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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Certificate (Definition)

Citation:

900.2(h) Certificate means the certificate described in section 900.11(a).

Discussion:

After October 1, 1994, all mammography facilities are required to have an MQSA certificate issued by FDA or the Certifying State to legally perform mammography. To obtain an MQSA certificate from FDA or the Certifying State, facilities are required to be accredited by an approved accreditation body or other entity, as designated by FDA, and to meet the quality standards as published in 900.12.

By law, MQSA certificates must be prominently displayed where they can be viewed by mammography patients.

 Question 1: Where does a facility with more than one patient/examinee reception area display its MQSA certificate?
Question 2: Can a facility with a large Spanish-speaking population get a Spanish-language MQSA certificate?
Question 3: A facility has changed its name but has the same owner, personnel, and equipment. Is the MQSA certificate still valid even though the facility name is different?
Question 4: A facility moves or relocates and the address on its certificate is no longer correct. Is the MQSA certificate still valid?
Question 5: What should a facility do if it closes or decides that it will no longer provide mammography services?
Question 6: Our facility has several patient waiting areas. Can I photocopy our facility MQSA certificate and place copies in each area?
 Question 1: Where does a facility with more than one patient reception area display its MQSA certificate?

MQSA certification is facility based. Therefore, if a facility has more than one patient reception area, it may request an additional MQSA certificate for each reception area from FDA at no charge. Mobile facilities must have at least one original MQSA certificate displayed whenever the mobile unit is performing mammography. All MQSA certificates issued to a facility will share that facility’s unique 6-digit identification number. Contact the FDA MQSA Facility Hotline at 1-800-838-7715 to request additional MQSA certificates. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.

 Question 2: Can a facility with a large Spanish-speaking population get a Spanish-language MQSA certificate?.

FDA will issue an additional MQSA certificate at no charge translated into Spanish for those facilities serving a Spanish-speaking population for each patient reception area. The Spanish-language MQSA certificate(s) and the English-language MQSA certificate(s) should both be prominently displayed where they can be viewed by mammography patients. Contact the FDA MQSA Facility Hotline at 1-800-838-7715 to request a Spanish-language MQSA certificate. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.

 Question 3: A facility has changed its name but has the same owner, personnel, and equipment. Is the MQSA certificate still valid even though the facility name is different?

Your MQSA certificate is still valid. However, when a facility changes just its name, it must notify its accreditation body even though it still has the same owner, personnel, and equipment. The accreditation body will then inform FDA or the Certifying State of the facility’s new name. FDA or the Certifying State will then issue a new MQSA certificate to the facility.

Until the new MQSA certificate is received, the facility must prominently display its original MQSA certificate. The expiration date of the new MQSA certificate will be the same as the original since the facility has not been reaccredited or recertified. After the new MQSA certificate arrives, the original MQSA certificate should not be displayed. The facility should file or destroy the MQSA original certificate after it receives the new MQSA certificate.

 Question 4: A facility moves or relocates and the address on its certificate is no longer correct. Is the MQSA certificate still valid?

Your MQSA certificate is still valid. However, when a facility moves or relocates, it must notify its accreditation body. The facility is reminded that any mammography unit or processor that is disassembled and reassembled at the same or different location must have a mammography equipment evaluation. Any failures of a regulatory requirement found during the mammography equipment evaluation must be corrected before that piece of equipment is used for patient examinations. The accreditation body will direct the facility regarding any additional information and/or testing that it may require. The accreditation body will then inform FDA or the Certifying State of the facility’s new address. FDA will no longer issue replacement certificates for address changes. At the time of the next renewal, FDA-issued MQSA certificates will be issued with the facility name only. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding replacement of MQSA certificates.

 Question 5: What should a facility do if it closes or decides that it will no longer provide mammography services?

Before a facility permanently stops performing mammography, it should do the following:

1. Inform its accreditation body that it will no longer be performing mammography;

2. Notify its State radiation control program;

3. Arrange transfer of each patient’s medical record (original mammography films and reports) to the mammography facility where the patient will be receiving future care, the patient’s referring physician or health care provider, or the patient. This transfer will address the requirement that the facility maintain the patient’s permanent medical record for a period of not less than 5 years, or not less than 10 years if no additional mammograms are performed at the facility, or longer if mandated by State or local law. The facility should make reasonable attempts to inform its former patients of how they can obtain their mammography records. Facilities should check with State or local agencies to determine if their requirements are more stringent. Note: Radiology practices and other medical facilities that still see patients but have permanently stopped performing mammography, may choose to keep the patients’ medical records rather than transfer them to another facility (unless the patient requests such a transfer).

If option 3 is not viable, facilities could store the medical records in a hospital, if appropriate, or make arrangements to warehouse the records. The facility should assure that there is a mechanism to release the films to the appropriate entity when requested and that former patients are made aware of that mechanism. It should be noted that if no one else is willing to accept the records, the facility remains responsible for them. Under MQSA, facilities will not be held responsible for maintenance of examinations performed before October 1, 1994; however, State and local regulations may require otherwise.

Once the facility ceases operation, the MQSA certificate should no longer be displayed. The facility may file or destroy its MQSA certificate.

Due to the fact that some facilities have not followed the above recommendations, FDA has received inquiries from patients complaining that their mammography facility has closed, that they were not informed, and that they cannot find out where or how to gain access to their mammography records. For this reason, FDA requests that a facility that plans to stop performing mammography notify its Certifying Agency of how it intends to fulfill its obligations with respect to medical records. Such information may be sent to:

 FDA/CDRH/OCER/DMQRP

Attention: Closed Facility Notification of Records Retention
1350 Piccard Drive, HFZ-240
Rockville, MD 20850

 Facilities certified by States may send the above information to:

Mammography Accreditation Program
Iowa Department of Public Health
Lucas State Office Bldg., 5th Floor
321 East 12th Street
Des Moines, Iowa 50319
515-281-3478

State of Illinois
Office of Radiation Safety
Department of Nuclear Safety
1035 Outer Park Drive
Springfield, IL 62704
217-785-9974

State of South Carolina
Department of Health and Environmental Control
Division of Electronic Products
2600 Bull Street
Columbia, SC 29201
803-545-4400

 Question 6: Our facility has several patient waiting areas. Can I photocopy our facility MQSA certificate and place copies in each area?

While the Statute requires that the original MQSA certificate be prominently displayed (42 U.S.C. 263b(b)(1)(A)(iii)), the photocopying of the MQSA certificate so that it may be displayed in additional areas is not prohibited. However, we recommend that facilities wishing to display their MQSA certificate in several different areas obtain additional MQSA certificates (at no charge) by contacting FDA at 1-800-838-7715 or writing to: MQSA Hotline, P.O. Box 6057, Columbia, MD 21045-6057. Facilities with State-issued MQSA certificates should check with their Certifying State for their policies regarding additional MQSA certificates. Facilities are reminded that, at a minimum, they must have the original MQSA certificate displayed even if they choose to display additional copies of the MQSA certificate. Mobile facilities must have at least one original MQSA certificate displayed whenever the mobile unit is performing mammography.

 
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