Health, Health Systems Improvement, Licensing

Section R432-950-16

State Certification

Notice of Proposed Rule

(Amendment)

DAR File No.: 33426
Filed: 03/03/2010 12:58:44 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule change was reviewed by the Health Facilities Committee and approved on 02/10/2010. This committee has representation from a broad cross-section of the entities affected by this rule. As an efficiency effort in 2003, the Bureau started renewing all licenses and certificates on a two-year cycle instead of every year. The licensing renewal rules were changed at that time, but the Mammography rule was not. This rule change is proposed to amend the Mammography rule in accordance with that practice to save providers and Bureau staff time and effort.

Summary of the rule or change:

The State certification for mammography facilities is a 24-month certification period by practice and has been that way since approximately 2003. This rule amendment will change the requirement in the rule for renewal of a mammography certificate from 12 to 24 months.

State statutory or constitutional authorization for this rule:

• Title 26, Chapter 21
• Title 26, Chapter 23

Anticipated cost or savings to:

the state budget:

This rule change will have no effect on state budgets since the 24-month certification period has already been in place for several years.

local governments:

This rule change will have no effect on local government budgets since the 24-month certification period has already been in place for several years.

small businesses:

This rule change will have no effect on small businesses since the 24-month certification period has already been in place for several years.

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

This rule change will have no effect on businesses, individuals, local governments, and person that are not small businesses since the 24-month certification period has already been in place for several years.

Compliance costs for affected persons:

This rule change will have no effect on persons since the 24-month certification period has already been in place for several years.

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

This rule change implements a 24-month cycle for recertification. Practice had already implemented this action. This will confirm the change that is positive for business.

David N. Sundwall, MD, Executive Director

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

Health
Health Systems Improvement, Licensing
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Joel Hoffman at the above address, by phone at 801-538-6279, by FAX at 801-538-6024, or by Internet E-mail at [email protected]
• Carmen Richins at the above address, by phone at 801-538-9087, by FAX at 801-538-6024, or by Internet E-mail at [email protected]

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:

05/03/2010

This rule may become effective on:

05/10/2010

Authorized by:

David Sundwall, Executive Director

R432. Health, Health Systems Improvement, Licensing.

R432-950. Mammography Quality Assurance.

R432-950-16. State Certification.

(1) No facility, person or governmental unit acting severally or jointly with any other person, may establish, conduct or maintain a mammography unit without first obtaining a state certificate from the Department.

(2) An applicant for state certification shall file a Request for Agency Action/Certification Application with the Utah Department of Health on forms furnished by the Department.

(3) Each facility shall comply with all zoning, building and licensing laws, rules and ordinances and codes of the city and county in which the facility is located. The applicant shall submit the following to the Department:

(a) Verification of participation and quality control by the American College of Radiology for monitoring mammography services in the facility;

(b) Verification of licensure or certification of required personnel;

(c) Fees established by the Utah State Legislature pursuant to Section 63-38-3.

(4) The Department shall render a decision on the initial certification within 60 days of receipt of a completed application packet or within 6 months of date that the first component of an application packet was received.

(a) Upon verification of compliance with state certification requirements, the Department shall issue a provisional certificate.

(b) The Department shall issue a notice of agency decision under the procedures for informal adjudicative proceedings denying a state certification if the applicant is not in compliance with the applicable laws or rules. The notice shall state the reasons for denial.

(5) Certificate Contents and Provisions. The state certificate shall include the name of the mammography facility, owner, supervising physician, address, issue and expiration dates of the state certificate and the certificate number.

(b) The state certificate may be issued only to the owner and for the premises described in the application and shall not be assignable or transferable.

(c) Each state certificate is the property of the Department and shall be returned within five days if the certification is suspended, revoked, or if the operation of the facility is discontinued.

(d) The state certificate shall be prominently displayed where it can be easily viewed by the public.

(6) Certification periods shall be for [12]24 months, and expire at midnight [12]24 months from the date of issuance.

(a) A request for renewal and applicable fees shall be filed with the Department 15 days before the state certificate expires.

(b) Failure to make a timely renewal shall result in assessment of late fees as established by the Utah State Legislature pursuant to Section 26-21a-203.

(7) The owner shall submit a Request for Agency Action/Application to amend or modify state certification status at least 30-days before any of the following proposed or anticipated changes occur:

(a) Change in the name of the facility;

(b) Change in the supervising physician;

(c) Change in the owner of the facility.

(8) The owner who wants to cease operation shall complete the following:

(a) Notify the patients within 30 days before the effective date of closure.

(b) Make adequate provision for the safekeeping of records and notify the department where those records will be stored.

(c) Return the state certificate to the Department within five days after the facility ceases operation.

(9) The Department may issue a provisional state certificate to a facility as an initial certification and may issue a provisional state certification to a facility that does not fully comply with the requirements for a standard certification but has made acceptable progress towards meeting the requirements.

(a) In granting a provisional state certification, the Department must be assured that the lack of full compliance does not harm the health, safety, and welfare of the patients.

(b) A provisional state certificate is nonrenewable and shall be issued for no more than 6 months.

 

KEY: health facilities, mammography

Date of Enactment or Last Substantive Amendment: [October 19, 1995] 2010

Notice of Continuation: October 4, 2007

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