmental health inspectors both in the field on mobile devices and in the office using a web browser-based version. The mobile version can be run while not connected to the internet and brings all browser-based features to mobile devices for real-time use in the field.

i. Electronic inspection forms/checklists will provide access to applicable code and regulatory references related to specific violations such that they can be integrated into the inspection report.

ii. Electronic inspection forms/checklists, referrals, complaints, investigations, projects activities available on the web browser-based version will also be available on the mobile version.

iii. The inspection form/checklist format, regardless of subject material, will emulate the form, function, and layout of the FDA Food Code checklist. An example of this checklist can be seen in Annex 7, Form 3a of the FDA 2017 Food Code.

iv. Electronic inspection forms/checklists can be printed from both the web and mobile versions. Print format will follow the same layout described in Annex 7, Form 3a of the FDA 2013 Food Code.

g. Provide user permission levels based on user roles and geographic locations.

i. User administration interface for use by IHS mangers to add/edit users or user permissions.

ii. Table update/edit interface for use by IHS Headquarters managers. Ability to add/edit/modify survey types, violation codes, definitions, canned comments and electronic inspection forms.

h. Allow users to select, monitor, trend, and report specific electronic inspection violations.

i. Provide comprehensive data export functionality with parameters defined by the user.

j. Provide user support which includes the following items:

i. Application documentation

1. User Manuals for Environmental Health Inspectors.

2. Administrator Manuals for HQ and Area (regional) managers.

ii. Ability to broadcast email to system users.

iii. A help desk which has a toll free number and email address and is available 8 am to 8 pm Eastern Time, Monday through Friday.

k. Meet Federal IT/Security/FedRAMP/Accessibility requirements.

i. Offerors are required to have and provide FedRAMP certification of their solution and cloud service provider. Offerors shall provide either a Provisional Authority to Operate (P-ATO) or Joint Authorization Board (JAB) authorization documentation.

l. Have data redundancy and backup.

m. Ensure error resolution as follows:

i. Issues that impact overall system usability shall be resolved within 8 hours of discovery.

ii. Issues that do not impact overall system usability but do impact system users shall be resolved within 72 hours of discovery.

n. Have the capacity to provide a data transfer protocol which will allow web services to connect to external database products or commercial databases.

o. Have routine evaluations for system and data quality assurance.

p. Have routine system maintenance (hardware and software) provided by the contractor.

q. Provide a minimum of 24 hours’ notice prior to any action that will result in the system being inaccessible to users. An expected time of the system being back online will be included in the notice.

2. The contractor shall modify the system to include these requirements

a. Provide additional electronic inspection forms/checklists as requested by the IHS. IHS will provide applicable violations lists and associated code or regulatory references for each additional inspection type as needed.

b. Calculate Resource Requirements Methodology (RRM) figures to determine workload. The RRM value is based on the number of establishments and the work-day factor associated with each type of establishment as well as other pre-defined factors. (Calculation methodology for RRM is available upon request).

c. Establishments shall be identified using codes from the IHS coding system for Area, Service Unit, Tribe, Reservation, and Community. The IHS Standard Code Book may be viewed at http://www.ihs.gov/scb/index.cfm?module=disp_tablesSCB&newquery=1 Other IHS codes may be required and will be provided by IHS.

d. Document, track, and report tribal codes and ordinances such as food codes, fire codes, primary seat belt ordinances, and housing codes.

3. Reporting Capability The system shall generate the following reports:

a. Resource Requirements Methodology (RRM)

b. Environmental health and management related pre-existing reports and the ability to create ad-hoc reports from all data fields

c. System flexibility to allow IHS the ability to add/modify/delete and manage ad-hoc reporting fields

d. Summary reports based on user selected parameters

e. User selected inspection violation trend reports

f. Tribal code and ordinance reports

g. Workload planning and prioritization reports (i.e. next survey or activity due date calendar)

4. Training

The contractor shall provide:

a. Two on-site train-the-trainer sessions the first and third years of the contract

b. Two live webinars per year

Mandatory References:

IHS Standard Code Book -http://www.ihs.gov/scb/index.cfm?module=disp_tablesSCB&newquery=1 Resource Requirements Methodology Annex 7, Form 3a of the FDA 2017 Food Code - https://www.fda.gov/food/fda-food-code/food-code-2017

C.2 TRAVEL

If travel or Other Direct Costs (ODC) funding is identified as part of the proposal and a separate Contract Line Item Number (CLIN) established to invoice these costs, the following shall apply: Travel/ODC Travel shall be provided in accordance with the Joint Federal Travel Regulations. Travel and incidental Other Direct Costs (ODCs) shall be on a reimbursement of cost basis. Travel plans and anticipated ODC expenditures (to include estimated costs) shall be pre-approved by the COR by email prior to incurring the cost. Failure to obtain pre-approval may result in rejection of the expenditure. The contractor shall maintain a file of all travel authorizations as provided by the COR and include copies of invoice documents submitted for travel reimbursement. Additionally, travel or other direct costs in excess of the CLIN funded value shall not be reimbursed. Costs for local travel (i.e., travel within fifty (50) mile radius from the contractor’s office shall be included in program management and shall not be reimbursed.

C.3 SECURITY REQUIREMENTS

The contractor will have access to unclassified data. The Contractor shall coordinate with IHS to ensure any necessary Non-Disclosure Agreements (NDAs) in place. All Contractor personnel supporting IHS shall be US citizens.

Contract personnel visiting any Government facility in conjunction with this contract shall be subject to the standards of conduct applicable to Government employees. Site-specific approval regarding access to sensitive materials, computer facility access, issue of security badges, etc. shall be coordinated with the COR or Area POC as required.

C.4 CONTRACTOR IDENTIFICATION

Contractor employees shall identify themselves as Contractor personnel by introducing themselves or requesting they be introduced as contractor personnel and display distinguishing badges or other visible identification for meetings with Government personnel. In addition, Contractor personnel shall appropriately identify themselves as Contractor employees in telephone conversations and formal and informal written correspondence.

END OF SECTION

SECTION D – PACKAGING AND MARKING

D.1. MAILING AND SHIPPING REQUIREMENTS

All mailing and shipping required under this contract shall be done in accordance with all applicable laws and regulations.

SECTION E – INSPECTION AND ACCEPTANCE

E.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR Chapter 1) Number Title Date 52.246-4 Inspection of Services – Fixed-Price Aug 1996

SECTION F – DELIVERIES OR PERFORMANCE

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 CONTRACTING OFFICER

The Contracting Officer (CO) means a person who is the principal individual and responsible representative of the Government with the authority to enter into, administer and/or terminate contracts and make related determinations and findings pertaining to the contract. The Contracting Officer signs all contractual documents, approves and signs all modifications to contracts, processes and approves payment requests, reviews and makes final decisions on contractual discrepancies, and administers the contract. The Contracting Officer is the only authorized individual to make changes to the contract.

G.2 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) Contracting Officer's Representatives (COR), may be appointed for the purpose of representing the Contracting Officer and assuring compliance with the contract requirements.

(b) The COR has NO AUTHORITY to make any changes to the contract or any contract documents.

(c) The COR may approve minor field changes which do not affect the scope, period of performance and/or price of the contract. The COR is authorized to issue notices regarding noncompliance of contract requirements, and to stop work on any portion of the job if the Contractor's methods cause unsafe conditions or will result in noncompliant work which would be impracticable to correct or to replace while permitting other (conforming) portions of the work to continue. Issuance of a Notice of Noncompliance as described herein does not constitute a suspension of work as described in Section I, FAR Clause 52.242-14, Suspension of Work (April 1984).

(d) The COR is appointed in writing and the contractor will receive a copy of the appointment letter.

G.3. INVOICING INSTRUCTIONS

Invoices should be prepared and submitted in accordance with FAR 52.212-4(g). Invoices shall be submitted to the COR and CO for review and approval.

G.4. CERTIFICATION OF PAYMENTS – RELEASE OF CLAIMS (ROC)

The Contractor, when submitting final payment under this contract, shall submit to the Contracting Officer:

(a) A certification that the Contractor has made payment from proceeds of prior payments, or that he will make timely payment from the proceeds of the progress or final payment then due him, to any subcontractors and suppliers in accordance with established contractual arrangements; and

(b) A properly executed Contractor's Release. The Release of Claims form is available from the Contracting Officer. Failure to submit this completed release will result in a delay of final payment.

G.5. PERFORMANCE PERIOD

The contract will be for a base period of one (1) year from November 7, 2021 with four (4) options to extend the term of the contract for four (4) additional one-year periods to be exercised at the discretion of the Government.

BASE PERIOD: November 7, 2021 to November 6, 2022 OPTION PERIOD 1: November 7, 2022 to November 6, 2023 OPTION PERIOD 2: November 7, 2023 to November 6, 2024 OPTION PERIOD 3: November 7, 2024 to November 6, 2025 OPTION PERIOD 4: November 7, 2025 to November 6, 2026

G.6. CONTRACT CLOSE-OUT

The contract will be closed-out in accordance with FAR 4.804. Close-out is completed when all administrative actions have been completed, all disputes settled, release of claims has been received and final payment has been disbursed.

G.7. ADDRESS FOR CORRESPONDENCE

It is the intent of the Government to use electronic means as much as possible while administering this contract.

Most correspondence should be sent via email directly to the Contracting Officer and COR. If sending documents via postal mail, include the Contract Number on all correspondence. Overnight Mail and U.S.

Mail shall be sent to the Contracting Officer, unless otherwise specified, at the following address:

Indian Health Service (IHS) / Division of Engineering Services (DES)

Attn: Matthew Phelps or current Contracting Officer 701 Fifth Ave, Suite 1650 Seattle, WA 98104

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 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) 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.

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

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: [X] Low [ ] Moderate [ ] High

4) 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 3 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, reusing, 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.

5) 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.

6) 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 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 [OpDiv] policies. Unauthorized disclosure of information will be subject to the HHS/[OpDiv] 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).

7) 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).

8) 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.

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

10) 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 OpDiv-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 within twelve months of the effective date of this contract.

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 the COR upon request and at the conclusion of the contract.

11) 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 OpDiv non-disclosure agreement. [OpDiv inserted information/link should be cited here], 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.

12) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the OpDiv Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed. a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the OpDiv SOP or designee with completing a PIA for the system or information within six months after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the OpDiv 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 agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces 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/IHS 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 IHS Information Security Awareness, 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 annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role- Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

3) 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 IHS 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 OpDiv Information 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

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/IHS IRT teams within 24 hours, whether the response is positive or negative.

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 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”.

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) 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.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send IHS approved notifications to affected individuals within 24 hours of being instructed to do so in accordance with approved IHS processes and formats.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the OpDiv Incident Response Team (IRT) (IRT.Incident@ihs.gov), COR, CO, OpDiv SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable OpDiv and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall: a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information and IHS incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

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). The following position sensitivity designation levels apply to this solicitation/contract:

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.

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 within 30 days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 30 days of the 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 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 within 48 hours before an employee stops working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) if applicable 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 IHS policies.

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/IHS policies and shall not dispose of any records unless authorized by HHS/IHS.

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/IHS policies.

H.2 Security Requirements for GOCO and COCO Resources

1) Federal Policies. The Contractor (and/or any subcontractor) shall comply with applicable federal laws that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P), [Indian Health Manual Chapter 12]; Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Security and Privacy Controls for Federal Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

2) Security Assessment and Authorization (SA&A). A valid authority to operate (ATO) certifies that the Contractor’s information system meets the contract’s requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within twelve months of the effective date of this contract. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 80037, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, OpDiv must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

IHS acceptance of the ATO does not alleviate the Contractor’s responsibility to ensure the system security and privacy controls are implemented and operating effectively.

a. SA&A Package Deliverables -The Contractor (and/or any subcontractor) shall provide an SA&A package within twelve months of the effective date of this contract to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package:

System Security Plan (SSP) – due within twelve months of the effective date of this contract.

The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and IHS policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

Security Assessment Plan/Report (SAP/SAR) – due within twelve months of the effective date of this contract. The security assessment shall be conducted by assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and IHS policies. The assessor will document the assessment results in the SAR.

Independent Assessment - The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all “high” deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

POA&M – The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and OpDiv policies. All high-risk weaknesses must be mitigated within thirty

(30) days and all medium weaknesses must be mitigated within sixty (60) days from the date the weaknesses are formally identified and documented. IHS will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, IHS may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

Contingency Plan and Contingency Plan Test –The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and IHS policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

E-Authentication Questionnaire – The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines. Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

b. Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, and HHS IS2P. The following are the minimum requirements for ISCM:

Annual Assessment/Pen Test – Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (this may involve penetration testing conducted by the agency or independent third-party.) In addition, review all relevant SA&A documentation (SSP, POA&M, Contingency.

Asset Management – Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually. IT asset inventory information shall include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The contractor shall maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

Configuration Management – Use available SCAP-compliant automated tools, per NIST IR 7511, for authenticated scans to provide visibility into the security configuration compliance status of all IT assets, (computers, servers, routers, databases, operating systems, application, etc.) that store and process government information. Compliance will be measured using IT assets and standard HHS and government configuration baselines at least annually. The contractor shall maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

Vulnerability Management – Use SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets (computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least annually.

Patching and Vulnerability Remediation – Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeframes.

Secure Coding – Follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

Boundary Protection – The contractor shall ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities is routed through a Trusted Internet Connection (TIC).

3) Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to…

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