A19 - 75D301-22-R-72440 CDC ART Data Collection.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

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

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

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

(Type or Print)

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

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 131

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-22-R-72440

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

08/09/2022

6. REQUISITION/PURCHASE

NO.

00HCUCJB-2022-63454

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

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

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

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 2:00p local time 09/02/2022

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

Ronnie Williams

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(404) 498-2594

C. E-MAIL ADDRESS

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 60

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

X C DESCRIPTION/SPECS./WORK STATEMENT 4 X J LIST OF ATTACHMENTS 102

X D PACKAGING AND MARKING 33 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 34 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 35 X K OTHER STATEMENTS OF OFFERORS 103

X G CONTRACT ADMINISTRATION DATA 36 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 117

X H SPECIAL CONTRACT REQUIREMENTS 39 X M EVALUATION FACTORS FOR AWARD 121

OFFER (Must be fully completed by offeror)

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

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

13. DISCOUNT FOR PROMPT PAYMENT

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

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

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

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

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

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

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

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

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

FIRM FIXED PRICE

B-1. LINE ITEM DESCRIPTION: In accordance with this contract, the contractor, independently and not as an agent of the Government, shall provide all necessary materials, labor, equipment, and facilities, except as specified herein to be furnished by the Government, and shall do all that which is necessary or incident to the satisfactory and timely performance of the following Contract Line Item Number (CLIN):

Transition Period Items: (10/15/2022 – 12/31/2022)

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED

PRICE

0001 ART Data Collection

• Firm-Fixed Price CLIN

• This is a Non-Severable Line Item

Performance Period: 10/15/2022 – 12/31/2022

1 Job $_________ $_________

Total Transition Period Value: $___________

Base Period Items: (01/01/2023 – 10/14/02025)

PRICE

1001 ART Data Collection

• Firm-Fixed Price CLIN

• This is a Non-Severable Line Item

Performance Period: 01/01/2023 – 10/14/2025

1002 Base Period Travel

• This is a Severable Line Item

• This is a cost-reimbursable line item.

Performance Period: 01/01/2023 – 10/14/2025

1 Job NOT TO

EXCEED

NOT TO EXCEED

Total Base Period Value: $___________

Option Period 1 Items: (01/01/2024 – 10/14/02026)

PRICE

2001 ART Data Collection

• Firm-Fixed Price CLIN

• This is a Non-Severable Line Item

Performance Period: 01/01/2024 – 10/14/02026

2002 Option Period 1 Travel

Performance Period: 01/01/2024 – 10/14/2026

1 Job NOT TO

EXCEED

Total Option Period 1 Value: $___________

Option Period 2 Items: (01/01/2025 – 10/14/02027)

PRICE

3001 ART Data Collection

• Firm-Fixed Price CLIN

• This is a Non-Severable Line Item

Performance Period: 01/01/2025 – 10/14/02027

3002 Option Period 2 Travel

Performance Period: 01/01/2025 – 10/14/2027

1 Job NOT TO

EXCEED

Total Option Period 2 Value: $___________

CLIN Extended Total:

SECTION C – PERFORMANCE WORK STATEMENT

Title: CDC National Assisted Reproductive Technology (ART) Surveillance System (NASS) and ART

Data Collection

SECTION 1 – BACKGROUND

The Fertility Clinic Success Rate and Certification Act of 1992 [FCSRCA], Section 2 [a] of P.L. 102-493 [42

U.S.C. 263 (a) -1] requires that each assisted reproductive technology (ART) program operating in the United

States annually report to the Secretary of the Department of Health and Human Services (DHHS), through the

CDC, (a) pregnancy success rates achieved by such ART programs, and (b) the identity of each embryo laboratory used by such ART programs, and whether the laboratory is certified or has applied for such certification under the act. Section (6) states the DHHS, through the CDC, shall annually publish and distribute to the States and the public, pregnancy success rates reported to the Secretary under section 2 (a) (1) and, in the case of an ART program which failed to report one or more success rates as required under each section, the name of each such program and each pregnancy success rate which the program failed to report.

In 1997, CDC first implemented the FCSRCA by developing a partnership with the American Society for

Reproductive Medicine (ASRM), and the Society for Assisted Reproductive Technology (SART) to establish and adopt pregnancy success rate reporting definitions and procedures. Initially, CDC obtained ART data for the 1995-2003 ART procedures through a sole source contract with SART for the purchase of the SART proprietary Clinical Outcomes Reporting System (CORS) database, or SART-CORS. The CDC, ASRM, and

SART collaboration produced the first joint report, “1995 ART Success Rates Reports,” in December 1997.

Beginning with ART procedures initiated in 2004, CDC has contracted with Westat, Inc. to develop and maintain the National ART Surveillance System (NASS), a data collection system for the main purpose of monitoring the efficacy of ART in the U.S. Data collected included patient demographics, medical history and infertility diagnoses, clinical information pertaining to ART procedure, and information regarding resultant pregnancies and births. For the purposes of the CDC ART reporting system, the definition of ART includes all fertility treatments in which either eggs or embryos are handled outside the body, including in vitro fertilization (IVF) conducted with or without the use of intracytoplasmic sperm injection (ICSI), cryopreservation of oocytes, gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT).

IVF involves surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and transferring them into the woman’s uterus through the cervix. ICSI involves a procedure in which a single sperm is injected directly into an egg; the embryos are then cultured and transferred as in IVF. Oocyte cryopreservation involves freezing eggs for future use. GIFT and ZIFT involve rare procedures in which gametes or zygotes are transferred into the fallopian tubes rather than the uterus. In addition, ART is often categorized according to whether the procedure used a woman’s own eggs or eggs from another woman

(donor) and according to whether the embryos used were newly fertilized (fresh) or previously fertilized, frozen, and then thawed (frozen).

Because ART consists of several steps, an ART procedure is typically referred to as a cycle of treatment rather than a procedure at a single point in time. The start of an ART cycle is usually when a woman begins taking medication to stimulate egg production or begins monitoring with the intent of having embryos transferred. If eggs are produced, the cycle progresses to egg retrieval. Retrieved eggs can be combined with sperm to create embryos or frozen for future use. If fertilization is successful, embryos can be selected for transfer in the same cycle or frozen for future use. If embryo transfer results in implantation, the cycle may progress to clinical pregnancy and possibly a live-birth delivery. Data on all cycles started, even those discontinued before all steps were undertaken, are required to be submitted to CDC and are counted in a clinic’s success rates.

Before success rates based on live births can be calculated, every ART pregnancy must be followed up to determine whether a birth occurred. Therefore, the earliest possible date that clinics can report complete annual data is about 9 months past the end of the reporting year, when all the births have occurred. For example, the results of all the cycles initiated in 2019 (reporting year) were not known until October 2020 and their fertility success rates were published in 2021.

SECTION 2 – PURPOSE

The purpose of this project is to assist the Centers for Disease Control and Prevention (CDC) with collecting data from all practicing ART programs in the United States and its territories for ART procedures initiated in years 2023 – 2025 via the National ART Surveillance System (NASS), and to assist with preparing appendixes for the annual ART Fertility Clinic and National Summary report for reporting years 2023-2025 as required in the FCSRCA, Section 2[a] of P.L. 102-493 [42 U.S.C. 263 (a)-1]. NASS is currently operated by Westat, Inc. under contract number 75D301-20-F-07168. The final year of data that will be reported under this new contract will be 2025 data, reported in 2027.

SECTION 3 – SCOPE OF WORK

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all personnel, facilities, equipment, supplies, materials, procedures, and technical support necessary to assist CDC in collecting ART program data and producing appendixes of the annual ART Fertility Clinic and National

Summary Report, as mandated by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), P.L. 102-493.

SECTION 4 – TASKS TO BE PERFORMED

Transition Period: October 15 – December 31, 2022 (start-up, NASS maintenance planning)

The transition period covers all start-up and planning activities for the contractor related to the assuming responsibility for NASS maintenance which will occur on January 1, 2023 (base period start). The contractor shall review Office of Management and Budget (OMB) requirements, and security controls and measures to ensure compliance with federal security regulations and Authority to Operate (ATO) requirements in all option periods. The contractor shall perform the following specific tasks:

1. Plan a virtual post-award meeting with CDC to be held within 30 days of contract award. Key contractor staff should attend this meeting. Contractor shall be responsible for drafting the meeting agenda and taking meeting notes.

2. Conduct monthly conference calls with CDC. Contractor shall be responsible for drafting call agendas and taking call notes.

3. Ensure that project staff complete required onboarding tasks to gain access to CDC network in preparation for accessing and maintaining NASS in the base period, including mandatory CDC trainings.

4. Obtain access to NASS on CDC premises or CDC cloud and data collection website source code, such that the contractor can maintain the data collection system in accordance with all technical requirements as outlined in section 4.1 of this Statement of Work (e.g., CDC web template, .gov domain, etc.) starting in the base period.

5. Obtain existing variable specifications and quality assurance (QA) protocol including specific programming for detecting logic errors and out of range or questionable values. Update this protocol as directed in order to assume responsibility for collecting 2023 ART data in the base period.

6. Become familiar with and assess ART business processes, data life cycle, and identify and develop concrete recommendations for automation opportunities.

7. Obtain and become familiar with current data dictionary, NASS questionnaire, and success rates specifications documents.

8. Develop a detailed confidentiality protection plan in order to maintain security for all project data and records. Ensure that all project staff complete confidentiality training and sign CDC’s assurance of confidentiality forms.

9. Complete all required security assessments & authorization (SA&A) materials to obtain an initial

ATO for the system.

10. Obtain existing template and standard operating procedures (SOPs) for annual clinic tracking. Review and become familiar with clinic tracking requirements and procedures.

11. Obtain and review existing SOPs for staffing and maintaining the NASS Help Desk.

12. Obtain existing requirements, training materials, and SOPs for annual data validation, review and become familiar with data validation requirements, training materials, and procedures. Review and become familiar with ART data validation plan, including random and targeted selection of clinics to be implemented in the base period.

13. Review and become familiar with ART report production procedures including appendix requirements.

14. Develop transition progress report which summarizes achievements and issues with transition period tasks.

Base Period: January 1, 2023 – October 14, 2025 (2023 data collection, finalization, and validation, and creation of appendixes)

The base period covers all activities for the contractor to maintain the data entry programs and collect data for

2023 ART procedures. During this option period, the contractor shall finalize and validate data, and create report appendixes. The contractor shall perform the following tasks:

1. Conduct monthly conference calls with CDC. Contractor shall be responsible for drafting call agendas and taking call notes.

2. Develop quarterly progress reports which summarize achievements and issues with base period tasks.

3. Ensure that project staff complete required CDC trainings by specified deadlines throughout the option period to maintain access to CDC network.

4. Provide ongoing, technical assistance to each ART clinic.

5. Prepare and submit all certification and accreditation (C&A) materials and paperwork requested as part of the annual security evaluation.

6. Maintain a detailed confidentiality protection plan in order to secure all project data and records.

Ensure that all project staff complete annual confidentiality training, sign CDC’s assurance of confidentiality forms, and are compliant with assurance of confidentiality requirements and other relevant regulations and protection requirements.

7. Facilitate collection of data for 2023 ART procedures and current clinic information, including clinic name, address, phone number, medical director’s name, clinic services, SART membership, verified lab accreditation. Submit a report verifying the start of data collection for 2023 ART procedures.

8. Maintain and update (as needed) variable specifications, data dictionary, NASS questionnaire, and success rates specifications.

9. Perform data management including edit checks and quality assurance. Update quality assurance protocol as directed.

10. Distribute materials (software, instruction manuals, data collection tools, contractor-assigned unique clinic identification codes, etc.) to all ART clinics known to be in operation for collection of 2023

ART procedures.

11. Track all operating clinics for the 2023 reporting year.

12. Conduct conference calls with CDC to discuss plans for data validation site visits. Data validation will include cycles initiated in 2023. Contractor shall be responsible for drafting call agenda and taking call notes.

13. Develop sampling strategy for data validation site visits occurring in 2025.

14. Finalize data submission for 2023 ART procedures. Ensure data quality checks and clinic-follow ups are completed.

15. Obtain medical directors’ electronic signatures for ART Fertility Clinic and National Summary Report online.

16. Create datasets of reporting clinics and non-reporting clinics for 2023 reporting year.

17. Prepare draft and final ART Clinics Appendix including list of reporting and non-reporting clinics to be included in the final 2023 ART Fertility Clinic and National Summary Report online. Format is expected to be similar to that of the 2019 ART Fertility Clinic and National Summary Report.

18. Collect and compile feedback from the clinic feedback questionnaire administered online within the data collection system.

19. Create summary report for reasons clinics are not reporting, efforts undertaken to track non-reporters, and estimated number and percent of ART cycles performed at non-reporting clinics. Content is expected to be similar to that under question seven of the Frequently Asked Questions section of the

2019 ART Fertility Clinic and National Summary Report.

20. Develop a document containing all reporting clinics during reporting year 2023 that utilizes an entity identification number for each clinic to accurately represent the clinic’s status over time.

21. Train a team of data validators and conduct annual ART data validation site visits using electronic validation system. Validation visits may be conducted in person between contractor and clinics.

Provide data validation visit summary reports following each site visit. Create electronic database containing validation data (will include cycles initiated in 2023) and results of the validation analysis.

Prepare and send discrepancy tables and follow-up letters to validated clinics.

22. Prepare draft and final Data Validation Appendix including validation methods and summary table of discrepancy rates to be included in the final 2023 ART Fertility Clinic and National Summary Report online. Format is expected to be similar to that of the 2019 ART Fertility Clinic and National

Summary Report.

Option Period 1: January 1, 2024 – October 14, 2026 (2024 data collection, finalization, and validation, and creation of appendixes)

Option period 1 covers all activities for the contractor to maintain the data entry programs and collect data for

2024 ART procedures. During this option period, the contractor shall finalize and validate data, and create

1. Conduct monthly conference calls with CDC. Contractor shall be responsible for drafting call agendas and taking call notes.

2. Develop quarterly progress reports which summarize achievements and issues with option period 1 tasks.

3. Ensure that project staff complete required CDC trainings by specified deadlines throughout the option period to maintain access to CDC network.

4. Provide ongoing, technical assistance to each ART clinic by maintaining an online and telephone helpdesk for the data collection system beginning in October of 2024. The NASS Help Desk shall be staffed 9am – 5pm ET, Monday – Friday.

5. Prepare and submit all certification and accreditation (C&A) materials and paperwork requested as part of the annual security evaluation.

6. Maintain a detailed confidentiality protection plan in order to secure all project data and records.

Ensure that all project staff complete annual confidentiality training, sign CDC’s assurance of confidentiality forms, and are compliant with assurance of confidentiality requirements and other relevant regulations and protection requirements.

7. Facilitate collection of data for 2024 ART procedures and current clinic information, including clinic name, address, phone number, medical director’s name, clinic services, SART membership, verified lab accreditation. Submit a report verifying the start of data collection for 2024 ART procedures.

8. Maintain and update (as needed) variable specifications, data dictionary, NASS questionnaire, and success rates specifications.

9. Perform data management including edit checks and quality assurance. Update quality assurance protocol as directed.

10. Distribute materials (software, instruction manuals, data collection tools, contractor-assigned unique clinic identification codes, etc.) to all ART clinics known to be in operation for collection of 2024

ART procedures.

11. Track all operating clinics for the 2024 reporting year.

12. Conduct conference calls with CDC to discuss plans for data validation site visits. Data validation will include cycles initiated in 2024. Contractor shall be responsible for drafting call agenda and taking call notes.

13. Develop sampling strategy for data validation site visits occurring in 2026.

14. Finalize data submission for 2024 ART procedures. Ensure data quality checks and clinic-follow ups are completed.

15. Obtain medical directors’ electronic signatures for ART Fertility Clinic and National Summary Report online.

16. Create datasets of reporting clinics and non-reporting clinics for 2024 reporting year.

17. Prepare draft and final ART Clinics Appendix including list of reporting and non-reporting clinics to be included in the final 2024 ART Fertility Clinic and National Summary Report online. Format is expected to be similar to that of the 2019 ART Fertility Clinic and National Summary Report.

18. Collect and compile feedback from the clinic feedback questionnaire administered online within the data collection system.

19. Create summary report for reasons clinics are not reporting, efforts undertaken to track non-reporters, and estimated number and percent of ART cycles performed at non-reporting clinics. Content is expected to be similar to that under question seven of the Frequently Asked Questions section of the

2019 ART Fertility Clinic and National Summary Report.

20. Develop a document containing all reporting clinics during reporting year 2024 that utilizes an entity identification number for each clinic to accurately represent the clinic’s status over time.

21. Train a team of data validators and conduct annual ART data validation site visits using electronic validation system. Validation visits may be conducted in person between contractor and clinics.

Provide data validation visit summary reports following each site visit. Create electronic database containing validation data (will include cycles initiated in 2024) and results of the validation analysis.

Prepare and send discrepancy tables and follow-up letters to validated clinics.

22. Prepare draft and final Data Validation Appendix including validation methods and summary table of discrepancy rates to be included in the final 2024 ART Fertility Clinic and National Summary Report

Option Period 2: January 1, 2025 – October 14, 2027 (2025 data collection, finalization, and validation, Option period 2 covers all activities for the contractor to maintain the data entry programs and collect data for

2025 ART procedures. During this option period, the contractor shall finalize and validate data, and create

1. Conduct monthly conference calls with CDC. Contractor shall be responsible for drafting call agendas and taking call notes.

2. Develop quarterly progress reports which summarize achievements and issues with option period 2 tasks.

3. Ensure that project staff complete required CDC trainings by specified deadlines throughout the option period to maintain access to CDC network.

4. Provide ongoing, technical assistance to each ART clinic by maintaining an online and telephone helpdesk for the data collection system. The NASS Help Desk shall be staffed 9am – 5pm ET, Monday – Friday.

5. Prepare and submit all certification and accreditation (C&A) materials and paperwork requested as part of the annual security evaluation.

6. Maintain a detailed confidentiality protection plan in order to secure all project data and records.

Ensure that all project staff complete annual confidentiality training, sign CDC’s assurance of confidentiality forms, and are compliant with assurance of confidentiality requirements and other relevant regulations and protection requirements.

7. Facilitate collection of data for 2025 ART procedures and current clinic information, including clinic name, address, phone number, medical director’s name, clinic services, SART membership, verified lab accreditation. Submit a report verifying the start of data collection for 2025 ART procedures.

8. Maintain and update (as needed) variable specifications, data dictionary, NASS questionnaire, and success rates specifications.

9. Perform data management including edit checks and quality assurance. Update quality assurance protocol as directed.

10. Distribute materials (software, instruction manuals, data collection tools, contractor-assigned unique clinic identification codes, etc.) to all ART clinics known to be in operation for collection of 2025

ART procedures.

11. Track all operating clinics for the 2025 reporting year.

12. Conduct conference calls with CDC to discuss plans for data validation site visits. Data validation will include cycles initiated in 2025. Contractor shall be responsible for drafting call agenda and taking call notes.

13. Develop sampling strategy for data validation site visits occurring in 2027.

14. Finalize data submission for 2025 ART procedures. Ensure data quality checks and clinic-follow ups are completed.

15. Obtain medical directors’ electronic signatures for ART Fertility Clinic and National Summary Report online.

16. Create datasets of reporting clinics and non-reporting clinics for 2025 reporting year.

17. Prepare draft and final ART Clinics Appendix including list of reporting and non-reporting clinics to be included in the final 2025 ART Fertility Clinic and National Summary Report online. Format is expected to be similar to that of the 2019 ART Fertility Clinic and National Summary Report.

18. Collect and compile feedback from the clinic feedback questionnaire administered online within the data collection system.

19. Create summary report for reasons clinics are not reporting, efforts undertaken to track non-reporters, and estimated number and percent of ART cycles performed at non-reporting clinics. Content is expected to be similar to that under question seven of the Frequently Asked Questions section of the

2019 ART Fertility Clinic and National Summary Report.

20. Develop a document containing all reporting clinics during reporting year 2025 that utilizes an entity identification number for each clinic to accurately represent the clinic’s status over time.

21. Train a team of data validators and conduct annual ART data validation site visits using electronic validation system. Validation visits may be conducted in person between contractor and clinics.

Provide data validation visit summary reports following each site visit. Create electronic database containing validation data (will include cycles initiated in 2025) and results of the validation analysis.

Prepare and send discrepancy tables and follow-up letters to validated clinics.

22. Prepare draft and final Data Validation Appendix including validation methods and summary table of discrepancy rates to be included in the final 2025 ART Fertility Clinic and National Summary Report

SECTION 4.1 – DETAILED TECHNICAL REQUIREMENTS

Data Collection

The contractor shall collect or create only that information or data necessary for the proper performance of

CDC functions and which has practical utility. Limit the collection or creation of information which identifies individuals to that which is legally required, authorized, and necessary for the proper performance of CDC functions. Data collections shall only include the minimum information reasonably necessary to conduct public health activities. Unless there is a valid public health purpose, personally identifiable data (i.e., name, social security number, phone number) should not be collected or maintained. Prior to implementing data collections, minimum data elements should be specified, and consideration should be given to whether data collections of identifiable data will be necessary to achieve the intended public health goals. To ensure the issues of confidentiality, proprietary use, and informed consent are correctly addressed, a data management plan must be initiated during the project planning phase as to how the contractor will collect, analyze, distribute, and make available the data collected.

1. Case Definition

As defined in the August 2015 Federal Register Notice, cycle-specific data for the following patients must be reported:

a. All patients undergoing ART

b. All patients undergoing ovarian stimulation or monitoring with the intent of undergoing ART but who did not proceed to oocyte retrieval or transfer of embryos for any reason, including patients whose cycles were canceled for any reason

c. All patients providing donor oocytes

d. All patients undergoing monitoring and/or embryo (or oocyte) thawing with the intention of transferring cryopreserved embryos

Only cycles performed in the U.S. may be reported to CDC. In all cases in which a treatment cycle results in pregnancy, follow-up data related to the outcome of the pregnancy must be provided.

NOTE: Other Federal Register Notices may describe changes or clarification to data collection process.

2. Data Element Requirements

The contractor shall collect the requested data elements outlined in Attachment A for every ART treatment cycle. The contractor shall ensure that NASS data collection system is maintained on CDC servers or CDC cloud and collects or supports the collection (e.g., compatibility) of this information. The contractor shall provide an updated and complete data dictionary for all collected data elements. If determined by the CDC

COR and NASS Coordinator, these data elements may be revised.

Each patient receiving ART must be assigned a unique patient code. Data on each patient should be entered upon initiation of the first treatment cycle. Each subsequent treatment cycle for a specific patient must be assigned the same unique patient code, in conjunction with a unique cycle code for the cycle. It is important to note that a patient may undergo more than one ART treatment cycle in one year. Thus, the

NASS system was designed such that multiple ART cycles can be linked to one specific patient through a unique patient code. In the NASS data collection system on CDC servers or CDC cloud, every patient should be identified by the clinic code assigned by the contractor (see below) and the patient code generated by the data collection system. Individual clinics must be able to use these codes to link every cycle included in the data back to the name and other identifiers of a specific patient. Currently, the software system does not allow patient identifiable information (such as name and social security number) to be transmitted to the contractor or CDC. While the software needs to allow for patient identifiable information to be entered at the clinic level, patient identifiable data must not become part of the database maintained by the contractor on behalf of the CDC or as part of the final data.

The contractor will assign a unique clinic code to each ART clinic. The data collection system must be able to collect certain clinic level variables (e.g., clinic’s name, location, services provided, SART membership, lab accreditation) in addition to the data collected for individual ART treatment cycles performed by the clinic. Clinic level variables (e.g., SART membership, lab accreditation) must be verified.

NOTE: Clinic and patient codes should be maintained from previous years when applicable, and new codes should be generated accordingly.

3. Data Entry Application Requirements

It is expected that ART cycle data may be entered manually by reviewing the patient charts or by completing a data abstraction form and then entered into the data collection system, or may be directly imported from existing electronic medical records. The contractor shall utilize NASS which resides on

CDC servers or CDC cloud and supports the import of existing electronic medical records files (individual or batch), of varying file types dependent on the EMR, requiring no manual intervention to the file after import setup is complete. Thus, NASS must also have a mechanism that supports self-service mapping of the varying files’ data elements to NASS data elements as a component of an import setup capability.

3.1 Data entry software

The contractor shall obtain, update, and maintain NASS on CDC servers or CDC cloud to collect data electronically in accordance with OMB and CDC’s security requirements. The software will allow manual data entry as well as direct import of data in electronic format. NASS must remain free of charge to ART programs. NASS must also retain capabilities to record data for every intended and/or initiated ART treatment cycle. The application should allow accurate conversion of the data into a SAS System (with the most updated version).

3.1.1 Data entry software maintenance

The contractor shall maintain the existing NASS data entry software in compliance with the ART data reporting requirements. ART data are presently submitted by ART clinics through one of two main online data entry applications: SART – CORS online, which is operated by SART, and NASS, which is owned by the government. Technical specifications are outlined in this Statement of Work, and in Attachment A.

In addition, ART programs that have electronic medical record systems may submit data in batch using electronic formats specified by the CDC. The contractor shall evaluate the NASS system and provide to the government a written statement of any presumed deficiencies or inefficiencies in the system. The contractor may propose modifications or enhancements to the system. Any modifications or enhancements shall be subject to approval by the government.

Specific subtasks are outlined below:

Within 30 business days of the initial contract award date, the contractor will obtain the NASS data entry source code, and gain access to the current NASS database which resides on CDC servers or CDC cloud and is owned by the government, to prepare for use as the standardized ART data collection system starting in 2023, subject to all OMB and HHS/CDC IT requirements. The CDC will release the NASS source code to the contractor for use during the performance of this task. The government will not provide any expressed or implied warranties or guarantees in the use of the NASS application. The contractor shall be responsible for functionality, implementation, and maintenance of NASS in time to meet data collection schedules during each contract year.

NOTE: Any modification to the data collection system or validation process must first be requested in writing by the contractor and approved by the CDC COR and NASS coordinator prior to implementation.

3.2 Other system requirements

The data collection system will include data management and reporting capabilities to allow performing data quality assurance without requiring the use of additional software. Detailed requirements for additional features are provided later in this Statement of Work (see section on Quality Assurance

Requirements).

The contractor shall conduct a preliminary information system and data security risk assessment/analysis on the data collection system and complete all SA&A materials and paperwork required to obtain an initial

Authority to Operate (ATO) the data collection system. The contractor shall comply with all applicable

HHS, CDC, FISMA, HIPAA, NIST, and other federal policies and regulations in the performance of the security requirements. Required documentation and materials shall be submitted to the CDC COR and

NASS Coordinator, who will forward them to the Security Officer. The CDC COR and NASS Coordinator will communicate with the contractor on required revisions.

The contractor shall maintain safeguards to assure confidentiality is protected and provide for the physical security of all records. The contractor shall develop a detailed confidentiality protection plan to be submitted to the CDC COR and NASS Coordinator for approval. The plan must be CDC-approved before any data collection may begin.

During each contract year that the contractor is responsible for data collection, the contractor shall develop a document containing all reporting clinics that utilizes an entity identification number (for each clinic) to accurately represent the clinic’s status (e.g., name, SART-ID number when applicable) over time.

4. The contractor shall maintain, update, and/or develop detailed NASS instruction materials for ART programs. These materials shall contain:

• Technical specifications necessary to use the electronic software system

• Software system installation instructions

• Detailed information on the definitions, coding, data entry restrictions, and other relevant criteria for every data element included in the system

• Information on quality assurance edits incorporated into the system

• Data entry instructions and edit procedures

• Instructions for tabulating and printing clinic table statistics after data entry for all ART treatment cycles

• Instructions for downloading and submitting the final dataset to the contractor

5. The contractor shall maintain the ability for data to be extracted and directly imported into the CDC reporting system from other electronic medical record systems that may be maintained by ART programs. The contractor shall develop and provide all necessary clinic instruction materials for extracting and importing data and for checking imported data to ensure it retains the accuracy and compatibility of the data entry system. To safeguard and ensure data security and integrity while being accumulated, exported, imported, archived, and transmitted on behalf of, and to CDC, the contractor must ensure all data are encrypted using the Data Encryption Standard (DES), triple-DES, or current federal encryption standard. The contractor must either provide for encryption of the data file as a whole, or programmatically encrypt data items prior to being stored within the data files. The contractor must also secure and maintain encryption keys.

6. The CDC COR and NASS Coordinator shall annually review and approve all data elements. Updates to NASS, data elements, instruction materials, and/or success rate specifications may be necessary in all Option Periods (collecting 2023-2025 ART procedures). In such a case, CDC will work closely with the contractor.

7. For all Option Periods (reporting 2023-2025 ART procedures), the contractor shall annually submit, any instruction materials to be distributed to clinics, variable specifications, data dictionary, NASS questionnaire, success rates specifications, medical record abstraction forms, as requested by CDC.

Quality Assurance (QA) Requirements

The contractor shall obtain, update, and maintain a written quality assurance (QA) protocol for assessing the quality and completeness of data from each reporting ART program. ART data sent to CDC must have an acceptable level of data accuracy. The QA protocol will be shared with CDC at any time upon request from the

CDC COR or NASS Coordinator. The QA protocol will include the following:

• Plans for contacting non-reporting ART programs and gathering summary information on the characteristics of the clinic, of the patients, reasons for non-reporting, and estimated number of cycles performed.

• A detailed analytic plan, which describes specific programming for detecting logic errors between dataset elements, out of range, or questionable values for each data element, and completeness of reporting for each data element. Such analyses need to be performed for each clinic separately and for the entire dataset (all clinics combined).

• A detailed plan for determining thresholds for clinic re-contacts, a timeline for re-contacting clinics for error corrections, and a plan for documenting all corrections indicated by clinics and incorporating updates received during the clinic re-contact period into the final data. The prevailing consideration in determining thresholds for clinic re-contact shall be whether errors for a particular data item might possibly impact a statistic presented in the clinic specific success rates. By federal mandate, CDC must present clinic-level statistics; and thus, the accuracy of such statistics must be ensured at the clinic level.

Each ART program will be able to use NASS to tabulate and review its statistics at any time for internal quality assurance purposes and will verify the accuracy of annual statistics by electronic signature of the program’s medical director.

The contractor shall be responsible for maintaining clinic success rate specifications and providing technical assistance to clinics, government personnel and federal contractors as needed.

Clinic Data Submission

To be in compliance with the FCSRCA federal reporting requirements, an ART program must:

• Submit a dataset to the contractor in the required format by the established reporting deadline

• Verify, by electronic signature of the medical director, the accuracy of their program’s statistics by the same deadline

Clinics must have sufficient time to gather information on the outcomes of all pregnancies resulting from ART treatment cycles initiated in any given year. Thus, the anticipated deadline for clinic dataset submission to the contractor is December 15 of each year.

Technical Assistance (TA) to Reporting Clinics

Beginning in the base period and continuing through the end of the contract, the contractor shall provide TA to

ART programs via telephone, email, facsimile, and/or internet communication. The TA will include, but is not limited to:

• Clarification of data elements or variable specifications

• Definitions or other instruction materials

• Assistance with uploading the software system

• Technical issues with NASS

• Entering data or importing data from other systems

• Reviewing data

• Tabulating statistics

• Specifications for success rate calculations

• Extracting final data files for submission to the contractor

The contractor shall develop, implement, and maintain a TA Help Desk beginning in Option Period 1 through which users can obtain assistance via phone or email. The contractor shall also develop and maintain a TA log. The TA provided should be documented as soon after communication as possible and should be included in quarterly progress reports. The TA site-specific documentation should be in the form of a log and must include:

• Date of contact

• Contact name at the site

• Description of TA provided

• Action(s) taken

• Further action(s) needed

• Name of the TA provider

The TA log delivered to CDC must have a viable “search” function so that information can be easily referenced.

Pending conference approval obtained by CDC, the contractor shall arrange for one trip per contract year for one person to demonstrate the NASS system and educate ART program staff on how to use NASS during the

American Society for Reproductive Medicine (ASRM) Annual Meeting.

Data Delivery to CDC

The contractor shall review all received ART clinic data files. The final data will include all ART cycles submitted to the contractor by the ART clinics. Data on all cycles that were started, even those discontinued before all steps were undertaken, should be provided to CDC. The contractor must provide documentation detailing all quality assurance edits or procedures with the data.

The data must be accompanied by variable specifications and a data dictionary that includes:

• Each variable name as it appears in the dataset

• A description of each variable that corresponds with the data element in the original data collection system

• The data format for each variable and codes for responses to each categorical variable (data dictionary)

• A list of edit checks and errors identified in the data

The Contractor shall perform a QA analysis consistent with the QA protocol discussed above. The final data must be accompanied by the results of the contractor’s QA analysis including a listing by clinic of all edit failures encountered, and how the contractor addressed those edit failures.

CDC must approve the data quality of the final data. If upon review of the final data CDC requires revisions, the contractor shall develop an error correction schedule to be approved by the CDC and proceed to correct the data at no additional cost to the government.

Delivery of items to be furnished to the government under this contract will be made by any one of the private, overnight delivery services companies, via a Secure Data Network or FTP connection, uploaded to specified secure CDC shared drive folders or other approved and secure delivery system. Selection of an appropriate delivery method should be approved by the CDC COR and/or NASS Coordinator.

To safeguard and ensure the integrity of data while being accumulated, archived, and transmitted on behalf of, and to the CDC, the contractor must ensure that all data are encrypted by the DES, triple-DES, or current federal encryption standard. The contractor shall either provide for the encryption of the data files as a whole or can programmatically encrypt data items prior to being stored within the data files. It is recommended that an archival or recovery mechanism be utilized with encryption implemented so files encrypted by lost or forgotten passwords or keys can be recovered. All materials or data containing personally identifying information sent to the government, or any other location, must be electronically encrypted.

Reporting and Non-Reporting Clinic Datasets

The contractor shall prepare and submit a dataset containing name and contact information for all ART clinics that submit data to the contractor and thus are included in the annual ART Fertility Clinic and National

Summary Reports (i.e., all ART clinics that reported data in NASS). This dataset must be submitted in a standard spreadsheet format such as Microsoft Excel or Access. For each clinic, the listing must include:

• Clinic name (current and former, if applicable)

• Medical Director’s name

• Clinic address

• Clinic telephone number

• Clinic email address and website URL, if available

• Clinic fax number

• Names of embryo laboratories used

• Current certification status for such embryo laboratories

The contractor shall prepare and submit a dataset containing name and contact information for all ART clinics who meet FCSRCA reporting requirements but fail to report data to the contractor by the pre-set deadline. This dataset must be submitted in a standard spreadsheet format such as Microsoft Excel or Access. For each clinic, the listing must include:

• Clinic name (current and former, if applicable)

• Medical Director’s name

• Clinic address

• Clinic telephone number

• Clinic email address and website URL, if available

• Clinic fax number

• Reason for categorization as a non-reporting clinic

The contractor shall also prepare a report summarizing the results of efforts to track non-reporting clinics, provide information on the characteristics of the clinics, of their patients, and reasons for non-reporting. The contractor shall consult with CDC on the data to be used to provide this information. The report should also include the definition(s) of non-reporting clinics developed in collaboration with CDC and identification of the type of non-reporting clinic (e.g., data reported late, data not reported, data reported but not meeting standards, data not verified by Medical Director).

ART Report ART Clinics Appendix Requirements

The contractor shall prepare the ART Clinics Appendix of annual ART reports, to be approved by the

CDC. The ART Clinics Appendix will include:

1. Name and contact information for all ART clinics that submit data to the contractor, by state

2. Name and contact information for all ART clinics who meet FCSRCA reporting requirements but fail to report data to the contractor by the pre-set deadline, by state

Contact information for clinics is expected to follow the same requirements as the Reporting and Non-

Reporting Clinic Datasets above. The precise layout of the ART Clinics Appendix will be determined by the

CDC COR and NASS Coordinator but is expected to follow the model of the 2019 Assisted Reproductive

Technology Fertility Clinic and National Summary Report published by the CDC. (See https://www.cdc.gov/art/reports/2019/fertility-clinic.html).

NOTE: For each year that the annual ART Fertility Clinic and National Summary Report is produced, the contractor and CDC will review the layout and format of the ART Clinics Appendix and decide if revisions to the reporting format…