Updated September 12, 2025The Maryland Hospital Patient Safety Program is designed to enhance patient safety, reduce preventable harm, and ensure hospitals comply with state-mandated patient safety regulations. The program operates under Code of Maryland Regulations (COMAR) 10.07.06, requiring hospitals to identify, report, and analyze adverse events to improve healthcare quality and protect patient well-being. The Maryland Department of Health’s Office of Health Care Quality administers the Maryland Hospital Patient Safety Program. Below are answers to frequently asked questions (FAQ) about the program related to adverse event reporting, root cause analysis requirements, compliance expectations, and best practices for patient safety improvement, as well as the FY23 report.What is the purpose of the Maryland Hospital Patient Safety Program?The Maryland Hospital Patient Safety Program was established to create a safer care environment by minimizing adverse events in hospitals and ensuring that adverse events and near misses are identified and reported. (COMAR 10.07.06.02(B)(8) defines a near-miss as: "A situation that could have resulted in an adverse event but did not, either by chance or through timely intervention.") The data collected on events is intended to be used for learning and improvement purposes. This program fosters transparency and encourages the implementation of strategies that prioritize patient safety. What are the key regulatory requirements for hospitals under the Maryland Hospital Patient Safety Program?
Under the Maryland Hospital Patient Safety Program, Maryland hospitals must: How does the Maryland Hospital Patient Safety Program define “adverse events”?
Per COMAR 10.07.06.02(B)(2), adverse events are defined as unexpected occurrences related to an individual's medical treatment, not linked to the natural course of the patient’s illness or underlying conditions.
They are categorized into three levels based on severity: - Level 1: Events resulting in death or serious disability.
- Level 2: Events requiring medical intervention to prevent death or serious disability.
- Level 3: Less severe events that neither result in death nor require significant intervention.
What are common examples of adverse events in hospitals?
Some adverse events can occur despite the implementation of best practices. Common examples of adverse events include: - Falls: Linked to inadequate risk assessments or failure to implement tailored interventions.
- Pressure Injuries: Linked to inadequate patient monitoring, device use, or failure to turn and reposition patients regularly.
- Delays in Treatment: These are frequently caused by communication failures, staffing shortages, or insufficient diagnostic processes.
- Surgical Events: Including retained foreign objects and unexpected intra-operative or post-operative deaths.
Where can hospitals access information about what should be reported to the MHPSC and how to report?Hospitals can find all necessary reporting guidelines, including what should be reported and how to submit reports, on the Maryland Department of Health's Office of Health Care Quality Patient Safety website. This resource provides hospitals with the required forms, detailed reporting criteria, and additional tools to support compliance with Maryland’s hospital patient safety requirements. What happens if a hospital fails to report an adverse event?
- Regulatory citations requiring corrective action.
- On-site investigations by the Office of Health Care Quality.
- Potential administrative penalties or loss of licensure.
What is a root cause analysis and why is it required?
A root cause analysis is a structured investigation process used to identify underlying system failures contributing to adverse events. Hospitals must conduct a root cause analysis for all Level 1 adverse events and submit findings to the Maryland Hospital Patient Safety Program within 60 days (COMAR 10.07.06.06).
What must be included in a root cause analysis submission?
Per COMAR 10.07.06.06, a root cause analysis must include: - A timeline of events leading to the incident.
- Cause-and-effect analysis (e.g., Ishikawa/fishbone diagrams).
- Corrective action plans with measurable safety improvements.
Are root cause analysis reports confidential?
Yes. COMAR 10.07.06.09(C) and Health Occupations Article §1-401 protect root cause analysis reports from public disclosure, civil litigation discovery, or Maryland Public Information Act requests. What are examples of corrective action plans hospitals have taken in response to adverse events?
Examples of corrective action plans taken by hospitals in response to adverse events include:- Example 1: A Maryland hospital reported an event in which a patient’s breathing tube was dislodged during a CT scan. The staff accompanying the patient to the radiology suite were unable to immediately replace the tube due to swelling caused by an infection in the patient’s neck. In response to this event, the hospital developed a special task force to address emergencies in patients with difficult airways. The task force implemented a new process which proactively identified patients with difficult airways and assigned them each a designated airway emergency equipment travel bag. In addition, the hospital developed a new hospital-wide difficult airway emergency response protocol with specially-trained response staff.
- Example 2: A Maryland hospital reported an event in which a pathologist misdiagnosed a tumor, leading to incorrect treatment. This prompted a significant reorganization of the pathology department’s internal processes, including the addition of blinded review by another pathologist and a restructuring of the “tumor board” process to ensure each diagnosis was discussed and scrutinized by multiple physicians.
- Example 3: A Maryland hospital reported an event in which a baby died in the emergency room after resuscitation efforts were delayed. They identified numerous issues, including a provider who was not trained to place intraosseous lines, a lack of easily accessible pediatric emergency equipment in the trauma bay, and insufficient availability of pharmacists in the emergency department (ED). Following this event, the facility trained all ED providers in intraosseous line placement, reorganized their emergency supplies to ensure easy access to pediatric equipment, and hired two ED pharmacists.
What were the major trends in adverse event reporting in FY23?
The FY23 report includes all adverse events that were reported to the Maryland Department of Health that occurred in Maryland’s hospitals between July 1, 2022 and June 30, 2023. In FY23, adverse event reporting increased by 5% compared to FY22, with 957 events reported, of which 808 met the criteria for Level 1 events. Hospitals reported that 118 of Level 1 events were associated with mortality; however, only 49 were determined to be attributable to the Level 1 reported events. The remaining deaths occurred alongside the event but were caused by underlying medical conditions or other factors.
Why is there an increase in reported events in FY23?
The increase in reported adverse events in Maryland reflects both a positive shift in hospital safety culture and an opportunity for improvement. Several factors may contribute to this trend:- Improved Reporting Culture & Just Culture Principles
- Hospitals are fostering a culture of transparency, where staff feel safe reporting errors without fear of punishment.
- COMAR 10.07.06 encourages hospitals to embrace just culture principles, where:
- Human errors are acknowledged and used as learning opportunities.
- At-risk behaviors are coached to prevent recurrence.
- Reckless behaviors are appropriately addressed.
- Enhanced Awareness & Regulatory Reinforcement
- Potential Increase in Events
- While an improved reporting culture likely accounts for some of the rise, the data could also indicate a genuine increase in adverse events due to persistent challenges like workforce shortages, increased patient acuity, and the residual effects of the COVID-19 pandemic.
- We are exploring next steps to address any increases. See below for additional information about actions the Maryland Department of Health is taking to prevent future events.
Which categories of events accounted for the highest frequency in FY23?
The top categories contributing to 80% of reported events were: - Pressure injuries (most frequently reported, though down 2% from FY22).
- Falls (second most reported, with a 22% increase from FY22).
- Delays in treatment.
What measures help reduce pressure injuries related to devices?
Suggested measures include: - Conducting comprehensive skin assessments, including areas under medical devices.
- Using multi-layer foam dressings to offload pressure from bony prominences.
- Ensuring devices are properly secured and adjusted to reduce skin irritation.
What practices have been suggested to prevent falls?
Key recommendations include: - Conducting accurate, ongoing fall risk assessments tailored to patient conditions.
- Engaging patients and families in preventive strategies.
- Implementing operational fall-prevention equipment (e.g., alarms, tele-sitters) effectively.
What guidance exists to manage surgical errors effectively?
Recommendations for minimizing errors include: - Employing detailed surgical site marking and time-out protocols.
- Empowering staff to speak up and advocate for patient safety.
- Assigning and clarifying team member roles to ensure accurate surgical counts and oversight.
Can you provide more information about which types of hospitals had the most adverse events?The following table provides a breakdown of event rates by hospital size:
Reported Level 1 Adverse Events in Maryland Hospitals by Hospital Size, FY23
Hospital Size* | Number of Hospitals | Reported Level 1 Events | Mean Reported Level 1 Events Per Hospital | Reported Level 1 Events Per Bed |
300+ beds | 12 | 433 | 36.1 | 0.074 |
200 - 299 beds | 13 | 193 | 14.9 | 0.064 |
100 - 199 beds | 14 | 121 | 8.6 | 0.060 |
< 100 beds | 20 | 61 | 3.1 | 0.055 |
*Licensed acute care beds in Maryland during fiscal year 2023, per FY23 MHCC Chartbook of Maryland General and Special Hospital Facilities and Services
What action is the Maryland Department of Health taking to prevent future events?
The Maryland Department of Health is taking several steps to improve root cause analyses across the state. - First, we are moving to a standardized form that incorporates best practices from national Patient Safety Organizations.
- Second, we are collaborating with the state’s designated Patient Safety Organization to ensure hospitals receive education about best practices to prevent adverse events like falls and pressure injuries.
- Third, as we identify new trends in adverse events, we are seeking new partnerships and initiatives to address them.
- Additionally, we are exploring the possibility of expanding the agency’s authority to verify that these strong actions are being successfully implemented.
What are the report’s recommendations for hospital improvement?
The report includes recommendations to hospitals for improving and enhancing patient safety. These include fostering a workforce environment where staff feel empowered to speak up at every level; ensuring a just culture striving for zero harm; and prioritizing safety using a total systems approach (using tactics and strategies proposed by the National Steering Committee for Patient Safety). The report also highlights best practices to prevent the most commonly identified adverse event types. Best practices include comprehensive skin assessments to reduce the risk of pressure injuries, operational fall-prevention equipment to minimize fall risk, and clearly defined roles and responsibilities for operating room staff to prevent surgical errors.
In partnership with hospitals and industry leaders, the Maryland Department of Health will use the report's findings and recommendations to continue to identify safety risks and implement solutions to reduce medical harm inside hospitals.
