Warning: Human Error May Be Hazardous to Your Health
East Tennessee Medical News – March 2009
by Diana L. Gustin

In 1999, the Institute of Medicine report titled “To Err is Human” cited studies that found at least 44,000 and as many as 98,000 people die in hospitals each year as a result of preventable medical errors.  Based on these studies and others, the report estimated the total national costs of preventable adverse events to be between $17 billion and $29 billion (including lost income, lost household productivity, disability and health care costs).FN1  In the decade since the report was published, both federal and state legislation has developed to address the problem.  Some laws focus on mandatory reporting events while others are aimed at voluntary reporting for the purpose of gathering data to study and analyze.  Some laws have developed to limit payment for situations which should not have occurred.  Medicare developed a list of events that should ‘never occur in a health care setting’ with final rules to deny payment for eight hospital acquired conditions. 

The shocking statistics on preventable deaths and the magnitude of the financial cost to our nation was the impetus for the Patient Safety and Quality Improvement Act of 2005.FN2  This legislation was designed to improve patient safety and to reduce the incidence of adverse events.  Patient Safety Organizations (PSOs) are now being organized pursuant to this legislation to create a protected sphere where reports and studies can be analyzed with the highest degree of confidentiality.  The PSO activities go beyond traditional state-based peer review activities which are more limited in scope and purpose.  This article will describe some key functions of the PSO and the protections it affords those who participate in the process.

Q. – What is a Patient Safety Organization?

A Patient Safety Organization (PSO) is defined as a private or public entity, or component thereof that is listed as a PSO by the SecretaryFN3 in accordance with the regulations.FN4  A health insurance issuer or a component thereof may not be a PSO.  (Other exclusions are also listed at 42 C.F.R. § 3.102.)  Under the regulations, a variety of entities may be listed as PSOs by the Secretary of Health and Human services based on their certifications of expertise regarding patient care and the mission to improve patient care.

Q. – What does a Patient Safety Organization do?

The PSO gives health care providers an opportunity to voluntarily report on a privileged and confidential basis patient safety events and quality of care situations which will be studied and analyzed in order to prevent future errors.  The organization will collect, aggregate, analyze and study the information in order to give feedback to participants for improvement to patient safety.

Q. – What kind of patient safety situations might be reported to the PSO?

The Agency for Healthcare Research and Quality (AHRQ) is responsible for administering the provisions of the Patient Safety Act in dealing with PSO Operations.FN5  This agency developed common formats for reports as well as common format event descriptions.  For example:

Patient safety incident – A patient safety event that reached a patient, and either resulted in no harm (no harm incident) or harm (harm incident).  The concept “reached a patient” encompasses any action by a healthcare practitioner or worker or healthcare circumstance that exposes a patient to harm.

Patient safety event – Something that happens to or involves a patient; encompasses patient safety incident and near miss. 

Near miss – An event that did not, or could not, reach a patient, such as discovery of a dispensing error by a nurse in the process of administering the medication (which if not discovered would have become an incident).

Adverse outcome – Undesired patient outcome of healthcare; clinical complication of healthcare (which may or may not be a patient safety incident).

Adverse reaction – Unexpected adverse outcome resulting from a justified action where the correct process was followed for the context in which the event occurred.

Contributing factor – A circumstance, action or influence which is thought to have played a part in the origin or development of an incident or to increase the risk of an event.

(See AHRQ Common Formats Version 0.1 Beta Release – August 2008 Appendix 2 Glossary for complete list of terms and definitions.)

Q. – Why should anyone want to participate in a PSO?

The goal is to permit voluntary reporting opportunities in order to gather data for the study and improvement of health care.  This should lead to breakthroughs in patient safety during the delivery of health care. 

Q. – Are there risks associated with reporting information?

The PSO organization is designed to encourage voluntary reporting without negative consequences.  Adverse employment action based upon good faith reporting is prohibited under the Patient Safety Act.  The ‘Patient Safety Work Product’ is privileged and shall not be subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including a Federal, State or local civil or administrative disciplinary proceeding against a provider.FN6  The confidentiality of ‘Patient Safety Work Product’ is also protected, with certain exceptions for criminal proceedings, for equitable relief for reporters who allege adverse employment action, for permitted disclosures which are authorized by identified providers and for various other patient safety activities.FN7  Overall, the rules were designed to protect health care providers’ internal deliberations and analysis of patient safety information.  To insure that the confidentiality provisions are taken seriously, the statute contains a substantial penalty for breaches of the protections which are subject to civil money penalty of up to $10,000.  All of these protections should encourage providers to participate in the process which will permit improvement initiatives that will personally benefit individual patients and at the same time, reduce the negative financial impact of adverse events.

Disclaimer:  The information contained herein is strictly informational; it is not to be construed as legal advice.

Disclaimer: The information contained herein is strictly informational; it is not to be construed as legal advice.