Objectives

To determine whether the Department of Health (Department) is meeting the goals and objectives of the Patient Safety Center (PSC) and is collecting and utilizing designated revenue for that purpose. Our audit covered the period from April 1, 2015 through May 16, 2019.

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 PSC was established within the Department for the purpose of maximizing patient safety, reducing medical errors, and improving the quality of health care through data reporting, collection, analysis, and dissemination as well as improving public access to health care information. PHL also identified several other areas of PSC quality improvement, including safety goals and best practices.

The Department is responsible for monitoring compliance with applicable federal and State laws and regulations and, through its Bureau of Administrative Hearings (Legal), for enforcing violations. Regulatory enforcement occurs through a formal resolution process, which may culminate in stipulated settlement agreements (Orders) 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 (Revenue) is responsible for overseeing the PSC special revenue account, including the collection of penalties and the allocation of funds into the account.

Key Findings

• The Department has generally met the primary objectives of the PSC regarding data reporting, collection, and analysis and the dissemination of health care information, including public access to such information. However, we found a lack of formal guidance governing certain enforcement and recordkeeping practices. By not adequately enforcing and administering such responsibilities, the Department undermines achievement of PSC goals.
• The Department needs to improve its oversight of PSC revenues and related activities to ensure that the PSC account is receiving all revenue due. Specifically, we found:
  • A lack of formalized policies and procedures and poor internal communications contributed to PSC revenue either not being collected or not being properly allocated to the PSC account for PSC-related activities.
  • In some cases, Legal allows payment plans for penalties but does not monitor respondents’ compliance with payment terms. There is a risk that respondents who are not adhering to these legally binding payment plans are not being held accountable for the full extent of the penalty imposed for their misconduct.
• Notably, while the enacted State budget has provided the Department with an appropriation to spend from the PSC fund for non-personal service expenditures, PSC costs have been paid for by the General Fund – the major operating fund of the State – and federal funding.

Key Recommendations

• Develop procedures to ensure Revenue is informed of all Order codes that are applicable to the PSC account.
• Take steps to enhance accountability over PSC account activities.
• Develop formal policies and procedures documenting the basis for approving Order terms including fine amounts, payment plans, and referrals to licensing authorities.