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Recent Developments in the Implementation of the Patient Safety and Quality Improvement Act of 2005

Posted Apr 25 2010 12:00am

By Jeanine Juillet

Semaphore signal for error. Image by Denelson83 via Wikimedia

Semaphore signal for error. Image by Denelson83 via Wikimedia

In 2000 the Institute of Medicine (IOM) published a report entitled “To Err is Human: Building a Safer Health System.” The report estimated that as many as 98,000 people die in America each year due to medical errors.  In order to combat this problem, the IOM recommended that providers should voluntarily report errors and the results should be evaluated to discover weaknesses in the health care delivery system in the United States.

Congress responded to this appeal for reform by passing the Patient Safety and Quality Improvement Act of 2005 .  The Act calls for voluntary and confidential self-reporting by health care providers and creates independent local or regional Patient Safety Organizations (PSOs) to collect and analyze safety events in the hope of uncovering problems with the current system. Hospitals, physicians or other health care professionals submit reports, memoranda, analyses, or written or oral statements referred to as a patient safety work product (PSWP) , describing adverse events. PSWP may include details identifying the providers involved in the event as well as protected patient information as defined by the Health Insurance Portability and Accountability Act (HIPAA) . Based upon an assessment of the data, PSOs develop insights into underlying problems contributing to patient safety events. Moreover, in order to aggregate data on a larger scale, the Act provides for the establishment of a Network of Patient Safety Databases (NPSD); PSOs contribute PSWP information after removing patient and provider identifiers before submission to the NPSD. The database includes definitions and reporting formats in order to facilitate analyses of information. Through use of the NPSD, large volumes of data are available in order to rapidly identify patterns with the goal of developing strategies to avoid, mitigate or eliminate risks and hazards in the delivery of patient care nationally.

The success of the Act depends on providers voluntarily reporting medical errors. To this end, the Act includes federal privilege and confidentiality protections for PSWP. This protection alleviates provider concerns that reported information will be used against them in civil and criminal actions, specifically, medical malpractice litigation. Further, the Act forbids disciplinary actions as a result of a provider’s report. In order to ensure confidentiality of patient information, the Office for Civil Rights (OCR) will investigate allegations of violations and the HHS Secretary has the power to impose civil money penalty (CMP) of up to $10,000 per violation.

The Act vests oversight responsibilities in the Health and Human Services (HHS), Agency for Healthcare Research and Quality (AHRQ). The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) , the regulation implementing the Act, was published on November 21, 2008 and became effective on January 19, 2009. The Patient Safety Rule provides a framework for PSOs by identifying 15 distinct statutory criteria that an organization must meet before it is qualified by the AHRQ. These public or private entities do not receive federal funding to fulfill this role and cannot be a health insurance issuer or be owned, managed or controlled by a health insurance issuer. Additionally, employees of PSOs must have expertise in analyzing patient safety events. The Patient Safety Rule also authorizes AHRQ to conduct PSO site visits to assess continued compliance with the eligibility requirements.

Supporters are excited that specialized organizations will be analyzing providers’ adverse events in order to identify common patterns that will minimize risks associated with health care delivery. Not only will this save lives, it will also reduce health care costs. Medical mistakes are expensive and needlessly waste resources. The Act also encourages the submission of information by providing protection for reporters from legal liability and professional sanctions. Additionally, it protects the patients by requiring that all information submitted to the database comply with HIPAA regulations. Further, the NPSD represents the largest effort to collect data from various providers across the country and the immense amount of information gathered may be able to identify improvements that could not be identified otherwise.

Opponents of the Act are particularly critical of the exceptions to the Patient Safety Work Product including disclosure exceptions. It remains to be seen how broadly these exceptions will be interpreted since the Act has a limited history. Additionally, by not offering federal funding for PSOs and by forbidding insurance companies from providing capital, the source of revenue to support these organizations is uncertain. Providers are also skeptical that standardized data gathered by PSOs will be effective in curtailing medical errors or that PSOs will be able to provide useful information for various provider structures (i.e., hospitals, doctors offices, etc.) in states across the country. Critics also argue that the existing state organizations, which currently collect this information, are likely to be more effective than PSOs. On the other hand, such peer review protections are limited in their scope and do not offer the same confidentiality protection.

Another area as yet to be defined is the overlap between this initiative and FDA measures to evaluate drug effects in a more thorough and timely manner. These latter initiatives include the Observational Medical Outcomes Partnership (OMOP) , which will assess the feasibility of using a range of analytical methods against multiple data sources to evaluate safety events. Moreover, through the Sentinel initiative , claims databases and electronic health records will be integrated nationally, linking data from 25 million patients by July 1, 2010 and 100 million by July 1, 2012. Thus, both OMOP and the Sentinel Network taken together may be used to identify and evaluate safety risks for marketed products. These initiatives, while focused on drug and device safety, will need to be integrated with similar data generated from the NPSD.

The underlying purpose of the Act to collect data and identify weaknesses in the health care system is an unprecedented and laudable goal. However, it is unclear whether the Act will achieve its stated goals. The rules establishing a critical element of the Act, PSOs, have only been in effect for little more than a year. The success of the Act requires more time for implementation in order to adequately assess the effectiveness of this ambitious effort.

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