Conducting an Investigation

As part of implementing a risk management and patient safety program, each physician practice will need to implement its own policies and procedures for event reporting, investigation and analysis of data collected from events, and follow-up improvement and monitoring mechanisms. We offer the following guidelines to assist the practice manager or other designated individual responsible for investigating events.

1)      Policy should state and staff should be trained to notify the practice manager (or other designated individual) promptly of any injuries, loss of life, and/or criminal acts, and defer to appropriate people to contact law enforcement or regulatory agencies.

2)      Ensure that any injured patient(s), visitor(s) or worker(s) get prompt medical attention. Safeguard other personnel in the area, if needed.

3)      Secure the area, and protect (under lock if possible) any physical evidence that could be important later.

4)      Collect as much information as possible about the area before, during, and after the event:

a)      Inspect the incident site immediately, but do not disturb the site unless it presents a hazard. 

b)      Identify and interview key affected healthcare workers, patients and witnesses. Identify the physician to whom the event was reported (if applicable) and that physician's response (orders given).

c)       If the event was not witnessed, try to speak with others, such as your office staff, co-workers or relatives who might have interacted earlier with the person involved.

d)      Take photographs and measurements; sketch key aspects of the site; secure surveillance videotape, if available.

e)      Collect physical evidence and samples for laboratory analysis, if applicable. Physical evidence includes:

i)        Position of injured patients, workers or visitors.

ii)       For device/equipment related events, record pertinent serial numbers, manufacturer and model names, settings at time of event; safety or warning devices and/or personal protective equipment that was in use.

iii)     Materials being used at the scene, including medications/injections/anesthesia/chemicals (records of doses, etc.).

iv)     Condition of environment: lighting, temperature, smoke, dust, mist, fumes; housekeeping and sanitation conditions (e.g. spilled liquid on floor or other involved surfaces) 

Additional Points to Remember

The person conducting the investigation (after an event has been reported) and preparing a follow-up report should try to look back over the entire sequence of events that led to the event (with or without injury), going as far back in time as the investigator feels is relevant, rather than focusing only on the injury. This allows an organization to identify and implement a wider variety of corrective actions.

Staff should treat any and all documents generated as part of the follow-up investigation as strictly confidential, to optimize opportunity for legal protection. All information obtained in the investigation should be maintained in a separate file, and never placed in the patient’s medical record.

As with event reporting, persons with responsibility for preparing investigation follow-up reports should state facts only, not opinions or assumptions.

The practice manager or other designated individual should consider seeking input from legal counsel about the design of follow-up reports and how to standardize follow-up procedures.

Collect background information after immediate investigation at the site (appropriate to event):

• Employee records: training information, licenses, certifications, and employment records
• Equipment records: maintenance logs, service reports, work orders, operating manuals, and manufacturer instructions
• Previous incident reports (involving same patient, employee, device or equipment)
• Weather reports (as relevant to location of event)
• Review existing documents, including: material safety data sheets (MSDS), job safety analyses, safety audit results, safety committee minutes, product/equipment specifications, equipment maintenance records, policies and procedures, floor plans/mechanical drawings and blueprints

Interviewing Tips

• Conduct interviews of staff, witnesses and others involved while details are still fresh to them
• Be a good listener
• Keep in mind that the focus is on prevention, so ask open-ended questions
• Get the facts, without placing blame or expressing opinions
• Pay attention to unsolicited comments
• For important points, repeat back what you heard to clarify and confirm facts

Timing

• Each investigation should be conducted as soon after the event as possible. A delay of only a few hours may permit important evidence to be destroyed or removed, intentionally or unintentionally.
• The designated investigator or committee should present the results of the inquiry as quickly as possible to all staff; this enhances the value of safety education for clinical and non-clinical staff 

After Investigation: Analyze and Learn

The ultimate objectives - and value - of investigating events are to:

• identify the contributing factors and root cause(s) of the reported events;
• learn lessons that will help prevent similar events or near-misses from re-occurring;
• support efforts to eliminate and control those factors.

After a thorough investigation (as outlined above) has been completed, and the necessary reports have been written and submitted (per internal procedures and externally mandated requirements), the practice manager or other designated individual(s) should consider the following actions:

• Analyze the data collected in the investigation to determine possible causes, such as unsafe conditions, materials, equipment or practices.  
• Use aggregate event data (types, numbers of events, locations, etc) to identify and uncover trends in organizational risks.  Provide findings from aggregate data analysis to appropriate clinical and non-clinical management of the practice. 
• Use findings to develop risk prevention and safety strategies. Develop a system to measure the effectiveness of corrective actions implemented and revise as needed. 
• Give staff feedback on findings of data analysis and results of their risk-reduction efforts.