PWS.pdf

PERFORMANCE WORK STATEMENT

MEDICAL PHYSICIST RADIOLOGICAL SERVICES

ROSEBUD IHS SERVICE UNIT

I. STATEMENT OF PURPOSE

This is a non-personal services contract to provide Medical Physics services for the Rosebud IHS Service Unit.

Services shall ensure compliance with applicable federal regulations, accreditation requirements, radiation safety standards, and quality assurance programs for diagnostic imaging equipment and procedures.

II. SCOPE OF SERVICES

A. The contractor shall conduct the “Optimizing Patient Dose” and “Staff Exposures” activities listed in Table 2, including but not limited to:

1) Review, recommend improvements, provide examples if needed, and evaluate compliance with each radiology program’s policies, procedures, and protocols to ensure the program has policies in place consistent with their scope of work that are sufficient to protect staff and patients and minimize patient dose and are reviewed annually. Policies on the following minimum topics should be in place and implemented:

a) Imaging referral justification and verification

b) Pre-procedure screening and patient condition assessment

c) Safe use of sedation and anesthesia (if in use)

d) Staff qualifications

e) Continuing education (radiology staff, and medical providers)

f) Equipment maintenance process and documentation

g) Personnel monitoring and means to prevent/reduce exposure

h) Appropriateness and ALARA in imaging; Decision Support Systems (if in use)

i) Patient dose estimation, documentation, and reporting

j) Protection of pregnant patients and workers; fetal protection and dose calculation

k) Equipment Performance Monitoring

l) Protective equipment inspection

m) Quality Assurance/ Performance improvement

n) Patient rights, education, and consent; and medical over-ride

o) Annual imaging program evaluation

p) Management of imaging records

q) Equipment planning

r) Infection control (including housekeeping, standard and Transmission-based precautions)

s) Chemical hygiene and hazardous material/waste handling

t) Radiation Safety Officer appointment and scope of responsibilities

u) Patient incident and over-exposure reporting and analysis.

2) Contactor shall provide consultation to assure an optimized balance between image quality and patient dose by ensuring the optimum technique factors are utilized by the facility

3) Contractor shall evaluate patient dose/Entrance Skin Exposure with comparison to FDA NEXT or equivalent diagnostic reference levels via patient dose estimates using appropriate phantoms.

4) Verify optimization process (whether they have a Clinical Decision Support mechanism/software in place, and if so, how well it was being implemented to limit patient dose) and dose documentation in the medical records while conducting the Appropriateness Criteria Audit (Section A above).

B. Contractor shall conduct “Device Performance” and “Quality Control Measures” activities listed in table 2 and according to AAPM Report 74 (http://www.aapm.org/pubs/reports/rpt_74.PDF) and consistent with the below cited references and will assist in establishing a facility radiology quality assurance program.

C. The contractor will provide details to the local site contact on any equipment that is not in proper working condition, or any environmental condition negatively impacting patient safety/privacy or program operations.

D. The contractor will provide acceptance testing for new x-ray devices installed during the contract period when directed by a properly executed supplement agreement/change order.

E. The contractor shall include additional equipment and Radiation Shielding Surveys under this contract when directed by a properly executed supplement agreement/change order.

F. The contractor shall consult with the Radiology Supervisor concerning patient and fetal dose determinations under this contract when needed. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

III. SPECIFICATIONS

A. Medical Physicist Certification Requirements: The Services shall be performed by a Qualified Medical

Physicist (QMP) meeting the American Association of Physicists in Medicine (AAPM) definition. In cases where an eligible a s s i s t a n t / t e c h n i c i a n p e r f o r m s t h e m e a s u r e m e n t s , t h e Q M P i s r e s p o n s i b l e f o r t h e w o r k p e r f o r m e d . A Q u a l i f i e d M e d i c a l P h y s i c i s t i s a p e r s o n w h o i s c e r t i f i e d , o r b o a r d e l i g i b l e , b y t h e A m e r i c a n B o a r d o f R a d i o l o g y , A m e r i c a n B o a r d o f M e d i c a l P h y s i c s , o r t h e C a n a d i a n C o l l e g e o f P h y s i c i s t s i n M e d i c i n e . T h e c o n t r a c t o r m u s t s u b m i t e v i d e n c e o f b o a r d c e r t i f i c a t i o n w i t h t h e i r q u o t e . AAPM defines a qualified medical physicist as, “an individual with the following credentials:

1. Masters or Doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education. (AAPM, 2012)

a. These certification requirements are consistent with the national practice guidelines referenced in

Rosebud IHS Equipment List

Radiology X-ray Units:

CT: Siemens SOMATOM go.top 128 slice RF Room: GE Discovery RF 180 General Rad Room: GE Definium VR 656 Shimadzu/ Mobile Dart Portables (2) Canon Aplio i700 Ultrasound machine Canon Aplio MX Ultrasound machine Hologic Selenia Dimensions 500 Mammography Unit Lead garments (aprons) (30-50)

Dental:

Progeny Dental Bitewing Preva (8) Aribex Nomad Pro 2 hand held bitewing (1) Sirona Orthophos S (1)

Table 1. Medical physicist performance monitoring reports shall include verification of professional certification. For the subfield of Diagnostic Medical Physics, AAPM recommends certification by the American Board of Radiology; or the American Board of Medical Physics; or the Canadian College of Physicists in Medicine. (AAPM, 2012).

B. Radiation Safety Surveys - Performance Monitoring and Testing of Medical and Dental Imaging Equipment:

Services to meet the most recent nationally recognized standards of practice regarding x-ray equipment performance monitoring and testing according to the American College of Radiology (ACR) and the National Council on Radiation Protection and Measurement (NCRP) Technical Standards. Contractor shall provide all supplies, kits, test equipment, tools and parts required to perform monitoring and testing services. All required services as noted below will be conducted.

1. Radiation Safety Surveys will be conducted according to ACR, MQSA/FDA and NCRP standards and equipment manufacturers’ recommendations.

2. Performance Monitoring Tests and Services will be conducted according to the schedule noted in the table below, verify that new equipment meets manufacturer specifications and regulatory requirements, as well as identify any corrective maintenance or modifications to process or procedures that need to be addressed.

3. Contractor shall schedule visits with the Lead Radiologist or Radiology Supervisor for medical x-rays and

Dental Director for dental x-ray tubes at least two weeks in advance of the proposed site visit.

4. With thorough testing and measurements, the contractor shall verify that any new radiology equipment meets manufacturer specifications and regulatory requirements, as well as identify any problem areas that need to be addressed.

Table 1 – Medical Physicist Performance Monitoring Services

Modality Reference Physicist Services

Radiology – CT American College of Radiology (ACR) Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment (ACR, 2012)

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring.

-Performance check after replacement or repair of major components.

-Annual assessment of patient radiology dose. Review and, when necessary, recommend improvements to radiology program’s policies, procedures, and protocols to minimize patient dose.

-Assist in establishing a facility quality radiology assurance program.

Radiology -above table, portable x-ray

ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Radiographic Equipment, 2016.

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring.

-Performance check after replacement or repair of major components.

-Annual assessment of patient dose.

-Review and, when necessary, recommend improvements to radiology program’s policies, procedures, and protocols to minimize patient dose.

-Establish and monitor performance of a facility quality assurance program.

Fluoroscopy – under-table, and C-Arm

ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Fluoroscopic Equipment, 2016.

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring.

-Performance check after replacement or repair of major components.

-Annual assessment of patient dose.

-Review and, when necessary, recommend improvements to radiology program’s policies, procedures, and protocols to minimize patient dose.

-Establish and monitor performance of a facility quality assurance program.

Mammography

Mammography Quality Standards Act (MQSA) Regulations – 21 CFR Part 900 – Mammography

(FDA, 2009)

-Food and Drug Administration (FDA) Guidance for Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under

MQSA (FDA, 2005)

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring which includes a summary of the evaluation of the facility quality control testing with any recommendations for necessary improvements and/or corrective actions, as needed.

-Performance check after replacement or repair of major components (including image processors).

Dental (includes portable, hand-held, and panoramic devices)

NCRP Report Number 145:

Radiation Protection in Dentistry

(NCRP, 2003)

-All new dental x-ray installations and existing installations not previously surveyed shall have a radiation protection survey.

-Resurveys shall be performed; resurvey interval should not exceed 4 years.

-A resurvey shall be made after any change in the installation, workload, or operating conditions that might significantly increase occupational or public exposure (including x-ray machine service or repair that could affect the x-ray machine output or performance).

Ultrasound-US Inspection of ultrasound equipment shall conform to the ACR/AIUM performance tests for ultrasound.

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring -Performance check after replacement or repair of major components.

-Performance check after replacement or repair of major components (including image processors).

-Oversee the quality and appropriateness of ultrasound operations of the practice -Ensure diagnostic equipment operates safely and accurately.

- Physics testing verifies spatial resolution, contrast resolution, image uniformity, dead zone, and geometric accuracy

Table 2 – Standard Physicist Performance Monitoring Tests

Standard Physicist Performance Monitoring

Medical Fluoroscopy Dental Mammography CT Ultrasound

Optimizing Patient Dose Policies are in place and followed regarding protection of pregnant patients, credentialing and competencies verification of operators, who can prescribe, apron testing and frequency, etc.

X X X X As recommended by the ACR

2012 Computed Tomography

Quality Control Manual

Tests include:

A. Review of Clinical Protocols B. Image

Uniformity C. Scout

Prescription and Alignment Light Accuracy

C. Image Thickness – Axial Mode

D. Table Travel Accuracy

E. Radiation Beam Width

F. High/Low- Contrast

Performance G. Spatial Resolution

H. CT Number Accuracy I. Artifact Evaluation

J. CT Number Uniformity

K. Dosimetry L. Gray Level

Performance of CT Acquisition

Display Monitors

As recommended by ACR, AIUM and IAC annual ultrasound physics testing is performed to ensure diagnostic equipment operates safely and accurately.

Tests should verify spatial resolution, contrast resolution, image uniformity, dead zone, and geometric accuracy.

Appropriateness of technique factors

X X X X X

Patient Dose/Entrance Skin Exposure Evaluation with comparison to FDA NEXT or equivalent reference value via CDRH phantoms – Provide recommendations for reducing exposure if beyond expected 3rd quartile.

Adult Chest, Abdomen, & Spine

Maximum exposure rate

Intraoral Adult

Bitewing

MQSA required medical physicist tests for certification.

21 CFR 900.12(e)(9)

- Surveys

Fluoroscopic entrance exposure rates.

X

Patient dose monitoring system calibration

X

Review or establishing technique charts

X X X

Recommended fastest screen-film system available, as needed

X X

Monitoring

Medical Fluoroscopy Dental Mammography CT Ultrasound

Staff Exposures Policies are in place and followed regarding protection of staff, including pregnant staff, personnel monitoring, etc.

X X X X X

Appropriately donning radiation dosimeters, providing summary reports to staff, and maintaining exposure records

X X X X X

Device Performance Integrity of unit assembly.

X X X MQSA required medical physicist tests for certification.

21 CFR 900.12(e)(9)

- Surveys

As recommended by the ACR 2012

Computed Tomography

Quality Control Manual

Tests include:

A. Review of

Clinical Protocols B. Scout

Prescription and Alignment Light

Accuracy C. Image

Thickness – Axial Mode

D. Table Travel Accuracy

E. Radiation Beam Width

F. Low-Contrast

Automatic exposure control system performance kVp accuracy and reproducibility

Linearity of exposure versus mA or mAs

Exposure reproducibility

Timer accuracy X X

Beam quality assessment (half-value layer)

Equipment radiation safety functions.

Digital image receptor performance

If Digital X If Digital MQSA required medical physicist tests for certification.

21 CFR 900.12(e)(9)

- Surveys

Performance G. Spatial Resolution

H. CT Number Accuracy I. Artifact Evaluation

J. CT Number Uniformity

K. Dosimetry L. Gray Level

Performance of CT Acquisition Display Monitors

Tube Head Stability X

Collimation Acceptance Test (AT)

X AT

Center and Bucky Alignment

AT

Source to Imaging Receptor Distance

AT AT

Other performance tests recommended by the manufacturer or physicist

AT AT AT MQSA required medical physicist tests for certification.

21 CFR

900.12(e)(10) – Mammography

Equipment Evaluations

Monitoring

Medical Fluoroscopy Dental Mammography CT Ultrasound

Verification of preventive maintenance of devices.

X X X X As recommended by ACR, AIUM and IAC annual ultrasound physics testing is performed to ensure diagnostic equipment operates safely and accurately.

Tests should verify spatial resolution, contrast resolution, image uniformity, dead zone, and geometric accuracy.

Fluoroscopic system resolution

X

Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed modes, field-of-view [FOV] variation

X

Fluoroscopic phantom image quality

X

Quality Control Review Repeat analysis X X X

See Above

Artifact Review X X X

XX

Diagnostic Workstation

- View boxes, image monitors, and viewing conditions

X X X X

Darkroom and screen cleanliness, darkroom fog, analysis of fixer retention, screen-film contact analysis

If Film/Screen Processing

If Film/Screen Processing

If Film/Screen Processing

Processor quality control (time, temperature, chemical, reference film for daily comparisons and manufacturer recommendations as needed.

If Film/Screen

If Film/Screen

If Film/Screen Processing

Computed Radiography and Digital Radiography (CR&DR) system performance – Uniformity. noise, contrast/sharpness, erasure

If CR&DR If CR&DR If CR&DR

Video and digital monitor performance

X X

Laser film printer quality control

As needed. As needed. As needed. As needed.

Exposure Indicator Analysis

If CR&DR If CR&DR If CR&DR

Integrity Test of Protective Clothing and other devices

Quality assurance log with record of observable quality variance and corrective action taken.

Completion of Service and Documentation:

On completion of all performance monitoring and testing services, the contractor’s representative shall brief the Radiology Supervisor for medical x-rays and Dental Director for dental x-ray tubes and provide documentation of all services that were performed; in addition a copy of the report is to be provided to the Radiology Supervisor, Bio-med, Clinical Director and the Division of Environmental Health Services (DEHS) Director of the Great Plains Area Office.

The documentation shall be a prepared form that provides at a minimum the following information:

A. Documents of the services performed for each item or system.

Results on Appropriateness Use Criteria audit:

1. Facility risk profile/stratification

2. Decision support system name/process type if available,

3. Exam prioritization selection,

4. Data sources available and reviewed,

5. Number of exams/data evaluated,

6. Number of exams lacking data needed for review,

7. Number of exams consistent, inconsistent, and undefined with appropriateness criteria,

8. Notable findings or facility comments,

9. Potential trends or areas for further facility QAPI/Medical Committee review,

10. Exams for which dose is/not reported, comparison of reported doses to diagnostic reference levels shall be in an easily readable format.

11. Shall be of ink or print type that can be photocopied on a standard copy machine.

B. Documentation shall include:

1. Facility Location

2. Names of key staff contacted, interviewed, and/or briefed while on site

3. Equipment Model Number

4. Equipment Manufacturer’s Serial Number

5. Location of Equipment

6. Date of Service

7. Type of service performed

8. Identification of methods and instrumentation and supplies used

9. Results of any tests or inspections performed

a. Automatic Exposure Level Standards based on latest Conference of Radiation Control Program Directors (CRCPD).

10. Provide for a check off or sign off to indicate “unit fully operational as specified by original manufacturer”.

11. If deficiencies in equipment or operation are found, corrective action plan is provided to Radiation Program Manager at each Service Unit and to the Director, DEHS.

12. Method of identifying Contractor’s service personnel

13. Block for local IHS Personnel to sign and date when service is complete.

5. Manner and Time of Conducting Work:

A. Contact the Service Unit Radiology Supervisor 30 days prior to service date for a brief consult and review of site conditions.

B. Contractor shall schedule visits with the Radiology Supervisor for medical x-rays and Dental Director for dental x-ray at least two weeks in advance of the proposed site visit.

C. Upon arrival at and before departing from the facility, the contractor’s representative shall physically check in with the Radiology Supervisor for medical x-rays and Dental Director for dental x-ray tubes.

6. Quality Assurance: The government procedures to verify that services being performed by Contractor are performed according to acceptable standards.

Quality Control: All necessary measures taken by the Contractor to ensure that the quality of and end Product or service shall meet contract requirements.

Place of Performance:

Rosebud IHS Service Unit PO Box 550 800 Hospital Drive Rosebud, SD 57555

Contracting Officer’s Representative (COR) Designation/Point of Contact

The COR is responsible for monitoring the Contractor’s technical progress; interpreting the performance work statement; technical evaluations, inspections and acceptance required by this contract. Will assist the contractor in the resolution of technical problems encountered during performance of this contract.

The designated COR for this contract is:

TBD

Point of Contact:

TBD

Period of Performance: 1 year from the date of Award

Hours of Operation:

All work shall be performed during business hours of 8:00 am to 5:30 PM. Hours can differ if the facility is open for business 24/7 or if mutually agreed between the facility and contractor representative for the benefit of the surveyor. If a service has begun during regular business hours and it must be completed before any patients can be imaged according to the American College of Radiology (ACR), The Accreditation Association for Ambulatory Health Care (AAAHC), or the Mammography Quality Standards Act (MQSA), then the physicist must complete the service.

Invoice Submission:

Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests.

The IPP website address is: https://ww.ipp.gov. IPP Helpdesk: (866) 973-3131 (M-F 8AM to 6PM ET) Email:

IPPCustomerSupport@fiscal.treasury.gov

Contracting Authority

The Contracting Officer (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 performance of this contract. No person other than the Contracting Officer has authority to bind the Government with respect to this contract. No action or omission of any government employee or representative other than the Contracting Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract. In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract: An understanding or agreement between the Contractor and anyone other than the Contracting Officer; A purported modification or change order issued by anyone other than the Contracting Officer; A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or An order, direction, consent, or permission from anyone other than the Contracting Officer to: Incur costs in excess of a specified estimated cost, allotment of funds, or other ceiling; or expend hours in excess of a specified level of effort.