DAR File No. 38173
This rule was published in the January 1, 2014, issue (Vol. 2014, No. 1) of the Utah State Bulletin.
Health, Family Health and Preparedness, Licensing
General Health Care Facility Rules Inspection and Enforcement
Notice of Proposed Rule
DAR File No.: 38173
Filed: 12/12/2013 09:17:56 AM
Purpose of the rule or reason for the change:
During the inspection process, licensed providers sometimes deny access to our staff at various levels, asking what rule gives us authority to review, inspect, and copy documents. The statute gives us the authority, as well as the agreement that the licensed provider signs as part of the license application. However, this amendment clearly establishes in one location that the Department may access licensed facilities and agencies. The Health Facility Committee reviewed and approved these rule amendments on 11/13/2013.
Summary of the rule or change:
The amendment adds a new Section R432-3-4, Access for Inspection, which defines who can inspect the licensed providers, what can be reviewed and copied, and what the licensed provider must allow. It clarifies that copies taken by the Department are property of the Department, and therefore no longer subject to the HIPAA privacy and security requirements.
State statutory or constitutional authorization for this rule:
- Title 26, Chapter 21
Anticipated cost or savings to:
the state budget:
This rule amendment will have no effect on state budgets since there will be no change in current practice.
This rule amendment will have no effect on local government budgets since there will be no change in current practice.
This rule amendment will have no effect on small businesses since there will be no change in current practice.
persons other than small businesses, businesses, or local governmental entities:
This rule amendment will have no effect on persons since there will be no change in current practice.
Compliance costs for affected persons:
This rule amendment will have no effect on persons since there will be no change in current practice.
Comments by the department head on the fiscal impact the rule may have on businesses:
There will be no effect on business because this makes no modification of current practice.
David Patten, PhD, Executive Director
The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:Health
Family Health and Preparedness, Licensing
CANNON HEALTH BLDG
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 firstname.lastname@example.org
- 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@example.com
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:
This rule may become effective on:
David Patton, Executive Director
R432. Health, Family Health and Preparedness, Licensing.
R432-3. General Health Care Facility Rules Inspection and Enforcement.
R432-3-1. Legal Authority.
This rule is adopted pursuant to Title 26, Chapter 21.
This rule delineates the role and responsibility of the Department and the licensing agency in the enforcement of rules and regulations pertaining to health, safety, and welfare in all licensed and unlicensed health facilities and agencies regulated by Title 26, Chapter 21. These provisions provide guidelines and criteria to ensure that sanctions are applied consistently and appropriately.
R432-3-3. Deemed Status.
The Department may grant licensing deemed status to facilities and agencies accredited by The Joint Commission (TJC), Accreditation Association for Ambulatory Health Care (AAAHC), Accreditation Commission for Health Care, Community Health Accreditation Program or the American Osteopathic Association's Health Facilities Accreditation Program (AOA/HFAP) in lieu of the licensing inspection by the Department upon completion of the following by the facility or agency:
(1) As part of the license renewal process, the licensee shall identify on the Request for Agency Action/Application its desire to:
(a) initiate deemed status,
(b) continue deemed status, or
(c) relinquish deemed status during the licensing year of application.
(2) This request shall constitute written authorization for the Department to attend the accrediting agency exit conference.
(3) Upon receipt from the accrediting agency, the facility shall submit copies of the following:
(a) accreditation certificate;
(b) Joint Commission Statement of Construction;
(c) survey reports and recommendations;
(d) progress reports of all corrective actions underway or completed in response to accrediting body's action or Department recommendations.
(4) Regardless of deemed status, the Department may assert regulatory responsibility and authority pursuant to applicable state and federal statutes to include:
(b) complaint investigations,
(c) verification of the violations of state law, rule, or standard identified in a Department survey or, violations of state law, rule, or standard identified in the accrediting body's survey including:
(i) facilities or agencies granted a provisional or conditional accreditation by the Joint Commission until a full accreditation status is achieved,
(ii) any facility or agency that does not have a current, valid accreditation certificate, or
(iii) construction, expansion, or remodeling projects required to comply with standards for construction promulgated in the rules by the Health Facility Committee.
(5) The Department may annually conduct validation inspections of facilities or agencies accredited for the purpose of determining compliance with state licensing requirements. If a validation survey discloses a failure to comply with the standards for licensing, the provisions relating to regular inspections shall apply.
4]. Statement of Findings.
The Department or its designee may inspect each facility or
agency at least once during each year that a license has been
granted, to determine compliance with standards and the applicable
rules and regulations. (2)] Whenever the Department has reason to believe
that a health facility or agency is in violation of Title 26,
Chapter 21 or any of the rules promulgated by the Health Facility
Committee, the Department shall serve a written Statement of
Findings to the licensee or his designee within the following
(a) Statements for Class I and III violations are served immediately.
(b) Statements for Class II violations are served within ten working days.
3]) Violations shall be classified as Class I,
Class II, and Class III violations.
(a) "Class I Violation" means any violation of a statute or rule relating to the operation or maintenance of a health facility or agency which presents imminent danger to patients or residents of the facility or agency or which presents a clear hazard to the public health.
(b) "Class II Violation" means any violation of a statute or rule relating to the operation or maintenance of a health facility or agency which has a direct or immediate relationship to the health, safety, or security of patients or residents in a health facility or agency.
(c) "Class III Violation" means establishing, conducting, managing, or operating a health care facility or agency regulated under Title 26, Chapter 21 and this rule without a license or with an expired license.
4]) The Department may cite a facility or agency
with one or more rule or statute violations. If the Department
finds that there are no violations, a letter shall be sent to the
facility acknowledging the inspection findings.
5]) The Statement of Findings shall include:
(a) the statute or rule violated;
(b) a description of the violation;
(c) the facts which constitute the violation; and
(d) the classification of the violation.
5]. Plan of Correction.
(1) A health facility or agency shall submit within 14 calendar days of receipt of a Statement of Findings a Plan of Correction outlining the following:
(a) how the required corrections shall be accomplished;
(b) who is the responsible person to monitor the correction is accomplished; and
(c) the date the facility or agency will correct the violation.
(2) Within ten working days of receipt of the Plan of Correction, the Department shall make a determination as to the acceptability of the Plan of Correction.
(3) If the Department rejects the Plan of Correction, the Department shall notify the facility or agency of the reasons for rejection and may request a revised Plan of Correction or issue a Notice of Agency Action directing a Plan of Correction and imposing a deadline for the correction. If the Department requests a revised Plan of Correction, the facility or agency shall submit the revised Plan of Correction within 14 days of receipt of the Department request.
(4) If the facility or agency corrects the violation prior to submitting the Plan of Correction, the facility or agency shall submit a report of correction.
(5) If violations remain uncorrected after the time specified for completion in the Plan of Correction or if the facility or agency fails to submit a Plan of Correction as specified, the Department shall notify the facility or agency.
(6) Any person aggrieved by the agency action shall have the right to seek review under the provisions outlined in Rule R432-30, Adjudicative Proceedings.
(7) If a licensed or unlicensed health facility or agency is served with a Statement of Findings citing a Class I violation, the facility or agency shall correct the situation, condition, or practice constituting the Class I violation immediately, unless a fixed period of time is determined by the Department and is specified in the Plan of Correction.
(a) The Department shall conduct a follow-up inspection within 14 calendar days or within the agreed -upon correction period to determine correction of Class I violations.
(b) If a health facility or agency fails to correct a Class I violation as outlined in the accepted Plan of Correction, the Department shall pursue sanctions or penalties through a formal adjudicative proceeding as outlined in Rule R432-30.
(8) A facility or agency served with a Statement of Findings citing a Class II violation shall correct the violation within the time specified in the Plan of Correction or within a time-frame approved by the Department which does not exceed 60 days unless justification is provided in the accepted Plan of Correction.
(9) The Department may issue a conditional license or impose sanctions to the license or initiate a formal adjudicative proceeding to close the facility or agency if a facility or agency is cited with a Class II violation and fails to take required corrective action as outlined in Rule R432-30.
(10) The Department shall determine which sanction to impose by considering the following:
(a) the gravity of the violation;
(b) the effort exhibited by the licensee to correct violations;
(c) previous facility or agency violations; and
(d) other relevant facts.
(11) The Department shall serve a facility or agency with a Statement of Findings for a Class III violation. A facility of agency cited for a Class III violation must file a Request for Agency Action/License Application form and pay the required licensing fee within 14 days of the receipt of the Class III Statement of Findings.
(a) The Statement of Findings may include the names of individuals residing in the facility who require services outside the scope of the proposed licensing category.
(b) The facility shall arrange for all individuals to be relocated if the facility is unable to meet the individuals' needs within the scope of the proposed license category.
(c) If the facility or facility fails to submit the Request for Agency Action/License Application as specified, the Department shall issue a written Notice of Agency Action ordering closure of the facility or agency.
(d) If the Executive Director determines that the lives, health, safety or welfare of the patients or residents cannot be adequately assured pending a full formal adjudicative proceeding, he may order immediate closure of the facility or agency under an emergency adjudicative proceeding, as outlined in Rule R432-30.
6]. Sanction Action on License.
(1) The Department may initiate an action against a health facility or agency pursuant to Section 26-21-11. That action may include the following sanctions:
(a) denial or revocation of a license if the facility or agency fails to comply with the rules established by the Committee, or demonstrates conduct adverse to the public health, morals, welfare, and safety of the people of the state;
(b) restriction or prohibition on admissions to a health facility or agency for:
(i) any Class I deficiency,
(ii) Class II deficiencies that indicate a pattern of care and have resulted in the substandard quality of care of patients,
(iii) repeat Class I or II deficiencies that demonstrate continuous noncompliance or chronic noncompliance with the rules, or
(iv) permitting, aiding, or abetting the commission of any illegal act in the facility or agency;
(c) distribution of a notice of public disclosure to at least one newspaper of general circulation or other media form stating the violation of licensing rules or illegal conduct permitted by the facility or agency and the Department action taken;
(d) placement of Department employees or Department-approved individuals as monitors in the facility or agency until such time as corrective action is completed or the facility or agency is closed;
(e) assessment of the cost incurred by the Department in placing the monitors to be reimbursed by the facility or agency;
(f) during the correction period, placement of a temporary manager to ensure the health and safety of the patients; or
(g) issuance of a civil money penalty pursuant to UCA 26-23-6, not to exceed the sum of $10,000 per violation.
(2) If the Department imposes a restriction or prohibition on admissions to a long-term care facility or agency, the Department shall send a written notice to the licensee.
(a) The licensee shall post the copies of the notice on all public entry doors to the licensed long-term care facility or agency.
(b) The Department shall impose the restriction or prohibition if:
(i) the long-term care facility or agency has previously received a restriction or prohibition on admissions within the previous 24 month period; or
(ii) the long-term care facility or agency has failed to meet the timeframes in the Plan of Correction which is the basis for the restriction or prohibition on admissions; or
(iii) circumstances in the facility or agency indicate actual harm, a pattern of harm, or a serious and immediate threat to patients.
(3) If telephone inquiries are made to a long-term care facility or agency with a restriction or prohibition on admissions, the facility or agency shall inform the caller, during the call, about the restriction or prohibition on admissions. If the facility or agency fails to inform the caller, the department may assess penalties as allowed by statute and shall require the facility or agency to post a written notice on all public entry doors.
7]. Immediate Closure of Facility.
(1) The Department may order the immediate closure of any licensed or unlicensed health facility or agency when the health, safety, or welfare of the patients or residents cannot be assured pending a full formal adjudicative proceeding.
(2) The provisions for an emergency adjudicative proceeding as provided in section 63-46b-20 shall be followed.
(3) If the Department determines to close a facility or agency, it shall serve an order that the facility or agency is ordered closed as of a given date. The order shall:
(a) state the reasons the facility is ordered closed;
(b) cite the statute or rule violated; and
(c) advise as to the commencement of a formal adjudicative proceeding in accordance with this rule.
(4) The Department may maintain an action in the name of the state for injunction or other process against the health facility or agency which disobeys a closure order as provided in section 26-21-15.
(5) The Department may assist in relocating patients or residents to another licensed facility or agency.
(6) The Department may pursue other lesser sanctions in lieu of the closure order.
(7) The Department may, in addition to emergency closure, seek criminal penalties.
8]. Mandatory License Revocation.
(1) The Department may revoke a license or refuse to renew a license for a health care facility that is in chronic noncompliance with one or more of the rule requirements identified as mandatory license revocation criteria in the rules specific to the facility or agency licensing category.
(2) The Department may not revoke a license or refuse to renew a license for chronic noncompliance on the third or subsequent violation unless it has documented within 14 working days from receipt of the Statement of Findings two prior violations and given the licensee or facility administrator a written warning notice. The written notice shall include a statement that continued violation could result in revocation of the license.
(3) If the Department revokes the license because of chronic noncompliance and the evidence supports the Department's finding of chronic noncompliance, no lesser sanction may be substituted, either by the Department or upon subsequent review by the Health Facility Committee or the courts.
KEY: health care facilities
Date of Enactment or Last Substantive Amendment: [
April 24, 2013]
Notice of Continuation: August 12, 2013
Authorizing, and Implemented or Interpreted Law: 26-21-5; 26-21-14 through 26-21-16
More information about a Notice of Proposed Rule is available online.
The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull-pdf/2014/b20140101.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.
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For questions regarding the content or application of this rule, please contact Joel Hoffman at the above address, by phone at 801-538-6279, by FAX at 801-538-6024, or by Internet E-mail at firstname.lastname@example.org; 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@example.com.