1. (a) General.

   1. (1) The facility must develop, implement, maintain and enforce an effective, ongoing, organization-wide, data driven Patient Safety Program (PSP).

      1. (A) The governing body must ensure that the PSP reflects the complexity of the facility's organization and services, including those services furnished under contract or arrangement, and focuses on the prevention and reduction of medical errors and adverse events.

      2. (B) The PSP must be in writing, approved by the governing body and made available for review by the department. It must include the following components:

         1. (i) the definition of medical errors, adverse events and reportable events;
         2. (ii) the process for internal reporting of medical errors, adverse events and reportable events;
         3. (iii) a list of events and occurrences which staff are required to report internally;
         4. (iv) time frames for internal reporting of medical errors, adverse events and reportable events;
         5. (v) consequences for failing to report events in accordance with facility policy;
         6. (vi) mechanisms for preservation and collection of event data;
         7. (vii) the process for conducting root cause analysis;
         8. (viii) the process for communicating action plans; and
         9. (ix) the process for feedback to staff regarding the root cause analysis and action plan.
      3. (C) The facility must provide patient safety education and training to staff who have responsibilities related to the implementation, development, supervision or evaluation of the PSP. Training must include all PSP components as set out in subparagraph (B) of this paragraph.

   2. (2) The facility must 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. These responsibilities shall include:

      1. (A) coordinating all patient safety activities;
      2. (B) facilitating assessment and appropriate response to reported events;
      3. (C) monitoring root cause analysis and resulting action plans; and
      4. (D) serving as liaison among facility departments and committees to ensure facility-wide integration of the PSP.

   3. (3) Within 45 days of becoming aware of a reportable event specified under subsection (b)(1)(A) of this section, the facility must:

      1. (A) complete a root cause analysis to examine the cause and effect of the event through an impartial process; and

      2. (B) develop an action plan identifying the strategies that the facility intends to employ to reduce the risk of similar events occurring in the future. The action plan must:

         1. (i) designate responsibility for implementation and oversight;
         2. (ii) specify time frames for implementation; and
         3. (iii) include a strategy for measuring the effectiveness of the actions taken.
      3. (C) must make the root cause analysis and action plan available for on-site review by department representatives.

2. (b) Reporting requirements. The following requirements are effective July 1, 2004.

   1. (1) Annual events report.

      1. (A) On the renewal of the facility's license, or annually based on the facility's original licensing date, the facility shall submit to the department a report that lists the number of occurrences at the facility, including any outpatient facility owned or operated by the facility, of each of the following events occurring during the preceding year:

         1. (i) a medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient;
         2. (ii) the suicide of a patient in a setting in which the patient received care 24 hours a day;
         3. (iii) the sexual assault of a patient during treatment or while the patient was on the premises of the facility;
         4. (iv) a hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities;
         5. (v) a patient death or serious disability associated with the use or function of a device designed for patient care that is used or functions other than as intended.
      2. (B) The facility is not required to include any information other than the total number of occurrences of each of the events listed under subparagraph (A) of this paragraph.

   2. (2) Best practices report.

      1. (A) On the renewal of the facility's license, or annually based on the facility's original licensing date, the facility shall submit to the department at least one report of the best practices and safety measures related to a reported event.
      2. (B) The best practices report may be submitted on a form to be prescribed by the department, or the facility may submit a copy of a report submitted to a patient safety organization.
      3. (C) Facilities may voluntarily report additional best practices and safety measures.

Source Note:The provisions of this §510.47 adopted to be effective May 9, 2004, 29 TexReg 4159; transferred effective June 1, 2019, as published in the Texas Register May 17, 2019, 44 TexReg 2469.