Massachusetts Department of Public Health Serious Reportable Events

Massachusetts Department of Public Health Serious Reportable Events 2018 June 12, 2019 Public Health Council Katherine T. Fillo, Ph. D. , MPH, RN-BC Bureau of Health Care Safety and Quality Katherine Saunders, MS Bureau of Health Care Safety and Quality

Overview • Purpose • Background • Serious Reportable Event Category Definitions • Outcomes • Quality Improvement Activities Massachusetts Department of Public Health mass. gov/dph 2

Purpose This presentation is given for the following purposes: • To provide an update of the Serious Reportable Event program and related quality improvement activities at the Bureau of Health Care Safety and Quality; and • To share the trends in the types and volume of Serious Reportable Events reported in 2018 and previous years. Massachusetts Department of Public Health mass. gov/dph 3

Background • Adverse events that occur in the health care setting are a patient safety concern and public health issue. • The Office of the Inspector General found that adverse events occur in 13. 5% of hospital admissions of Medicare beneficiaries (2010). • It is also projected that 10% of Medicare patients nationally experience an adverse event during a rehabilitation hospital stay (OIG, 2016). • Section 51 H of chapter 111 of the Massachusetts General Laws authorizes the Department to collect adverse medical event data and disseminate the information publicly to encourage quality improvement. Massachusetts Department of Public Health mass. gov/dph 4

Background • The National Quality Forum (NQF) has operationalized a group of adverse events into measurable, evidence-based outcomes called Serious Reportable Events (SRE). • MA adopted SREs as its adverse event reporting framework in 2008. • There is no federal adverse event reporting system. Twenty-seven other states developed and implemented state-based adverse event reporting programs. • Over half use the SRE framework including Connecticut, Minnesota and New Hampshire. Massachusetts Department of Public Health mass. gov/dph 5

SREs Defined • Section 51 H of Chapter 111 of the General Laws: “Serious reportable event”, an event that results in a serious adverse patient outcome that is clearly identifiable and measurable, reasonably preventable, and that meets any other criteria established by the department in regulations. • 105 CMR 130. 332 and 105 CMR 140. 308: Serious Reportable Event (SRE) means an event that occurs on premises covered by a hospital's license that results in an adverse patient outcome, is clearly identifiable and measurable, has been identified to be in a class of events that are usually or reasonably preventable, and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the hospital. The Department issued a list of SREs based on those events included on the NQF table of reportable events to which 105 CMR 130. 332 and 105 CMR 140. 308 apply in guidance. Massachusetts Department of Public Health mass. gov/dph 6

Reporting Requirements • Hospitals and ambulatory surgical centers (ASCs) are required to report SREs to the patient/family and the Bureau of Health Care Safety and Quality (BHCSQ) within seven days of the incident. • An updated report to BHCSQ, the patient/family and the insurer is required within 30 days of the incident, including documentation of the root cause analysis findings and determination of preventability as required by 105 CMR 130. 332(c) & 105 CMR 140. 308(c). • In June 2009, the Department implemented regulations prohibiting health care facilities from charging for services provided as a result of preventable SREs. • Amendments adopted as part of the hospital regulatory review completed in 2017 streamlined the reporting process without removing transparency. Massachusetts Department of Public Health mass. gov/dph 7

SRE Types Surgical or Invasive Procedure Events • Wrong Site Surgery or Procedure • Surgery or Procedure on Wrong Patient • Wrong Surgery or Procedure • Unintended Retention of a Foreign Object • Intraoperative or Immediate Postoperative Death of an ASA Class 1 Patient Product or Device Events • Death or Serious Injury Related to Contaminated Drugs, Biologics, or Devices • Death or Serious Injury Related to Device Misuse or Malfunction • Death or Serious Injury Due to Intravascular Air Embolism Patient Protection Events • Discharge of a Patient/Resident of Any Age to Other Than Authorized Person • Death or Serious Injury Associated with Patient Elopement • Patient Suicide, Attempted Suicide, or Self-Harm That Results in Serious Injury Massachusetts Department of Public Health mass. gov/dph 8

SRE Types Care Management Events Massachusetts Department of Public Health mass. gov/dph • Death or Serious Injury Associated with a Medication Error • Death or Serious Injury Associated with Unsafe Blood Product Administration • Maternal Death or Serious Injury Associated with Low. Risk Pregnancy Labor or Delivery • Death or Serious Injury of a Neonate • Death or Serious Injury Associated with a Fall • Stage 3, Stage 4 or Unstageable Pressure Ulcer • Artificial Insemination With Wrong Donor Sperm or Egg • Death or Serious Injury from Irretrievable Loss of a Specimen • Death or Serious Injury from Failure to Follow Up on Test Result

SRE Types Environmental Events Radiologic Events Potential Criminal Events Massachusetts Department of Public Health mass. gov/dph • Patient or Staff Death or Serious Injury Associated with an Electric Shock • Any Incident In Which No Gas, Wrong Gas or Contaminated Gas Delivered to Patient • Patient or Staff Death or Serious Injury Associated with a Burn • Death or Serious Injury Associated with Restraints or Bedrails • Death or Serious Injury of Patient or Staff Associated with Introduction of a Metallic Object Into MRI Area • Any Instance of Care Provided by Someone Impersonating a Health Care Provider • Resident/Patient Abduction • Sexual Abuse/Assault on a Patient or Staff Member • Death or Serious Injury of Patient or Staff Member as a Result of Physical Assault

Acute Care Hospital Data Total Number of SREs in Acute Care Hospitals by Year 1400 1313 ** 1200 1000 800 1012 ** 1066 922 821 600 400 200 0 2014 2015 2016 2017 ** Two events in 2015 and 2016 affected a large number of patients and is reflected in the increase in SREs reported. Data abstracted on May 22, 2019 from the Health Care Facility Reporting System Massachusetts Department of Public Health mass. gov/dph 2018

Acute Care Hospital Surgical Data 60 Key Findings 49 50 Increasingly SREs occur outside of the operating room in radiology, labor and delivery, and outpatient procedure units. 41 40 36 35 31 30 24 26 25 20 The most frequently reported outcome is that patients require an additional surgery or procedure to remove the object. 10 10 12 6 0 0 2 1 2015 8 2 Wrong Site Surgery or Procedure on Wrong Patient 2014 12 11 0 Wrong Surgery or Procedure 2016 Data abstracted on May 22, 2019 from the Health Care Facility Reporting System Massachusetts Department of Public Health mass. gov/dph 2017 Unintended Retention of a Foreign Object 2018 0 0 Intraoperative or Immediate Postoperative Death of an ASA Class 1 Patient

Acute Care Hospital: Product/Device Data Key Findings 500 446 ** 450 In the contaminated drugs, device or biologics event, one incident, that affected a significant number of patients in 2016, represents most of the category. 400 The hospital engaged in a robust corrective action plan to address the root causes of these incidents. 150 300 250 200 138 ** 100 50 0 37 21 8 14 12 9 21 11 Contaminated drugs, device or Device misuse or malfunction biologics 2014 2015 2016 2017 6 2 9 7 3 Intravascular air embolism 2018 **Two events in 2015 and 2016 affected a large number of patients and is reflected in the increase in SREs reported. Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 13

Acute Care Hospital: Environmental Data 35 Key Findings 30 Burn events represent second degree or more severe burns. 25 Burn events result from equipment including radiology machines and cautery devices, chemotherapy and hot beverage spills. 15 30 30 29 28 25 20 10 5 0 2014 00000 Serious injury or death from electric shock 2015 000 4 22 Oxygen or gas delivery error 2016 Serious injury or death from burn 2017 1222 12100 Serious injury or death from physical death from metallic restraints object in MRI 2018 Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 14

Acute Care Hospital: Patient Protection Data 45 Key Findings 41 40 35 There were 2 completed suicide and 34 self-harm or attempted suicide events in 2018. 36 35 31 30 25 25 20 Cutting and ingesting objects are the methods reported as having the highest incidence in the suicide and self-harm events. 15 2014 10 5 0 2 2 2 0 1 Patient discharged to unauthorized person 0 0 2 2 3 Elopement with death or Suicide or self-harm with serious injury 2015 2016 2017 2018 Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 15

Acute Care Hospital: Potential Criminal Event Data 50 Key Findings 45 45 Over half of the physical assaults or abuse events that resulted in serious injury were patient on staff member encounters, often resulting in lost work days. 41 40 34 35 30 25 22 18 20 Inpatient psychiatric units followed by emergency departments and medicalsurgical units are the most frequently reported location within the hospital for these events. 15 9 10 10 5 0 0 0 2 Provider impersonation 2014 5 20 7 0 0 0 Patient abduction 2015 2016 Sexual assault/abuse 2017 Physical assault/abuse with serious injury 2018 Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 16

Acute Care Hospital: Care Management Data Key Findings Falls that result in serious injury and pressure ulcers are the two most commonly reported events. Pressure injuries are most common serious injury, about 60% of those reported occurred on the back, spine or buttocks. 393 400 341 350 317 300 290 308 294 285 250 272 224 226 200 150 100 50 0 36 51 43 52 48 0 Serious injury or death from medication error 0 0 1 0 Unsafe blood transfusion 6 10 6 7 13 Maternal serious injury or death associated with 2014 labor or delivery 27 15 19 11 18 Newborn serious injury or death associated with 2015 delivery 0 Serious injury or death after a fall 2016 0 0 2 1 5 2 6 5 1 6 10 9 Stage 3, Stage 4 or Artificial Serious injury or unstageable insemination with death from loss of death from lack of pressure ulcer wrong egg or sperm irreplaceable follow up or 2017 2018 biological specimen communication of lab result Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 17

Non-Acute Care Hospital Data Total Number of SREs in Non-Acute Care Hospitals by Year 250 236 237 196 200 194 2014 150 2015 2016 100 2017 2018 50 0 Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 18

Non-Acute Care Hospital: Category Data Reported SREs 2014 -2018 (Non-acute care hospitals) Key Findings Three types of hospitals: public health, rehabilitation or psychiatric. 140 125 128 120 108 100 95 80 Like acute care hospitals, falls and pressure ulcers continue to be the most common events. 68 60 71 58 60 43 40 22 20 0 119 2 5 4 16 16 11 17 13 14 10 12 11 0 2 2 Serious injury or Suicide or self death from harm medication error 2014 6 6 5 6 2 0 0 Serious injury or death after burn death from physical assault physical restraints 2015 2016 Stage 3, 4 or Serious injury or unstageable death after a fall pressure ulcer 2017 2018 Data abstracted on May 22, 2019 from the Health Care Facility Reporting System. Massachusetts Department of Public Health mass. gov/dph 19

Ambulatory Surgical Centers Data Key Findings There are 59 ASCs in Massachusetts. All SREs were related to cataract procedures. DPH continues to outreach and provide education regarding reporting and trends in order to encourage submissions. 10 9 8 7 6 5 4 3 2 1 0 6 2014 4 2015 4 4 3 2 1 0 Wrong patient procedure or surgery 0 2016 3 2017 2 1 1 0 0 0 Wrong site/side Wrong procedure Serious injury or procedure or or surgery death after fall surgery 2018 0 0 Device Misuse Data abstracted on May 22, 2019 from the Health Care Facility Reporting System Massachusetts Department of Public Health mass. gov/dph 20

Quality Improvement Activities • Working with individual facilities after a SRE occurs to develop corrective action plans and prevent an event of a similar type from happening in the future. • Sharing de-identified pressure ulcer events with wound ostomy and continence nurse stakeholder groups. • Continued collaboration with DPH’s Suicide Prevention Program to share event data and promote use of online curriculum detailing best practices for reducing suicide and self-harm in the facility setting. • Actively participating in MA Coalition for the Prevention of Medical Errors. • Sharing electronic health system related events and opportunities to address causal factors. • Partnering with Betsy Lehman Center to address the following: • Utilize their monthly newsletter to share patient safety trends; and • Maintaining an Interagency Service Agreement to allow for more seamless data sharing, as intended by the 2012 cost containment act. • Utilizing DPH list serves for widespread education and to share appropriate guidance. Massachusetts Department of Public Health mass. gov/dph 21

Contact Information Thank you for the opportunity to present this information today. Please direct any questions to: Katherine T. Fillo Ph. D, MPH, RN-BC Director, Clinical Quality Improvement Bureau of Health Care Safety and Quality katherine. fillo@state. ma. us Massachusetts Department of Public Health mass. gov/dph 22