01. RFQ - HHSN-21-Q-000088.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO.

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

5. SOLICITATION NUMBER

HHSN-21-Q-000088

6. SOLICITATION ISSUE DATE

07/11/2021

Anthony Q. Hawley anthony.hawley@nih.gov 08-

12PM

09-2021

(EST)

Y

541611

$16.5 Million

X

N/A

RFQ IFB

National Institutes of Health (NIH) Clinical Center (CC) Department of Clinical Research Informatics (DCRI) 10 Center Drive Bethesda, MD 20814

CC

National Institutes of Health (NIH) Clinical Center (CC) Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892

Please see Payment and Invoice Procedures

See CONTINUATION Page

The National Institutes of Health (NIH), Clinical Center (CC), Department of Clinical Research Informatics (DCRI) has a need for Staffing Analysis Services. The scope of this project is to evaluate, analyze, and make recommendations on DCRI’s current staffing model. Specifically, a five-to-eight week assessment which includes interviews/focus groups, job shadowing, site visits, and industry research and analysis. Please see Statement of Work (SOW) and Price Schedule for all specifics pertaining to Project Deliverables.

Proposals Due: Monday, August 09, 2021 at 12:00 p.m. (EDT) nih.gov byQuestions shall be emailed to anthony.hawley@

5:00 p.m. (EDT) on Monday, July 26, 2021.

CONTRACTOR NAME/POC:

CONTRACTOR DUNS AND TIN NUMBER:

CONTRACTOR EMAIL ADDRESS:

CONTRACTOR PHONE NUMBER:

PLEASE SUBMIT ALL PROPOSALS AND SUBSEQUENT PROPOSAL MATERIALS

VIA EMAIL TO THE CONTRACTING OFFICER AT anthony.hawley@nih.gov.

See CONTINUATION Page

X X

National Institutes of Health (NIH) Clinical Center (CC) Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892

CC

CC

X

X mailto:anthony.hawley@va.gov

SOLICITATION #: HHSN-21-Q-000088

TABLE OF CONTENTS

B.1 CONTRACT ADMINISTRATION

B.2 STATEMENT OF WORK

B.3 PRICE SCHEDULE

B.4 DELIVERY SCHEDULE

SECTION C – CONTRACT CLAUSES

C.1 52.219-14 LIMITATIONS ON SUBCONTRACTING (JAN 2017)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN

2017) ………………………………………………………………………………………………27

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 52.216-18 ORDERING (OCT 1995)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-21 REQUIREMENTS (OCT 1995)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 35

SECTION D – CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT 1 – WAGE DETERMINATIONS AND REQUESTS – SERVICE

CONTRACT ACT (SCA) – NIH CLINICAL CENTER (BETHESDA, MD (MONTGOMERY COUNTY) ... 36

D.2 ATTACHMENT 2 – PAST PERFORMANCE QUESTIONNAIRE

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017) 47

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (FEB 2012)

E.2 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (OCT

2015) ………………………………………………………………………………………………52

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)

………………………………………………………………………………………………53

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (NOV 2017)

B.1 CONTRACT ADMINISTRATION

All contract administration matters shall be handled by the following:

CONTRACTOR:

GOVERNMENT:

Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892

1. PAYMENT AND INVOICE PROCEDURES:

[X] FAR 52.232-34, Payment by Electronic Funds Transfer – Other Than System for Award Management

ELECTRONIC INVOICING INSTRUCTIONS FOR NIH CONTRACTORS/VENDORS

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. INVOICE REQUIREMENTS

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within seven (7) days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under III. below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

∗ NOTE: If your invoice must differ from the line items on the award, please contact the Contracting

Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

II. ELECTRONIC INVOICE SUBMISSION INSTRUCTIONS

A. Invoice Instructions for NIH Fixed-Price Type Contracts are listed below. Following the instructions provided below are paramount to ensure a “proper/correct/accurate” invoice is submitted pursuant to FAR 32.9 therefore ensuring timely payment for supplies delivered or services performed.

(1) Invoices shall be submitted in the following manner:

o The Contractor shall submit an Electronic Copy of the Invoice via email to the Contract Specialist and to the designated Contracting Officer’s Representative (COR). The Invoice shall be transmitted as an attachment via e-mail in a format compatible with the computer systems at NIH [e.g., MS Word, MS Excel, or Adobe Portable Document Format (PDF)]. The purpose of submitting an Electronic Copy of the Invoice to the aforementioned individuals is to ensure accuracy/completion. The COR will validate the contents of the invoice (i.e. Accurate Quantities of Services Received, Pricing, etc.) and will enter receiving for the Invoice provided. The Contract Specialist will validate that the contents of the invoice are accurate and correct. If changes are required, the Contract Specialist will provide notification of these revisions. Once the invoice is deemed accurate and complete by the Contract Specialist, a follow-up email will be provided to the Contractor by the Contract Specialist directing the Company to submit the invoice to the Office of Financial Management (OFM), Commercial Accounts.

(2) Upon receipt of the finalized invoice from the Contract Specialist, the Contractor/Vendor shall:

o Submit an Electronic Copy of the Invoice via email to the NIH Centralized Invoice in accordance with the instructions provided below:

4 Steps to Create the Invoice Submission Email

PLEASE READ THE BELOW INSTRUCTIONS THOROUGLY BEFORE SUBMITTING YOUR INVOICE

ELECTRONICALLY.

*Note: The key words (Vendor, PO, and Invoice), Colon (:) character following the keywords and the PIPE (|) character must be present to identify the information. The pipe (|) character is entered by pressing and holding the shift key and the backslash (\) key at the same time. The term “PO” is being used as a generic term to identify the award number [purchase order, contract, Blanket Purchase Agreement (BPA) call, task or delivery order] and must be used in the subject line, regardless of the specific type of your award.

Step 1:

Send invoices to the following email address:

invoicing@nih.gov

Step 2:

Subject line must follow this format for the invoice you are submitting (see note* below)

Step 3:

Attach the invoice to the email as either a PDF or Word document.

See Reminders below.

Step 4:

In the body of the email, type “Correspondence Email:” followed by your email address.

How to Properly Format the Subject Line of Your Email

EXAMPLE 1 – If Your Contract Includes a Contract Number AND an Order Number or Call Number:

Vendor: Name of the Contractor or Vendor|PO:Contract Number/Order Number or Call Number|Invoice:9999999

EXAMPLE 2 – If Your Contract ONLY Includes a Contract Number:

Vendor: Name of the Contractor or Vendor|PO:Contract Number|Invoice:9999999 EXAMPLE 3 – If Your Contract ONLY Includes an Order Number:

Vendor: Name of the Contract or Vendor|Order Number|Invoice:99999999

Screenshot of How to Locate the Contract Number and Order Number on Your SF 1449 (SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS Form)

The screenshot below shows where the Contract Number and Order Number are located on the SF 1449.

The SF 1449 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your SF 1449 to populate the correct Contract Number and Order Number in the subject line of your email invoice submission.

The Contract Number is required in order to process all invoices. The Contract Number is the same as the “PO” on the invoice email subject line. The Order Number is only applicable for certain contracts and can be found in field number 4, on the SF 1449 form. If your SF 1449 does not include an Order Number, then follow EXAMPLE 2 above to ensure the Subject line of your email is properly formatted.

Screenshot of How to Locate the Contract Number on Your SF 1447 (SOLICITATION/CONTRACT Form)

The screenshot below shows where the Contract Number is located on the SF 1447. The SF 1447 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your SF 1447 to populate the correct Contract Number in the subject line of your email invoice submission.

The Contract Number is required in order to process all invoices. The Contract Number is the same as the “PO” on the invoice email subject line.

Screenshot of How to Locate the Contract Number and Release Number on Your OF 347 (ORDER FOR SUPPLIES OR SERVICES Form)

The screenshot below shows where the Contract Number and Order Number are located on the OF 347.

The OF 347 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your OF 347 to populate the correct Contract Number (if any) and Order Number in the subject line of your email invoice submission.

The Order Number is required in order to process all invoices. If there is no Contract Number, the Order number is the same as the “PO” on the invoice email subject line. The Contract Number is only applicable for certain contracts and can be found in field number 2, Contract Number, on the OF 347 form. If your OF 347 does not include a Contract Number, then follow EXAMPLE 3 on page 2 to ensure the Subject line of your email is properly formatted.

Subject Line Examples

For your reference, below is a chart listing examples of the correct and incorrect subject lines. Note:

These are just examples, you must enter the applicable information for the invoice you are submitting.

Subject Line Correct Incorrect Vendor: XYZ Corp|PO:HHSN299202000053J/75X98019S00848|Invoice:XYASAD

XYZ Corp|PO # HHSN299202000053J \75X98019S00848|Invoice # XYASAD

XYZ Corp| HHSN299202000053J \75X98019S00848|Invoice # XYASAD

XYZ Corp| HHSN299202000053J \75X98019S00848| XYASAD

Vendor: XYZ Corp,PO: HHSN299202000053J \75X98019S00848,Invoice:XYASAD

Reminders

• Effective December 1, 2020, OFM will no longer accept hard copy vendor invoices sent to the OFM billing office via any shipping services (i.e., USPS, FedEx, UPS, DHL, etc.) or those delivered by any in-person drop off. OFM will not accept any invoices postmarked and/or delivered in-person on/after December 1, 2020. Please follow the electronic submission instructions on page 1. Failure to follow the above electronic submission instructions will result in invoice processing delays.

• Only invoices should be sent to the following mailbox: invoicing@nih.gov. Please do not send emails to this mailbox requesting a status of your invoice(s) and do not include the invoicing@nih.gov email address in your correspondence with NIH Institutes/Centers.

• You must submit only one invoice per email.

• Follow the system size limits that apply to the email and each invoice: individual email attachments cannot exceed 5 megabytes each; and the email plus all attachments cannot exceed a total of 30 megabytes.

• Clearly identify a valid and complete contract number on each invoice.

• Clearly identify an accurate DUNS number on each invoice.

• DO NOT include confidential information such as Social Security Numbers (do not include TIN if it is a Social Security Number).

The invoice attached to the email must be in a PDF or Word format. The date/time that a valid invoice is submitted electronically to the email box (invoicing@nih.gov) will be the same date/time logged as the invoice is received by NIH.

Questions?

Please direct inquiries regarding the status of invoices such as receipt of invoices, due date, or payment of invoices to the OFM Commercial Accounts Branch, Customer Service Office. The OFM Customer Service contact information and of methods to contact are available at the following OFM website https://ofm.od.nih.gov/Pages/Customer-Service.aspx and below.

The Customer Service Office is open Monday – Friday from 8:30 am to 5:00 pm (Eastern Standard Time) and is closed daily between 12:00 pm to 1:00 pm (Eastern Standard Time). The Customer Service Office phone number is 301-496-6088.

Vendor: XYZ Corp|PO:HHSN299202000053J|Invoice:XYASAD

Vendor: XYZ Corp|PO:HHSN311201600011U|Invoice:XYASAD mailto:invoicing@nih.gov https://ofm.od.nih.gov/Pages/Customer-Service.aspx

Instructions for Contractor/Vendor Courtesy Copy Electronic Invoice Submission to the Contracting Officer (CO):

The Contractor/Vendor shall send a cc: copy to the NIH Contracting Officer and the NIH Contracting Officer’s Representative (COR) stated in the award and the NIH Program point of contact when submitting the invoice to NIH/OFM for payment.

III. INVOICE PAYMENT

A. A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

IV. INTEREST PENALTIES

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the

Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

V. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

2. SOLICITATIONS: Proposals for furnishing the supplies or services in the Schedule will be received at the address specified in Block 9 of SF 1449, or if hand carried, to the address shown in block 9, until the date and time specified in Block 8. CAUTION - LATE Submissions, Modifications, and Withdrawals: See provision 52.212-1. All offers are subject to all terms and conditions of this solicitation.

3. ACKNOWLEDGEMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NUMBER DATE

4. MISSING PAGES: It is the responsibility of the offeror to examine this solicitation to verify that he or she has received all pages. In addition, in compiling this package, some pages may have been duplicated. If the offeror feels that pages are missing or duplicated, the offeror is encouraged to contact the Contracting Officer at the telephone number shown in Block 7B, Standard Form 1449, Solicitation/Contract/Order for Commercial Items.

5. ORDER PROCESSING SEQUENCE: The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) is the only activity authorized to issue orders under this contract.

6. NOTICE TO PROSPECTIVE AWARDEE(S): Prospective Awardee(s) MUST be registered in the

System for Award Management (SAM) at https://www.sam.gov/SAM/, PRIOR TO AWARD and through Final Payment, and must complete the Online Representations and Certifications Applications (ORCA) at https://www.sam.gov/SAM/ PRIOR TO AWARD and through Final Payment.

CONTRACT WILL NOT BE AWARDED UNTIL SAM REGISTRATION HAS BEEN COMPLETED

AND VERIFIED.

7. GOVERNMENT HOLIDAYS:

Holidays observed by the Federal Government:

New Year’s Day January 1st Martin Luther King, Jr.’s Birthday Third Monday in January

President’s Day Third Monday in February Memorial Day Last Monday in May https://www.sam.gov/SAM/ https://www.sam.gov/SAM/

Independence Day July 4th Labor Day First Monday in September

Columbus Day Second Monday in October Veterans Day November 11th

Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

8. ADDITIONAL INFORMATION FOR OFFERORS:

∗ Contract Type: The Federal Government intends to award a Firm-Fixed Price (FFP) Indefinite- Delivery Indefinite-Quantity Contract Type in accordance with FAR 16.504. Attention should be directed to FAR Clauses 52.216-18 “Ordering” and 52.216- 19 “Order Limitations”, which are a part of this solicitation/contract.

∗ Non-Personal Services Contract: The services provided in the contract will involve non-personal services. The personnel rendering the services of the contract are not subject, either by contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

∗ PRE-BID SITE VISIT: Due to limited access to the NIH Clinical Center and subsequent sites as a result of the current COVID-19 Pandemic, a Pre-Bid Site Visit will not be facilitated. However, NIH Clinical Center site-specific information needed to successfully complete this project will be provided upon request.

B.2 STATEMENT OF WORK

1. PROJECT TITLE

Staffing Analysis Services for the National Institutes of Health (NIH), Clinical Center (CC), Department of Clinical Research Informatics (DCRI)

2. BACKGROUND

The mission of the NIH Clinical Center is to serve as the nation’s premier research hospital for conducting clinical research to improve the health of human kind. It also serves as a national resource for clinical research by developing diagnostic and therapeutic interventions, enhancing systems to ensure the safe, efficient, and ethical conduct of clinical research, training clinical researchers, and leading the response to the nation’s public health needs.

The Clinical Center provides the NIH intramural researchers and limited extramural collaborators with physical infrastructure and medical expertise to perform groundbreaking and innovative clinical research.

Of the approximately 1,600 research protocols underway at the Clinical Center, approximately half are natural history studies, especially rare diseases, and the other half are mostly clinical trials, predominantly Phase I and Phase II, often first-in-human to test safety and efficacy of new drugs and therapies.

The DCRI at the NIH Clinical Center provides support for the NIH Intramural Research Program (IRP)’s electronic health record (EHR) system. The EHR is referred to as the Clinical Research Information System (CRIS) and is reviewed in Appendix B. In addition to CRIS, DCRI provides information technology (IT) support and information management support to the entire Clinical Center. This includes systems, servers and applications owned by DCRI, as well as those independently owned and managed by internal Clinical Center departments but still requiring DCRI support and oversight. There are also departments that independently own and manage devices include the Positron Emission Tomography (PET) Department, Radiology and Imaging Sciences (RADIS) Department, and the Department of Transfusion Medicine (DTM). Due to the consolidation of the CC’s Health Information Management Department (HIMD) into DCRI, DCRI will also begin providing medical records management, release of medical information services, and diagnostic and procedural coding services for the CC.

The vision, mission and goals of DCRI are as follows:

VISION:

The DCRI will serve as a model of collaborative excellence. We will lead through outstanding service for quality care and through innovation in the development, use, training, and evaluation of informatics for clinical research with the highest respect and value for privacy and confidentiality.

MISSION:

The DCRI is committed to delivering secure, responsive, high-quality, customer-oriented IT services and support that enhance clinical care and research studies.

GOALS:

Provide clinical systems that support efficient and effective workflow processes, enhance patient safety and allow rapid user-friendly access to reliable data necessary to promote information exchange and increase knowledge in the user community.

Provide a secure, dependable and accessible technical environment that supports the growing IT requirements related to an available, complete EHR.

Maintain the highest levels of customer satisfaction with IT systems, applications and support.

Work within the complexity of the NIH clinical research environment to provide integrated and unified health information services through partnership with NIH institutes and Clinical Center patients.

Ensure complete and accurate documentation to support patient safety, clinical research, and high quality healthcare data through a clinical documentation integrity program.

Ensure patient engagement through organizational programs and health information technology services to support research participants’ understanding, competence, and willingness to participate in care decisions and support clinical trial adherence.

3. DCRI Organization DCRI reports to the NIH Clinical Center, Office of the Chief Financial Officer (OCFO). DCRI is led by the Chief Information Officer (CIO), who is supported by the Chief Health Information Officer, Chief Medical Information Officer, Deputy CIO for Clinical Informatics, and Deputy CIO for Technical Operations. A high-level organizational chart is available in Appendix A. Additionally, DCRI’s key functional business areas are described in Appendix C.

3.1 Timesheet Analysis

The DCRI, like many other departments at the Clinical Center, does not currently track the amount of time staff spend completing individual tasks or projects. Instead, staffing hours are tracked via an online database, which primarily captures leave and telework schedules, which are verified by the employee every two weeks. This system does not account for any time that is spent on work tasks by contractual staff. If employees need to work beyond their standard tour of duty, they are expected to obtain approval from their supervisor ahead of time and then complete an overtime form to account for those hours.

Although this process has worked well, it fails to account for time spent on specific activities, and there is no way to verify whether staff have worked beyond their normal tour of duty if they decide not to obtain approval or file appropriate paperwork.

To help understand the current capacity and workload of the department, a timesheet analysis was conducted over a six week timeframe, from January 12 through February 22, 2020. The analysis was conducted prior to HIMD’s consolidation with DCRI, so their teams and responsibilities were not represented. Every DCRI employee was asked to submit a weekly timesheet, documenting the hours they spent performing specific tasks. Employees were assured that the timesheets they submit would not be used for auditing purposes, awards, or penalizations, which allowed them to document they time as realistically as possible, regardless of whether they had filed applicable paperwork regarding overtime activities. A similar analysis has been conducted every two-to-three years since 2006, which helps to indicate trends over time.

Each employee submitted their timesheets to their section lead or supervisor, who consolidated the data for their team. Each team’s timesheets were then gathered into team and department-level reports by the chair of the department’s leadership committee. Individual activities were grouped into one of four categories:

1. Project Work (defined as any single initiative that takes more than 40 hours to complete).

2. System operations and maintenance (O&M) Work, defined as any modifications to existing systems, including break-fix services.

3. Administrative Duties (defined as any other non-system related task, such as meetings).

4. Leave (defined as any non-work status, including sick leave and holidays).

The primary usage of the data were as follows:

1. To understand team availability for new projects

2. To analyze which teams had significant amounts of overtime and may need additional support

3. To visualize how time is spent in each of the four categories by the department over time

All of the data compiled through this timesheet analysis will be shared with the awardee of this contract, in addition to a summary of workload metrics, the current number of customer and server devices supported by DCRI and a review of DCRI’s current project list.

4. OBJECTIVES

The objective of this engagement is to provide evaluation, analysis, and recommendations on the NIH Clinical Center DCRI’s current staffing model.

5. SCOPE

The scope of this project is to evaluate, analyze, and make recommendations on the NIH Clinical Center DCRI’s current staffing model. Specifically, a five-to-eight week assessment which includes interviews/focus groups, job shadowing, site visits, and industry research and analysis will be completed in order to make recommendations on:

1. Services provided, including alignment with CC organizational mission and vision;

2. Services provided, including alignment with DCRI mission, vision, staffing and structure;

3. Staff mix including staff to workload ratios;

4. Best practices to implement proposed staffing model, including strategies to manage and adapt workload;

5. Staff and related workload metrics for on-going monitoring of staff activities;

6. Recommendations on staff skill sets, competencies, and training;

7. Strategies to improve recruitment and retention efforts;

8. Assess any efficiencies to be gained with the recent consolidation of HIMD into DCRI.

On-site interviews and job shadowing is preferred; however, interviews/focus groups and job shadowing activities may be conducted virtually as needed to comply with any social distancing requirements that may be in place due to COVID-19. Recording of any virtual activities that may take place is prohibited.

Both DCRI employees and contractors shall be assessed as part of this engagement.

Following interviews and review activities, contractors will have up to five weeks for follow-up activities, initial draft report with recommendations, and delivery of a final report with recommendations.

5.1 Task Orders

The NIH Clinical Center seeks assistance in the following Task Areas:

5.1.1 Task 1 - Task Order (TO) Management

1. Prepare a Task Order Management Plan describing the technical approach and the organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout task order execution.

2. Organize a post-award kick-off meeting to include review of the Task Order Management plan and discussion of the requirements included in this SOW. The kick-off meeting will include a review of DCRI’s mission, vision, structure, and staffing, in addition to workload and operational metrics.

3. If the completion date of the final task designated in the task order management plan’s schedule differs from the contract expiration date, the contract expiration date prevails.

5.1.2. Subtask 1.1 – Bi-weekly Status Report

1. Provide bi-weekly (every two weeks) progress meetings and monthly status reports which tracks all tasks that have been completed, tasks in progress, and the percent complete for each task.

2. Provide deliverable review meetings as requested by COR and/or Executive Sponsor.

5.1.3. Task 2 – CC Department of Clinical Research Informatics’ Current Staffing Review The contractor shall document CC DCRI’s current staffing model to support operations, conduct job shadowing of DCRI staff, and interviews and focus groups of DCRI leadership/staff and CC and IC stakeholders. All scheduling of interviews and focus groups will be completed by the contractor, with assistance from the CC as needed.

The purpose of the interviews/focus groups and job shadowing is to learn, evaluate and document:

1. DCRI services provided. A listing of DCRI’s current services is provided in Appendix D;

2. DCRI’s operations and how it’s currently staffed to support these operations;

3. DCRI’s functions and the processes they employ to fulfill these activities;

4. Current operations and project workload;

5. Current processes used by DCRI to capture and analyze workload; and

6. Needs identified by leadership, staff and stakeholders that are not currently met.

Job shadowing shall be conducted for up to two people per DCRI team, for up to eight hours per team.

The contractor shall shadow approximately 15 teams; the team designations will be provided to the contractor upon award.

Interviews/focus groups shall be completed for DCRI and DCRI’s stakeholders, as outlined below:

1. Interviews of CC and DCRI leadership shall be conducted on an individual basis (approximately five-to-eight individuals), with an emphasis on workload/workload management.

2. Interviews of the DCRI staff will be conducted in groups for each team, on a voluntary basis.

The contractor shall interview approximately 15 teams; the team designations will be provided to the contractor upon award.

3. DCRI stakeholders include the CC departments that independently own and manage IT systems which have a direct impact on DCRI’s workload. The aforementioned CC departments include RADIS, DTM, and PET. Additionally, there are CC departments and Institutes and Centers (IC) user groups who are considered major drivers/heavy users of DCRI’s IT Systems and monitoring programs, including Nursing, Pharmacy, Clinical Quality/Patient Safety (CQ/PS), and Rehabilitation Medicine Department (RMD).

a. Three-to-five interviews shall be conducted of DCRI’s stakeholders. Interviews may be conducted in functional groups; for example, one focus group for the clinical departments, a group for IC stakeholders, a focus group for clinical support departments, etc.

5.1.4. Task 3 – Benchmark Analysis

Collect and analyze department-specific staff workload to benchmark internally and/or externally (if available). Purpose is to learn, evaluate and document:

1. Areas that are overstaffed;

2. Areas that are understaffed; and

3. Areas that require a different staffing mix.

5.1.5 Subtask 3.1 – Alignment of Processes to Best Practices

Identify and document staff model best practices that are or are not currently in place, and how DCRI can benefit from aligning their processes to them. Best practices will be identified through literature review as well as site visits as outlined below:

1. Conduct at least three-to-four site visits at Academic Medical Centers (AMCs), such as George Washington, Johns Hopkins, Children’s National Medical Center, Memorial Sloan Kettering, Duke and City of Hope. At least two of the site visits shall be local (Washington DC metro region). The site visits shall be approximately one business day in duration.

2. The scope of the site visits will include an evaluation of the organization’s staffing, space, and alignment to delivery of services as comparable to list in Appendix D.

3. Gather information on benchmarking for staffing and workload metrics.

On-site site visits are preferred; however, site visits may be conducted virtually as needed to comply with any social distancing requirements that may be in place due to COVID-19.

5.1.6. Task 4 – Staff Skill Set/Competencies/Training

The contractor shall provide recommendations on the appropriate and ideal staff competencies, skill sets, certification, and training according to the services provided by DCRI. The contractor shall clearly define the skill sets that are needed for each team. The contractor will not be required to complete an assessment of the skill set, competencies, and training of current staff as part of this activity.

5.1.7. Task 5—Initial Assessment & Presentation

An initial written assessment which includes the project team’s analysis and potential recommendations shall occur one week after the review activities are completed. The assessment should include a draft report and a management level presentation.

5.1.8. Task 6—Final Report & Presentation

Provide a final written report and management presentation to include executive summary, methodology, and findings of all tasks under Section 4.2, and recommendations, as well as appendices (i.e. interview summaries, additional benchmarking data). Recommendations will include proposed timeframes for implementation.

6. CONTRACT TYPE

In accordance with FAR 16.504, a Firm-Fixed Price (FFP) Indefinite-Delivery Indefinite-Quantity Contract Type will be utilized for this acquisition because the risk associated with this award arrangement for the Government is deemed minimal and can be predicted with an acceptable degree of certainty.

7. PLACE OF PERFORMANCE

Ideally, the contractor shall perform all work related to job shadowing and interviewing DCRI staff and stakeholders at the NIH Clinical Center. However, if there are social distancing requirements in place due to COVID-19, interviews and job shadowing activities may be conducted virtually as an alternative to on-site visits.

If on-site activities occur, designated office space will not be provided to the contractors. However, contractors will have access to schedule into NIH Clinical Center conference rooms to host meetings as needed. Work which does not require face-to-face interaction with NIH staff will be completed off-site.

8. PERIOD OF PERFORMANCE

The Period of Performance for this project shall consist of a Base Period of five (5) months and one (1) three (3) month Option Period.

9. DELIVERABLES/DELIVERY SCHEDULE

SOW TASK # DELIVERABLE TITLE #CALENDAR DAYS AFTER TO

AWARD

1 Task Order Management Plan Draft—submitted with proposal; Final version within 10 business days of contract award

1.1 Bi-weekly Progress Meetings Every two weeks following project kick-off meeting

1.1 Monthly Status Reports Every month following project kick-off meeting

2 Department Staffing Review Included in deliverable for Task Order 5 and 6

3 Benchmark Analysis Included in deliverable for Task Order 5 and 6

3.1 Alignment of Processes to Best

Practices

Included in deliverable for Task Order 5 and 6

4 Staff Skill Set/Competencies/Training

Included in deliverable for Task Order 5 and 6

5 Initial Assessment & Presentation

16 weeks after award

6 Final Report & Presentation 20 weeks after award

10. OWNERSHIP OF RECORDS

The term "Records" means all working papers and such other information and materials as may have been accumulated or generated by the Contractor or Contractor agents in performing under this contract, including, but not limited to: documents, data, plans, books, computations, drawings, specifications, notes, reports, records, estimates, summaries and correspondence, kept or stored in any form, including by magnetic or electronic means.

The Contractor, upon the request of the NIH, shall promptly give to the NIH all original records, or, in the sole discretion of the NIH, copies thereof. The Contractor shall otherwise maintain all original Records, or copies thereof, for a period of ten (10) years after the termination of this Agreement. Unless the NIH designates otherwise in writing, all Records are the exclusive property of the NIH and no one else shall have any right, including, but not limited to, any copyright, trademark or other intellectual property rights, in those Records.

11. SECURITY

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information. Contractor personnel who need to be on-site to perform service and maintenance must be escorted and monitored at all times. A NDA must be signed if services and maintenance requires access PII/PHI or sensitive government information.

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

3) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Crimi1nal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

4) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

5) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role- Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

2) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual NIH Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

D. Incident Response The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/ NIH IRT teams as soon as possible, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving

PII.”

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send NIH approved notifications to affected individuals.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT), COR, CO, NIH SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, as soon as possible, and consistent with the applicable NIH and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum:

company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information HHS/NIH incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as…