ATTACHMENT 1 - PWS.docx

Commissioning, TPS Beam Modeling and Model Validation for the Edge Radiosurgery System

Performance Work Statement (PWS)

1.0 Description of Services Needed: The Contractor shall furnish all personnel to provide the services necessary to perform onsite Therapeutic Medical Physicist Support Services, to commission the Varian Edge Linac for the Department of Veterans Affairs Medical Center, James A. Haley Veterans Hospital. The Radiation Oncology Service shall be accredited by ACR and follow the standards & guidelines set forth by American College of Radiology (ACR). As such any Contractor providing on-site radiation oncology commissioning services for the Edge linac must adhere to all the American College of Radiology Guidelines & Technical Standards for Radiation Oncology: The on-site radiation oncology services must provide evidence the radiation oncology practice meets or exceeds the American College of Radiology Guidelines for Radiation Oncology. http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation-Oncology http://www.acr.org/Quality-Safety/Standards-Guidelines/Technical-Standards-by-Modality/Medical-Physics.

Place of Performance: Services shall be provided on site in Radiation Oncology Service, VAMC 13,000 Bruce B. Downs. Blvd., Tampa, FL 33612.

This project will be comprised of seven (7) major elements plus two (2) (administrative elements):

1) Beam matching of the new Edge system with the existing TrueBeam system, both of which have the HD120 multileaf collimator,

2) Beam measurements, modeling, and validation of the Edge with the Pinnacle treatment planning system with beam model matching,

3) Beam measurements, modeling, and validation of the Edge with the Brainlab iPlan with Elements treatment planning system with beam model matching,

4) Beam measurements, modeling, and validation of the Edge with the Eclipse treatment planning system with beam model matching,

5) Small Field specific beam measurements, modeling and validation of the Edge with the Eclipse treatment planning system as described in the body of this document,

6) IMRT and VMAT commissioning and commissioning tests on linear accelerator for IMRT & VMAT Configuration of optimization algorithms Test plans using final Eclipse and Pinnacle photon algorithms Portal Dosimetry configuration and tests for Eclipse,

7) Radiation survey with site survey report for the Edge treatment room area including photon and neutron measurements.

8) Edge OBI Physics QA Review.

9) Standards of Practice.

1.1 Beam matching of the new Edge system with the existing TrueBeam system. The commissioning of the Edge shall start with establishing beam matching between the existing TrueBeam linear accelerator unit (SN H193031) and the new Edge linear accelerator. The commissioning contractor shall take adequate measurements of the Edge photon and electron beams to verify that the beams are dosimetrically equivalent, i.e., within 1% of the dose in the central 80% of the beam dose profiles taken at depths: dmax, 5cm, 10cm, 20cm; within 0.3% along the central axis depth dose curve from dmax to 20cm depth; and within 2mm in the 80% to 20% penumbral region of the department’s existing TrueBeam unit. Any of the Edge’s beams that are not verified as dosimetrically equivalent shall be made so by the coordinated effort of the commissioning contractor with Varian Service personnel to adjust the Edge’s beams before treatment planning data collection begins. Evaluation of dosimetric MLC characteristics and possible tests of the MLC, evaluations, and/or adjustments with the engineer need to be performed to match the MLC to existing linear accelerator. Provide Beam Data Book that will allow for manual hand calculations of photon and electron beams for patient treatment.

1.2 Beam measurements, modeling and model validation of the Edge with the Pinnacle treatment planning system including beam model matching.

1.2.1 Perform beam data measurements and validation measurements for beam matching for Pinnacle Treatment Planning System for three (3) standard photon energies (6, 10 and 18 MV with open and EDWs), two (2) FFF photon energies (6 and 10 FFF with open fields), and four (4) electron energies (with six electron cones). This service includes the following components:

1.2.1.1 Measure scanned PDD data for photons at 100 cm SSD;

1.2.1.2 Measure profile beam data for photon open fields at 100 cm SSD for validation of the profiles used in Pinnacle configuration;

1.2.1.3 Measure square field output factors as described in the Pinnacle Physics Reference Guide for validation of the factors used in Pinnacle configuration (90 cm SSD, d=10cm), and including small field measurements down to 0.5x0.5cm and 1.0x1.0cm field sizes;

1.2.1.4 Measure representative Enhanced Dynamic Wedges’ (EDWs) factors for two field sizes for each standard photon energy (90 cm SSD, d=10cm), including multiple off-axis points;

1.2.1.5 Measure electron PDIs and output factors for use in validation of the electron model (six electron cones per energy);

1.2.1.6 Compare measured data with reference data to validate accuracy of measurements performed;

1.2.1.7 Compare Edge measured data with TrueBeam model data to validate beam‐matching accuracy;

1.2.1.8 Provide copy of beam data measurements; processed beam data; and beam data analysis to Clinic; and

1.2.1.9 Provide electronic report to Clinic setting forth the beam data measurements, the processed beam data, and an analysis of the beam data match.

1.2.2 Pinnacle configuration and testing. Including modeling one (1) Pinnacle photon beam algorithm for three (3) standard photon energies (6, 10 and 18 MV with open and EDWs) and two (2) FFF photon energies (6 and 10 FFF with open fields) and one (1) electron beam algorithm for four (4) electron energies. The modeling is based on beam matching considerations with existing TrueBeam model. This service includes the following components:

1.2.2.1 Perform modeling of the treatment planning Pinnacle photon algorithm for all photon energies at 100 cm SSD using existing validated beam‐matched model (modeling includes open fields and seven (7) EDWs for standard photon energies; open fields for FFF photon energies);

1.2.2.2 Perform modeling of the treatment planning Pinnacle electron algorithm for all electron energies at 100 cm SSD using existing validated beam‐matched model (modeling includes up to six electron cones);

1.2.2.3 Setup and validate dose parameters for algorithm configuration based on Clinic’s calibration protocol;

1.2.2.4 Analyze the Pinnacle photon algorithm configuration results using beam analysis workspace;

1.2.2.5 Compare representative measured commissioned data with standard modeled data;

1.2.2.6 Evaluate the Pinnacle photon model by comparing independently measured point dose data with algorithm predicted data (point doses at three depths for seven square field sizes, two rectangular fields, and seven EDW central‐axis and two off‐axis point doses, as applicable, at one SSD);

1.2.2.7 Evaluate the Pinnacle photon model by comparing various standard and asymmetrical photon model profiles and predicted doses using an array system and demonstrate accurate model representation of machine geometry;

1.2.2.8 Evaluate the electron model by comparing predicted open‐field cone output factors with algorithm predicted output factors (up to six (6) cones) and two point doses (calibration cone); and

1.2.2.9 Provide electronic report of beam data configuration and algorithm test results to Clinic.

1.3 Beam measurements, modeling, and validation of the Edge with the Brainlab iPlan with Elements treatment planning system with beam model matching. Perform beam data measurements and validation measurements for beam matching for Brainlab. Measurements are for the Pencil Beam and MonteCarlo algorithms for 6FFF and for the PencilBeam algorithm for 10FFF energy. Smaller field data should be measured using two chambers to ensure accuracy.

1.3.1 Measure PDDs in‐water and in‐air for beam‐matching evaluation;

1.3.2 Measure profiles in‐water and in‐air for beam‐matching evaluation;

1.3.3 Measure output factors in ‐water and in‐air for beam matching evaluation;

1.3.4 Compare measured data to reference data to validate accuracy of measurements;

1.3.5 Demonstrate accurate model representation of Edge machine geometry;

1.3.6 Compare measured data with TrueBeam model data to validate beam‐matching accuracy; and

1.3.7 Obtain additional small field point‐dose data for four field sizes to be used in the validation of the original commissioned treatment planning model at one isocentric setup (95 cm SAD); and

1.3.8 Provide electronic report of beam data measurements and the algorithm point dose tests.

1.4 Beam measurements, modeling, and validation of the Edge with the Eclipse treatment planning system with beam model matching

1.4.1 Edge commissioning beam‐matched for Eclipse. Perform beam data measurements and validation measurements for beam matching for Eclipse Treatment Planning System for three (3) standard photon energies (6, 10 and 18 MV with open and EDWs), two (2) FFF photon energies (6 and 10 FFF with open fields), and four (4) electron energies (6, 9, 12, and 16 with six electron cones). These are the required components:

1.4.1.1 Evaluate beam flatness, symmetry, and energy to ensure that the applicable parameters are within the machine specifications designated by the manufacturer;

1.4.1.2 Measure scanned PDD data for photon open fields at 100 cm SSD for beam matching evaluation and validation of PDDs used in Eclipse;

1.4.1.3 Measure photon profiles for four open fields at 100 cm SSD for beam matching evaluation and validation of the profiles used in Eclipse configuration;

1.4.1.4 Supervise energy matching adjustments, if applicable;

1.4.1.5 Measure square field output factors and appropriate rectangular output factors for validation of the dosimetric tables used in Eclipse configuration;

1.4.1.6 Measure Sc and Sc,p for dosimetric tables;

1.4.1.7 Measure representative Enhanced Dynamic Wedges (EDWs) factors for two field sizes for each standard photon energy, including multiple off-axis points;

1.4.1.8 Measure scanned and non‐scanned beam data for electrons at 100 cm SSD (PDIs and output factors for each open electron cone and largest open field size);

1.4.1.9 Obtain additional photon dosimetric data to test the treatment planning system beam matching considerations. Measurements include point doses at three depths for seven square field sizes, two rectangular field sizes, and EDWs central‐axis and two off‐axis point doses at one SSD);

1.4.1.10 Process and evaluate measured beam data to validate the data used in beam configuration;

1.4.1.11 Compare measured data with reference data to validate accuracy of measurements performed;

1.4.1.12 Provide copy of beam data measurements; processed beam data; and beam data analysis to Clinic;

1.4.1.13 Provide copy of photon and electron beams performance (energy, flatness, and symmetry) baseline data to be used for TG‐142 yearly QA measurements; and

1.4.1.14 Provide electronic report to Clinic setting forth the beam data measurements, the processed beam data, and an analysis of the beam data match.

1.4.2 Eclipse configuration and testing. Includes modeling the AAA and Acuros algorithm for three (3) standard photon energies (6, 10 and 18 MV with open and EDWs) and two (2) FFF photon energies (6 and 10 FFF with open fields). Electron beam modeling includes the eMC algorithm for four (4) electron energies (6, 9, 12, and 16 MeV) for use with up to six electron cones at 100 cm SSD. The modeling is based on beam matching considerations with existing TrueBeam model. This service includes the following components:

1.4.2.1 Perform modeling of the treatment planning AAA photon algorithm for all photon energies at 100 cm SSD using existing validated beam‐matched model (AAA modeling includes open fields and seven (7) EDWs for standard photon energies; open fields only for FFF photon energies);

1.4.2.2 Perform modeling of the treatment planning Acuros photon algorithm for all photon energies at 100 cm SSD using existing validated beam‐matched model (Acuros modeling includes open fields and seven (7) EDWs for standard photon energies; open fields only for FFF photon energies);

1.4.2.3 Perform modeling of the treatment planning eMC electron algorithm at 100 cm SSD using existing validated beam‐matched model, as applicable, for each electron energy (electron modeling includes up to six (6) electron cones per electron energy);

1.4.2.4 Setup and validate dose parameters for algorithm configuration based on Clinic’s calibration protocol;

1.4.2.5 Compare representative measured commissioned data with beammatched modeled data;

1.4.2.6 Evaluate the AAA photon model by comparing independently measured point dose data with algorithm predicted data (for seven square field sizes, two rectangular field sizes, and EDWs centralaxis and two off‐axis point doses at one SSD);

1.4.2.7 Evaluate the AAA photon model by comparing photon model profiles and predicted doses using an array system (three (3) open square fields; two (2) MLC fields; two (2) EDW fields, as applicable, per photon energy) and demonstrate accurate model representation of machine geometry;

1.4.2.8 Evaluate the Acuros photon model by evaluating the predicted and measured doses for a subset of the point doses and fluence fields used for AAA validation and demonstrate accurate model representation of machine geometry;

1.4.2.9 Evaluate the eMC model by comparing predicted open‐field cone output factors with algorithm predicted output factors (up to six (6) cones) and two point doses (calibration cone); and

1.4.2.10 Provide electronic report of beam data configuration and algorithm test results to Clinic.

1.5 Eclipse small field commissioning and test. Commissioning and evaluation of one (1) photon algorithm for small field delivery with 6FFF (down to 1x1 cm2). Data will be measured using two detectors at multiple field sizes to ensure accuracy and reproducibility of measurements. Appropriate small field correction factors based on AAPM‐IAEA TRS483 guidelines will be applied. This service includes the following components:

1.5.1 Measurement of small field (down to 1x1) output factors for use in one (1) photon algorithm for 6FFF;

1.5.2 Modify the photon algorithm to include small field output factors (down to 1x1 cm2).

1.5.3 Measure PDD and two profiles for three MLC fields (1x1, 2x2, and 3x3 cm2 fields) at one SSD (95 cm SSD) and evaluate with modelled algorithm;

1.5.4 Measure point doses at two depths and one SSDs (95 cm SSD) for three small MLC fields (1x1, 2x2, and 3x3 cm2 fields) to evaluate algorithm accuracy for fields <4x4 cm2;

1.5.5 Review and discuss treatment planning settings for small field deliveries;

1.5.6 Evaluate and modify the Portal Dosimetry algorithm for small field deliveries;

1.5.7 Perform absolute dose measurements for two 6FFF RapidArc test plans using a phantom and pin‐point chamber system to evaluate the accuracy of the dose delivered by simulated small field RapidArc treatment deliveries;

1.5.8 Perform dose distribution dose measurements for two 6FFF RapidArc test plans using the Portal Dosimetry system; and

1.5.9 Provide an electronic report setting forth all data measurements, data analysis, and test results.

1.6 IMRT and VMAT commissioning and tests. Includes IMRT and VMAT commissioning tests and the configuration or validation of the related optimization algorithms for two (2) standard photon energies (6 and 10 MV) and two (2) FFF photon energies (6 and 10 FFF). This service includes the following components:

1.6.1 Perform commissioning tests on the linear accelerator that affect its dynamic IMRT and VMAT delivery mode. These tests include evaluation of MLC positioning accuracy as a function of gantry angle, evaluation of the dynamic dose delivery as function of gantry angle, validation of the dose rate linearity, evaluation of the effects of varying dose rate and gantry speed on dose delivery, and evaluation of the effects of varying MLC speed on dose delivery;

1.6.2 Perform measurements of MLC data (leaf gap and transmission factor) for configuration of the Eclipse optimization algorithms;

1.6.3 Configure the Eclipse PO optimization algorithm;

1.6.4 Evaluate and adjust the Eclipse MLC modeling parameters by delivering appropriate MLC dynamic test patterns to a chamber and an array system;

1.6.5 Plan and deliver two simulated IMRT treatments to a Quality Assurance (“QA”) phantom system to evaluate dose delivery accuracy with final dose calculations performed using the Eclipse planning system and the Pinnacle planning system;

1.6.6 Plan and deliver two simulated VMAT treatments to a QA phantom system to evaluate dose delivery accuracy with final dose calculations performed using the Eclipse planning system and the Pinnacle planning system;

1.6.7 Plan, measure, and compare planning and QA results to the TG119 report for both the Head and Neck and C-shape cases, as described in AAPM TG119, using Ion chamber, film and/or array, for both IMRT and VMAT treatments on both Pinnacle and Eclipse planning systems;

1.6.7 Perform Portal Dosimetry configuration using reference model;

1.6.8 Perform Portal Dosimetry configuration tests;

1.6.9 Plan and deliver two simulated RapidArc treatments to the Portal Dosimetry system to evaluate dose delivery accuracy; and

1.6.10 Provide electronic report to Clinic summarizing the IMRT and VMAT commissioning test results.

1.7 Room Radiation Shielding Survey: The on‐site room radiation survey relating to x‐ray and neutron radiation will be performed for one room housing one new Varian Edge linear accelerator. This survey is intended to evaluate the adequacy of the room based upon the original treatment room shielding design and based on the current status of the room. The services described herein include the use of the contractor’s calibrated neutron meter for use during the survey measurements. This service includes the following components:

1.7.1 The radiation survey will include the areas immediately surrounding the radiation treatment room housing the accelerator (e.g., the office spaces, hallways, control console area, and roof, as applicable). Areas that could be affected by skyline radiation will also be evaluated, if applicable.

1.7.2 The radiation survey will be performed in accordance with recommended guidelines and standards as promulgated by the AAPM and as set forth in relevant professional publications.

1.7.3 A detailed electronic radiation room survey report will be provided to the Clinic for its records and for submission to applicable regulatory agencies. Note that submission of any such report to a regulatory or governmental agency will be the sole responsibility of the Clinic’s medical physicists.

1.8 Edge OBI physics QA overview: These services consist of providing a demonstration of the following typical OBI physics QA procedures:

1.8.1. Demonstrate the calibration procedures (MV, KV, and CBCT).

1.8.2. Review the IsoCal calibration and evaluation procedure.

1.8.3. Demonstrate tests to evaluate the OBI kV accuracy for the isocenter as a function of gantry angle, for the imager magnification, and for the couch shift accuracy.

1.8.4. Demonstrate tests to evaluate the CBCT spatial accuracy, uniformity, contrast, resolution, and HU calibration.

1.9. Standards of Practice: They must meet the same standard that any VA employee must meet according to NHPP AAPM and ACR. Contractor shall be evidence based best practices that meet or exceed all standards of professional practice and performance measures applicable to VAMC medical professionals, including, but not limited to, NHPP, AAPM and TJC standards and ACR current practice guidelines in radiation oncology.

Contractor shall cover the range of services as would be provided in a state-of-the-art civilian medical treatment facility. Contractor shall provide evidence that radiation oncology standard of care is of a quality that meets or exceeds currently recognized VA and ACR national standards as established by:

The American College of Radiology (ACR) Guidelines for Radiation Oncology. http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation-Oncology http://www.acr.org/Quality-Safety/Standards-Guidelines/Technical-Standards-by-Modality/Medical-Physics

The requirements contained in this PWS:

Contractor shall provide Quality Assurance reports for the Radiation Safety Committee.

1.9.1 Contractor shall track, evaluate, and document all equipment-related quality assurance data including TLD and credentialing measurements for independent 3rd party analysis.

1.9.2 All reports which pertain to the safe and accurate operation of the radiation therapy simulator(s), treatment unit(s), dosimetry system(s) and applications thereof.

QUALIFICATIONS:

The Therapeutic Medical Physicist must be Board Certified in Medical Physics or Therapeutic Medical Physics by the ABR and maintain licensure with the Board of Licensure for Professional Medical Physicists, if applicable. Certification must be maintained throughout the contract period of performance.

Technical Proficiency - Contract Therapeutic Medical Physicist shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history and shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations that govern medical staff behavior.

· TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

· OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractors shall provide generic self-study training; provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

· The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

· Clinical/Professional Direction: The qualifications of the Contractor are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional direction of all clinical personnel covered by this contract will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

ADMINISTRATIVE:

(A) Contractor shall be board certified in accordance with ACR Standards and available to provide the required scheduled services.

· Acceptable Quality Level: No deviations from the standard (100%).

· Surveillance Method: Periodic Sampling of qualification documentation submitted in accordance with contractor reporting requirements.

· Incentive: Positive Past Performance

· Disincentive: Negative Past Performance

(B) Measure: Quality Assurance/Quality Improvement (QA/QI) Documentation

· Performance Requirement: The Contractor shall have an operational performance improvement process in accordance with ACR Standards; including data collection, measurement, assessment, and improvement. Data shall be required on processes, outcomes, and quality control. Appropriate statistical quality control techniques in compliance with ACR standards must be utilized.

· Standard: 100% of QA/QI documents complete in accordance with ACR standards and reported as required to VA Radiation Oncology Service QA Committee.

· Acceptable Quality Level: Almost all (90%) of QA/QI documents complete in accordance with ACR standards and reported as required to the VA Radiation Oncology Service QA Committee.

· Surveillance Method: Unrestricted surveillance and interaction with the contractor during the commissioning process

· Frequency: Ongoing

· Incentive: Positive Past Performance

· Disincentive: Negative Past Performance

(C) Measure: ACR Radiation Safety Standards

· Performance Requirement: NRC/NHPP Radiation safety standards, policies, and procedures, including the NRC Quality Management Program rule, shall be met, and be reported.

· Standard: All (100%) Radiation safety standards and external review requirements shall be met, including those of the NRC and the NHPP. Quality Management report shall be submitted to the JAH VAMC Radiation Safety Committee.

· Acceptable Quality Level: 100%

· Surveillance Method: Periodic Inspection

· Frequency: Weekly

· Incentive: Positive Past Performance

· Disincentive: Negative Past Performance The CO shall resolve complaints concerning Contractor relations with the Government employees. The CO is final authority on validating complaints. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

· For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have thirty days to submit any comments and re-assign the report to the CO.

· Failure to have a current registration with the CPARS database, or to re-assign the report to the CO within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond.

GOVERNMENT RESPONSIBILITIES:

Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to the COR and contact information for COR, Clinical point of contact, and any other relevant personnel involved).

CO Responsibilities:

· The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity, or quality of performance of this contract.

· The CO shall resolve complaints concerning Contractor’s provider relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

· In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for the contract staff to be provided by the VA; replacement of the contract staff and/or renegotiation of the contract terms or termination of the contract.

COR Responsibilities:

· The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

· The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to enter data that may be collected.

· The COR will maintain a record-keeping system of services by electronic record. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

· The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

*** All contract administration functions will be retained by the VA.

SPECIAL CONTRACT REQUIREMENTS:

Reports: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

The following are brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly’; annually, etc. identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

Billing:

Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI).The X12 EDI Web site (http://www.x12.org).

The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program or OB10:

Payment Adjustments/Performance Related Payment Deductions: Contract shall be adjusted at the end of the period of performance in accordance with actual cost.

Performance Deductions: If the contractor fails to meet the Acceptable Quality Level on any performance measure that references a deduction as a disincentive, the following method for calculating and applying the deduction shall be employed:

• The COR will prepare a contract discrepancy report and will notify the CO in the event the contractor failed to meet the AQL established for any performance measure. The CO will provide the contractor with the CDR and documentation (as appropriate) supporting the performance level of the contractor and the government’s intent to apply the deduction in the following manner: 25% reduction of monthly invoice in accordance with section (reference contract page and paragraph) under the Performance Measures. The 25% reduction shall be applied to the next invoice billed. The contractor has thirty (30) days to respond if the contractor wishes to provide evidence that the AQL was met or to assert that the government’s action or inaction prevented the Contractor from reaching performance at the AQL. The Contracting Officer shall make the final determination regarding the deduction after reviewing the contractor’s response.

The contractor will be evaluated in accordance with the following:

PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall 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 surveillance activities.

GOVERNMENT ROLES AND RESPONSIBILITIES:

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Paul A. Jarrett - Paul.Jarrett@va.gov Telephone: 813 972-2000 Ext. 3107 Organization or Agency: Network Contracting Office - 8

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Veronica McCoy, Administrative Officer Organization or Agency: Department of Veterans Affairs, JAHVH

PERFORMANCE STANDARDS:

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed on Attachment 3 - QASP. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

INCENTIVES/DEDUCTS:

The Government shall use past performance as incentives. Incentives shall be based on ratings received on the performance standards (Inclusion of any monetary incentives requires approval through the Department’s Senior Procurement Executive (SPE).

METHODS OF QA SURVEILLANCE:

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· DIRECT OBSERVATION: 100% surveillance by observation by the Chief Physicist

· PERIODIC INSPECTION: Inspections scheduled and reported quarterly per COR delegation or as needed. For example, ten (10) randomly selected patient files will be reviewed per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

With No Sensitive Data but Requires Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

VA INFORMATION CUSTODIAL LANGUAGE:

a. 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.

b. 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.

c. 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.

d. 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.

SECURITY INCIDENT INVESTIGATION:

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

The Certification and Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required for this SOW.

All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions, so they are in compliance with James A. Haley Veterans’ Hospital policies:

HPM NO. 90-25; JANUARY 2014; HEALTHCARE VENDOR ACCESS AND COMPETENCY

HPM NO. 132-04; DECEMBER 2012; SECURITY MANAGEMENT PROGRAM

HPM NO. 132 05; DECEMBER 2012; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; MAY 2013; PHARMACEUTICAL COMPANY REPRESENTATIVES

HIR are required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. . The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR are not permitted in patient care areas or clinics unless a prior appointment has been made.

Pharmaceutical Company Representative (PCR) refers to anyone acting on behalf of a pharmaceutical company or its business partners for the purpose of promoting the use of items managed under the VA formulary process. These items primarily include drugs, but to a lesser extent also include any medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy. Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor’s badge as well as their company’s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued on a daily basis and must include the following information: Company name, project number, date, and name of individual. Contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver’s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to police dispatch. The contractor will provide Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact.

VHA Supplemental Contract Requirements for Combatting COVID-19