A19 - RFP - Data Centers - 75D301-22-R-72244.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

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

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 83

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-22-R-72244

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

07/18/2022

6. REQUISITION/PURCHASE

NO.

0000HCCP-2022-62652

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. Proposals are due to Contract Specialist Marie Bartkevicius by email to vgj6@cdc.gov until 2:00pm EST local time on 08/17/2022 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

Marie Francoise. Bartkevicius

B. TELEPHONE (NO COLLECT

CALLS)

AREA CODE NUMBER: EXT:

(770) 488-8493

C. E-MAIL ADDRESS

Vgj6@cdc.gov

11. TABLE OF CONTENTS

(X) DESCRIPTION (X) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 40

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 51

X D PACKAGING AND MARKING 23 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 23 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 23 X OTHER STATEMENTS OF OFFERORS 52

X G CONTRACT ADMINISTRATION DATA 27 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 71

X H SPECIAL CONTRACT REQUIREMENTS 29 X M EVALUATION FACTORS FOR AWARD 80

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

See Section B

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 mailto:vgj6@cdc.gov

Section B - Supplies Or Services and Prices/Costs

Base Period

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Data Centers

All work performed within accordance of the Performance

Work Statement

This is a Firm Fixed Price Severable Line Item

12 Months $ $

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0002 Data Centers

Optional Task 4 (Only applicable to Data Centers 2 and 3)

- Consenting NPN and Survivor CCE members

This is a Firm Fixed Price Severable Line Item

12 Months $ $

Option 1

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

1001 Data Centers

All work performed within accordance of the Performance

Work Statement

This is a Firm Fixed Price Severable Line Item

12 Months $ $

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

1002 Data Centers

Optional Task 4 (Only applicable to Data Centers 2 and 3)

- Consenting NPN and Survivor CCE members

This is a Firm Fixed Price Severable Line Item

12 Months $ $

Option 2

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

2001 Data Centers

All work performed within accordance of the Performance

Work Statement

This is a Firm Fixed Price Severable Line Item

12 Months $ $

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

2002 Data Centers

Optional Task 4 (Only applicable to Data Centers 2 and 3)

- Consenting NPN and Survivor CCE members

This is a Firm Fixed Price Severable Line Item

12 Months $ $

Option 3

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

3001 Data Centers

All work performed within accordance of the Performance

Work Statement

This is a Firm Fixed Price Severable Line Item

12 Months $ $

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

3002 Data Centers

Optional Task 4 (Only applicable to Data Centers 2 and 3)

- Consenting NPN and Survivor CCE members

This is a Firm Fixed Price Severable Line Item

12 Months $ $

Option 4

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

4001 Data Centers

All work performed within accordance of the Performance

Work Statement

This is a Firm Fixed Price Severable Line Item

12 Months $ $

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

4002 Data Centers

Optional Task 4 (Only applicable to Data Centers 2 and 3)

- Consenting NPN and Survivor CCE members

This is a Firm Fixed Price Severable Line Item

12 Months $ $

B.1 Labor Categories and Hours

The Government estimates that the requirements of this PWS can be fulfilled utilizing the labor categories and a total annual range of hours as reflected below. However, the offerors are advised to conduct their own analysis of the requirements and propose their best solutions based upon their independent assessments.

BASE OPTION 1 OPTION 2 OPTION 3 OPTION 4

Hours Hours Hours Hours Hours

Member Service Representative 2400.00 2400.00 2400.00 2400.00 2400.00

Computer Specialist 3600.00 3600.00 3600.00 3600.00 3600.00

Executive Assistant 1880.00 1880.00 1880.00 1880.00 1880.00

Computer Systems Manager 1880.00 1880.00 1880.00 1880.00 1880.00

Applications Manager 3600.00 3600.00 3600.00 3600.00 3600.00

Computer Specialist (Software) 3650.00 3650.00 3650.00 3650.00 3650.00

Programmer I 3600.00 3600.00 3600.00 3600.00 3600.00

Business Analyst 3660.00 3660.00 3660.00 3660.00 3660.00

DC Director 1880.00 1880.00 1880.00 1880.00 1880.00

Administrative Staff Analyst 1504.00 1504.00 1504.00 1504.00 1504.00

IT Security Team Lead 1880.00 1880.00 1880.00 1880.00 1880.00

Deputy Agency Chief Contracting

Represenative 1880.00 1880.00 1880.00 1880.00 1880.00

Administrative Director 3600.00 3600.00 3600.00 3600.00 3600.00

Executive Assistant I 3600.00 3600.00 3600.00 3600.00 3600.00

Program Director 2880.00 2880.00 2880.00 2880.00 2880.00

Pharmacy Benefits Manager 1880.00 1880.00 1880.00 1880.00 1880.00

Executive Assistant II 3600.00 3600.00 3600.00 3600.00 3600.00

Executive Assistant III 3660.00 3660.00 3660.00 3660.00 3660.00

Pulmonologist I 2256.00 2256.00 2256.00 2256.00 2256.00

Junior Biostatistician *2 3760.00 3760.00 3760.00 3760.00 3760.00

Cancer Lead 1800.00 1800.00 1800.00 1800.00 1800.00

Clinical Program Analyst 1880.00 1880.00 1880.00 1880.00 1880.00

Program Associate 1800.00 1800.00 1800.00 1800.00 1800.00

Data Entry 1850.00 1850.00 1850.00 1850.00 1850.00

Data Entry II 3600.00 3600.00 3600.00 3600.00 3600.00

Pulmonologist II 1880.00 1880.00 1880.00 1880.00 1880.00

Mental Health Director 1880.00 1880.00 1880.00 1880.00 1880.00

Nurse Clinical Coordinator 1880.00 1880.00 1880.00 1880.00 1880.00

Research Program Coordinator 1880.00 1880.00 1880.00 1880.00 1880.00

Research Professor 3600.00 3600.00 3600.00 3600.00 3600.00

Section C – Data Center (DC) Contract Performance Work Statement

C.1 BACKGROUND

On January 2, 2011, the President signed Public Law No. 111-347, the James Zadroga 9/11 Health and

Compensation Act (“Zadroga Act”). Title I of the Zadroga Act amended the Public Health Service Act to add Title

XXXIII establishing a new federal health care program called the “World Trade Center Health Program within the

Department of Health and Human Services. See “James Zadroga 9/11 Health and Compensation Act of 2010,”

Public Law 111-347 (codified at 42 U.S.C. §§ 300mm – 300mm-61). On December 18, 2015, the Zadroga Act was amended to provide authority and funding for the WTC Health Program to continue through 2090. See Pub. L. 114-

113 (Dec. 18, 2015), “Consolidated Appropriations Act, 2016,” Div. O, Title III (“James Zadroga 9/11 Health and

Compensation Reauthorization Act”). Further information regarding the WTC Health Program Laws can be found at: http://www.cdc.gov/wtc/laws.html and http://www.cdc.gov/wtc/ppm.html.

The WTC Health Program was established to provide care for previously enrolled responders (Fire Department -

New York City -FDNY and general responders) and affected community members (now called “WTC survivors”), and for newly enrolled responders and survivors. The Program has been structured through a series of contracts for

Clinical Centers of Excellence (CCEs), a Nationwide Provider Network (NPN), and Data Centers (DCs). The

CCEs/NPN are authorized to provide health screening or medical monitoring evaluation, diagnostic and treatment services for a limited number of qualifying conditions, social benefits counseling, and limited outreach activities.

The DCs ensure standardization of medical and screening protocols, create medical diagnostic and treatment guidelines, collect, maintain and analyze data from standardized assessments in a uniform and quality manner, receive and analyze health care claims data, provide annual health surveillance reports, conduct analyses for program operational support and improvement, and supply approved datasets for peer-reviewed scientific research efforts. Additional, secondary efforts include coordination activities in a manner to help facilitate transparency and collaboration of outreach and retention activities of the CCEs, in accordance with the WTC Health Program’s overarching strategic plan for outreach and retention. Coordination activities shall be conducted in a manner to meet the needs of all CCEs and using a framework and point of contact established by NIOSH.

In the spring of 2011, CDC awarded a contract to provide operational support services to assist NIOSH with implementation of the WTC Health Program as defined by the Zadroga Act. A major function of this support contract was to process health care claims for services rendered by Program providers, route them for federal payment and communicate the specific payment details back to the rendering provider. A periodic extract of claims paid was then sent to the DC to represent the treatment data for assigned member cohorts. The WTC Health

Program and its Contractors (CCEs, DCs, Nationwide Provider Network [NPN], and Support contractors) are engaged with stakeholders through formalized Steering Committees established under the Zadroga Act.

As of October 31, 2021, the WTC Health Program has 114,953 members, including 17,041 FDNY Responders, 65,533 General Responders, 1,117 Pentagon/Shanksville Responders, and 32,379 Survivors. Of these, 26,114 responders and survivors are part of the Nationwide Provider Network. Current WTC Health Program statistics and reports can also be found at https://www.cdc.gov/wtc/ataglance.html.

The Zadroga Act sets forth a number of statutory requirements for the WTC Health Program, including specific requirements for contracts with CCEs, and DCs, as well as requires the establishment of a nationwide network of healthcare providers to ensure reasonable access to Program benefits for enrolled WTC responders and survivors residing outside the New York City metropolitan area. In addition to the statutory requirements for the Program codified in 42 U.S.C. §§ 300mm – 300mm-61, the WTC Program Administrator has also promulgated regulations governing the administration of the Program at 42 C.F.R. pt. 88.

http://www.cdc.gov/wtc/laws.html http://www.cdc.gov/wtc/ppm.html https://www.cdc.gov/wtc/ataglance.html

C.1.1 Membership Categories

There are currently seven (7) CCEs and one Short-Term Survivor Clinic (SSC) in the New York metropolitan area

(NYMA), and the NPN that provide medical monitoring examinations, diagnosis, and treatment services for WTC-related health conditions. CCEs correspond to a cohort-specific DC (Table 1). CCE and NPN services include physician and allied health professional visits, test procedures, medical devices, utilization review and authorization of pharmacy benefits, case management, health education, and social service counseling. The CCEs and the NPN work as a clinical consortium using information from cohort-specific medical monitoring protocols and emerging clinical challenges to encourage consistent programmatic decision-making across the practice sites. The CCEs and the NPN are actively engaged with labor representatives and stakeholder members of the New York City community to discuss program policies and ensure awareness of emerging issues.

Under previous contracts, the WTC Health Program portfolio has three DCs:

1. Data Center 1: one (1) CCE that corresponds to one (1) DC addressing FDNY-Affiliated Responders ;

2. Data Center 2: Five (5) CCEs that correspond to one (1) DC addressing non- FDNY-Affiliated Responders

; and

3. Data Center 3: one (1) CCE that corresponds to one (1) DC addressing WTC Survivors in the NYMA.

Data Center 1 Data Center 2 Data Center 3

FDNY-Affiliated Responders Non-FDNY-Affiliated

Responders

WTC Survivors (Non-

Responders) in NYMA

One CCE Five CCEs One CCE

The NPN (survivor and responders) and SSC (survivors) were previously not assigned to a DC, but the intent is to assign them to a DC as part of this PWS. Thus the DC breakdown under this contract(s) is intended to be as identified in the following chart based on enrollment type:

Data Center 1 Data Center 2 Data Center 3

FDNY-Affiliated Responders Non-FDNY-Affiliated

Responders in NYMA, and

NPN Responders

Survivors in NYMA and

NPN Survivors

One CCE Five CCEs and NPN Responders Two CCEs and NPN Survivors

Enrolled WTC Responders affiliated with the Fire Department of the City of New York (FDNY; active or retired) – size approximately 17,100 individuals: who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites (including Ground Zero, Staten Island Landfill, and the New York

City Chief Medical Examiner’s Office), or; a surviving immediate family member of a member of the Fire

Department of New York City (whether fire or emergency personnel, active or retired) who was killed at the World

Trade Center site on September 11, 2001, if the family member received any treatment after September 11, 2001 but before September 2, 2008 for a WTC-related mental health condition;

Enrolled WTC Responders who were not affiliated with FDNY – size approximately 64,500 individuals: An individual who worked or volunteered onsite in rescue, recovery, demolition, debris cleanup, or related support services in lower Manhattan (south of Canal St.), the Staten Island Landfill, or the barge-loading piers; a member of the Police Department of New York City (active or retired) or a member of the Port Authority Police of the Port

Authority of New York and New Jersey (active or retired) who participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.), including Ground Zero, the Staten Island

Landfill, or the barge loading piers; an employee of the Office of the Chief Medical Examiner of New York City involved in the examination and handling of human remains from the World Trade Center attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff; a worker in the Port Authority

Trans-Hudson Corporation Tunnel; or a vehicle-maintenance worker who was exposed to debris from the former

World Trade Center while retrieving, driving, cleaning, repairing, and/or maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks;

Enrolled WTC Survivors – size approximately 32,800 individuals: individuals present in the New York City disaster area in the dust or dust cloud on September 11, 2001; an individual who lived, worked, went to school, childcare, or adult daycare in lower Manhattan south of Houston Street and certain parts of Brooklyn; certain cleanup and maintenance workers in the New York City disaster area; and certain residents and individuals whose places of employment were deemed eligible to receive certain grants from the Lower Manhattan Development

Corporation.

Enrolled Pentagon/Shanksville Responders – size approximately 1,100: Fire or police department employees (fire or emergency personnel, active or retired); recovery, or cleanup contractor workers, or volunteers, who performed rescue, recovery, demolition, debris cleanup, or other related services after the terrorist-related aircraft crashes on

September 11, 2001, at the Pentagon in Arlington, VA, or in Shanksville, PA. From a cohort perspective, most are considered NPN Responders, though a handful who may now live in New York City are considered Non-FDNY

Responders in NYMA.

C.2 PURPOSE

The purpose of this contract is to provide Data Center services to the WTC Health Program in a manner that is consistent with the requirements of the Zadroga Act. The Zadroga Act defines a Data Center as “a Center that the

WTC Program Administrator determines has the capacity to carry out the responsibilities for a Data Center under

Section 3305(a)(2).” Section 3305(b)(2). These responsibilities are set out in this Performance Work Statement.

C.3 SCOPE OF WORK

The Scope of Work for a Data Center (DC) is based on requirements in Sections 3304 and 3305(a)(2)(A) of the

Zadroga Act and is enumerated below in Section C.4 – Tasks to be Performed.

At a summary level, the DC is responsible for ensuring high-quality collection, analysis, and reporting of WTC

Health Program member data in a manner that is uniform, secure, and facilitates research. The DC Contractor is responsible for an up-to-date understanding of and compliance with the Zadroga Act and the Program’s implementing regulations, including any amendments, as well as the Program’s policies, standard operating procedures, technical guidance documents, and WTC Health Program Administrative Manual. The DC contractor shall provide these services with the goals of minimizing costs to the WTC Health Program. The CDC contractor shall manage the contract to ensure that subcontracts, staffing, reporting, security, deliverables, repositories, and services meet the requirements of the contract.

C.4 TASKS TO BE PERFORMED

All tasks are to be completed for the Base and all Option Periods, unless otherwise specified.

Task 1 – Operations Manual Implementation and Maintenance

The DC contractor shall:

a. Develop and maintain a DC Operations Manual which contains procedures for providing all required services under this contract.

b. Collaborate with other Data Centers to create uniformity in the core data elements, core surveillance analyses, and reporting that is documented in the Operations Manual.

c. DC Operations Manual shall include communication and engagement strategies, and frequencies of interaction between the DC and its stakeholders.

d. Develop and maintain a complete set of written standard operating procedures (SOPs) which guide all contract-related services, processes, and activities, including management of the biannual WTC Health

Program Scientific Forum. The SOPs shall be used to meet the objectives outlined in this PWS and provide the requisite security and process support for the WTC Health Program, to include evidentiary documentation for formal Federal audits as well as Security Certification and Accreditation of contractor-provided systems for the program.

e. DC Operations Manual shall be aligned with the Administrative Manual for the WTC Health Program.

f. Provide administrative support of ongoing updates to the WTC Health Administrative Manual. The WTC

Health Program Administrative Manual can be found at https://www.cdc.gov/wtc/ppm.html.

g. Submit a finalized DC Operations Manual to the WTC Health Program for approval within sixty (60) days of contract award. The contractor will have two (2) weeks to submit a revised-finalized Contract

Operations Manual upon receipt of comments from NIOSH. Once approved by the WTC Health Program, any changes to the Operations Manual shall be updated as part of the Monthly Report and an updated

Operations Manual shall be submitted annually at the end of each contract year for the duration of the contract.

Task 2 - Data Security and Continuity of Operations

a. Ensure data security, and continuity of operations, and the transfer of all data to the WTC Health Program.

The data security and continuity of operations plan should follow standard FISMA and CDC guidelines.

b. Develop and maintain a comprehensive Data Security and Continuity of Operations Plan. The Plan shall outline the DC contractor’s policies and procedures for ensuring data security, continuity of operations, and the transfer of data to the WTC Health Program. The Data Security and Continuity of Operations Plan shall follow the requirements of a certification and accreditation process and allow for continuous monitoring as outlined by CDC’s Office of the Chief Information Officer (OCIO).

c. Submit a draft of the DC Contract Data Security and Continuity of Operations Plan to the WTC Health

Program for review within sixty (60) days of contract award. The contractor will have two (2) weeks to submit a finalized plan upon receipt of comments from NIOSH. Once approved by the WTC Health

Program, any changes to the Contract Data Security and Continuity of Operations Plan shall be updated as part of the Monthly Report and an updated Plan shall be submitted annually at the end of each contract year for the duration of the contract.

Task 3 - Risk Management

The DC contractor shall

a. Identify any potential program risk and propose stategies to reduce and mitigate these risks.

b. Implement risk management strategies in coordination with Program

c. Document risks and risk management strategies in a Risk Management Plan in accordance with SEI

(Software Engineering Institute) Risk Management Methods (or equivalent) and CDC/NIOSH policy for a continuous improvement approach to project performance.

d. Submit a draft DC Contract Risk Management Plan to the WTC Health Program for review within sixty

(60) days of contract award. The contractor will have two (2) weeks to submit a finalized plan upon receipt of comments from NIOSH. Once approved by the WTC Health Program, any changes to the Risk

Management Plan shall be updated as part of the Monthly Report and an updated Plan shall be submitted annually at the end of each contract year for the duration of the contract.

Optional Task 4 (Only applicable to Data Centers 2 and 3) - Consenting NPN and Survivor CCE members

Obtaining consent is generally the responsibility of CCEs; however, based on current contractors, it is possible that a future Survivor CCE may not have an IRB and will not be able to obtain IRB approval to administer consent forms. Additionally, it is known that the current NPN vendor does not have an IRB.

The contractor’s approach to obtaining informed consent for NPN and/or second Survivor CE members will be determined through consensus involving the DC, the NPN/Survivor CCE contractor, and NIOSH. The Data Center contractor shall ask NPN/Survivor CCE members to provide consent for their monitoring exam and treatment data to be used in data aggregation and linkage studies (e.g. linkage to the National Death Index and linkage to statewide cancer registries) and to provide consent to be contacted by researchers to invite them to participate in other research studies (note that if the member agrees to participate in such other research studies, a separate consent will be administered by that researcher, and this consent process is not the responsibility of the DC).

https://www.cdc.gov/wtc/ppm.html

The DC contractor shall provide each NPN/Survivor CCE member the opportunity to consent to research as specified above (i.e. for data aggregation, data linkage and contact by researchers); however, WTCHP members are not required to provide consent. As with the current CCEs, it is expected that 90% or more of NPN/Survior CCE members will provide consent for aggregation and linkage studies. At least quarterly, the DC will report on the progress of their consenting efforts (e.g. any revisions to the approach taken to consent members, the number of

NPN/Survivor CCE members who were contacted about the consent process; the number of NPN/Survivor CCE members who were consented; the number of NPN/Survivor CCE members who refused consent; and the number of

NPN/Survivor CCE members who withdrew their consent). The DC must also provide an opportunity for the

NPN/Survivor CCE’s members to withdraw their consent.

The DC contractor(s) shall:

a. Administer the process to obtain informed consent for research from NPN members (Responders and

Survivors). Because the NPN serves both Survivors and Responders, NPN data will be split between the

Responder Data Center (“Data Center 2”) and Survivor Data Center (“Data Center 3”). Both Data Centers will need to coordinate to ensure that the consenting process meets the needs of both the Survivor and

Responder Data Centers. This process includes getting contractor’s IRB approval to consent NPN members.

b. Administer the process to obtain informed consent for research from Survivor CCE members (if applicable). This will only be needed if a future Survivor CCE does not have an IRB; in that situation, the

Data Center that is awarded the Survivor Population (“Data Center 3”) shall obtain informed consent for research on behalf of the Program from the second Survivor CCE.

Task 5 – Fraud, Waste, and Abuse Compliance and Reporting

If the DC contractor identifies potential FWA incidents or receives FWA complaints related to covered services, they shall notify the Program within one (1) business day of discovery.

a. The DC contractor shall provide a written report and share relevant data with the Program within five (5) business days of discovery. The report should include the following information, at a minimum:

1. The name of the individual or entity suspected to be involved in FWA;

2. The source or surveillance method that identified the FWA;

3. The type of provider, entity or organization that committed the FWA;

4. A description of the FWA;

5. The approximate dollar amount of the FWA;

6. The legal and administrative disposition of the case including actions taken by law enforcement officials to whom the case has been referred; and

7. Other data/information as prescribed by the WTC Health Program or deemed pertinent by the DC contractor.

a. Prepare a Fraud, Waste, and Abuse (FWA) Compliance Plan. The contractor’s Fraud, Waste, and Abuse

Compliance Plan shall address how the DC contractor shall mitigate, detect, respond to, and prevent Fraud, Waste, and Abuse (FWA) incidents;

b. Ensure executive and essential personnel attend training in FWA detection, prevention, and reporting; and

c. Designate an officer or director in its organization with responsibility and authority for carrying out the provisions of the FWA Compliance Plan.

d. Submit a draft DC FWA Compliance Plan to the WTC Health Program for review within sixty (60) days of contract award. The contractor will have two (2) weeks to submit a finalized plan upon receipt of comments from NIOSH. Once approved by the WTC Health Program, any changes to the FWA

Compliance Plan shall be updated as part of the Monthly Report and an updated Plan shall be submitted annually at the end of each contract year for the duration of the contract.

Task 6 – Member Transfers

a) Record member transfers into and out of the corresponding CCE(s) and NPN.

b) Use the existing WTC Health Program Member Transfer Standard Operating Procedure (Attachment 4) for transferring the care of a member to another entity within the WTC Health Program.

c) Request and accept member transfers utilizing the CARE Portal

Task 7 – Uniform Receiving, Analyzing, and Reporting of Data

The DC contractor shall comply with all HHS Directives and Regulations, Office of Management and Budget

(OMB) Circulars, and applicable federal laws. The work shall also be consistent with American National Standards

Institute (ANSI) standards and National Institute of Standards and Technology (NIST) standards. Reference documents can be found through the following organizations (web sites provided for information only):

a) HHS Directives and Regulations: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (acquisition policies);

b) HHS Policies and Regulations: http://www.hhs.gov/policies/index.shtml;

c) CMS Directives and Policies: http://www.cms.hhs.gov/home/regsguidance.asp;

d) OMB Circulars: http://www.whitehouse.gov/omb/circulars/index.html

e) ANSI Standards: http://www.ansi.org/

f) NIST standard references: http://csrc.nist.gov/publications (computer security division, including FIPS);

All data collection, management and analysis shall be conducted and maintained in a manner that protects the confidentiality of individually identifiable health information consistent with applicable statutes and regulations, including, as applicable, Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (Pub. L. 104–191;

42 U.S.C. § 1320d), as modified, and the corresponding implementing regulations, including the Privacy, Security, Breach Notification, and Enforcement Rules (45 C.F.R. Parts 160, 162, and 164).

a) receive, analyze, and report on claims level data that have been collected and reported to suchDC by the corresponding CCEs and /or NPN (clinical data, monitoring exam data) and the WTC Health Program (claims data, treatment and pharmacy). Key medical and scientific elements of the WTC disaster exposures and health findings shall be included to describe the demographic, occupational, health and health-related quality of life characteristics of the population under surveillance over time.

b) collect, analyze and report data in a uniform manner that captures the prevalence of WTC-related health conditions that are medically associated with WTC-related conditions, co-occurring or latent diseases of interest for targeted surveillance, and data quality metrics.

c) develop, maintain and implement the Data Analysis Plan (DAP) as approved by the WTC Program

Administrator, with respect to the analytic approach (goals, level of efforts, time reference, data inclusiveness, and analytic method), periodicity, and priority of analyses to be conducted to support the Program. The DAP will be provided and include a complete data dictionary of all data elements in the intended analytical dataset that will be included in the database for analysis purposes. In addition, related data analytic software programs

(e.g., SAS, R, SPSS) should be delivered to the Program. Standard health surveillance, health care utilization and quality indicator reports shall be prepared for use by the WTC Program Administrator and CCEs/NPN with a frequency no less than semi-annually.

d) include data analysis activities in the plan for the first performance period and next, if option years are exercised.

e) revise the DAP and submit the final version for approval within thirty (30) days of receiving feedback from the

WTC Health Program. Once approved, updates to the DAP shall be reported in the Monthly Reports. An updated DAP shall be provided annually for the duration of the contract.

f) use an integrated data system to receive and exchange data as needed to perform their functions. The DC’s data system shall enable corresponding entities to access and generate reports and analyze data on its members within the confines of the data security requirements established by NIOSH. The DC shall acknowledge requests from the NPN and/or CCE within 1 business day of receipt by the DC for electronically received data requests and within 10 business days for data requests received via non-electronic means. The DC shall collect data on September 11, 2001 disaster exposures and health findings to describe the demographic, occupational, health (physical and mental) and health-related quality of life (and disability) characteristics of the population http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.hhs.gov/policies/index.shtml http://www.cms.hhs.gov/home/regsguidance.asp http://www.whitehouse.gov/omb/circulars/index.html http://www.ansi.org/ http://csrc.nist.gov/publications over time.

g) develop and revise, as needed, data dictionaries, data collection mechanisms and operational processes, as well as procedures for quality control, security, training, and data management. The DCs shall monitor the appropriateness and the quality of data received from the corresponding NPN and/or CCEs, provide reports to the WTC Program Administrator as required, and serve as a central repository for research data. The DCs shall support data analysis and statistical evaluations.

h) conduct routine meetings with representatives of other DCs, CCEs, NPN contractor and others to define common data collection and transfer protocols, standardized forms, and the data entry system for the creation and maintenance of the data set for research and claims level data for program integrity purposes. The DC shall prepare, disseminate, and update the data set related to their members, maintain an Operations Manual which defines the details of all activities, data collection forms, databases, and reports. The DC shall also maintain and verify accuracy of the resulting dataset.

i) convene the WTC Health Program Scientific Forum through coordination among the awarded contractors, corresponding CCEs, and the NPN and the Health Program Evaluation contractor. The vendor shall engage in collaborative engagement with designated scientific staff from the WTC Health Program at least two times a year. The Contractors shall maintain methods for collaboration with other DC Contract recipients and mechanisms for hosting the Scientific Forum that do not require all attendees to be present to participate fully in the meetings.

TASK 8: Establish a uniform approach to data management

The DC Contractor shall develop and execute a strategy for data and business information management that satisfies all responsibilities and requirements listed herein and complies with the Zadroga Act, Program policy, Program technical guidance, and CDC policy for data accessibility, storage, and preservation.

The contractor’s strategy must be documented in its Data Management Plan (DMP), which should include the following information per CDC policy:

a) A description of the public health data to be collected or generated in the contract period of performance;

b) Standards to be used for the collected or generated public health data;

c) Mechanisms for or limitations to providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights) or justification for why data cannot be made accessible. This section should address access to identifiable and de-identified data (see below for additional information about access);

d) Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

e) Plans for archiving and long-term preservation of the data, or explanation of why long-term preservation and access are not justified. This section should address archiving and preservation of identifiable and de-identified data (see below for additional information regarding archiving).

Additionally, the contractor shall:

1) Structure their database in a way that allows the data collected and used to be easily accessible so that data can be efficiently retrieved for reports and analyses, and can be manipulated for data analysis purposes to show trends, relationships, and patterns

2) Store all data collected in a uniform manner

3) Ensure continuity of services and minimize impact of any disasters, such as terrorism/cyber hacking, earthquakes, hurricanes, tornadoes, etc. Their plan should be documented in a comprehensive Disaster

Recovery Plan

4) Ensure recoverability, integrity, security, and availability of the data. Recoverability is defined as a way to store data as a backup and then test the backups to make sure that they are valid. Integrity means that data which are pulled for certain records or files are in fact valid and accurate. Security includes giving clearance and access to certain data sets. Availability is making sure a database is operational when needed.

The DC contractor shall implement and maintain a comprehensive Data Management Plan (DMP). Once approved by the WTC Program Administrator, the DMP shall be implemented within 3 months of approval.

Through the DMP, the contractor shall provide the data for research projects that have been and will be funded in response to Funding Opportunity Announcements published by NIOSH.

Section 3305(a)(2)(D) of the Zadroga Act states: ‘‘(D) TRANSPARENCY OF DATA.—A contract entered into under this subsection with a Data Center shall require the Data Center to make any data collected and reported to such Center under subsection (b)(1)(B)(iii) available to health researchers and others as provided in the CDC/

ATSDR Policy on Public Health Research and Nonresearch Data Management and Access.”

The DMP is the DC’s assurance that the dissemination of any and all data collected under the WTC Health Program shall be released as follows:

a) In a timely manner.

b) Completely, and as accurately as possible.

c) To facilitate the broader community’s research.

d) Developed in accordance with CDC/ATSDR Policy on Public Health Research and Nonresearch Data

Management and Access.

The CDC/ATSDR Policy on Research and Non-Research Data Management and Access is attached (Attachment 5).

The DC’s DMP shall contain a provision that all initial and annual monitoring exam data collected under the WTC

Health Program shall be made available to the WTC Program Administrator in an electronic format on an annual basis, if requested.

As a part of their DMP, the DC Contractor shall create and maintain an Analytical Data Set. The Analytical Data Set is defined as those data points to be used for research. The DC’s Monthly Report shall include a current status of the

Analytical Data Set. This status update shall include a listing of all data points identified as being a part of the

Analytical Data set, the date through which data are available, and the completeness of the data collected that are available for research.

Task 9 – Collect and maintain a database of standardized medical monitoring and screening exams

a. establish and maintain a secure database of all monitoring and screening data collected by the corresponding CCE(s)/NPN which will be used for surveillance analysis and research conducted by externally funded and approved researchers.

b. Maintain a subcontractor monitoring plan for any entities involved in warehousing and cleaning the data along with the protections in place to maintain data security.

c. Collaborate with NIOSH and other relevant stakeholders to ingest legacy NPN and SSC data

Task 10 - Tracking numbers of members consented for aggregation of data and contact by outside researchers for study recruitment

The DC Contractor shall:

a. maintain a description of the collection of consent for aggregation of data and consent for contact by researchers signed by members of corresponding CCE(s) and NPN, and how those consents will be made searchable by disease category as outlined in the WTC Health Program list of covered conditions.

b. The contractor shall have a mechanism for making these data available to the WTC Health Program, CCEs, NPN and outside researchers in accordance with the DMP.

Task 11 – Annual Health Surveillance

The DC Contractor shall:

a. prepare, discuss, and submit an annual cohort health surveillance report from the aggregated data from initial health evaluation, monitoring and cancer screening, in accordance with the report template and methodology approved by the WTCHP Administrator. Key medical and scientific elements of the 9/11 disaster exposures and health findings shall be included to describe the demographic, occupational, health

(mental and physical) and health-related quality of life (and disability) characteristics of the population under surveillance over time. The intent is to discuss this with the WTCHP Medical and Scientific Forums and the respective stakeholder Steering Committees. Separate reports will be developed for each specific cohort assigned to the DC contractor (e.g. FDNY, Survivor CCE(s) , and NPN).

b. propose elements that may be unique to characterize their specific cohort, such as demographicsThe

WTCHP will then review and provide final approval before the work is authorized.

c. prepare a 2-3 page synopsis of the characteristics of the specific cohort using the report template and methodology approved by the WTCHP Administrator. Separate reports will be developed for Responder and

Survivor Steering Committees by the DC contractor assigned to those entities.

Task 12 - Collaborating with CCEs/NPN, HPE contractors and NIOSH’s subject matter experts (SMEs) to develop medical quality guideline and protocols

The DC contractor shall:

a. collaborate with relevant stakeholders to develop:

i. monitoring and initial health evaluation protocols;

ii. cancer screening guidelines;

iii. care coordination guidelines;

iv. case management guidelines;

v. diagnostic and treatment guidelines with respect to WTC-related health conditions.

Task 13 – Special Analytic Studies

a. propose and conduct each of the Data Center Special Analytic Studies listed below, collaborating with

NIOSH to ensure that methodology meets Program requirements. Special analytic projects are expected to be time-limited, non-routine, resource intensive and align with allowable activities and program priorities:

1. Active Surveillance Project: Upon conducting assessments of cohort information, evaluating trends, and determining that new program-relevant conditions may be emerging from the standardized exams and cancer screening data, DCs shall conduct active surveillance on noted areas of concern. Active surveillance is constrained to obtaining source clinical records from treating providers and abstracting the information needed to determine the diagnosis using consistent criteria. Active surveillance is not meant to conduct further research or alter/extend the existing standardized exams, nor to administer additional medical tests or questionnaires with program members. Contractors shall prepare the technical approach for conducting active surveillance for two (2) specific disease areas for which active surveillance is indicated and justified. Conditions of particular interest for active surveillance include cardiovascular disease, autoimmune disease, neurologic disease (e.g., Parkinson's, motor neuron disease and cognitive impairment), non-malignant liver disease, cancer, and chronic renal failure.

2. Data Linkage Project: Conduct linkage projects with formal disease (e.g., tumor registries) and vital record systems to verify medical diagnoses of concern or to confirm the death, cause of death, and date of death for a deceased member in the DC cohort. Linkage projects are intended to enrich the dataset and be available to researchers as per the approved data management plan. The selection of state-based registries or vital record systems shall be constrained to the states with a large percentage of members, including New York, New Jersey, Pennsylvania, Connecticut, and

Florida.

Task 14 – Meeting Attendance and Support

a) Coordinating and Administering Steering Committee Meetings

The DC contractor shall maintain schedules and methods of conducting the steering committee meetings for the

Survivor and Responder cohorts as established under Section 3302(b). Data Center contractors shall work with each other, NIOSH, and the chairs of the respective committees to determine frequency, time and place for meetings as outlined in the law. The DC contractor is also responsible for producing meeting minutes for each

Steering Committee meeting.

b) Routine CCE/NPN Meetings to Obtain Input on Analysis and Data Reporting

The DC contractor shall meet regularly with its corresponding CCE(s) and the NPN to obtain input on the analysis and reporting of data collected under clause (i) and on the development of monitoring and initial health evaluation protocols, cancer screening, diagnosis and treatment guidelines under clause (ii). See

3305(a)(2)(A)(i) through (vi).

These discussions should include CCE and/or NPN-specific health care utilization and subpopulation (and full population) surveillance data, input on the analysis and reporting of data being collected for Program support, continuous quality improvement, and for strategic revision of standardized protocols and clinical guidelines.

These meetings shall be extended to relevant stakeholders including Program representation as appropriate, particularly when the objectives are focusing on program improvement.

c) Scientific Forum Meeting(s)

1. The DC contractor shall formalize at least twice yearly programmatic discussion of scientific approaches for the following:

a) Analyze existing initial health evaluation/periodic monitoring and cancer screening data;

b) Analyze existing tools for possible enhancements to meet new and/or changing data collection needs, such as alterations of the standardized monitoring exam or information from treatment records;

c) Develop operational program metrics and quality indicators that would be of service in achieving the

WTCHP program mission of providing excellence in care and identifying health effects associated with

9/11 exposures.

2. Forum discussions may lead to proposing future Special Analytic Studies, therefore the contractor shall

a. provide a draft analytical proposal to: (1) propose the concept and (2) propose the methodology for completing this additional research/study work.

3. More resource intensive analytic projects may also be indicated via routine examination of data and evolving discussions within the WTCHP Medical and Scientific Forums to advance the programmatic mission.

a. propose such projects where level of effort and methodology is preapproved by the WTCHP Administrator and coordinated with the WTCHP Science Team.

b. coordinate to administratively support/facilitate the WTCHP Scientific Forum, routinely collaborate with designated scientific personnel associated with the WTCHP, and engage the appropriate corresponding

CCEs. This forum can be conducted virtually, or be scheduled in proximity to regularly recurring stakeholder meetings in NYC to optimize travel for attendees. The DC Contractor shall propose methods for collaboration with other DC Contractor(s) and mechanisms for hosting the Scientific Forum. A draft management plan for managing these meetings should be described and incorporated into the DC

Operations Manual.

Task 15 –Outreach and Member Retention Coordination

a. arrange virtual or physical meeting space and facilitate regular committee meetings to assist them in the execution of their duties (i.e. monthly outreach coordination calls)

b. share responsibility for developing, coordinating, and revising retention metrics, monitoring trends and provide recommendations.

All of the DCs equally share responsibility for coordinating and administering the activities of the respective WTC

Health Program Steering Committees based on the type of member population served ( e.g., responder or survivor).

Program-wide outreach and retention activities will be coordinated through a NIOSH point of contact, with assistance from the Data Center contractor(s) in synchronizing activities within their cohort. The DC contractors’ activities in outreach and retention coordination should be approved by NIOSH and should be limited to efforts to assist the CCEs/NPN in a manner to enhance communication, transparency, cooperation, and avoidance of duplication of efforts when engaging the relevant cohort. Coordination activities also include engaging all CCEs/NPN for planning cohort-wide events or fostering CCE/NPN participation in outreach and retention activities in the local NYC-area for the cohort.

Task 16 – Collaboration with the WTC Health Registry

In accordance with Section 3304(c) of the Zadroga Act ((42 U.S.C. § 300mm-3(c)), the DC contractors shall work together with the WTC Health Registry1 to ensure collaboration between the Program and the WTC Health Registry.

For example, the DC contractor and the Registry may work…