Statement of Work Morgantown Medical Services.pdf

Statement of Work

Medical Services for NIOSH Morgantown

Period of Performance: January 27, 2025, to January 26, 2030 Base: January 27, 2025, to January 26, 2026

Option 1: January 27, 2026, to January 26, 2027 Option 2: January 27, 2027, to January 26, 2028 Option 3: January 27, 2028, to January 26, 2029 Option 4: January 27, 2029, to January 26, 2030

1 Background and Need

The contractor shall provide the medical services in the appropriate specialties for the National Institute of Occupational Safety and Health, Morgantown, WV, in accordance with the Statement of Work.

The National Institute of Occupational Safety and Health (NIOSH) provides physicals and medical surveillance programs to CDC/NIOSH Morgantown employees. All employees have the opportunity to participate in the medical monitoring program. Those employees who elect to participate in the program are given physicals based on their age. NIOSH has a requirement for an estimated 150 Physical Examinations (i.e., physicals) per year.

NIOSH has employees that are part of the CDC Emergency Response Team as well as the PHS Commissioned Corps Readiness Team. These teams are involved in incident management activities to include the prevention of, preparedness for, response to, and recovery from terrorism, major natural disasters, and other major emergencies.

Depending on the type and magnitude of the emergency, additional NIOSH employees not currently on the team may be called to respond to an emergency. This would require immediate medical services which would include a responder readiness (general fit for duty) medical clearance (See Attachments 1 – 4) and may also include immunizations and/or respiratory medical clearance. It is essential that the contractor administering the medical surveillance program for the NIOSH-Morgantown facility be located nearby to the facility (within approximately 20 miles) or be able to provide services in that vicinity within eight (8) hours of request for services.

2 Project Objective – The following objectives are established for the contractor to provide the minimum services:

- Employee physicals

- Medical monitoring and surveillance

- Monitored care when appropriate

- Records and Data Management

- Support as required for the emergency and disaster preparedness team

- Other occupational medical services described herein

- Supporting transition between medical services providers

- Additional Services as described herein.

3.Scope of Work –

The physical exams performed for NIOSH include vital signs and standard systems checks (height, weight, blood pressure, pulse, respiration, etc.) and an assessment and review of systems (head, ears, eyes, heart, lungs, extremities). The charge per exam must include the administrative time of the physician to complete necessary paperwork, dictation, overhead, supplies, etc. Services, in addition to, and those provided outside the scope of the physical exam process, shall be a separate charge and are described below. Those types of services may include respirator clearance exams (may include spirometry and OSHA questionnaire review), hearing tests for mandatory hearing conservation program, testing for Beryllium exposure, influenza clinic animal allergy questionnaire, etc.

Results of the examination and additional services will be sent to the patient/employee.

NIOSH has employees that are part of the CDC Emergency Response Team as well as the PHS Commissioned Corps Readiness Team. These teams are involved in incident management activities to include the prevention of, preparedness for, response to, and recovery from terrorism, major natural disasters, and other major emergencies.

This would require immediate medical services which would include a general fit for duty medical clearance and may also include immunizations and/or respiratory medical clearance. Therefore, it is essential that the contractor be located nearby to the facility (within approximately 20 miles) or be able to provide services in that vicinity within eight (8) hours of request for services.

4. Services required:

Physicals are performed one or two days per month. Quotes shall be priced per unit per item. Any estimated quantity provided in this scope of work is not a guaranteed minimum and is used solely for estimation purposes and as a determination as to the acceptability and reasonableness of the prices proposed by the offeror. The Government will make a determination as to the acceptability and reasonableness of the prices proposed by the offeror. Prices shall be fully burdened and inclusive of overhead, G&A, profit, etc. for the performance periods. Services include:

Services Estimated quantity (per year not a guaranteed minimum)

Non-Emergency Response or Commissioned Corps Readiness Team employees 150 Emergency Response and Commission Corps Team employees 20

Other Services

Responder Readiness Medical Clearance 20 Responder Readiness Program Interim Medical Evaluation 20 Post-Deployment Health Assessment 20 Respirator Evaluation Questionnaire 100 SCBA plus pulmonary function and possible stress tests. 2 Animal Allergy Questionnaire 75 Beryllium Surveillance BeLPT (blood work) 4 Hearing Test for mandatory Hearing Conservation Program 5

Influenza

Influenza on site clinic 200

5 Description of service

Physical Exam

The physical exams are scheduled one or two days per month and include vital signs, standard systems checks (height, weight, blood pressure, pulse, respiration, etc.), as well as the actual physical exam and assessment performed by the physician (See Attachment 5). This may include an assessment and review of systems (head, ears, eyes, heart, lungs, extremities, etc.).

Physicals examinations for Public Health Service Commissioned Officers will include completion of two forms (See attachments 14 & 15) along with the paperwork completed for standard physicals. Extra time and administration is required for these physicals. Additional physical testing requirements may also be included with these examinations, such as a stress test and a hearing test.

Respirator Clearance Questionnaire

Conduct medical clearance questionnaire for respirator use in accordance with 29 CFR 1910.134 and upon completion, will provide clearance decisions to the NIOSH Morgantown Respiratory Protection Program administrator. SCBA clearances will include same clearance requirements as other respirators plus a Pulmonary Function Test and possibly a stress test (to be determined by contractor based on health status and age of employee).

Hearing Conservation

Hearing Conservation (audiometric testing): Audiometric screening shall be performed as needed for emergency responders and for workers in high-risk noise positions in accordance with 29 CFR, 1910.95. In addition, the contractor will provide medical follow up with anyone exhibiting standard threshold shift (STS) (Attachment 12).

Beryllium Surveillance (BeLPT)

Beryllium surveillance in accordance with 10 CFR 850.34 - https://www.gpo.gov/fdsys/pkg/CFR-2011-title10-vol4/pdf/CFR-2011-title10-vol4-sec850-34.pdf - for personnel participating in on-site work at beryllium facilities.

Beryllium is a hard, lightweight metal that is very strong and easy to shape. It has many industrial uses. Beryllium-copper alloys and beryllium-oxide ceramics are used in the electronic, nuclear and aerospace programs. Beryllium parts for nuclear weapons were manufactured and used at a number of Department of Energy (DOE) laboratories.

This manufacturing process continues at some laboratories today.

All personnel working with or visiting sites that use beryllium will be enrolled in beryllium surveillance. The surveillance will be the beryllium lymphocyte proliferation test (Be LPT). The Be LPT is a blood test used to detect a person’s sensitivity to beryllium.

Animal Allergy Questionnaire

Employees who work with laboratory animals will be administered the Laboratory Animal Allergy Questionnaire on a bi-annual basis (Attachment 8).

Immunization Program

Administer necessary immunizations to at-risk employees identified by the Project Officer. The Contractor shall provide individual employees with records of immunizations documented in their chart as may be required for occupational health or international travel purposes, in accordance with the CDC/ATSDR Occupational Immunization Program. The Contractor shall also enter this data into an electronic records system (such as a spreadsheet) daily. These immunizations may include, but are not limited to, the following licensed vaccines, toxoids, or globulins: tetanus-diphtheria toxoids, immune globulins, hepatitis-A vaccine, hepatitis-B vaccine, influenza vaccine, immune measles, mumps, and rubella vaccine, meningococcal vaccine, and poliomyelitis vaccine. Vaccines may be furnished by NIOSH when it is advantageous to the government.

The Immunization Program provides immunizations at no cost to employees who have potential occupational exposure to infectious agents. The Program provides immunizations to laboratory workers, engineering personnel, animal care personnel, field investigators, and other individuals who may be at potential risk of exposure to the disease agents. Contract employees are not eligible for these immunizations unless pre-approved by the Project Officer. Immunizations included in the program are Influenza, Rubella, Adult Tetanus-Diphtheria (Regular), Adult Tetanus-Diphtheria (Adacel), Pneumococcus, Hepatitis A, Varicella, Polio and MMR.

Influenza Clinic

Administer influenza vaccine annually to the NIOSH Morgantown workforce. The influenza immunization campaign shall be conducted at the NIOSH Morgantown facility. The Contractor and Project Officer will review historical data regarding the number of persons who received the vaccine in the prior year and any employee population increase to determine the number of vaccinations to plan for each year. Influenza immunizations are https://www.gpo.gov/fdsys/pkg/CFR-2011-title10-vol4/pdf/CFR-2011-title10-vol4-sec850-34.pdf https://www.gpo.gov/fdsys/pkg/CFR-2011-title10-vol4/pdf/CFR-2011-title10-vol4-sec850-34.pdf offered annually to all employees by the contractor. An "all employees" announcement of availability of the vaccine is issued in the fall with two flu clinics held onsite at NIOSH. Additional influenza vaccines may be administered at the contractor’s office.

6. Technical Requirements –

Operations – Provide personnel and medical supplies to support operations that include the following services:

- Provide qualified medical personnel. The contractor’s workforce shall be board certified by their appropriate occupational health or medical discipline.

- Provide administrative oversight to manage personnel, pharmaceuticals, medical records, equipment and supplies.

- Conduct employee physical examinations (approximately 150 annually), including: analysis of clinical results and patient interaction. Examinations will include: vital signs (height, weight, blood pressure, pulse, and respirations) as well as the actual physical exam and assessment performed by the physician. This may include an assessment and review of systems (head, ears, eyes, heart, lungs, extremities, etc.).

- Provide respirator certifications as needed (approximately 100 annually) for job specific occupational exposure. Employees who may be exposed to hazardous atmospheres in the conduct of their work will require respirator clearance.

- Maintain appropriate corresponding medical inventories including a supply of vaccines (tetanus-diphtheria, Hepatitis B, Hepatitis A, MMR, TB testing materials, etc.) in order to accomplished the requirements in the SOW.

- Provide employee medical record maintenance and administrative support for medical records of current and former employees in accordance with Federal, state, and local laws.

- Protect the privacy of employees and confidentiality and physical security of all employee medical records, and provide access to employee medical and behavioral health records, in a manner consistent with: 1) The Privacy Act as codified in 10 CFR 1008; 2) “Access to Exposure and Medical Records” as codified in 29 CFR 1910.1020 (OSHA Standard); and 3) The Health Insurance Portability and Accountability Act.

- Provide copies of medical records to other professional medical and behavioral health providers and third-party medical claims processor(s) as appropriate and in a manner consistent with all applicable laws and standards.

- Manage durable medical supplies.

- Provide consultation services for occupational health issues for services provided by this contract.

- The contractor shall supply pharmaceuticals, and other controlled medical supplies, as appropriate, and required to accomplish the work under this contract.

- The contractor shall furnish the infrastructure, equipment, and supplies (consumable medical supplies and general office supplies, to include lab equipment, clinic furniture, medical beds, exam tables, etc.)

to enable the services described herein.

7. Reporting Schedule –

- Concurrently, but in separate email from Monthly invoice, a monthly detailed report of services rendered during the month by price, type/category, quantity, and patient. The report must list all services rendered including physical exam, immunizations, questionnaires, and any other services provided. Monthly invoices must not include Personally Identifiable Information (PII).

9. Government Furnished Property

- The Government may provide space for the contractor during fall influenza clinics.

- The Government may provide space for the contractor to conduct medical examinations.

10. Deliverables–

Deliverables –

1.) The contractor shall provide a monthly detailed report of all services rendered during the month by price, category, and patient.

2.) The contractor shall provide each employee who undergoes a physical:

1) a copy of all forms completed, test results, exam reports, etc.,

2) post-exam counseling only (no formal follow-up communication is expected/required),

3) an advisement letter explaining medically significant data with any abnormal findings,

4) written (typed in English) recommendations for addressing these concerns.

11. Special Considerations

-Privacy Act: It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals.

508 Language

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

504 Authoring Tools

602 Support Documentation http://www.hhs.gov/web/508 http://www.access-aboard.gov/sec508/standards.htm

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Section I: Procurements Requiring Information Security and/or Physical Access Security

Baseline Security Requirements

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

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.

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, http://hhs.gov/web/508 http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html firmware and similar procedures, services (including support services), and related resources.

Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC/NIOSH policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

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:

Protect the:

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.

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.

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.

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

Categorize all information owned and/or collected/managed on behalf of HHS/CDC/NIOSH and information systems that store, process, and/or transmit HHS information 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, 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: [ ] Low [ ] Moderate [ ] High

Integrity: [ ] Low [ ] Moderate [ ] High

Availability: [ ] Low [ ] Moderate [ ] High

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

Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/CDC/NIOSH regardless of location or purpose.

Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one

(1) hour or less, to the government representative(s).

Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/CDC/NIOSH 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 all applicable security and privacy policies by contacting the CO/COR or HHS/CDC/NIOSH security and/or privacy officials.

Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/CDC/NIOSH privacy policies, and complete all the requirements below:

Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (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.

To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how HHS collects, disseminates, maintains, or disposes of the public's PII.

The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within [OpDiv to insert contract-specific timeline] 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.

The Contractor must support the agency 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.

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:

marked appropriately;

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

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 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.

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 by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

Per NIOSH Security and Privacy requirement, the Contractor (and/or any subcontractor) shall employ a formal sanctions process for individuals failing to comply with established privacy policies and procedures.

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 [CDC] policies. Unauthorized disclosure of information will be subject to the HHS/[CDC] sanction policies and/or governed by the following laws and regulations:

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

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

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

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). .

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.

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

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

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

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.

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).

Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor shall provide a written copy of the validation documentation to the COR.

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 Officer (OCISO).

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. Contractors (and/or subcontractors) must a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

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.

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.

Training

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.

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 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.

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.

Rules of Behavior

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, HHS Rules of Behavior for Privileged Users.

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.

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:

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.

The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/CDC IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "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" and a privacy breach is "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." For additional information on the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

All contractors and subcontractors shall report a suspected or confirmed breach in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC, 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. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

Not include any sensitive information in the subject or body of any reporting e-mail;

and

Encrypt sensitive information in attachments to email, media, etc.

Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS/CDC privacy breach response policies when handling PII breaches.

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.

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.

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.

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.

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, 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 for PII.

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).

All contractors with routine access to PII requires both a valid need to know and requires a Tier 2S background investigation to ensure the individual being provided access is suitable. These requirements extend to developers of information systems containing PII and PHI.

[ ] Tier 1

[ ] Tier 2s

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

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.

Contract Initiation and Expiration

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).

System Documentation. Contractors (and/or any subcontractors) must follow and adhere to 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.

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.

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.

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.

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.

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.

Requirements for Procurements Involving Privacy Act Records Privacy Act

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records about individuals from which records are retrieved by name or other identifying particular.

The System of Records Notice that is applicable to this contract is: [Insert SORN name/number if one exists. Applicable SORNs are found at https://www.hhs.gov/foia/privacy/sorns/index.html, and may be chosen from CDC, or HHS, or Government-wide. If there is no SORN, indicate that a new or revised SORN will be developed].

The system of records design, development, or operation work the Contractor is to perform is: [ Insert description of design, development, and/or operation work; see definitions in the FAR at

24.101 - Definitions].

The disposition to be made of the Privacy Act records upon completion of contract performance is:

[Insert records disposition instructions and as applicable, the corresponding Records Schedule that the Contractor and any subcontractor must follow upon completion of contract performance32].

http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf http://www.hhs.gov/foia/privacy/sorns/index.html