Solicitation 75R60122Q00006.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

621399

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORNHDP2

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

07/25/2022 1500 CT

07/05/2022

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

75R60122Q00006

5. SOLICITATION NUMBER

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

1 3 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

$8.00

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 SCHEDULE

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: Orthotics Technician Services Initiative ID#: NHDP172 C 3676 Award Type: Firm-Fixed Price

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 621399; Offices of All Other Miscellaneous Health Practitioners, with a small business size standard of $8.00M with PSC Code Q518; Medical -

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

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

JENNIFER M. LOHMEIER

. 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.

Physical Medicine/Rehabilitation. This requirement is being solicited as Unrestricted, all qualified offerors are eligible to submit a quote under this Solicitation. This announcement constitutes the only solicitation, quotations are being requested and a separate solicitation will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC)

2022-05.

The contractor shall provide the required

Orthotics Technician Services and all identified services in accordance with the attached

Statement of Work (SOW), Attachment A.

Provide the following information:

1. Contact Name, Phone and Fax Number:

2. Email Address: _______________________

3. UEI Number: _______________________

Note the following attachments with this form:

Attachment A - Statement of Work (SOW)

Attachment B - Contractor Non-Disclosure

Agreement (NDA)

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

3 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 3

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

75R60122Q00006

Attachment C - Clauses, Instructions and

Evaluation

Attachment D - Past Performance Questionnaire

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.

Contracting Officer Representative (COR):

Contact information to be entered at time of award.

Contracting Office Point of Contact:

Contact information to be entered at time of award.

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

Sponsored by GSA

FAR (48 CFR) 53.110

Title: Orthotics Technician Services; Attachment A – Statement of Work (SOW); Solicitation Number 75R60122Q00006

Attachment A Statement of Work (SOW)

Title: Orthotics Technician Services Date: July 5, 2022

I. Background

The Department of Health and Human Services (HHS), Health Resources and Services Administrations (HRSA), Healthcare Systems Bureau (HSB) provides for care, treatment, education, and research on Hansen’s Disease (HD, Leprosy) through the National Hansen’s Disease Program (NHDP), centered in Baton Rouge, Louisiana. The legislative authority for the National Hansen’s Disease Programs (NHDP) is Public Law 99-117, Section 2. (a.), Section 320, and is guided by Department of Health and Human Services (DHHS) regulations. This program has been owned and operated by the Federal Government since 1921 and has statutory responsibility to provide care for patients with HD. Even though HD patients are no longer admitted as residents, NHDP continues to provide care for:

a. 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 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, 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, but they are no longer eligible to become long-term care patients.

b. Outpatients who reside within a 250-mile commuting area of the NHDP.

c. One (1) long-term care patient residing at Saint Clare Manor nursing home in Baton Rouge, LA where they receive considerable care in their daily living arrangements

II. Purpose

NHDP requires orthotics technician services for the operation of the NHDP Clinical Branch shoe shop. The technician fabricates orthotics and sandals, performs shoe modifications, and maintains inventory and equipment.

III. Period of Performance/Place of Performance

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

The anticipated start date is September 26, 2022.

The Place of Performance shall be at NHDP, 9181 Interline Ave, Baton Rouge, LA 70809.

The place of performance is at the Government’s site. No contractor personnel has the authority to work off-site 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. HRSA staff do not supervise contractor employees and do not approve or monitor contractor employees. Only a HRSA Contracting Officer has authority to approve off-site 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.

Core Days and Hours of Operation:

Standard orthotics technician services shall be required twenty-one (21) hours each week, 7 hours per day, Monday through Friday, between 8:00 AM and 4:30 PM CST. The Contractor shall coordinate services to be performed 3 days each week to fulfil the tasks listed in the SOW. Standard orthotics technician services lasting longer than 6 hours each day shall have a 30-minute non-reimbursable break. The contractor shall provide a qualified substitute for the Orthotics Technician in the event of an absence of the primary personnel. In order to provide continuity in the operation of the NHDP shoe shop and completion of projects, the primary key personnel shall provide support for 80% of the contract workload.

No overtime shall be authorized under this contract.

No services 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).

IV. Tasks

Task 1: Federal Records Management.

Task 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.

Task 1.2. 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 course during the life of the contract. The training is located at https://humancapital.learning.hhs.gov/courses/2021recordsmanagement/01_index.html. At the end of the Records Management training, the “Congratulations" slide is considered your certificate of completion. Please send the completion certificates to the Contracting Officer Representative (COR) of the contract. The listing of completed training shall be included in the first progress report.

Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report.

Task 2: Orthotics Technician Services.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhumancapital.learning.hhs.gov%2Fcourses%2F2021recordsmanagement%2F01_index.html&data=05%7C01%7CCWhitney%40hrsa.gov%7C861eb864702246d0c9d508da383f3beb%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637884141480014695%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sri7l5t2RbTQaxduQUw6k0fiVNbf04YlkgqFginBOxw%3D&reserved=0

The Contractor shall:

1. Construct, modify and repair custom molded sandals; and modify and repair prefabricated sandals. Custom sandal fabrication using Amfit system, plaster molds/vacuum press, and/or directly moldable materials and secured with strapping to the foot. Repair sandal components for prevention of injury.

2. Modify commercially available shoes and repair both commercially available and custom shoes. Footwear modifications and customization to include rigid rocker modifications, pressure relief applications, stretching, flares, heel modifications, etc.

3. Construct and modify total contact orthoses. Fabricate custom orthoses using Amfit system; plaster molds/vacuum press and/or directly moldable materials. Modify orthoses with pressure relief techniques, metatarsal pads, toe fillers, etc.

4. Assist Physical Therapist with fabrication of foot models from various molding medium and adjust foot models as needed. Create model of patient foot using digital Amfit system, plaster techniques or foam box. Modify molds as needed to balance foot or relieve high-pressure areas.

5. Repair and/or adjust belts and prosthetic harnesses. Prostheses, footwear, and lower/upper extremity orthoses have belts, straps and harnesses that become frayed, torn or broken, requiring occasional repair or adjustment to function correctly and safely.

6. Consult with Physicians, Nurses, Orthopedic Surgeon, Physical Therapists and Occupational Therapists on patient cases.

7. Maintain records of work orders. Complete shoe shop work order form on every requested order and submit to Clinical Program Specialist.

8. Compile monthly report on number of orthotics/sandals/monofilaments fabricated, shoes modified and stockings sewed and submit to COR.

9. Provide maintenance of inventory by tracking materials and supplies used in the shoe shop using Excel spreadsheet.

10. Safely store materials utilized in the shoe shop. All hazardous materials shall be secured in a locked “Flammable” cabinet in the storage room of the shoe shop.

11. Provide assistance to Occupational & Physical Therapy departments in maintaining and fabricating a stock of monofilaments, cut out felt and other frequently used clinical items and assist in transfer of patients to/from department.

12. Provide education and training of visiting health care providers in sandal construction, shoe modification, construction of foot models and adjustments, and construction of total contact orthoses.

Task 3: Baseline Security Requirements.

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

1. Access (Physical or Logical) to Government Information: A Contractor employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

2. 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.

Task 4: Safeguarding Information and Information Systems.

In accordance with the Federal Information Processing Standards Publication (FIPS) 199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

1. Protect government information and information systems in order to ensure:

• 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.

2. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

3. Adopt and implement the policies, procedures, controls, and standards required by the HHS 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 the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

4. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

Task 5: Controlled Unclassified Information (CUI).

CUI is defined 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. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall 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

Federal 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. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

Task 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 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.

Task 7: Confidentiality and Nondisclosure of Information.

Any information provided to the contractor 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 mailto:fisma@hhs.gov 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 officer or 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 officer or employee 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 HRSA policies. Unauthorized disclosure of information will be subject to the HHS/HRSA sanction policies and/or governed by the following laws and regulations:

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

18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Task 8: Contractor Non-Disclosure Agreement (NDA).

Contractor personnel having access to non-public government information under this contract shall complete the HRSA non-disclosure agreement (Attachment B). A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and CO Representative (COR) prior to performing any work under this acquisition.

Task 9: Training.

1. Mandatory Training for All Contractor Staff. All Contractor personnel assigned to work on this contract shall complete the applicable HHS/HRSA 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 HHS/HRSA 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.

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

Task 10: Standard for Encryption.

The Contractor shall:

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

2. 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 FIPS 140-2 validated encryption solution.

3. 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).

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

Cryptographic Module Validation Program (http://csrc.nist.gov/groups/STM/cmvp/documents/140-1/140val-all.htm) to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

5. 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.

Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

Task 11: Rules of Behavior.

1. The Contractor shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior (included in the HRSA Information Security and Privacy Awareness Training), and any applicable system-level 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 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 HRSA 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 COR per defined timelines above.

Task 12: Incident Response.

The Contractor shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/HRSA IRT teams within 24 hours, 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 http://csrc.nist.gov/groups/STM/cmvp/documents/140-1/140val-all.htm http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf 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 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 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 Security Operations Center (SOC), COR, CO, HRSA 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, 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, 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 and HRSA incident 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.

Task 13: Position Sensitivity Designations.

All Contractor personnel must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

Public Trust/Moderate.

Task 14: Homeland Security Presidential Directive (HSPD)-12.

The Contractor and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors;

OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor shall develop, have the ability to access, or host and maintain a government information system(s). The roster shall be submitted to the COR and CO within 14 days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall 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 shall provide a position description and the Government will determine the appropriate suitability level.

Task 15: Contract Initiation and Expiration.

1. General Security Requirements. The Contractor shall 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.

2. System Documentation. Contractors must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, 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.

3. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor shall provide all required documentation to the CO and 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.

4. Notification. The Contractor shall notify the CO and COR and system ISSO within two weeks before an employee stops working under this contract, unless the contractor was immediately terminated.

5. Contractor Responsibilities Upon Physical Completion of the Contract. The contractor shall 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 COR. Additionally, the Contractor shall 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 HRSA policies.

6. The Contractor shall 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 two weeks of the employee’s exit from the contract. All documentation shall be made available to the CO and COR upon request.

Task 16: Records Management and Retention.

The Contractor shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/ HRSA policies and shall not dispose of any records unless authorized by HHS/ HRSA.

In the event that a contractor accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/HRSA policies.

V. Schedule of Deliverables

508 Compliance

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 a deliverable 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. Remediation of any materials that do not comply with the applicable requirements as set forth below, shall be the responsibility of the vendor.

HHS guidance regarding accessibility of documents can be found at http://www.hhs.gov/web/section-508/making-files-accessible/index.html.

The contractor shall submit the following deliverables as identified in the tasks listed in the SOW and in the quantities stipulated and during the periods listed below.

Schedule of Deliverables for Baseline Security Requirement Tasks

Item Quantity Due Date Place to Report

Task 8 Contractor Employee Non- Disclosure Agreement (NDA)

One (1) per Contractor Employee

Prior to performing any work on behalf of HHS

Email to the COR:

ccrnko@hrsa.gov

Task 9.2 Training Records

One (1) Training certificate for each Contractor Employee assigned

In conjunction with contract award and annually thereafter or upon request

Email to the COR:

ccrnko@hrsa.gov

Item Quantity Due Date Format and Place to Report

Task 1.2 Provide Records Management training completion certificates

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.

Email to the COR:

ccrnko@hrsa.gov

Task 2.7 Work Order

1 per requested order

As Needed Email to Clinical Program Specialist:

msingleton@hrsa.gov in Excel

Task 2.8 Workload Report

12 per 12-month period of performance

Last business day of each month

Email to the COR:

ccrnko@hrsa.gov in Word

Task 2.9 Inventory Report

12 per 12-month period of performance

Last business day of each month last business day of each month

Email to Clinical Program Specialist:

msingleton@hrsa.gov in Excel to the contract

Task 11.2 Rules of Behavior

One (1) signed ROB for each Contractor Employee assigned to the contract

Initiation of contract and at least annually thereafter

Email to the COR:

ccrnko@hrsa.gov

Task 12.3 Incident Report (as incidents or breaches occur)

One (1) report for each incident

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Email to the COR:

ccnko@hrsa.gov

Task 12.4 Incident Response

One (1) Incident and Breach Response Plan

Upon request from government

Email to the COR:

ccrnko@hrsa.gov

Task 13 Background Investigation

One (1) onboarding documentation per contract employee when beginning contract.

Prior to performing any work on behalf of HHS

Contact Anita Scott:

ascott@hrsa.gov

Task 14 Personnel Security Responsibilities

One (1) List of Personnel with defined roles and responsibilities

Within 14 days that is before an employee begins working on this contract.

Email to the COR:

ccrnko@hrsa.gov

Task 15 Contract Initiation and Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/ Decommission Plan

At contract expiration. Email to the COR:

ccrnko@hrsa.gov

Task 15.5 Certification of Sanitization of Government and Government Activity-Related Files, Information, and Devices.

Form or deliverables required by HRSA.

At contract expiration. Email to the COR:

ccrnko@hrsa.gov

Task 15.6 Personnel Security Responsibilities

One (1) Off-boarding documentation, equipment and badge when leaving contract

Within two weeks after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Contact: Anita Scott:

ascott@hrsa.gov

VI. Payment Schedule

The contractor shall be reimbursed in twelve equal monthly firm-fixed price payments, after performance of services and within 30 days of submission and acceptance of a proper invoice.

Title: Orthotics Technician Services; Attachment B - Contractor Non-Disclosure Agreement (NDA);

Solicitation Number 75R60122Q00006

Contractor Non-Disclosure Agreement

Information Technology Systems Security Contractor Non-Disclosure Agreement

Access to sensitive information (such as personally identifiable information [PII]), non-public information, confidential information, and/or Controlled Unclassified Information (CUI) from the files of the Department of Health and Human Services (HHS) is required in the performance of my official duties, under contract number between (HHS/HRSA) and my employer (Employer’s Name) .

I agree that I shall not release, publish, or disclose such information to unauthorized personnel, and I shall protect such information in accordance with relevant laws and regulations available for research and review at any Law Library. Among these laws may be various provisions of:

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).

I affirm that I have received a written and/or verbal briefing by my company concerning my responsibilities under this agreement. I understand that violation of this agreement may subject me to criminal and civil penalties.

Signed:

Type or Print Name:

Date:

Witnessed by:

Date:

Copies are to be retained by: HRSA Contracting Officer Representative Contractor’s Contract Management Individual Signatory

Title: Orthotics Technician Services; Attachment C – Clauses, Instructions and Evaluation; Solicitation Number 75R60122Q00006

Clauses, Instructions to Offerors, and Evaluation Criteria

The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses.

FAR 52.212-1 - Instructions to Offerors - Commercial Products and Commercial Services (NOV 2021), applies to this acquisition.

General

Contained herein are the minimally acceptable requirements for quote information that is to be submitted in accordance with the following instructions for the format and content of quotes.

Offeror’s shall submit the quote volumes stated below to be considered responsive to this solicitation, no exceptions. Failure to submit a completed quote by the time that quotes are due will result in the exclusion from further consideration by the Government for award.

Quotes shall stipulate that it is predicated upon all the terms and conditions of this solicitation. In addition, it must contain a statement to the effect that the quote is valid for a period of at least 90 days from the date of receipt by the Government. Offerors shall submit quotes and data comprehensive enough to provide the basis for a sound evaluation. The data and information should be precise, factual, and responsive and shall be keyed to each paragraph of the technical quote requirements as outlined below.

Quote information shall be submitted in separate volumes and clearly labeled. Each volume shall be separate and complete unto itself so that the evaluation of one volume may be accomplished independently of the evaluation of the other volume(s).

Quotes shall be submitted in three (3) volumes as follows:

Volume Title

I Technical Quote II Past Performance III Business Quote

The solicitation shall be signed by an official authorized to bind your organization and shall be submitted with your quote by email by the date and time specified on page 1 of the solicitation to Charisse Whitney at cwhitney@hrsa.gov.

All questions and/or inquiries concerning this solicitation shall be submitted via email to Charisse Whitney at cwhitney@hrsa.gov by 10AM Central Time, July 13, 2022. Questions submitted after the due date and time for questions will not be accepted. Any resulting addition, deletion, or change to the solicitation will be made by issuing a formal amendment. Offerors are

Title: Orthotics Technician Services; Attachment C – Clauses, Instructions and Evaluation; Solicitation instructed to contact only the issuing contract office in connection with any aspect of this requirement prior to contract award.

Electronic documents submitted as part of your quote shall be submitted in Word or PDF, single spaced, printable on 8.5 x 11-inch paper, paginated front to back, font 12 Times New Roman, .5 to 1 inch margins, and searchable. Pricing information shall be submitted in MS Excel format with formulas intact. Each page shall be numbered in a page X of Y format, for example; page 1 of 3, page 2 or 3, page 3 of 3. Each page shall include a header that states the organizational name and if applicable a footer on applicable pages that notes that proprietary information. Each volume shall be formatted to include a table of contents which corresponds to the section of that volume.

Technical Quotes shall not exceed 15 pages, excluding attachments, addendums, resumes and other required appendices. Offerors are advised to strictly observe limitations on the length and format specified since review of the quote will be limited to 15 pages. There is no page limit for the business quote.

Where data and/or information appear in one volume, it does not have to be repeated in any other part. However, if data and/or information does appear in more than one volume it shall be cross referenced by indicating the specific location including the volume and page number as a minimum. The clarity, relevance, and conciseness of the quote is important, not the length.

The Government will evaluate quotes in accordance with the evaluation criteria set forth within this solicitation.

This solicitation does not commit the Government to pay any cost for preparation or submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition.

United States Governmental, or Department of Health and Human Services, or Health Resources Services Administration, or National Hansen’s Disease Program letterhead and/or logo should not be included in your quote. Your quote also should not include quotes from past contracts unless it is requested in the past performance section.

Technical Quote Instructions – Volume I

Volume I–Technical Quote shall not contain references to price/cost; however, resource information such as data concerning labor hours and categories, materials, subcontracts, etc., shall be contained in the technical quote so that the Offerors understanding of the statement of work may be evaluated. It shall disclose the technical approach in sufficient detail to provide a clear and concise presentation that includes the requirements of the technical quote instructions.

Volume I–Technical Quote shall include a statement indicating whether or not any exceptions are taken to the terms and conditions of this solicitation as part of the quote transmittal letter.

Title: Orthotics Technician Services; Attachment C – Clauses, Instructions and Evaluation; Solicitation

Any exceptions taken must include identification of the specific paragraphs and rationale for each exception. Exceptions shall also be noted in the quote, at the location of the exception.

In order to establish uniformity and to facilitate the evaluation, volume I shall address and be organized as follows:

Factor 1: Technical

1. Understanding the Scope of Work

The Offeror shall:

• Demonstrate, in the Offeror’s own words, a clear understanding of the mission of the NHDP and the objectives and tasks described in the Statement of Work (SOW).

• Describe its understanding of peripheral nerve damage and the management of the secondary effects of nerve damage.

2. Technical Approach

The Offeror shall describe its technical approach in meeting each of the requirements set forth in the SOW.

3. Key Personnel and Staffing Plan

The Offeror shall:

• Provide a detailed staffing plan describing its approach to backfilling the orthotics technician primarily assigned under this contract in the event they are unavailable or unable to perform.

• Identify the individual(s) to perform as the orthotics technician and backup orthotics technician under this contract.

• Provide a resume or curricula vitae (CVs) of the orthotics technician to perform the required tasks described in the SOW.

• Describe the candidate’s experience, specifically including the following minimum requirements:

o Documented experience working with fabrication of orthotics, insoles, sandals and making shoe modifications.

o Documented experience scanning feet, designing and fabricating orthotics with the AMFIT system.

o Experience working with individuals affected by Hansen’s disease or an equivalent neuropathic patient.

Factor 2: Past Performance

Title: Orthotics Technician Services; Attachment C – Clauses, Instructions and Evaluation; Solicitation

Past Performance Instructions – Volume II

Volume II – Past Performance shall contain information related to the offerors past performance on past contracts where the offeror was the prime contractor or subcontractor for relevant work completed within the past three (3) years as required by this solicitation. “Relevant” is defined as similar in size, scope and complexity to this procurement.

If the Offeror has not held any relevant Federal contracts, then the Offeror may submit references from state/local, private sector clients, or Federal clients using the Past Performance Questionnaire (Attachment D). Offeror’s shall forward a copy the Past Performance Questionnaire to their clients to complete. The completed questionnaire shall be submitted by the client in PDF format by July 25, 2022 at 3:00PM via email to cwhitney@hrsa.gov.

In the case of an Offeror without a record of past performance or for whom information on past performance is not available, the Offeror may not be evaluated favorably or unfavorably.

Therefore, the Offeror shall be determined to have a neutral past performance.

The Government reserves the right to obtain information for use in the evaluation of past performance from any and all sources including sources outside of the government.

Acceptable methods for providing a total of three (3) past performance references are:

a. Past Performance Questionnaire (Attachment D).

b. Contractor Performance Assessment System (CPARS) reports/ratings.

c. Combination of questionnaires and CPARS reports/ratings.

Factor 3: Price

Business Quote – Volume III

The price quote shall propose labor categories, labor hours, any unit pricing used, any discounts offered and any other relevant pricing information that adequately fulfill the requirements set forth in the SOW for the base and all optional items/tasks. The Offeror shall furnish a price breakdown to accomplish the SOW including a total firm-fixed price associated to the tasks listed in the SOW.