PWS for Medical Physicist2.docx

Performance Work Statement Medical Physicist Testing and Reporting Service

1.0. Introduction

1.1. The Government requires a Certified Diagnostic Medical Physicist to perform tests on radiation producing equipment used for patient care.

2.0. Description / Scope / Objective

2.1. The Contractor must provide all labor, equipment, tools, material, supervision and other items and services necessary to perform the work as defined in this Performance Work Statement.

3.0. Applicable Documents

3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

3.2. Glossary. Acronyms used in this PWS are listed below for easy reference:

4.0. Performance Requirements

4.1 The vendor shall perform imaging equipment (x-ray equipment, nuclear medicine cameras, PET/CT cameras, and MRIs) inspections to ensure compliance with the current American College of Radiology (ACR) and Mammography Quality Standards Act (MQSA) requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the Service Chief, RSO, or Biomedical Engineering Chief prior to the vendor leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO immediately upon discovery. A written report of the results shall be provided to the Service Chief, RSO, or Biomedical Engineering Chief within 5 working days after completion of the inspection. All imaging equipment shall be inspected at least annually, not to exceed 14 months.

4.2 The vendor shall perform a full inspection of imaging equipment after repairs or modifications that may affect the radiation output or image quality. The inspection shall be completed within 48 hours after the facility contacts the vendor. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the Service Chief, RSO, or Biomedical Engineering Chief prior to the vendor leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO immediately upon discovery. A written report of the results shall be provided to the Service Chief, RSO, or Biomedical Engineering Chief within 5 working days after completion of the inspection.

4.3 The vendor shall perform acceptance testing of all new or relocated imaging equipment prior to first clinical use. The acceptance testing shall comply with ACR or MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the Service Chief, RSO, or Biomedical Engineering Chief prior to the vendor leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO immediately upon discovery. A written report of the results shall be provided to the Service Chief, RSO, or Biomedical Engineering Chief within 5 working days after completion of the inspection.

4.4 The vendor shall assist in the development of a comprehensive technical quality assurance (QA) program (e.g., technique charts, repeat/reject analysis monitoring, monitoring of exposure indices to radiographic image receptors, QA program for display monitors, QA for CT, monitoring of dose metrics from fluoroscopy studies), which complies with ACR recommendations, for all modalities.

4.4.1 The vendor shall review at least annually the QA program. A written report of the results shall be provided to the Service Chief, RSO, or Biomedical Engineering Chief within 5 working days after completion of the inspection.

4.5 The vendor shall review CT protocols at least annually.

4.6. The vendor shall perform Quarterly mammography quality control checks in January, April, July, and October. The Contractor shall provide diagnostic medical physicist services to ensure compliance with the Mammography Quality Standards Act in accordance with Title 21, Code of Federal Regulations, Section 900 (21 CFR 900.)

4.7 The vendor shall provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations for each shall comply with the National Council for Radiation Protection and Measurements (NCRP) Report No. 147, and, for dental units, NCRP Report No. 145, and shall be documented in a written report which includes a diagram showing adjacent areas. A written report of the shielding design calculations shall be provided to the RSO within 5 workings days after the shielding design calculations has been completed.

4.7.1 The vendor shall perform a shielding survey to verify the structural shielding was installed per the shielding design calculation report and complies with the design goals. A written report of the shielding survey shall be provided to the RSO within 5 workings days after the shielding survey has been completed.

4.8 Diagnostic computed tomography (CT) services shall be performed on an annual basis during the month of March.

4.8.1. Measurement the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following four CT protocols: adult brain, adult abdomen, pediatric brain, and pediatric abdomen. However, since the Miami VA does not set up protocols for pediatric diagnostics, two other protocols may be utilized based on feedback by the customer.

4.8.2. Verification that the radiation dose (in the form of CTDIvol) produced and measured for each protocol tested is within 20 percent of the CTDIvol displayed on the CT console. The dates, results, and verifications of these measurements are documented and delivered to the COR as listed in section 6 of the PWS.

4.9. A performance evaluation of all CT imaging equipment report shall (at a minimum) include the following :

- Image uniformity

- Slice thickness accuracy

- Slice position accuracy (when prescribed from a scout image)

- Alignment light accuracy

- Table travel accuracy

- Radiation beam width

- High-contrast resolution

- Low-contrast resolution

- Geometric or distance accuracy

- CT number accuracy and uniformity

- Artifact evaluation

4.10. A performance evaluation of all MRI imaging equipment report shall include the evaluation results, along with recommendations for correcting any problems identified. The evaluation includes the use of phantoms to assess the following imaging metrics:

- Image uniformity for all radiofrequency (RF) coils used clinically

- Signal-to-noise ratio (SNR) for all coils used clinically

- Slice thickness accuracy

- Slice position accuracy

- Alignment light accuracy

- High-contrast resolution

- Low-contrast resolution (or contrast-to-noise ratio)

- Geometric or distance accuracy

- Magnetic field homogeneity

- Artifact evaluation

4.11. A performance evaluation containing the use of phantoms to assess the following imaging metrics of all nuclear medicine imaging equipment report shall (at a minimum) include the following:

- Image uniformity/system uniformity

- High-contrast resolution/system spatial resolution

- Sensitivity

- Energy resolution

- Count-rate performance

- Artifact evaluation

- Low-contrast resolution test or detectability for non-planar acquisitions.

4.12. A performance evaluation containing the use of phantoms to assess the following imaging metrics of all positron emission tomography (PET) imaging equipment report shall (at a minimum) include the following:

- Image uniformity/system uniformity

- High-contrast resolution/system spatial resolution

- Low-contrast resolution or detectability (not applicable for planar acquisitions)

- Artifact evaluation

- Test for sensitivity, energy resolution, and count-rate performance

Note: For computed tomography (CT), positron emission tomography (PET), nuclear medicine (NM), or magnetic resonance imaging (MRI) services: The annual performance evaluation conducted by the diagnostic medical physicist includes testing of image acquisition display monitors for maximum and minimum luminance, luminance uniformity, resolution, and spatial accuracy.

4.13. Repair of equipment is not authorized; however, retesting of devices or systems that fail during testing will be accomplished as soon as repairs or adjustments take place.

4.14 Vendor shall provide all instruments to be required for the proper performance of this service contract. Some phantoms owned by the VA will be available for use by the LIS.

4.15 Vendor shall be available for emergency requests and are responded to with a call within 24 hours, with on-site service within 48 hours.

5.0. Performance Location and Hours.

5.1. Primary place of performance is the Bruce W. Carter, Miami VA Medical Center, 1201 N.W. 16th Street, Miami, Florida, 33125.

5.2. The secondary place of performance is the William (Bill) Kling VA Broward County Outpatient Clinic, located at 9800 W. Commercial Blvd., Sunrise, 33351.

5.3. Government normal duty hours are from 0730-1630, Monday through Friday, excluding Federal holidays. Contractor access will be provided during this time period.

6.0. Deliverables.

6.1. Field action report stating work performed.

6.2. Evaluation results, along with recommendations for correcting any problems identified, are documented and submitted to the GPOC its entirety.

6.3. Functional Test Reporting include the following Joint Commission Standards, which also include ACR standards are to be strictly adhered to with regards to both testing and reporting.

7.0. Key Personnel Replacement and Substitution.

7.1. Requests for approval of substitutions shall be in writing and shall provide a detailed explanation of the circumstances necessitating the proposed substitutions. The request shall contain a complete resume for the proposed substitute, and any other information requested or required by the Contracting Officer to approve or disapprove the request. Proposed substitutes shall have qualifications that are equal to or higher than the personnel being augmented. The Contracting Officer or his/her authorized representative shall evaluate such requests and promptly notify the Contractor in writing whether the proposed substitution is acceptable.

7.2. If the Contracting Officer determines that, (1) suitable and timely replacement of personnel who have been reassigned, terminated or have otherwise become unavailable for the contract work is not reasonably forthcoming, or (2) the resultant substitution would be so substantial as to impair the successful completion of the contract or the delivery order in accordance with the proposal accepted by the Government at time of contract award, the Contracting Officer may, (1) terminate the contract for default or for the convenience of the Government, as appropriate, or (2) at his discretion, if he finds the Contractor at fault for the condition, equitably adjust the contract price downward to compensate the Government for any resultant delay, loss or damage.

8.0. Contractor Personnel and Management.

8.1. Contractor Personnel. The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

8.4. Contractor Badges. Notwithstanding the requirement to wear a Government furnished badge, Contractor personnel shall also wear a laminated contractor identification badge at all times when performing services under this Contract, including when on Government directed travel The badge will contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard.

8.5. All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials. They must also ensure that all documents or reports produced by Contractor personnel are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

8.6. Safety/Security Requirements. The Contractor shall comply with all applicable federal, state and local laws and ensure performance is secure while protecting material, equipment, and supplies from damage and loss. Government security personnel shall have the express right to inspect for security violations at any time during the term of the contract.

8.7. All information generated in performance of this contract becomes property of the Government and must be surrendered upon request and/or completion of the contract. The Contractor must protect against the destruction and/or misplacement of all information produced under this contract, unless directed under local policy to destroy. This includes both hard and soft copies of data.

8.8. The Contractor shall not release any information (including photographs, files, public announcements, statements, denials, or confirmations) on any part of the subject matter of this contract or any phase of any program hereunder without the prior written approval of the GPOC.

8.9. Standards of conduct.

8.9.1. Conduct of Personnel. Contractor personnel shall conduct themselves in a professional manner (i.e. timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of the Government. The hospital director or designated representative has the authority to bar individuals from the Government facility. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. The Government shall not reimburse the Contractor for travel and other expenses associated with the removal of personnel.

8.9.2. Contractor personnel are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

8.9.3. Working Attire and Appearance. Contractor personnel shall present a professional appearance commensurate with standards delineated for Government civilian personnel acting in similar capacities.

8.9.4 The Government reserves the right to review Contractor personnel qualifications. Upon request, resumes shall be provided to the Contracting Officer prior to clearance approval, for review and acceptance by the GPOC. The intent is verification purpose and not for the Government to become the hiring authority.

9. TRAVEL

9.1 Travel not authorized

10. NON-PERSONAL SERVICE STATEMENT

10.1. Contractor employees performing services under this order will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the PWS. Contractor employees will perform their duties independent of, and without the supervision of, any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

11. PERSONNEL QUALIFICATIONS

11.1. The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The work history of each contractor employee must contain experience directly related to the task and functions he/she is intended to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purposes of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the PWS in an efficient, reliable, and professional manner.

11.2. Specific Personnel Qualifications Requirements – Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum:

11.2.1. Must be authorized or permitted to work in U.S.

11.2.2. Have experience specific to work performed under this PWS.

11.3 All work shall be completed by a qualified Diagnostic Medical Physicist. A qualified Diagnostic Medical Physicist is a person who is certified by the American Board of Radiology, American Board of Medical Physics, or the Canadian College of Physicists in Medicine. For mammography, a qualified Medical Physicist can have state licensure to perform mammography inspections in lieu of board certification. For diagnostic computed tomography (CT), nuclear medicine, PET, or MRI, a qualified Medical Physicist can meet the following requirements in lieu of board certification:

11.3.1 A graduate degree in physics, medical physics, biophysics, radiologic physics, medical health physics, or a closely related science or engineering discipline from an accredited college or university

11.3.2 Formal graduate-level coursework in the biological sciences with at least one course in biology or radiation biology and one course in anatomy, physiology, or a similar topic related to the practice of medical physics

11.3.3 Documented 3 years of clinical experience in CT, nuclear medicine, PET, or MRI.

The physicist must document the 3 years of experience for the modality being inspected.

11.4. The vendor shall provide to the VA, training names of the primary and secondary field service personnel as well as their certificates showing their competency to perform such services.

12. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT

12.1. Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection.

12.2 The QASP and its performance objectives are as follows:

Standard

4.1

4.6

4.7 Physicist X-ray Tube Certifications:

Mammography QC Inspections

Shielding Calculation(s):

X-ray Tubes certified by ACR standars

Inspections are in compliance with the Mammography Quality Standards Act and IAW Title 21, Code of Federal Regulations, Section 900 (21 CFR 900.)

Inspections are in compliance with National Council on Radiation Protection and Measures (NCRP) report guidelines.

99% performance level

Provide Service record/report for every item serviced within a two week period of performing services.

Visual inspection conducted by the GPOC

Below AQL, non-acceptance of services. A Contract Discrepancy Report (CDR), will be issued for performance below the AQL. The Contractor will have five workdays to provide a response that includes an improvement strategy for addressing the issues. 30 days after issuing the CDR, the Contractor will be re-rated. If performance does not comply with PWS, the CO will be notified, the performance record will be documented, and CO may pursue contract action.

4.15

6.1 Respond to emergency requests

Field action report stating work performed.