Radiation Control Program



                                            The Texas Department of State Health Services, Radiation Control Program, has the important mission to protect and promote the physical and environmental health of the people of Texas. We strive to prevent unnecessary radiation exposure to the public through effective licensing, registration, inspection, enforcement, and emergency response.


NOTICE

Industrial Radiographer COVID-19 Renewal Exam Waiver

April 13, 2020

Due to the current COVID-19 state of disaster in Texas, the Department of State Health Services (DSHS) requested and the Office of the Governor granted the following waiver:

Industrial Radiography Personnel License Renewal Extension

In accordance with section 418.016 of the Texas Government code, the Office of the Governor granted DSHS’s request to suspend 25 TAC §289.255(h)(3)(B). This waiver will allow industrial radiography personnel whose license has expired after March 13, 2020, to timely renew their license without taking the industrial radiography exam. The testing requirement for renewals will be suspended for the remainder of the governor’s declared emergency for COVID-19 or until DSHS resumes administering the industrial radiography exams. This rule suspension applies only to industrial radiographer license renewal applicants that have timely submitted the renewal applications and fees.

DSHS will issue a “timely renewal” letter to industrial radiographers who have not completed testing but have submitted timely applications and fees to renew their license. The “timely renewal” letter will allow radiographers to continue operating under their license until the waiver of the rule section is terminated and the testing requirements can be fulfilled.  


NOTICE to Mammography and X-ray Registrants 

On March 19, 2020, DSHS Radiation Control began receiving information that some medical facilities are limiting access to vendors due to restrictions they have implemented because of COVID-19. Those prohibitions include restricting or barring access to licensed medical physicists who conduct required machine testing, which would result in a delay in conducting physics surveys. 

The current Texas regulations on mammography, fluoroscopy, computed tomography, and other x-ray devices require testing at a specified interval. DSHS also aligns its practices to guidance offered by federal regulatory agencies such as the U.S. Food and Drug Administration. 

DSHS supports facilities’ efforts to protect public health and offers the following guidance for registrants to ensure a continuity of radiation safety during COVID-19-related restrictions. This is a fluid situation and subject to change. 
 



Mammography Devices
The U.S. Food and Drug Administration has a policy for mammography devices that allows facilities to notify their state inspector or state certifying agency and request permission in writing to defer the current survey until the extenuating circumstance(s) is no longer applicable. The policy requires facilities to make the notification before the expiration of their current physics survey.  

In its request, the facility must include the date the survey expires, explain in writing the reason for the requested deferral, and propose a schedule showing the date by which the deferred physics survey will be completed. As the date when COVID-19 restrictions will end and the resources available for testing at the end of restrictions may be unknown at this time, the facility may satisfy this requirement by describing the efforts they plan to take in the three months immediately following the survey expiration. The department understands this proposed schedule may need to be amended.  
 
Quality assurance testing will still need to be performed by the facility for as long as they continue to perform imaging procedures. In situations where the mammography device requires repair before being used, the facility will direct patients to a facility with properly working mammography devices until the repairs and testing can be completed.  
 
Mammography facilities should notify Trae Windham at trae.windham@dshs.texas.gov to request permission to defer the current survey.
 
Fluoroscopy, Computed Tomography, and Other X-Ray Devices
If the physics survey is delayed due to circumstances related to COVID-19, the facility is required to document the issue and determine a schedule to have the required testing completed. This documentation should start before the current physics survey expires. If the proposed schedule needs to be amended, the facility should update their documentation. This documentation should be made available to department inspection staff upon request. In situations where the x-ray device requires repair before being used, the facility will direct patients to a facility with properly working x-ray devices until the repairs and testing can be completed.  
 
Questions can be sent to RadiationXRayInspections@dshs.texas.gov 


NOTICE to Radioactive Material Licensees

On March 19, 2020, the Texas Department of State Health Services (DSHS) Radiation Control began receiving information that some medical facilities are limiting access to vendors due to restrictions they have implemented because of COVID-19. Those prohibitions include restricting or barring access to licensed medical physicists and contractors who conduct required surveys at authorized radioactive material licensees, which will result in a delay in conducting some physics surveys. 

The Texas regulations on radioactive material (RAM) include various testing and notifications to be conducted to maintain compliance. DSHS supports facilities’ efforts to protect public health and follow the Executive Orders and Declarations issued by Texas Governor Abbott and Texas Commissioner of Health, Dr. Hellerstedt.

DSHS offers the following guidance for registrants to ensure a continuity of radiation safety during COVID-19-related restrictions. 

  • Licensees should continue following the current regulations.
  • If the radiation safety officer or other person responsible for completing a required regulated task is unable to perform his or her duties due to illness, governmental guidance, or orders related to COVID-19, a licensee must make reasonable efforts to find another qualified individual who can timely perform the regulated task.
  • All licensees must document any mitigating factors encountered during this time and make the documentation available to department inspection staff upon request. DSHS will consider extenuating circumstances that are documented when making decisions regarding compliance actions.  

Compliance with the following requirements is required at all times:

  • Reports of lost, stolen or missing radioactive sources
  • Notification of incidents involving radioactive material
  • Notification of exceeding annual dose limits
  • Notification of medical events as described in current Texas regulations 

For facilities that have received a Notice of Violation (NOV):

  • Facilities should respond to the NOV. If facilities are unable to respond in the specified timeframe please contact the reviewer listed in the NOV.
  • Facilities must document reasons corrective action or the response to the NOV was delayed or prevented and provide that documentation to the reviewer at a future date.

Direct your questions to: 

Please check back regularly for updates.  

 

In accordance with Senate Bill 202 (84th Regular Session, 2015), regulatory authority over the State’s Laser Hair Removal Program has been transferred to the Texas Department of Licensing and Regulation (TDLR). All inquiries in regard to this occupation should be directed to TDLR.

Please click the link below to access the Laser Hair Removal section of the TDLR website for details:

TDLR Laser Hair Removal page



New Radioactive Material License Format 

As of January 2018, the Texas Department of State Health Services has revised the radioactive material license format and standard license conditions as explained in the following memo and medical use crosswalk.  The updated license formats only apply to licenses issued after January 1, 2018.  
New License Format
Crosswalk of Revised Medical Use, Radioactive Material Listing and Authorized Physician User Uses


To radioactive material licensees impacted by Hurricane Harvey: 

You should follow the recommendations of your local emergency response organization to protect yourself and others from harm.  If you discover that radioactive material in your possession has become lost, you should contact the Radiation Hot Line at 512 458-7460 to report the loss.  A team of radiation control staff is available to respond to your call.

As a reminder, lost and damaged radioactive isotopes requiring the physical protection specified in 289.252(ii) must be reported immediately by telephone after the loss, attempted actual theft or damage becomes known.  Other radioactive isotopes are reported according to the activity of the isotope.  Isotopes equal to or greater than 1000 times the value found in the table at 289.202(ggg)(3) of the Radioactive Material License Rules must be reported immediately by Telephone.  Isotopes equal to or greater than 10 times the value in 289.202(ggg)(3) must be reported in writing within 30 days if it is still missing.

If your facility is affected by the storm, and if you have determined that your radioactive material is secure and accounted for, please notify us after the storm passes your area by email ( ramnotice@dshs.texas.gov) or fax (512 834-6654). If you determine radioactive material is missing or damaged, or the security of your storage facility is compromised, notify us immediately by telephone using the numbers provided below during business hours, or after business hours, use our emergency assistance number 512-458-7460.

Lost or damaged records:

The Radiation Control Program is aware that some of you in areas affected by Harvey and flooding have lost or had damage to the records that you are required to maintain for compliance.  You may be able to replicate some of the lost or damaged records by requesting copies from your service providers, consultants, or from your undamaged electronic versions of the documents. Our inspectors are aware of the areas that have been affected by Harvey and will take this into consideration during future inspections.

We recommend you make a complete assessment as soon as possible of the documents that are permanently lost and unrecoverable, and maintain this assessment for future review by the agency. The assessment should include the category or type of document (ex.: leak test, storage area survey, instrument or dose calibrator calibration, public dose estimate, occupational dose record), the date or date range for the lost documents, and the reason for loss. Do not submit the assessment to the agency. We will review the assessment during our next site visit or inspection.  

To x-ray and mammography registrants impacted by Hurricane Harvey:

The Radiation Control Program is aware that some of you have lost or had damage to the records that you are required to maintain for compliance.  Our inspectors are aware of the areas that have been affected by Harvey and will take this into consideration during future inspections.

If you have questions or need assistance with x-ray inspection matters, please contact us at  RadiationXRayInspections@dshs.texas.gov  or at (737) 218-7136.

If you have questions or need assistance with x-ray registration and/or mammography matters, please contact us at  XRAYregistration@dshs.texas.gov or at (737) 218-7110.

Additional mammography guidance is available from the FDA at the below link.

FDA Mammography Guidance

To assist you with re-building your records:

  • Make an assessment and document as soon as possible record(s) that were lost and were unable to be replaced due to damage caused by hurricane Harvey and/or floods. Do not submit the assessment to the agency. We will review the assessment during our next site visit or inspection.
  • Reach out to your service company, Licensed Medical Physicist and the provider of personnel monitoring for replacement records
  • The radiation program file room maintains copies of your current Certificate of Registration and previous correspondence.  We do not maintain all of the records registrants need for compliance. 

If your x-ray system needs repair, please ensure that  requirements of 25 TAC §289.227(h) and §289.232(i)(10) regarding repairs to certified x-ray systems are met. 

If your mammography facility has to replace a mammography equipment system, you must go through the normal certification and accreditation process for the new equipment.  If repair is needed, follow current mammography requirements for when repairs are made or major components are changed and you must have a physicist do a Mammography Equipment Evaluation (MEE).



Important Notice for Licensees Subject to Category 1 and Category 2 Quantities of Radioactive Material (formerly Increased Controls)



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Last updated May 18, 2020