CHAPTER 5. REMEDIES FOR BREACHES; PLANS OF CORRECTION
IC 16-28-5
Chapter 5. Remedies for Breaches; Plans of Correction
IC 16-28-5-1
Classification of rules
Sec. 1. The executive board shall adopt rules under IC 4-22-2 toclassify each rule adopted by the executive board to govern a healthfacility under this article into one (1) of the following categories:
(1) An offense, which presents a substantial probability thatdeath or a life-threatening condition will result.
(2) A deficiency, which presents an immediate or a direct,serious adverse effect on the health, safety, security, rights, orwelfare of a patient.
(3) A noncompliance, which presents an indirect threat to thehealth, safety, security, rights, or welfare of a patient.
(4) A nonconformance, which is any other classified breach notcovered by subdivision (1), (2), or (3).
As added by P.L.2-1993, SEC.11. Amended by P.L.179-1993, SEC.5.
IC 16-28-5-2
Citations
Sec. 2. On a determination by the commissioner that a breach ofthis article or a rule adopted under this article has occurred, thedirector shall issue a citation under IC 4-21.5-3-6 to the administratorof the health facility in which the breach occurred. The citation muststate the following:
(1) The nature of the breach.
(2) The classification of the breach.
(3) The corrective actions required of the health facility toremedy the breach and to protect the patients of the facility.
(4) Any penalty imposed on the facility.
As added by P.L.2-1993, SEC.11.
IC 16-28-5-3
Review of citations
Sec. 3. A person aggrieved by a citation issued under this chaptermay request a review under IC 4-21.5-3-7. If a request for a hearingis not filed within the fifteen (15) day period, the determinationcontained in the citation is final.
As added by P.L.2-1993, SEC.11.
IC 16-28-5-4
Remedies for breaches
Sec. 4. (a) The commissioner shall impose the following remediesfor breaches of this article or a rule adopted under this article:
(1) For an offense, the remedies specified in subsection (b)(1)through (b)(2). The commissioner may also impose the remedyspecified in subsection (b)(3).
(2) For a deficiency, the remedies specified in subsection (b)(1).The commissioner may also impose the remedies specified in
subsection (b)(4).
(3) For a breach that is a repeat of the same deficiency withina fifteen (15) month period, the remedies specified insubsection (b)(1) through (b)(2). The commissioner may alsoimpose the remedy specified in subsection (b)(3).
(4) For a noncompliance, the remedies specified in subsection(b)(5) through (b)(6).
(5) For a breach that is a repeat of the same noncompliancewithin a fifteen (15) month period, the remedies specified insubsection (b)(1). The commissioner may also impose theremedies specified in subsection (b)(4).
(6) For a nonconformance, the remedies specified in subsection(b)(5).
(7) For a breach that is a repeat of the same nonconformancewithin a fifteen (15) month period, the remedies specified insubsection (b)(5) through (b)(6).
(b) The remedies for breaches of this article or rules adoptedunder this article are as follows:
(1) Issuance of an order for immediate correction of the breach.
(2) Imposition of a fine not to exceed ten thousand dollars($10,000) or suspension of new admissions to the health facilityfor a period not to exceed forty-five (45) days, or both.
(3) Revocation by the director of the health facility's license orissuance of a probationary license.
(4) Imposition of a fine not to exceed five thousand dollars($5,000) or suspension of new admissions to the health facilityfor a period not to exceed thirty (30) days, or both.
(5) A requirement that the health facility comply with any planof correction approved or directed under section 7 of thischapter.
(6) If the health facility is found to have a pattern of breach, thecommissioner may suspend new admissions to the healthfacility for a period not to exceed fifteen (15) days or impose afine not to exceed one thousand dollars ($1,000), or both.
(c) If a breach is immediately corrected and the commissioner hasimposed remedies under subsection (b)(2), the commissioner maywaive not more than fifty percent (50%) of the fine imposed andreduce the number of days for suspension of new admissions byone-half (1/2).
(d) The commissioner may, with the concurrence of a licensedphysician, impose the following:
(1) For an omission of care or an act that does not fall within aclassification of a rule under this section and that the facilityshould reasonably have known would present a substantialprobability that death or a life threatening condition will result,one (1) or any combination of the remedies specified insubsection (b)(1) through (b)(3).
(2) For an omission of care or an act that:
(A) does not fall within a classification of a rule under thissection; and (B) the facility should reasonably have known would resultin an immediate or a direct, serious adverse effect on thehealth, safety, security, rights, or welfare of a patient;
the remedies specified in subsection (b)(1) or (b)(4), or both.
As added by P.L.2-1993, SEC.11. Amended by P.L.179-1993, SEC.6.
IC 16-28-5-5
Determination of remedies
Sec. 5. (a) In determining appropriate remedies or waivers undersection 4 of this chapter, the commissioner shall consider thefollowing:
(1) Whether the breach occurred for reasons outside of thehealth facility's control.
(2) Whether the health facility has demonstrated that the healthfacility has taken the appropriate steps to reasonably ensure thatthe breach will not recur.
(3) The history of breaches by the health facility.
(4) The effect of the breach on the patient.
(b) If the health facility furnishes sufficient relevant financialinformation, the commissioner may consider the following indetermining appropriate remedies or waivers under section 5 of thischapter:
(1) Whether any financial savings or benefit accrued to thehealth facility as a result of the breach.
(2) The cost incurred by the health facility in correcting thebreach.
As added by P.L.2-1993, SEC.11. Amended by P.L.179-1993, SEC.7.
IC 16-28-5-6
Correction of breaches; time allowed
Sec. 6. An order for immediate correction under section 4(b)(1)of this chapter shall state a specific date by which the correction shallbe made. The date shall be set by the commissioner according to thecircumstances of the breach but may not exceed five (5) days fromthe time the health facility receives written notification from thecommissioner.
As added by P.L.2-1993, SEC.11.
IC 16-28-5-7
Corrective period
Sec. 7. (a) A plan of correction submitted to the commissioner forapproval and acceptance shall contain a fixed time within which thecorrection must be made.
(b) When accepting or directing a corrective period, thecommissioner shall consider the following:
(1) A reasonable amount of time needed by a health facility toachieve compliance.
(2) The effects of the continuing breach on patients.
(3) Temporary measures that will be taken to protect patientsduring the time allowed for correction.As added by P.L.2-1993, SEC.11. Amended by P.L.179-1993, SEC.8.
IC 16-28-5-8
Plans of correction; actions; notices of rejection; reports ofcorrection
Sec. 8. (a) A plan of correction may be:
(1) accepted;
(2) modified upon agreement between the commissioner and thehealth facility; or
(3) rejected by the commissioner.
(b) If a plan of correction is rejected, the commissioner:
(1) shall send notice of the rejection and the reasons for therejection to the health facility; and
(2) may impose a directed plan of correction on the healthfacility.
(c) If a breach was corrected before submission and approval ofa plan of correction, the health facility may submit a report ofcorrection in place of a plan of correction.
As added by P.L.2-1993, SEC.11. Amended by P.L.179-1993, SEC.9.
IC 16-28-5-9
Modification of plans of correction
Sec. 9. (a) A directed plan of correction imposed on a healthfacility by the commissioner may also be modified upon agreementbetween the commissioner and the health facility.
(b) A petition for modification of an approved plan of correctionmust be filed with the commissioner before the expiration of thecorrection time period approved by the commissioner. The burden ofproof is on the petitioner to show good cause for not complyingwithin the approved correction time.
As added by P.L.2-1993, SEC.11. Amended by P.L.179-1993,SEC.10.
IC 16-28-5-10
Failure to correct breaches; additional penalties
Sec. 10. If:
(1) a breach is not corrected within the time fixed by the orderof correction or is not corrected within the time fixed by theplan of correction; and
(2) an extension has not been granted under section 9 of thischapter;
the commissioner may find a new breach that may be subject to theimposition of additional penalties as the class would warrant.
As added by P.L.2-1993, SEC.11.