CHAPTER 5. PATIENT SAFETY PROGRAMS
IC 16-40-5
Chapter 5. Patient Safety Programs
IC 16-40-5-1
"Agency"
Sec. 1. As used in this chapter, "agency" means:
(1) an independent entity:
(A) that certifies that it meets the criteria under 42 U.S.C.299b-24 as a patient safety organization and whosecertification has been accepted by the federal Department ofHealth and Human Services; or
(B) that has been determined by the state department tosatisfy the criteria in 42 U.S.C. 299b-24 for certification asa patient safety organization to a degree sufficient to enablethe entity to perform the activities of an agency under thischapter; or
(2) an academic institution if:
(A) the academic institution is most qualified; or
(B) there is not an independent entity as described insubdivision (1); and
the academic institution has entered an agreement with the statedepartment under section 4 of this chapter.
As added by P.L.101-2007, SEC.3.
IC 16-40-5-2
"Health care facility"
Sec. 2. As used in this chapter, "health care facility" includes thefollowing:
(1) An abortion clinic licensed under IC 16-21-2.
(2) An ambulatory outpatient surgical center licensed underIC 16-21-2.
(3) A birthing center licensed under IC 16-21-2.
(4) A hospital licensed under IC 16-21-2.
(5) An office-based setting under IC 25-22.5-2-7(10) includinga facility, clinic, center, office or other setting where proceduresare performed that require moderate sedation, deep sedation,general anesthesia, or regional anesthesia.
As added by P.L.101-2007, SEC.3.
IC 16-40-5-3
"Personnel of agency"
Sec. 3. As used in this chapter, "personnel of the agency" meansthe agency's directors, officers, employees, representatives, agents,attorneys, investigators, assistants, clerks, staff, and any otherindividual or organization serving the agency in any capacity.
As added by P.L.101-2007, SEC.3.
IC 16-40-5-4
Patient safety agency agreement; procedures; identifyinginformation; duties Sec. 4. (a) Subject to appropriation by the general assembly, thestate department shall enter into an agreement with an agency thatcollects, analyzes, interprets, and disseminates findings on astatewide basis regarding patient safety that are based on confidentialand privileged information voluntarily submitted to the agency by:
(1) a health care facility;
(2) a health care professional; or
(3) an individual.
(b) The state department shall ensure that the agency's board hassufficient procedures in place to allow the agency to fairly,objectively, and accurately perform the duties set forth in theagency's agreement under this chapter with the state department.
(c) Information submitted by the agency to the state departmentmay not contain information that identifies the health care provideror the patient.
(d) The agency shall analyze data, develop policies, anddisseminate and assist in the implementation of procedures thatenhance patient safety.
As added by P.L.101-2007, SEC.3.
IC 16-40-5-5
Report of patient harm
Sec. 5. A health care facility, a health care professional, or anindividual may file with the agency referred to in section 4 of thischapter a report that alleges that a health care facility or a health careprofessional, by an action taken or a failure to act, caused or couldhave caused harm to a patient, including harm that resulted from orcould have resulted from:
(1) an adverse drug event; or
(2) an unexpected infection, including an infection that wasprobably acquired in the health care facility.
As added by P.L.101-2007, SEC.3.
IC 16-40-5-6
Confidential and privileged information
Sec. 6. (a) Except as provided in subsections (d) and (e):
(1) oral or written information or reports given to the agency;and
(2) proceedings, records, deliberations, and findings of theagency;
that are generated, undertaken, or performed as a result of a reportdescribed in section 5 of this chapter or under the agreementdescribed in section 4(a) of this chapter are confidential andprivileged from use as evidence in an administrative or judicialproceeding.
(b) Neither the personnel of the agency nor any participant orwitness in an agency proceeding or deliberation may disclose to aperson outside of the agency the contents of:
(1) communications to the agency;
(2) agency records; or (3) agency findings;
that are generated, undertaken, or performed as a result of a reportdescribed in section 5 of this chapter or under the agreementdescribed in section 4(a) of this chapter.
(c) Information that is otherwise discoverable or admissible fromoriginal sources is not immune from discovery or use in anyproceeding merely because it was presented during proceedings ordeliberations of the agency. Neither the personnel of the agency norany participant or witness in any agency proceeding or deliberationmay be prevented from testifying:
(1) as to matters within the individual's own knowledge; and
(2) in accordance with the other provisions of this chapter.
However, a witness cannot be questioned about testimony on othermatters before the agency or about opinions formed by the witnessas a result of the agency's proceedings or deliberations.
(d) The agency may disclose information concerning patientsafety or quality of health care matters addressed in the agreementdescribed in section 4(a) of this chapter, including informationreported to the agency by a health care facility, a health careprofessional, or an individual, if the information does not discloseany of the following:
(1) The identity of the health care facility, health care provider,or patient.
(2) The identity of a person that provided information to theagency.
(3) Information that could reasonably be expected to result inthe identification of a health care facility, health care provider,patient, or person that has provided information to the agency.
(e) Information or material that is confidential and privilegedunder this section may be used as evidence in a criminal proceedingonly if the court first makes an in camera determination that theinformation:
(1) is relevant to the criminal proceeding;
(2) is material to the proceeding; and
(3) is not reasonably available from another source.
As added by P.L.101-2007, SEC.3. Amended by P.L.3-2008,SEC.111.
IC 16-40-5-7
Rules
Sec. 7. The state department may adopt rules under IC 4-22-2 toadminister this chapter.
As added by P.L.101-2007, SEC.3.
IC 16-40-5-8
Expiration
Sec. 8. This chapter expires June 30, 2010.
As added by P.L.101-2007, SEC.3.