​Patient safety takes a team, and eveyone's position is critical to the win, but there is one position that exective leadership underappreciates time and again. It's the patient safety officer. The Medical Care Availability and Reduction of Error Act (MCARE) set up this role to catalyze patient safety improvement at the local level. Are you using this position to the best advantage for your organization and patients? If you are not sure, consider this question:​

Where does your patient safety officer fall on the organizational chart?

​​​While there is no requirement to do so, ensuring that this position has a direct reporting relationship to the chief executive officer has distinct advantages. The patient safety officer is solely responsible for ensuring the investigation of all reports of serious events and incidents and for taking action that is immediately necessary to ensure patient safety as a result of those investigations.

​These are some of the most important responsibilities within your organization. If the patient safety officer reports to a chief other than the executive or, even worse, to someone further down the line, you run the risk of that person not having the level of authority and autonomy necessary to fulfill their MCARE obligations. The patient safety officer's independence provides a check and balance for all service lines.

Where is this position in relation to your risk management department? When patient safety and risk management aren't integrated, you increase the odds that your patient safety officer may not be privy to critical information necessary to take immediate action to ensure patient safety after an event. If your risk management department holds the key to investigation findings, you set your patient safety officer and your organization up for failure.

Protecting the investigation findings should always be secondary to improving patient safety. Worry about what's in the findings should trigger an early resolution process for claims, not a deadbolt on the file. The most important finding from any event is how we stop it from happening again.

When we "risk manage" patient safety, we lose.

​​​​I know that as a healthcare leader you want to improve safety, and I also know that you want to protect your organization from unnecessary loss. Shifting the responsibility of all investigations to your patient safety officer may help you do both.

Placing your patient safety officer at the top of the investigation pyramid helps to ensure that the investigation is credible, thorough, and deep enough to uncover both organizational and individual issues that need to be addressed. Remember, it is their responsibility under MCARE to ensure this happens. The additional, often unrecognized, benefit is that doing so may provide additional protection that otherwise might not be utilized. As mentioned, your patient safety officer is responsible for ensuring investigation of serious events and incidents and taking action to ensure patient safety as a result of those investigations. The patient safety committee is responsible for evaluating the investigations and actions of the patient safety officer.

Last April, the Pennsylvania Superior Court decided Ungurian v. Beyzman, et al., 2020 Pa. Super.105 (April 28, 2020), weakening the protection of certain documents under the Patient Safety and Quality Improvement Act, 42 U.S.C. §299b (PSQIA) and the Pennsylvania Peer Review Protction Act, 63 P.S. §425.4 (PRPA). It doesn't appear that MCARE protection was argued in the case, and without seeing the details, we don't know why. It might be reasonable to assume that the documents in question weren't prepared solely for the patient safety committee. What if they had been? What if all investigative findings were conducted at the direction and under the umbrella of the patient safety committee in order to meet its MCARE obligations? Would that change things? Maybe.

Under MCARE, the documents, materials, or information prepared solely for this purpose are not discoverable or admissible as evidence in any civil or administrative action or proceeding. In other words, if your patient safety officer is the person conducting the investigative activity and action measures at the direction of your patient safety committee, this may add another layer of protection.

In speaking with a local defense attorney, he reminded me that it is critically important to include the policy and process for event investigation in your patient safety plan. Some key points you may wish to consider include:

• State that investigations of events are conducted to identify actions to be taken to ensure patient safety, and they are conducted at the directive of the patient safety committee in its fulfillment of MCARE requirements. 
  
• Delineate who is responsible for conducting the investigation. 
  
• Identify key investigative activities, such as root cause analyses and peer review, that are included in the process. 
  
• Keep all investigative findings under the umbrella of the patient safety committee. 
  
• Ensure that all recommendations to eliminate future serious events and incidents are issued through the patient safety committee, as required by MCARE.
  
• Involve counsel in policy review and changes.
  
• Follow your policy and process precisely. 
  

​When we elevate the patient safety officer position to the same level as the rest of the executive team, it underscores the priority level of patient safety within you organization. Recognizing that patient safety and risk management are two sides of the same coin is paramount to effect real improvement in patient safety and real mitigation of future risk. I encourage you to evaluate your current structure and reposition for success.​