1. Statment of Work- Radiological Equipment Surveys.pdf

Statement of Work (SOW) Radiological Equipment Safety Surveys and Monitoring Services Federal Bureau of Prisons (BOP)

1.0 Background

The Federal Bureau of Prisons (BOP) delivers healthcare to inmates across 122 institutions in the United States, Puerto Rico, and Hawaii. Medical services must comply with:

• Federal statutes and regulations

• BOP Program Statements, DOJ policies, and directives

• Joint Commission (JCAHO), AAAHC, and ACA accreditation standards

The BOP must ensure all diagnostic radiological equipment is maintained and certified in accordance with:

• Executive Order 10831 and Public Law 86-373 (42 U.S.C. 2021(h))

• 21 CFR 1020.30–32 (x-ray performance standards)

• FDA Compliance Program 7386.003

• Federal Guidance Report No. 14 (FGR-14)

• NCRP Report No. 147 (structural shielding design and radiation safety)

2.0 Scope of Services

The task of providing biennial on–site inspection and certification of all medical and dental x-ray equipment of all BOP medical and dental x-ray equipment includes calibration, adjustment, and mechanical checks for proper operation of clinical equipment with documentation of inspections to be provided as required by law.

Requirements include:

• Conduct a comprehensive evaluation of medical radiation used in each facility surveyed by performing radiological safety surveys and radiation use evaluations, for all medical and dental facilities utilizing diagnostic radiological equipment in accordance with current FDA policy and other federal policies on radiation protection: particularly the extent of the evaluation as specified in the most current version of the FDA Compliance Program 7386.003.

• The contractor will be expected to assess image quality through analysis of beam alignment, dynamic range, contrast resolution, spatial resolution, and homogeneity, utilizing IEC and DIN compliant phantoms, and provide recommendations for improvement when indicated.

• Recommendations to reduce patient and occupational exposures (per FGR-14)

• Review of institution radiation safety program and occupational exposure monitoring

• Immediate reporting of unusual exposures to COR and facility HSA

• Development of an Annual Inspection Schedule at the start of each performance year

• Training/refresher sessions for new staff when approved by COR

• Coordination of travel and scheduling with each institution’s HSA

• Submission of a Quality Assurance/Quality Control (QA/QC) Plan within 30 days of award, outlining calibration standards, phantom test procedures, and data integrity measures

Not included in the scope of this Statement of Work:

• MRI, MRA, CT, PET/CT, and nuclear medicine equipment

• Mammography units

• Preventive maintenance and repairs (contractor shall not open or modify equipment beyond calibration and safety testing)

Average coverage: ~5.5 radiology units per institution; higher at Federal Medical Centers.

3.0 Off-Schedule Equipment Inspections

• Repaired Equipment: Inspect within 3 business days of repair.

• New Equipment: Inspect within 30 days of completed installation.

4.0 Personnel Qualifications

• Minimum 6 years’ experience in diagnostic radiological surveys.

• Certification by the American Board of Health Physics (ABHP) or American Board of Medical Physics (ABMP) are preferred but not required.

• All federal, state, and local licenses must be valid and maintained throughout contract.

5.0 Continuity of Support & Conduct

• Contractor will ensure uninterrupted support and provide fully qualified replacements within 5 business days of notice to COR.

• Contractor employees must:

o Display government-issued ID badges at all times, must be displayed above the waist in plain view o Identify themselves as contractors in meetings, emails, and phone calls when their status is not readily apparent o Adhere to DOJ/BOP rules of safety, security, and conduct

• The Government may, at its sole discretion (in coordination with the Contracting Officer where practical), direct the Contractor to remove any Contractor employee from BOP facilities for misconduct or security reasons. Removal does not relieve the Contractor of the responsibility to continue providing the services required under the contract. The

Contracting Officer will provide the Contractor with a written explanation to support any request to remove an employee.

6.0 Security Requirements

All contractor personnel must undergo and pass BOP clearances, including but not limited to:

• NCIC and NACI checks

• Fingerprinting (FD-258)

• Credit check and employment history verification (5 years)

• Urinalysis (if required)

• Release of Information

• Other forms necessary for the position and/or institutional security

Timeline: All required clearance documents must be submitted 30 calendar days prior to start of work.

7.0 Period of Performance

• Base Year: Date of award – 12 months

• Option Year 1: Months 13–24

• Option Year 2: Months 25–36

• Option Year 3: Months 37–48

• Option Year 4: Months 49–60

• Optional 6 Month Extension: Months 61-66

8.0 Hours of Operation

Contractor employees perform all work between the hours of 7:30 a.m. and 4:00 p.m. in their respective time zones Monday through Friday (except Federal holidays). However, there may be occasions when Contractor employees shall be required to work other than normal business hours, including weekends and holidays, to fulfill requirements under this SOW.

9.0 Travel

Contractor is responsible for all travel and costs.

10.0 Deliverables & Reports

Deliverable Frequency Recipient(s) Format/Content

Inspection Report

Within 10 business days of survey

Facility HSA

& COR

Findings, pass/fail ratings, inspector signature, recommendations, security or access barriers encountered at location

Quarterly Report Quarterly COR Facilities surveyed and summary of results

Monthly Roll-Up Monthly COR Aggregate inspection data; trends and issues

Annual Inspection Schedule

Annually (start of period) COR Institution survey plan

Training Materials As requested Facility staff

& COR Handouts/slides, attendance sheet

QA/QC Plan Within 30 days of award COR Testing protocols, calibration methods, record-keeping Immediate Exposure Notification

As needed COR & Facility HSA Phone/email within 24 hours

11.0 Government Furnished Resources

• The Government will provide facility access and necessary documentation.

• Contractor shall safeguard all Government-furnished information and return it at contract closeout.

12.0 Protection of Information

Contractor shall comply with:

• Privacy Act of 1974

• DOJ-02 (PII handling)

• OMB M-06-16 (Safeguarding PII)

• FAR 52.204-21 (Safeguarding Contractor Systems)

Reports and data must be encrypted (FIPS 140-2 compliant) in transit and storage.

13.0 Definitions

• COR – Contracting Officer’s Representative

• HSA – Health Services Administrator

• BOP – Bureau of Prisons

15.0 Attachments

• List of BOP Institution Physical Addresses