Solicitation_18-258-SOL-00013;_Title_Orthopedic_Surgeon_Services.pdf

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Orthopedic Surgeon Services Federal contract opportunity
Solicitation number
18-258-SOL-00013
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Department of Health and Human Services Health Resources and Services Administration

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Solicitation: 18-258-SOL-00013; Title: Orthopedic Surgeon Services

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Document Type: Combined Synopsis/Solicitation

Solicitation Number: 18-258-SOL-00013

Posted Date: July 6, 2018

Date, Time and Place Where Offers are Due: July 24, 2018, at 2:00PM (EDT)

Jlohmeier@hrsa.gov

Classification Code: 8062

NAICS Code: 621111

Contracting Office Address

Health Resources and Services Administration

Office of Acquisition Management & Policy

5600 Fishers Lane, Room 14W26

Rockville, MD 20857

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and

Solicitation for Commercial Items,” as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation, proposals are being requested and a written solicitation document will not be issued.

The Health Resources and Services Administration (HRSA) is contemplating issuance of award pursuant to Federal Acquisition Regulation (FAR) Part 13.106.

This combined synopsis/solicitation (18-258-SOL-00013) is a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular 2005-97.

This is a Firm Fixed Price Requirement. The Government is not responsible for payment exceeding the award amount.

Statement of Work

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.

II. Purpose / General Description

The purpose of this requirement is for Orthopedic Surgeon services. The services shall include diagnosis and treatment of orthopedic conditions related to Hansen’s disease. The primary focus of treatment shall be on patients with peripheral neuropathy and neuropathic limb dysfunction secondary to Hansen’s mailto:Jlohmeier@hrsa.gov disease, performance of surgical wound debridement, management of inflamed/compressed nerves, reconstructive surgery and prevention of UE and LE amputations.

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, exact dates to be entered at time of award.

The place of performance shall be primarily at the National Hansen's Disease Programs located at

Ochsner Hospital Medical Center Drive Physicians Plaza II, Baton Rouge, LA. However, performance shall also be required at Saint Clare Nursing Home, Baton Rouge, LA 70816, Lane Memorial Hospital

Zachary, LA and presentations shall be conducted at various sites in the Baton Rouge area, including the

NHDP and Gillis W. Long Center in Carville, LA.

Core Days and Hours of Operation

Services shall be required 6 hours per week during the core hours of 7:30am to 5:00pm, Monday through

Friday (except Federal Holidays).

No services or deliverables shall be provided on Federal Government Holidays, or any other day as set forth by Presidential Executive Order.

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)

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)

VI. Tasks

The Contractor shall:

1. Provide orthopedic evaluation and treatment primarily to patients with peripheral neuropathy effecting the hands and feet.

2. Perform orthopedic surgery when indicated (approximately 48 procedures per year), pre-op/post-op follow-up and diagnostic and treatment services. The contractor shall submit operative reports or oral dictation as required. The contractor may be required to return to the NHDP facility and/or local hospital(s) for emergency calls.

3. Perform surgical procedures including: amputations, reconstructive surgery on clawed hands and dropped feet, nerve transpositions, nerve biopsies, wound debridement and other reconstructive surgeries on hands and feet.

4. Consult with NHDP physicians, Ambulatory Hansen’s Disease Program physicians, Private

Physicians and medical professionals throughout the country, and provide training to ambulatory clinic staff and visiting health professionals.

5. Attend bi-weekly Hand /Foot Clinics. The contractor shall participate in the meetings which address treatment needs of current patients, pre-admission needs for potential patients, and discharge planning for patient needs when treatment is completed.

6. Provide PowerPoint presentations and provide a speaker for NHDP affiliated seminars to lecture on topics related to lower extremity amputation prevention, orthopedic evaluation and surgical procedures related to the management of the neuropathic hands and feet including wound debridement, evaluation and management of Charcot foot, and reconstructive surgery.

7. The contractor shall manage and maintain Federal records, including electronic records, 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 recordkeeping systems for electronic records?”, and

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, “Guidance on Managing Records in Cloud

Computing Environments”

(http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html).

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 records to NARA or deletion of temporary records in accordance with

NARA-approved retention schedules.

8. Adhere to Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or order (hereafter

“contract”), or portion thereof, includes either or both of the following:

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

http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25 https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html

b. Operate a Federal System Containing Information: A Contractor 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.

b. 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 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.

c. 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.

d. 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 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).

e. 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 A). 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.

f. 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 CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. The contractor shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HRSA Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life of the contract. The training can be requested by emailing the records management team at recordsmanagement3@hrsa.gov. 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.

g. 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, the HRSA Information

Technology 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/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 HRSA

Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable.

h. Incident Response

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT

Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security

Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident

Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

In the event of a suspected or confirmed incident or breach, the Contractor 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, mailto:recordsmanagement3@hrsa.gov the Contractor shall send notifications to affected individuals as expeditiously as practicable, without unreasonable delay, and in accordance with applicable law.

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.

i. Position Sensitivity Designations

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

j. Homeland Security Presidential Directive (HSPD)-12

Contractor personnel 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 will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR, with a copy to the Contracting Officer, 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.

k. 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. All information systems development or enhancement tasks supported by the contractor shall follow the HRSA EPLC framework and methodology (https://sharepoint.hrsa.gov/oo/oit/dcppm/pmo/Shared

Documents/z_Old PMO Archives/Documents.aspx) and in accordance with the HHS

Contract Closeout Guide (2012).

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/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.

4. Notification. The Contractor shall notify the CO and COR and system ISSO within 10 days before an employee stops working under this contract.

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 CO and/or 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/or HRSA policies.

https://sharepoint.hrsa.gov/oo/oit/dcppm/pmo/Shared%20Documents/z_Old%20PMO%20Archives/Documents.aspx https://sharepoint.hrsa.gov/oo/oit/dcppm/pmo/Shared%20Documents/z_Old%20PMO%20Archives/Documents.aspx

6. The Contractor shall perform and document the actions identified in the HRSA

Contractor Employee Separation Checklist when an employee terminates work under this contract within 10 days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

V. Schedule of Deliverables

508 Compliance

All products and services delivered under this contract must be Section 508 compliant in accordance with the HHSAR Clause provided. The Section 508 Standards applicable to this contract are:

1194.21, 1194.22, 1194.23, 1194.24, 1194.31 and 1194.41.

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 Reports, Invoices, and Deliverables

Item Quantity Due Date Place to Report

Task 2. Operative

Report

10-12 per year 7 working days of procedure Faxed to Medical

Records Department 225-

756-3706

Task 6.

PowerPoint

Presentation

2-4 PowerPoint due to COR 1 week before the delivery (date of event will be communicated to contractor at least 3 months in advance of presentation).

PowerPoint file due to

COR 1 week before the delivery.

Task 10. Baseline

Security

Requirements:

Roster

Roster Within 14 days of the effective date of the award

Email to the COR:

jfigarola@hrsa.gov http://www.hhs.gov/web/section-508/making-files-accessible/index.html http://www.hhs.gov/web/section-508/making-files-accessible/index.html mailto:jfigarola@hrsa.gov

Task 10. Baseline

Security

Requirements:

Contractor

Employee Non-

Disclosure

Agreement (NDA)

Contractor

Employee Non-

Disclosure

Agreement

(NDA)

Prior to performing any work on behalf of HHS

Email to the COR:

jfigarola@hrsa.gov

Task 10. Baseline

Security

Requirements:

Training Records

Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Email to the COR:

jfigarola@hrsa.gov

Task 10. Baseline

Security

Requirements:

Rules of Behavior

Signed ROB for all employees

Initiation of contract and at least annually thereafter

Email to the COR:

jfigarola@hrsa.gov

Task 10. Baseline

Security

Requirements:

Incident Response

Incident Report

(as incidents or breaches occur)

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

Email to the COR:

jfigarola@hrsa.gov

Task 10. Baseline

Security

Requirements:

Incident Response

Incident and

Breach

Response Plan

Upon request from government Email to the COR:

jfigarola@hrsa.gov

Task 10. Baseline

Security

Requirements:

Personnel Security

Responsibilities

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:

jfigarola@hrsa.gov mailto:jfigarola@hrsa.gov mailto:jfigarola@hrsa.gov mailto:jfigarola@hrsa.gov mailto:jfigarola@hrsa.gov

VI. Payment Schedule

The contractor shall submit monthly invoices on a firm-fixed price basis after services are rendered and accepted by the Government.

VII. 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

Task 10. Baseline

Security

Requirements:

Personnel Security

Responsibilities

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 Brigitte Fields:

bfields@hrsa.gov

Task 10. Baseline

Security

Requirements:

Background

Investigation

Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

Contact Brigitte Fields:

bfields@hrsa.gov

Task 10. Baseline

Security

Requirements:

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:

jfigarola@hrsa.gov mailto:bfields@hrsa.gov mailto:bfields@hrsa.gov 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.

Contracting Officer Representative (COR)

The person identified below is hereby designated as the COR for this contract. The responsibility of the

COR-is to ensure that the services as outlined in this contract are carried out by the contractor. To this end the COR will provide necessary information, direction, coordination, and et cetera, within scope of this contract. Issuance of changes which affect this contract such as scope or terms and conditions will be accomplished by the Contracting Officer who is the only party authorized to commit the Federal

Government. The Contracting Officer shall unilaterally change the COR when necessary.

COR

(To Be Determined at Time of Award)

Pricing Schedule:

Line

Item Description Quantity Unit Price Total Price

Orthopedic Surgeon Services

Base Period 12 months

Orthopedic Surgeon Services

Option Period I 12 months

Orthopedic Surgeon Services

Option Period II 12 months

Orthopedic Surgeon Services

Option Period III 12 months

Orthopedic Surgeon Services

Option Period IV 12 months

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) AND DEPARTMENT

OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR

CHAPTER 3) CONTRACT CLAUSES

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CONTRACT

CLAUSES

Provisions at FAR 52.212-1; Instructions to Offerors–Commercial Items (Jan 2017), applies to this acquisition. The following agenda also apply:

Submit a Firm Fixed Price quote for the base period and all option periods.

o Quote shall:

Include unit and total pricing per included schedule.

Include detailed specifications for services to be provided.

Clearly list exception(s) and rationale for the exception(s).

Be signed by an official authorized to bind the organization to contractual awards.

The Government intends to make award as a result of this combined synopsis/solicitation that will include the terms and conditions as set forth herein. To facilitate an award, quotes shall include a statement regarding the terms and conditions as set forth herein as follows:

a) The terms and conditions in the combined synopsis/solicitation are acceptable to be included in the award document without modification, deletion, or addition.

Or

b) The terms and conditions in the combined synopsis/solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:

One electronic quote shall be submitted via email to Jennifer Lohmeier at jlohmeier@hrsa.gov.

This RFQ does not commit the Government to pay any cost for the preparation and 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 acquisition.

Questions regarding this solicitation shall be submitted electronically via email to Jennifer

Lohmeier at jlohmeier@hrsa.gov no later than 10:00AM ET, Friday, July 13, 2018.

1. Technical Factors

a. Technical Approach and Understanding

The Offeror shall demonstrate in its own words a clear understanding of the mission of the NHDP and of the objectives and tasks of the scope of work. The offeror shall describe an understanding of Hansen’s disease related complications and prevention of disability in patients with neuropathy. The Offeror shall describe its approach to carrying out the tasks identified in the Statement of Work.

b. Management Plan

The Offeror shall provide a management plan that demonstrates an effective approach to provide qualified staff and backup personnel to carry out the task listed in the statement of work specifically evaluating and managing the neuropathic hand and foot to prevent amputations, disability and deformity by effective http://acquisition.gov/comp/far/index.html mailto:jlohmeier@hrsa.gov orthopedic evaluation and treatment, surgical management of wounds, reconstructive surgery, presentations and education of patients and training health professionals.

c. Key Personnel

The offeror shall identify the individual(s) proposed to perform the Orthopedic Surgeon tasks and provide a resume/CV. The Offeror shall describe the proposed candidate’s experience, including specifically the following minimum requirements:

Board Certified Orthopedist

Completion of Hand Surgery Fellowship

Member of American Society for Surgery of the Hand

Licensed Orthopedic Surgeon

At least ten years of experience as an Orthopedic Surgeon

Five years postgraduate experience performing tendon transfers, arthrodesis, and amputations, on both hands and feet of patients' with Hansen’s disease. (CV to include hospitals where surgery on hands and feet was performed and point of contact).

At least five years of experience with wound management and neuropathic hand and foot care.

d. Organizational Experience

The Offeror shall demonstrate its experience and competence in providing Orthopedic Surgery services.

2. Past Performance Factor

The proposal shall document the offerors experience, which shall include a statement of the mission and purpose, and general background of the organizational entity offering to conduct the work described in this contract. The proposal shall include clear descriptions of prior contracts that are relevant to the content and approaches of this solicitation. Each description shall indicate the type of the contract, and the name, organization and phone number of an individual who could be contacted for information about the prior work. It is incumbent upon the Offeror to explain the relevance of all past performance data and information provided. The Government does not assume the duty to search for data to cure challenges with past performance data and information. The burden of providing thorough and complete past performance data and information remains with the Offeror.

The proposal shall identify three (3) past performance references on same or similar work as required by this solicitation and completed within the past three (3) years. A list shall be included that cites these references and explains the relevance of each contract to this solicitation. The proposal may include one

(1) past performance reference for a subcontractor if a portion of the proposed work is to be subcontracted. If a past performance reference for a subcontractor is used, the proposal shall state the subcontractor’s name, project manager’s name, street address, phone number, and e-mail address. The subcontractor’s past performance reference will be included in the maximum number of three (3) past performance references. In addition, offerors are responsible for ensuring that the provided references submit the past performance questionnaire form (Attachment B) as part of their proposal by the solicitation closing date and time.

The past performance questionnaire is provided as Attachment B to this solicitation. Offerors shall complete section 1 of the attached past performance questionnaire and forward a copy of the entire questionnaire to be completed by the three (3) organizations identified as past performance references.

Offerors shall advise the reference reporting organizations that: (a) the completed questionnaire is to be considered source selection sensitive in accordance with FAR 3.104 and (b) shall be submitted to Jennifer

Lohmeier at jlohmeier@hrsa.gov by the closing date and time of this solicitation.

Any questionnaires received from organizations other than those identified as the three (s) past performance references will not be considered. In accordance with FAR 15.306, the Offeror may be given the opportunity to address adverse past performance information obtained from the questionnaires to which the Offeror has not previously had an opportunity to respond.

Offerors are reminded that both independent data (such as information obtained from PPIRS databases, other databases available to the Government, and any and all sources including sources outside of the

Government) and data provided by the offerors in their past performance information may be used to evaluate an offerors past performance.

The following information shall be included in the past performance proposal, list of three (3) past performance references:

Offeror Name, Cage Code and DUNs.

Program Title.

Name of Contracting Agency/Commercial Activity.

Contract Number/Identification Number

Award Date.

Contract Type (FFP, FPIF, CPIF, etc.).

Awarded Amount.

Name, mailing address, telephone number, fax number and email address of the customer program manager, PCO and ACO for each Government contract, or the contract administrator for each major subcontract/commercial contract.

Contract Period of Performance.

Relevancy: Describe the relevancy of the past or present contract/subcontract to this solicitation.

Relevancy discussion may also include end item comparison with respect to use or complexity;

size and scope of the effort.

Provide any other information that the Offeror deems important to understand the past performance on the contract/subcontract, the offerors ability to deliver quality products and services, meet schedule/performance requirements, and achieve customer satisfaction.

For offerors with no past performance history, the proposal shall state "No Past Performance History

Available".

3. Cost/Price Factor

The quote shall include sufficient administrative and management data and information that will enable a complete analysis of the responsibility of the organization. Financial capabilities related to performance of the statement of work shall be included. Additionally, data and information related to the extent of proposed subcontracting with small businesses shall be included, if applicable.

Complete the Pricing information for the CLINs.

Complete the required reps and certs.

Provisions at FAR 52.212-2; Evaluation – Commercial Items (Oct 2014), applies to this acquisition.

The following agenda also apply:

A Best Value Trade-off type of evaluation methodology will be utilized, and explained as follows:

The Technical Factors are more important than the Past Performance Factor. When the Technical Factors and the Past Performance Factor are combined they are significantly more important than the Cost/Price

Factor.

1. Technical Factors

a. Technical Approach and Understanding (25 points)

The Government will evaluate the Offeror’s technical approach and understanding to ensure there is a clear understanding of the mission of the NHDP and of the objectives and tasks of the scope of work as well the Offeror’s understanding of Hansen’s disease related complications and prevention of disability in patients with neuropathy.

b. Management Plan (25 Points)

The Government will evaluate the Offerors management plan to ensure quality, completeness, and effectiveness of the plan for meeting the requirements

c. Key Personnel (40 Points)

The Government will evaluate the Offerors key personnel to ensure they have the knowledge, skills and abilities as required for the Orthopedic Surgeon described.

d. Organizational Experience (10 Points)

The Government will evaluate the Offerors demonstrated experience and competence in providing Orthopedic Surgery services to determine its ability to adequately carry out the tasks identified in the SOW.

2. Past Performance Factor

Past performance will be rated in accordance with the following table:

Rating Definition

Substantial

Confidence

Based on the Offeror’s recent/relevant performance record, the Government has a high expectation that the Offeror will successfully perform the required effort.

Satisfactory

Confidence

Based on the Offeror’s recent/relevant performance record, the Government has a reasonable expectation that the Offeror will successfully perform the required effort.

Limited Confidence Based on the Offeror’s recent/relevant performance record, the Government has a low expectation that the Offeror will successfully perform the required effort.

Rating Definition

No Confidence Based on the Offeror’s recent/relevant performance record, the Government has no expectation that the Offeror will be able to successfully perform the required effort.

Unknown Confidence

(Neutral)

No recent/relevant performance record is available or the Offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.

Sources of past performance information that will be used for evaluation is as follows:

Past performance information provided by the Offeror, as solicited.

Past performance information obtained from questionnaires tailored to the circumstances of the acquisition.

Past performance information obtained from any other sources available to the Government to include, but not limited to, PPIRS or other databases; interviews with Program Managers, Contracting Officers, and Fee-Determining Officials.

3. Cost/Price Factor

The Government will evaluate the offerors total proposed cost/price to determine if it is fair and reasonable.

Provisions at FAR 52.212-3; Offerors Representations and Certifications–Commercial Items (Nov

2017), applies to this acquisition. The offeror shall ensure that Representations and Certifications are complete when submitting their quote.

Provisions at FAR 52.212-4; Contract Terms and Conditions – Commercial Items (Jan 2017), applies to this acquisition. The following agenda also apply:

FAR 52.204-7 System for Award Management

FAR 52.204-13 System for Award Management Maintenance

FAR 52.204-16 Commercial and Government Entity Code Reporting

FAR 52.204-17 Ownership or Control of Offeror

FAR 52.204-18 Commercial and Government Entity Code Maintenance

FAR 52.204-19 Incorporation by Reference of Representations and Certifications

FAR 52.204-20 Predecessor of Offeror

FAR 52.209-2 Prohibition on Contracting with Inverted Domestic Corporations—Representation

FAR 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony

FAR 52.222-25 Affirmative Action Compliance

FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or

Transactions Relating to Iran--Representation and Certifications.

FAR 52.232-39 Unenforceability of Unauthorized Obligations

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

FAR 52.252-2 Clauses Incorporated by Reference

Provisions at FAR 52.212-5; Contract Terms and Conditions Required to Implement Statues or Executive

Order – Commercial Items (Jan 2018), applies to this acquisition. The following agenda also apply:

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan

2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations

Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(3) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)(Public Laws 108-77 and 108-78

(19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or

Executive orders applicable to acquisitions of commercial items:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I

(Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of

2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American

Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016)

(Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of

Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016)

(Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013)

(41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT

2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved]

__ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

X_ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2)and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15

U.S.C. 657 f).

__ (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged

Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business

Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

X_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

X_ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

(E.O. 13496).

X_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O.

13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items

(May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons

(JUN 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air

Conditioners (JUN 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and

13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015)

(E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)

(E.O. 13513).

__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C.

chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and

112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

__ (48) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301note).

X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct

2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10

U.S.C. 2302 Note).

__ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42

U.S.C. 5150).

__ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002)…

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