About Lay Letter Contact Information

QUESTION: 

We are moving forward on updating our client letters and would appreciate clarification on the following. 

We see that the new regulations state:

Patient Lay Summaries

The patient's name, address and telephone number of the facility performing the exam. 

We currently have multiple sites with off-site centralized scheduling numbers on their lay letters. Does that number meet the new regulations? Or do the letters need to have the actual facility phone number?  

ANSWER:

The name recognized by the FDA for a facility is the name under which the facility is accredited by its accreditation body. For mammograms performed on a mobile unit that travels to different locations, the facility identification information in the report to the referring healthcare provider and the lay summary sent to the patient must include the name and address under which the facility is accredited and certified. For mobile units that travel to different locations, the facility may include additional information, such as the physical location where the mammogram was performed.

The regulations do not specify where the facility identification information must appear in the medical report or lay letter. A facility may choose to include additional information about a healthcare network, affiliated site, or centralized scheduling on its medical reports and lay summaries. However, suppose additional information about an affiliated site or healthcare network is included. In that case, the report and lay summary should identify the address and phone number of the specific facility where the mammogram was performed.

All information in this answer and all others are sourced from the MQSA Hotline at +1 (800) 838-7715. For other questions, contact Mammologix or the MQSA Program directly!