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

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

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 NormanApple Fellow

Objectives

Summarize the key components of HB 1614.

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Identify the minimum regulatory requirements for a patient safety program.

Describe the process for reporting medical errors and best practices to TDH.

Summarize the TDH process for evaluating compliance with the medical error and patient safety regulations.

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78th Legislative Session

House Bill 1614

“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.”

78th Legislative Session

House Bill 1614

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

78th Legislative Session

House Bill 1614

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

78th Legislative Session

House Bill 1614

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

78th Legislative Session

House Bill 1614

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

78th Legislative Session

House Bill 1614

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

78th Legislative Session

House Bill 1614

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

78th Legislative Session

House Bill 1614

REPORTING REQUIREMENTEFFECTIVE WITH

JULY 2004 LICENSE RENEWALS

The Patient Safety Rules

Requirements are the same for: Hospitals ASCs Private Psychiatric Hospitals

Exception: The specific occurrences which must

be reported

The Patient Safety Rules

Adverse Event:

An event that results in unintended harm to thepatient 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

Definitions

The Patient Safety Rules

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

thatshould have been completed, that results in an adverse event.

Patient Safety: Achieving a New Standard of Care,

Institute of Medicine, 2004

Definitions

The Patient Safety Rules

Reportable Event:

A medical error or adverse event or occurrence

which the hospital is required to report to the

department...

Definitions

The Patient Safety Rules

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

Patient Safety Program Requirements

The Patient Safety Rules

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

Patient Safety Program Requirements

The Patient Safety Rules

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

Patient Safety Program Requirements

The Patient Safety Rules

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 avariation 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.

Patient Safety Program Requirements

The Patient Safety Rules

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.

Patient Safety Program Requirements

The Patient Safety Rules

Patient safety education and training must be providedto all staff who have any responsibilities related to theimplementation, development, supervision or evaluation of the Patient Safety Program.

The training program must cover all of the elements previously outlined describing the required

componentsof the Patient Safety Program.

Patient Safety Program Requirements

The Patient Safety Rules

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

Patient Safety Program Requirements

The Patient Safety Rules

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

Patient Safety Program Requirements

The Patient Safety Rules

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

Patient Safety Program Requirements

The Patient Safety Rules

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 safetymeasures related to one of the reported events

Reporting Requirements

The Reportable Events

HospitalsAmbulatory Surgical Centers

Private Psychiatric Hospitals & CSUs

a medication error resulting in a patient’sunanticipated death or major permanentloss of bodily function in circumstancesunrelated to the natural course of the illness or underlying condition of the patient

The Reportable Events

HospitalsAmbulatory Surgical Centers

Private Psychiatric Hospitals & CSUs

the suicide of a patient in a setting in which the patient received care 24 hours a day

The Reportable Events

HospitalsAmbulatory Surgical Centers

Private Psychiatric Hospitals & CSUs

the sexual assault of a patient during treatment or while the patientwas on the premises

The Reportable Events

HospitalsAmbulatory Surgical Centers

Private Psychiatric Hospitals & CSUs

a hemolytic transfusion reactionin a patient resulting from theadministration of blood or bloodproducts with major blood groupincompatibilities

The Reportable Events

HospitalsAmbulatory Surgical Centers

Private Psychiatric Hospitals & CSUs

a patient death or serious disabilityassociated with the use or functionof a device designed for patient carethat is used or functions other thanas intended

The Reportable Events

HospitalsAmbulatory Surgical Centers

a surgical procedure on the wrong patient or on the wrong body partof a patient

The Reportable Events

HospitalsAmbulatory Surgical Centers

a foreign object accidentally left in a patient during a procedure

The Reportable Events

Hospitals

a perinatal death unrelated to a congenital condition in an infantwith a birth weight greater that2,500 grams

The Reportable Events

Hospitals

the abduction of a newborn infant patient from the hospital or the discharge of a newborninfant patient from the hospital into the custodyof an individual in circumstances in which thehospital knew, or in the exercise of ordinarycare should have known, that the individualdid not have legal custody of the infant

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

Examples...

Example of Best Practices Report...

1. 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 patient2. 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.

 (1)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, andd. 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.

Example of Best Practices Report...(2)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.

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..

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 patient’s room would be less

effective in reducing the vulnerability to an adverse outcome.

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.”  

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.

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

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.

The Reporting Process

This report may be submitted at any time during the year. Each facility will be requestedto 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.

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 yourreports, 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

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 don’t wait until the “due date”

The Reporting Process

The Texas Hospital Association’s Quality and Patient Safety Committee will be assisting us in evaluating the best practices and safety measureswhich are submitted

The best examples will be posted to the TDH Patient Safety website

Collection & Evaluation of Information

The Reporting Process

Evaluating Compliance

What to expect when theTexas Department of Health

Inspectors arrive at your facility...

Evaluating Compliance

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

Complaint Investigations

Evaluating Compliance

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

Complaint Investigations

Evaluating Compliance

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

Complaint Investigations

Evaluating Compliance

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?

Surveys, Inspections and Investigations

Evaluating Compliance

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?

Surveys, Inspections and Investigations

Evaluating Compliance

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

Surveys, Inspections and Investigations

Evaluating Compliance

You are encouraged to share RCAs covering other types of occurrences as a means of demonstrating you have an active, effective patient safety program

Don’t “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

Surveys, Inspections and Investigations

Evaluating Compliance

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

Surveys, Inspections and Investigations

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

cindy.bednar@tdh.state.tx.us

512-834-6639

QUESTIONS