Objective

To determine the extent of implementation of the four recommendations included in our initial audit report, Patient Safety Center Activities and Handling of Revenues (Report 2019-S-15).

About the Program

The Patient Health Information and Quality Improvement Act of 2000 (Act), enacted October 6, 2000 and known as Lisa’s Law, was named after Lisa Smart, a 30-year-old woman who died in 1997 as a result of a medical error introduced during surgery by a physician with a history of negligence unknown to the patient. Pursuant to the Act’s amendments to the Public Health Law (PHL), a Patient Safety Center (PSC) was established within the Department of Health (Department) for the purpose of maximizing patient safety, reducing medical errors, and improving overall quality of health care. The Department’s Office of Quality and Patient Safety does this through systems of data reporting, collection, analysis, and dissemination as well as improving public access to health care information. PHL charged the PSC with developing a system for the voluntary reporting of medical errors and identified several other areas of PSC quality improvement, including safety goals, best practices, and reporting of adverse events in office-based surgery.

The Department is responsible for monitoring compliance with applicable federal and State laws and regulations and, through its Bureau of Administrative Hearings, for enforcing violations. Regulatory enforcement occurs through a formal resolution process, which may culminate in stipulated settlement agreements with violators, including penalty amounts. Pursuant to PHL, a portion of the penalties imposed against facilities or individuals found to be in violation of certain sections of law are allocated to a special revenue fund created specifically to support PSC expenditures. The Department’s Bureau of Accounts Management is responsible for overseeing the PSC special revenue account, including the collection of penalties and the allocation of funds into the account. As of July 2023, the PSC account balance totaled about $6.3 million.

The objective of our initial audit, issued on March 10, 2021, was to determine whether the Department was meeting the goals and objectives of the PSC and collecting and utilizing designated revenue for that purpose. The audit covered the period from April 1, 2015 through May 16, 2019. We found that the Department had generally met the primary objectives of the PSC regarding data reporting, collection, and analysis as well as the dissemination of health care information, including public access to such information. However, we found a lack of formal guidance governing certain enforcement and record-keeping practices. Additionally, we found that the Department needed to improve its oversight of PSC revenues and related activities to ensure that the PSC account is receiving all revenue due.

Key Finding

Department officials made significant progress in addressing the issues identified in the initial audit report and implemented all four of the report’s recommendations.