Solicitation 36C25024Q8555.pdf

PAGE 1 OF 85 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

Not Applicable

36C25024Q8555 09-18-2024

Brad Burhite (513) 692-7340 09-25-2024

10:00 EDT

36C250

Department of Veterans Affairs Network Contracting Office (NCO) 10 260 E. University Avenue Cincinnati OH 45219

X

339112

1000 Employees

N/A

See PWS and PRICE/COST SCHEDULE

36C250

Department of Veterans Affairs Network Contracting Office (NCO) 10

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The contractor shall provide all required labor, material, supplies, equipment and supervision of contractor personnel necessary to provide an ANKLOMETER WORKING PROTOTYPE for the innovation office at Cincinnati VA Medical Center (VAMC) in accordance with the terms and conditions established herein.

This solicitation shall be conducted in accordance with FAR Part 13 and is anticipated to result in the award of a firm-fixed price (FFP) type contract.

The anticipated performance periods are recapped as follows:

- Base Period: 28 September 2024 to 31 January 2025

See CONTINUATION Page

Subject to FAR 52.232-18 (Availability of Funds)

X X

X 1

Bradley Burhite

VA-VHA-2020-230A0A03

Solicitation 36C25024Q8555

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE dated 9 September 2024

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT dated 10 September 2024

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

C.3 52.215-22 LIMITATIONS ON PASS-THROUGH CHARGES—IDENTIFICATION OF

SUBCONTRACT EFFORT (OCT 2009)

C.4 52.215-23 LIMITATIONS ON PASS-THROUGH CHARGES (JUN 2020)

C.5 52.219-14 LIMITATIONS ON SUBCONTRACTING (OCT 2022)

C.6 52.224-2 PRIVACY ACT (APR 1984)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.8 52.242-15 STOP-WORK ORDER (AUG 1989)

C.9 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.12 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 49

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION (WD) 2015-4719-R27 HAMILTON COUNTY, OHIO

DATED 7/22/2024 (see attached)

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-2 (Addendum A) – Past Performance Questionnaire E.6 52.212-2 (Addendum B) – Statement of FAR 52.219-14 Limitations on Subcontracting Compliance

E.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.9 52.216-1 TYPE OF CONTRACT (APR 1984)

E.10 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C250

Network Contracting Office (NCO) 10

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Invoices shall be submitted monthly in the arrears upon completion of authorized services.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE dated 9 September 2024

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 EA $____________ $______________

Patient Anklometer Working Prototype (Ankle Meter):

The contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, and other items necessary to provide Patient Anklometer Working Prototype (Ankle Meter) to Cincinnati VA Medical Center (CVAMC) Innovation Office as established in this Performance Work Statement (PWS) and in accordance with terms and conditions established herein. The contractor shall meet all required milestones specified under contract line-item number (CLIN) 0001 which include sub CLIN (SLIN) numbers 0001-AA, 0001-AB-, 0001-AC and 0001-AD.

The contractor shall be available for face-to-face meetings at CVAMC at any time during the contract performance period to discuss the status of this requirement and answer all questions and inquires that the government might have with the progress and status of this requirement.

INVOICING: The contractor shall be authorized to invoice upon final government acceptance with the delivered Anklometer Working Prototype to the Innovation Office at Cincinnati VA Medical Center (CVAMC).

Contract Period: Base POP Begin: 09-28-2024 POP End: 01-31-2025

0001AA

1.00 EA

NSP

Kickoff Meeting: The contractor shall provide a deliverable time phase execution plan to meet deliverable SLIN-0001 (AB), SLIN-0001 (AC) and SLIN-0001 (AD) for design concept submission at the firm-fixed price established under SLIN-0001 (AA) not later than 9/30/2024.

Contract Period: Base POP Begin: 09-28-2024 POP End: 09-30-2024

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: Q999 - Medical – Other

36C25024Q8555

0001AB

Bill of Material (BOM) for Functional Prototype: The contractor shall submit bill of material (BOM) with a list of all Commercially Off The Shelf (COTS) and/or Government Developmental Items that are production ready to the government program manager for review/final concurrence at the firm-fixed price established under SLIN-0001 (AB) not later than 10/31/2024.

Contract Period: Base POP Begin: 09-28-2024 POP End: 10-31-2024

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical

0001AC

CAD Design and Dimensioned Drawings for Functional Prototype: The contractor shall submit a CAD design and dimensioned drawings which meets the government needs for the Patient Anklometer Working Prototype to the government program manager (PM) for review/final concurrence at the firm-fixed price established under SLIN-0001 (AC) not later than 12/02/2024.

Contract Period: Base POP Begin: 09-28-2024 POP End: 12-02-2024

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical

0001AD

Patient Anklometer Functional Prototype (Ankle Meter):

The contractor shall submit the Patient Anklometer Working Prototype to the government program manager (PM) for review/final concurrence at the firm-fixed price established under SLIN-0001 (AD) not later than 1/31/2025.

Contract Period: Base POP Begin: 09-28-2024 POP End: 01-31-2025

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical

PRODUCT/SERVICE CODE: Q999 - Medical - Other

GRAND TOTAL $_________________

B.3 PERFORMANCE WORK STATEMENT dated 10 September 2024

PERFORMANCE WORK STATEMENT (PWS)

Patient Anklometer Working Prototype (Ankle Meter) for Innovation Office at Cincinnati VAMC

10 September 2024

1. GENERAL. This is a non-personnel services contract in which the contractor shall provide a Patient Anklometer Working Prototype (Ankle Meter) to Cincinnati VA Medical Center (VAMC) Innovation Office on a firm-fixed price basis. The government shall not exercise any supervision or control over the contract service providers performing the services herein.

BACKGROUND: The Department of Veterans Affairs (VA) relies on information and data to meet mission goals, including the need for accurate, reliable data to continuously improve processes as the organization works toward zero harm. Veterans’ Health Administration (VHA) Innovation Ecosystem (IE) is the catalyst for enabling the discovery and spread of mission-driven health care innovation to advance care delivery and service that exceeds expectations, restores hope, and builds trust with the Veteran community, which is one of the key components towards VHA’s transformation to a high reliability organization (HRO).

The idea for the “anklometer” (or ankle meter) arose at Cincinnati VAMC due to the realization that there is no device available on the open market for patients to ‘self-measure’ ankle swelling or lymphedema diameter or circumference. Most of our patients rely on a bathroom weighing scale to track their daily body weights. This is problematic because it is arduous for patients to use a weighing scale due to the fact that some do not have the balance, strength or mobility to use one. A self-measuring device in the form of an anklometer can provide a safer, easier alternative to improve the healthcare of our Veteran patients.

1.1 SCOPE SUMMARY. The contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, and other items necessary to provide Patient Anklometer Working Prototype (Ankle Meter) to Cincinnati VA Medical Center (VAMC) Innovation Office as established in this Performance Work Statement (PWS) and in accordance with terms and conditions established herein.

1.2 PERIOD OF PEFORMANCE. The periods of performance for the base and all option periods for this contract are summarized as follows:

Base Period (CLIN-0001): Patient Anklometer Working Prototype (Ankle Meter) o 28 September 2024 to 31 January 2025

1.3 GENERAL REQUIREMENTS

1.3.1 Federally Recognized Holidays. The service provided by the contractor is anticipated to be unaffected by Federally recognized holidays in accordance with the terms and conditions established in this PWS to include but not limited to the following:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

1.3.2 Hours of Operation. The business hours of operation are Monday through Friday from 0800-EST to 1630- EST, except on Federally recognized holidays.

1.3.3 Place of Performance. The contractor shall provide services in accordance with the terms and conditions of this contract as specified herein which shall be performed at the contractor’s facility.

1.3.4 Type of Contract. The government intends to award a single-award firm-fixed price (FFP) contract for the effort specified herein. The base and option periods (if any) specified in the PRICE/COST SCHEDULE shall be exercised at the discretion of the government. The authority that will be utilized to award this effort is FAR Part

13.5 (Simplified Procedures for Certain Commercial Items).

1.3.5 Security Requirements and Background Checks. Not Applicable.

1.4.12.1 VAMC/VAACC Identification Badges: No.

1.4.12.2 PHYSICAL Security: Not Applicable.

1.4.12.3 Key Control: Not Applicable.

1.4.12.4 Lock Combinations: Not Applicable.

1.3.6 Post Award Conference/Periodic Progress Meetings. The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, government program manager, and other government personnel, as appropriate, may meet periodically with the contractor to review the contractor’s performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor’s performance and the contractor will apprise the government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.3.7 Government Program Manager (Government PM). The government PM will be identified by the cognizant government contracting officer (CO) in writing. The PM monitors all technical aspects of the contract and assists in contract administration. The PM is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract: maintain written and oral communications with the contractor concerning technical aspects of the contract that are within scope: monitor contractor’s performance and notifies both the contracting officer and contractor of any deficiencies; coordinate availability of government furnished property and provide site entry of contractor personnel. The PM shall be specified in writing by the CO and is not authorized to change any of the terms and conditions of the resulting contract.

1.3.8 Key Personnel. The following personnel are considered key personnel by the government: Project Manager/Alternate Project Manager. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract.

1.3.9 Contractor Travel: Any required travel shall be incorporated in the all-inclusive pricing established in PRICE/COST SCHEDULE for this firm-fixed price (FFP) contract.

1.3.10 Other Direct Costs: Any Other Direct Costs be incorporated in the all-inclusive pricing established in PRICE/COST SCHEDULE for this firm-fixed price (FFP) contract.

1.3.11 Data and Other Rights: See contract.

1.3.12 Organizational Conflict of Interest: Not Applicable

1.3.13 Phase-In /Phase-Out Period: Not Applicable

2. DEFINITIONS AND ACRONYMS

2.1. DEFINITIONS: Not Applicable

2.2. ACRONYMS: Not Applicable

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1 Services: Not applicable

3.2 Facilities: Not applicable.

3.3 Utilities: Not applicable.

3.4 Equipment: Not applicable.

3.5 Materials: Not applicable.

3.6 Information: Not applicable.

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform all services under this contract as defined in this PWS and in accordance with the terms and conditions of this contract.

4.2 Materials, Supplies and Equipment: The contractor shall provide all supplies and materials necessary to produce a fully functioning Patient Anklometer Working Prototype (Ankle Meter) in accordance with this PWS and the terms and conditions of the resultant contract.

5. REQUIREMENTS – DELIVERABLES and SPECIFIC TASKS:

5.1. DELIVERABLES for Patient Anklometer Working Prototype (Ankle Meter)

5.1.1. DELIVERABLE SLIN-0001 (AA) –Kickoff Meeting: The contractor shall provide a deliverable time phase execution plan to meet deliverable SLIN-0001 (AB), SLIN-0001 (AC) and SLIN-0001 (AD) for design concept submission at the firm-fixed price established under SLIN-0001 (AA) not later than 9/30/2024.

o The contractor shall be available for face-to-face meetings at CVAMC at any time during the contract performance period to discuss the status of this requirement and answer all questions and inquires that the government might have with the progress and status of this requirement.

5.1.2. DELIVERABLE SLIN-0001 (AB) –Bill of Material (BOM) for Functional Prototype: The contractor shall submit bill of material (BOM) with a list of all Commercially Off The Shelf (COTS) and/or Government Developmental Items that are production ready to the government program manager for review/final concurrence at the firm-fixed price established under SLIN-0001 (AB) not later than 10/31/2024.

o The contractor shall be available for face-to-face meetings at CVAMC at any time during the contract performance period to discuss the status of this requirement and answer all questions and inquires that

5.1.3. DELIVERABLE SLIN-0001 (AC) –CAD Design and Dimensioned Drawings for Functional Prototype: The contractor shall submit a CAD design and dimensioned drawings which meets the government needs for the Patient Anklometer Working Prototype to the government program manager (PM) for review/final concurrence at the firm-fixed price established under SLIN-0001 (AC) not later than 12/02/2024.

o The contractor shall be available for face-to-face meetings at CVAMC at any time during the contract performance period to discuss the status of this requirement and answer all questions and inquires that

5.1.4. FINAL DELIVERABLE SLIN-0001 (AD) – Patient Anklometer Functional Prototype (Ankle Meter): The contractor shall submit the Patient Anklometer Working Prototype to the government program manager (PM) for review/final concurrence at the firm-fixed price established under SLIN-0001 (AD) not later than 1/31/2025.

o The contractor shall be available for face-to-face meetings at CVAMC at any time during the contract performance period to discuss the status of this requirement and answer all questions and inquires that

5.1.5. ASSUMPTIONS: The contractor shall provide all deliverables under CLIN-0001 on a firm-fixed price basis at no additional cost to the government other than the price established in the PRICE/COST SCHEDULE in the contract.

5.1.6. PERFORMANCE SPECIFICATIONS:

5.1.6.1 FUNCTIONAL OVERVIEW: The patient shall be able to utilize the Anklometer from a chair in a seated position by manually loosening the measurement lasso from the digital tape measure (Anklometer) by using their left hand or right hand. The patient shall then be able to place the Anklometer against their leg and loop it around the swollen limb surface for which the patient would like to measure to determine the diameter or circumference. To ensure a minimum effort is required, the patient shall be able to utilize an adjustable Anklometer pole that can retract to a minimum length of 2 feet and extend to a maximum length of 3 feet. Once the Anklometer is in the proper position to operate, the patient shall be able to then squeeze the hand trigger using their right or left hand to enable the lasso to securely retract around the swollen limb, measure the limb in inches and produce a display on the LCD screen that lasts at least 30 seconds. From this point, the patient shall have the ability to manually tug on the Anklometer in a gentle manner to loosen the lasso grip on the swollen limb. Thereafter, the patient shall be able to take the device off the limb and look at the LCD screen which shall display the measurement in inches and shall last for 30 seconds before the screen clears. From a bed position, in which the patient is sitting slightly upright, the patient shall have the ability to repeat the steps above to verify the accuracy of Anklometer measurements.

5.1.7. MAJOR SYSTEM COMPONENTS:

5.1.7.1 MAJOR COMPONENT #1 | HANDLE: The contractor shall ensure that the handle grip of the patient control system is made of hard plastic for durability. Furthermore, the contractor shall ensure the design concept contour of the handle grip considers ease of use of a trigger mechanism operated by the push of a button or squeeze of a button to engage the digital measuring tape.

5.1.7.2 MAJOR COMPONENT #2 | PATIENT CONTROL MECHANISM: The contractor shall ensure that the patient control system/mechanism is of analog construction and not motorized (no batteries).

It shall be located on the opposite end from the digital measuring tape and extension pole. In addition, the contractor shall ensure that the patient control system/mechanism has either a trigger mechanism operated by the push of a button or squeeze of a button to engage the digital measuring tape.

5.1.7.3 MAJOR COMPONENT #3 | EXTENSION POLE: The contractor shall ensure that the Anklometer extension pole is fully adjustable with a minimum retractable length of 2 feet and maximum extendable length of 3 feet.

5.1.7.4 MAJOR COMPONENT #4 | LASSO FOR MEASUREMENT: The contractor shall ensure that the lasso material is made of either a ribbon of cloth or flexible plastic. In addition, the contractor shall ensure that the lasso size/width is at least 0.5 of an inch. Further, the contractor shall ensure that the anklometer lasso has a measuring length starting from 0 inches and extending up to 36 inches in total length. Please note that the measurement unit shall be in inches for the lasso.

5.1.7.5 MAJOR COMPONENT #5 | MEASURMENT DEVICE: The contractor shall ensure that the swollen limb is able to be measured by a digital measuring tape device. In addition, the contractor shall ensure that the measuring device is battery powered and has a digital LCD to register the limb measurement in large numbers to be displayed for at least 30 seconds. Furthermore, the contractor shall ensure that the digital measuring device has the capability to automatically retract the lasso to obtain a limb measurement and manually loosen or extend to release from the limb. And lastly, the contractor shall ensure that the digital measuring tape is permanently affixed to the extension pole for safety and ease of use.

5.1.8. CONCEPTUAL PICTURES:

5.3. SPECIFIC TASK | Weekly Status Reports: The contractor shall submit weekly status reports in Microsoft Word or Excel format to the government program manager (PM) every Monday not later than 1000-EST during the performance period until all contractual requirements have been met at no additional cost to the government.

5.4. SPECIFIC TASK | Contract Kickoff Meeting: The contractor shall conduct a contract kick-off meeting within five (5) working days of contract award to validate contract scope, deliverable timelines and invoicing requirements with the government program manager (PM) and government contracting officer (CO) at no additional cost to the government.

5.5 PATENTS: This first-ever Anklometer concept was created at Cincinnati VA Medical Center (VAMC) in Ohio. Therefore, the contractor shall protect all intellectual and proprietary rights of the government which shall be codified in the forthcoming U.S. Patent for this requirement in accordance with Federal Law as prescribed in the Federal Acquisition Regulation (FAR).

5.6 EVALUATION CRITERIA: All offerors shall be expected to submit a Technical Plan in response to the forthcoming solicitation IAW FAR 52.212-2 to provide the following information to ascertain their ability to meet the specification of this PWS:

All offerors shall provide a rudimentary sketch or drawing of the proposed prototype to include all major component parts and subparts.

All offerors shall submit photos and the full specifications for all proposed major component parts and subparts to build this Anklometer working/functioning prototype. These specifications shall include the make, model, part number and serial number of all items that will be utilized to create this working prototype. Please ensure that each part and subpart is specified as either COTS or a Developmental Item as defined in the FAR.

All offerors shall provide shall describe how they shall be available for face-to-face meetings at CVAMC at any time during the contract performance period to discuss the status of this requirement and answer all questions and inquires that the government might have. Please note that this availability for face-to-face meetings shall be at no additional cost to the government other than the agreed Firm-Fixed Price (FFP) established in the resultant contract.

6. OTHER REQUIREMENTS:

6.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall identify and define the management concept for ensuring compliance with all contract requirements. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor will have an on-going quality assurance and /or quality improvement program designed to objectively and systematically measure, assess, and improve performance to enhance patient care and all patient care services. The contractor’s quality control program is the means by which the contractor assures that all work complies with the requirement of the contract. The contractor shall provide a copy of the QCP with their offeror as specified by the Contracting Officer and upon request thereafter. After acceptance of the quality control plan, the contractor shall immediately notify the contracting officer of any proposed changes to their quality control program and submit a change request in writing to the contracting officer. The contractor shall furnish copies of these records if requested by the Contracting Officer, GOVERNMENT PM or individual(s) designated by the GOVERNMENT PM and/or CO in writing. The contractor’s quality control program shall include the following:

6.2 Quality Assurance. The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

6.3. INVOICING PROCEDURES. The contractor shall comply with the terms and conditions established in this contract for invoicing procedures which shall include the following:

6.3.1. Invoicing Procedures. The contractor shall submit invoices only upon completion of work authorized by a government representative designated by the contracting officer in writing. The contractor shall only invoice for authorized work completed not-to-exceed (NTE) the amounts established in the PRICE/COST SCHEDULE for this contract. The contractor shall ensure all invoices reference the following information to be considered for payment by the government:

Contract Number Purchase Order (PO) Number Quantity of items delivered and/or services rendered by Contract Line Item Number (CLIN) and/or

Sub-contract Line Item Number (SLIN) which shall be invoice in the arrears upon delivery and/or completion of services.

7. PERFORMANCE REQUIREMENTS:

7.1 Performance Requirements Summary: The performance requirements are the thresholds of minimum acceptable levels of service critical to successful performance of this contract which are summarized as follows:

PERFORMANCE REQUIREMENTS SUMMARY

Performance Objectives

Performance Standard Acceptable Quality

Level (AQL)

Method of Monitoring

1) Timeliness All deliverables specified within this PWS shall be completed on the date(s) specified in this PWS.

Failure to perform may result in a contract termination IAW FAR 52.212‐4(m).

100% Compliance

PM, COR and/or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

2) Weekly Status Reports

The contractor shall provide weekly status reports every Monday not later than 1000‐EST to the government PM in accordance with the terms and conditions established in the contract.

95% On‐Time

PM, COR and/or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

3) Invoicing Accuracy, Timeliness and Billing Errors

The contractor shall submit invoices in a timely manner for products delivered and/or services rendered the arrears upon completion not later than 5 days after performance in accordance with the PRICE/COST SCHEDULE, PWS and the overall terms and conditions established in the contract.

98% Compliance

PM, COR and/or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

4) Compliance with English Language Requirement

The contractor shall ensure that all employees are fully proficient in the English language at a level sufficient to seamlessly perform all services required in accordance with the terms and conditions of this contract.

100% Compliance

PM, COR and/or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

5) Compliance with FAR 52.219‐14 Limitations on Subcontracting Requirements

The contractor shall submit confirmation of compliance with the FAR 52.219‐14 ‐‐ Limitations on Subcontracting requirement that “at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern” as specified by the Contracting Officer (CO) in writing within four (4) hours of request.

100% Compliance

Contracting Officer (CO) will conduct random compliance checks with the contractor as necessary.

6) Compliance with DOL Wage Determination Labor Rate Requirement

The contractor shall submit confirmation of compliance with the current Department of Labor (DOL) wage determination (WD) hourly rate if requested by the Contracting Officer (CO) in writing within four (4) hours of request which may include an itemized list of the hourly rate being paid for all employees performing services under this contract.

100% Compliance

Contracting Officer (CO) will conduct random compliance checks with the contractor as necessary.

NOTE: The performance of these requirements by contractor will be documented by the government in the CPARS system based on the contractor’s ability to comply with the terms and conditions established in the contract.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a

SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g.

for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA

Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office.