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

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Title: 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 departments 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 internal reporting 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 patients
  • 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

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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

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44
Examples...
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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 physicians 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 dont 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 patients
name, (b) full social security number or birth
date, and (c) the location on the patients 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 patients 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. .
51
Example of Best Practices Report...
Asking the patient to state rather than confirm
their name helps prevent miscommunication and
wrong-patient procedures. Patients who are
hard-of-hearing or distracted by illness or
other temporary or permanent disability may say
yes to a name that is not theirs, but it is
very unlikely that they will misstate their name
and birth date or social security number when
asked. Asking the patient to state where the
patient expects to be operated on is a final
check prior to the provision of anesthesia, after
which the patient will likely be unable to
intervene on his or her own behalf. Verifying
the information physically and temporally close
to the place and time of the procedure helps
prevent wrong patient procedures. Verifying the
information in the patients room would be less
effective in reducing the vulnerability to an
adverse outcome.
52
Example of Best Practices Report...
(5) The OR team will verify their agreement as to
the intended surgery prior to the start of the
procedure. The standard method of a time out
will be required, during which a designated
member of the OR team states the name of the
patient, the procedure to be performed, the
location of the site (including laterality if
applicable), and the specifications of the
implant to be used (if applicable). After the
statement, other members of the team verbally
state that they concur with this information
before the procedure begins. At minimum, this
process must include the surgeon, the circulating
nurse, and the anesthesia provider. Successful
completion of this process must be
documented. This makes sure everyone is on
the same page.  
53
Example of Best Practices Report...
  Prior to the implementation of these revised
policies, the facility had experienced 4 cases
of incorrect site surgeries during the previous 6
month period. Upon implementation of the new
policies and training of staff, the patient
safety coordinator reviewed 100 of patient
records for a 6 week period, and observed the
practical implementation of the required steps in
the operating room suites over a 3 month period.
Infrequent deviations from the "time out"
policy were initially observed and staff were
immediately reminded to complete this step. Six
months following implementation of the new
procedures, the facility had identified no new
occurrences of wrong site surgery.
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Examples of Best Practices Reports...
  • Other examples of well known best practices and
    safety measures are related to
  • medication safety, including such actions as
  • Computerized physician order entry
  • Electronic Medication Administration Record and
    patient bar-coding
  • systems
  • Development of standard prescribing protocols
  • Strict limitations on the use of abbreviations
  • Strict limitations on the use of verbal orders
  • Standardized procedures regarding
    verbal/telephone orders, including
  • Identity verification
  • Receiver writing out the complete order,
    repeating the order as it is being written
  • Receiver ensuring all required components of the
    order are included
  • Receiver reading the order back in its entirety
  • Receiver spelling out sound alike drugs

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59
The Reporting Process
  • This report must be submitted at the time of
    license renewal, or the anniversary of
  • the licensing date. Please enter the total
    number of each of the following events that have
    occurred at your facility within the previous
    12-month period. The total
  • number of reported occurrences must include data
    from all locations under this
  • license number, including any multiple location
    sites or outpatient clinics.
  • This information will be completely
    de-identified, and the reports will be destroyed
  • after the information is reviewed and compiled.
    Reports should be placed in an
  • envelope stamped "CONFIDENTIAL" and mailed to
    Cindy Bednar, Director of Licensing Programs,
    Health Facility Licensing and Compliance
    Division, Texas Department of Health, 1100 W.
    49th Street, Austin, Texas, 78756.

60
The Reporting Process
  • This report may be submitted at any time during
    the year. Each facility will be requested
  • to provide a minimum of one best practice report
    at the time of license renewal, or the
  • anniversary of the licensing date, if one has not
    been submitted in the previous 12-month
  • period. Only one best practice report is
    required however, additional reports may be
  • submitted. If the facility has no occurrences to
    report, then no best practice report is
  • required. Please do not include any information
    that could identify individuals involved.
  • The following information is the minimum
    required, although facilities are encouraged to
  • provide additional information within their
    individual comfort levels, particularly related
  • to contributing causal factors that may prove
    helpful to other facilities in improving patient
  • safety. Additional pages may be included at the
    facility's discretion but are not required.
  • Copies of best practice reports submitted to a
    recognized patient safety organization may
  • be submitted in lieu of this form. This
    information will be completely de-identified, and
    the
  • reports will be destroyed after the information
    is reviewed and compiled. Reports should
  • be placed in an envelope stamped "CONFIDENTIAL"
    and mailed to Cindy Bednar,
  • Director of Licensing Programs, Health Facility
    Licensing and Compliance Division,
  • Texas Department of Health, 1100 W. 49th Street,
    Austin, Texas, 78756.

61
The Reporting Process
Collection Evaluation of Information
  • Collection of both the occurrence reports and the
  • best practices reports will be done by the
    licensing section
  • Once we have checked off that you submitted your
  • reports, all identifying information will be
    removed from the forms
  • The data will be entered into a simple database,
  • which will not include any facility identifying
  • information

62
The Reporting Process
Collection Evaluation of Information
  • Follow-up letters will be sent to facilities if
    your
  • reports are not received by your license renewal
  • date
  • Data may be confirmed through an onsite visit
  • Best practice reports can be sent anytime if
    you
  • have a great best practice to share, please
    dont
  • wait until the due date

63
The Reporting Process
Collection Evaluation of Information
  • The Texas Hospital Associations Quality and
  • Patient Safety Committee will be assisting us in
  • evaluating the best practices and safety
    measures
  • which are submitted
  • The best examples will be posted to the TDH
  • Patient Safety website

64
Evaluating Compliance
What to expect when the Texas Department of
Health Inspectors arrive at your facility...
65
Evaluating Compliance
Complaint Investigations
  • A root cause analysis and action plan must be
    completed for all events related to a
    reportable occurrence
  • The investigator will review the RCA related to
    the complaint, and may review any others which
    were completed for similar events

66
Evaluating Compliance
Complaint Investigations
  • In evaluating the RCA, we will look for
  • Any immediate actions taken
  • A thorough description of the events
  • Descriptions of the root causes and contributing
  • factors
  • Recommended actions for addressing the root
  • causes and contributing factors
  • Responsibility for implementing actions
  • Description of the outcome measures for the
    actions
  • Target dates for completion

67
Evaluating Compliance
Complaint Investigations
  • Remember that the RCA must focus on systems and
    processes, including an analysis of
  • underlying cause and effect
  • Actions must be clear and have direct relevance
    to the root cause
  • Outcome measures should be specific and
    quantifiable, and must measure the impact of
    the action on the root cause

68
Evaluating Compliance
Surveys, Inspections and Investigations
  • Review of the overall patient safety program
  • Is it effective, ongoing and organization-wide?
  • Does it focus on the prevention and reduction of
    adverse events and medical errors?
  • Is it integrated with other departments in the
    facility?
  • Are staff knowledgeable of the patient safety
    program and their responsibilities?

69
Evaluating Compliance
Surveys, Inspections and Investigations
  • Review of the overall patient safety program
  • Are events being reported internally within the
    the specified time frames?
  • Is an RCA and action plan being completed within
    45 days?
  • Is the effectiveness of the action plan being
    evaluated?
  • Has the facility accurately reported their data
    to the department?

70
Evaluating Compliance
Surveys, Inspections and Investigations
  • The goal of the department is to improve patient
    safety, not to use the RCA against you
  • The RCA is confidential, and the inspectors may
    not remove, copy, reproduce, redact, or dictate
    from any part of a root cause analysis or
    action plan.
  • The law only requires that the department
    representative be allowed to review the RCA
    and action plan related to a reportable event

71
Evaluating Compliance
Surveys, Inspections and Investigations
  • You are encouraged to share RCAs covering other
    types of occurrences as a means of demonstrating
    you have an active, effective patient safety
    program
  • Dont hide behind the RCA process
  • If something goes wrong, you must be able to
    demonstrate what you did to investigate it, and
    what actions you took to prevent it from
    happening again

72
Evaluating Compliance
Surveys, Inspections and Investigations
  • You could be cited for failing to complete an RCA
    and action plan on one of the required
    reportable events
  • You could be cited if your safety program and RCA
    process does not meet the intent of the law and
    the rules
  • You could be cited if you fail to report to the
    department in accordance with the law

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Reading Between the Rules The New Medical
Error Reporting and Patient Safety Requirements
QUESTIONS
Cindy Bednar, R.N. Director of Licensing
Programs Health Facility Licensing Compliance
Division cindy.bednar_at_tdh.state.tx.us 512-834-6639
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