CDC-RFA-OE22-2202.pdf

Centers for Disease Control and Prevention

Center for Surveillance, Epidemiology, and Laboratory Services

Enhancing US Clinical Laboratory Workforce Capacity

CDC-RFA-OE22-2202

04/29/2022

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- OE22-2202. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Enhancing US Clinical Laboratory Workforce Capacity C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

New-Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-OE22-2202

E. Assistance Listings Number:

93.322 F. Dates:

1. Due Date for Letter of Intent (LOI):

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

2. Due Date for Applications:

04/29/2022 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

An informational conference call will be held on March 16, 2022 at 10:00 AM. Please use the following to call in.

Dial: US : +1 669 254 5252 or +1 646 828 7666 or +1 669 216 1590 or +1 551 285 1373 Meeting ID: 160 604 8787 Password: 61652673

G. Executive Summary:

1. Summary Paragraph CDC announces the availability of funding for a three-year cooperative agreement to help CDC reach a larger proportion of clinical laboratory professionals and bridge, train, and sustain the laboratory community to support rapid, large-scale responses to the COVID-19 pandemic and other public health emergencies. This NOFO aims to support the following three categories of strategies to help build laboratory preparedness and response competencies amongst clinical laboratory professionals: 1) Bridge— strengthening essential links between clinical laboratory and public health laboratory training/continuing education professionals and CDC; 2) Train— developing and evaluating education and training resources for clinical laboratory professionals;

and 3) Sustain— expanding the reach of CDC’s training and workforce development resources among the clinical laboratory community and promoting awareness of the laboratory profession to broader audiences. The three strategies will be implemented using a data-driven approach to enhance the clinical laboratory community's ability to combat emerging threats, learn evolving practices, and stay current with the newest standards and technologies. The goals of the NOFO are in accordance with Healthy People 2030 goals. The funded recipient(s) must have the capacity to meet the measurable program outcomes outlined in the Logic Model (See Part II).

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$3,000,000

e. Average One Year Award Amount:

$300,000

f. Total Period of Performance Length:

g. Estimated Award Date:

August 01, 2022

h. Cost Sharing and / or Matching Requirements:

https://www.grants.gov/

No Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Clinical laboratory professionals, including those who perform point-of-care testing, play an indispensable role in the public health laboratory system. Clinical laboratories are often the first line in detecting known and emerging diseases and conditions of public health importance. An effective public health laboratory system requires ongoing communication between clinical laboratories and public health laboratories and the ability of clinical laboratory professionals to have access to relevant, high-quality training (continuing education) resources that support their role in the public health system, especially regarding preparedness and response to public health emergencies.

The COVID-19 pandemic has demonstrated in an unprecedented way the importance of the connections and dependencies between public health laboratories and both clinical and commercial laboratories. Many of the fundamental challenges during the COVID-19 emergency response, including development of new assays, capacity of surge testing facilities, reporting of test result data, and sequencing of emerging new strains, have been exacerbated because of the traditional silos that have separated public health laboratories and clinical laboratories.

Furthermore, the laboratory testing community continues to evolve rapidly.

CDC created the OneLab Initiative to bridge, train, and sustain a capacity-building community among public health laboratory and clinical laboratory communities. The initiative includes a community of clinical and public health laboratory education and training professionals (OneLab Network), the development of resources to support the continuing education and training of laboratory professionals, and CDC’s new learning management system tailored to clinical laboratory professionals (OneLab REACH), among other components.

It is estimated that less than 10% of clinical laboratory professionals currently access CDC training and workforce development resources. The activities under this cooperative agreement will expand the reach of CDC’s training and workforce development resources for both the public health laboratory and clinical laboratory community—including those who perform point-of-care testing—building essential bridges between healthcare and public health. The program will include data-driven development, promotion, and dissemination of laboratory capacity-building initiatives and resources that enhance the clinical laboratory community’s ability to combat emerging threats, learn evolving practices, and stay current with the newest standards and technologies.

b. Statutory Authorities This cooperative agreement is authorized under sections 317(k)(2) of the Public Health Service Act, as amended [42 U.S.C Sections 247d(k)(2) and 242l]. Applicants must be fully capable of managing the required activities in accordance with the American Rescue Plan (ARP) Act, 2021 (Sections 2301-2403).

c. Healthy People 2030

This program addresses the Healthy People 2030 focus area of Public Health Infrastructure:

https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure.

d. Other National Public Health Priorities and Strategies N/A

e. Relevant Work This NOFO builds on and supports CDC's OneLab Initiative: cdc.gov/onelab.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Strategy 1: Bridge

- Recruit additional clinical laboratory professionals for the OneLab Network to foster an ongoing learning community of laboratory education and training professionals

- Provide technical assistance and logistical support to CDC for training and workforce needs assessments

Strategy 2: Train

- Provide clinical laboratory-related content for and review of high-quality training resources for laboratory professionals

Strategy 3: Sustain

- Educate and inform clinical laboratory audiences about CDC/DLS training dissemination platforms, including syndication and OneLab REACH, CDC’s new learning management system tailored to clinical laboratory professionals

SO-1. Improved engagement and participation of clinical laboratory professionals in training and workforce development programs

SO-2. Improved awareness and understanding of training and workforce development needs, challenges, and opportunities

SO-3. Increased use of laboratory education and training resources tailored to clinical laboratory professionals

SO-4. Increased uptake of

CDC/DLS

dissemination platforms and improved awareness of the high-quality training resources housed on those platforms

IO-1. Improved networking, communication, and knowledge sharing of best practices/lessons learned between clinical and public health laboratory professionals

IO-2. Enhanced knowledge, skills, and abilities/competence among clinical laboratory professionals

LO-1. Sustained learning communities that facilitate the exchange of necessary tools, resources, and networks to effectively prepare for and respond to public health emergencies

LO-2. Increased application of best practices in laboratory settings https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure

i. Purpose The program purpose is to enhance US clinical laboratory workforce capacity by building competency to support rapid, large-scale responses to the COVID-19 pandemic and other public health emergencies. The outlined activities support CDC’s OneLab Initiative to bridge, train, and sustain a capacity-building community among public health laboratory and clinical laboratory communities. The activities will expand the reach of CDC’s laboratory training and workforce development resources and help build essential bridges between the clinical laboratory and public health laboratory communities.

ii. Outcomes By the end of the period of performance, recipients are expected to achieve four short-term outcomes: SO-1) Improved engagement and participation of clinical laboratory professionals in training and workforce development programs; SO-2.) Improved awareness and understanding of training and workforce development needs, challenges, and opportunities; SO-3.) Increased use of laboratory education and training resources tailored to clinical laboratory professionals;

and SO-4.) Increased uptake of CDC/Division of Laboratory Systems (DLS) dissemination platforms and improved awareness of the high-quality training resources housed on those platforms. Recipients are also expected to achieve two intermediate outcomes: IO-1.) Improved networking, communication, and knowledge sharing of best practices/lessons learned between clinical and public health laboratory professionals and IO-2.) Enhanced knowledge, skills, and abilities/competence among clinical laboratory professionals.

iii. Strategies and Activities Aligned with the purpose and goals of the broader OneLab Initiative, there are three strategies:

Bridge, Train and Sustain.

Bridge is to expand the reach of the Centers for Disease Control and Prevention (CDC's) training and workforce development resources among the clinical laboratory community, including those who perform point-of-care testing, and promote awareness of the laboratory profession to broader audiences. Bridge is to strengthen essential links between clinical and public health laboratory training professionals and CDC. Recipients will be expected to recruit clinical laboratory professionals for the OneLab Network to foster an ongoing learning community of laboratory education and training professionals. The recipient may use existing or new listservs, newsletters, websites, and other communication channels, as well as targeted outreach to education and training professionals, to promote the OneLab Network and recruit new members. A variety of communication channels can also be used to to promote awareness of the laboratory profession to various audiences (e.g., students). The second major activity under Bridge is to provide technical assistance and logistical support to CDC for training and workforce needs assessments. The recipient is expected to collaborate with CDC on the design, development, dissemination, analysis, and reporting of needs assessments. The details and frequency of this work will be determined in collaboration with CDC once the cooperative agreement is awarded.

Train is to develop and evaluate education and training resources for clinical laboratory professionals to be ready, respond, and lead others. Recipients will be expected to provide clinical laboratory-related content for, and review of, high-quality training resources for laboratory professionals. Subject matter experts (SMEs) from the recipient organization itself can contribute to this activity, and it is additionally expected that the recipient will solicit SMEs from an array of clinical laboratories to provide content and review.

Sustain is to embed feasible long-term capacity-building within clinical laboratories so they can maintain an active learning community amongst clinical laboratory professionals. Recipients will be expected to widely educate and inform clinical laboratory audiences about CDC/DLS training dissemination platforms, including course syndication and OneLab REACH (CDC’s new learning management system tailored to clinical laboratory professionals) through a variety of communication channels, such as listservs, newsletters and other mechanisms.

1. Collaborations

a. With other CDC projects and CDC-funded organizations:

Recipient(s) may collaborate with the other recipients of funds under this cooperative agreement to accomplish program activities and achieve program outcomes.

b. With organizations not funded by CDC:

Recipient(s) are expected to collaborate, as deemed appropriate, with clinical laboratory professional organizations, healthcare organizations/associations, and other entities not funded by CDC that can assist the recipient in reaching a larger proportion of clinical laboratory professionals than the recipient(s) can reach alone. This may be particularly needed for outreach to clinical laboratory professionals who work in physician office laboratories and persons who perform point-of-care testing in various non-clinical environments (e.g., schools, nursing homes, correctional facilities).

2. Target Populations The target population is clinical laboratory professionals, which we are defining in a broad sense to encompass professionals who work in a hospital laboratory, physician office laboratory, or other types of clinical laboratories, in commercial laboratories conducting clinical testing, and persons who perform clinical point-of-care testing.

a. Health Disparities This NOFO will contribute to the reduction of health disparities by enhancing the capacity and capabilities of clinical laboratories to address factors that challenge health equity and health outcomes nationally, especially in regard to public health emergencies.

iv. Funding Strategy Coronavirus Disease 2019 (COVID-19) Funds: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139); the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the

United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.

In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.

This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Evaluation and performance measurement allows the recipient and CDC to track progress and measure outcomes of recipient’s effort. The purpose of evaluation and performance measurement is to help CDC and the recipient: (1) Monitor the extent to which activities planned were successfully completed (e.g., were activities implemented correctly in the expected timeframe?);

(2) Demonstrate how activities contribute towards program outcomes (e.g., were outcomes of interest achieved?); and (3) Inform decisions about continuous program improvement for more efficient and effective program performance (e.g., what and how could things be improved?).

The overall CDC Evaluation and Performance Measurement Strategy includes the following components to ensure effective program implementation, accomplishment of outcomes, quality of data, and accountability of funds: 1) Assessment of the performance of the overall project;

2) Process evaluation to monitor activities during program implementation and operation;

3) Outcome evaluation to examine the progress and successes toward achieving the intended outcomes of the NOFO; and 4) Accountability for how NOFO funds are allocated and spent.

Proposed process measures:

Strategy and Activity Process Measure

S1a Recruit additional clinical laboratory professionals for the OneLab Network to foster an ongoing learning community of laboratory education and training professionals

Number of outreach activities conducted

Number of different communication channels used https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

Strategy and Activity Process Measure Number of laboratory professionals contacted

S1b Provide technical assistance and logistical support to CDC for training and workforce needs assessments

Number of training and/or workforce needs assessment materials (e.g., guides for laboratory staff, questionnaires, etc.) for which SME input was provided

Number of training and/or workforce needs assessments for which logistical support was provided

S2 Provide clinical laboratory-related content for and review of high-quality training resources for laboratory professionals

Number of just-in-time training and workforce development resources for which pilot testers were recruited

Number of just-in-time training and workforce development resources for which SMEs were enlisted and/or content was provided

S3 Educate and inform clinical laboratory professionals about CDC/DLS training dissemination platforms, including syndication and OneLab REACH (CDC's new learning management systems tailored to clinical laboratory professionals).

Number of informational and promotional activities conducted

Number of promotion channels used

Number of laboratory professionals who received informational and promotional materials

Proposed outcome measures:

Outcome Outcome Measures PO-1 Improved engagement and participation of clinical laboratory professionals in training and workforce development programs

Number of OneLab Network members

Number of unique laboratories represented in OneLab Network

Number of annual visits to OneLab and OneLab Network web pages

Number of subscribers to OneLab Network listserv

Number of attendees at OneLab Network events

Number of attendees at OneLab Summit (a meeting/conference of laboratory training and education professionals)

PO-2 Improved awareness and understanding of training and workforce development needs, challenges, and opportunities

Number of laboratory professionals to whom each needs assessments was sent

Number of respondents for each needs assessment

Response rate (proportion of recipients who responded) for each needs assessment

Number of laboratory training topics identified and prioritized

PO-3. Increased use of laboratory education and training resources tailored to clinical laboratory professionals

Number of laboratory professionals who access new and existing training tools and resources

Number of laboratory professionals who register for on-demand VR and eLearning courses

Number of laboratory professionals who complete on-demand VR and eLearning courses

PO-4. Increased uptake of CDC/DLS dissemination platforms and improved awareness of the high-quality training resources housed on those platforms

Number of OneLab REACH accounts

Number of OneLab REACH users

Number of visits to OneLab REACH homepage

Number of registrations for training courses, resources, and materials on OneLab REACH

Number of syndication partners

Number of learners within syndication partners’ LMS’s

Number of members in Laboratory Training Group on CDC TRAIN

IO-1. Improved networking, communication, and knowledge sharing of best practices/lessons learned between clinical and public health laboratory professionals

Quantitative feedback from OneLab Network members and other laboratory professionals

Qualitative feedback from OneLab Network members and other laboratory professionals

Proportion of OneLab Network members who attend at least 3 live events per year

IO-2 Enhanced knowledge, skills, and abilities/competence among clinical laboratory professionals

Proportion of learners who self-report knowledge gain after completing DLS laboratory trainings

Proportion of learners with a knowledge gain of ≥10% (post-test

vs. pre-test)

Proportion of learners who score ≥80% on post-tests

Proportion of learners who self-report that training was relevant

Proportion of learners who self-report intent to apply knowledge or skills gained through training and workforce development resources

The recipient will be required to further establish relevant and high- priority process and outcome measures.

CDC will work with the recipient to finalize the detailed work plan and Evaluation and Performance Management Plan (EPMP) ((to include a Data Management Plan (DMP)), in accordance with CDC program guidance. As part of the proposed EPMP, the recipient must provide a proposed DMP describing: the process of retrieving and collecting data; how data will be analyzed and interpreted for continually monitoring, refining, and planning programmatic activities to address all CDC required outputs, outcomes, and performance measures; how and for whom data reporting and programmatic accomplishments will be developed and disseminated; how the recipient will provide public access to data; how data will be stored, archived, and preserved long term, in accordance with CDC standards.

The recipient will be expected to document the implementation of their work plan and demonstrate measurable progress toward achieving the short- and medium-term outcomes that are bolded in the logic model. The recipient will track, collect, and submit the required quantitative and qualitative program performance data, using CDC- approved applications (e.g., software), systems (e.g., online request and tracking system), and Performance Progress and Monitoring Reports (PPMRs), according to established CDC schedules and guidance.

Monitoring activities include routine and ongoing communication between CDC and the recipient and recipient reporting (including work plans, performance, and financial reporting).

Potential data sources regarding monitoring and evaluation activities could include the recipient application and progress reports (e.g., work plans, performance measures), surveys, and interviews with select clinical laboratory partners or learners. Data collection requirements during the period of performance will need to comply with applicable law and regulations, including review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements: tracking recipient progress in achieving the desired outcomes; ensuring the adequacy of recipient systems that underlie and generate data reports; and creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award: ensuring that work plans are feasible based on the budget and consistent with the intent of the award; ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes; working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets; monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

CDC will use the data to produce reports on the program accomplishments, achievement of key indicators and outcomes, feedback reports, and other monitoring and evaluation reports.

Evaluation findings can be used by the recipient and CDC to ensure continuous program and system improvement, help create an evidence base for project strategies, demonstrate the value of the NOFO, and assess which strategies are scalable and effective. CDC may report findings at national and regional conferences, online, and in other public forums.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

The evaluation plan should also discuss any barriers or challenges expected for implementing the plan, collecting the performance measures, and reporting evaluation results. The plan should also describe how the known or potential barriers would be addressed.

c. Organizational Capacity of Recipients to Implement the Approach Applicants should be entities that represent the interests of the clinical laboratory profession and/or the interest of clinical laboratory professionals across the US. Applicants should describe how many clinical laboratory professionals the organization currently reaches, the geographic distribution of those professionals, and the variety of clinical laboratory professionals reached, including work settings (e.g., commercial laboratory, hospital laboratory, physician office laboratory, point-of-care testing site), areas of specialty, years of experience in the profession, and roles within the laboratory (e.g., entry-level bench staff, supervisory/managerial staff). The applicant must describe current promotion and communication channels, including listservs. The applicant must have experience working with external partners and stakeholders of clinical laboratories and must describe a history of successful partnerships, credibility, and influence among clinical laboratories and clinical laboratory staff, as well as describe relationships, productivity, and influence in health care at large.

The applicant must also demonstrate organizational capacity to effectively execute the strategies https://www.cdc.gov/grants/additional-requirements/ar-25.html and conduct the activities listed in the NOFO. Applicants should demonstrate relevant experience and capacity (management, administrative, and technical) to implement the activities and achieve the project outcomes, experience and capacity to implement the evaluation plan, and a staffing plan and project management structure sufficient to achieve the project outcomes and which clearly defines staff roles. Applicants should provide CVs/resumes of key staff (or position descriptions for vacant positions) who will oversee or carry out funded activities, including those (if any) who can serve as subject matter experts in clinical laboratory science. Applicants must name this file "CVs/Resumes" and upload it at www.grants.gov. The applicant must be fully capable of managing the required activities in accordance with 45 CFR part 75. Recipients will be expected to identify and hire staff, if needed, with appropriate qualifications to implement and manage the outlined activities of the

NOFO.

The applicant must also attest that they have a financial management system that will allow proper funds management and segregation of funds by program, and meet the requirements as stated in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards found at: https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302 45 CFR Part 75.302. The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such funds have been used according to the federal statutes, regulations, and terms and conditions of the federal award.

d. Work Plan Applicants should provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years. For the first year, the applicant should list: tasks for each Activity specified in the logic model that outline the steps to be taken to accomplish each Activity; who the responsible party will be for each task; and the expected completion dates. No specific work plan format is required at this time, as long as it is clear how the components in the work plan crosswalk to the strategies and activities, outcomes, and evaluation and performance measures presented in the logic model and the narrative sections of the NOFO. Applicants may use the sample template table below.

Sample work plan template:

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies, Activities, and Tasks

Process Measure

[from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

4.

5.

In this format, the table would be completed for each period of performance outcome.

After the award is made, the proposed work plan should be adjusted in collaboration with CDC technical monitors to better integrate and delineate more specifically how the recipient plans to achieve the period of performance outcomes. In addition, the recipient must update the work plan each budget period to reflect any changes in period of performance outcomes, strategies, activities, personnel, and partners who will complete the activities, and the timeline for completion. The work plan will outline the details of all necessary activities that will be supported through the approved budget period.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

The recipient must provide quarterly financial reporting in an effort to ensure sound fiscal management. Financials will include the recipient’s forecasting/spend-down plan. (A sample template will be provided after award of the cooperative agreement.) This will ensure both CDC and the recipient are monitoring the cooperative agreement funds and individual programmatic activities. The spend-down plan will ensure funds are expended in support of approved activities; tracking and reporting of expenditures are performed in a timely manner;

unobligated balances are prevented; and persons responsible for fiscal management, including oversight of contractor/consultants, are identified.

f. CDC Program Support to Recipients

CDC staff will have substantial involvement beyond monthly calls and regular performance and financial monitoring during the period of performance. CDC staff will collaborate or participate in project or program activities. For example, the assigned CDC technical monitors in collaboration with other subject matter experts across the agency will do the following:

Provide guidance to recipient on data collection tools for data submission for monitoring and evaluation activities, performance measurement, and work plan development

Provide technical guidance to recipient to improve the quality and effectiveness of work plans, evaluation strategies, products and services.

Work with recipient to identify and address challenges that may impede the success of the project

Facilitate national coordination of activities

Collaborate with the recipient on the design of needs assessments

Ensure that established quality standards are met for training, guidance, and technical tools

Provide technical assistance to ensure products that are a direct result of this NOFO are made available in the public domain, for example: guidance on Section 508 accessibility standards

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

U47 - Laboratory/Other Diagnostic Medical Quality Improvement Cooperative Agreements

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$1,000,000

5. Total Period of Performance Funding:

$3,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$3,000,000

6. Total Period of Performance Length:

year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$300,000 Per Budget Period

9. Award Ceiling:

$1,000,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$100,000 Per Budget Period

11. Estimated Award Date:

August 01, 2022

12. Budget Period Length:

12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants Eligibility Category:

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

Additional Eligibility Category:

Government Organizations:

State governments or their bona fide agents (includes the District of Columbia)

Local governments or their bona fide agents

Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau

State controlled institutions of higher education

American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Non-government Organizations

American Indian or Alaska native tribally designated organizations

2. Additional Information on Eligibility Applicants should be entities that represent the interests of the clinical laboratory profession and/or the interest of clinical laboratory professionals across the US. The term “clinical laboratory professionals” is used here in a broad sense to encompass professionals who work in a hospital laboratory, physician office laboratory, or other types of clinical laboratories, in commercial laboratories conducting clinical testing, and persons who perform clinical point-of-care testing.

3. Justification for Less than Maximum Competition N/A

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

5. Maintenance of Effort N/A

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

PLEASE NOTE: For applications due on or after April 4, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission (SF-424, field 8c). In preparation for the federal government’s April 4, 2022 transition to the Unique Entity Identifier (UEI) from the Data Universal Numbering System (DUNS), applicants must obtain a UEI. The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and grants.gov. Entities registering in SAM.gov prior to April 4, 2022 must still obtain a DUNS number before registering in SAM.gov registration. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number to register in SAM.gov prior to April 4, 2022. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B).

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number and a Unique Entity Identifier (UEI). All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC.

If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at SAM.gov and the SAM.gov Knowledge Base.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://grants.gov/ https://www.grants.gov/ http://www.grants.gov/

Step System Requirements Duration Follow Up

Data Universal Number System

(DUNS)

(Required until April 4, 2022)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-

System for Award Management

(SAM)

1. Retrieve organizations DUNS number (required until April 4, 2022)

2. Go to SAM.gov and designate an E-Biz POC (You will need to have an active SAM account before you can register on grants.gov). The UEI is generated as part of your registration.

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fs d.gov/ fsd-gov/ home.do Calls: 86 6-606-8220

3 Grants.gov

1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative

(AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants MUST obtain a DUNS number and SAM account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://sam.gov/content/home https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

a. Letter of Intent Deadline (must be emailed)

Number Of Days from Publication 14

03/10/2022

b. Application Deadline

Due Date for Applications 04/29/2022

04/29/2022 11:59 pm U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Due Date for Information Conference Call An informational conference call will be held on March 16, 2022 at 10:00 AM. Please use the following to call in.

Dial: US : +1 669 254 5252 or +1 646 828 7666 or +1 669 216 1590 or +1 551 285 1373 Meeting ID: 160 604 8787 Password: 61652673

5. Pre-Award Assessments Risk Assessment Questionnaire Requirement

CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually.