Attachment 1 - Draft Performance Work Statement.pdf

DRAFT – SOURCES SOUGHT NOTICE

B.3 PERFORMANCE WORK STATEMENT dated 19 August 2024

PERFORMANCE WORK STATEMENT (PWS)

Patient Anklometer Working Prototype (Ankle Meter)

19 August 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 27 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 12/01/2024.

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.