Relates to adverse event reporting and notification by hospitals and diagnostic treatment centers

* replace references to "incident" with the term "adverse event;"

* require adverse event reporting by D&TCs;

* expand the list of adverse events that must be reported by general hospitals and D&TCs to include serious crimes and other serious events;

* require reporting of an adverse event within 24 hours of the hospital or DT&C becoming aware of such event;

* identify the categories of adverse events that automatically trigger the requirement for a hospital or DT&C to conduct an investigation and provide DOH with an investigation report;

* identify the categories of adverse events that require investigation and an investigation report upon the direction of DOH;

* provide that a hospital or DT&C may request an extension of time if it cannot complete an investigation and investigation report within 30 days, which may be granted in the discretion of the Commissioner of Health;

* require DOH to analyze adverse event reports and use the analyses in the development, dissemination and tracking of patient safety goals and best practices;

* authorize DOH to release to hospitals and DT&Cs and the public analyses and findings derived from the adverse event data;

* require DOH to consult with a variety of experts on matters related to improving the adverse event reporting system and patient safety; require general hospitals and D&TCs that provide ambulatory surgery, diagnostic or therapeutic radiation or end-stage renal disease services to establish a Patient Safety Committee that will analyze and apply evidence-based patient safety practices, analyze adverse and near-miss events, and develop protocols to prevent their recurrence; and

* authorize enhanced civil penalties to be imposed upon hospitals and DT&Cs that fail to report and investigate adverse events as required.

Sections 2 and 3 of the bill would make conforming provisions to PHL § 2805-m and Education Law § 6527(3) respectively to substitute the term "adverse event" for "incident." In addition, the bill clarifies that the confidentiality provisions of PHL § 2805-m apply to the actions and records of a patient safety committee required by PHL § 2805-1.

Section 4 of the bill would amend Chapter 62 of the Laws of 2003, Part X2, § 4, as amended by Chapter 21 of the Laws of 2010, § 1, to remove the March 31, 2011 expiration of DOH's authority to utilize funds of the Office of Professional Medical Conduct (OPMC) for patient safety and quality activities,

Section 5 of the bill would make the bill effective 180 days after it is enacted.

Existing law

PHL § 12 provides that a violation of the PHL is punishable by a maximum penalty of $2,000, or more in the case of repeated or egregious violations, unless a penalty is specified by a specific provision of law.

PHL § 2805-l requires general hospitals to report to DOH "incidents" that fall within seven categories: submit "incident" reports to DOH related to seven types of events: (1) the death of a patient or the impairment of a patient's bodily functions, except when such death or impairment is related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards; (2) a fire in the hospital that disrupts patient care or harms patients or staff; (3) an equipment malfunction during diagnosis or treatment that could have or did harm patients or staff; (4) a poisoning within the hospital; (5) a strike by hospital staff; (6) a disaster or other emergency situations external to the hospital environment which affect hospital operations; and (7) termination of any services vital to the continued safe operation of the hospital or to the health and safety of its patients and personnel, such as anticipated or actual termination of utility services.

PHL § 2805-l further requires general hospitals to conduct investigations of incidents that fall within the first four categories outlined above within 30 days of obtaining knowledge of any information which reasonably appears to show that such incident occurred. However, if the hospital reasonably expects that the investigation will not be completed within 30 days, it must advise DOH of the expected completion date. In addition, the hospital must submit an investigation report within 24 hours of completing the investigation.

PHL § 2805-m provides that information collected by hospitals and D&TCs for purpose of complying with various quality assurance requirements, including the reporting of incidents by general hospitals under PHL § 2805-1 or by D&TCs as otherwise required shall be kept confidential, and no person or entity shall be subject to monetary liability for complying with such requirements.

PHL § 2995 requires DOH to undertake an initiative for the purposes of increasing the information available to patients about health care providers and health care plans, and improving the quality of health care in this state, by creating a statewide health information system, collecting health information for dissemination by means of such system, and studying additional uses of such information. Language stating that funds may not be diverted for use under the section from the existing uses of the Office of Professional Medical Conduct was deleted by Chapter 62 of the Laws of 2003, Part X2, § I, which, pursuant to Chapter 62 of the Laws of 2003, Part X2, § 4, as amended by Chapter 21 of the Laws of 2010, § 1, expires March 31, 2011.

PHL § 2998 established the Patient Safety Center, the purpose of which is to maximize patient safety, reduce medical errors, and improve the quality of health care by improving systems of data reporting, collection, analysis and dissemination, and to improve public access to health care information not otherwise restricted.

Education Law § 6527(3) protects from liability for damages individuals who engage in certain hospital quality assurance activities or who participate in the preparation of incident reports pursuant to PHL § 2805-l.

10 NYCRR § 751.10 requires D&TCs to report to DOH five types of events: (1) patient deaths or transfers to a hospital; (2) fires in the center or other occurrences which disrupt the provision of patient care services or cause harm to patients or staff; (3) equipment malfunction during treatment or diagnosis of a patient which adversely affects a patient or staff; (4) termination of any services vital to the continued safe operation of the center or the health and safety of its patients and staff, such as utility services; and (5) strikes by staff.

Legislative history

This is a new bill.

Statement in support

In 1998, DOH established NYPORTS in 1998 to collect information about "incidents" that general hospitals must report pursuant to PHU§ 2805-1 and 10 NYCRR § 403.8. NYPORTS is Internet-based and permits hospitals both to report incidents electronically and to query the system for information that permits them to compare their experience with that of other hospitals on a statewide, regional or peer basis.

One year later, the Institute of Medicine (TOM) of the National Academy of Sciences released a report, "To Err is Human," which suggested that between 44,000 and 98,000 people die each year in the United States as a result of medical errors. The report emphasized that most medical errors are not the result of bad actors - i.e., reckless or incompetent health care practitioners - but rather are caused by flawed systems or processes that make it difficult for practitioners and institutions to provide the right care. The IOM identified mandatory adverse event reporting systems as an important tool for improving patient safety. Adverse event reporting systems help to identify error-prone health care activities and provide information on what leads to adverse events so that systems and processes can be developed to prevent human errors from adversely affecting patient outcomes. In addition, such systems provide a mechanism for oversight bodies to promote hospital implementation of safety systems that reduce the likelihood that adverse events will be repeated. Such systems also permit dissemination of information learned from events to other facilities so that they too can avert future errors.

Over the last decade, much has been done by hospitals, professional societies, and accrediting organizations to promote patient safety, identify risks, and develop new safety strategies. Yet in many aspects of patient care, measurable improvements in patient safety have remained elusive. This bill strengthens NYPORTS as a tool for promoting patient safety and enhances hospital and D&TC safety efforts.

To further promote the culture of safety advanced by the IOM, this bill requires general hospitals, ambulatory surgery centers, clinics that use radiation for diagnostic or therapeutic purposes and dialysis facilities to create high-level Patient Safety Committees, chaired by an executive who reports directly to the facility's chief executive officer or administrator. These committees will spearhead patient

safety efforts at the facility and analyze and respond to adverse events.

This bill facilitates a movement towards a culture of patient safety, not only for health care facilities, but also for DOH. Under this bill, DOH will analyze the experiences of providers from across the State, and acting in partnership with the health care industry, will share findings that can influence change and improve patient safety within the health care system and its own organization.

Finally, the bill improves the completeness of NYPORTS data by increasing penalties for failure to report and investigate adverse events in a timely manner. Although the effectiveness of the NYPORTS system as a patient safety tool depends in part on compliance with reporting requirements, there remains wide variation among hospitals in the rate of reporting. This Variation cannot be explained away by differences in patient safety efforts. The bill seeks to induce more consistent compliance with NYPORTS requirements by creating stronger incentive to report and investigate adverse events.

Budget implications

This bill is not expected to have a fiscal impact to the State or localities.

Effective date

This bill will take effect 180 days after it is enacted.