RFP_2016-N-17729_SHEPHERD_IDIQ.doc

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SHEPHERD 2016 IDIQ AWARD Federal contract opportunity
Solicitation number
2016-N-17729
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

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FBO_NOTICE_OF_AWARD_DETAILS.docx DOCX document
Amendment_4-_Price_Breakout_Worksheet-Attachment_16.xlsx XLSX spreadsheet
Amendment_3-_Price_Breakout_Worksheet-Attachment_16.xlsx XLSX spreadsheet
AMENDMENT_2-ATTACHMENTS.zip ZIP file
ATTACHMENT_7-Domain_7_Sample_RFTOP.docx DOCX document
ATTACHMENT_12-Schedule_of_Milestones_for_Performance_Form.docx DOCX document
ATTACHMENT_15-SHEPheRD_Labor_Category_Breakout.docx DOCX document
ATTACHMENT_13-ACH_Form.docx DOCX document
ATTACHMENT_5-Domain_5_Sample_RFTOP.docx DOCX document
ATTACHMENT_3-Domain_3_Sample_RFTOP.doc DOC document
ATTACHMENT_9-Past_Performance_Questionnaire.docx DOCX document
ATTACHMENT_10-Contractor_Performance_Evaluation.docm DOCM document
ATTACHMENT_14-Labor_Rate_Table.docx DOCX document
ATTACHMENT_8-Domain_8_Sample_RFTOP.docx DOCX document
ATTACHMENT_6-Domain_6_Sample_RFTOP.docx DOCX document
ATTACHMENT_1-Domain_1_Sample_RFTOP.docx DOCX document
ATTACHMENT_4-Domain_4_Sample_RFTOP.doc DOC document
ATTACHMENT_2-Domain_2_Sample_RFTOP.doc DOC document
ATTACHMENT_11-SHEPheRD_Labor_Category_Descriptions.docx DOCX document
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SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2016-N-17729

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

00HCVLDC-2016-92873

7. ISSUED BY
CODE
2542
8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention

Office of Acquisition Services M-18 2920 Brandywine Road, Rm 3000

Atlanta, GA 30341-5539

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 handcarried, in the depository located in 2:00pformtext until local time 05/17/2016 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

Kimberly Golden

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2672

C. E-MAIL ADDRESS

SHEPIDIQ@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
43
X
B
SUPPLIES OR SERVICES AND PRICES/COSTS
2
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X
C
DESCRIPTION/SPECS./WORK STATEMENT
8
X
J
LIST OF ATTACHMENTS
52
X
D
PACKAGING AND MARKING
16
PART IV – REPRESENTATIONS AND INSTRUCTIONS

X

E
INSPECTION AND ACCEPTANCE
17

REPRESENTATIONS, CERTIFICATIONS, AND

X
F
DELIVERIES OR PERFORMANCE
18
X
K
OTHER STATEMENTS OF OFFERORS
53
X
G
CONTRACT ADMINISTRATION DATA
19
X
L
INSTRS., CONDS., AND NOTICES TO OFFERORS
63
X
H
SPECIAL CONTRACT REQUIREMENTS
28
X
M
EVALUATION FACTORS FOR AWARD
87

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 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

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

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

Section B - Supplies Or Services And Prices/Costs

ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0001
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 1

Healthcare-Associated Infection and Other Adverse Healthcare Event Prevention Research Protocol Development and Implementation

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 1 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

Period of Performance-

Date of Award-9/29/2021

TBD on individual task orders
Pricing Table to include labor categories and rates (see business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0002
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 2

Acute Inpatient Care Quality Improvement and Research Implementation Infrastructure

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 2 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

Period of Performance-

Date of Award-9/29/2021

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0003
Safe Healthcare, Epidemiology, Prevention Research and Development (SHEPheRD) Program

DOMAIN 3

Long Term Acute Care/Long Term Care Quality Improvement and Research Implementation Infrastructure

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 3 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0004
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 4

Dialysis Center Quality Improvement and Research Implementation Infrastructure

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 4 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0005
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 5

Healthcare Information Technology Development, Implementation

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 5 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0006
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 6

Advanced Molecular Epidemiology and Microbial Community Analysis

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 6 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0007
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 7

International HAI and Other Adverse Healthcare Event Prevention Research

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 7 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders
ITEM
SUPPLIES/SERVICES
QTY/UNIT
UNIT PRICE
EXTENDED PRICE
0008
Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

DOMAIN 8

Veterinary Healthcare Quality Improvement and Research Protocol Development and Implementation

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all knowledgeable key workers, expertise and necessary materials in performing Healthcare-associated infections (HAIs) Research studies in Domain 8 for the CDC in accordance with the attached Performance Work Statement (PWS) and individual task orders to be issued against this task order.

TBD on individual task orders
Pricing table to include labor categories and rates (See business proposal instructions)
TBD on individual task orders

B.1 General

The Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program Program is an indefinite delivery, indefinite quantity (IDIQ) contract that will provide the Centers for Disease Control and Prevention (CDC) scientific, technical, and management expertise, and related services as they relate to healthcare epidemiology research.

The Contractor, acting as an independent contractor and not as an agent of the government, shall furnish all materials, personnel, facilities, support and management necessary to provide the services as set forth below in accordance with the Performance Work Statement (PWS).

B.2 Base and Option Periods

The term of this IDIQ contract is 60 months.

B.3 Ordering of Services

Orders for services will be conducted through the issuance of individual task orders in accordance with Paragraph F.10, Award of Task Orders, and the Ordering Clauses in Section I. Funds will be obligated under each individual task order.

Task Orders will be issued in compliance with FAR Part 16.505(b) (1), Orders under Multiple-Award Contracts, Fair Opportunity, including the specified exceptions. CDC/NCZEID intends to issue several task orders listed under (Section J, attachments 1 -8 and Section L herein) upon award of this IDIQ. Task Orders will be issued with specific performance periods.

B.4 Type of Contract

This is a multiple award, IDIQ-type contract. At the discretion of the Contracting Officer, the government may use a variety of task order types under this contract, including Firm Fixed Price (FFP), Time and Materials (T&M), Labor-Hour (LH) or a combination thereof.

Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s proposed task order type.

B.5 Minimum Ordering Amount

The government is obligated only to the extent of $1,000.00 to each contractor. This obligation is satisfied when either the contractor is issued a task order for at least $1,000.00 or at the end of the base period, if no task orders are issued to the contractor, the government pays $1,000.00 to the contractor. The government has no minimum guaranteed obligation for funding to any contractor after the base period of the contract.

(End of Clause)

B.6 Maximum Ordering Amount

The maximum amount of all orders issued and awarded under all contracts over the 5 year period of performance is estimated to be $200,000,000.00. There is no specific estimated dollar award for each domain.

B.7 Service Contract Act

The contract labor categories are considered bona fide scientists, research associates project managers, professional labor and generally exempt from the Service Contract Act. Each RFTOP will be reviewed for applicability.

B.8 Performance-Based Preference

Pursuant to FAR 37.102(a) (1), the Contracting Officer will use performance-based acquisition methods to the maximum extent practicable. Pursuant to FAR 37.102(a) (2), the government’s preference is to award a firm-fixed price performance-based contract and/or task order.

Section C - Description/Specification/Work Statement

PERFORMANCE WORK STATEMENT

Title: Healthcare Epidemiology and Infection Control Research C.1 Background and Need

As the nation’s leading health protection agency, CDC focuses on the public’s health and safety. To accomplish this mission, CDC conducts critical scientific research and provides health information to promote public health. CDC's Centers, Institutes, and Offices (CIOs) allow the agency to be responsive and effective when dealing with public health concerns. Each CIO implements CDC′s response in their areas of expertise, while also providing intra-agency support and resource-sharing for cross-cutting issues and specific health threats.

Healthcare research is critical to identifying new knowledge, promote better quality and safety, and implementing the agency mission. Such research focuses on the health status of individuals, families, communities, states, and the nation. Specifically, there is a need to support healthcare epidemiology research to advance scientific discovery and research innovation. Healthcare Epidemiology and Infection Control research is integral in CDC’s mission to detect and prevent diseases by reducing the morbidity, mortality, and costs associated with these conditions.

C.2 Objective

The Division of Healthcare Quality Promotion (DHQP), within the Centers for Disease Control and Prevention (CDC), objective is to provide healthcare epidemiology prevention Research, Implementation, Evaluation, Surveillance and Medication Safety studies under an IDIQ mechanism. The utilization of the Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program

IDIQ vehicle will allow the CDC the ability to address questions related to healthcare epidemiology prevention research broadly and specifically across five phases of translational HAI research, as outlined in the ‘Research Framework for Reducing Preventable Harm’ (http://www.ncbi.nlm.nih.gov/pubmed/?term=research+framework+for+reducing+preventable+harm).

C.3 Project Identification and Purpose The purpose of this indefinite delivery, indefinite quantity (IDIQ) contract is to provide CDC an ‘as needed’ mechanism to obtain healthcare epidemiology and health associated infections research in the following eight (8) domains:

1. Healthcare-associated infection (HAI) and Other Adverse Healthcare Event Prevention Research Protocol Development and Implementation

2. Acute Inpatient Care Quality Improvement and Research Implementation Infrastructure

3. Long Term Acute Care/Long Term Care Quality Improvement and Research Implementation

Infrastructure

4. Dialysis Center Quality Improvement and Research Implementation Infrastructure:

5. Healthcare Information Technology Development, Implementation, and Services

6. Advanced Molecular Epidemiology and Microbial Community Analysis

7. International HAI and Other Adverse Healthcare Event Prevention Research

8. Veterinary Healthcare Quality Improvement and Research Protocol Development and Implementation.

An offeror may propose on one or more domains. If an offeror proposes on more than one domain, the organization must submit separate proposals for each domain. The determination of which domain to use for task orders will be made on a case by case basis with final approval of domain section made by the Contracting Officer. Contractors holding an award under the domain selected are eligible to compete for the task order.

CDC will have final approval regarding publications, presentations and products developed as a result of this contract. The specific responsibilities regarding the development of publications, presentations and products will be negotiated on a case-by-case basis.

C. 4 Scope of Work

This IDIQ will be divided into eight functional domains: As independent organization and not as an agent of the Government, the Contractor shall furnish all necessary personnel, facilities, supplies, and equipment to perform the full range of services listed under one of the eight domains listed in this contract, though a single Contractor may perform in one (1) or more (8) domains.

C.4.A Domain 1: HAI and Other Adverse Event Prevention Research Protocol Development and Implementation

The purpose of this domain is to obtain services for successfully answering research questions posed by CDC, including study design, protocol development, database development, statistical support, background literature review, study implementation, and data management and analysis services. Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. Scientific and technical support for research design and planning

2. Protocol development and pilot testing

3. Data system development and implementation

4. Data modeling, management, analysis, and informatics

5. Preparation of OMB and IRB packages as required

6. Research design and planning

a. The contractor shall formulate research question, develop a detailed research plan and protocol, and successfully implement the protocol, analyzing and interpreting results, and serving as lead authors in publication of the findings in peer reviewed literature. Specifically, given a specific healthcare epidemiology-related research question posed by CDC, the contractor shall have the capacity to propose an approach to successfully answering the question, including but not limited to study design, protocol development, database development, statistical support, background literature review, study implementation, data management and analysis.

b. The contractor shall have primary expertise in clinical trial design, including statistical expertise in complex power calculations involving clustered designs and analyses, is an advantage. Access to the healthcare settings and patient populations sufficient for implementing the protocols is not a requirement for this domain.

c. The contractor shall be capable of designing protocols for implementation in healthcare settings and systems selected by CDC that are not directly affiliated with their home or partner institutions. Contractor shall be capable of maintain a leading role in coordinating and overseeing the implementation of studies, as well as leading analysis, interpretation, and publication of findings.

C.4.B Domain 2: Acute Inpatient Care Quality Improvement and Research Implementation Infrastructure

The purpose of this domain is to obtain services for implementation of single and multi-center quality improvement and/or research projects in large networks of acute inpatient care facilities. Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. Provide access to integrated electronic medical systems and population based outcomes in inpatient and outpatient facilities.

2. Provide access to clinical data, including administrative data from a large number of healthcare institutions that collect data in a standardized fashion are preferable

3. Contractors shall own or operate a clinical network comprised of acute care and outpatient facilities within which single- and multi-center quality improvement and/or research projects can be implemented. The networks shall implement HAI and other adverse event prevention quality improvement or research study protocols provided by the funding agency technical preference is given to Contractors who own or operate multicenter networks comprised of at least 15 acute care healthcare hospitals, in addition to associated outpatient facilities. Contractors shall own or operate networks of acute healthcare facilities having the following:

a. Common information technology infrastructures within which clinical data routinely generated during the course of patient care across multiple facilities is collected and stored in a central location using common data format and structure, and is accessible through a central point of contact within the network.

b. Contractors shall recruit healthcare facilities and patients within the network to participate in quality improvement or research initiatives, mainly related to prevention of HAIs or other adverse events related to healthcare, or related to other patient safety issues. The contractor shall implement quality improvement and/or research studies across the network, as opposed to merely collecting or purchasing data from facilities in the network.

c. The contractor shall oversee all aspects of implementation of quality improvement projects or clinical research studies pertaining to prevention of HAIs, including providing access to personnel to staff projects and other necessary material resources. The Contractor shall prepare and submit IRB and OMB packages in addition to having a single Centralized Institutional Review Board (IRB) capacity for the entire network of facilities.

d. The contractor may be requested to extract data for tailored requests for clinical information (i.e., have demonstrated capacity to generate custom data extractions, not just “canned” report structures that are embedded within a proprietary health information system).

C.4.C Domain 3: Long Term Acute Care/Long Term Care Quality Improvement and Research Implementation Infrastructure

The purpose of this domain is to obtain services for implementation of single and multi-center quality improvement and/or research projects in long term acute care, long term care, and skilled nursing facilities. Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. Provide access to integrated electronic medical systems and population based outcomes in inpatient and outpatient facilities.

2. Provide access to clinical data, including administrative data from a large number of healthcare institutions that collect data in a standardized fashion.

3. Contractors shall own or operate a clinical network comprised of either long term acute care hospitals, skilled nursing facilities, or both, within which single- and multi-center quality improvement and/or research projects can be implemented. Contractors with a network of these facilities, shall implement HAI and other adverse event prevention quality improvement or research study protocols provided by the funding agency preference will be given to Contractors who own or operate multicenter networks comprised of either or both of the following: 1) at least 10 long term acute care healthcare hospitals, 2) at least 15 skilled nursing facilities.

4. Contractors owning or operating networks of long term acute care or skilled nursing facilities shall have the following:

a. Common information technology infrastructures within which clinical data routinely generated during the course of patient care across multiple facilities is collected and stored in a central location using common data format and structure, and is accessible through a central point of contact within the network.

b. Contractors shall recruit healthcare facilities and patients within the network to participate in quality improvement or research initiatives, mainly related to prevention of HAIs or other adverse events related to healthcare, or related to other patient safety issues. It is expected that the contractors have the capability to actually implement quality improvement and/or research studies across the network, as opposed to merely collecting or purchasing data from facilities in the network.

c. Contractors shall have the ability to oversee all aspects of implementation of quality improvement projects or clinical research studies pertaining to prevention of HAIs, including providing access to personnel to staff projects and other necessary material resources. Have the ability to prepare and submit Centralized Institutional Review Board (IRB) and Office of Management and Budget (OMB) packages as required, in addition to having a single IRB capacity for the entire network of facilities.

d. The contractor shall extract data for tailored requests for clinical. Must generate custom data extractions, not just “canned” report structures that are embedded within a proprietary health information system).

4. Contractors shall collaborate with CDC in the development, refinement, or tailoring of research or quality improvement project plans and protocols in the contractor’s Long Term Acute Care Hospitals/Long Term Care Facilities (LTACH/LTCF) settings. Contractors shall implement these project plans and protocols as appropriate within network facilities. The leading role in coordinating and overseeing the implementation and evaluation of the protocol will be actively shared with CDC.

C.4.D Domain 4: Dialysis Center Quality Improvement and Research Implementation Infrastructure

The purpose of this domain is to obtain services for implementation of single and multi-center quality improvement and/or research projects in networks of Dialysis facilities. Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. Provide access to integrated electronic medical systems and population based outcomes in dialysis facilities.

2. Provide access to clinical data, including administrative data from a large number of healthcare institutions that collect data in a standardized fashion are preferable

3. Contractors shall own or operate a clinical network comprised of dialysis centers within which single- and multi-center quality improvement and/or research projects can be implemented. The contractor shall implement HAI and other adverse event prevention quality improvement or research study protocols provided by CDC in their network of Dialysis centers. Preference will be given to Contractors who own or operate, multicenter networks comprised of at least 20 dialysis facilities.

4. The facilities in the network shall have the following characteristics:

a. Common information technology infrastructures within which clinical data routinely generated during the course of patient care across multiple facilities is collected and stored in a central location using common data format and structure, and is accessible through a central point of contact within the network.

b. The contractor shall have the ability to recruit dialysis healthcare facilities and patients within the network to participate in quality improvement or research initiatives, mainly related to prevention of HAIs or other adverse events related to dialysis healthcare, or related to other patient safety issues. It is expected that the contractors have the capability to actually implement quality improvement and/or research studies across the network, as opposed to merely collecting or purchasing data from facilities in the network.

c. Contractors shall have ability to oversee all aspects of implementation of quality improvement projects or clinical research studies pertaining to prevention of HAIs, including providing access to personnel to staff projects and other necessary material resources in a dialysis care setting. Prepare and submit IRB and OMB packages, in addition to having a single IRB capacity for the entire network of facilities.

d. Contractors shall be flexible in extracting data for tailored requests for clinical information (i.e., Must generate custom data extractions, not just “canned” report structures that are embedded within a proprietary health information system).

5. Contractors under this domain must directly operate large networks of healthcare facilities. The contractors shall also have the capacity to make and implement administrative and policy decisions related to infection prevention on behalf of the entire network, and to implement such decisions uniformly across all facilities in the network

6. Contractors shall collaborate with CDC in the development, refinement, or tailoring of research or quality improvement project plans and protocols in the contractor’s network of Dialysis facilities. , Contractors shall implement these project plans and protocols as appropriate within network facilities. The leading role in coordinating and overseeing the implementation and evaluation of the protocol will be actively shared with CDC.

C.4.E Domain 5: Healthcare Information Technology Development, Implementation, and Services

The purpose of this domain is to obtain services from owners of proprietary electronic healthcare record systems and/ or other healthcare information technology products to review, recommend, and accelerate implementation of reporting protocols for the National Healthcare Safety Network (NHSN).

Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. Provide expertise in healthcare data surveillance and management.

2. Provide access to surveillance data of large healthcare systems, specifically sites reporting to NHSN.

3. Provide access to and established relationships with tertiary care facilities, including long term care, nursing home, pediatric care, outpatient care, and dialysis centers

4. Contractors shall own and contract out to a large network of healthcare facilities, proprietary electronic healthcare record systems or other healthcare information technology products or services. Contractors shall work collaboratively with CDC to (a) review the NHSN reporting protocols for HAIs and other adverse healthcare events (i.e., protocols in use and under development), in terms of their operational fit with current healthcare information technology architectures, platforms, and databases (b) recommend to NHSN SMEs or Business Analysts modifications to data requirements for both existing and future definitions to best leverage pre-existing electronic data in Electronic Health Record (EHR) systems or other information used in healthcare, and, (c)accelerate implementation and provide technical support for electronic reporting solutions that enable healthcare facilities to submit HAI and other adverse healthcare event data to CDC.

C.4.F Domain 6: Advanced Molecular Epidemiology and Microbial Community Analysis

The purpose of this domain is to obtain services for performing metagenomics community analysis of patient specimens and/or environmental samples to describe the community composition and complexity, presence of known antimicrobial resistance determinants, and presence of established virulence determinants. Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. As related to performing complex molecular procedures:

a. Providing access to facilities and/or laboratories, including in diverse geographic locations.

b. Providing access to laboratory capabilities and current infrastructure to conduct isolate collection, storage and shipping.

c. Ability to obtain rare isolates by organism as needed

2. Contractors shall perform complex molecular procedures, such as Performing generation of next-generation sequence data;

3. Laboratory analysis of molecular mechanisms of resistance and other strain characteristics

4. Identification of known antimicrobial resistance determinants, strain characteristics, and genomic sequences of public health importance from genomic data.

5. Analyzing genomic data to determine strain relatedness and assess transmission dynamics in a variety of healthcare.

6. Contractors shall perform metagenomics community analysis of patient specimens and/ or environmental samples to describe the community composition and complexity, presence of known antimicrobial resistance determinants, and presence of established virulence determinants.

C.4.G Domain 7: International HAI and Other Adverse Healthcare Event Prevention Research

The purpose of this domain is to obtain services for development and implementation of research projects and protocols focusing on healthcare associated infections in Low and Middle Income Countries. Low and Middle Income Countries discussed in the World Health Organization Fact Sheet on “Health Care Associated Infections” at http://www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. International healthcare epidemiology research design tasks, such as:

a. Assess the cost-effectiveness of infection prevention and control practices in low and middle income countries.

b. Assess the impact of improved antimicrobial resistance testing/antibiograms on clinical/hospital-level prescribing practices in low and middle income countries

2. International healthcare epidemiology prevention research implementation and evaluation tasks, such as:

a. Ability to evaluate the impact of infection control improvements on healthcare associated infection or associated metrics in resource limited countries.

b. Design and/ or evaluate strategies to measure antimicrobial use in low and middle income countries.

c. The contractor shall evaluate the impact of antimicrobial stewardship activities on antimicrobial resistance or associated metrics in resource limited countries.

3. International healthcare surveillance research and development, such as:

a. Assess the burden of healthcare associated infections in low and middle income countries via longitudinal or point prevalence methodology.

b. Assess antimicrobial use and prevalence of antimicrobial resistance in low and middle income countries via longitudinal or point prevalence methodology.

4. Contractors shall provide access to clinical infrastructures in low and or middle income countries within which single- or multi-center research study protocols can be implemented.

5. Contractors shall conduct research within settings in low and middle income countires.

6. Contractors shall establish relationships with relevant in-country partners (e.g., Ministry of Health, local research institutes/universities).

C.4.H Domain 8: Veterinary Healthcare Quality Improvement and Research Protocol Development and Implementation

The purpose of this domain is to obtain services for the development and implementation of quality improvement research services in veterinary settings. Each task order under this domain will provide specific instructions on what activities and deliverables will be required. The specific activities/tasks that may be conducted under this domain include:

1. Develop nationally representative data sets related to the use of antibiotics in companion animal and other veterinary settings;

2. Perform data analysis on these data sets related to antibiotic use in companion animal and veterinary settings;

3. Perform Sentinel Surveillance of antibiotic resistant bacteria

4. Develop Recommendations to inform Antibiotic Stewardship Guidelines for Veterinary Practices.

5. Contractors shall provide animal healthcare or animal healthcare epidemiology, initiate and lead quality improvement projects and/or multiple steps across the spectrum of scientific inquiry including formulating a research question, developing a detailed plan and protocol designed to address the question, including epidemiological and prevention research plans and protocols, and successfully implementing the protocol, analyzing and interpreting results, and leading publication of the findings in peer reviewed literature if appropriate. The contractor shall propose various approaches to successfully answering research questions or implementing quality improvement strategies, in addition but not limited to study design, protocol development, database development, statistical support, background literature review, study implementation, data management and analysis.

C.5 Quality Assurance Surveillance Plan (QASP) The QASP will be used to ensure that systematic quality assurance methods are used in the administration of the Performance-Based Service Contract (PBSC) standards included in this contract. The QASP will be defined at the task order level.

The contractor is responsible for management and quality control actions necessary to meet the quality standards set forth in the task order. The Performance Standards and Surveillance Activity Checks defined in the QASP at the task order level shall be used by the COR in the technical administration of the QASP.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

FAR SOURCE
TITLE AND DATE

52.246-4

52.246-6 Inspection of Services – Fixed Price (Aug 1996)

Inspection - Time-and-Material and Labor-Hour (May 2001)

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Contracting Officer Representative (COR) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance

FAR SOURCE
TITLE AND DATE
52.242-15
Stop-Work Order (Aug 1989)

F.1 Period of Performance (Task/Delivery Order Contracts) (Jul 1999)

(a) The period of performance of the Basic contract shall be for sixty (60) months from the effective date of the contract. The anticipated period of performance is from the date of award – 09/29/2021.

(b) Task Orders: The time for completion for each task order shall be determined under each individual task order through the mutual agreement of the parties involved. Task orders under this contract may be awarded by the Contracting Officer at any time within the contract period. The actual performance of the work may extend beyond the basic contract period of performance.

(End of Clause)

F.2 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract at: to be specified in each task order.

(End of Clause)

F.3 Deliverables Specifications for Deliverables will be as set forth in individual task orders.

(End of provision)

Section G - Contract Administration Data G.1 Small Business Subcontracting Plan (Oct 2015)

(a) The Contractor shall comply with FAR 52.219.9. Submit the Individual Subcontract Report (ISR) and/or the Summary Subcontract Report (SSR), in accordance with paragraph (l) of this clause using the Electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

(End of Clause)

G.2 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013)

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]

G.3 Payment (Performance-Based Services)

(a) General

It is the objective of the Government to obtain complete and satisfactory performance in accordance with the terms of the specifications and requirements of this contract. The procedures set forth in this clause will be used by the Government in determining monetary deductions for nonperformance of work under this contract, or for deficiencies in the performance of work, and supplements the Inspection of Services clause contained in Section E of this contract.

(b) Adjusting Payments

(1) Under the Inspection of Services clause of this contract, payments may be adjusted if any service does not conform with contract requirements. The Contracting Officer or a designated representative will inform the Contractor, in writing, of the type and dollar amount of proposed deductions by the l0th workday of the month following the performance period for which the deductions are to be made.

(2) The Contractor may, within 10 working days of receipt of the notification of the proposed deduction, present to the Contracting Officer specific reasons why any or all of the proposed deductions are not justified. Reasons must be solidly based and must provide specific facts that justify reconsideration and/or adjustment of the amount to be deducted. Failure to respond within the 10 day period will be interpreted to mean that the Contractor accepts the deductions proposed.

(3) All or a portion of the final payment may be delayed or withheld until the Contracting Officer makes a final decision on the proposed deduction. If the Contracting Officer determines that any or all of the proposed deductions are warranted, the Contracting officer shall so notify the Contractor, and adjust payments under the contract accordingly.

(End of Clause)

G.4 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.

(End of Clause)

G.5 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.

(End of Clause)

G.6 Contracting Officer’s Representative (COR) Technical Guidance (Sep 2009)

CDC0_G008 Contracting Officers Representative (COR) Technical Guidance 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 feels that 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 in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. 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. 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 delegation memorandum for the COR. Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

G.7 Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)

(a) Method of payment.

(1) All payments by the Government under this contract shall be made by electronic funds transfer (EFT), except as provided in paragraph (a) (2) of this clause. As used in this clause, the term “EFT” refers to the funds transfer and may also include the payment information transfer.

(2) In the event the Government is unable to release one or more payments by EFT, the Contractor agrees to either—

(i) Accept payment by check or some other mutually agreeable method of payment; or

(ii) Request the Government to extend the payment due date until such time as the Government can make payment by EFT (but see paragraph (d) of this clause).

(b) Contractor's EFT information. The Government shall make payment to the Contractor using the EFT information contained in the System for Award Management (SAM) database. In the event that the EFT information changes, the Contractor shall be responsible for providing the updated information to the SAM database.

(c) Mechanisms for EFT payment. The Government may make payment by EFT through either the Automated Clearing House (ACH) network, subject to the rules of the National Automated Clearing House Association, or the Fedwire Transfer System. The rules governing Federal payments through the ACH are contained in 31 CFR Part 210.

(d) Suspension of payment. If the Contractor’s EFT information in the SAM database is incorrect, then the Government need not make payment to the Contractor under this contract until correct EFT information is entered into the SAM database; and any invoice or contract financing request shall be deemed not to be a proper invoice for the purpose of prompt payment under this contract. The prompt payment terms of the contract regarding notice of an improper invoice and delays in accrual of interest penalties apply.

(e) Liability for uncompleted or erroneous transfers.

(1) If an uncompleted or erroneous transfer occurs because the Government used the Contractor’s EFT information incorrectly, the Government remains responsible for—

(i) Making a correct payment;

(ii) Paying any prompt payment penalty due; and

(iii) Recovering any erroneously directed funds.

(2) If an uncompleted or erroneous transfer occurs because the Contractor’s EFT information was incorrect, or was revised within 30 days of Government release of the EFT payment transaction instruction to the Federal Reserve

System, and—

(i) If the funds are no longer under the control of the payment office, the Government is deemed to have made payment and the Contractor is responsible for recovery of any erroneously directed funds; or

(ii) If the funds remain under the control of the payment office, the Government shall not make payment, and the provisions of paragraph (d) of this clause shall apply.

(f) EFT and prompt payment. A payment shall be deemed to have been made in a timely manner in accordance with the prompt payment terms of this contract if, in the EFT payment transaction instruction released to the Federal Reserve System, the date specified for settlement of the payment is on or before the prompt payment due date, provided the specified payment date is a valid date under the rules of the Federal Reserve System.

(g) EFT and assignment of claims. If the Contractor assigns the proceeds of this contract as provided for in the assignment of claims terms of this contract, the Contractor shall require as a condition of any such assignment, that the…

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