S02 - PWS - ATCH - AA to FF - Remote Patient Monitoring Home Telehealth FY 22 09082021.pdf

Attachment AA - 36C79121R0008

Attachment AA

Definitions of Terms; Acronyms; References

DEFINITIONS

TERM DEFINITION

Browser A web browser (commonly referred to as a browser) is a software application for accessing information on the World Wide Web. When a user requests a web page from a particular website, the web browser retrieves the necessary content from a web server and then displays the page on the user's device.

Care Coordinator Web Viewer

(CCWV)

A secure web portal for viewing clinical data transmitted by any and all Remote Patient Monitoring – Home Telehealth (RPM-HT) platforms. The CCWV is a “dashboard” screen that displays an overview of information for a large panel of Veterans and automatically indicates to the user which Veterans on the panel are at high, medium or low health-risk based on parameters established for each individual Veteran for their Disease Management Protocol responses and vital signs.

Commercial off the shelf item

Any item, other than real property, that is of a type customarily used by the general public or by non-governmental entities for purposes other than governmental purposes, and (i) Has been sold, leased, or licensed to the general public; or (ii) Has been offered for sale, lease, or license to the general public; (See FAR 2.101 –

Definitions for complete definition)

Data Center

(VA)

Hosted environment that could include physical servers, virtual servers, or the VA

Cloud

Descriptive

Literature Information (e.g. illustrations, drawings, product documentation and brochures). As part of the proposal, they shall demonstrate and provide details that the product offered meets the specified minimum technical requirements (Attachment I) and shall contain significant elements such as follows:

• Design

• Materials

• Components

• Performance Characteristics

• Methods of Manufacture Disease Management Protocol

(DMP)

DMPs are clinical management algorithms that help patients to better manage their chronic disease, improve health outcomes, promote self-care management, and provide for timely care in collaboration with their assigned Care Coordinator and their providers.

Hub Stationary device that has capability to transmit data via Plain Old Telephone System

(POTS) and cellular communication channels. Excludes mobile device and Interactive

Voice Response. A mobile device in a stand or docking station is NOT considered a

Hub.

Interactive Voice Response

A telephony technology in which patient uses a touch-tone telephone or voice response to submit peripheral measurements and responses to questions.

Medical Device Data System

(MDDS)

A hardware or software product that transfers, stores, converts formats, and displays medical device data. (21 CFR 880.6310). For the purposes on this solicitation there are seven recognized/acceptable platforms. All proposed platforms should be commercial off-the-shelf (COTS) products which could be tailored to meet VA requirements.

Mobile

Device Platform, with or without wireless connectivity, that are handheld in nature.

Examples of these mobile platforms include mobile computers such as smart phones, tablet computers, or other portable computers. Device could be Vendor provided, VA provided, or Veteran provided.

Mobile Application (Mobile App)

A mobile application, most commonly referred to as an app, is a type of application software designed to run on a mobile device, such as a smartphone or tablet computer.

Mobile applications frequently serve to provide users with similar services to those accessed on PCs.

Panel A group of patients assigned to a Care Coordinator.

Pexip® P browser, and installed clients on Personal Computers

(PC) and

Mac.

Pexip Infinity® is a video conferencing software. It enables quick scaling of video, voice and data collaboration across the enterprise. Pexip supports video connectivity from many clients to include web

Remote upgrade

The ability to apply updates, upgrades and patches to existing hardware and software remotely.

Significant changes to an information system

As defined in VA Handbook 6500.3 https://www.va.gov/vapubs/search_action.cfm?dType=1

System Change Request

(SCR)

Process

System Request (SR) will be initiated by the vendor and submitted to the VA to review the contractor submitted System Change Request (SCR) to address a change to the A established product baseline. The SCR will be reviewed by the RPM-HT Change

Control Board (CCB) and final approval/disapproval will be provided to the contractor upon completion of the CCB review process.

System Incident Report (SIR) Process

A System Request (SR) will be initiated by the vendor and submitted to the VA to review the contractor submitted SIRs. These will address corrections that occur when a product fails to satisfy a previously misinterpreted or not clearly understood, and when the output is different from the identified requirements for the device or product producing the output. established requirement, when a fix or patch shall be installed to correct an operational problem or a security vulnerability, when a requirement was

System Request (SR) Form

A System Request (SR) is completed by the vendor to initiate the SCR or SIR process.

The form is submitted to the VA for review and approval by the CCB. This process is referenced in Section 9 of the RPM-HT Telehealth Configuration Management Plan

(Attachment X).

Technology Refresh

The periodic replacement of Commercial Off-The-Shelf (COTS) components, e.g.

processors, displays, computer operating systems, Commercially Available Software

(CAS) within consolidated procurements to assure continued supportability of that system through an indefinite service life.

Update Updates are software patches of code that are released in order to address certain issues or to activate specific functionalities. Updating means patching regularly. For example, this could be from version 5.1 to version 5.1.1.

Upgrade Upgrade is the act of replacing your product with a newer, and often more superior, version or similar product. Upgrading from one version to the other. For example, this could be from version 5 to version 6.

Video Hub A hub with video capability

ACRONYMS see

PWS

REFERENCES

VA or VHA references https://www.va.gov/vapubs/search_action.cfm?dType=1

NIST or FIPS documents https://csrc.nist.gov/publications/detail/fips/140/2/final;

https://csrc.nist.gov/publications/detail/fips/140/3/final

Pexip® https://docs.pexip.com/files/v10/Pexip_Infinity_Specifications_and_Requirements

_v10.a.pdf

QASP | Remote Patient Monitoring - Home Telehealth

Attachment BB

36C79121R0002

Department of Veteran Affairs

Quality Assurance Surveillance Plan

For

Remote Patient Monitoring - Home Telehealth

Contract Number:___________________________

Contractor:_______________________________________

Date Version Editor/Author Notes

1.0 Initial Version

36C79121R0002

Contents

1. INTRODUCTION

1.1 PURPOSE

1.2 PERFORMANCE MANAGEMENT APPROACH

1.3 PERFORMANCE MANAGEMENT STRATEGIES

2. ROLES AND RESPONSIBILITIES

2.1 Contracting Officer

2.2 Contracting Officer Representative

2.3 Other Key Government Personnel

2.4 Contractor Representative(s)

3. IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY

LEVELS

3.1 General Areas to be Monitored during Contract Performance

Quality of Services Provided

Timeliness of Performance / Adherence to Schedule

Cost Control

7 Business Relations

Regulatory Compliance

3.2 Performance Standards

36C79121R0002

3.3 Contract Monitoring

4. Methods of Quality Assurance (QA) Surveillance

4.1 Customer Feedback

4.2 Verification of Documentation Provided by Contractor

4.3 Periodic Inspection

4.4 Random Monitoring

4.5 Acceptable Quality Levels

4.6 Process for Missed Targets

5. Quality Assurance Documentation

5.1 The Performance Management Feedback Loop

5.2 Monitoring Forms

5.2.1

6. Analysis of Quality Assurance

6.1 Determining Performance

6.1.1 Performance Documentation

6.2 Reporting

6.3 Reviews and Resolution

6.3.2

6.3.3

36C79121R0002

6.4 CPARS Annual Assessment

7. QASP ANNUAL ASSESSMENT

8. SUMMARY

9. LIST OF APPENDIX

Appendix Q1: PERFORMANCE REQUIREMENT SUMMARY

APPEMDIX Q2: Quality Assurance Monitoring Form

APPENDIX Q3: QUALITY ASSURANCE MONITORING FORM – CUSTOMER

COMPLAINT INVESTIGATION

APPENDIX Q4: Submittals Table Checklist

APPENDIX Q5: Surveillance Activity Checklist

Appendix Q6: CONTRACT DISCREPANCY REPORT

APPENDIX Q7: PM/COR Monthly Report to Contracting Officer

APPENDIX Q8: QASP PERIODIC MAINTENANCE, REVIEW AND ACCEPTANCE

1. INTRODUCTION

This IDIQ level quality assurance surveillance plan (QASP) sets forth procedures and guidelines the Department of Veteran Affairs, Commodities Services and Acquisition Services (CSAS) and

Prosthetics will use in ensuring the required performance standards and supplies are achieved by the contractor.

Authority to issue this QASP is provided under Federal Acquisition Regulation (FAR) Clause

52.212-4(a) Alt I Inspection/Acceptance, and FAR 52.246-4 Inspection of Services which provided for inspections and acceptance of the articles, services, and documentation called for in the contract to be accomplished by the contracting officer or a duly appointed representative.

1.1 PURPOSE

The purpose of the QASP is to describe the systematic methods used to monitor the IDIQ performance and the identify the required documentation and the resources to be employed. The

QASP provides a means for evaluating whether the contractor is meeting the performance standards identified in Attachment Q1.

The QASP defines the roles and responsibilities of all members of the integrated project team

(IPT), identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes the quality assurance documentation requirements and describes the analysis of quality assurance monitoring.

This QASP is based on the premise the Government desires to maintain a quality standard in customer service operations and repairing defective devices and that a service contract to provide the service is the best means of achieving that objective.

1.2 PERFORMANCE MANAGEMENT APPROACH

The QASP will define the performance management approach taken by CSAS to monitor contractor’s performance to ensure performance standards identified in Attachment are achieved.

Performance Management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether acceptable performance under the IDIQ is being achieved by the contractor.

1.3 PERFORMANCE MANAGEMENT STRATEGIES

The government representative(s) will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against the performance standards shown in attachment.

The contractor is responsible for the quality of all work performed. The contractor measures that quality through the contractor’s own quality control (QC) program which can be commercial standard practices. QC is work output, not workers, and therefore includes all work performed under this IDIQ regardless of whether the work is performed by contractor employees, teaming partners, or subcontractors.

The first major step to ensuring a “self-correcting” contract is to ensure that the quality control program approved at the beginning of the contract provides the measures needed to lead the contractor to success.

The Contractor shall provide a general Quality Control Plan (QCP) with the technical proposal.

The contractor is responsible for ensuring services are performed in accordance with PWS requirements. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The QCP shall outline how performance issues will be remedied or addressed (i.e. performance improvement plans, suspensions, reprimands and/or terminations).

Once the quality control plan is approved, careful application of the process and standards presented in the remainder of this document will ensure a robust quality assurance program. This

QASP is a “living document” and the Government may review and revise it on a regular basis.

The Government will coordinate changes with the contractor through contract modification.

Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing the surveillance activities. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

2. ROLES AND RESPONSIBILITIES

2.1 Contracting Officer

The contracting officer (CO) is responsible for monitoring IDIQ compliance and administration and for resolving any differences between observations documented by the program office contracting officer’s representative (COR) and the contractor. The CO will designate a COR as the government authority for performance management. Assigned CO:-

2.2 Contracting Officer Representative

The contracting officer’s representative (COR) is designated in writing by the CO to act as his or her authorized representative to assist in administering the IDIQ. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf. Any changes that the contractor deems may affect price, terms, or conditions shall be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance.

Assigned

COR:_________________________________________________________________________

2.3 Other Key Government Personnel

Contracting Specialist(s), Contracting Officer Representative (COR), and Program Manager

(PM) will provide contractual guidance and requirements when needed or appropriate. Any unforeseen or potential conflicts or problems can be addressed with the individuals listed but for any contractual changes, the Contracting Officer is the ONLY authority to make any change to the contract. If applicable, this QASP will be revised to include relevant POC information

Assigned

PM:__________________________________________________________________________

2.4 Contractor Representative(s)

The Contractor has the responsibility for complying fully with the terms and conditions of the contract, participating as a member of the multi-functional team in the post-award management phase, maintaining and implementing a Quality Control Plan that complements the Performance

Plan insuring that non-conforming contract services are identified and corrected. The Contractor will perform for the Government services that conform to the contract requirements and recommend changes to the contract that will provide more effective operations or eliminate unnecessary costs. The Contractor will be responsible for the execution of both the contractual and technical aspects of the contract performance.

The following employee(s) of the contractor shall serve as the contractor’s program manager(s) for this contract.

Primary: ____________________________________________________________________

Alternate: ___________________________________________________________________

3. IDENTIFICATION OF REQUIRED PERFORMANCE

STANDARDS/QUALITY LEVELS

The required IDIQ performance standards and/or quality levels are included in Attachment Q1, “Performance Requirements Summary.”

3.1 General Areas to be Monitored during Contract Performance The following PBSC items are identified within the PWS to be applicable on a wide basis and are to be monitored under this QASP.

See the Performance Requirements Summary Attachment and Section

Quality of Services Provided o Compliance with Contract Requirements o Technical

Excellence

Timeliness of Performance / Adherence to Schedule o Responsiveness to Customer requests o Completion of Repair

Services o Reliability

Cost Control o Demonstration of Daily Operational Efficiencies o

Incorporation of Innovative Practices Resulting in Cost

Savings o Effectiveness in Forecasting, Managing &

Controlling Contract Cost/Price o Ability to Keep Within the

Total Estimated Cost or Fixed Prices o Accuracy, Completeness & Timeliness of Invoicing

Business Relations o Customer-focus o Management Effectiveness o Flexibility o Timeliness of Notification and Mitigation of Problems

▪ Effectiveness of Contractor’s Recommended Contractor solutions

▪ Effectiveness of Execution of Problem Resolution Contractor solution

Regulatory Compliance o Contract security o Contract clauses o Contract reporting requirements o Quality assurance surveillance plan o Industry-related requirements, safety/environmental requirements, and standard and unique contract-specific requirements o FDA o Contractor Technician Certification o Utilization of Small

Business o Maximum practicable opportunity o Compliance with terms and conditions

Section II of this QASP provides further technical guidance and lists the specific operational plans as Contractor Associated with this Services contract.

3.2 Performance Standards

Performance Standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. The Performance Work Statement identifies Government objectives and performance standards for each task contracted. The Government will use these standards to assess Contractor performance against these objectives to ensure performance is, at a minimum, satisfactory. The VA surveillance will measure contractor performance in meeting the standards using the following ratings (definitions provided below in section 6):

Unsatisfactory, Marginal, Satisfactory, Very Good, or Exceptional.

The COR will use the performance standards to determine contractor performance rating and will compare contractor performance to the performance threshold of Table A: Performance Standard

Measures. The standards, measures and ratings will be used in the assessment process for the

Contractor Performance Assessment Report (CPARS).

3.3 Contract Monitoring

It is the intention of both parties to conduct joint reviews prior to the expiration of the contract to determine and evaluate that services are being performed in accordance to contract terms, to include invoicing and payment are being handled in accordance to contract terms. The parties will jointly determine if this agreement is satisfactory to both parties in the terms of services provided and consideration received. This review may include but not limited to:

• Analyze all billings

• Analyze all payments

• Analyze cost administrative issues

• Veteran beneficiary satisfaction

• Quality of Service

• Other documentation related to services received.

Performance Standard Measures – Refer to Appendix Q1 below.

4. Methods of Quality Assurance (QA) Surveillance Various methods exist to monitor performance. Reviews and reports will be conducted in compliance with VA Privacy and Information Security Standards. The PM or COR shall use surveillance methods listed below in administration of the QASP.

In addition to specific instructions that may be mentioned, the appropriate and standardized form that is to be used for documentation of QA surveillance is the Surveillance Activity Checklist, Appendix Q5.

4.1 Customer Feedback – Customer feedback may be obtained either from the results of formal customer satisfaction surveys or from random customer complaints. Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed and must be forwarded to the PM.

The PM shall maintain a summary log of all formally received customer complaints as well as a copy of each complaint in a documentation file. The PM shall also keep the tabulated results of all customer satisfaction surveys on file and shall enter the summary results into the Surveillance

Activity Checklist.

4.2 Verification of Documentation Provided by Contractor - This level of inspection shall be accomplished by monitoring and documentation. Each month, the PM, or if Contractor designated the appropriate Technical Monitor, shall review the generated documentation and enter summary results into the Surveillance Activity Checklist.

4.3 Periodic Inspection - Periodic inspections shall be conducted if and when specified in individual task orders. For the potential tasks that have been identified Contractor far and included in this QASP, the appropriate Technical Monitor typically performs the periodic inspection on a monthly basis.

4.4 Random Monitoring - Random monitoring shall be conducted if and when specified in individual task orders. For the potential tasks that have been identified Contractor far and included in this QASP, the random monitoring shall be performed by the PM or by the appropriate designated Technical Monitor.

The Inspection and Acceptance clauses (or other applicable clauses) become the basis for any actions that the Contracting Officer may deem appropriate when performance requirements are not being met or the quality is of an unsatisfactory level.

4.5 Acceptable Quality Levels - The acceptable quality levels (AQLs) included in

Attachment Q1, Performance Requirements Summary Table, for contractor performance are structured to allow the contractor to manage how the work is performed while providing negative incentives for performance shortfalls.

4.6 Process for Missed Targets

Process for justification/explanation of missed targets:

• Contracting Officer will notify the Contractor in writing of failure to meet target/metric/performance standard

• Contractor must submit a written appeal to the CO within 10 days of receipt of notification of failure to meet the standard. The appeal must contain the following:

o An explanation for the failure to meet the standard o A performance improvement plan (PIP) o A date for completion of the performance improvement plan, and for regaining satisfactory target goals

• If standards are not met, the Contracting Officer may take appropriate steps to remedy the

Contractor’s failure to meet the terms and conditions of the contract.

5. Quality Assurance Documentation

5.1 The Performance Management Feedback Loop The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the PWS and are assessed using the performance monitoring techniques shown in Attachment Q3

5.2 Monitoring Forms

The government’s QA surveillance, accomplished by the COR, will be reported using the monitoring forms in Attachments Q2 and Q3. The forms, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required results service and quality levels are being achieved.

5.2.1 The COR will retain a copy of all completed QA surveillance forms in

COR File as well as upload to eCORS.

6. Analysis of Quality Assurance

6.1 Determining Performance

Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels.

6.1.1 Performance Documentation

The COR will, in addition to providing documentation to the Contracting Officer, maintain a complete Quality Assurance file. The file will contain copies of all reports, evaluations, recommendations, and any actions related to the Government’s performance of the quality assurance function, including the originals of all Surveillance Activity Checklists. All such records will be retained for the life of this contract. The COR shall forward these records to the

Contracting Officer at termination or completion of the contract.

• Contractor performance on this contract will be documented in the manner described below:

o Acceptable performance. The Government will document performance that meets or exceeds minimum expectations. A

Performance Report will be used for this documentation effort and is to be used whenever the COR performs monitoring/surveillance (i.e. inspections, visits, etc.) on the contract. A template for this Report can be found at

Appendix Q5. All Performance Report documentation will be placed in the COR file. It is important to note that these

Performance Reports can become part of supporting documentation for appropriate actions taken under this contract.

o Unacceptable performance. When unacceptable performance is observed, in addition to completing a Performance Report, the COR will complete a, Contract Discrepancy Report

(CDR). An example of this form can be found at Appendix

Q6. This form serves as the official written notification to the CONTRACTOR of an observed contract discrepancy.

(Note: Only under unique circumstances will verbal communication be used to initially inform the

CONTRACTOR of a potential contract discrepancy.

However, in those cases, the COR will follow-up with written notification of the finding as Contractor on as possible, coordinate it through the CO, and provide to the

CONTRACTOR.) As part of the CDR process:

o The CONTRACTOR shall acknowledge receipt of the CDR in writing.

o The CONTRACTOR will prepare a corrective action plan to document how the CONTRACTOR shall correct the unacceptable performance and avoid recurrence.

o The CDR will clearly indicate a due date by which the

CONTRACTOR has to present this corrective action plan to the COR.

The Government will review the CONTRACTOR’s corrective action plan to determine acceptability

• Summary of Methodology & Purpose for Performance Documentation. The reports & forms referenced in this QASP are designed to collectively serve as a traceable documented history of CONTRACTOR performance. These will align Contractor support recordkeeping requirements mandated by the VA Contracting Officer’s

Representative Training (CORT) tool, as well as annual performance assessments mandated by Contractor Performance Assessment Reporting System (CPARS).

Specifically:

o Performance Report (Appendix Q5) -- Used by the COR whenever performing contract monitoring/surveillance on the contract. Both negative and positive aspects of the

CONTRACTOR’s performance are documented. The information recorded in Performance Reports can serve as a significant Contractor source of documented

CONTRACTOR performance. This information can subsequently be used in developing the COR Monthly Report to the Contracting Officer.

6.2 Reporting

At the end of each month, the COR will prepare a written report for the CO summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report, which includes the contractor’s submitted monthly report and the completed quality assurance monitoring forms (Attachment Q7), will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives and/or performance standards, including cost/technical/scheduling objectives.

6.3 Reviews and Resolution

The CO may require the contractor’s project manager, or a designated alternate, to meet with the

COR, CO and other government IPT personnel as deemed necessary to discuss performance evaluation. The CO will define a frequency of in-depth reviews with the contractor, including appropriate self-assessments by the contractor; however, if the need arises, the contractor will meet with the COR and CO as often as required or per the contractor’s request. The agenda of the reviews may include: ¬ Monthly performance assessment data and trend analysis ¬ Issues and concerns of both parties ¬ Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis ¬ Recommendations for improved efficiency and/or effectiveness ¬ Issues arising from the performance monitoring processes

6.3.2 The COR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

6.3.3 The COR and contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the PCO/ACO.

6.4 CPARS Annual Assessment

The Contractor will be annually assessed and rated for their performance and operation of the utility system listed per the contract. Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The CPARS will be utilized to perform this assessment:

6.4.1 CPARS training can be accessed at: https://www.cpars.gov/ (Use “Assessing

Official Representative” role) (Approx. 2 hrs. to complete)

6.4.2 The COR will establish an account in CPARS in order to officially contribute to the

Government’s annual assessment of the Contractor’s performance. The COR’s input will carry significant weight in the development of the Government’s overall annual rating of the Contractor’s performance under this contract.

6.4.3 The COR will assign a rating to the Contractor’s performance under the contract using the following table:

Exceptional • Performance exceeded many of the contract requirements to the

Government’s benefit.

• Few minor problems resulted from the performance; any corrective actions taken were highly effective.

https://www.cpars.gov/ https://www.cpars.gov/

Very Good • Performance exceeded Contractor some of the contract requirements to the Government’s benefit.

• Contractor me minor problems resulted from the performance; any corrective actions taken were effective.

Satisfactory • Performance met all of the contract requirements.

Contractor some minor problems resulted from the performance;

corrective actions taken were satisfactory.

Marginal • Performance did not meet Contractor some of the contract requirements, causing impact to the Government.

• Serious problems resulted from the performance, but recovery was still possible; corrective actions taken were either marginally effective or not fully implemented.

Unsatisfactory • Performance did not meet most of the contract requirements, causing impact to the Government.

• Serious problems resulted from the performance, and recovery was not considered likely; corrective actions taken were ineffective.

6.4.4 The COR’s assessment and recommended rating will be reviewed by the Contract

Specialist /Contracting Officer to ensure sufficient justification. Upon completion of the

Government’s annual assessment and rating of the Contractor’s performance, the assessment and rating will be officially recorded in the Past Performance Retrieval

System (PPIRS). Information in PPIRS will serve as a valuable Government Contractor source of CONTRACTOR past performance information for future Contractor solicitations upon which the Contractor may offer.

a. PPIRS training can be accessed at:

http://www.ppirs.gov/webtrain/webtrain.htm

b. Contractor shall assign point of contact for CPARs reviews

7. QASP ANNUAL ASSESSMENT

To provide for changing quality assurance and quality performance conditions, due to changes in regulatory requirements and/or VA and contractor capabilities, the components of

QASP measurement and reporting will be reviewed at least annually or more frequently if required by changes in regulatory requirements.

8. SUMMARY

The QASP serves as an important guiding document, providing the framework for government monitoring, surveillance, and coordination of the Contractor’s activities and responsibilities under this Remote Patient Monitoring - Home Telehealth (RPM-HT) contract. The typical longlife of this contract, its many moving parts, and the fact that the Contractor manufactures, requires a close, long-term partnership between the government and the Contractor. The deliberate and methodical approach to the development and maintenance of this QASP will help ensure this partnership continues to be nurtured, resulting in long-term quality utility service to

Department of Veteran Affairs.

9. LIST OF APPENDIX

Appendix Q1 – Performance Requirements Summary

Appendix Q2 – Quality Assurance Monitoring Form

Appendix Q3 – Quality Assurance Monitoring Form - Customer Complaint Investigation or

Customer Compliment

Appendix Q4 – Submittals Table Checklist

Appendix Q5 – Surveillance Activity Checklist

Appendix Q6 – Contract Discrepancy Report

Appendix Q7 – COR/PM Quarterly Report Instructions

Appendix Q8 - QASP PERIODIC MAINTENANCE, REVIEW AND ACCEPTANCE

Appendix Q1: PERFORMANCE REQUIREMENT SUMMARY

Performance

Objectives

PWS Section Performance Standard

(and AQL)

Method of Performance

Assessment

Provide timely resolution on Serial

Number

Discrepancies

(Vendor created error) once notified by Government

Representative

PWS 6.3 • No more than 24 hours (1 business day) for resolution

• Notify government official of corrective action taken

• 100% review of discrepancies

• Review complaints •

Review quality control activities •

Review reports

Quality

Improvement

Reports (QIR)

Integrated

Home

Telehealth

Application

(IHTA)

Attachment W

• Vendor responds to each QIR within 10 business days excluding holidays.

• Vendors shall have no more than

3 late responses in a month.

• 100% review

• Review automatic emails from the IHTA system

• Review QIR reports in IHTA

Customer Support PWS 3.3 • Less than 2 complaints a month about the Customer

Support as determined by the

COR and reported to the Program

Office

• 100% review of

Customer Support

Forms submitted

• Assessed through use of

Customer

Support Form

Maintain Customer

Access to CCWV and all awarded platforms

PWS 3.3 • Services must not be unavailable due to unscheduled outages attributed to the vendor’s system (scheduled outages and VA interruptions are

• Review submitted SIR

• Internal and external customer complaints not included).

Monthly outages should not be more than:

▪ 0 – incidents greater than 4 hours

▪ No more than

1 incident lasting 1-4 hours

▪ No more than

3 incidents lasting 60 minutes or less

• 100% review

Maintain ATO compliance

PWS 3.1 A •

Maintain 100% compliance

Review eMass status (see

Attachment C)

• eMass and consolation with

RPM-HT ISSO

Data base backup validation

PWS 3.1.A.1

and 3.1 A.4

Monthly report

100% compliance

100% review

• Review of

Selfcertification in Monthly

Report

Quarterly COOP

(Shifting system production operations between two VA sites)

PWS 3.1 A.4 •

Perform quarterly alternate site switchovers per

VA designated plan

(primary/alternate)

100% review

• Review COOP

After Action

Report

Submit all required

Reports (except

Patient Census

Report see below)

See

Deliverables and Submittals

All deliverables are submitted

Accurate reports are delivered within two (2) business days to appropriate government contact

90% of time

• Review reports and logs by

COR

Patient Census

Report

Attachment V • Timely per

Attachment V

• Reported weekly by

All rejections resolved within 72 hours

Compliant with both bullets above

Equal or greater than 75% of the time

OIT Census

Team

DMP PWS 3.2 A •

Release changes to field according to schedule in

PWS

Per Quarterly schedule

Equal or greater than 75% of the time

• Review

Quarterly release schedule

APPEMDIX Q2: Quality Assurance Monitoring Form

ROES ORDER

NUMBER:_________________________________________________________

CLINICIAN/CLINIC:____________________________________________________________

SURVEY

PERIOD:_______________________________________________________________

SURVEILLANCE METHOD (Check):

Random Sampling

100% Inspection

Periodic Inspection Customer

Complaint

LEVEL OF SURVEILLANCE (Check):

Monthly

Quarterly As

Needed

ANALYSIS OF RESULTS:

Contractor’s Performance (Check):

Meets Standards

Does Not Meet Standards

Narrative of Performance During Survey Period: -

Prepared By:

(Name, Title, Date)

APPENDIX Q3: QUALITY ASSURANCE MONITORING FORM – CUSTOMER COMPLAINT

INVESTIGATION or CUSTOMER COMPLIMENT

CIRCLE APPROPRIATELY: COMPLAINT COMPLIMENT

CONTRACTOR: _______________________________________________________

BPA/TASK ORDER NUMBER: __________________________________________

DATE/TIME RECEIVED: _____________ ________ AM / PM

SOURCE OF COMPLAINT/COMPLIMENT: _______________________________ (NAME)

_______________________________ (ORGANIZATION

_______________________________ (PHONE NUMBER)

_______________________________ (EMAIL ADDRESS)

NATURE OF COMPLAINT/COMPLIMENT:

FOR COMPLAINTS – RESULTS OF COMPLAINT INVESTIGATION:

DATE/TIME SERVICE PROVIDER INFORMED OF COMPLAINT: ___________________

AM / PM

CORRECTIVE ACTION TAKEN BY SERVICE PROVIDER:

RECEIVED AND VALIDATED BY:

PREPARED BY: ___________________________________ DATE: _____________________

APPENDIX Q4: Submittals Table Checklist

Contract Number: ___________________________________________________

POC/Phone/Email: __________________________________________________

Submittal/Deliverable Reference Frequency

Quality Control Plan

Safety & Accident

Prevention Plan

Infection Control Plan

Customer Relationship

Management Plan

APPENDIX Q5: Surveillance Activity Checklist

Contract Number: ___________________________________________________

POC/Phone/Email: __________________________________________________

Ref.

Del.

No.

Performance

Standard

Method of

Measurement

Performance

Metrics

Method of

Surveillance

Date

Accomplished

Compliance

(Exceeded, Met or

Partially Met)

Appendix Q6

CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

3. TO (Contractor and Manager's Name) 4. FROM (Name of COR)

5. DATES (Y Y Y Y MMDD)

a. PREPARED b. RETURNED BY CONTRACTOR c. ACTION COMPLETE

6. DISCREPANCY OR PROBLEM (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

7. SIGNATURE OF CONTRACTING OFFICER

8a. TO (Contracting Officer) b. FROM (Contractor)

9. CONTRACTOR RESPONSE AS TO CAUSE, CORRECTIVE ACTION AND ACTIONS TO PREVENT RECURRENCE. (Cite applicable Q.C. program procedures or new Q.C.

procedures. Attach continuation sheet(s) if necessary.)

10. SIGNATURE OF CONTRACTOR REPRESENTATIVE b. DATE (Y Y Y Y MMDD)

11. GOVERNMENT EVALUATION (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary)

12. GOVERNMENT ACTIONS (Reduced payment, cure notice, show cause, other)

13. CLOSE OUT

NAME

(1)

TITLE

(2)

SIGNATURE

(3)

DATE (YYYYMMDD)

(4)

a. CONTRACTOR

NOTIFIED

b. COR

c. CO

Attachment BB - 36C79121R0008 Page 24 of 26 Adobe Professional 8.0

QASP | Remote Patient Monitoring - Home Telehealth

APPENDIX Q7: PM/COR Monthly Report to Contracting Officer The PM or COR shall complete either a Monthly Report depending on the phase of the contract to the Contracting Officer (shown below) to document both negative and positive aspects of the

Contractor’s performance for the contract. The report shall be submitted to the Contracting

Officer in accordance with a mutually established submittal schedule.

The report shall minimally include the following information:

1. Contract Number

2. Contract Period of Performance

3. Contractor Name:

4. Method of Surveillance (ex: Direct Observation, Assessment of Deliverables, Review of

Invoice/Payments):

5. Compliance: This document is in accordance with the Inspection of Services Clauses under FAR

52.246-4 (for non-regulated contracts) and the Quality Assurance Surveillance Plan

Requirements.

6. Overall Assessment: Complete items 6a to 6f below by providing a detailed explanation in Item

7. Attach additional documentation for support evidence.

a. Quality of Work (Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory)

b. Deliverable provided by the contractor this moth (list here):

c. Was contract performance timely?

d. Are there any significant issues identified and should be brought to Contracting Officer’s attention?

e. Are actions being taken by the Contractor to correct discrepancies?

f. Customer Complaints?

i. # of Complaints

ii. # of Valid Customer Complaints

7. Additional Comments

8. Sign and Date the report.

APPENDIX Q8: QASP PERIODIC MAINTENANCE, REVIEW AND ACCEPTANCE

The functional team members’ signatures below indicate their review and acceptance of the

Quality Assurance & Surveillance Plan, dated _________ , for Remote Patient Monitoring –

Home Telehealth services provided at (insert facility name) under contract (insert contract number). These signatures indicate coordination on this Government QASP at the time of (insert contracting period) and will remain in effect until the Plan is modified.

Signature/Date Signature/Date

(insert name of Current Contracting Officer) (insert name of COR)

(insert title and organization)

Attachment CC-PAST PERFORMANCE QUESTIONNAIRE

This information will be provided to the U.S. Department of Veterans Affairs, for use in selecting a contractor to perform service/supply work for Solicitation # 36C79121R0008-

Remote Patient Monitoring – Home Telehealth (RPM-HT).

This information must be submitted no later than the date of receipt of proposals as stated in Block 8 of the SF-1449. It is the offeror’s responsibility to ensure each questionnaire is distributed timely and ensures that the company providing past performance information submits the completed form on time. IT IS THE

RESPONSIBILITY OF THE COMPANY FILLING OUT FORM TO SUBMIT.

Completed forms shall be submitted by email to: Star Yeo, star.yeo@va.gov

Subject Line should read as: Solicitation #, Past Performance Questionnaire

Describe the nature of your contract with the referenced Vendor (If more space is needed, please use the (“Additional Comments” block on the second page)

Solicitation Number 36C79121R0008

Offeror under Evaluation Name

Company/Organization Providing

Reference

Company Representative

Completing Questionnaire

Company Representative Email

Company Representative Phone

Number

Contract Description the Offeror was Awarded

Contract Number or Project ID

Period of Performance

Contract Award Amount

What was the role of Offeror?

Prime or Subcontractor?

Complete the following questions, by marking the adjectival ratings and providing comments in which there was significant discrepancies or excellent performance.

PLEASE NOTE: In accordance with Federal Acquisition Regulations, contractors may be advised of adverse remarks and given an opportunity to respond. However, the contracting officer will not provide your name or copies of this questionnaire to the contractor or any other party not directly involved in the evaluation of the contractor’s proposal.

ADJECTIVAL RATINGS DEFINITIONS

“E” Excellent: Performance meets contractual requirements and exceeds the

Government’s expectations. The contractual performance of the element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

(HIGH CONFIDENCE)

“VS” Very Good: Performance meets contractual requirements and exceeds some requirements to the Government’s benefit. The contractual performance of the element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective. (SIGNIFICANT

CONFIDENCE)

“S” Satisfactory: Performance meets contractual requirements. The contractual performance of the element contains some minor problems for which corrective action taken by the contractor appear or were satisfactory. (CONFIDENCE)

“M” Marginal: Performance does not meet some contractual requirements. The contractual performance of the element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

(LITTLE CONFIDENCE)

“U” Unsatisfactory: Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective. (NO CONFIDENCE)

“N” Neutral: No relevant past performance record is identifiable upon which to base a meaningful performance risk prediction. A search was unable to identify any relevant past performance information for the contractor or their key personnel.

(This is neither a negative nor positive assessment.).

PAST PERFORMANCE ADJECTIVAL RATINGS

1. How well were the contract requirements met in compliance with contractual terms and conditions?

E VS S M U N

Compliance of technical data/report preparation terms?

Comments:

2. To what extent did the contractor adhere to the

E VS S M U N

Performance schedule? Quality Control?

3. How responsive was the contractor in resolving

E VS S M U N

quality, schedule, or other contract issues?

4. How effective was the contractor in addressing

E VS S M U N

unforeseen or unusual customer needs and issues?

5. How well was the contractor in ability to meet quality

E VS S M U N

standards for technical performance?

6a. If you represent a government agency, and contract included a small business subcontracting plan, how well did the contractor adhere to the plan requirements?

6b. If you represent a government agency, and contract included a small business subcontracting plan, how was performance against subcontract goals?

E VS S M U N

6c. If you represent a government agency, and the contract included a small business subcontracting plan, how was compliance with subcontracting plan in general?

E VS S M U N

6d. If you represent a government agency, and the contract included a small business subcontracting plan, was there timely eSRS reporting?

7. How satisfied were you with the contractor’s overall

E VS S M U N

performance?

Additional Comments:

Additional Comments Continued:

Thank you for your response.

Proposal Adequacy Checklist

References Submission Item Provided

(Yes/No)

Proposal

Page reference

General Instructions-Must submit the following:

Standard Form 1449 - Completed and Signed

Standard Form 30 - Amendments, Completed and Signed

Representations and Certifications from FAR 52.212-3

Small Business Participation (Attachment EE)

Factor 5 - Price Proposal

Company FEI Number & Registration Number from FDA - annotate here #

PWS - Section 3.1 B Performance Requirements Attachemnt I Minimum Technical Requirements

Proposed at least 2 platforms (Hub with POTS & Cellular, IVR or Mobile

Application)

Attachment I Minimum Technical

Requirements HUB transmits via POTS and/or Cellular Connectivity

Requirements Hub is configurable to remove items that are not VA approved

Requirements IVR has ability for key pad and voice entry

Requirements IVR transmits VS via modem and manual entry

PWS - Section 3.1 B Performance Requirements Attachemnt I Minimum Technical Requirements Provide a CCWV

Requirements CCWV cannot be accessed through the public internet as described in the top narrative

PWS Section 3 Copy of your organizational change/configuration management policy

PWS Section 3 Topological diagram with narrative

PWS Section 3

Description of at least 6 months of company's commercial market experience and operations for CCWV and each additional platform asubmitted

Attachment DD

36C79121R0008

PWS Section 6 RPM-HT Product Detail Form 6550 for all offered devices and peripherals

PWS Section 7 Organization chart and all required resumes

Attachment DD

36C79121R0008

ATTACHMENT EE – SMALL BUSINESS

SUBCONTRACTING PLAN

READ CAREFULLY: The purpose of this form is for the offeror to submit information so the

Government to understand the offeror’s commitment to use small businesses, small disadvantaged businesses, woman-owned small businesses, HUBZone small businesses, and service-disabled veteran-owned small businesses as subcontractors on the project. An offeror that is a large business shall also attach a copy of its Small Business Subcontracting Plan as required by the solicitation’s clause 52.219-9, Alternate II. Fill in the information by typing or printing legibly.

IMPORTANT: This form is to be included in the offeror’s Volume I proposal, AND IS TO BE

SUBMITTED IN ADDITION TO YOUR SUBCONTRACTING PLAN IF YOU ARE A LARGE BUSINESS.

This plan follows the format for addressing the fifteen elements as shown at Federal Acquisition

Regulation (FAR) 52.219-9(d). Please be sure to address all fifteen elements.

Contractor: <insert contractor name>

Address: <insert contractor address>

DUNS: <insert contractor DUNS number>

Solicitation or Contract Number: 36C79121R0008

Item/Service: Remote Patient Monitoring – Home Telehealth (RPM-HT)

(1) TYPE OF PLAN

List the total estimated dollar value of all planned subcontracting (to all types of business concerns, both large and small). Select only one of the following:

___ Individual Plan (This Contract Only) Contract #/Solicitation #

Total value of projected subcontracts (both large and small businesses): Base

Period: $

Total Contract Value (including options): $

___ Master Plan

Total projected sales: $

Total value of projected subcontracts (both large and small businesses): $

Subcontracts Represent ___% of Total Annual Sales

____ Commercial Plan Total projected sales: $

Total value of projected subcontracts (both large and small businesses): $ Subcontracts

Represent ____% of Total Annual Sales

Attachment EE 37C79121R0008

(2) GOALS

State the percentage of total planned subcontracting dollars that will go to all Small Business

(SB) concerns, Historically Underutilized Business Zone (HUBZone) SB concerns, Small

Disadvantaged Business (SDB) concerns, Woman-Owned SB (WOSB) concerns, Veteran-Owned

SB (VOSB) concerns, and Service-Disabled Veteran-Owned SB (SDVOSB) concerns.

[NOTE TO THE OFFEROR/CONTRACTOR: For contracts containing options, the percentage goals and dollars must be shown separately for the basic contract period and for EACH option period.

All subcontracts that contribute to contract performance must be included, and a proportionate share of products and services that are normally allocated as indirect costs may be included.

Subcontracts awarded to an Alaska Native Corporation (ANC) or Indian tribe must be counted towards the subcontracting goals for SB and SDB concerns, regardless of the size or Small

Business Administration (SBA) certification status of the ANC or Indian tribe.

If this is a Master Plan, this element does…