No. 43004 (Amendment): Rule R432-3. General Health Care Facility Rules Inspection and Enforcement

(Amendment)

DAR File No.: 43004
Filed: 06/15/2018 10:44:40 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to remove the Class III violations to match the current licensing inspection process for licensed health care facilities. In addition, it includes several technical corrections. The Health Facility Committee reviewed and approved this rule amendment on 05/09/2018. This amendment was recommended in 2017 by the legislative auditors.

Summary of the rule or change:

This amendment removes the Class III violations to match the current licensing inspection process for licensed health care facilities. In addition, it includes several technical corrections and several Federal reference and rule updates. The Health Facility Committee reviewed and approved this rule amendment on 05/09/2018. This amendment was recommended in 2017 by the legislative auditors.

Statutory or constitutional authorization for this rule:

• Title 26, Chapter 21

Anticipated cost or savings to:

the state budget:

The state government health facility survey process was thoroughly reviewed. This proposed rule amendment could lead to increased health care facility sanctions, however, with all the variables within the survey process and the facility practices, this is an inestimable benefit.

local governments:

Local government city business licensing requirements were considered. This proposed rule amendment should not impact local governments revenues or expenditures.

small businesses:

After conducting a thorough analysis, it was determined that this rule amendment could lead to increased costs for small business licensed health care facilities as it may result in increased sanctions, however, with all the variables within the survey process and the facility practices, this is an inestimable cost. There are 661 small businesses (NAICS codes used - Homes for the Elderly 623312, Nursing Care Facilities 623110, General Medical/Surgical Hospital 622110, Psychiatric and Substance Abuse Hospitals 622210, Other Hospitals 622310, Home Health 621610, End Stage Renal Disease 621492, and Free Standing Ambulatory Surgical Centers 621493).

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

After conducting a thorough analysis, it was determined that this rule amendment will not result in a fiscal impact to other persons because this amendment modifies health care facility requirements.

Compliance costs for affected persons:

After conducting a thorough analysis, it was determined that this proposed rule amendment will not result in a fiscal impact to affected persons because this amendment modifies health care facility requirements and therefore, would not add any compliance costs to affected persons.

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

There may be a fiscal impact to businesses if there is an increase in sanctions for violation of this rule.

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]
• Carmen Richins at the above address, by phone at 801-273-2802, 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:

07/31/2018

This rule may become effective on:

08/07/2018

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

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described above. Inestimable impacts for Non - Small Businesses are described below.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

There are 114 non-small businesses (NAICS codes used -Homes for the Elderly 623312, Nursing Care Facilities 623110, General Medical/Surgical Hospital 622110, Psychiatric and Substance Abuse Hospitals 622210, Other Hospitals 622310, Home Health 621610, End Stage Renal Disease 621492,and Free Standing Ambulatory Surgical Centers 621493).

 

After conducting a thorough analysis, it was determined that this rule amendment could lead to increased costs for non-small business licensed health care facilities as it may result in increased sanctions,however,with all the variables within the survey process and the facility practices,this is an inestimable cost.

 

The Department of Health Executive Director Joseph K. Miner, MD,has reviewed and approved this fiscal analysis.

 

 

R432. Health, Family Health and Preparedness, Licensing.

R432-3. General Health Care Facility Rules Inspection and Enforcement.

R432-3-3. Deemed Status.

The Department may grant licensing deemed status to facilities and agencies accredited by Federally approved accreditation agencies[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]c) 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:

(a) inspections,

(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] accreditation agencies 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.

 

R432-3-5. Statement of Findings.

(1) 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 timeframe.

(a) Statements for Class I[and III violations] are served immediately.

(b) Statements for Class II violations are served within ten working days.

(2) Violations shall be classified as Class I[,] or 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.]

(3) 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.

(4) 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.

 

R432-3-6. 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]may issue 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.]

 

R432-3-7. 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 ; or

(h) issuance of a conditional license.

(2) If the Department imposes a restriction or prohibition on admissions to a [long-term]health 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]health care facility or agency.

(b) The Department [shall]may impose the restriction or prohibition if:

(i) the [long-term]health care facility or agency has previously received a restriction or prohibition on admissions within the previous 24 month period; or

(ii) the [long-term]health 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.]

 

R432-3-8. 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]63G-4-502 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.

 

[R432-3-9. 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.]

 

R432-3-1[0]1. Alternative Remedies for Nursing Facilities.

(1) The department conducts on-site inspections of nursing facilities to determine compliance with state and federal nursing home requirements. When the department finds that a nursing facility is out of compliance with requirements of participation, the department may [apply]recommend to CMS or the state Medicaid agency the imposition of remedies, including Federal civil money penalties (CMP) to compel the facility to implement corrective measures to achieve compliance.

(2) For Medicare and/or Medicaid certified nursing facilities the authority to apply the remedies described in this section is defined in the federal Omnibus Budget Reconciliation Act (OBRA) of 1987 (P.L. 100-203), which mandates compliance with requirements for participation in the program[, and in Section 26-18-3 of the Utah Code Annotated 1953]. Section 1819(h) and 1919(h) of the Social Security Act specifies remedies available to [a]CMS or the state Medicaid agency when a skilled nursing facility (SNF) or nursing facility (NF) is out of compliance with the participation requirements. Th e available remedies are intended to compel facilities to[is section requires the state to ensure] prompt compliance with participation requirements or be subject to termination from the Medicare or Medicaid program[, and it further specifies that the available remedies are in addition to other remedies available under state or federal law and, except for Federal CMP, are imposed prior to the conduct of a hearing].

(3) This rule establishes criteria for the imposition of remedies authorized by statute.

(4) The department adopts and incorporates by reference the regulations in 42 CFR, Part 488-Survey, Certification, and Enforcement Procedures, as amended in the Federal Register for [November 10, 1994]October 4, 2016, [59 FR 56237]81 FR 68688. Remedies available for non-compliance with one or more participation requirements may include:

(a) temporary management;

(b) denial of payment for new admissions;

(c) transfer of residents;

(d) closure of the facility and transfer of residents;

(e) directed plan of correction;

(f) directed inservice training;

(g) state monitoring; and

([f]h) Civil Money Penalties. Civil Money Penalties may be imposed for either:

(i) the number of days a facility is out of compliance with one or more participation requirements; or

(ii) for each instance that a facility is not in substantial compliance.

(5) Interest shall be assessed on the unpaid balance of the Federal CMP, beginning on the due date. The interest rate charged shall be the average of the bond equivalent of the weekly 90-day U.S. Treasury bill auction rates during the period for which interest will be charged.

(6) [Disposition of Federal CMP Collected.

(a) The department shall deposit Federal CMP and corresponding interest collected from Medicaid certified facilities in the General Fund in accordance with Section 26-18-3(5).

(b) ]Federal CMP collected by the department must be applied in accordance with Section 1819 and 1919 of the act for the protection of the health and property of residents.

 

KEY: health care facilities

Date of Enactment or Last Substantive Amendment: [December 6, 2016]2018

Notice of Continuation: January 29, 2018

Authorizing, and Implemented or Interpreted Law: 26-21-5; 26-21-14 through 26-21-16

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