Attachment_I_SOW_Radiologic_Inspections_4-10-15pc.pdf

Attachment I Statement of Work

Radiological Equipment Safety Surveys and Radiology Monitoring Services Federal Bureau of Prisons

BACKGROUND:

The Federal Bureau of Prisons provides healthcare to inmates in 121 institutions geographically dispersed throughout the contiguous United States, Hawaii, and Puerto Rico. Medical services rendered to all federal inmates are governed by federal law, Bureau policies and procedures, and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and American Corrections Association (ACA) standards.

The Bureau protects society by confining offenders in controlled environments of institutions and community-based facilities that are safe, humane, cost-efficient, and appropriately secure. The health care mission of the Bureau is to deliver medically necessary health care to inmates effectively in accordance with proven standards of care without compromising public safety concerns inherent to the Bureau’s overall mission. The term “medically necessary” is used to determine the types of health care services that are necessary.

Each Bureau facility has one, or more, x-ray units, typically a minimum of one medical radiology unit and one dental radiology unit. All institutions are currently using Digital Radiography equipment. The Food and Drug Administration (FDA) requires all x-ray units in use to be monitored in accordance with the most current FDA Compliance Program. Pursuant to “Radiation Protection Guidance to Federal Agencies for Diagnostic X Rays”, published in the Federal Register, Wednesday, February 1, 1978, Part V, the President approved recommendations for the guidance of federal agencies in providing radiation protection for patients in the application of diagnostic x-rays. Executive Order 10831 and Public Law 86-373 (42 U.S.C. 2021 (h)) delegated certain radiation, in the healing arts, and the bearing on the setting of health care policy, to FDA, which included research and training concerning radiation hazards, the development and promulgation of recommendations for radiation users, advice to the States, information for the public, performance standards for electronic products that emit radiation and regulations for the sale, distribution, and use of medical devices. Based on this Executive order and recommendation, the FDA and Environmental Protection Agency (EPA) guidelines shall be adhered to while performing the requirements outlined in this contract. These guidelines are stated in the EPA Federal Guidance Report No. 14 “Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures”, published in the Federal Register on April 3, 2013. Diagnostic medical and dental radiography equipment are to be inspected to ensure that such equipment remains in compliance with FDA safety regulations stated in 21 CFR 1020.30-32 Subchapter J.

OBJECTIVE:

The objective of this procurement is to award a contract to a contractor capable of providing radiological equipment safety surveys and radiation use evaluations for all medical and dental facilities utilizing diagnostic radiography equipment and operation procedures. The contract shall include the task of providing biennial on–site inspection and certification of all medical and dental x-ray equipment including calibration, adjustment, and mechanical checks for proper operation of clinical equipment with documentation of inspections to be provided as required by law. The contractor will be required to monitor for conformance with existing FDA and EPA policy on radiation protection. All inspections are to be conducted according to FDA and EPA guidelines for diagnostic radiography equipment on Federal property.

CONTRACTOR’S REQUIREMENTS AND RESPONSIBILITIES:

The contractor shall provide all labor, material, and equipment necessary to accomplish the following services:

1. Conduct a comprehensive evaluation of medical radiation equipment used in each facility by performing radiological safety surveys and radiation use evaluations, for all medical and dental facilities utilizing diagnostic radiography equipment in accordance with current FDA and EPA policy on radiation protection:

particularly the extent of the evaluation as specified in the EPA Federal Guidance Report No. 14 “Radiation Protection Guidance for Diagnostic and Interventional X- Ray Procedures”, published in the Federal Register on April 3, 2013. The Bureau requires each of its institutions to have its diagnostic radiography equipment inspected every 2 years. The contractor shall notify the institution’s Health Services Administrator (HSA) and the Bureau’s Contracting Officer’s Representative (COR) when certain equipment at an institution is beginning to require more frequent repairs and inspections, and should therefore be replaced. The Bureau will not mandate a schedule for the contractor, but the contractor should be aware of the consideration mentioned regarding the existing biennial schedule. Contractor is free to divide and schedule the Bureau facilities (Bureau physical address provided in the Attachment V) into geographic areas, but must realize that because a set biennial schedule has been in place for the past 5 years, some institutions will need their inspection sooner than others and cannot be made to wait another year to receive their inspections.

2. Conduct “off-schedule” inspections as necessary, when notified by a Bureau institution or the COR. An “off-schedule” inspection becomes necessary when an institution either has some of its existing x-ray equipment repaired or installs new x-ray equipment well in advance of its next regularly scheduled inspection.

The newly repaired or installed equipment must be inspected before it can be placed into service. The inspection should be conducted as soon as possible after completion of the repair or installation, and no longer than three business days after such completion to limit machine down time. The same reporting requirement for normally-scheduled inspections applies to off-schedule inspections. Contractor must indicate on its invoices which inspections were off-schedule and the reason for the off-schedule inspection. The Bureau anticipates that approximately 9-12 off-schedule inspections will occur during each performance period.

3. Recommend modifications or changes in equipment and operation procedures which, when implemented, will reduce patient and occupational radiation exposures.

4. Provide the required reports in accordance to this

Statement of Work (SOW).

5. Provide to the COR, by COB on the 10th business day after the beginning of the performance period, a schedule in electronic format of Bureau facilities that the contractor anticipates inspecting during the performance period. It is expected that approximately 25% of the facilities on this schedule will be inspected during each quarter of the performance period.

6. Provide to the COR, upon request, a searchable list in electronic format (searchable Adobe PDF or Microsoft Excel or Microsoft Word) of all Bureau facilities and their most recent inspection date, preferably sorted by facility name.

7. Provide refresher training on proper radiography equipment usage techniques when necessary to new staff, as requested upon written approval of the COR or HSA.

8. Coordinate all travel and scheduling arrangements with the individual facility’s HSA or designee prior to conducting any inspection.

9. Notify the COR immediately, and provide all required documentation when contractor wishes to add or change inspectors of Bureau facilities. No contractor personnel will be permitted access to Bureau facilities prior to being cleared by the Bureau’s security background check process (see “SPECIAL SECURITY AND CLEARANCE

REQUIREMENTS”).

10. Provide immediate notification of unusual exposures to the COR by telephone or email, concurrent with the immediate notification to the facility’s Health Services Administrator.

EQUIPMENT INSPECTION/SERVICES NOT REQUIRED

1. Magnetic Resonance Imaging (MRI), Nuclear Medicine, Computed Tomography (CT), and Positron Emission Tomography (PET)/CT equipment are not to be inspected.

2. Mammography equipment is not to be inspected. The local institution will coordinate inspection of their Mammography equipment with the FDA.

3. Preventative maintenance or repair will not be required on the diagnostic radiological equipment being inspected.

The contractor should include a comment and explanation in its inspection report indicating equipment requiring service, maintenance or repair.

The contractor must acknowledge its acceptance of the terms included in this section in its offer.

REPORTS

1. The contractor shall provide the surveyed Bureau facility’s HSA and the COR, an inspection report showing the results of the survey and any recommendations the contractor may have for the surveyed facility. The report shall be provided within 10 days of survey completion. The report shall include a description and discussion of the following topics:

List of radiograph equipment that was inspected at the facility, including model/serial number, equipment type, and manufacture date.

Features of the radiograph equipment that were evaluated for compliance with federal safety standards.

Tools used to perform the inspection.

The facility’s compliance with federal safety standards for radiation exposure to medical staff working in the facility.

An assessment of the radiation safety program at the facility, to include how well medical personnel are following existing policy and procedures.

Physicist’s findings and recommendations.

The contractor must submit a sample final report for a typical inspection with its offer.

2. The contractor shall provide the COR, by the 10th business day of the performance period, a report of aggregate results from Bureau inspections performed during the previous performance period. The report shall include percentages of all institutions having acceptable and unacceptable inspection results, security or access barriers encountered when attempting to perform inspections, and a brief summary of any recommendations the contractor may have regarding the radiography equipment and its use.

3. All reports that the contractor submits to the Bureau shall be in searchable electronic format, preferably in searchable Adobe PDF, Microsoft Excel or Microsoft Word format (unless other report options are indicated in this document). A reader of the report should be able to quickly search for specific words or phrases contained in the report.

CONTRACTOR QUALIFICATIONS:

The contractor must have at least six years of demonstrated experience inspecting a wide range of diagnostic radiography equipment according to federal safety standards in healthcare organizations such as hospitals and healthcare systems.

Experience must be included in the proposal submitted and can be demonstrated via resume, recommendations of past and present clients, and past performance on similar contracts.

Certification in Health Physics by the American Board of Health Physics or American Board of Medical Physics is preferred but not required.

The Bureau recognizes that state and local licenses or permits are not required for performing radiography equipment inspections in federal correctional institutions because these institutions are located on federal property. It is not mandatory that health physicists possess or acquire state or local licenses or permits in all Bureau facility locations to fulfill the requirements of this SOW. The contractor must possess required licenses or permits as part of its normal business operations. Contractor must submit copies of current licenses and/or permits with their proposal.

The contractor shall employ staff whose qualifications are commensurate with job responsibilities and the authority level of the corresponding conditions. The Bureau requires that personnel performing inspections have health physicist experience and training. These persons must have a minimum of 6 years professional experience in health physics or medical physics. Certification in Health Physics by the American Board of Health Physics or American Board of Medical Physics is preferred but not required. Contractor must submit resumes for all inspectors it anticipates would be performing inspections under this contract.

The contractor must be registered in the System for Award Management (SAM), an online system that replaces CCR/FedReg, the Online Representations and Certifications Application (ORCA), and the Excluded Parties List System (EPLS). Contractors can go to www.sam.gov to find their information. Contractors shall maintain a current and accurate record in the SAM database annually. Registration in no way guarantees that a contract will be awarded. The contractor must provide proof that it is registered in the SAM database.

http://www.sam.gov/

COMPLIANCE WITH CONTRACT REQUIREMENTS:

The contractor is notified this proposed contractual arrangement will be a nonpersonal services contract and not a personnel appointment. Payment is based on the provision of an end product and the accomplishment of a specific task. The service does not constitute an employer/employee relationship. The contractor will not be subject to government supervision, except for security related matters. However, the contractor’s performance will be closely monitored by the COR to ensure the required services are achieved.

The government reserves the right to review, inspect, and evaluate all services rendered during the performance of this contract. The contractor must acknowledge its acceptance of the terms included in this section in its proposal.

QUALITY CONTROL:

Stringent quality control procedures shall be monitored and maintained by the COR on all information collected and produced by the contractor. In addition, the Bureau requires the contractor to implement and maintain quality control measures sufficient to meet the Bureau’s performance requirements.

Contractor must submit a Quality Control Plan which provides a detailed description of the measures it has in place to provide the most accurate and timely information possible to the Bureau regarding its medical radiograph equipment, policy, and procedures. Quality control measures should address:

• Inspection procedures followed by contractor’s personnel.

• Review of reports for accuracy and clarity before submission to the Bureau.

• Communications policies and procedures between contractor’s personnel and Bureau personnel.

• Any other measures contractor implements to facilitate better quality of service.

During contract performance, the contractor must forward in writing to the COR any changes to its quality control measures implemented.

PERIOD OF PERFORMANCE:

The contract term will be established as a one-year base period with four one-year option periods as follows:

Base Period Date of Award through 12 months Option Period One: 13 months through 24 months Option Period Two: 25 months through 36 months Option Period Three: 37 months through 48 months Option Period Four: 49 months through 60 months

CONTRACT PAYMENTS

Payments for services performed under this contract will be made by quarterly task orders. Contractor should submit an invoice listing all Bureau facilities that were inspected during the previous quarter of the performance period. Invoices should be submitted to both the Bureau Central Office Business Office and the COR to the address below. The contractor must acknowledge its acceptance of the terms included in this section in its proposal.

Federal Bureau of Prisons Central Office Business Office 320 First Street, NW Suite 5009 Washington, DC 20534

SPECIAL SECURITY AND CLEARANCE REQUIREMENTS:

It shall be the responsibility of the contractor, as directed by the COR, to ensure that all necessary security forms and information are completed and submitted in a timely manner before work begins.

In addition to the background investigations noted above, Bureau security requirements include, but are not limited to, the following:

1) National Crime Information Center (NCIC) checks.

2) National Agency Check with Inquiries (NACI).

3) Law Enforcement Agency checks.

4) National Law Enforcement Telecommunication System(NLETS) checks.

5) Credit check.

6) Completed Standard Fingerprint Form (FD-258).

7) Completed Office of Personnel Management Optional Form (OF-306), Declaration of Federal Employment and Appropriate Resume and Optional Application.

8) Completed Contractor Pre-Employment Form.

9) Release of Information.

10) Urinalysis.

11) Employment Vouchering over the past five years.

If urinalysis is required, the test shall be administered at the closest Bureau facility where work is to be performed. If the test is positive for drug usage, the individual(s) assigned to perform the work shall be excluded and the contractor shall be required to provide acceptable replacement personnel subject to the same security requirements.

Each of the contractor’s assigned employees shall submit to a security background check. This will require each employee to provide full name, birth date, address, and social security number to the Bureau, authorizing the Bureau to check this data with the National Crime Information Center. This information will be considered confidential and will be maintained in the Bureau Central Office.

The contractor will agree that no employee will be allowed access to any Bureau institution without the security check as required above or any additional security checks/information that may be required by the Bureau in the future. Therefore, this process will need to be completed prior to performance. The contractor must acknowledge its acceptance of the terms included in this section in its proposal.