Scope of Work Physicist PAO.pdf

30 July 2020

RFQ-20-PHX-034 Physicist, PAO

Purpose and Background. To ensure that patients (and staff) receive minimal radiation exposure, the Indian Health Service (IHS) must utilize and follow nationally-recognized standards of practice regarding x-ray equipment performance monitoring and testing as part of its medical imaging services. This monitoring includes conducting quality assurance reviews of each facility’s radiation safety program/policies. Adherence to this policy will also ensure that IHS is meeting the Center for Medicare and Medicaid Services’ regulatory requirements for reimbursement. The equipment tested shall include (but not limited to); above table X-Ray (x-radiation) units, mobile X-Ray units, fluoroscopy units, computed tomography units (CTs).

C. SPECIFICATIONS:

The contractor shall provide an annual radiation safety survey for Phoenix Area Office, service Unit listed below.

1. Location:

a) Phoenix Indian Medical Center, Phoenix, AZ

b) Arizona Non-Metro Service Units:

1) Whiteriver Hospital Indian Hospital, Whiteriver, AZ

2) Cibecue Health Center, Whiteriver, AZ

3) Hopi Health Care Center, Polacca, AZ

4) Parker Indian Health Center, Parker, AZ

5) Peach Springs Health Center, Peach Springs, AZ

6) Havasupai Health Station, Supai, AZ

7) Chemehuevi Health Station, Havasu Lake, AZ

8) Ft. Yuma Health Center, Winterhaven, AZ c ) Nevada/Utah:

1) Southern Bands Health Center, Elko, NV

2) Ft. Duchesne Health Center, Ft. Duchesne, UT

2. Specific Tasks:

Line Item 1: The vendor will survey all x-ray generating medical imaging equipment at PIMC.

Line Item 2: The vendor will survey all Arizona based x-ray generating medical equipment an IHS facilities outside the Phoenix metropolitan area.

Line Item 3: The vendor will survey x-ray generating medical equipment at the federal facilities of Southern Bands Health Center in Elko, Nevada and Ft. Duchesene Indian Health Center in Ft. Duchesne, Utah.

Line Item 4: The Phoenix Area IHS IEH Program personnel have been trained to conduct radiation safety surveys and are capable of surveying all x-ray imaging modalities except Computed Tomography (CT).

Surveying diagnostic x-ray equipment by the medical physicist is outside the scope of this contract;

however the IEH program personnel conduct the surveys. Since 2015, IEH radiation safety survey reports have been revived and validated by a qualified medical physicist. As part of this contract, the Phoenix Area IHS is seeking to have the vendor review six radiation safety survey reports conducted by Phoenix Area IEH program personnel per year.

Line Item 5: The vendor will survey new equipment within 30 days upon request.

3. Radiation Safety Surveys:

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

Services to meet 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, at no additional charge, must provide all supplies, kits, test equipment, tools and parts required to perform services. All required services as noted below will be conducted.

3.2 Radiation Safety Surveys must be conducted according to ACR and NCRP standards and equipment manufacturers’ recommendations.

3.3. Performance Monitoring Tests and Services must be conducted according to the bid schedule provided in tables 1 and 2 below.

3.4. Contractor must schedule visits with each site’s Lead Radiologist or X-Ray Technician for medical x-rays and Dental Chief for dental x-ray tubes at least one week in advance of the proposed site visit. Locations and points of contact are identified in the bid schedule table.

3.5. The contractor must review and recommend improvements to (each facility named in the bid schedule table) radiology program’s policies, procedures, and protocols to minimize patient dose.

3.6. The contractor may consult with the radiologist (at each facility named in the bid schedule table) concerning patient and fetal dose determinations under this contract when directed by a properly executed supplement agreement/change order.

3.7. The contractor may consult on Radiation Shielding calculations or Surveys regarding new facility design or remodels under this contract when directed by a properly executed supplement agreement/change order.

3.8. The Government expects it will take 6 months to complete all testing of the sites, requiring annual testing.

4. Specifications and Measurements

4.1. 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 that would affect dose (i.e. x-ray tube housing assembly, x-ray controls, high voltage generators, spot film devices and image intensifiers).

-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 radiology quality assurance program.

Radiology - above table x-ray

ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment

(ACR, 2011)

-Acceptance testing upon installation and before clinic use.

-Annual device performance monitoring.

-Performance check after replacement or repair of major components that would affect dose (i.e. x-ray tube housing assembly, x-ray controls, high voltage generators, spot film devices and image intensifiers).. -Annual assessment of patient radiology dose.

Modality Reference Physicist Services -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.

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

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

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

NCRP Report Number 145:

Radiation Protection in Dentistry (NCRP, 2003)

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

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

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

-A resurvey must 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).

4.2. Table 2 – Standard Physicist Performance Monitoring Tests

Standard Physicist Performance Monitoring

Medical Fluoroscopy Dental Mammograp hy

CT

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

Automatic exposure control system performance

X X kVp accuracy and reproducibility

X X X

Linearity of exposure versus mA or mAs

X X

Exposure reproducibility

X X C. Image Thickness – Axial Mode D. Table Travel Accuracy E. Radiation Beam Width F. 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

Timer accuracy X X Beam quality assessment (half-value layer)

X X X

Equipment radiation safety functions.

X X X

Digital image receptor performance

If Digital X If Digital

MQSA

required medical physicist tests for certification.

21 CFR

900.12(e)(9) - Surveys

Tube Head Stability X Collimation Acceptanc e 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) Mammograph y Equipment Evaluations

Verification of preventive maintenance of devices.

X X X X

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

Optimizing Patient Dose

Policies are in place and followed regarding protection of pregnant patients.

X X X X See Above

Appropriateness of technique factors

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

Intraor al

Adult Bitewi ng

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

Staff Exposures Policies are in place and followed regarding protection of pregnant patients and staff.

X X X X X

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

X X X X X

Quality Control Review Repeat analysis X X X See Above Artifact Review X X X Diagnostic Workstation - View boxes, image

X X X X monitors, and viewing conditions Darkroom and screen cleanliness, darkroom fog, analysis of fixer retention, screen-film contact analysis

If Film/Scree n Processing

If Film/S creen Process ing

If Film/Screen Processing

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

If Film/Scree n

If Film/S creen

If Film/Screen Processing

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

If CR&DR If

CR&D

R

If CR&DR

Video and digital monitor performance

X

Laser film printer quality control

As needed. As needed. As needed.

As needed.

Exposure Indicator Analysis

If CR&DR If

CR&D

R

If CR&DR

Integrity Test of Protective Clothing and other devices

X X X X

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

X X X X

5. Completion of Service and Documentation:

5.1. Upon completion of all performance monitoring and testing services, the contractor’s representative attempt to have an exit meeting and brief the location’s Clinical Director or Chief Executive Officer (CEO) on the findings. Contractor must provide documentation of all services that were performed to the CEO and Contracting Officer Representative (COR) no later than 30 days post survey-test. The documentation provided must contain the following information:

5.2. Documentation on the services performed for each item or system.

1. Documentation must be in an easily readable format.

2. Documentation must be of ink or print type that can be photocopied on a standard copy machine.

3. Documentation must include:

a. Facility Location.

b. Equipment Model Number.

c. Equipment Manufacturer’s Serial Number.

d. Date of Service.

e. Type of service performed.

f. Identification of methods and instrumentation and supplies used.

g. Results of any tests or inspections performed.

a. Automatic Exposure Level Standards based on latest CRCPD.

h. Provide a sign off to indicate “unit fully operational as specified by original manufacturer”.

i. If deficiencies in equipment or operation are found, corrective action plan is provided to the CEO and Project

Officer no later than 30 days post- test. Any necessary immediate action must be communicated verbally and in writing during the exit meeting. A copy of such notification must be included in the completion of service documentation.

j. Method of identifying Contractor’s personnel.

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

6. Service Delivery Summary and Acceptable Quality Level (AQL).

Required Services (Performance Requirements)

Indicators Acceptable Quality Level

Method of Surveillance Minimum Payment % for Meeting

AQL

Contractor Qualifications.

Certification requirements as identified in the Performance work statement.

Current The government will conduct Random validation checks.

100%

Contractor must conduct Annual Radiation Safety Surveys.

Contractor to develop schedule based on expiration periods for re-surveying/

Radiation surveys must be conducted and all equipment is within compliance.

The government will review reports of completed Radiation surveys and through random validation checks.

100%

Radiation Safety Survey Report.

Report due within 30 days after Radiation Safety Survey Report.

Report provided to COR within 30 days.

The government will ensure reports are provided by using the approved contractor’s schedule and random validation checks.

95 to 100%

Findings and recommendations from contractor.

Usability of report Understood by facility staff in order to implement recommended corrective actions.

Random review by subject matter expert.

75%

7. Contractors Qualifications.

7.1. Contractor shall certify data submitted by technical qualified field personnel to a Certifying Official. The certification official shall serve in the capacity of a Physicist in Medicine American Association of Physicists in Medicine (AAPM) or American College of Radiology (ACR) in the sub-field of diagnostic physicists. The following is provided as informational regarding requirement for certification:

• Has earned a master's or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

• Has been granted 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)

8. Schedule and Notification:

8.1. Manner and Time of Conducting Work: A proposed schedule of work shall be provided to the Project Officer for final review and approval of a final schedule. Upon arrival at and before departing from the facility the contractor’s representative shall confer in person with the location’s Lead X-Ray Technician for medical x-rays and Dental Chief for dental x-ray tubes.

9. Operating Hours:

9.1 All work shall be performed during the Normal Work Hours of Monday through Friday, except for Federal Holidays, 8:00 am through 4:30 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.

E. PAYMENT AND INVOICING INSTRUCTIONS:

10. Invoices shall be prepared with the following information CLEARLY identified on the invoice:

1. Invoice Date and Number

2. Contract Number

3. Charges for service or products identified BY LINE ITEM Number

4. Itemized description and location of services delivered.

5. Charges should follow Line Item structure on contract to include Quantity, Unit of Issue, Unit Price, and Total Amount as applicable 6. Dates of Service or Shipment

Invoices shall be prepared and submitted electronically and in accordance with rates and terms as stated in the contract.

11. Payment:

Measurement of Payment: Completed items of work must be measured and paid for in accordance with requirements listed in the performance work statement. Payment will be based on actual quantities or services completed and must represent actual work under the contract line items.

12. Travel. The Government is aware that the contractor is expected to travel throughout the designated areas and travel may require additional expenditures on the Contractor’s behalf. The contractor is expected to include price burdens associated with travel into individual Contract Line Items.

13 Invoice Submission: The contractor shall submit an invoice based on the Contract Line Items. The contractor shall bill on a recurring monthly basis (1 month period). Invoice should be submitted to the Contracting Officer Technical Representative (COTR) for certification of work. At a minimum the invoice shall contain the following:

Invoices should be sent electronically to the following departments and addresses in the same e-mail:

Finance Office.

Finance: _______________@ihs.gov For purposes of interest accrual and time of official receipt, Finance is designated as the point of receipt for the Government. Invoices shall be submitted electronically to the e-mail address listed above.

SOL: 75H71220R00016 COVID-19 Supplies and Service, PAO Page 4

Acquisitions: _____________@ihs.gov A copy of the invoice should be sent electronically to the contract specialist(s) at the address listed above.

Service Unit Representatives: _____________@ihs.gov A copy of the invoice should be sent electronically to the Service Unit Representative(s) at the address listed above.

14. Contracting Officer Representative:

The Contracting Officer will designate in writing a COR who shall be responsible for:

1 Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer, changes in requirements;

2 Interpreting scope of work;

3 Performing technical evaluations required;

4 Performing technical inspections and acceptances required by this contract;

5 Monitoring funds available for obligation under this contract;

6 The resolution of technical problems encountered during performance of this contract;

In no event is the COR empowered to change any of the terms and conditions of the contract. Changes in the scope of work, contract price, quantity, and quality or delivery schedule shall be made only by the Contracting Officer by a properly exercised modification.

The designation of a COR does not authorize or provide a legal right to change any kind of contractual terms regardless of the Contractor’s apparent difficulties in fulfilling contract requirements.

Environmental Health & Engineering Indian Health Service, 40 N. Central Ave., Suite 606., Phoenix, AZ 85004

L. INSTRUCTION TO OFFERORS:

RFP Submission Guidelines

PART 1: TECHNICAL PROPOSAL PREPARATION

Page Limit:

Limit to 10 pages including the cover page. Any pages in excess of 10 pages will not necessarily be evaluated.

Content:

a) Offerors must submit a current certificate as a Qualified Medical Physicist from the American Board of Radiology.

b) Offerors must submit proposal describing their experience evaluating medical imaging programs for proper dose, technique factors and safety practices.

c) Offerors must submit a proposal describing their past performance evaluating x-ray generating diagnostic imaging equipment (CT, Fluoscope, Above Table, Dental Panoramic and IntraOral equipment) in accordance with FDA CDRH and the American College of Radiology performance standards.

d) Offerors must submit proposal describing their ability manage traveling to assess imaging equipment and imaging programs in multiple sites in remote locations including the Havasupai Village in the Grand Canyon, the Hopi Indian Reservation and Northern Ute Reservation.

e) Offerors must submit a sample of a past medical imaging survey report.

PART 2: PAST PERFORMANCE

Page Limit:

Limit to 10 pages including the cover page. Any pages in excess of 10 will not necessarily be evaluated.

Content:

Offerors must submit past performance that is current and relevant as defined below. Offerors may submit a maximum of 5 examples of their past performance with their offer. Past performance information should contain the following:

1. contract number and contract type

2. dollar value

3. contract award and completion dates

4. Description of the work and the relevancy, (include modalities managed)

5. Contact name and number for reference site.

Definitions:

• Current is defined as having been completed within the last 36 months from solicitation close date.

• Relevant is defined as any contract or subcontract valued at similar magnitude or greater for the same type of service,

• Same type of service is defined as service for the clinical interpretation of multi-modality images,

• Experience reflects whether the contractors have performed similar work before,

• Past performance describes how well contractors performed the work.

PART 3: PRICE PROPOSAL PREPARATION

Format:

A price schedule will be supplied with the solicitation. Price shall be inclusive of scope, travel, reporting requirement, other incidental expenses. Complete Price Schedule for base and all options.

Content:

The total price for the contract should be filled out completely with the total prices for the base and option years, identifying the price per services.

M. Evaluation Criteria Evaluation of offers received will be in accordance with provision 52.212-2 – Evaluation – Commercial Items as stated below:

Evaluation -- Commercial Items (OCT 2018)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical:

a) Capability to provide the technical narrative proposed under content of the Section 7 Contractors Qualification.

b) Capability to provide the technical narrative proposed under content section 3 Radiation Safety Surveys.

c) Capability to provide the technical narrative proposed under content Section 4 Specification and

Measurements.

d) Capability to provide the technical narrative proposed under content section 1 Location.

e) Capability to provide the technical narrative proposed under content section 2 Specific Task/Line 4.

2. Past Performance:

Information must be submitted in accordance with 52.212-1 Instruction to Offerors – Commercial Items PPIRS and FAPIIS data will be reviewed

3. Price:

Technical and past performance, when combined, are significantly greater when compared to price.

Technical and Past Performance will be evaluated first, do not include price proposal in the Technical Proposal and Past Performance.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

I. CONTRACT CLAUSES:

This contract is covered under the terms and conditions of FSS/GSA # _________ and the following addendum clauses:

I. Clauses incorporated by reference

NUMBERTITLE DATE

52.202-1 DEFINITIONS (Nov 2013)

52.203-3 GRATUITIES (APR 1984) (IAW FAR 3.202)

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM

EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014)

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS (DEC 2014)

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT.

52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT.

52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018)

52.224-1 PRIVACY ACT NOTIFICATION (APR 1984)

52.224-2 PRIVACY ACT (APR 1984)

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013)

1 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS

(DEC 2013)

II. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3)

CLAUSES (INCORPORATED BY REFERENCE):

NUMBER TITLE DATE

352.201-70 PAPERWORK REDUCTION ACT (JAN 2006)

352.203-70 ANTI-LOBBYING (JAN 2006)

352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS

(JAN 2010)

352.223-70 SAFETY AND HEALTH (JAN 2006)

352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006)

352.231-71 PRICING OF ADJUSTMENTS (JAN 2001)

52.252-2 Clauses Incorporated by Reference. (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://farsite.hill.af.mil/ http://acquisition.gov/far

TAXES

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, PHOENIX AREA INDIAN HEALTH SERVICE IS TAX EXEMPT UNDER A.R.S. 42-5063 (C)(3)(a), 42-5067 (B)(1), 42-5065 (B)(2)(a), 42-5066 (B)(3)(a), 42-5074 (B)(7), 42-5071 (B)(2)(a), 42-5061 (A)(25)(a), and 42-5159(A)(13)(a), (b), (c)

J. ATTACHMENTS:

Attachment A-Price Schedule Attachment B-Wage Determination http://farsite.hill.af.mil/ http://acquisition.gov/far