Medical_Physicist_Services_Schedule_B__Price_schedule_revised_05-16-19LD--REVISED05-17-19.docx

SECTION B

B.1 PRICE SCHEDULE – MEDICAL PHYSICIST SERVICES

The Billings Area Indian Health Service (IHS) is requesting quotes in accordance with the requirements of RFQ-05-16-2019LD, to acquire Medical Physicist Services for the Fort Belknap Service Unit, Harlem, Montana. The procurement is conducted pursuant to the authority of Federal Acquisition Regulation (FAR) Part 13, Simplified Acquisition Procedures and FAR 37.101, Non-Personal Service Contracts. The associated North American Industry Classifications System Code is 541690 and the small business size standard is $15.0 Million.

The requirement is set-aside 100% for Small Businesses. Offerors shall submit an all-inclusive rate for each Contract Line Item Number (CLIN). The Billings Area IHS intends to award firm fixed price contract in response to RFQ-05-16-2019LD.

CLIN #1 – BASE YEAR

CLIN #2 – OPTION YEAR ONE

CLIN #3 – OPTION YEAR TWO

CLIN #4 – OPTION YEAR THREE (Dental Unit Included)

CLIN #5 – OPTION YEAR FOUR

B.2 PERIOD OF PERFORMANCE

Performance of this purchase order shall be for 12 months from June 1, 2019, through May 31, 2020, with four (4) 12-month options. If the Government exercises the options pursuant to Federal Acquisition Regulation (FAR) 52.217-9, Option to Extend the Term of the Contract (MAR 2000), the period of performance shall be extended in accordance with the following schedule:

Year Option Period

B.3 PURPOSE OF THE CONTRACT

The primary purpose of this contract is to hire a contractor to assist the department in conducting Radiological Physics Surveys on x-ray equipment.

B.4 STATEMENT OF WORK

The Contractor shall be responsible for providing all necessary labor, equipment, and supplies to conduct Radiological Physics Surveys on the x-ray equipment located at the Fort Belknap Hospital, Harlem, MT and Eagle Child Health Clinic, Hays, MT.

MAJOR DUTIES:

The Contractor shall conduct the following QC tests on the Mammography equipment:

· Mammographic Unit Assembly Evaluation

· Collimation Assessment

· Artifact Evaluation

· kVp Accuracy and Reproducibility

· Beam Quality Assessment – HVL Measurement

· Evaluation of System Resolution

· Automatic Exposure Control (AEC) Function Performance

· Breast Entrance Exposure, AEC Reproducibility and Average Glandular Dose

· Radiation Output Rate

· Phantom Image Quality Evaluation

· Signal-To-Noise Radio and Contrast-To-Noise Ratio Measurement

· Diagnostic Review Workstation (RWS) QC

· Detector Flat Field Calibration

· Compression Thickness Indicator

· Compression

The Contractor shall evaluate the site’s Technologist QC Program to include:

· Artifact Evaluation

· Signal-To-Noise and Contrast-To-Noise Measurements

· Phantom Image

· Detector Flat-Field Calibration

· Compression Thickness Indicator

· Visual Checklist

· Reject Analysis

· Compression

· Review Workstation QC - Overall

The Contractor shall conduct the following tests on the Radiographic Equipment:

· kVp Accuracy

· Beam Quality (Half-Value Layer)

· Exposure Reproducibility

· Timer Accuracy

· mAs Calibration

· Entrance Skin Exposures

· Scatter Radiation Measurements

· Light and Radiation Field Congruence

· Indication of Exposure exists

· Technique Factors

· X-ray Field

· Exposure Switch

· Radiation protective apparel is provided

· Radiation Monitoring Badges are provided

DELIVERABLES COVERED BY CONTRACT:

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.

*Staff qualifications *Equipment maintenance process and documentation *Personnel monitoring and means to prevent/reduce exposure using ALARA principal *Patient dose estimation, documentation, and reporting *Protection of pregnant patients and workers; fetal protection and dose calculation *Equipment Performance Monitoring *Protective equipment inspection *Quality Assurance/ Performance improvement *Annual imaging program evaluation *Management of imaging records *Radiation Safety Officer appointment and scope of responsibilities *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.

REQUIREMENTS:

A. 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. Table 3 lists the equipment by location.

B. 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. The local site contact will follow up on necessary service calls or maintenance under a separate purchase order through proper acquisition channels. It is not expected that the contractor bidding will provide any maintenance services, just recommendations for repair or servicing.

C. 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.

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

E. The contractor shall consult with the Lead X-Ray Technician concerning patient and fetal dose determinations under this contract when needed. (To be procured through a separate purchase order).

References:

· ACR–SPR Practice Parameter for General Radiography Res. 30 – 2013, Amended 2014 https://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/General_Radiography.pdf

· American College of Radiology Appropriateness’ Criteria and Diagnostic Radiology Guidelines https://acsearch.acr.org/list)

· Protecting Access to Medicare Act, 2014

· CY 2017 Physician Fee Schedule (PFS) Final Rule https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-26668.pdf

· Scope of Practice of Clinical Medical Physics https://www.aapm.org/org/policies/details.asp?id=317&type=PP

· Quality Control in Diagnostic Radiology AAPM Report 74 (http://www.aapm.org/pubs/reports/rpt_74.PDF

· FDA, Mammography Quality Standards Act Regulations (MQSA). 21 CFR §900. http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm110906.htm

· NCRP, Report Number 145 - Radiation Protection in Dentistry, October 2004.

· ADA/FDA, The Selection of Patients for Dental Radiographic Examinations, November 28, 2012. http://www.fda.gov/Radiation-EmittingProducts/default.htm

· ACR–AAPM–SIIM Technical Standard for Electronic Practice of Medical Imaging, 2012

· ACR Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Computed Tomography Equipment. 2007

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

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

SCHEDULE:

Fort Belknap Hospital:

REPORT WRITING

Eagle Child Health Clinic:

REPORT WRITING

A. Contractor shall schedule visits with the site’s Radiology Department for medical equipment surveys, and Dental Department for dental equipment surveys at least two weeks in advance of the proposed site visit.

B. Upon arrival at and before departing from the facility, the contractor’s representative shall physically check in with the Radiology Department and/or Dental Department.

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

B.5 MEDICAL PHYSICIST REQUIREMENTS

A. Medical Physicist Certification Requirements: The Services shall be performed by a certified qualified medical physicists meeting the American Association of Physicists in Medicine (AAPM) definition. AAPM defines a qualified medical physicist as, “an individual with the following credentials:

1. 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

2. 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)

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

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

3. 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.

4. Contractor shall schedule visits with each site’s Radiology Department and Dental Department at least two weeks in advance of the proposed site visit.

5. With thorough testing and measurements, 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.

B.6 PERFORMANCE MONITORING AND TEST TABLES

Table 1 – Medical Physicist Performance Monitoring Services

-Annual device performance monitoring.

-Performance check after replacement or repair of major components. (To be procured through a separate purchase order).

-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.

-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). (To be procured through a separate purchase order).

-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). (To be procured through a separate purchase order).

Table 2 – Standard Physicist Performance Monitoring Tests

Optimizing Patient Dose

X

21 CFR 900.12(e)(9) - Surveys

Recommended fastest screen-film system available, as needed

X

Staff Exposures

Device Performance

X

X

X

X

X

X

Tube Head Stability

X

AT

Center and Bucky Alignment

AT

AT

21 CFR 900.12(e)(10) – Mammography Equipment Evaluations

Quality Control Review

Diagnostic Workstation - Image monitors and viewing conditions X

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

If Film/Screen Processing

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

If Film/Screen

Laser film printer quality control

As needed.

Completion of Service and Documentation: On completion of all performance monitoring and testing services, the contractor’s representative shall brief the locations Lead X-Ray Technician for medical x-rays and Dental Chief 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 Chief Medical Officer and the Division of Environmental Health Services (DEHS) Director of the Billings Area Office. The documentation shall be a prepared form that provides at a minimum the following information:

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

B. Shall be in an easily readable format.

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

D. 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.

B.7 SERVICE LOCATIONS AND POINTS OF CONTACT:

B.8 CONTRACTING OFFICER AUTHORITY

Authority to negotiate changes in the terms, conditions or amounts cited in this purchase order is reserved for the Contracting Officer.

B.9 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The COR shall be responsible for:

1. Monitoring the Contractor’s technical progress;

2. Interpreting the statement of work;

3. Technical evaluation as required;

4. Technical inspections and acceptance required by this contract; and,

5. Assisting the Contractor in the resolution of technical problems encountered during performance of this purchase order.

B.10 INVOICE SUBMISSION AND PAYMENT

The Contractor shall submit the invoices on an annual basis to:

The Contractor agrees to include the following information on each invoice:

(1) Contractor’s name and address;

(2) Contact name, title, and telephone number;

(3) Contract Number;

(4) Invoice number and date;

(5) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed;

(6) Remit to Address;

(7) Taxpayer Identification Number (Employer Identification Number or Social Security Number); and

(8) Data Universal Numbering System (DUNS) number (to ensure payment is made to the correct bank account) and vendor mailing address, as provided in the System for Award Management (SAM), formerly known as the Central Contractor Registration (CCR) database.

Payment shall be made by the Billings Area Financial Management Branch, P.O. Box 36600, Billings, Montana 59107.

B.11 CHILD CARE NATIONAL AGENCY CHECK AND INVESTIGATION (CNACI)

A CNACI must be completed for all Indian Health Service (IHS) contract personnel within the Billings Area. Public Law (P.L.) 101-630, Indian Child Protection and Family Violence Prevention Act, requires the IHS to conduct a criminal history background investigation on all contractors performing services in IHS facilities. The character and background investigations will be conducted by the Service Units.

SECTION C

SECTION C – CONTRACT CLAUSES

C.1 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 addresses:

https://www.acquisition.gov/

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES

Certifications 52.209-2 Prohibition on Contracting with Inverted Domestic Nov 2015 Corporations-Representation.

52.209-10 Prohibition on Contracting with Inverted Domestic Nov 2015 Corporations.

Law

Vegetation

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR)(48 CFR CHAPTER 3) CLAUSES

352.222-70 Contractor Cooperation in Equal Employment Dec 2015 Opportunity Investigations.

Notice

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

1. (a) The Government may extend the term of this contract by written notice to the Contractor within __30___; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least __60___ days before the contract expires. The preliminary notice does not commit the Government to an extension.

2. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

3. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed __5 years_________.

(End of clause)

C.3 PRO-CHILDREN ACT OF 1994

The Contractor certifies that it will comply with the provisions of Public Law 103-227, Pro-Children Act of 1994, which imposes restrictions on smoking where federally funded children's services are provided.

C.4 CHILD CARE NATIONAL AGENCY CHECK AND INVESTIGATION (CNACI)

Fingerprint checks must occur as part of the pre-employment process and must be completed before the contractor is allowed to work. The fingerprint check should be coordinated with the Billings Area Office (BAO).

A CNACI must be completed for all Indian Health Service (IHS) contractor personnel within the Billings Area. Public Law (P.L.) 101-630, Indian Child Protection and Family Violence Prevention Act and P.L. 101-647, Crime Control Act of 1990, require the IHS to conduct a character and criminal history background investigation on all contractors performing services in IHS facilities. The character and background investigations will be conducted by the BAO.

C.5 AWARD DECISION

The Government will award a purchase order 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 offers must contain a technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. The following factors shall be used to evaluate offers:

1. TECHNICAL: Offeror must submit a technical proposal, not to exceed 3 pages, that addresses the following sub-factor:

Sub-Factor 1: Understanding of the Statement of Work, specific tasks, and planned execution of the project.

2. PAST PERFORMANCE: The Offeror must demonstrate its record of successful performance in past contracts and/or jobs, Government and/or commercial. Each offeror will be evaluated on its performance under existing and prior contracts/jobs. The offeror must include at least (3) three contracts/jobs that are related to this project. The Government is seeking to determine whether the Offeror has the experience that will enhance its technical capability to perform the tasks described in the statement of work. In evaluating past performance, the government will only take into consideration the relevant experience and the past performance record of the offeror. Submit the most recent contracts/jobs, within the past 3 years. Please complete the attached Past Performance Questionnaire for each past contract/job. Offerors will be given the opportunity to clarify information concerning the relevancy of an offeror’s past performance information, and any adverse past performance information to which the offeror has not previously had an opportunity to respond. If the offeror has no relative past performance, they shall affirmatively state so. NOTE: The Government reserves the right to contact any reference provided by the offeror in evaluating the offeror’s past performance. Furthermore, the Government reserves the right to use any information that comes to the attention of the Government in evaluating the offeror.

COST/PRICE: EVALUATION APPROACH: The content of the written quotations, as well as information derived from discussions/negotiations, if discussions are held, will be evaluated to determine the degree and extent to which the requirements and objectives set forth in the solicitation are satisfied. No assumption will be made by Government evaluators regarding areas not defined in the offeror's written material/information provided to the Government for evaluation.

Technical and past performance, when combined, are considered approximately equal to cost or price. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

BASIS FOR AWARD: Selection of the successful offeror will be made to the offeror whose proposal provides the combination of features that offers the best overall value to the Government. The quotations will be evaluated and a contract awarded under the Best Value Continuum approach to permit tradeoffs among cost or price and non-cost factors. This will allow the Government to consider award to other than the lowest priced offeror or other than the highest technically rated offeror. The Government is more concerned with obtaining performance capability rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate factor for award of a contract as proposals are considered more equal through evaluation.