Solicitation 75R60123Q00002.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

NHDP2

National Hansens Disease Program Management and Policy Office of Acquisition

HRSA/OAMP/NHDP

CODE 16. ADMINISTERED BYCODE

X

X

X

621340

SIZE STANDARD:

100.00 % FOR:SET ASIDE:UNRESTRICTED ORNHDP2

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

07/27/2023 1300 CT

07/06/2023

225-756-3785ANGELA WHITNEY

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75R60123Q00002

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 5 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

Baton Rouge LA 70809

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Baton Rouge LA 70809 National Hansens Disease Program Management and Policy Office of Acquisition

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$12.5

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

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

HRSA/OAMP/NHDP

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Title: Physical Therapy and Hansen's Disease Education Services Initiative ID#: NHDP172_C_4566

This is a combined synopsis/solicitation for commercial items. This requirement is issued pursuant to Federal Acquisition Regulation (FAR) Part 12.102 and Part 13.500 under NAICS Code 621340; Office of Physical, Occupational and Speech Therapists, and audiologists, with a small business size standard of $11M with PSC Code

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

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

ANNE M. STEPHAN

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Q518; Medical - Physical Medicine/Rehabilitation.

This requirement is being solicited as a small business set-aside, all qualified offerors are eligible to submit a quote under this

Solicitation. This announcement constitutes the only solicitation, and quotations are being requested. A separate solicitation will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC)

2023-04.

It is anticipated a Firm-Fixed Price type

Purchase Order will be issued as a result of this combined synopsis/solicitation.

PLEASE COMPLETE THIS FORM AND PROVIDE THE

FOLLOWING INFORMATION:

1. Contact Name, Phone and Fax Number:

2. Email Address: _______________________

3. UEI Number: _______________________

1 BASE PERIOD (SEPTEMBER 23, 2023 - SEPTEMBER 22,

2024)

The contractor shall provide Physical Therapy and

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

5 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 5

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75R60123Q00002

Hansen's Disease Education Services in accordance with Statement of Work (SOW) dated July 6, 2023.

Period of Performance: 09/23/2023 to 09/22/2024

2 OPTION PERIOD ONE (SEPTEMBER 23, 2024 - SEPTEMBER

22, 2025)

The contractor shall provide Physical Therapy and

Hansen's Disease Education Services in accordance with Statement of Work (SOW) dated July 6, 2023.

(Option Line Item)

09/23/2024

Period of Performance: 09/23/2024 to 09/22/2025

3 OPTION PERIOD TWO (SEPTEMBER 23, 2025 - SEPTEMBER

22, 2026)

The contractor shall provide Physical Therapy and

Hansen's Disease Education Services in accordance with Statement of Work (SOW) dated July 6, 2023.

(Option Line Item)

09/23/2025

Period of Performance: 09/23/2025 to 09/22/2026

4 OPTION PERIOD THREE (SEPTEMBER 23, 2026 -

SEPTEMBER 22, 2027)

The contractor shall provide Physical Therapy and

Hansen's Disease Education Services in accordance with Statement of Work (SOW) dated July 6, 2023.

(Option Line Item)

09/23/2026

Period of Performance: 09/23/2026 to 09/22/2027

5 OPTION PERIOD FOUR (SEPTEMBER 23, 2027 -

SEPTEMBER 22, 2028)

The contractor shall provide Physical Therapy and

Hansen's Disease Education Services in accordance with Statement of Work (SOW) dated July 6, 2023.

(Option Line Item)

09/23/2027

Period of Performance: 09/23/2027 to 09/22/2028

6 6-MONTH OPTION PERIOD (SEPTEMBER 23, 2028 - MARCH

22, 2029)

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

4 5

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75R60123Q00002

The contractor shall provide Physical Therapy and

Hansen's Disease Education Services in accordance with Statement of Work (SOW) dated July 6, 2023.

(Option Line Item)

09/23/2028

Period of Performance: 09/23/2028 to 03/22/2029

Special Authorities and Requirements

This is a nonpersonal health care services contract, the policies and procedures of which are provided in FAR subpart 37.4. As required by

FAR 37.401, this contract provides the following:

(a) This is a nonpersonal healthcare service contract, under which the contractor is an independent contractor.

(b) The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of service rendered

(e.g. professional judgments, diagnosis for specific medical treatment).

(c) As a condition of this contract, the contractor agrees to indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

(d) As a condition of this contract, the contractor agrees to maintain medical liability insurance in a coverage amount not less than the amount normally prevailing within the local community for the medical specialty concerned in accordance with FAR 52.237-7 -- Indemnification and Medical Liability Insurance, and;

(e) As a condition of this contract, the contractor agrees to ensure that any and all of its subcontracts for provisions of healthcare services contain all of the requirements of FAR

52.237-7 -- Indemnification and Medical Liability

Insurance, including, but not limited to, maintenance of medical liability insurance.

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

5 5

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75R60123Q00002

Attachments:

Attachment A - Statement of Work (SOW)

Attachment B - Clauses, Instructions to Offerors, and Evaluation Criteria

Attachment C - Past Performance Questionnaire

Attachment D - Contractor Non-Disclosure

Agreement (NDA)

Note to Contractor:

The Contracting Officer Representative (COR) does not possess the authority to approve additional hours/services/changes in the period of performance and/or pricing under this procurement. The Contracting Officer (CO) is the only entity that can authorize these type of changes. A written request should be forwarded to the Contracting Office Point of Contact prior to providing the Government additional hours/services. Once your written request has been submitted, an official modification document or verbal approval from the HRSA Contracting

Office should be received before proceeding.

Failure to comply could result in cost overruns that will not be the responsibility of the

Government.

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Solicitation Number 75R60123Q00002; Title: Physical Therapy and Hansen’s Disease Education Services

Attachment A Statement of Work (SOW)

Title: Physical Therapy and Hansen’s Disease Education Services

July 6, 2023

I. Background

The National Hansen’s Disease Program (NHDP), Baton Rouge, Louisiana is a specialized federal medical facility for the treatment of persons with Hansen’s disease (HD). The NHDP, operated by the Federal Government since 1921, has statutory responsibility to provide care for outpatients with HD.

More information on NHDP is available at https://www.hrsa.gov/hansens-disease. The facility serves as a clinic for outpatients and as housing quarters to onsite patients who are diagnosed with HD and are referred from Ambulatory Care Clinics or private physicians for medical services.

NHDP provides care for two (2) to six (6) short-term care patients, on average, from various parts of the United States (U.S.) that may be housed by the NHDP for treatment. Eligible referrals are determined on a case-by-case basis, and may be indicated for confirmation of diagnosis, initiation of HD treatment, and management of HD complications including medical management of reaction and corrective surgery/rehabilitation for hand and foot deformities common with this diagnosis. The short-term care patients may stay a few days or several months depending upon their condition.

II. Purpose / General Description

NHDP requires physical therapy services to include assessment of patients; identification of therapy diagnosis; formulation of therapy treatment plan, goals, and implementation; supervision and modification of therapy program for each patient; education and training of ambulatory staff and visiting health care providers, to include preparing and delivering presentations; preparing and editing education materials; and collecting clinical research data. The focus of the treatment shall be on patients with neuropathic limb dysfunction secondary to HD, performance of wound management, total contact cast fabrication, fabrication of orthotics, and modification of footwear.

III. Period of Performance / Place of Performance

The period of performance shall be a base period of 12 months plus four (4) 12-month option periods.

The anticipated start date is September 23, 2023.

The work shall be performed at the NHDP facility, a Government site, located at 9181 Interline Ave, Baton Rouge, LA. Additionally, presentations shall be conducted at multiple locations in the Baton Rouge area, including the NHDP and Gillis W. Long Center in Carville, LA. No contractor personnel has the authority to work at an alternate location under this contract, unless approved in advance by the Contracting Officer. In the event of Government closure or non-access to the Government site, due to weather, catastrophe, emergencies, lapse in appropriations, or force majeure, a determination will be made for continuation of performance at an alternate work location.

If there is a Government closure or non-access to the Government site for the reasons stated above, the Contractor shall submit written requests to the Contracting Officer Representative (COR) and the Contracting Officer of its intent to work at an alternative work location. The Contractor shall ensure continuity of performance by personnel performing work under this contract. Health Resources and Services Administration (HRSA) staff do not supervise contractor employees and do not approve or https://www.hrsa.gov/hansens-disease monitor contractor employees. HRSA staff may assist contracted personnel with accessing web-based mandatory training and pulling completed certificates. Only a HRSA Contracting Officer has authority to approve alternate work arrangements on behalf of HRSA.

Contractor personnel shall only use Government-Furnished Equipment (GFE) that has been properly configured for security by HRSA’s Office of Information Technology (OIT) while performing on this contract. The Government shall provide maintenance and technical support for GFE used while performing off-site. All Contractor personnel’s use of GFE and government information shall be for contractual performance only, and shall be protected from unauthorized access, disclosure, sharing, transmission, or loss.

For purposes of accelerated implementation of off-site performance under this contract, the Contracting Officer may immediately elect to authorize off-site work upon concurrence from the COR. The Contracting Officer will execute a formal contract modification within 30 calendar days from issuance of this authorization. If the Contracting Officer and COR determine that off-site work has adversely affected contract performance, the Contracting Officer may immediately suspend/terminate this authorization upon written notification to the Contractor.

IV. General Requirements / Tasks

Task 1. Federal Records Management

1.1 – Records and Information Regulation Guidelines

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

1.2 – Records and Information Management

The contractor shall manage and maintain Federal records and/or information, including electronic records and/or information, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to the Federal Records Act (44 U.S.C.

Chapters. 21, 29, 31, 33); 36 CFR § 1236.20 What are appropriate record keeping systems for electronic records? & 1236.22 What are the additional requirements for managing electronic mail records? (http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25); NARA Bulletin 2013- 02, August 29, 2013, Guidance on a New Approach to Managing Email Records (https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and NARA Bulletin 2010-05 September 08, 2010 (http://www.archives.gov/records-mgmt/bulletins/2010/2010- 05.html), Guidance on Managing Records in Cloud Computing Environments.

Managing the records includes, maintaining records to retain functionality and integrity throughout the records’ full lifecycle including: (1) maintenance of links between records and metadata, and

(2) categorization of records to manage retention and disposal, either through transfer of permanent https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ecfr.gov%2Fcgi-bin%2Ftext-idx%3Frgn%3Ddiv5%26node%3D36%3A3.0.10.2.25&data=05%7C01%7CHAlbertie%40hrsa.gov%7C5b98824f160c4b23a29e08db1b2b2a6d%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638133644425163220%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=SmyIbpejcgDM9ckaFqScJGXrG1Nyyag5qmPrcUcDGQQ%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.archives.gov%2Frecords-mgmt%2Fbulletins%2F2013%2F2013-02.html&data=05%7C01%7CHAlbertie%40hrsa.gov%7C5b98824f160c4b23a29e08db1b2b2a6d%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638133644425163220%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tdjCC05mYfVTGVcKKmY2TY75%2BNRphJ5lQtO%2B0y7XopY%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.archives.gov%2Frecords-mgmt%2Fbulletins%2F2010%2F2010-05.html&data=05%7C01%7CHAlbertie%40hrsa.gov%7C5b98824f160c4b23a29e08db1b2b2a6d%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638133644425163220%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=gYJ1uj8kZRbb%2BbwwWirACoGVPHO9qLs7beuo9QmRTa0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.archives.gov%2Frecords-mgmt%2Fbulletins%2F2010%2F2010-05.html&data=05%7C01%7CHAlbertie%40hrsa.gov%7C5b98824f160c4b23a29e08db1b2b2a6d%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638133644425163220%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=gYJ1uj8kZRbb%2BbwwWirACoGVPHO9qLs7beuo9QmRTa0%3D&reserved=0 records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

1.3 – Records Management Training

The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HHS Records Management Training before performing work under this contract, and thereafter completing the annual refresher training during the life of the contract. The training is located at https://humancapital.learning.hhs.gov/courses/2022recordsmanagement/01_index.html. At the end of the Records Management training, please send the “Certificate of Completion” to the Contracting Officer Representative (COR) of the contract. The listing of completed training shall be submitted to the COR.

Any revisions to this listing as a result of staffing changes shall be submitted to the COR.

Task 2. Kickoff meeting

The contractor shall:

2.1 Attend Kickoff Meeting: meet with the COR and other Government staff within two (2) weeks of the effective date of contract to review the requirements of the contract, SOW, and deliverable schedule. The Contractor shall meet with HRSA via video conference/teleconference. Attendees shall include the contractor’s project director/administrator and the physical therapy staff that will be performing work on this contract. The COR shall provide the meeting agenda and meeting access information prior to the meeting, and the Contractor shall submit the meeting minutes within 5 days following the kick-off meeting.

The kickoff meeting will occur during the base period only.

Task 3. Provide and Train Physical Therapy Staff

The contractor shall:

3.1 Provide Physical Therapy Staff for the Core Hours of Operation to perform all tasks in this contract.

Breakdown of billable hours is as follows.

3.1.1 Standard hours for physical therapy and educational services shall be required thirty-two

(32) hours each week, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Central Standard Time (CST). The Contractor shall coordinate services to be performed 3-5 days each week to fulfil the tasks listed in the SOW. Standard physical therapy services lasting longer than 6 hours each day shall have a 30-minute non-reimbursable break. Physical therapy services shall be scheduled with the COR up to one month in advance but no later than one week prior to when they are to be in effect. The Contractor shall provide a qualified substitute for the Physical Therapist in the event of an absence of the primary personnel. To provide continuity in the operation of the Physical Therapy Department and completion of projects, the primary key personnel shall provide support for 75% of the contract workload. Maximum number of billable labor hours per contract year for base period and option periods 1-4: 1472 hours/year; 6-month extension period max is 736 hrs.

3.1.2 Extended hours for physical therapy and educational services shall be required during the

NHDP Neuropathic Foot Seminars, Monday through Friday, 8:00 a.m. through 4:30 p.m. CST, for forty (40) hours per week, five (5) days per week, eight (8) hours per day. When extended physical therapy services are required, those weeks shall replace/supersede standard physical therapy services weeks. Extended physical therapy services lasting longer than 6 hours each day shall have a 30-minute non-reimbursable break. Extended physical therapy services shall be scheduled with https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhumancapital.learning.hhs.gov%2Fcourses%2F2022recordsmanagement%2F01_index.html&data=05%7C01%7CHAlbertie%40hrsa.gov%7C5b98824f160c4b23a29e08db1b2b2a6d%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638133644425163220%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=QcpJzMTdAqwKL2KR6EGjLB9M60dDt877S%2BWcIWVxvvk%3D&reserved=0 the COR up to one month in advance but no later than one week prior to when they are to be in effect. Maximum number of billable labor hours per contract year for base period and option period 1-4: 240 hours /year. 6-month extension period max is 120 hrs.

No overtime shall be authorized under this contract.

No services (except Task 5 reporting of IT threats or hazards; computer incident response) or deliverables shall be provided on Saturdays, Sundays, Federal Government Holidays, or any other day as set forth by Presidential Executive Order, or any other Federal Government closures.

The following Federal Government holidays are established by law (5 U.S.C. 6103)

• New Year’s Day (January 1)

• Birthday of Martin Luther King, Jr. (Third Monday in January)

• Washington's Birthday (Third Monday in February)

• Memorial Day (Last Monday in May)

• Juneteenth Day (June 19)

• Independence Day (July 4)

• Labor Day (First Monday in September)

• Columbus Day (Second Monday in October)

• Veterans Day (November 11)

• Thanksgiving Day (Fourth Thursday in November)

• Christmas Day (December 25)

3.2 Complete NHDP annual training. An introduction to the COR, competency testing including the ability to use a computer, access government sites and navigate electronic medical records, and an onsite tour of the NHDP facility by a NHDP staff member shall be completed prior to performing work under this contract.

3.3 Mandatory Training for All Contractor Personnel. Contractor personnel assigned to work on this contract shall complete the applicable HHS/HRSA Cybersecurity, Rules of Behavior, Records Management, Basic Life Saving for Healthcare Providers, and other HRSA mandated training (provided upon Effective Date of Contract (EDOC) before performing any work under this contract). Thereafter, the employees shall complete the HRSA Cybersecurity, Rules of Behavior, Records Management, Basic Life Saving for Healthcare Providers, and other HRSA mandated training, during the life of this contract. All provided training shall be compliant with HHS training policies.

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

3.5 Training Records. The contractor 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 COR within 30 days EDOC and annually thereafter, or upon request.

Task 4. Physical Therapy and Hansen’s Disease Education Services (to be performed according to Core Hours in task 3.1.1 and 3.1.2)

The contractor shall:

4.1 Evaluate and treat patients, perform foot screens, and refer patients within one (1) day to specialty clinics with foot problems and other functional needs. Implement appropriate treatment according to findings.

4.2 Perform wound care management according to patient needs, to include callus and nail trimming and offloading.

4.3 Modify footwear; fabricate orthotics, splints, and casts; fit compressive stockings; and perform pre and post operative management of amputations.

4.4 Maintain and track inventory materials and supplies used in the Physical Therapy department and each month provide the COR an inventory of items that need to be restocked.

4.5 Photograph and record video clips of patient evaluation, baseline and progression throughout treatment that shall be documented in NHDP electronic medical record.

4.6 Document all patient care related activities in NHDP Electronic Health Record in compliance with

HIPPA.

4.7 Consult with NHDP Physicians, Nurses, and Social Services regarding functional and social concerns of patients and make appropriate recommendations.

4.8 Consult with attending physicians and collaborate with other staff regarding evaluation results and treatment goals.

4.9 Consult with health providers throughout the U.S. and its territories.

4.10 Attend weekly Clinical Conference meetings; bi-weekly Hand/Foot Clinics; and participate in meetings which address treatment needs of current patients, pre-admission needs for potential patients, and discharge planning for patients’ needs after treatment is completed.

4.11 Attend all clinical care coordination conferences with the NHDP interprofessional team.

4.12 Educate and train ambulatory care staff and visiting health care providers in the evaluation and treatment of the neuropathic patient and in prevention of injury and disability, and Carville Lower Extremity Amputation Prevention Protocol.

4.13 Develop 20 PowerPoint presentations; 8 online presentations; and provide a speaker for 10

NHDP affiliated seminars to lecture on topics related to Prevention of Disability in HD that include lower extremity amputation prevention, management of the neuropathic foot, footwear modification, alternative offloading, orthotic, cast and splint fabrication, and foot screening.

4.14 Develop and edit professional and patient education materials to include brochures, posters, and multimedia materials (80 per year) related to the management of HD associated complications.

4.15 Collect clinical research data, based on schedule provided by the COR (30 times per year).

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

4.17 Contracted physical therapists shall participate and comply with mandates from accreditation agencies (e.g., Joint Commission accreditation). All licensed healthcare providers who perform patient care at the National Hansen’s Disease Program will be required to participate in the credentialing process to meet program standards. The healthcare license, position, and level of autonomy may require a licensed healthcare provider to be privileged to perform work at the program. The credentialing and privileging process may require the completion of a credentialing application, an updated résumé or CV, a copy of certifications, a copy of current licensing, references, National Provider Databank NPI review, and original transcripts. Credentialing or privileging may need to be completed every 2 to 3 years to meet program or survey standards.

Task 5. Procurements Involving Information Security and/or Physical Access Security

Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or modification (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) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/HRSA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

a. Protect the:

Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

Availability, which means ensuring timely and reliable access to and use of information.

b. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

c. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/HRSA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or HHS/HRSA security and/or privacy officials.

3) Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

4) Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/OpDiv privacy policies, and complete all the requirements below:

a. Per the Office of Management and Budget (OMB) Circular A-130, Personally

Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

5) Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as

"information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R.

2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

a. Marked appropriately;

b. Disclosed to authorized personnel on a Need-To-Know basis;

c. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800- 88, Guidelines for Media Sanitization.

6) 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

7) 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must 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 must 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 must be protected in accordance with HHS and HRSA policies. Unauthorized disclosure of information will be subject to the HHS/HRSA 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 (Criminal Code: Disclosure of Confidential Information); and

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

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

9) Standard for Encryption. The Contractor (and/or any subcontractor) must:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with current FIPS 140 validation certificate from the NIST

CMVP.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and HRSA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic

Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the HRSA non-disclosure agreement (Attachment D). Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

http://csrc.nist.gov/publications/

11) Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract and have access to HRSA’s network must complete the applicable HHS/HRSA Cybersecurity Awareness Training training (provided upon contract award) before performing any work under this contract.

Thereafter, the employees must complete HHS/HRSA Cybersecurity Awareness Training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. 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 for IT Admin 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.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with HHS policy.

A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

12) Rules of Behavior

a. 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 (included in the HHS/HRSA Cybersecurity Awareness Training), and any applicable system-level rules of behavior.

b. 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 HHS/HRSA Cybersecurity 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.

13) Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of

Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "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" and a privacy breach is "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 mailto:hrsacsirt@hrsa.gov information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

1. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

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 must send HRSA approved notifications to affected individuals following specific instructions from the HHS Privacy Incident Response Team (PIRT).

3. Report all suspected and confirmed information security and privacy incidents and breaches to the HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) or 301-443-3333, COR, CO, HRSA SOP (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable HRSA 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

Not include any sensitive information in the subject or body of any reporting e-mail; and 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, and HHS and HRSA privacy breach response policies when handling PII breaches.

5. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

14) Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and mailto:hrsacsirt@hrsa.gov

731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: non-sensitive Tier 2 moderate risk background investigation.

15) Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy;

and Executive Order 13467, Part 1 §1.2.

16) Roster The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO within 14 days of the effective date of this contract.

Any revisions to the roster as a result of staffing changes must be submitted within 14 days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

17) Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation, including HRSA Disposition Plan to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within 14 days before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or HRSA policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the HRSA Clearance Form for Separating Employees and Contractors (Form-419) when an employee terminates work under this contract within 14 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

V. Schedule of Deliverables

Section 508 requires that all external public facing content and non-public facing official agency communications be accessible. Regardless of format, all digital content or communications materials produced as deliverables under this contract must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

The contractor shall complete and submit the applicable HHS Section 508 Accessibility Compliance Checklist per Section 508 deliverable. The checklist will serve as an artifact declaration of the Section 508 deliverable's compliance. Remediation of any Section 508 deliverables that do not comply with the applicable requirements as set forth below shall be the contractor's responsibility.

HHS guidance and checklists regarding accessibility of documents can be found at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html.

Deliverables (Base and Option Periods) EDOC: Effective Date of Contract

Item Title Quantity Due Date

Records Management Training: list of completed training (Task 1.3)

1 Per Contractor Employee

Within 30 days after contract award and upon new staff onboarding, and thereafter, completing the annual refresher course during the life of the contract, or upon request.

2 Kickoff meeting minutes (Task 2.1) 1 Within 5 days following the kickoff meeting

3 Training Records (Task 3.5)

1 Per Contractor Employee for each mandatory training topic

Within 30 days EDOC and upon new staff onboarding, and thereafter, completing the annual refresher course during the life of the contract, or upon request.

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

4 Inventory List of Supplies (Task 4.4) 1 per month End of Each Month

Photographs and record video clips of patient evaluations (Task 4.5)

As needed As needed

Presentations (Task 4.13)

20 PowerPoint;

8 online As needed

Professional and patient education materials (Task 4.14)

80/year As needed

8 Clinical research data (Task 4.15) 30/year As assigned by COR

9 Accreditation…