Radiological Surveys Sources Sought
Sheridan Radiology
Compliance Survey Services
This is a Sources Sought Notice (NOT A SOLICITATION). The Sheridan VA Medical Center is seeking potential sources to provide Compliance Surveys for Radiological Equipment as direct by the FDA Title 21(21CFR1020.30).
Please direct all questions to michael.smith26@va.gov
General Requirements:
Complete annual radiation compliance surveys of all (medical) X-ray equipment at the Sheridan VA Medical Center to identify diagnostic x-ray systems that fail to comply with applicable performance standard requirements and to protect the public from unnecessary radiation hazard.
Follow up surveys may be required after obtaining correction of noncompliant systems identified in (3.1.4) above and will be executed by the Contracting Officer prior to coordination by the Point of Contact (POC)
Specific Tasks
Task 1: The Radiation Survey will be performed on the following types of x-ray machines:
RADIOGRAPHIC UNITS
PORTABLE X-RAY SYSTEMS
DENTAL RADIOGRAPHIC UNITS
COMPUTED TOMOGRAPHY SYSTEMS
MAGNETIC RESONANCE SYSTEMS
Task 2: All equipment will be tested as listed in the tables of Appendix B and in accordance with AAPM standards. Further clarification can be found at http://www.aapm.org/pubs/reports/rpt_74.PDF and FDA Title 21 (21CFR1020.30)
KVP panoramic dental units should be tested where possible using a non-invasive meter to evaluate the QC.
Task 3: Surveyor requirements.
Surveyor must be a fully Qualified Medical Physicist, i.e., board certified in diagnostic radiology or board certified health physicist, certified by the American Board of Radiology or the American Board of Health Physics.
Surveyor shall be required to provide all test equipment and phantoms necessary for testing.
Hospital will provide an equipment operator to assist in operating the equipment being tested.
Task 4: Survey Documentation.
Surveyor will provide a detailed written report of the survey to include the following
site visited
modality tested
date of test
test performed
results of test
evaluation of findings
All reports will follow the format list at http://www.aapm.org/pubs/reports/rpt_74.PDF
Contractor will label all equipment with:
Date of Test
Results of Test
Date of Retest (if applicable)
Initials
Task 5: Enterprise Management Controls
Survey will be conducted under the escort of a Biomedical Equipment Support Specialist (BESS) representative from the Dept. of Biomedical Engineering.
The BESS representative will provide access, performance monitoring, on-site review, and other assistance as needed.
Surveyor will be required to provide all test equipment and phantoms needed to complete the survey.
Surveyor will provide documentation of calibration certification of test equipment used.
Surveyor will provide a detailed report of work done, findings, and evaluations
Performance Monitoring Surveyor will be accompanied by a BESS representative to ensure proper usage of equipment tested, verify calibration certifications on test equipment used, and to ensure all equipment contracted is tested. Report will be reviewed for accuracy and completeness.
Security Requirements Surveyor will be around computers that have patient information. However, a VA employee will operate these devices and will set up the equipment and there will be no patient information included. All tests will be run using a new study under the name of Safety Survey . It is possible that the surveyor may be within visual range of patient information during the course of his/her duties while conducting the survey.
Other Pertinent Information or Special Considerations. Surveyor will need to be able to survey all equipment as listed in Specific Tasks 1 and Appendix A, not just a portion of it. Surveyor must also be available for follow up visit if necessary.
Identification of Possible Follow-on Work. In the event that the survey s findings reveal non-compliance of before mentioned regulations (see 3.Background), surveyor may be called back for retesting once corrections have been made so that compliance to these regulations can be satisfied.
Inspection and Acceptance Criteria. Acceptance will be determined once the surveyor has proved detailed documentation of the survey and its findings, evaluations, recommendations and providing no follow up survey testing is required. If follow up is required, acceptance will be contingent on receipt of final report.
Risk Control A Biomedical Equipment Support Specialist (B.E.S.S.) representative will accompany the surveyor during the survey and a technologist will be available when applicable
Place of Performance.
Sheridan VAMC, 1898 Fort Road, Sheridan, WY, 82801
Surveyor will be responsible for providing his/her own transportation to and from this location.
Delivery Schedule.
Inspection is to be conducted within 30 days of request.
Survey report is due within 30 days after inspection.
Follow up inspection (as required) is to be conducted within 90 days of initial failure.
References
VA Radiology Guide http://vaww1.va.gov/RADIOLOGY/Online_Guide_Personnel.asp
Compliance Regulations
FDA Title 21 (21CFR1020.30) http://www/accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.30
All prospective vendors must be registered and current within the System for Award Management (SAM). Visit www.sam.gov for details. In addition, all SDVOSBs and VOSBs must be registered and current within VetBiz. Visit www.vetbiz.gov for details. All responses must be received by 5-31-2017 at 4:30 pm MST
POC for this notice is Ian Boettcher / michael.smith26@va.gov
Michael Smith
michael.smith26@va.gov
303-202-8302
michael.smith26@va.gov
