Regulatory and Reporting

​​​​​​Keeping our patients informed — and our hospitals compliant.

It can be difficult to stay informed of the ever-shifting regulatory and reporting requirements at the state and national level. That’s why IHA has collected information on everything from which medical errors and adverse events you’re obligated to report and when you need to report them. If you have any additional questions about your organization’s regulatory and reporting obligations, we’re happy to help. Please contact Andy VanZee.

Reporting Medical​ Errors and Adverse Events

In 2005, former Indiana Gov. Mitch Daniels signed an executive order mandating public reporting of medical errors. His goal was to help consumers better understand the quality of care at the health care providers they choose and what questions to ask before treatment. 

If you are a member hospital with more questions concerning the annual Medical Error Report, contact Annette Handy. We are here to help with your questions.

Types of Reportable Adverse Events and Medical Errors

Today, Indiana hospitals are required to report on the National Quality Forum’s consensus list of 28 serious adverse events. Most of the 28 reportable events are preventable medical errors that result in death, serious disability or significant injury.  Other events, such as abduction or sexual assault, simply shouldn't happen, regardless of whether they result in death or serious disability.

Indiana implemented the medical error reporting system to reduce the frequency of medical errors, reveal the causes of medical errors and empower health care professionals to prevent errors before patients are harmed.

SURGICAL EVENTS:

  • Surgery performed on a wrong body part
  • Surgery performed on the wrong patient
  • The wrong surgical procedure performed on a patient
  • Foreign objects left in a patient after surgery or other invasive procedure
  • Death during or immediately after surgery of a normal, healthy patient

PRODUCT OR DEVICE  EVENTS:
These include patient death or serious disability associated with:

  • The use of contaminated drugs, devices or biologics provided by the facility
  • The use or function of a device in patient care in which the device is used or functions other than as intended
  • An intravascular air embolism that occurs while being cared for in a facility

PATIENT PROTECTION  EVENTS:

  • An infant discharged to the wrong person
  • Patient death or serious disability associated with patient elopement (i.e. disappearance)
  • Patient suicide or attempted suicide resulting in serious disability while being cared for in a health care facility

CARE MANAGEMENT  EVENTS:
These include patient death or serious disability associated with:

  • A medication error
  • A hemolytic reaction due to incompatible blood or blood products
  • Hypoglycemia, the onset of which occurs in the facility
  • Hyperbilirubinemia in newborn infants

As well as the following:

  • Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in the hospital
  • Stage 3 or 4 ​ pressure ulcers acquired after admission to a facility
  • Artificial insemination with the wrong donor sperm or wrong egg

ENVIRONMENTAL EVENTS:
These include patient death or serious disability associated with:

  • An electric shock while being cared for in a facility
  • A burn incurred while being cared for in a facility
  • The use of restraints or bedrails while being cared for in a facility
  • A fall while being cared for in a facility
  • Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances.

CRIMINAL EVENTS:
These include any instance of care ordered or provided by someone impersonating a physician, nurse, pharmacist or other licensed health care professional, including:

  • Abduction of a patient of any age
  • Sexual assault on a patient within or on the grounds of a facility
  • Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility

HEALTH CARE AQUIRED  INFECTION REPORTING:
The Indiana State Department of Health requires all Indiana hospitals to report the following infections:

  • Central line-associated bloodstream infections (CLABSI) in all intensive care units
  • Surgical site infections (SSI) for all abdominal hysterectomies and colon surgeries
  • Catheter-associated urinary tract infections (CAUTI) in all adult and pediatric intensive care units

These infections must be reported through the National Healthcare Safety Network (NHSN) on a monthly basis.

Read the Indiana HAI reporting rule

When to Report

Once a hospital’s quality assessment and improvement program determines a serious adverse event has taken place, it must be reported to the Indiana State Department of Health (ISDH) within 15 days. The data elements being reported are:

  • Name of the hospital
  • Type of event
  • Quarter of the year in which it occurred

These data are filed electronically with the ISDH and made publically available annually.

Additional Regulatory and Reporting Resources ​

  • Conditions of Participation. In order to participate in the Medicare and Medicaid programs, hospitals must meet the requirements outlined in the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs). Hospitals must achieve deemed status through being surveyed by an organization accredited to survey hospitals' compliance with the CoPs. The standards outlined in the CoPs are considered the foundation for providing quality care to patients. ​

  • The Prospective Payment System, Value-Based Purchasing and HITECH Meaningful Use rules require additional quality measures as part of their implementation. Downlo​ad this table ​of required quality measures, updated August 2018, to find out when each measure will be used for ​payment purposes and when data collection will begin. The table has been updated to include changes finalized in the FY 2019 IPPS/LTCH, IRF PPS and IPF PPS rules released in July and August 2018. Changes recently proposed for hospital outpatient, ambulatory surgery centers and ESRD facilities are also included.