History of Medical Errors

Health care quality and safety represents a constantly recurring theme in U.S. health policy. In radiation oncology, recently published incidents involving medical events have received increased public attention and Congressional scrutiny. The practice and business of radiation oncology is rapidly changing as pressure increases to reduction medical errors and increase patient safety. The History of Medical Errors and Patient Safety is a snapshot of past, current, and future initiatives taken by state and federal governments to improve quality of care and patient safety.

Introduction

Patient safety is defined as freedom from accidental injury due to medical care, or absence of medical errors, or absence of misuse of services.^1,2,3,4 An error is described as the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).⁵ In radiation oncology, a variety of injuries and errors can occur in the diagniostic imaging and therapeutic treatment delivery process. Various descriptors of the term “error” found in radiation oncology are unintended deviation, incident, accident, mistake, unusual occurrence, recordable event, adverse event, misadministration, medical event, and sentinel event.

History

The Institute of Medicine (IOM) report in 1999 focused a great deal of attention on the issue of medical errors and patient safety. The report stated that 44,000 to 98,000 deaths occur per year in U.S. hospitals as a result of medical errors.⁶ In addition, 10,000 deaths per year occur in Canadian hospitals. Deaths in the U.S. alone exceed annual death rates from road accidents, breast cancer, and AIDS combined. The IOM estimated costs due to medical errors in the U.S. of approximately $37.6 billion per year.⁷ Of the $37.6 billion, about $17 billion are associated with preventable errors. Of that $17 billion, about $8 to $9 billion are for direct health care costs. Updated estimates place costs for errors in hospitals nationwide to be between $17 billion and $29 billion each year.⁸

The Healthcare Research and Quality Act of 1999 required the Agency for Healthcare Research (ARHQ) to support research and build private-public partnerships. The purpose was to identify causes of preventable health care errors and patient injury; develop, demonstrate, and evaluate strategies for reducing errors and patient injury; and disseminate such strategies.⁹

Federal initiatives taken by former President Clinton on February 22, 2000 were based on IOM recommendations. These initiatives included creation of a comprehensive strategy to reduce medical errors by developing an external reporting system along with national patient safety centers, and targeting at least a 50% reduction of errors over 5-years.^10,11

Key legislation followed in 2000 with the Patient Safety and Quality Improvement Act. This act certified patient safety organizations in each state to collect data and report on medical errors.¹² State patient safety centers started to be created. Since 2000, 27 states and the District of Columbia have passed legislation or regulations related to hospital reporting of adverse events to states.¹³  These laws required creation of mandatory reporting systems for serious adverse events. Concurrently, the National Academy for State Health Policy endorsed a directive indicating states must demand quality and efficiency from their health care systems.

Since 2000, a number of patient safety advisory groups have been created: Health Care Risk Manager Advisory Council (Florida), Illinois Adverse Health Care Events Reporting Advisory Council, Betsy Lehman Center for Patient Safety and Medical Error Reduction (Massachusetts), Nevada Hospital Association Sentinel Events Registry Work Group, and Patient Safety Authority Board of Directors (Pennsylvania).¹⁴

The Joint Commission (TJC) revised their standards on July 1, 2001 to address patient safety. The revised standards required all TJC hospitals (5,000) to implement ongoing medical error reduction programs.¹⁵ Since 2001, almost 50 percent of all TJC standards have been directly related to safety.¹⁶ The creation of TJC’s sentinel event policy required that hospitals identify sentinel events, take action to prevent their recurrence, complete a thorough and credible root cause analysis, and implement an action plan.¹⁷

In 2002, the National Quality Foundation (NQF) issued a list of 27 serious (“never”) reportable events for hospitals.¹⁸ In addition, state Medicare programs would no longer reimburse providers for procedures associated with reportable events.

The AHRQ established safety indicators (PDIs) in 2003. The PDIs were are a measuring and monitoring tool. The measures comprised 20 hospital and 7 regional measures.¹⁹ Additionally, AHRQ started their WebM&M website. This comprises an online forum and journal for patient safety and quality issues.

TJC’s Office of Quality Monitoring was established in 2004. This office receives, evaluates and tracks complaints and reports of concerns about health care organizations. The office conducts unannounced on-site evaluations. Also in 2004, TJC and CMS formulated an agreement. The agreement created a means for working together to align Hospital Quality Measures (TJC’s ORYX Core Measures and CMS’ 7th Scope of Work Quality of Core Measures) with CMS and TJC initiatives.²⁰

In 2005, CMS created quality directives and incentives. The directives are implemented through Quality Improvement Organizations (QIOs). The QIOs are contracted by CMS to operate in every state. These organizations perform independent quality audits. At this same time, incentives were introduced through the Premier Hospital Quality Initiative. The initiative was a 3-year demonstration project with 280 hospitals where these institutions were recognized and provided financial reward for demonstrating quality. CMS partnered with Premier, Inc. and a nationwide purchasing alliance was created. The incentive allowed hospitals in the top 20% of quality for 5 clinical areas to get financial reward. In year 1, the top decile received a 2% Diagnosis Related Group (DRG) bonus. In year 2, the 2nd decile received a 1% DRG bonus. In year 3, the hospitals performing below 9th and 10th decile baseline levels received DRG payments reduced 1% and 2%, respectively.²¹

Additionally in 2005, CMS quality incentives were introduced through the Medicare/State Children’s Health Insurance Program (SCHIP) Quality Initiative.²² This initiative introduced Pay-For-Performance (P4P). In 2005, 12 states adopted some form of performance measurement. Efforts were to align payment with quality. The quality performance measurements were created in collaboration with TJC, NCQA, HQA, AQA, NQF, medical specialty societies, AHRQ, and VA. P4P was tied to Medicare service payments associated with efficiency, economy, and quality of care standards.

Between 2005 and 2006, CMS quality initiatives continued to be proposed. The CMS consumer website was started where CMS contracted with NQF and worked with TJC to develop hospital quality measures for public reporting. Hospital quality data then became available for the general public at www.HospitalCompare.hhs.gov or by calling 1-800-MEDICARE. Additionally, at this same time, data indicators were established to allow hospitals to report quality data to Medicare and receive a 3.7% increase in inpatient payments. Non-reporters would only receive a 3.3% increase. This initiative started with 10 quality indicators for cardiology, but is expected to expand into other disciplines.²³

CMS quality incentives continued with the 2007 Physician Quality Reporting Initiative (PQRI). This initiative provided a financial incentive to participate in voluntary reporting of 77 evidence-based quality measures. A bonus payment of 1.5% was paid to participants.²⁴

The National Priority Partnership (NPP) was created in 2008. Deemed 1 of 6 national priorities, it included 555 endorsed measures. Approximately 100 of the measures were related to patient safety.²⁵ In 2009, the NPP endorsed 34 safe practices (Safe Practices for Better Healthcare) and 28 serious reportable events.²⁶

CMS expanded the PQRI incentives in 2008. Physicians were allowed to report on 119 quality measures and receive a 2% incentive payment. CMS introduced tracking of 5 quality measures in adoption of healthcare information technology (EMR). A 2% incentive payment was allocated for e-prescribers. PQRI data was made available for public view including performance rates.²⁷ In 2009, the PQRI initiative increased to a total of 153 quality measurements. A 2% incentive payment was maintained. However e-prescribing was removed and placed into a separate incentive program.²⁸ In 2010, the CMS PQRI quality incentive increased the quality measures to a total of 179. The 2% incentive payment was maintained. Regarding EMR, new tracking of 10 quality measures was allowed for adoption of EMR. A 2% additional incentive payment is allowed for e-prescribers (see discussion below).²⁹

More recently, the American Recovery and Reinvestment Act of 2009 provides significant financial incentives to Medicare (and Medicaid) providers that use “meaningfully use” electronic health records (EHRs) to improve the quality of care delivery.^30,31 The Patient Protection and Affordable Care Act (ACA) builds upon these efforts and other quality measurement and reporting systems. The main objective of the ACA is to improve the quality and value of health care delivery in the Medicare program.

Future

A new program called Quality Reporting for PPS (Prospective Payment System)-Exempt Cancer Hospitals (ACA - Section 3005) will begin in 2012.^32,33 The ACA establishes a new quality measurement and reporting program for cancer hospitals that are exempt from the PPS. The entity must meet a number of measures for performance standards. If a cancer hospital does not report selected quality measures, the hospital’s annual Medicare market basket update will be reduced (specific penalty not prescribed). Currently proposed is a 2 – 5% incentive of the hospital’s base operating payment for each DRG, contingent on performance of specific measures. The 1st year, a 100% incentive is based on reporting. The 2nd year, there is a 50% reporting and 50% performance incentive. The 3rd year, there is a 100% reporting incentive.

Improvements to PQRI through ACA (Section 3002) will continue.³⁴ The ACA re-authorizes incentive payments under the Physician Quality Reporting Program through 2014 (maximum one percent of estimated allowed charges). It institutes a penalty for failure to report beginning in 2015 (maximum two percent). The ACA also authorizes an additional incentive payment (0.5%) for eligible professionals who satisfactorily submit data on quality measures through a Maintenance of Certification Program. Finally, Section 3002 requires the Secretary to provide feedback to eligible professionals on their performance on reported quality measures, and to develop a plan to integrate reporting on quality measures with reporting on the meaningful use of EHRs.

The ACA will improve upon the Value-based Purchasing Programs (Sections 3001, 3007, 3006(a), 3006(b), and 3006(f) added by Section 10301).³⁵ Between 2012 and 2015, the ACA moves beyond quality measurement and reporting and requires implementation of (or plans to implement) value-based purchasing programs for several providers (including certain cancer treatment and research facilities) and for physicians (through the use of a payment modifier).

Meaningful Use of EHRs will continue with existing and newly developed quality measures. These measures will also be used to determine whether participating providers are “meaningfully using” EHRs to improve the quality of care delivered and qualify for incentive payments.

Public Reporting of Performance Information (Physician Compare Website) (ACA - Section 10331) continues to be an important part of the ACA.³⁶ The ACA requires CMS to establish a “Physician Compare” website that will publicly report information on physicians and other eligible professionals who participate in the Physician Quality Reporting Program. Information reported must include the quality measures collected under the Physician Quality Reporting System as well as assessments of patient health outcomes, risk-adjusted resource use, efficiency, patient experience, and other relevant information deemed appropriate by the HHS Secretary.

Public Reporting of Quality Information for Other Providers (ACA - Sections 3004, 3005, and 10322) will require newly authorized quality reporting programs for non-PPS cancer hospitals. The HHS Secretary will require reported quality information from these programs be made available to the public.

¹Hurt ado M, Swift E, Corrigan JM, eds. Envisioning the National Health Care Quality Report. Washington, DC: National Academy of Sciences; 2001.
²McNutt R, Abrams R, Aarons D. Patient Safety Efforts Should Focus on Medical Errors. JAMA. 2002; 287(15):1997-2001.
³Department of Health and Human Services. The Challenge and Potential for Assuring Quality of Health Care for the 21st Century. Washington, DC: Department of Health and Human Services; 2000.
⁴ The President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry. Quality First: Better Health Care for All Americans; 1998.
⁵To Err is Human: Building a Safer Health System. Institute of Medicine (IOM). The National Academies (11/29/99).
⁶To Err is Human: Building a Safer Health System. Institute of Medicine (IOM). The National Academies (11/29/99).
⁷To Err is Human: Building a Safer Health System. Institute of Medicine (IOM). National Academies (11/29/99).
⁸2007 Guide to State Adverse Event Reporting Systems: State Health Policy Survey Report, National Academy for State Health Policy, Vol. 1, No. 1, December 2007.
⁹Advancing Patient Safety – A Decade of Evidence, Design, and Implementation, Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services, Accessed through www.ahrq.gov/qual/advptsafety.htm.
¹⁰Announced by President Clinton and senior administration officials in James S. Brady Press Briefing Room on February 2, 2000.
¹¹Recommendations issued in report entitled To Err is Human: Building a Safer Health System by the Institute of Medicine (IOM) of the National Academies (11/29/99).
¹²Reducing Medical Errors, Issue Module, Kaiser EDU.org, Accessed through www.kaiseredu.org.
¹³Authorizing Statues and Regulations, National Academy for State Health Policy, Accessed September 28, 2010 through www.nashp.org.
¹⁴State Patient Safety Centers: A New Approach to Promote Patient Safety, The Flood Tide Forum, National Academy for State Health Policy, 10/04, Accessed & updated through www.nashp.org.
¹⁵Patient Safety - Essentials for Health Care, 2nd edition, Joint Commission on Accreditation of Healthcare Organizations. Oakbrooke Terrace, IL: Department of Publications, 2004.
¹⁶Sentinel Event Policies and Procedures - Revised: July 2002, Joint Commission on Accreditation of Healthcare Organizations, Accessed through www.jcaho.org/accredited+organizations/long+term+care/sentinel+events/index.htm.
¹⁷Sentinel Event Policies and Procedures - Revised: July 2002, Joint Commission on Accreditation of Healthcare Organizations, Accessed through www.jcaho.org/accredited+organizations/long+term+care/sentinel+events/index.htm.
¹⁸A National Survey of Medical Error Reporting Laws, Yale Journal of Health Policy, Law, and Ethics, 2008.
¹⁹Advancing Patient Safety – A Decade of Evidence, Design, and Implementation, Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services, Accessed through www.ahrq.gov/qual/advptsafety.htm.
²⁰Joint Commission, CMS to Make Common Performance Measures, Joint Commission on Accreditation of Healthcare Organizations, Accessed through www.jcaho.org/accredited+organizations/long+term+care/sentinel+events.
²¹Medicare Looks for Ways to Boost Quality Care Comments Sought on New Plan for Quality Improvement Organizations, Centers for Medicare & Medicare Services (CMS), Accessed through www.cms.hhs.gov.
²²Letter Announcing Medicare/State Children’s Health Insurance Program (SCHIP) Quality Initiative, Centers for Medicare & Medicare Services (CMS), Accessed through www.cms.hhs.gov.
²³Medicare to Pay Hospitals for Reporting Quality Data, Modernhealthcare, accessed through www.modernhealthcare.com.
²⁴Physician Quality Reporting Initiative, Centers for Medicare & Medicare Services (CMS), Accessed through www.cms.hhs.gov.
^25,26Patient Safety Measures - National Voluntary Consensus Standards for Patient Safety, Accessed thru www.qualityforum.org.
²⁷CMS Ups Quality-Reporting Program Measures, Modern Health Care, 12/10/07. Accessed through www.modernhealthcare.com.
²⁸Proposed 2009 Changes to Payment Policies and Rates Under Medicare Physician Fee Schedule, CMS, 6/30/08. Accessed through www.cms.hhs.gov.
²⁹Proposed 2010 Changes to Payment Policies and Rates Under Medicare Physician Fee Schedule, CMS, Accessed through www.cms.hhs.gov.
³⁰The American Recovery and Reinvestment Act (ARRA), P.L. 111-5, 123 Stat. 115 (2009).
³¹Social Security Act § 1903 (a)(3)(F) [42 U.S.C. § 1396b et seq.] (as added by ARRA § 4201(a)(1)).
³²Hospital Value-Based Purchasing Program, Bricker & Eckler Attorneys at Law. Accessed through www.bricker.com.
³³Patient Protection and Affordable Care Act (Pub. L. 111-148) §3005 (2010), adding Social Security Act §1866(k).
³⁴Patient Protection and Affordable Care Act (Pub. L. 111-148) §3002 (2010), amending Social Security Act §1848.
³⁵Patient Protection and Affordable Care Act (Pub. L. 111-148) §10331 (2010).
³⁶Patient Protection and Affordable Care Act (Pub. L. 111-148) §3001 (2010), adding Social Security Act §1886(o) (hospitals); Patient Protection and Affordable Care Act (Pub. L. 111-148) §3007 (2010), adding Social Security Act §1848(p) (physicians).