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Patient Safety Program Requirements




House Bill 1614 affects all licensed hospitals, ambulatory surgical centers and private psychiatric hospitals. These facilities are required to develop and implement an effective ongoing, organization-wide, data driven Patient Safety Program (PSP) that is approved by the facility's governing body. The PSP must include all of the following components:

  • the definition of medical errors, adverse events and reportable events
  • the process for internal reporting of medical errors, adverse events and reportable events
  • a list of events and occurrences which staff are required to report internally
  • time frames for internal reporting of medical errors, adverse events and reportable events
  • consequences for failing to report events in accordance with hospital policy
  • mechanisms for preservation and collection of event data
  • the process for conducting root cause analysis
  • the process for communicating action plans
  • the process for feedback to staff regarding the root cause analysis and action plan

The facility is required to provide patient safety education and training to all staff who have responsibilities related to the implementation, development, supervision or evaluation of the PSP.

The facility is also required to designate one or more individuals, or an interdisciplinary group, qualified by training or experience, to be responsible for the management of the patient safety program. This individual or individuals will be responsible for:

  • coordinating all patient safety activities
  • facilitating assessment and appropriate response to reported events
  • monitoring root cause analysis and resulting action plans
  • serving as liaison among hospital departments and committees to ensure hospital-wide integration of the PSP

A root cause analysis (RCA) must be completed and a corrective action plan developed within 45 days for those events specified in the legislation and rules. The RCA mus t focus on systems and processes, and include an analysis of underlying cause and effect, progressing from special causes in clinical processes to common causes in organizational processes, and identify potential improvements in processes or systems. The action plan must include specific measures to correct identified problems or areas of concern; identify strategies for implementing system improvements; and include outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas. The action plan must specifically address responsibility for implementation and oversight, time frames for implementation, and the strategy for measuring the effectiveness of the actions.


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Texas Department of State Health Services, Health Facillity Licensing Program
1100 West 49th Street - Austin, Texas 78756 - (512) 834-6646

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Last updated May 09, 2013