About this file

This Request for Proposal (RFP) solicits services to re-specify the Antibiotic Utilization Healthcare Effectiveness Data and Information Set (HEDIS) measure. The Centers for Disease Control and Prevention (CDC) seeks to revise the current measure to focus specifically on acute respiratory infections rather than all diagnoses, and re-specify it as an episode-based measure. Questions are due by April 10, 2020, and proposals are due by May 7, 2020. The solicitation is issued by the CDC Office of Acquisition Services. Services include revising the current measure, convening a stakeholder panel, obtaining approval from the National Committee for Quality Assurance, finalizing and updating the revised measure for inclusion in HEDIS. The period of performance is June 1, 2020 through May 31, 2022.

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PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 47

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-20-R-67870

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

00HCVLD1-2020-40996

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 10AM local time 05/07/2020

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Germaine Mullins

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-1938

C. E-MAIL ADDRESS

Gmullins@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 28

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 3 X J LIST OF ATTACHMENTS 33

X D PACKAGING AND MARKING 8 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 9 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 10 X K OTHER STATEMENTS OF OFFERORS 34

X G CONTRACT ADMINISTRATION DATA 12 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 39

X H SPECIAL CONTRACT REQUIREMENTS 15 X M EVALUATION FACTORS FOR AWARD 45

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies Or Services And Prices/Costs

ITEM SUPPLIES / SERVICES QTY /

UNIT

UNIT PRICE EXTENDED

PRICE

0001 Re-specification of Appropriate Antibiotic Use Healthcare

Effectiveness Data and Information Set (HEDIS) Measures

Non-Severable Services

Period of Performance June 1, 2020 through May 31, 2022

Firm Fixed Price

1 Job

Milestones for Performance-Based Payments

In accordance with the Federal Acquisition Regulations (FAR) 52.232-32 (April 2012) – The Contractor may submit requests for payment of performance-based payments not more frequently than monthly, in a form and manner acceptable to the Contracting Officer. Unless otherwise authorized by the Contracting Officer, all performance-based payments in any period for which payment is being requested shall be included in a single request, appropriately itemized and totaled. The Contractor’s request shall contain the information and certification detailed in paragraphs (l) and (m) of this clause.

The amount proposed below shall equal the amount listed in the Contract Line Item Number (CLIN) 0001 above.

Task Amount Proposed Percentage of Overall

Proposed Amount

Task 1: Revision of the current antibiotic utilization HEDIS measure

Task 2: Finalization of the revised measures and request for NCQA approval

Task 3: Finalization and update of the revised measure

Total proposal price for the requested services

Total for the 24-month Period: _________________

The Government anticipates a Firm Fixed Price requirement for the requested Non-Severable Services.

Section C - Description/Specification/Work Statement

PERFORMANCE-BASED WORK STATEMENT

RE-SPECIFICATION OF THE ANTIBIOTIC UTILIZATION MEASURE IN THE HEALTHCARE

EFFECTIVENESS DATA AND INFORMATION SET (HEDIS)

1. Background

Antibiotic resistance continues to be one of the most pressing public health issues of our time. A new report by the

Centers for Disease Control and Prevention (CDC) estimates that more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result. (1) Further, it is well documented that antibiotic use is a main driver of antibiotic resistance. (2-4) Antibiotics are life-saving drugs that are essential for treating bacterial illnesses, but unnecessary use for viral illnesses increases selective pressure that contributes to antibiotic resistance.

The National Committee for Quality Assurance (NCQA) is an organization dedicated to improving health care quality. NCQA regularly collects and reports statistics that track the quality of care delivered by the nation’s health plans. This is done through the use of the Healthcare Effectiveness Data and Information Set (HEDIS). HEDIS is one of the most widely used sets of health care performance measures in the United States and is a tool used by more than 90 percent of America’s health plans to measure performance on important dimensions of care and service. This allows health plans, policymakers, other payers, public health professionals, and others to compare health plan performance on many important healthcare quality issues. This can then be used for reimbursement and payment incentives, to develop and target interventions to improve care, or for the public to make decisions regarding their health care. In 2004, two measures were added to HEDIS related to appropriate antibiotic use and include Appropriate Testing for Children with Pharyngitis and Appropriate Treatment for Children with Upper

Respiratory Infections (URI). In 2006, a third appropriate use indicator was added, Avoidance of Antibiotic

Treatment in Adults with Acute Bronchitis. All three of these measures were re-specified in 2018 and 2019 to include all age groups instead of only the adult or pediatric population.

Additionally, NCQA’s HEDIS measures include one focused on Antibiotic Utilization (ABX). This measure currently summarizes data on outpatient utilization of antibiotic prescriptions per member stratified by age and gender. This measure captures antibiotic prescribing for all diagnoses and is used as an overall gauge of antibiotic prescribing. As this measure is currently written it is difficult to determine the drivers of changes seen in antibiotic utilization over time, specifically in regard to respiratory tract infections, many of which are treated with antibiotics unnecessarily. There is concern that clinicians may purposefully code a diagnosis differently in order to avoid scrutiny when prescribing inappropriate antibiotics. This phenomenon, known as ‘diagnosis shifting’ may be taking place intentionally or unintentionally. An example of this would be to use the diagnostic code for sinusitis instead of viral upper respiratory infection to justify an antibiotic, even when the patient does not meet diagnostic criteria for sinusitis. In doing so, the episode would not qualify for inclusion in the current measure “Appropriate Treatment for

Upper Respiratory Infection”. Thus, while improvements may be seen in the current, diagnosis-specific, HEDIS measures related to antibiotic use, what we do not know is if providers are simply coding differently in order to justify an antibiotic prescription. Because the current antibiotic utilization measure includes all diagnoses, it is impossible to determine if overall antibiotic use for acute respiratory conditions is decreasing or staying the same, which would indicate the possibility of ‘diagnosis shifting’. Additionally, as the current measure is calculated per-member rather than an episode-based measure, it is difficult for health plans and health systems to compare provider performance, especially for providers in urgent care or retail health settings, where patients are increasingly being seen for acute respiratory infections.

Re-specifying the Antibiotic Utilization measure to include only acute respiratory infections of interest and to be calculated as per episode of care, rather than as a per-member rate, will be a benefit to public health and antibiotic stewardship interventions. It will provide an opportunity to determine if true improvements are being made in antibiotic prescribing for acute respiratory infections, or if providers are simply coding differently in an effort to justify their use of antibiotics. Additionally, an episode-based measure of the antibiotic prescribing for acute respiratory infections will allow health plans, health systems, and clinics to benchmark their performance against others as part of quality improvement initiatives.

1.1 Purpose

The purpose of this requirement is to revise the current antibiotic utilization measure in the Healthcare Effectiveness

Data and Information Set (HEDIS) by focusing on acute respiratory infections (not all diagnoses) and re-specifying the measure as an episode-based measure rather than a per-member measure. Re-specifying the Antibiotic

Utilization measure in this way will be beneficial to public health research and antibiotic stewardship interventions as it will provide an opportunity to determine if the improvements are being made or if providers are simply coding differently in an effort to justify the use of antibiotics. An episode-based measure of the antibiotic prescribing for acute respiratory infections will allow health plans, health systems, and clinics to benchmark the performance against others as part of quality improvement initiatives.

1.2 Scope of Work

As an independent organization, and not as an agent of the Government, the contractor shall furnish the necessary management, tools, services, supplies, and labor necessary to fulfill the task requirements listed in the Performance

Work Statement. The contractor shall:

1. Revise and re-write a draft of the current antibiotic utilization measure to specifically include acute respiratory infections (not all diagnoses) and to be an episode-based measure rather than a per-member measure.

2. Convene a multi-disciplinary stakeholder panel for guidance and expert opinion on the revisions.

3. Obtain written approval from the National Committee for Quality Assurance (NCQA) measurement committee on the changes.

4. Publish proposed revisions for public comment.

5. Incorporate all relevant changes from numbers 3 and 4 listed above.

6. Include the revised measure in the next HEDIS data collection and promote the measures for use by other organizations that utilize healthcare quality measures.

7. Provide a final report to CDC indicating the summary of all elements, outcomes of stakeholder panel, any major findings from the public comment period, and expected timing for release of new measures.

2. Tasks to be Performed:

Task 1: Revise the current Antibiotic Utilization HEDIS measure.

The Contractor shall:

a. Revise the measure to only include acute respiratory infections and to be episode-based. Development of the re-described measures may include a need for feasibility testing, either with individual health plans or using a claims database.

Task 2: Finalize the revised measure and request the National Committee for Quality Assurance (NCQA) approval.

a. Convene a multi-stakeholder panel, including experts in an appropriate antibiotic use, infectious disease pediatrics and family practice and/or internal medicine, state policy makers and federal policy makers, and commercial and Medicaid plans, to provide expert opinions (input) on results of evidence gathering and feasibility testing and appropriate revisions to measure specifications.

b. Working with findings from this panel and relevant experts, finalize the newly described measure.

c. Present the revised measure to NCQA approval committees.

Task 3: Finalize and update revised measure.

a. If approved by NCQA, post the measure for the public comment and revise the measure as necessary.

Finalize and include an updated revised measure in the HEDIS Health Plan measures set. Promote the revised measure to other healthcare quality stakeholder groups for uptake and use within their own quality improvement and incentive systems.

b. If not approved for inclusion in the HEDIS measures, promote the revised measure to other interested agencies and stakeholders for use in their healthcare quality improvement practices and incentive-based systems.

c. Submit a final report to the Centers for Disease Control and Prevention (CDC) that summarizes the results of all of the work including any feasibility testing that was performed, any relevant expert panel recommendations, relevant public comments, and final outcomes.

3. Travel

Travel is not authorized under this contract.

4. Minimum Contractor Qualifications

The Contractor shall be a known authority (expert) in the development, re-specification, maintenance and promotion of HEDIS quality measures related to an appropriate antibiotic use in the United States. The Contractor shall regularly report health plan performance on quality measures.

5. Referenced Materials

1. Antibiotic Resistance Threats in the United States. Centers for Disease Control and Prevention 2019;

CDC website. https://www.cdc.gov/drugresistance/biggest-threats.html

2. Hicks LA, Chien YW, Taylor TH Jr, Haber M, Klugman KP, Active Bacterial Core Surveillance

Team. Outpatient antibiotic prescribing and nonsusceptible Streptococcus pneumoniae in the United

States, 1996-2003. Clin Infect Dis. 2011;53(7):631-639. doi: 10.1093/cid/cir443.

3. Bronzwaer SL, Cars O, Buchholz U, et al; European Antimicrobial Resistance Surveillance System. A

European study on the relationship between antimicrobial use and antimicrobial resistance. Emerg

Infect Dis. 2002;8(3):278-282.

4. Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ.

2010;340:c2096. doi: 10.1136/bmj.c2096.

https://www.cdc.gov/drugresistance/biggest-threats.html

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. The thresholds are critical to the success of this requirement.

Performance Objectives Performance Standard Surveillance

Method

Performance

Requirement

Incentives/Disincentives

Task 1:

The contractor shall submit any relevant interim findings, draft revised measure, and planned date for stakeholder panel to the

CDC.

The contractor provided content shall describe all of the work conducted in

Task 1 and include the plans to complete all tasks within the period of performance.

Surveillance methods may include a mix of

(1) 100 percent inspection and/or (2) random sampling.

Incentive – 100 percent of the invoice paid and an acceptable rating in the Contractor

Performance Assessment

Reporting System.

Disincentive – 20 percent reduction of the invoice for not satisfactorily meeting the criteria for

Task 1.

Task 2:

The contractor shall submit the findings from the stakeholder panel and proof of submission of the revised measure to the

NCQA approval committee

The contractor provided content shall describe all of the work conducted in

Task 2 and include the plans to complete all tasks within the period of performance. Proof of submission to the NCQA approval committee shall be included.

Surveillance methods may include a mix of

(1) 100 percent inspection and/or (2) random sampling.

Incentive – 100 percent of the invoice paid and an acceptable rating in the Contractor for not satisfactorily meeting the criteria for

Task 2.

Task 3:

The contractor shall provide the final report to

CDC including the summary of all results and recommendations, approvals, and date of inclusion of new measure

(if applicable)

The contractor provided report shall be easy to understand and must describe all of the work and findings for the entire period of performance.

Proof of an approval/disapproval from NCQA must be included in the report.

The date of inclusion of new measures must be included (if applicable).

Surveillance methods may include a mix of

(1) 100 percent inspection and/or (2) random sampling.

Incentive – 100 percent of the invoice paid and an acceptable rating in the Contractor for not satisfactorily meeting the criteria for

Task 3.

Methods of Surveillance:

100 percent inspection – Inspect and evaluate performance each time task is performed.

Random sampling – evaluate randomly selected tasks to determine the acceptability.

Government Quality Assurance: Contractor performance will be monitored to determine if it meets the contract standards as set forth in the Performance Requirements Summary above. A variety of methods may be used, including the following: (1) 100 percent inspection and (2) random sampling.

Performance Evaluation: Performance of the services listed in the Performance Work Statement will be evaluated to determine whether or not it meets the performance requirements of the contract, as follows:

Satisfactory performance is defined as meeting the Performance Requirements for the tasks set forth above. If the contractor maintains a satisfactory performance in each of the tasks set forth above in a specific month, 100 percent of the invoice will be paid for meeting the Performance Requirement for that particular task.

Excellent performance is defined as exceeding the Performance Requirements for the tasks set forth above.

Unsatisfactory performance is defined as failing to meet the Performance Requirements for the tasks set forth above.

If the contractor engages in unsatisfactory performance in any of the tasks set forth above in any calendar month, a deduction shall be made from the payment for that task. The deduction shall be computed as follows: The appropriate payment for the task will be reduced by 20 percent.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

E.1 FAR 52.246-4 Inspection of Services – Fixed Price (Aug 1996)

(a) Definition: “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the

Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may --

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may --

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the

Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

(End of Clause)

Section F - Deliveries Or Performance

F.1 FAR 52.242-15 Stop-Work Order (Aug 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either –

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the

Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if –

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage;

provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the

Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting

Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

F.2 Government Delay of Work (Apr 1984)

(a) If the performance of all or any part of the work of this contract is delayed or interrupted (1) by an act of the

Contracting Officer in the administration of this contract that is not expressly or impliedly authorized by this contract, or (2) by a failure of the Contracting Officer to act within the time specified in this contract, or within a reasonable time if not specified, an adjustment (excluding profit) shall be made for any increase in the cost of performance of this contract caused by the delay or interruption and the contract shall be modified in writing accordingly. Adjustment shall also be made in the delivery or performance dates and any other contractual term or condition affected by the delay or interruption. However, no adjustment shall be made under this clause for any delay or interruption to the extent that performance would have been delayed or interrupted by any other cause, including the fault or negligence of the Contractor, or for which an adjustment is provided or excluded under any other term or condition of this contract.

(b) A claim under this clause shall not be allowed—

(1) For any costs incurred more than 20 days before the Contractor shall have notified the Contracting Officer in writing of the act or failure to act involved; and

(2) Unless the claim, in an amount stated, is asserted in writing as soon as practicable after the termination of the delay or interruption, but not later than the day of final payment under the contract.

(End of clause)

F.3 Place(s) of Performance

The Contractor shall perform all work under this contract at: Contractor’s facility.

F.4 Period of Performance

The period of performance is as follows: June 1, 2020 through May 31, 2021

F.5 Deliverable(s) Schedule

The Contractor shall deliver, within the time frames specified in the chart below:

TASK(S) DESCRIPTIONS QUANTITY DELIVERY DATE(S) DELIVER TO

Task 1 Revise the current Antibiotic Utilization HEDIS measure.

One (1) MS Word document via email

Six (6) months after award

Contracting Officer’s Representative or Designee

Task 2 Finalize the revised measure and request the National Committee for Quality

Assurance (NCQA) approval.

One (1) MS Word document via email

On or before January 31, Contracting Officer’s

Representative or

Designee

Task 3 Finalize and update revised measure. One (1) MS Word document via email

May 31, 2021 Contracting Officer’s

Representative or

Designee

Section G - Contract Administration Data

G.1 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.2 CDC0_G008 Contracting Officer’s Representative (COR) (Jul 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

G.3 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States

Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.4 CDCA_G001 – Invoice Submission (Jul 2017)

(a) The Contractor shall submit the original contract invoice/voucher to the address shown below:

The Centers for Disease Control and Prevention

Office of Financial Resources (OFR)

P.O. Box 15580

Atlanta, GA 30333

Or – The Contractor may submit the original invoice via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice to the cognizant contracting office previously identified in this contract. These invoice copies shall be addressed to the attention of the Contracting Officer.

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Contracting Officer’s

Representative (COR) concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

(14) Electronic funds transfer (EFT) banking information

G.5 CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer –System for Award Management, in

Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the

Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

mailto:FMOAPINV@CDC.GOV

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Office of Financial Resources (OFR)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

G.6 CDCA_G020 Applicable Service Contract Labor Standards Wages (Jul 2017)

The referenced Wage Determination, No. ____ dated _____ specifies hourly rates of wages and fringe benefits that shall be paid to covered employees performing work required under this contract. These rates have been determined by the Secretary of Labor in accordance with the provisions of the Service Contract Labor Standards statute. (See

FAR 52.222-41, incorporated by reference in Section I.)

Section H - Special Contract Requirements

H.1 CDCA_H004 Identification of Data (May 1998)

The Contractor shall identify the technical data delivered to the Government as required by this contract with the number of the contract and the name and address of the Contractor or subcontractor that generated the data.

H.2 HHSAR 352.203-70 Anti-Lobbying (December 18, 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in subsections (a), (b), and (c) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

H.3 CDCA_H009 Key Personnel (Jul 2017)

The key personnel cited below are considered essential to the work performed under the contract. Pursuant to the terms of HHSAR Clause 252.237-75, Key Personnel, the Contractor shall not replace or divert any of these individuals without the written consent of the Contracting Officer.

Personnel Title

H.4 CDC0_H022 Smoke Free Working Environment (May 2009)

In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR smoke-free working environment policy at all times. This policy prohibits smoking in all CDC/ATSDR buildings and in front of buildings which are open to the public. This policy is also applicable to contractor personnel who do not work full-time within

CDC/ATSDR facilities, but are attending meetings within CDC/ATSDR facilities.

H.5 CDCA_H037 Observance of Legal Holidays and Administrative Leave (Government Facilities

Performance) (Feb 2011)

(a) Holidays

Government personnel observe the following listed days as holidays:

Washington's Birthday

Memorial Day

Independence Day

Labor Day

Veterans' Day

Thanksgiving Day

Christmas Day

New Year's Day

Columbus Day

Martin Luther King Day

Any other day designated by Federal Statute

Any other day designated by Executive Order

Any other day designated by Presidential proclamation

For purposes of contract performance, the Contractor shall observe the above holidays on the date observed by the

Government. Observance of such days shall not be cause for an additional period of performance or entitlement to compensation except as otherwise set forth in the contract. No form of holiday or other premium compensation will be reimbursed, however this does not preclude reimbursement for overtime work authorized in writing by the

Contracting Officer.

(b) Unscheduled Facility Closures

In the event Government facilities are closed due to inclement weather, potentially hazardous or unsafe conditions, or other special circumstances, contractor personnel assigned to work within those facilities are automatically dismissed. Notwithstanding the terms of this clause, the contractor shall comply with any specific contract terms that require a level of ongoing support for critical operations during times of facility closure. The contractor may also continue to provide support under a scheduled telework arrangement in accordance with the terms of the contract if the contract expressly authorizes telework in writing.

(c) Cost Impact

Accounting for costs associated with an unscheduled facility closure is unique to each contract and depends upon a number of factors such as:

i) Contract type, e.g. Fixed Price, Time and Materials, or Cost Reimbursement.

ii) Contractor's established management and accounting practices for unproductive time.

iii) The inclusion and applicability of other contract clauses.

iv) The ability of the contractor to mitigate costs by reassigning employees to work on other contracts, to work from a different facility, or to work remotely from home in accordance with contract telework provisions.

H.6 CDC0_H046 Agency Ombudsman (Feb 2018)

CDC is committed to ensuring fair opportunity for all offerors submitting proposals for competitive task/delivery orders issued against existing Indefinite Delivery Indefinite Quantity contracts in accordance with FAR 16.505.

Offerors/Contractors may protest task/delivery order awards of any amount on the grounds that the order increases the scope, period, or maximum value of the contract under which the order was issued. These complaints may be lodged at the agency level or protested with the General Accountability Office (GAO).

Additionally, in accordance with 41 U.S.C. 253(j), protests of task/delivery orders valued in excess of

$10,000,000.00 should be filed directly with the GAO in accordance with FAR 33.104.

In accordance with FAR 16.505(b)(5), CDC has designated an agency Task/Delivery Order Ombudsman who is responsible for reviewing the complaints from contractors on the task/delivery order process. The Ombudsman's responsibility is to review complaints and ensure that all contractors are afforded a fair opportunity to be considered, consistent with procedures in the contract. The Contract Ombudsman is independent of the contracting office. The process for handling complaints under the Ombudsman is as follows:

(a) The written complaint must include all the information required for agency protests in FAR 33.103 and must be sent to:

Centers for Disease Control and Prevention

Attn: Sherry Smallwood, Agency Ombudsman

1600 Clifton Rd, NE

Bldg. 16, Mailstop-C12 Atlanta, GA 30329

Telephone: 404-639-7291

Email: svs9@cdc.gov

Complaints must be submitted to the Agency Ombudsman no later than 10 days after the basis of the protest is known or should have been known, whichever is earlier.

(b) The Ombudsman will contact the complainant by phone, to assure full understanding of the issues raised in the protest. This contact will be made within 2 business days of the receipt of the protests by the Ombudsman. Since there is only one individual serving as the agency Task/Delivery Order Ombudsman, there may be protests received when the Ombudsman is in a travel or leave status. In that instance, the Ombudsman will begin action on the complaint immediately upon return to the office.

H.7 CDC37.0001 Non-Personal Services (Apr 2015)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors' Employees and Safeguarding Government Information.” No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. . The contractor is limited to performing the services identified in the contract Performance Work Statement and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting

Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the substance of this clause. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier.

(d) Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

H.8 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Apr 2015)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the

Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR

15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

[End of Clause]

H.9 IT Security and Privacy requirements

Security Compliance

➢ If the contract is not IT related, the contractor shall follow the Standard 7.

http://www.cpars.gov/

Stardard-7: Generic Information Technology Security and Privacy Language

Safeguarding Information and Information Systems. In accordance with the Federal Information Processing

Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information

Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure: Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information; Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and Availability, which means ensuring timely and reliable access to and use of information.

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

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information

Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the

Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

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

Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or

Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.”

The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified

Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term

“handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, reusing, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

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

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information

Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information

Systems and Organizations if handled by internal Contractor system; and

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

Sanitization.

Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

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.

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