RISK MANAGEMENT AND PATIENT SAFETY BEFORE TAKING ON THE ASSIGNMENT, PLEASE ENSURE THAT YOU UNDERSTAND ALL OF THE INFORMATION AND REQUIRED READINGS AND ATTACHMENTS THAT GO ALONG WITH

The Patient Safety and Quality Im- provement Act of 2005 was intro- duced to amend Title IX of the Public Health Service Act. It is a re- sponse to the call for a national re- porting system to track and reduce errors. This Act was signed into law on July 29, 2005, and will most likely be administered by the Health and Human Service’s Agency for Health- care Research and Quality (AHRQ).

■ What the Act Does The Act establishes a voluntary sys- tem for healthcare providers to re- port errors as well as safety and quality-related information to a new body, termed a “Patient Safety Orga- nization” (PSO). A PSO’s job is to analyze this information and de- velop safety-related information and protocols. The information submit- ted by providers will be confidential

and privileged. The Act also requires AHRQ to

facilitate the creation and mainte- nance of a network of patient safety databases to provide an interactive evidence-based management re- source for providers, PSOs, and other bodies. The information re- ported to the databases must be used to analyze national and regional sta- tistics, including trends and patterns or healthcare errors. Such informa- tion must be available to the public

in annual reports. The Act provides specific protec-

tions. For instance, a PSO cannot be compelled to disclose information collected or developed under the Act, with certain exceptions. An ac- crediting body cannot take action against a provider based on the provider’s good faith participation in the collection, development, re- porting, or maintenance of a Patient Safety Work Product. A provider may not take an adverse employ- ment action against an individual because the individual reported in- formation in good faith to the provider with the intent of having the information reported to a PSO.

The Act creates a private right of action for an aggrieved individual prohibiting retaliation, seeking rein- statement, and allowing for back pay and restoration of benefits. Addi-

tionally, there is a $10,000 penalty per violation.

The Act does not alter the im- plementation of the Health Insur- ance Portability and Accountability Act’s confidentiality regulations. The privilege and confidentiality provi- sions of the Act preempt other state and local laws unless the state and local laws provide greater privilege or confidentiality protections, gov- ern information not protected by the Act, or require a provider to re-

port information not otherwise re- quired to be reported. The Act does not, however, preempt the require- ments under the Food and Drug Ad- ministration (FDA) for reporting information regarding the safety of a product or activity regulated by the FDA.

■ PSO Criteria There are certain necessary require- ments that an entity must have to be certified as a PSO. The organization must certify that it has policies and procedures in place to perform the functions of the Act, and that it will comply with the criteria of the Act. Its mission must be to conduct ac- tivities to improve patient safety and to provide quality healthcare. It also must have qualified staff, including licensed professionals. It must have contracts with providers for receiv- ing and reviewing information. All financial, reporting, or contractual relationships with providers must be disclosed. The entity must collect in- formation in a standardized manner and may not be a health insurance issuer or a component of one. If an entity becomes certified as a PSO, it must be recertified every 3 years.

Nurse practitioners (NPs) can use this information to identify trends in patient safety issues as well as healthcare errors. This will let the NP know when policies and proce- dures should be modified to im- prove patient care, which can reduce the chance of errors and aid in the prevention of adverse patient out- comes.

www.tnpj.com14 The Nurse Practitioner • Vol. 30, No. 12

Legal File Cathy A. Klein, MSN, MSEd, APN, Esq.

Legal File Editor

The Act is a response to the call for a national reporting

system to track and reduce errors.

The Patient Safety and Quality Improvement Act of 2005