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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 25, 2017 FBO #5662
DOCUMENT

H -- Radiological Surveys Sources Sought - Attachment

Notice Date

5/23/2017
 

Notice Type

Attachment
 

NAICS

541690 — Other Scientific and Technical Consulting Services
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
 

ZIP Code

80246
 

Solicitation Number

VA25917N0569
 

Response Due

5/31/2017
 

Archive Date

6/15/2017
 

Point of Contact

Michael Smith
 

E-Mail Address

2-8302<br
 

Small Business Set-Aside

Veteran-Owned Small Business
 

Description

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
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25917N0569/listing.html)
 

Document(s)

Attachment
 

File Name: VA259-17-N-0569 VA259-17-N-0569.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3522043&FileName=VA259-17-N-0569-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3522043&FileName=VA259-17-N-0569-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04518434-W 20170525/170523234839-343cf2e380592a5b2c55919290f2eb70 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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