Radiation oncology is an exceedingly complicated system. The treatment workflow involves a long chain of clinical and technical steps involving numerous subsystems, multiple vendors, and a variety of medical professionals. Therefore, medical errors can occur, and, crucially, such errors can propagate to future steps unless detected and addressed immediately.
Complexity of the entire system connected with inherent trust of digital transfers may result in data transfer errors not being identified. Procedural intricacies of accurate and timely radiation treatment add to further risk of making errors. Ensuring the quality of checks to identify errors in the entire treatment process is difficult as treatment complexity continues to evolve in radiotherapy environments.
An error reduction program helps institutions reduce errors, improve process, minimize risk to patients, reduce liability, increase compliance, lower medical costs, and positively contribute to patient outcomes.
Exact numbers of reported errors world-wide in radiation oncology are unknown.
Between 1976 and 2007, the World Health Organization (WHO) has recorded 7,741 incidents and “near misses”. Of these events, 3,125 incidents caused harm ranging from underdose (resulting in increasing risk of recurrence) to overdose (causing toxicity)1. Near misses accounted for 4,616 events.
1WHO – World Alliance for Patient Safety, Radiotherapy and Oncology: International Review of Patient Safety Measures in Radiotherapy Practice; 2009: Vol. 92:1, 15-21.
According to a New York Times article published in January 2010, radiation therapy accidents are chronically underreported, and some states do not require any error reporting1.
“… it is likely that many more incidents have occurred but either went unrecognized, were not reported to the regulatory authorities, or were not published in the literature.”2
1https://www.nytimes.com/2010/01/24/health/24radiation.html
2ICRP, Radiological Protection and Safety in Medicine; ICRP Publication 73; 1996: Ann. ICRP 26 (2).
In the U.S., most current data in radiation oncology suggests that approximately 0.04% to 4.7% of patients undergoing radiation therapy experience some operational and clinical shortcoming. Approximately 0.003% to 0.01% experience some level of harm per treatment. And approximately 100 and 500 patients experience some harm annually in the U.S. and worldwide, respectively. This figure corresponds to approximately 6 to 100 serious events per million treatments, of which some lead to death1,2.
A recent study showed a similar error rate to most current data in radiation oncology of approximately 4.2% per patient in the treatment delivery process. However, the error rate in the entire pre and post treatment process (from patient registration to completion of treatment) was a remarkable 82%3.
Although the associated risk of mistreatment is estimated to be rare, the consequences of an error may be high4.
1Howell, C., Tracton, G., Amos, A., Chera, B., Marks, L. B., & Mazur, L. M. (2019). Predicting radiation therapy process reliability using voluntary incident learning system data. Practical radiation oncology, 9(2), e210-e217.
2Ford, E. C., Fong de Los Santos, L., Pawlicki, T., Sutlief, S., & Dunscombe, P. (2012). Consensus recommendations for incident learning database structures in radiation oncology. Medical physics, 39(12), 7272-7290.
3E.B. Kline, et. al., International Journal of Radiation Oncology*Biology*Physics, Proceedings of the American Society for Therapeutic Radiology and Oncology: 24 October 2020 – 28 October 2020, Results of a Risk Management Program at Multiple Radiation Oncology Centers, Volume 108, Number 3, Supplement S1-S192, November 2020, Abstract 2470, e209-e210.
4Ford, E. C., & Terezakis, S. (2010). How safe is safe? Risk in radiotherapy. International journal of radiation oncology, biology, physics, 78(2), 321-322.
According to the IAEA (SAFRON), of all external beam radiotherapy incidents reported world-wide, therapists identify the most errors. Therapists at the treatment unit report approximately 62% and 78% of errors identified in the pre-treatment and treatment phases, respectively1.
In the U.S., ASTRO (RO-ILS) shows that most errors are identified by therapists. Approximately 75% of all errors are reported by therapists and physicists, of which therapists report approximately twice as many errors as physicists2.
Of reported errors world-wide using ROSIS, radiation therapists at the treatment machine report 69% of all errors3.
1IAEA, Statistical Reports: Distribution by Who Discovered the Incidents. SAFRON. 2/15/20. Accessed through www.rpop.iaea.org/ SAFRON/Report/ReportList.aspx.
2ASTRO, 2017 Year in Review. RO-ILS. 2/15/20. Accessed through
www.https://www.astro.org/uploadedFiles/MAIN_SITE
/Patient_Care/Patient_Safety/RO-ILS/2017YearInReview.pdf.
3Radiation Oncology Safety Information System (ROSIS) Database, 2010. http://www.rosis.info. Accessed April 29, 2010.
The potential for errors in radiotherapy is high. There is no consensus as yet as to how best to deal with errors not covered by regular system quality assurance checks. However, it is imperative that proper QA measures are in place in order to reduce the likelihood of accidents and errors occurring, and increase the probability that the errors will be recognized and rectified if they do occur1.
1WHO – World Alliance for Patient Safety, Radiotherapy and Oncology: International Review of Patient Safety Measures in Radiotherapy Practice; 2009: Vol. 92:1, 1-4.
The Institute of Medicine (IOM), an authority at the intersection of medicine and society, released a report titled “To Err is Human: Building a Safer Health System” in November 1999. Its goal was to break the cycle of inaction regarding medical errors by advocating a comprehensive approach to improving patient safety. Based on two studies [conducted in 1984 and 1992], the IOM concluded that between 44,000 and 98,000 patients die every year in United States (U.S.) hospitals due to medical errors. Costs alone from medical errors were approximately $37.6 billion per year. About $17 billion were associated with preventable errors1.
Given the intense level of public and scientific reaction to the report, various stakeholders responded swiftly to take action. In February 2000, President Clinton announced a national action plan to reduce preventable medical errors by fifty percent within five years. Congress mandated the monitoring of progress in preventing patient harm.
In July 2004, a Healthgrades Quality Study asserted that IOM had in fact vastly underestimated the number of deaths due to medical errors, citing 195,000 deaths per year2. In September 2013, a study covering the period 2008 to 2011 estimated preventable medical errors leading to patient death at 210,000 to 400,000 each year3. Of $2.5 trillion spent on domestic healthcare costs in 2009, $765 billion (or 30%) was attributed to preventable errors4. In May 2016, Johns Hopkins released a study suggesting more than 250,000 deaths per year were due to medical errors in the U.S. This figure made medical errors the third leading cause of death in the U.S.5
Today, preventable deaths due to medical errors are 10 times higher than the IOM estimate based on quality-adjusted life years. A 2012 study estimated that preventable medical errors may cost the U.S. economy up to $1 trillion in lost human potential and contributions6.
Consumers are concerned about the safety of health care. Federal and state governments are facing significant costs associated with preventable patient safety events.
1Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. (Eds.). (2000). To Err is Human: Building a Safer Health System. Institute of Medicine (US) Committee on Quality of Health Care in America. National Academies Press (US).
2Smith, D. S. (2005). Patient safety. The Case Manager, 16(3), 74-79.
3James, J. T. (2013). A new, evidence-based estimate of patient harms associated with hospital care. Journal of patient safety, 9(3), 122-128.
4Olsen, L., Saunders, R. S., & Yong, P. L. (Eds.). (2010). The healthcare imperative: lowering costs and improving outcomes: Workshop series summary. . Roundtable on Evidence-Based Medicine – Institute of Medicine; National Academy of Sciences. 2010; p 2-3, 51.
5Makary, M. A., & Daniel, M. (2016). Medical error—the third leading cause of death in the US. BMJ, 353.
6Andel, C., Davidow, S. L., Hollander, M., & Moreno, D. A. (2012). The economics of health care quality and medical errors. Journal of health care finance, 39(1), 39.
U.S. government regulations have flourished in an attempt to reduce medical errors. Federal and state legislation was passed to establish safety standards and deter bad performance of healthcare providers. Medical providers and healthcare organizations spend significant resources and money to comply with federal quality and safety requirements to avoid civil penalties and reduced insurance reimbursement. A number of federal agencies and regulations were created to promote quality of care and patient safety.
More recently, regulations were enacted that affect the finances of the hospital or healthcare provider. Under the Health Insurance Marketplace Quality Initiatives – Patient Protection and Affordable Care Act, health plan insurers are required to verify that hospitals use a patient safety evaluation system (PSES) or else the Center for Medicare & Medicaid Services (CMS) will not reimburse the hospital for medical expenses1. The government also introduced incentives for providing better quality and patient safety. CMS announced quality incentives such as “Pay-for-Performance” and Physician Quality Reporting Initiative (PQRI) to reward good performance in the form of financial reward2. These incentives have further taken root in today’s marketplace under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and Quality Payment Program (QPP) where CMS ties payments to quality and value. Financial penalties (-4 to -9%) and bonuses (+4 to +9%) apply in this program under the Merit-based Incentive Payment System (MIPS)3. Further CMS proposed the Radiation Oncology (RO) Model to test whether prospective episode-based payments to designated providers reduce CMS expenditures while preserving or enhancing the quality of care for Medicare recipients. The RO Model would qualify as an Advanced Alternative Payment Model (Advanced APM) and a MIPS APM under the CMS QPP4.
Despite numerous regulations, resources, training courses, webinars, and standards, certain sentinel events continue to occur with alarming frequency. And although there has been an intense focus over two decades to improve safety of medicine in the U.S., it appears little if any improvement has been made5.
1https://www.govinfo.gov/content/pkg/FR-2016-03-08/pdf/2016-04439.pdf
2https://www.hhs.gov/guidance/document/provider-inquiry-assistance-program-overview-2010-physician-quality-reporting-initiative
3https://go.cms.gov/QualityPaymentProgram
4https://innovation.cms.gov/innovation-models/radiation-oncology-model
5Farokhzadian, J., Dehghan Nayeri, N., & Borhani, F. (2018). The long way ahead to achieve an effective patient safety culture: challenges perceived by nurses. BMC health services research, 18(1), 1-13.
In the U.S., under the Health Insurance Marketplace Quality Initiatives – Patient Protection and Affordable Care Act, health plan insurers are required to verify that hospitals use a patient safety evaluation system (PSES) or else the Center for Medicare & Medicaid Services (CMS) will not reimburse the hospital for medical expenses1. Accordingly, hospitals must measure, analyze, and track quality indicators, including adverse patient events. Hospitals must also implement preventive actions and mechanisms with feedback and feedback/learning throughout the hospital. To ensure compliance, state survey agencies perform surveys and review functions for Medicare. In turn, hospitals are encouraged to report adverse events to Patient Safety Organizations (PSO). PSOs are public, private for-profit, and not-for profit organizations. AHRQ validates PSOs by certifying that PSOs have process to collect and analyze reported events. PSOs report data to the Department of Health and Human Services.
1https://www.govinfo.gov/content/pkg/FR-2016-03-08/pdf/2016-04439.pdf
Approximately 40% of all external beam radiation therapy tasks are focused primarily on detecting and fixing errors1.
1Ford E, de Los F, Santos L, et al. Consensus recommendations for incident learning database structures in radiation oncology. Med Phys. 2012; 39: 7272– 7290.
Of $2.5 trillion spent on U.S. domestic healthcare costs in 2009, $765 billion (or 30%) was attributed to preventable errors1.
Today, preventable deaths due to medical errors are 10 times higher than the Institute of Medicine 1999 estimate based on quality-adjusted life years. A 2012 study estimated that preventable medical errors may cost the U.S. economy up to $1 trillion in lost human potential and contributions2.
Overall annual medical liability costs in the U.S. are estimated to be a staggering $55.6 billion in 2008 dollars3. Each year alone there are approximately 340,000 potential cases of malpractice arising from care in hospitals4.
1Olsen, L., Saunders, R. S., & Yong, P. L. (Eds.). (2010). The healthcare imperative: lowering costs and improving outcomes: Workshop series summary. . Roundtable on Evidence-Based Medicine – Institute of Medicine; National Academy of Sciences. 2010; p 2-3, 51.
2Andel, C., Davidow, S. L., Hollander, M., & Moreno, D. A. (2012). The economics of health care quality and medical errors. Journal of health care finance, 39(1), 39.
3Mello, M. M., Chandra, A., Gawande, A. A., & Studdert, D. M. (2010). National costs of the medical liability system. Health affairs (Project Hope), 29(9), 1569–1577.
4American Board of Radiology. Radiation Oncology Non-Clinical Skills Domain: A Syllabus. www.theabr.org/wpcontent/uploads/ 2018/12/RO_NCS_Syllabus.pdf.
Published September 2015.
In the U.S., one study showed that over one year, errors alone resulted in costing cancer centers approximately $489,000 and $714,000 in additional expenses1. In another study, errors cost a cancer center approximately $452,000 over roughly 1.5 years2. In a third study, errors cost 5 cancer centers approximately $250,000 annually3.
1Kline EB, The Financial Impact of Radiation Oncology Errors, Proceedings from US Cancer Therapies Seminar for Radiation Oncology: 14 September 2020 – 15 September 2020; 21-28.
2Washington University School of Medicine, Mallinckrodt Institute of Radiology, St. Louis, MO.
3Rahimian, Javad & Meshkati, N & Forell, B & Tome, M & Kagan, AR. (2003). Human Errors in External Beam Radiotherapy. American Society for Therapeutic Radiology and Oncology. Abstract. June 2003; 1345-1345.
The cost of cancer care in the U.S. was projected at $173 billion in 20201. During that time, an estimated 1.8 million new cancer cases were diagnosed in the U.S. which is the equivalent of approximately 4,950 new cases each day2. In the U.S., approximately 50% of cancer patients receive radiation therapy as part of their care at one of 2,322 radiation therapy centers in the U.S.3
From a worldwide perspective, cancer diagnosis is projected to increase by 80% in low-income countries compared to 40% in high-income countries through 20304. The global radiotherapy market is projected to reach $11.5 billion by the end of 2027, growing at a CAGR (compound annual growth rate) of 7.3%5.
1Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States. 2010-2020. J Natl Cancer Inst 2011; 103:117–285. (www.who.int 2020).
2Siegel, R. L., Miller, K. D., & Jemal, A. (2020). Cancer statistics, 2020. CA: a cancer journal for clinicians, 70(1), 7-30.
3Bajaj A. The Impact of COVID-19 on Radiation Oncology Department Workflow in the United States. Appl Rad Oncol. 2020;9(2):6-7. June 22, 2020.
4Tumor Ablation Market Size, Share & Trends Analysis Report By Technology (Radiofrequency, Microwave), By Treatment (Surgical, Laparoscopic, Percutaneous), By Application, By Region, And Segment Forecasts, 2028 – 2030, Grand View Research, 1/21, Accessed through www.grandviewresearch.com.
5Radiation Oncology Market Size, Share & Trends Analysis Report By Type (External Beam Therapy, Internal Beam Radiation Therapy), By Application, By Technology, By Region, And Segment Forecasts, 2020 – 2027, Grand View Research, 2/20, Accessed through
www.grandviewresearch.com.
There are a number of ways MERP can help.
#1 Current patient safety reporting systems (PSRSs) in the U.S. and international market are inadequate to investigate incidents, identify contributory factors, and implement and embed learning. In 2019, RadPhysics Services LLC conducted a comprehensive survey of various cancer centers and hospitals in the U.S. to determine their use of a PSRS for quality metrics and patient safety. The results showed that approximately 85% of the respondents either did not have and/or had never used a PSRS specific to radiation oncology for patient safety. The survey concluded that most entities did not have a practical tool for identifying and correcting errors. MERP meets this need. MERP is a PSRS application specifically designed to help minimize errors, improve performance, increase quality, decrease costs, and reduce regulatory infractions in the entire radiation oncology treatment delivery process. MERP serves as a ready-made tool for reducing preventable system-related errors by helping identify errors, measuring improvement, and increasing patient safety.
#2 MERP complies with all federal, state, and international requirements to provide better care by reducing errors and improving quality of care. In addition, regulatory burden is significantly reduced resulting in measurable savings passed on to the healthcare provider and organization.
#3 The Health Insurance Marketplace Quality Initiatives – Patient Protection and Affordable Care Act requires U.S. health plan insurers to verify that hospitals use a patient safety evaluation system (PSES) or else Center for Medicare and Medicaid Services (CMS) will not reimburse the hospital for medical expenses1. MERP qualifies as a PSES for radiation oncology and will comply with CMS requirements for hospital reimbursement.
#4 MERP meets CMS MACRA/QPP-MIPS certain criteria for bonus payments under the “Improvement Activities” performance category as well as the proposed, future CMS RO Model2.
1Patient Protection and Affordable Care Act – HHS Notice of Benefit and Payment Parameters for 2017, Federal Register, Vol.81, No. 45, March 8, 2016, Rules and Regulations: 45 CFR Parts 144, 147, 153, et al.
2Quality Payment Program. http://go.cms.gov/QualityPaymentProgram. Accessed February 13, 2023.
MERP software provides a comprehensive, interactive process for managing risk and making systems improvement. MERP is a powerful tool for implementing proactive risk reduction through error analysis and action plans. MERP facilitates a comprehensive approach to improving patient safety through the reduction of preventable systems-related errors. MERP empowers the user in these following key aspects: (1) defines the roles and responsibilities of key individuals, (2) characterizes the critical elements for managing mistakes, (3) measures process improvement, (4) provides a road map for error evolution and documentation, and (5) builds step-by-step benchmark procedures based on lessons learned from actual errors, not irrelevant or immaterial policies that are not being followed.
An important element in establishing an organizational culture of patient safety includes the creation of an environment in which errors are openly identified and reported. MERP is an effective tool in helping create a culture of patient safety.
Yes, MERP does a thorough and credible root cause analysis. Root cause analysis is a process for identifying the basic or casual factor(s) underlying performance, including the occurrence and potential occurrence of a sentinel event, medical event, or regulatory infraction. The root cause is defining the fundamental reason for the failure or inefficiency of a process. The analysis involves understanding the contributing factors and the fundamental reasons why the problem has occurred. Fundamentally, root cause analysis is used to uncover the underlying factors that lead to errors, failures, or inefficiencies. Root cause analysis also applies to causation associated with less-serious errors and near misses. Root cause analysis helps radiation oncology centers prevent system-related failures.
MERP serves as a critical tool in the quest to reduce mistakes. Without an error reduction program, centers run a greater risk of exposure to disadvantageous and potentially injurious consequences. MERP provides a solution for reducing risk to your center:
- Help minimize the occurrence of medical or sentinel events, and possible patient/physician litigation,
- Provide a system for assessing tangible and measurable improvements in patient safety,
- Help prevent violations of state, federal, and international radiation safety regulations,
- Employ a program of “self-identification” to preclude citing of violations by state, NRC, or CMS inspectors,
- Mitigate sanctions and enforcement (e.g., civil penalties and newspaper releases) levied by state and NRC inspectors,
- Comply with fraud/abuse laws related to Medicare reimbursement for errors in charge capture and billing activities,
- Reduce facility liability and physician malpractice insurance premiums,
- Help fulfill facility certification standards as established by The Joint Commission, ACR, ASTRO, and certain state agencies,
- Define a system of “who is responsible” for a particular process, action plan, and error approval,
- Provide a system for modifying or creating new department procedures based on action plans from actual medical events,
- Meet various state, federal, and international initiatives to reduce medical errors, increase patient safety, and decrease unwarranted expenses,
- Provide a continuous improvement model for increasing quality, lowering medical costs, and increasing profitability,
- Help comply with Medicare criterion that U.S. hospitals use a patient safety evaluation system for reimbursement, and
- Meet CMS MACRA/QPP-MIPS criteria for participation in bonus payments under the “Improvement Activities” performance category as well as the proposed, future CMS RO Model.
No, MERP can be a very effective tool for use in small radiation oncology centers or clusters of small/medium size centers. Unlike large centers, small individual centers or clusters of centers have limited resources. For example, small centers may have employees and physicians (such as Nurses, Therapists, Dosimetrists, Physicists, and Radiation Oncologists) working part-time or locums working under contract. In cases where there are multiple centers, employees and physicians may support centers located in different geographical areas. In both scenarios, single or multiple centers are often under pressure to contain costs.
Tracking of errors in MERP helps identify problem areas at the center level and allows for more effective and cost effective utilization of your limited resources throughout your organization.
Whether one or multiple centers, MERP creates scales of efficiency that best optimizes allocation and deployment of your staff and physicians.
No, MERP is very useful in large radiation oncology centers or hospitals due to the increased number and sophistication of procedures. Large centers or hospitals may have a number of employees dedicated for QA purposes. However, it is often difficult to determine where the procedural breakdown occurs in large, detailed processes. For example, can the adverse event be traced to a particular department? Are there multiple causative factors such as training or lack of adequate procedures? Is it isolated to one hospital or could it be recurring at others? In short, MERP provides a process for analyzing fundamental reasons for the failure or inefficiency at large institutions as well as multiple hospitals within corporations. Risk reduction strategies can be more effectively deployed across a large organization and any of its affiliates or satellites.
Yes, we will help you configure MERP for your center’s treatment delivery methods (conventional EBRT, 3D-CRT, IMRT, SRS, and SBRT). This includes configuring specific roles, users and routing of errors for review/approval in MERP.
Yes, we will install MERP on your server and workstations. The server and workstations must meet minimum requirements to host MERP.
Virtual Server
- 2 Cores 2.1Ghz; or better
- 4 GB RAM minimum; 8 GB RAM recommended
- 100 GB Hard Drive
- Network interface 1 NIC 100/1000Mbps, compatible with the network operating system and cabling
- Microsoft® Windows® OS Architecture 64 bit
- NT file system (NTFS)
- Microsoft® Windows® Server 2016 (Standard)
- Microsoft® SQL Server Express 2019
Physical Side
- (Dual) Intel® Dual Core Xeon® 5130 2.1Ghz or higher, 4MB Cache 1333MHz FSB; or better
- Microsoft®.net framework (.NET 4.7.2 and later)
- 4 GB RAM minimum, 8 GB RAM recommended
- Bus Type PCI-E
- 100 GB Hard Drive
- Drive controller – The equivalent of Dual channel SAS 3.0Gb/s RAID controller with ≥ 256 MB cache
- Network interface 1 NIC 100/1000Mbps, compatible with the network operating system and cabling
- Windows® OS Architecture 64 bit
- Separate Microsoft® Windows® compatible backup solution
- Network card
- Microsoft® Windows® Server 2016 (Standard)
- NT file system (NTFS)
- Windows® 2012 (updated with latest service pack); or better
- Microsoft® SQL Server 2019 Express
Client Side
- (Single) Intel® Core™ 2 Duo® at 2.13 GHz with 2 MB L2 cache; or better
- ≥4GB RAM
- Bus Type PCI-E
- Enough hard drive space for application, typically 40 MB of free space
- Drive Controller SATA-II
- Network interface 1GBps, compatible with the network operating system and cabling
- Microsoft®.net framework (.NET 4.7.2 and later)
- 17” LCD monitor capable of 1280 x 1024 at 60 Hz
- Microsoft® Windows®-compatible 101-key keyboard
- Microsoft® Windows®-compatible 2-button scroll mouse
- Microsoft Windows® 10 editions
- Microsoft® Windows® installer 3.1; or better
- NT file system (NTFS)
- Windows® OS Architecture 64 bit
- Microsoft® Word 2019 or Word 2021
- PDF printer
Yes, we will provide remote applications training in MERP for staff and physicians. This initial training is included in the purchase price. Onsite applications training is available and can be purchased separately. Travel-related expenses specific to locations outside the continental U.S. are not included in the onsite applications training.
Yes, remote and onsite training has been approved by ASRT for 6.0 hours of Category A credit.