No. 43136 (Amendment): Rule R432-950. Mammography Quality Assurance

(Amendment)

DAR File No.: 43136
Filed: 08/07/2018 09:39:24 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to add language consistent with the requirements of H.B. 258 passed during the 2018 General Session.

Summary of the rule or change:

This amendment will require all mammography providers to provide notice to women with dense breast tissue of the relevant health care information related to that type of tissue. The specific notice to be given is provided in the statute and added to this rule.

Statutory or constitutional authorization for this rule:

• Title 26, Chapter 21a

Anticipated cost or savings to:

the state budget:

The mammography reporting process was reviewed. This proposed amendment will not add any new process steps for the regulatory agency. This proposed amendment is not expected to impact state revenues or expenditures.

local governments:

Local governments were considered, however, this won�t affect any government processes.

small businesses:

This amendment will not affect small mammography businesses. They already provide information to women who have been screened.

persons other than small businesses, businesses, or local governmental entities:

This amendment will not affect businesses or other individuals. Mammography facilities already provide information to women who have been screened.

Compliance costs for affected persons:

After conducting a thorough analysis, it was determined that this proposed amendment will not result in a fiscal impact to affected persons because this amendment does not introduce any new processes to mammography facilities.

Comments by the department head on the fiscal impact the rule may have on businesses:

After conducting a thorough analysis, it was determined that this rule will not result in fiscal impact to businesses.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Family Health and Preparedness, Licensing
3760 S HIGHLAND DR
SALT LAKE CITY, UT 84106

Direct questions regarding this rule to:

• Joel Hoffman at the above address, by phone at 801-273-2804, by FAX at 801-274-0658, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

10/01/2018

This rule may become effective on:

10/08/2018

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Person

$0

$0

$0

Total Fiscal Costs:

$0

$0

$0

Fiscal Benefits

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Persons

$0

$0

$0

Total Fiscal Benefits:

$0

$0

$0

Net Fiscal Benefits:

$0

$0

$0

 

Appendix 2: Regulatory Impact to Non - Small Businesses

This amendment will not affect non-small businesses. The mammography facilities affected by this rule amendment already provide information to women who have been screened. There are no new requirements.

 

After conducting a thorough analysis, it was determined that this rule will not result in fiscal impact to businesses. Joseph K. Miner, MD, Executive Director.

 

 

R432. Health, Family Health and Preparedness, Licensing.

R432-950. Mammography Quality Assurance.

R432-950-13. Mammography Records.

(1) A medical record shall be maintained for each patient on whom screening or diagnostic mammography is performed.

(a) Provision shall be made for the filing, safe storage and accessibility of medical records.

(b) Records shall be protected against loss, defacement, tampering, fires, and floods.

(c) Records shall be protected against access by unauthorized individuals.

(d) All records shall be readily available upon the request of:

(i) The attending physician,

(ii) Authorized representatives of the Department for determining compliance with licensure rules;

(iii) Any other person authorized by written consent.

(e) The facility shall establish a system to assure that the patient's mammogram is accessible for clinical follow-up when requested.

(i) A copy of the mammogram and other appropriate information shall be sent to the requesting party responsible for subsequent medical care of the patient no later tha[t]n 14 working days from the request for information. This shall include the full notification and follow up required under Utah Code 26-21a-206 and Administrative Code R432-950-14.

(ii) Medical information may be released only upon the written consent of the patient of her legal representative.

(2) The facility shall attempt to obtain a prior mammogram for each patient if the prior mammogram is necessary for the physician to properly interpret the current exam.

(3) The interpreting physician shall prepare and sign a written report of his interpretation of the results of the screening mammogram.

(a) The written report shall include a description of detected abnormalities and recommendations for subsequent follow-up studies.

(b) The interpreting physician shall render the report as soon as reasonably possible.

(c) The interpreting physician or his designee shall document and communicate the results of the report to the referring physician or his designated representative by telephone, by certified mail, or in such a manner that receipt of the report is assured.

(d) The interpreting physician or his designee shall notify self-referred patients, that is, patients who have no referring physician, of the results of the screening study in writing and in lay language.

(4) The interpreting physician or his designee shall document and communicate the results of all diagnostic reports in the high probability category with suspicion of breast cancer to the referring physician or his designated representative by telephone, by certified mail, or in such a manner that receipt of the report is assured.

(5) The physician shall document and communicate in person in lay language, by certified mail, or in such a manner that receipt of the diagnostic report is assured to all self-referred patients within the high probability category with a suspicion of breast cancer. The report shall indicate whether the patient needs to consult with a physician.

(a) The interpreting physician or his designee shall attempt to make a follow-up contact with the patient to determine whether she has consulted a physician for follow-up care.

(b) The interpreting physician or his designee shall document in the patient's medical record attempts to communicate the results to the patient.

(6) The facility shall retain the original and subsequent mammograms for a period of at least five years from the date of the procedure.

 

R432-950-14. Education and Notification Requirements.

(1) A patient has the right to be treated with dignity and afforded privacy during the examination.

(2) The facility shall establish an education system to ensure that the patient understands:

(a) The purpose of the mammogram and how it is used to screen for breast cancer;

(b) The process required to obtain the mammogram;

(c) The importance of the screening mammography to her ongoing health.

(3) As required in Utah Code 26-21a-206, the facility shall include the following notification and information with a mammography result provided to a patient with dense breast tissue: "Your mammogram indicates that you have dense breast tissue. Dense breast tissue is common and is found in as many as half of all women. However, dense breast tissue can make it more difficult to fully and accurately evaluate your mammogram and detect early signs of possible cancer in the breast. This information is being provided to inform and encourage you to discuss your dense breast tissue and other breast cancer risk factors with your health care provider. Together, you can decide what may be best for you. A copy of your mammography report has been sent to your health care provider. Please contact them if you have any questions or concerns about this notice."

(4) The copy of the mammography report provided to the patient and the health care provider shall include the dense breast tissue notification required under Utah Code 26-21a-206.

 

KEY: health care facilities, mammography

Date of Enactment or Last Substantive Amendment: [June 2, 2010]2018

Notice of Continuation: September 15, 2016

Authorizing, and Implemented or Interpreted Law: 26-21a-203

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