Relates to the collection and reporting of hospital data on sepsis

This bill would provide the Department of Health (Department) and all hospitals the time necessary to assure that certain hospital quality measures relating to sepsis are accurate, valid and reliable, and appropriately reflect care provided by individual hospitals before public release of hospital specific data.

Summary of Provisions:

Section 1 of the bill would add new Public Health Law (PHL) § 2805-m (4) to deem the initial-period of collection of hospital sepsis data by the Department pursuant to 10 NYCRR § 405.4(a)(7) as a "pilot phase not exceed two years. During the pilot, the Department would: (1) ensure that all sepsis data included in public databases and reports is encrypted to prevent hospital identification; (2) provide each hospital with access only to the data submitted by that particular hospital; (3) consult with appropriate stakeholders regarding the public release of such data concerning hospital performance; and (4) provide regular reports to hospitals regarding the accuracy of the data submitted and give guidance for improving the accuracy of such data.

Section 1 of the bill would also provide that after the pilot phase, the sepsis data submitted by hospitals and compiled in a database by the Department would include hospital identifiers. The reports made publicly available from such data would also include hospital identifiers. The Department would also develop and post the data on the Department's web site.

Section 2 of this bill provides that the bill would take effect immediately.

Existing Law:

PHL § 2805-m contains the confidentiality provisions governing information collected and maintained for purposes of medical, dental and podiatric malpractice prevention programs, investigations prior to granting or renewing privileges, and adverse event reporting via the New York Patient Occurrence and Tracking System.

Legislative History:

This is a new bill but is consistent with legislation enacted as part of the collection of hospital acquired infections data (Chapters 239 and 284 of the Laws of 2005).

Statement in Support:

The data collection and reporting requirements within the regulations governing sepsis measures adopted in 2013 are novel both in New York State and throughout the nation (if not internationally). As such, the

process for evaluating the data collected to assure completeness and accuracy, as well as the modeling necessary to develop fair and accurate risk-adjusted measures of mortality attributable to sepsis, are also novel and untested. Accordingly, premature release of this data before thorough and careful analysis, may improperly damage hospitals and mislead consumers.

This legislation would allow for a pilot phase lasting no more than two years, to complete data collection and analytics to assure that the information ultimately made public is accurate and meaningful. The Department would publish this data after validation.

The section of law proposed for amendment, § 2805-m, protects information collected and maintained for purposes of medical, dental and podiatric malpractice prevention programs, investigations prior to granting or renewing privileges and adverse event reporting via NYPORTS under 10 NYCRR § 405.8. This section requires that such data be kept confidential and not be released except in specific situations. Similarly, the data collected for purposes of evaluating adherence to protocols for the prevention and treatment of severe sepsis and septic shock, as well as data collected for the purpose of establishing risk adjusted mortality rates related to severe sepsis and septic shock, must be kept confidential until such time as it is determined that the data collected are complete and accurate and the calculations used to develop risk adjust mortality rates have been evaluated and tested and found to be accurate. This is consistent with the general intent of PHL § 2805-m to maintain the confidentiality of hospital quality assurance and improvement programs before any final determinations by the Department regarding hospital performance.

While it is possible for organizations to develop and publish mortality rates from sepsis by hospital using existing datasets now readily available through Health Data NY, the results are likely to be misleading since they would not accurately reflect important differences between patients treated at different hospitals. In addition, the data as currently available does not: (1) adequately adjust for the mix of patients with severe underlying conditions that dramatically increase the risk of death from sepsis, such as cancer and AIDS; (2) reliably adjust for sepsis severity; or (3) reflect patients who are not eligible for treatment due to advance directives. At the end of the proposed pilot phase of data collection, the clinical data collected and analyzed from hospitals would take those factors into consideration when calculating rates and comparing one hospital to another.

Budget Implications:

This bill is not anticipated to have a fiscal impact on the State.

Effective Date:

This bill would take effect immediately.