75FCMC19R0034_-_Terms_and_Conditions.pdf

INFECTIOUS DISASES PREVENTION AND CONTROL CONSULTANT

75FCMC19R0034

TABLE OF CONTENTS

SECTION A – SF1449

SECTION B – CONTINUATION OF SF1449 (BLOCKS 19, 20, 24)

B.1 BRIEF DESCRIPTION OF SERVICES

B.2 TYPE OF CONTRACT

B.3 SCHEDULE OF SUPPLIES/SERVICES

B.4 PERIOD OF PERFORMANCE

SECTION C – CONTRACT CLAUSES

C.1 FAR 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL

ITEMS, ALTERNATE I – BY REFERENCE

C.2 ADDENDUM TO 52.212-4 CONTRACT TERMS AND CONDITIONS –

COMMERCIAL ITEMS

C.3 FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS – COMMERCIAL

ITEMS

SECTION D – ATTACHMENTS

D.1 STATEMENT OF WORK

D.2 PRICING TEMPLATE

D.3 PAST PERFORMANCE QUESTIONAIRE

D.4 CONTRACTOR PERSONAL CONFLICT OF INTEREST FINANCIAL

DISCLOSURE TEMPLATE

D.5 CONTRACTOR BUSINESS ETHICS, CONFLICT OF INTEREST AND

COMPLIANCE PROGRAM REQUIREMENTS

D.6 SECTION 508 PAT

SECTION E – SOLICITATION PROVISIONS

E.1 FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS

E.2 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS –

COMMERCIAL ITEMS)

E.3 ADDENDUM - EVALUATION PROCEDURES AND CRITERIA

E.4 FAR 52.212-3 OFFERORS REPRESENTATION AND CERTIFICATIONS –

COMMERCIAL ITEMS

E.5 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE

E.6 FAR 52.233-2 -- SERVICE OF PROTEST (SEP 2006)

E.7 FAR 52.222-49 -- SERVICE CONTRACT LABOR STANDARDS -- PLACE

OF PERFORMANCE UNKNOWN (MAY 2014)

SECTION B-CONTINUATION OF SF1449 (BLOCKS 19, 20, 24)

B.1 BRIEF DESCRIPTION OF SERVICES

Under sections 1819(a-d, f) and 1861(e) of the Social Security Act (the Act), the Secretary has the responsibility to assure that Medicare requirements are met and their enforcement are adequate to protect the health and safety of all individuals in nursing homes and hospitals. Section 1864 of the Act grants State Agencies (SAs) the authority to perform surveys of nursing homes and hospitals to determine initial and ongoing compliance.

CMS seeks consultative services of a Contractor to assist in developing strategies and approaches that improve the care and services provided to Medicare and Medicaid beneficiaries. The Contractor will have significant expertise in infection prevention and control and will provide clinical strategies and approaches that improve the care and services provided to nursing home residents, and patients in other Quality, Safety, and Oversight Group provider types/settings such as hospitals, ambulatory care centers, dialysis facilities, home health, and hospice. In addition, this Contractor will provide infection prevention and control recommendations on policies to include but are not limited to the prevention of HAIs and spread of infections during transitions of care, optimal use of antimicrobials, and multi-drug resistant organisms (MDROs).

B.2 TYPE OF CONTRACT

This is a Time and Materials (T&M) contract.

B.3 SCHEDULE OF SUPPLIES/SERVICES

Completion of contract line item numbers (CLINS) shall be in accordance with the Statement of Work (Attachment 1). The following is the Not-to-Exceed (NTE) amount by period of performance and CLIN:

(See also Attachment 2 CLIN Schedule for labor categories and rates.)

BASE YEAR

CLIN

Description PSC Accounting Classification

Unit of Measure QTY Unit

Price Not to Exceed

(NTE)

T&M – Infectious Diseases Prevention and Control Consultant

R406 TBD Dollars $ $1 $

OPTION YEAR 1

CLIN

Description PSC Accounting Classification

Unit of Measure QTY Unit

Price Not to Exceed

(NTE)

T&M – Infectious Diseases Prevention and Control

OPTION YEAR 2

Description PSC Accounting Classification

Unit of Measure QTY Unit

Price Not to Exceed

(NTE)

T&M – Infectious Diseases Prevention and Control

OPTION YEAR 3

Description PSC Accounting Classification

Unit of Measure QTY Unit

Price Not to Exceed

(NTE)

T&M – Infectious Diseases Prevention and Control

OPTION YEAR 4

Description PSC Accounting Classification

Unit of Measure QTY Unit

Price Not to Exceed

(NTE)

T&M – Infectious Diseases Prevention and Control Consultant

R406 TBD Dollars $ $1 $

*The contractor shall be allowed to vary the labor mix in the Attached D.2 schedule for each CLIN.

However, in no event shall the contractor exceed the total not-to-exceed ceiling price per CLIN as shown above.

B.4 PERIOD OF PERFORMANCE

The period of performance of this contract is September 27, 2019 through September 26, 2020.

Options may be exercised in accordance with FAR 52.217-9, Option to Extend the Term of the Contract as follows:

Base Period Sept. 27, 2019 – Sept 26, 2020 Option Year 1 Sept. 27, 2020 – Sept. 26, 2021 Option Year 2 Sept. 27, 2021 – Sept. 26, 2022 Option Year 3 Sept. 27, 2022 – Sept. 26, 2023 Option Year 4 Sept. 27, 2023 – Sept. 26, 2024

SECTION C CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS,

ALTERNATE I (JAN 2017) BY REFERENCE

C.2 ADDENDUM TO 52.212-4 CONTRACT TERMS AND CONDITIONS –

COMMERCIAL ITEMS (JAN 2017)

I. FAR 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: www.acquisition.gov

NUMBER TITLE DATE

52.204-13 System for Award Management Maintenance

OCT 2018

52.204-23

Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Labs and Other Covered Entities

JUL 2018

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters

OCT 2018

52.217-8 Option to Extend Services

- Fill in: 10 days

NOV 1999

52.217-9 Option to Extend the Term of the Contract Fill in: (a) the current period of performance Fill in: (c) 5 years

MAR 2000

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

DEC 2013

II. 52.222-42 STATEMENT OF EQUIVALENT RATES FOR

FEDERAL HIRES (MAY 2014)

In compliance with the Service Contract Labor Standards statute and the regulations of the Secretary of Labor (29 CFR part 4), this clause identifies the classes of service employees expected to be employed under http://www.acquisition.gov/ the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C. 5341 or 5332.

III. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, with the same force and effect as if they were provided in full text. Upon request, the Contracting Officer will provide the information in full text. The full text of a clause is also available electronically at http://www.hhs.gov/policies/hhsar/.

NUMBER TITLE DATE

352.203-70 Anti-Lobbying DEC 2015 352.208-70 Printing and Duplication DEC 2015 352.211-3 Paperwork Reduction Act DEC 2015 352.222-70 Contractor Cooperation in Equal Employment

Opportunity Investigations

DEC 2015

352.224-70 Privacy Act DEC 2015 352.227-70 Publications and Publicity DEC 2015 352.231-70 Salary Rate Limitation DEC 2015 352.233-71 Litigation and Claims DEC 2015

IV. HHSAR 352.224-71 CONFIDENTIAL INFORMATION (DEC 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are http://uscode.house.gov/ http://uscode.house.gov/ http://www.hhs.gov/policies/hhsar/ restricted under this contract:

Full names and Personally Identifiable Information (PII) of the research participants.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: Release of this information could jeopardize the security of data (e.g., Personally Identifiable Information) and would pose a risk to the public interest if released.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

V. HHSAR 352.237-75 KEY PERSONNEL (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty (30) days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

NAME POSITION TITLE PHONE NUMBER EMAIL

ADDRESS

VI. RESERVED

VII. HHSAR 352.239-74 ELECTRONIC INFORMATION AND

TECHNOLOGY ACCESSIBILITY (DEC 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement.

The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are: See the Statement of Work.

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

VIII. PAYMENTS - PAYMENTS – INVOICES – Commercial Time &

Materials/Labor Hour Contracts (Sept 2018) http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/Far/02.htm#P10_603 http://www.hhs.gov/web/508 http://www.hhs.gov/web/508

a. GENERAL: The Contractor shall submit to the Government an invoice for payment in accordance with the instructions below.

b. BANKING CHANGES: The contractor shall notify CMS’ Division of Accounting Operations of all banking and address changes made in SAM via the following email address: CCRChanges@cms.hhs.gov.

c. CONTENT OF INVOICE: FAR 32.905 Payment Documentation and Process, provides the required content for a proper invoice. In addition to the requirements of FAR 32.905, the following items shall also be included on the invoice to be considered proper:

• Line item number (i.e. CLIN/SLIN as applicable)

• Contractor’s DUNS Number

• Period of performance for delivery date of goods or services provided.

d. INVOICE SUBMISSION: Invoices shall be submitted in electronic format via email as follows:

To…: InvoiceSubmission@cms.hhs.gov Cc…:Please “Cc…” your respective Contract Specialist (CS) and Contracting Officer’s

Representative (COR) as follows:

• Contract Specialist – paul.judd2@cms.hhs.gov ; and

• COR - TBD

Subject Line: The email subject line shall contain the following information: Contract Number, Task/Delivery Order Number (if applicable), Invoice Number, and Notification of Final Invoice (if applicable).

PLEASE DO NOT INCLUDE ANY ADDITIONAL INFORMATION

IN THE SUBJECT LINE, as doing so may delay internal processing of your invoice for payment.

Attachments: Invoice attachments shall be submitted in .pdf format. Only one invoice shall be attached per email. The first page of the attachment shall be the invoice, followed by any supporting documents as applicable.

e. PAYMENTS: The Government shall make payments on all invoices in accordance with the following clauses:

• FAR 52.232-33 Payments by Electronic Funds Transfer – System for Award

Management,

• FAR 52.212-4, Contract Terms and Conditions – Commercial Items, Alt I,

• FAR 52.232-7, Payments under Time-and-Materials and Labor-Hour Contracts

Payment shall be made upon acceptance by the Contracting Officer’s Representative (COR) of the required supplies/services in accordance with the applicable FAR Inspection and Acceptance clause and the Contracting Officer’s approval.

mailto:CCRChanges@cms.hhs.gov https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2032_9.html#wp1032997 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2032_9.html#wp1032997 mailto:InvoiceSubmission@cms.hhs.gov mailto:paul.judd2@cms.hhs.gov

Reimbursement for invoices submitted under this contract shall be made not later than 30 calendar days after receipt of a proper invoice from the Contractor at the paying office designated above. CMS will make every effort to accelerate payments to small businesses and prime contractors with small business subcontractors.

f. INTEREST ON OVERDUE PAYMENT: The Prompt Payment Act, Public Law 97-

177 (96 Stat.85.31 U.S.C. 1801) is applicable to payments under this contract and requires the payment of interest on payments made more than 30 calendar days after receipt of a proper invoice by the Division of Accounting Operations.

Determinations of interest due will be made in accordance with the provisions of the Prompt Payment Act and 5 CFR 1315.

X. CONTRACTOR PERFORMANCE EVALUATION(S) (OCT 2014)

a. General:

In accordance with Federal Acquisition Regulation (FAR) 42.15, Contractor Performance Information, past performance evaluations shall be prepared at least annually and at the time the work under a contract or order is completed. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary.

CMS will utilize the Contractor Performance Assessment Reporting System (CPARS), the Government-wide evaluation reporting tool for all past performance reports on contracts and orders, as appropriate. CPARS is a secure Internet website located at https://www.cpars.gov.

b. CPARS Process:

1. CPARS Training: Contractors may obtain CPARS training material and register for on-line training https://www.cpars.gov.

2. Post-Award Contract Registration: CMS is responsible for registering the contract in CPARS within 30 calendar days of contract award. The Contractor shall:

i.Designate at least one (1) point of contact that will be responsible for serving as the Contractor’s Representative (CR). Additional CRs may also be identified; and, ii.Provide the CMS Contract Specialist with the name(s) and email address(es) of the CPARS point(s) of contact.

Once CMS registers the contract in CPARS, the CR(s) will receive an automated CPARS email message that contains User IDs and instructions for creating a password for future past performance evaluation processing.

3. Interim, Annual and Final Past Performance Evaluation Reports:

a. Issuing the Evaluation: Once the CMS Assessing Official (AO) issues an evaluation to the Contractor in CPARS, the CR(s) will receive an email instructing them to login to CPARS to review the evaluation.

https://www.cpars.gov/ https://www.cpars.gov/

b. Contractor Comments: The CR has the option to provide comments on the evaluation, indicate if they concur or do not concur with the evaluation, sign, and then return the evaluation to the AO. The CR has a total of 60 days following the AO’s evaluation signature date to submit comments. If the CR submits comments within the first 14 days following the AO’s signature date and the AO closes the evaluation, the evaluation will become available in Past Performance Information Retrieval System - Report Card (PPIRS-RC) within 1 day.

On day 15 following the AO’s evaluation signature date, the evaluation will become available in PPIRS-RC with or without CR comments and whether or not it has been closed by the AO. If no CR comments have been sent and the evaluation has not been closed, it will be marked as “Pending” in PPIRS-RC.

If the CR sends comments at any time prior to 61 days following the AO’s evaluation signature date, those comments will be reflected in PPIRS-RC within 1 day. On day 61 following the AO’s evaluation signature date, the CR will be “locked out” of the evaluation and may no longer send comments.

XI. GOVERNMENT REPRESENTATIVES AND RESPONSIBILITIES (JUL

2016)

Following are the Government Representatives and their respective roles and responsibilities on this contract:

a. Contracting Officer

As defined in Federal Acquisition Regulation (FAR) 2.101, Definitions, and in accordance with FAR 1.602-1, Authority, “Contracting officers have authority to enter into, administer, and/or terminate contracts and make related determinations and findings.” There is no other authorized representative or any other Administrative Contracting Officer assigned to this contract to carry out a Contracting Officer’s duties, except for technical direction assigned to the Contracting Officer’s Representative, if applicable.

The Contracting Officer is:

Centers for Medicare & Medicaid Services Office of Acquisition & Grants Management Acquisition and Grants Group Division of Beneficiary Support Contracts ATTN: Elliott Sloan 7500 Security Blvd.

Mail-stop: B3-30-03 Baltimore, MD 21244-1850

Phone: 410-786-0320 Email Address: Elliott.Sloan@cms.hhs.gov mailto:Elliott.Sloan@cms.hhs.gov

b. Contract Specialist

Notwithstanding any of the other provisions of this Contract, the Contract Specialist will assist the Contracting Officer with her responsibilities as defined in the FAR.

The Contract Specialist is:

Acquisition and Grants Group Division of Beneficiary Support Contracts ATTN: Mr. PJ Judd 7500 Security Blvd.

Mail-stop: B3-30-03 Baltimore, MD 21244-1850

Phone: 410-786-4160 Email Address: Paul.Judd2@cms.hhs.gov

c. Contracting Officer’s Representative and Alternate Contracting Officer’s Representative

The Contracting Officer’s Representative (COR), as defined in FAR 2.101, Definitions, is:

ATTN:

7500 Security Blvd.

Mail-stop:

Baltimore, MD 21244-1850

Phone:

Email Address:

In accordance with FAR 1.602-2(d), Responsibilities, the COR’s delegated responsibilities are identified in the Contracting Officer’s appointment memorandum, a copy of which will be furnished to the contractor.

Technical direction must be within the general scope of the work stated in the contract. The term "technical direction" is defined to include, without limitation, the following:

(1) Directions to the Contractor which direct the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual technical requirements as identified in the Statement of Work or Performance Work Statement; or mailto:Paul.Judd2@cms.hhs.gov

(2) Provision of information to the Contractor, which assists in the interpretation of drawings, specifications, or technical portions of the work description.

The COR does not have the authority to:

1. Make changes to contract terms and conditions;

2. Direct the contractor to perform work or make deliveries not specifically required under the contract;

3. Waive or relax the Government’s rights with regard to the Contractor’s compliance with the specifications, price, delivery or any other terms or conditions of the contract;

4. Make any commitments or approve any actions that would create any financial obligation on the part of the Government; or

5. Issue direction that constitutes a “change” as defined in:

FAR 52.243-1, Changes – Fixed Price;

FAR 52.243-2, Changes – Cost Reimbursement;

FAR 52.243-3, Changes – Time and Material and Labor Hour;

FAR 52.243-4, Changes; or, FAR 52.243-5, Changes and Changed Conditions.

All technical direction shall be issued in writing by the COR or, if issued verbally, shall be confirmed in writing by the COR within five (5) business days after issuance.

The Contractor shall proceed promptly with the performance of technical direction duly issued by the COR within the scope of his/her authority.

If, in the opinion of the Contractor, any instruction or direction issued by a Government representative constitutes a change to the contract or constitutes a “Change Order” as defined in FAR 2.101, Definitions, the Contractor shall follow the instructions identified in FAR 52.243-7 Notification of Changes.

XII. POST AWARD BUSINESS ETHICS, CONFLICT OF INTEREST AND

COMPLIANCE (OCT 2015)

a. General: It is imperative that the Contractor and the services provided under this contract be free, to the greatest extent possible, of all Organizational and Personal Conflicts of Interest. In this clause, all references to Organizational and/or Personal Conflicts of Interests will be referred to individually or collectively, as the text justifies, as Conflicts of Interest (COI). Except as provided below, the Contracting Officer shall not maintain a contract with a Contractor that the Contracting Officer determines has, or has the potential for, an unresolved COI. However, in accordance with FAR 9.503 Waiver, the Contracting Officer may contract with a Contractor that has an unresolved COI if he/she determines that it is in the best interest of the Government to do so.

b. Definitions:

Actual COI– means that the COI is currently in existence as determined by the Offeror’s or Contractor’s Compliance Officer and/or as determined by CMS. This form of COI will require avoidance, neutralization or mitigation acceptable to CMS.

Affiliates – As defined in FAR 2.101 means associated business concerns or individual(s) if, directly or indirectly either one controls or can control the other; or a third party controls or can control both.

For purposes of this contract, affiliate control or influence may include, but is not limited to:

(a) Interlocking management or ownership (e.g., individuals serving in similar capacities in several companies);

(b) Identity of interests among family members such as spouse/domestic partner and/or any dependent of the respondent;

(c) Shared facilities and equipment;

(d) Common use of employees; or

(e) A business concern organized just prior to, or immediately following, the release of a solicitation or request for information, which has the same or similar management, ownership, or principal employees as the Offeror or Contractor.

Any business, whether or not it is organized for profit or located in the United States or its outlying areas, or person may be found to be an affiliate. Control may be affirmative or negative and it is immaterial whether it is exercised so long as the power to control exists.

Apparent (Perceived) COI – means that the COI on first observation appears to be an actual or potential COI, but may or may not be after analysis. Even if the apparent COI is determined to be non-existent, this perception may still require further explanation.

Financial Interests/Relationships – means a healthcare related direct or indirect ownership or investment interest (including an option or non-vested interest) in any entity that exists through equity, debt, or other means and includes any indirect ownership or investment interest no matter how many levels removed from a direct interest.

A financial interest/relationship may arise from the following non-exclusive examples:

(a) Compensation, including wages, salaries, commissions, professional fees, or fees for business referrals;

(b) Current or known future arrangements or requirements for which you are defined as an interested party including, but not limited to, an entity that may create one or more of the three forms of COI;

(c) Consulting relationships, including commercial and professional consulting and service arrangements, scientific and technical advisory board memberships, or serving as an expert witness in litigation;

(d) Services provided in exchange for honorariums including travel expense reimbursements;

(e) Research funding or other forms of research support;

(f) Healthcare related investment in the form of stock or bond ownership, including healthcare sector investment only mutual funds;

(g) Healthcare business ownership or partnership interests;

(h) Patents, copyrights, and other intellectual property interests;

(i) Seeking or negotiating for prospective employment or business; or

(j) Gifts, including travel.

Mitigation – means action taken by the Contractor to reduce the COI risk to a level acceptable to CMS on a present contract.

Organizational Conflict of Interest – In accordance with FAR 2.101 Definitions, means that because of other activities or relationships with other persons, a person is unable, or potentially unable, to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is, or might be, otherwise impaired, or a person has an unfair competitive advantage.

For purposes of this contract, the COI definition includes direct or indirect relationships including, but not limited to, the Contractor and its parent company, subsidiaries, affiliates, subcontractors, clients and principals.

Personal Conflicts of Interest – A situation in which a person has a financial interest, personal activity, or relationship that could impair the person’s ability to act impartially and in the best interest of the Government when performing under this contract.

(a) Among the sources of personal conflicts of interest are—

i. Financial interests of the person, spouse/domestic partner and/or any other dependent of the person, as defined for Federal tax purposes;

ii. Other employment or financial relationships (including seeking or negotiating for prospective employment or business) and,

iii. Gifts, including travel.

(b) For example, financial interests referred to in paragraph (a)(i) of this definition may arise from—

i. Compensation, including wages, salaries, commissions, professional fees, or fees for business referrals;

ii. Consulting relationships;

iii. Services provided in exchange for honoraria or travel expense reimbursements;

iv. Research funding or other forms of research support;

v. Healthcare related investments;

vi. Real estate investments;

vii. Patents, copyrights, and other intellectual property interests; or

viii. Business ownership and investment interests.

Potential COI – means that the COI could become an actual COI due to contingency events and/or as determined by CMS. This form of COI will require mitigation acceptable to CMS.

Principal – As defined in FAR 52.203-13, Contractor Code of Business Ethics and Conduct, means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager, plant manager, head of a division or business segment, and similar positions).

Three (3) Types of COIs include:

Conflict Types Definitions

Biased Ground Rules

Consists of situations in which a firm, as part of its performance of a Government contract, has helped (or is in a position to help) set the ground rules for another Government contract by, for example, writing the statement of work or the specifications, or establishing source-selection criteria. In these “biased ground rules” cases, the primary concern is that the firm could skew the competition, whether intentionally or not, in favor of itself and/or its affiliates.

Impaired Objectivity

Consists of situations where a firm has an interest (typically financial) that may conflict with the interest of the Government to whom the firm has a contractual obligation, and the firm’s work under the Government contract could give the firm the opportunity to benefit its other business interests. If the firm is providing recommendations, judgment or advice, and its other business interests could be affected by that recommendation, judgment or advice, the firm’s objectivity may be impaired. An example is where the firm was evaluating itself, an affiliate or a competitor, either through an assessment of performance under another contract or an evaluation of proposals.

Unequal Access to Information

“Unfair” access to non-public information – Consists of situations in which a firm has access to nonpublic information (including proprietary information and non-public source-selection information) as part of its performance of a Government contract and that information may provide the firm with a competitive advantage in a later competition for a Government contract. In these “unequal access to information” cases, the concern is limited to the risk of the firm gaining an unfair competitive advantage; there is no issue of bias. Note: Incumbency alone does not constitute an “unequal access to information.”

c. Conflicts of Interest Identified During Contract Performance – In accordance with FAR 3.10 and 52.203-13, Contractor Code of Business Ethics and Conduct, and this contract, the Contractor shall have procedures in place to detect and disclose all COIs throughout the life of the contract.

1. COI Oversight Program: The Contractor shall maintain an effective COI Oversight

Program. As part of the program, the Contractor shall implement company business practices, procedures, polices and internal controls for compliance with COI requirements, such as:

(a) Preventing conflicts of interest, prohibiting the use of non-public information accessed through this contract for personal gain, and obtaining a signed non-disclosure agreement to prohibit disclosure of non-public information accessed through this contract;

(b) Conducting Internal and External Audits;

(c) Policy Enforcement and Employee Disciplinary Actions;

(d) Retention of Records;

(e) Management of Subcontractors;

(f) Internal control systems;

(g) Display of Fraud Hotline Poster(s) in accordance with FAR 52.203-14

Display of Hotline Poster(s).

(h) Reviewing the information required by Attachment D.6, Contractor Personal

Conflict of Interest Financial Disclosure Template, for each principal, officer and governing body member (e.g., Board of Directors; Trustees; etc.) of the organization, as well as managers and key personnel who would be, or are involved with, the performance of this contract. It is recommended that individuals who have not disclosed changes within the reporting period, submit an annual disclosure update to their Compliance Officer for review;

(i) Informing employees, through an employee education and training program, of their obligation to disclose and prevent conflicts of interest, not to use non-public information accessed through performance of this contract for personal gain, and to avoid even the appearance of personal conflicts of interest; and,

(j) Reporting to the Contracting Officer any conflict of interest violations.

The following details are provided for respective COI disclosure expectations when/if a COI arises during contract performance:

2. Conflict of Interest:

COI information shall be submitted as follows:

(a) Conflict of Interest Submission During Contract Performance:

At any time during the performance of this contract, if the Contractor learns of any actual, potential, or apparent COI, whereby a reasonable business person might equate the COI to one (1) of the three (3) types of COIs identified in C.3.XII.b Definitions, the Contractor shall notify the Contracting Officer in writing within five (5) business days of the identification of the actual, potential, or apparent COI. Within 30 calendar days, or as otherwise negotiated with the Contracting Officer, the Contractor shall submit a COI Disclosure in accordance with 2(b) below.

(b) What is Required in a COI Disclosure: When an initial COI disclosure is submitted and/or a revision thereof is required, the Contractor shall provide an initial or revised, as the case may be, Attachment D.7 Contractor Business Ethics, Conflict of Interest and Compliance Program Requirements.

(c) Personal COI Information: It is the Offeror/Contractor’s responsibility to have a plan in place (see C.3.XII.c.1 COI Oversight Program) to ensure that actual, potential, or apparent personal conflicts of interest are identified, analyzed and mitigated for performance of this contract.

Personal COI information shall be obtained by the Offeror/Contractor for each:

• Manager or Key personnel who would be, or are involved with, the performance of this contract;

• Governing Body member (e.g., Board of Directors, Trustees, etc.); and,

• Principals of the organization as defined by FAR 52.203-13, Contractor

Code of Business Ethics and Conduct.

Attachment D.6, Contractor Personal Conflict of Interest Financial Disclosure Template is provided as a “sample” for the Offeror/Contractor to follow when identifying, analyzing and mitigating actual, potential, or apparent Personal COIs for this contract. Notwithstanding, Personal COI information obtained from the above individuals shall not be submitted to the Government.

(d) Mitigation/Resolution: The Contracting Officer determines whether a COI has been identified and whether the actual, potential or apparent COI has been mitigated/resolved to the Government’s satisfaction. The Mitigation/Resolution plan may include a COI audit requirement as determined by the Contracting Officer. The Contractor's approved COI Mitigation/Resolution plan shall be incorporated into the contract.

In cases whereby a COI cannot be, or has not been, mitigated to the Contracting Officer’s satisfaction, the Contracting Officer may take the following action including, but not limited to:

i. Request a post-award waiver in accordance with FAR 9.503 Waiver, from the Head of the Contracting Activity; or

ii. Make changes to the requirements of the contract; or

iii. Terminate the contract.

(e) Independent Audit: If the Contracting Officer requires a COI audit as part of the accepted mitigation plan, the Contractor shall obtain the services of an External/Independent auditor to conduct an audit. If the Government chooses to undertake the audit in lieu of the Contractor’s independent auditor, the Contracting Officer will notify the Contractor within 60 days of the anniversary date of the contract.

Such auditor shall have expertise in conducting compliance program and conflict of interest audits. The Contractor’s records may also be subject to audit by the Government to ensure compliance with this contract’s C.3.XII clause requirements and/or ensure that any corrective action, if necessary, has been implemented.

1. Subcontractors: A COI independent audit shall be required at the discretion of the Prime Contractor. If the Prime Contractor requires an audit of the subcontractor(s), the subcontractor’s audit shall be included with the Prime Contractor’s audit submission.

2. First Audit: When an audit is required as part of an acceptable mitigation plan, the Contracting Officer will negotiate the frequency of the audits and required deliverable dates. Generally, only one audit will be required during the period of performance subject to Contracting Officer discretion. The independent audit will be submitted by the auditor directly to the Contracting Officer with a copy to the Contractor.

3. Subsequent Audits: Additional audits are at the discretion of the Contracting Officer. The Contracting Officer will consider previous audit findings, any corrective action(s) and any new COI information, when making the decision to require subsequent audits.

4. Audit Findings: When Contractor Conflict of Interest Oversight findings are disclosed in an independent audit, the Contractor shall include in the draft audit report its proposed corrective action plan for each finding. The Contracting Officer may require a revised COI mitigation plan to be submitted as a result of the audit findings.

5. Independent Audit Requirements:

(a) The auditor shall decide what processes it will use to review, verify and confirm the information, processes and policies disclosed by the Contractor to the Government. The audit shall include a process for the contractor to review audit findings and provide a response to the auditor, which shall be included in the final audit submitted to the CMS Contracting Officer.

(b) The audit shall confirm that any and all COI mitigation plans, approved by the Government, have been implemented and are functioning as anticipated. Although not all inclusive, the auditor may also want to consider the following:

(i) Review of all COI disclosures submitted to the Government to validate the accuracy and completeness of such disclosures;

(ii) Conducting appropriate interviews with principals, key personnel and independent members of the board of directors, as appropriate;

(iii) Reviewing the Contractor’s organizational chart(s), articles of incorporation, bylaws and/or other documents, to validate the accuracy and completeness of COI disclosures to the Government;

(iv) Confirming that the Contractor annually, at a minimum, collects and reviews for assessment and appropriate action by the Compliance Officer, personal conflict information from its principals, key personnel (on the relevant contract(s)) and board of director members;

(v) Confirming whether the Contractor is in compliance with its internal Contractor Conflict of Interest Oversight program(s);

and,

(vi) For its Subcontractors, confirming whether the prime

Contractor is monitoring Subcontractor compliance with the required contract flow-down provisions and disclosed practices, in accordance with contract paragraph C.3.XII. The auditor may review other information as it deems appropriate to ensure that COI issues have been identified and resolved, in accordance with Contractor disclosures.

(vii) The auditor will also examine the Contractor’s records to verify that all of the requirements specified in FAR 52.203- 13(c)(2)(ii), Contractor Code of Business Ethics and Conduct, are met.

6. Reporting Requirements: The audit report, inclusive of all auditor findings and proposed corrective actions, shall be delivered via e-mail or US Postal Service to the Contracting Officer directly from the auditor.

d. Subsequent COI Disclosures (i) When/if a COI is discovered during contract performance, subsequent COI disclosures may be required as follows:

• If as a result of, the Government or Contractor independent auditor review, any findings require a change in the Initial Disclosure, submit a COI Disclosure Revision, in accordance d (ii). below, to the Contracting Officer within 30 calendar days of the final audit report.

• Within 30 calendar days when the Contracting Officer requests a revision.

• At least 45 calendar days prior to a change due to proposed or planned business actions, e.g., acquiring or selling a business or business segment, changes in ownership of the organization holding the contract, etc.

(ii)What is Required in a Revision:

When COI disclosures require revision, the Contractor shall provide a revised Attachment D.7, Contractor Business Ethics, Conflict of Interest and Compliance Program Requirements. Red-lined versions are preferred.

e. Subcontractor Flow-Down Clause: The prime Contractor is responsible for avoiding, neutralizing and mitigating all actual, potential, or apparent COIs of its Subcontractors, in accordance with this clause. Therefore, the prime Contractor shall flow-down C.3.XII. Post Award Business Ethics, Conflict of Interest and Compliance, of this contract in all subcontracts. For Subcontractors, wherever the term “Contractor” is used, insert “Subcontractor.”

XIII. CMS INFORMATION SECURITY (APR 2013)

All CMS information shall be protected from unauthorized access, use, disclosure, duplication, modification, diversion, or destruction, whether accidental or intentional, in order to maintain the security, confidentiality, integrity, and availability of such information. Therefore, if this contract requires the contractor to provide services (both commercial and non-commercial) for Federal Information/Data, to include any of the following requirements:

• Process any Information/Data; or

• Store any Information/Data (includes “Cloud” computing services); or

• Facilitate the transport of Information/Data; or

• Host/maintain Information/Data (including software and/or infrastructure developer/maintainers); or

• Have access to, or use of, Personally Identifiable Information (PII), including instances of remote access to, or physical removal of, such information beyond agency premises or control, The contractor shall become and remain compliant with the requirements set forth at the CMS Information Security website at https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Security-Contract-Clause-Provision.html https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Security-Contract-Clause-Provision.html

Items/CMS-Information-Security-Contract-Clause-Provision.html. The requirements cover all CMS contracts and associated deliverables, which are required on a “per contractor” basis.

The contractor shall ensure that the following Federal information security standards are met for all of its CMS contracts:

• Federal Information Security Management Act (FISMA) – FISMA information can be found at http://csrc.nist.gov/groups/SMA/fisma/index.html. FISMA requires each Federal agency to develop, document, and implement an agency-wide program to provide information security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source; and,

• Federal Risk and Authorization Management Program (FedRAMP) – FedRAMP information can be found at http://www.gsa.gov/portal/category/102371.

The FedRAMP is a government-wide program that provides a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services.

The Contractor shall include in all awarded subcontracts the FISMA/FedRAMP compliance requirements set forth at the CMS Information Security website at https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information- Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information- Security-Contract-Clause-Provision.html.

XIV. HIPAA BUSINESS ASSOCIATE CLAUSE (OCT 2014)

All Protected Health Information (PHI), as defined in 45 C.F.R. §160.103, that is relevant to this Contract, shall be administered in accordance with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA," 42 U.S.C. § 1320d), as amended, as well as the corresponding implementing regulations and this HIPAA Business Associate Clause.

a. Definitions:

All terms used herein and not otherwise defined, shall have the same meaning as in HIPAA, as amended, and the corresponding implementing regulations. Non-HIPAA related provisions governing the Contractor's duties and obligations, such as those under the Privacy Act and any applicable data use agreements, are generally covered elsewhere in the Contract.

The following definitions apply to this Contract Clause:

"Business Associate'' shall mean the Contractor (and/or the Contractor’s subcontractors or agents) if/when it uses individually identifiable health information on behalf of CMS, i.e. PHI, to carry out CMS’ HIPAA-covered functions.

"Covered Entity" shall mean the portions of CMS that are subject to the HIPAA Privacy Rule.

https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Security-Contract-Clause-Provision.html https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Security-Contract-Clause-Provision.html https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Security-Contract-Clause-Provision.html https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Security-Contract-Clause-Provision.html

"Secretary" shall mean the Secretary of the Department of Health & Human Services or the Secretary's designee.

b. Obligations and Activities of Business Associate:

Except as otherwise provided in this Contract, Business Associate, as defined above, shall only use or disclose PHI on behalf of, or to provide services to, Covered Entity in accordance with this Contract and the HIPAA Privacy and Security Rules.

Business Associate shall document in writing the policies and procedures that will be used to meet HIPAA requirements. The policies and procedures shall include the following, at a minimum:

1. Business Associate shall not:

i. Use or disclose PHI that is created, received, maintained or transmitted by Business Associate from, or on behalf of, Covered Entity other than as permitted or required by this Contract or as required by law;

ii. Sell PHI; or,

iii. Threaten, intimidate, coerce, harass, discriminate against, or take any other retaliatory action against any individual for:

A. Filing a complaint under 45 CFR § 160.306;

B. Testifying, assisting or participating in an investigation, compliance review, proceeding or hearing under 45 CFR Part 160; or

C. Opposing any act or practice that is unlawful under HIPAA, provided there is a good faith belief that the practice is unlawful, the manner of opposition is reasonable, and the opposition does not involve the disclosure of PHI in violation of subpart E of Part 164.

2. Business Associate shall:

i. Have a security…