Reading Between the Rules: The New Medical Error Reporting and Patient Safety Requirements

1. Reading Between the Rules: The New Medical Error Reporting and Patient Safety Requirements Cindy Bednar, R.N. Director of Licensing Programs Health Facility Licensing & Compliance Division

2. The Case for Patient Safety • Patient safety is a critical component of QUALITY • Health care is NOT as safe as it should be • The Institute of Medicine estimates that between 44,000 and 98,000 Americans die as a result of preventable errors • People do not come to work with the intent to hurt patients • We must change the culture – stop punishing people for making mistakes

3. The Case for Patient Safety “People make errors, which lead to accidents. Accidents lead to deaths. The standard solution is to blame the people involved. If we find out who made the errors and punish them, we solve the problem, right? Wrong. The problem is seldom the fault of an individual; it is the fault of the system. Change the people without changing the system and the problems will continue.” Don Norman Apple Fellow

4. Objectives 1 Summarize the key components of HB 1614. Identify the minimum regulatory requirements for a patient safety program. 2 Describe the process for reporting medical errors and best practices to TDH. 3 Summarize the TDH process for evaluating compliance with the medical error and patient safety regulations. 4

5. House Bill 1614 78th Legislative Session “An Act relating to the reporting of medical errors and the establishment of a patient safety program in hospitals, ambulatory surgical centers and mental hospitals.”

6. House Bill 1614 78th Legislative Session • Promotes public accountability through detection of statewide trends in the occurrence of certain medical errors by: • Requires reporting of errors • Provides the public with access to statewide summaries of the reports • Requires that facilities implement risk-reduction strategies • Encourages sharing of best practices and safety measures that are effective in improving patient safety

7. House Bill 1614 78th Legislative Session • Amends the Health and Safety Code • Chapter 241: Hospitals • Chapter 243: Ambulatory Surgical Centers • Chapter 577: Private Mental Hospitals and other Mental Health Facilities • Assigns specific responsibilities to TDH • Prescribes requirements for facilities regarding analysis of certain events and the reporting of events and best practices • Includes strong confidentiality provisions

8. House Bill 1614 78th Legislative Session TDH Responsibilities • Develop & administer Patient Safety Program • Compile & make available to the public a summary of reported events • Summary can only contain aggregate data • Summary information may not identify specific facilities, groups of facilities, individuals or specific reported events or circumstances • Hospitals will be grouped as: • 49 beds or less - 200 to 399 beds • - 50 to 99 beds - 400 beds or more • - 100 to 199 beds • ASCs and psychiatric hospitals will each be in single distinct groups

9. House Bill 1614 78th Legislative Session TDH Responsibilities • Review best practices reports • Compile a summary of effective best practices reports to be made available to the public • Summary information may not identify specific facilities, groups of facilities, individuals or specific reported events or circumstances • Hospitals will be grouped as: • 49 beds or less - 200 to 399 beds • - 50 to 99 beds - 400 beds or more • - 100 to 199 beds • ASCs and psychiatric hospitals will each be in single distinct groups

10. House Bill 1614 78th Legislative Session TDH Responsibilities • Evaluate the program & report back to the Legislature no later than December 1, 2006, addressing: • The ability to detect statewide trends based on the types and numbers of events reported • The degree to which the event summaries were accessed by the public • The effectiveness of the department’s best practices summaries in improving patient care • The impact of national studies on the effectiveness of state or federal systems of reporting medical errors • Legislation automatically expires on September 1, 2007, unless lawmakers vote to continue it

11. House Bill 1614 78th Legislative Session Facility Responsibilities • Conduct a root cause analysis of specific events when they occur and develop an action plan which identifies strategies to reduce the risk of similar events in the future. • Submit an annual report to the department that lists the numbers of specific occurrences that have occurred at the facility in the preceding year • Submit to the department at least one best practice and safety measure related to a reported occurrence

12. House Bill 1614 78th Legislative Session REPORTING REQUIREMENT EFFECTIVE WITH JULY 2004 LICENSE RENEWALS

13. The Patient Safety Rules • Requirements are the same for: • Hospitals • ASCs • Private Psychiatric Hospitals • Exception: • The specific occurrences which must be reported

14. The Patient Safety Rules Definitions Adverse Event: • An event that results in unintended harm to the patient by an act of commission or omission rather that by the underlying disease or condition of the patient. Patient Safety: Achieving a New Standard of Care, Institute of Medicine, 2004

15. The Patient Safety Rules Definitions Medical Error: • The failure of a planned action to be completed as intended, the use of a wrong plan to achieve an aim, or the failure of an unplanned action that should have been completed, that results in an adverse event. Patient Safety: Achieving a New Standard of Care, Institute of Medicine, 2004

16. The Patient Safety Rules Definitions Reportable Event: • A medical error or adverse event or occurrence which the hospital is required to report to the department...

17. The Patient Safety Rules Patient Safety Program Requirements • Effective, ongoing, and organization-wide • Must reflect the complexity of the hospitals organization and services • Must focus on the prevention and reduction of medical errors and adverse events • Must be in writing, and approved by the governing body

18. The Patient Safety Rules Patient Safety Program Requirements The safety program shall include: • The definition of medical errors, adverse events and reportable events • The process for the internalreporting of medical errors, adverse events and reportable events • A list of events and occurrences which staff are required to report internally

19. The Patient Safety Rules Patient Safety Program Requirements The safety program shall include: • The time frames for the internal reporting of medical errors, adverse events and reportable events. • The consequences for failing to report events in accordance with hospital policy. • The mechanisms for the preservation and collection event data

20. The Patient Safety Rules Patient Safety Program Requirements The safety program shall include: • The process for conducting root cause analysis. Root Cause Analysis: An interdisciplinary review process for identifying the basic or contributing causal factors that underlie a variation in performance associated with an adverse event or reportable event ... It focuses primarily on systems and processes, includes an analysis of underlying cause and effect, progresses from special causes in clinical processes to common causes in organizational processes, and identifies potential improvements in processes or systems.

21. The Patient Safety Rules Patient Safety Program Requirements The safety program shall include: • The process for communicating action plans. Action Plan: A written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas. • The process for feedback to staff regarding the root cause analysis and action plan.

22. The Patient Safety Rules Patient Safety Program Requirements • Patient safety education and training must be provided to all staff who have any responsibilities related to the implementation, development, supervision or evaluation of the Patient Safety Program. • The training program must cover all of the elements previously outlined describing the required components of the Patient Safety Program.

23. The Patient Safety Rules Patient Safety Program Requirements • An individual or individuals must be designated to be responsible for the Patient Safety Program. • Can be one person or several persons • Responsibility can be rotated • Person may have other duties (part-time patient safety coordinator) • May be an interdisciplinary group • Qualified by training and/or experience in patient safety

24. The Patient Safety Rules Patient Safety Program Requirements The responsibilities of the individual or group designated to manage the PSP include: • Coordinating all patient safety activities • Ensuring the appropriate response to all reported events • Monitoring the root cause analysis and action plan to ensure they are completed appropriately and within the designated time frames • Working with other hospital departments to ensure integration of the patient safety activities

25. The Patient Safety Rules Patient Safety Program Requirements Within 45 days of becoming aware of the occurrence of one of the specified reportable events, the facility must: • Complete a root cause analysis • Develop an action plan which includes strategies to reduce the risk of similar events in the future

26. The Patient Safety Rules Reporting Requirements Annually, at the time the facility renews their license (or on the anniversary of the licensing date), the following information must be be submitted: • The number of occurrences of each of the specified events during the preceding year • At least one report of best practices and safety measures related to one of the reported events

27. The Reportable Events Hospitals Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs • 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

28. The Reportable Events Hospitals Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs • the suicide of a patient in a setting in which the patient received care 24 hours a day

29. The Reportable Events Hospitals Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs • the sexual assault of a patient during treatment or while the patient was on the premises

30. The Reportable Events Hospitals Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs • a hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities

31. The Reportable Events Hospitals Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs • 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

32. The Reportable Events Hospitals Ambulatory Surgical Centers • a surgical procedure on the wrong patient or on the wrong body part of a patient

33. The Reportable Events Hospitals Ambulatory Surgical Centers • a foreign object accidentally left in a patient during a procedure

35. The Reportable Events Hospitals • a perinatal death unrelated to a congenital condition in an infant with a birth weight greater that 2,500 grams

36. The Reportable Events Hospitals • the abduction of a newborn infant patient from the hospital or the discharge of a newborn infant patient from the hospital into the custody of an individual in circumstances in which the hospital knew, or in the exercise of ordinary care should have known, that the individual did not have legal custody of the infant

37. The Reporting Process • Individual occurrences are not reported • Facility reports include only aggregate numbers of events for the previous year • RCAs should not be sent to the department

44. Examples...

48. Example of Best Practices Report... • What was the category of reportable occurrence that resulted in this best • practice report? • A surgical procedure on the wrong patient or on the wrong body part of the patient • 2. Describe a best practice safety measure that was initiated as a result of the • occurrence. Include an explanation of how you have evaluated the • effectiveness of the best practice and how it has improved patient safety. • Facility consent forms were revised to facilitate providing the required information on the: • a. Site of the procedure, • b. Laterality of the procedure, • c. Name of the procedure, and • d. Reason for the procedure. • This is to ensure that the patient understands where the surgeon intends to operate, as well as what procedure is to be performed and why. To improve safety, it gives the patient or their representative the opportunity to identify a mistake at a time that is removed from when the surgery is imminent when there may be many distractions that prevent attention to what is on the consent form.

49. Example of Best Practices Report... • Facility policy was expanded to specifying exactly how physicians or other • privileged providers are to mark operative sites and document that the marking process has been completed: the standard practice will be to use an appropriate marking pen and to mark the site with the physician’s initials. The site needs to be marked so that it is unambiguous; for example, for surgery on a finger, the finger is to be marked rather than the palm or back of the hand. Whenever possible the mark needs to be placed so that it will be visible in the operative field after of the site is prepared and draped. Only ink that will withstand pre-surgical preparation of the operative site will be used. • Marking the site makes clear where the surgery is to be performed. Having the surgeon or other designated member of the surgical team mark the site will help ensure that the mark is put at the correct site. Although patients need to corroborate the site as the surgeon marks it, patients are not to mark the site. • (3) Policy explicitly requires that the non-operative sites must not be marked, unless required for another aspect of care. • When non-operative sites are marked, these marks may cause confusion and have the opposite of the intended effect. For example, “X” may signify “operate here” to one person and “don’t operate here” to another.

50. Example of Best Practices Report... (4) The patient must be asked by staff to verbally state (not confirm): (a) the patient’s name, (b) full social security number or birth date, and (c) the location on the patient’s body at which the patient understands the procedure will take place. These responses must be checked by staff against the completed consent form, marked site, and patient identification band, as applicable. This must occur in the immediate pre-operating room (OR) environment, for example in the hallway adjacent to the OR, etc., but not in the patient’s room. In general, this needs to be done prior to sedation of the patient, but this may not be possible in some cases. Whenever possible in cases where the patient cannot act on their own behalf, the individual who provided informed consent needs to be asked to state the name of the patient and the site to be operated on. For emergencies these procedures need to be applied to the extent possible. .