Patient Safety Act Becomes Law – What Neurosurgeons Need to Know

After years of negotiations and revisions, the Patient Safety and Quality Improvement Act of 2005 became law on July 29. The legislation calls for creation of a new voluntary reporting system for medical “near misses” and errors. Through this system, anonymous patient data will be submitted to established or newly created patient safety organizations, the errors will be analyzed, and recommendations will be made for system changes to prevent future errors.

The law defines patient safety organizations as independent organizations certified every three years by the U.S. Department of Health and Human Services. These organizations will collect anonymous incident and patient information, which then will be forwarded to a national database. Based on this data the HHS, through the Agency for Healthcare Research and Quality, will make recommendations that include methods to reduce errors and improve patient safety. Importantly, the legislation will preserve confidentiality of patient information under the Health Insurance Portability and Accountability Act. Additionally, the information and recommendations will not identify specific providers or individuals; appropriate fines would be administered for such disclosures. However, information available outside the patient safety evaluation system, such as billing and medical records, will not be shielded.

Addressing concerns of medical practitioners and lawmakers alike that the reported data would be used for litigation purposes rather than to reduce medical errors, President Bush said that the legislation is a “common-sense law that gives legal protections to health professionals who report their practices to patient safety organizations.” The legislation is “litigation neutral”; that is, reported data cannot be used as new information in lawsuits, although the law does not prohibit the use of information that is currently available. Additionally, reported data cannot be used by an accrediting body or regulator to take action against a provider. An exception is provided in the case of a criminal act if a judge determines the information is not available from any other source.

The legislation’s voluntary reporting measure was an important concession for lawmakers. Earlier iterations had called for mandatory reporting of medical errors and had offered little or no confidentiality protections; passage of the law in such a form likely would have fueled new lawsuits.

The issue of medical errors was highlighted in a 1999 Institute of Medicine report, which found that between 44,000 and 98,000 Americans die every year from errors in healthcare. The report emphasized that most medical errors are not attributable to individual misconduct or negligence but rather are systems related. This emphasis on healthcare delivery systems subsequently was identified by the Agency for Healthcare Research and Quality as key to reducing medical errors. The medical errors topic has become a frequent focus of politicians, the press, and forums on improving medical quality and medical liability reform.

As integral members of the healthcare delivery system, physicians share these patient safety concerns and are taking action to reduce medical errors. In the past year, the surgical “time out” and marking the site of surgery have been two of many quality improvements instituted at local and regional levels in surgical practices. Additionally, restrictions on the number of hours residents can work also have taken effect with the goal of, among other things, improving patient safety. Several recent studies in neurosurgical and other subspecialty literature have closely examined the roles of physicians and healthcare organizations in the context of safety. Anesthesiology’s successful program to improve patient safety often has been hailed as a prototype: Over the past 20 years, the Anesthesia Patient Safety Foundation has been instrumental in reducing the number of anesthesia-related deaths from 1 in 10,000 to 1 in 200,000 patients using technological advances, standardization of equipment, checklists and patient safety education.

The Patient Safety and Quality Improvement Act of 2005 demonstrates lawmakers’ aggressive stance regarding medical quality in the marketplace. Although the legislation has no direct connection with value-based purchasing or medical liability reform, it certainly sets the stage for patient safety remaining in the public eye in the coming years. The fact that lawmakers already are proposing new legislation regarding patient safety, value-based purchasing, health information technology, and medical liability reform highlights the importance of patient safety in the national arena.

Alexander Mason, MD, is the CNS Public Policy Fellow working in the office of Senate Majority Leader Bill Frist.