The Evolution of Patient Safety Organizations

Despite the obvious need for entities like PSOs to facilitate confidential, privileged reporting of medical errors and other safety information, it still took several years before the passage of The Act in July 2005. More frustrating to many patient safety advocates, even after passage of The Act, it took even longer to fashion and promulgate final regulations implementing the work of PSOs.

The final regulations issued recently by HHS will implement PSOs and their operations beginning on January 19, 2009. PSOs are certified by the Agency for Healthcare Research and Quality (AHRQ), part of the Dept. of Health and Human Services. “They will serve a valuable analytical role that wasn’t previously available beyond the state level,” said William B. Munier, M.D., director of AHRQ’s Center for Quality Improvement and Patient Safety. “We have essentially freed up physicians to use a powerful tool to make care of higher quality and safer for their patients.” (Trapp D., HHS sets rules for confidential medical error reporting system; American Medical News; American Medical Association; Chicago, December 15, 2008 at:

http://www.ama-assn.org/amednews/2008/12/15/gvl11215.htm#w1).

What Type of Information is Protected from Legal Discovery?

Section 922 of The Act confers legal protection from discovery to what is referred to as “patient safety work product.” This term may pertain to any individual that is the subject of the work product or participating in activities that are the subject of a work product.  It also may pertain to individually identifiable patient information protected by HIPAA’s confidentiality provisions. Finally, it may pertain to any information reported in a form or manner which may identify an individual who reported the information, according to Section 922(e) (See Section 921(2) (A)(B)(C) of the Act at: http://www.pso.ahrq.gov/statute/pl109-41.htm).

“Patient Safety Work Product” is defined as data, reports, records, memoranda or analyses (such as root cause analyses) or written or oral statements which are assembled or developed by a provider for the purpose of reporting to a PSO. Patient Safety Work Product, however, does not apply to the medical record itself, when being used independently from the patient safety activities as described below. It may also pertain to activities developed by the PSO to improve patient safety, healthcare quality or clinical outcomes. These activities may identify the deliberations, analysis or fact of reporting, pursuant to a patient safety evaluation system (See subsection 7 of Sect. 921 of The Act).

“Patient Safety Activities” includes efforts to improve:

• Patient safety and the quality of healthcare delivery
   
• The collection and analysis of patient safety work product
   
• The development and dissemination of information such as protocols and recommendations for best practices 
   
• The information to create a patient safety culture and to provide feedback and assistance to minimize patient risk
   
• The maintenance of procedures to ensure the confidentiality of patient safety work product 
   
• The provision of security measures with respect to patient safety work product 
   
• The utilization of qualified staff 
   
• Activities related to the operation of a patient safety evaluation system 
   
• The provision of feedback to participants in a patient safety evaluation system (See subsection 5 of Sect. 921 of The Act).

A “Patient Safety Evaluation System” means the collection, management or analysis of information collected for reporting to or by a patient safety organization (See subsection 6 of Sect. 921 of the Act). Thus any provider reporting to a duly constituted and certified PSO (see below) medical errors or other related information which satisfies the above definition of “patient safety work product” can be assured that such information will be protected from discovery in legal actions. Of course, for every rule there are always exceptions. One of these exceptions may apply if “patient safety work product” could provide evidence of a criminal act in a proceeding where there was no alternative way of obtaining such evidence. Another exception could be if patient safety work product was authorized for disclosure by each provider who was a party to its creation. The final exception could be if disclosure of patient safety work product was necessary for cases requesting equitable relief, including adverse employment actions brought by a reporter.

The Creation and Listing of Patient Safety Organizations

For the legal protections from discovery to apply, patient safety work product (PSWP) must be reported to an entity that is listed as a PSO by the Secretary of Health and Human Services. Before submitting information to an entity that claims to be a PSO, healthcare providers should always verify that the entity is currently listed by the secretary. It is also important never to submit information to a PSO prior to its effective listing date. There are currently 20 PSOs certified by the Secretary of HHS. Their names, addresses, contact personnel and effective listing dates can be found at: http://www.pso.ahrq.gov/listing/psolist.htm.

Although none of the 20 currently HHS-certified and listed PSOs are headquartered in New Jersey, there are several located in suburban Philadelphia:

·         The ACCE Healthcare Technology Foundation
 

·         ECRI Institute PSO

·         The Institute for Safe Medication Practices
 

·         Peminic, Inc.

Reporting Medical Errors--Requirements to be Protected from Discovery

To summarize, for individual or entity providers to have their medical error reporting protected from discovery in legal actions, they should:

• Ensure that the medical errors they report are included within what could be characterized here and in The Act as a “patient safety work product”
   
• Derive from a “patient safety activity”
   
• Report the error as part of the workings of a “patient safety evaluation system”
   
• Only transmit this information to a currently listed PSO-certified as such by the Secretary of HHS.

Network of Patient Safety Databases

 AHRQ is responsible for PSO operations. As data become available from PSOs, a Network of Patient Safety Databases (NPSD) will receive, analyze, and report on de-identified and aggregated patient safety event information. The goal of the NPSD is to facilitate aggregation and analyses of patient safety event information to help reduce adverse events and improve healthcare quality—please see: http://www.pso.ahrq.gov/npsd/npsd.htm.

Use of this de-identified patient data is discussed in the Common Formats Overview at: http://www.pso.ahrq.gov/formats/commonfmt.htm.

PSO Contacts for Additional Information

Those interested in more detail about the final rule, the PSO listing process, listed PSOs, and other PSO operational issues may contact the AHRQ PSO Office at:

Telephone (toll free): (866) 403-3697

TTY (toll free): (866) 438-7231

E-mail: PSO@ahrq.hhs.gov

This article is intended to be merely an informational alert and is not intended either to be an exhaustive examination of the subject or to constitute legal advice. Review of the full text of the legislation and all of the regulations and guidance from counsel regarding any specific circumstances to which this might apply should be directed to your legal counsel.