Presentation on theme: "Cindy Bednar, R.N. Director of Licensing Programs"— Presentation transcript:
1 Reading Between the Rules: The New Medical Error Reporting and Patient Safety Requirements Cindy Bednar, R.N.Director of Licensing ProgramsHealth Facility Licensing & Compliance Division
2 The Case for Patient Safety Patient safety is a critical component of QUALITYHealth care is NOT as safe as it should beThe Institute of Medicine estimates that between 44,000 and 98,000 Americans die as a result of preventable errorsPeople do not come to work with the intent to hurt patientsWe 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 isto 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 systemand the problems will continue.”Don NormanApple Fellow
4 1 2 3 4 Objectives Summarize the key components of HB 1614. Identify the minimum regulatory requirements for a patient safety program.2Describe the process for reporting medical errors and best practices to TDH.3Summarize 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 errorsand the establishment of apatient safety program inhospitals,ambulatory surgical centers andmental hospitals.”
6 78th Legislative Session House Bill 161478th Legislative SessionPromotes public accountability through detection of statewide trends in the occurrence of certain medical errors by:Requires reporting of errorsProvides the public with access to statewide summaries of the reportsRequires that facilities implement risk-reduction strategiesEncourages sharing of best practices and safety measures that are effective in improving patient safety
7 78th Legislative Session House Bill 161478th Legislative SessionAmends the Health and Safety CodeChapter 241: HospitalsChapter 243: Ambulatory Surgical CentersChapter 577: Private Mental Hospitals and other Mental Health FacilitiesAssigns specific responsibilities to TDHPrescribes requirements for facilities regarding analysis of certain events and the reporting of events and best practicesIncludes strong confidentiality provisions
8 78th Legislative Session House Bill 161478th Legislative SessionTDH ResponsibilitiesDevelop & administer Patient Safety ProgramCompile & make available to the public a summary of reported eventsSummary can only contain aggregate dataSummary information may not identify specific facilities, groups of facilities, individuals or specific reported events or circumstancesHospitals will be grouped as:49 beds or less to 399 bedsto 99 beds beds or more- 100 to 199 bedsASCs and psychiatric hospitals will each be in single distinct groups
9 78th Legislative Session House Bill 161478th Legislative SessionTDH ResponsibilitiesReview best practices reportsCompile a summary of effective best practices reports to be made available to the publicSummary information may not identify specific facilities, groups of facilities, individuals or specific reported events or circumstancesHospitals will be grouped as:49 beds or less to 399 beds- 50 to 99 beds beds or more- 100 to 199 bedsASCs and psychiatric hospitals will each be in single distinct groups
10 78th Legislative Session House Bill 161478th Legislative SessionTDH ResponsibilitiesEvaluate 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 reportedThe degree to which the event summaries were accessed by the publicThe effectiveness of the department’s best practices summaries in improving patient careThe impact of national studies on the effectiveness of state or federal systems of reporting medical errorsLegislation automatically expires on September 1, 2007, unless lawmakers vote to continue it
11 78th Legislative Session House Bill 161478th Legislative SessionFacility ResponsibilitiesConduct 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 yearSubmit to the department at least one best practice and safety measure related to a reported occurrence
12 JULY 2004 REPORTING REQUIREMENT EFFECTIVE WITH LICENSE RENEWALS House Bill 161478th Legislative SessionREPORTING REQUIREMENTEFFECTIVE WITHJULY 2004LICENSE RENEWALS
13 The Patient Safety Rules Requirements are the same for:HospitalsASCsPrivate Psychiatric HospitalsException:The specific occurrences which must bereported
14 The Patient Safety Rules DefinitionsAdverse Event:An event that results in unintended harm to thepatient by an act of commission or omissionrather that by the underlying disease orcondition of the patient.Patient Safety: Achieving a New Standard of Care,Institute of Medicine, 2004
15 The Patient Safety Rules DefinitionsMedical Error:The failure of a planned action to be completedas intended, the use of a wrong plan to achievean aim, or the failure of an unplanned action thatshould have been completed, that results in anadverse event.Patient Safety: Achieving a New Standard of Care,Institute of Medicine, 2004
16 The Patient Safety Rules DefinitionsReportable Event:A medical error or adverse event or occurrencewhich the hospital is required to report to thedepartment...
17 The Patient Safety Rules Patient Safety Program RequirementsEffective, ongoing, and organization-wideMust reflect the complexity of the hospitalsorganization and servicesMust focus on the prevention and reduction of medical errors and adverse eventsMust be in writing, and approved by thegoverning body
18 The Patient Safety Rules Patient Safety Program RequirementsThe safety program shall include:The definition of medical errors, adverseevents and reportable eventsThe process for the internal reporting of medical errors, adverse events and reportable eventsA list of events and occurrences which staff are required to report internally
19 The Patient Safety Rules Patient Safety Program RequirementsThe safety program shall include:The time frames for the internal reporting ofmedical errors, adverse events and reportableevents.The consequences for failing to report events in accordance with hospital policy.The mechanisms for the preservation andcollection event data
20 The Patient Safety Rules Patient Safety Program RequirementsThe safety program shall include:The process for conducting root cause analysis.Root Cause Analysis: An interdisciplinary review process foridentifying the basic or contributing causal factors that underlie avariation in performance associated with an adverse event orreportable event ...It focuses primarily on systems and processes, includes ananalysis of underlying cause and effect, progresses from specialcauses in clinical processes to common causes in organizationalprocesses, and identifies potential improvements in processes orsystems.
21 The Patient Safety Rules Patient Safety Program RequirementsThe safety program shall include:The process for communicating action plans.Action Plan: A written document that includes specific measures tocorrect identified problems or areas of concern; identifies strategiesfor implementing system improvements; and includes outcomemeasures to indicate the effectiveness of system improvements inreducing, controlling or eliminating identified problem areas.The process for feedback to staff regarding theroot cause analysis and action plan.
22 The Patient Safety Rules Patient Safety Program RequirementsPatient safety education and training must be providedto all staff who have any responsibilities related to theimplementation, development, supervision or evaluationof the Patient Safety Program.The training program must cover all of the elementspreviously outlined describing the required components
23 The Patient Safety Rules Patient Safety Program RequirementsAn individual or individuals must be designated to be responsible for the Patient Safety Program.Can be one person or several personsResponsibility can be rotatedPerson may have other duties(part-time patient safety coordinator)May be an interdisciplinary groupQualified by training and/or experience in patient safety
24 The Patient Safety Rules Patient Safety Program RequirementsThe responsibilities of the individual or group designated to managethe PSP include:Coordinating all patient safety activitiesEnsuring the appropriate response to all reported eventsMonitoring the root cause analysis and action plan to ensurethey are completed appropriately and within the designatedtime framesWorking with other hospital departments to ensure integrationof the patient safety activities
25 The Patient Safety Rules Patient Safety Program RequirementsWithin 45 days of becoming aware of the occurrence ofone of the specified reportable events, the facility must:Complete a root cause analysisDevelop an action plan which includes strategiesto reduce the risk of similar events in the future
26 The Patient Safety Rules Reporting RequirementsAnnually, at the time the facility renews their license(or on the anniversary of the licensing date), thefollowing information must be be submitted:The number of occurrences of each of thespecified events during the preceding yearAt least one report of best practices and safetymeasures related to one of the reported events
27 Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs The Reportable EventsHospitalsAmbulatory Surgical CentersPrivate Psychiatric Hospitals & CSUsa medication error resulting in a patient’sunanticipated death or major permanentloss of bodily function in circumstancesunrelated to the natural course of theillness or underlying condition of thepatient
28 Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs The Reportable EventsHospitalsAmbulatory Surgical CentersPrivate Psychiatric Hospitals & CSUsthe suicide of a patient in a settingin which the patient received care24 hours a day
29 Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs The Reportable EventsHospitalsAmbulatory Surgical CentersPrivate Psychiatric Hospitals & CSUsthe sexual assault of a patientduring treatment or while the patientwas on the premises
30 Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs The Reportable EventsHospitalsAmbulatory Surgical CentersPrivate Psychiatric Hospitals & CSUsa hemolytic transfusion reactionin a patient resulting from theadministration of blood or bloodproducts with major blood groupincompatibilities
31 Ambulatory Surgical Centers Private Psychiatric Hospitals & CSUs The Reportable EventsHospitalsAmbulatory Surgical CentersPrivate Psychiatric Hospitals & CSUsa patient death or serious disabilityassociated with the use or functionof a device designed for patient carethat is used or functions other thanas intended
32 Ambulatory Surgical Centers The Reportable EventsHospitalsAmbulatory Surgical Centersa surgical procedure on the wrongpatient or on the wrong body partof a patient
33 Ambulatory Surgical Centers The Reportable EventsHospitalsAmbulatory Surgical Centersa foreign object accidentally leftin a patient during a procedure
35 a perinatal death unrelated to a congenital condition in an infant The Reportable EventsHospitalsa perinatal death unrelated to acongenital condition in an infantwith a birth weight greater that2,500 grams
36 The Reportable Events the abduction of a newborn infant patient from Hospitalsthe abduction of a newborn infant patient fromthe 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
37 The Reporting Process Individual occurrences are not reported Facility reports include only aggregate numbersof events for the previous yearRCAs should not be sent to the department
48 Example of Best Practices Report... What was the category of reportable occurrence that resulted in this bestpractice 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 theoccurrence. Include an explanation of how you have evaluated theeffectiveness 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, 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.
49 Example of Best Practices Report... Facility policy was expanded to specifying exactly how physicians or otherprivileged 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..
51 Example of Best Practices Report... Asking the patient to state rather than confirm their name helps preventmiscommunication and wrong-patient procedures. Patients who arehard-of-hearing or distracted by illness or other temporary or permanentdisability may say “yes” to a name that is not theirs, but it is very unlikelythat they will misstate their name and birth date or social security numberwhen asked. Asking the patient to state where the patient expects tobe operated on is a final check prior to the provision of anesthesia, afterwhich the patient will likely be unable to intervene on his or her own behalf.Verifying the information physically and temporally close to the place andtime of the procedure helps prevent wrong patient procedures.Verifying the information in the patient’s room would be less effective inreducing 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 hadexperienced 4 cases of incorrect site surgeries during the previous 6 monthperiod. Upon implementation of the new policies and training of staff, thepatient safety coordinator reviewed 100% of patient records for a 6 weekperiod, and observed the practical implementation of the required steps inthe operating room suites over a 3 month period. Infrequent deviations fromthe "time out" policy were initially observed and staff were immediatelyreminded to complete this step. Six months following implementation of thenew procedures, the facility had identified no new occurrences of wrong sitesurgery.
56 Examples of Best Practices Reports... Other examples of well known best practices and safety measures are related tomedication safety, including such actions as:Computerized physician order entryElectronic Medication Administration Record and patient bar-codingsystemsDevelopment of standard prescribing protocolsStrict limitations on the use of abbreviationsStrict limitations on the use of verbal ordersStandardized procedures regarding verbal/telephone orders, including:Identity verificationReceiver writing out the complete order, repeating the order as it is being writtenReceiver ensuring all required components of the order are includedReceiver reading the order back in its entiretyReceiver spelling out sound alike drugs
59 The Reporting ProcessThis report must be submitted at the time of license renewal, or the anniversary ofthe 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 totalnumber of reported occurrences must include data from all locations under thislicense number, including any multiple location sites or outpatient clinics.This information will be completely de-identified, and the reports will be destroyedafter the information is reviewed and compiled. Reports should be placed in anenvelope stamped "CONFIDENTIAL" and mailed to: Cindy Bednar, Director of Licensing Programs, Health Facility Licensing and Compliance Division, Texas Department of Health, W. 49th Street, Austin, Texas,
60 Texas Department of Health, 1100 W. 49th Street, Austin, Texas, 78756. The Reporting ProcessThis 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 theanniversary of the licensing date, if one has not been submitted in the previous 12-monthperiod. Only one best practice report is required; however, additional reports may besubmitted. If the facility has no occurrences to report, then no best practice report isrequired. Please do not include any information that could identify individuals involved.The following information is the minimum required, although facilities are encouraged toprovide additional information within their individual comfort levels, particularly relatedto contributing causal factors that may prove helpful to other facilities in improving patientsafety. 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 maybe submitted in lieu of this form. This information will be completely de-identified, and thereports will be destroyed after the information is reviewed and compiled. Reports shouldbe 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,
61 Collection & Evaluation of Information The Reporting ProcessCollection & Evaluation of InformationCollection of both the occurrence reports and thebest practices reports will be done by the licensing sectionOnce we have checked off that you submitted yourreports, all identifying information will be removed from the formsThe data will be entered into a simple database,which will not include any facility identifyinginformation
62 Collection & Evaluation of Information The Reporting ProcessCollection & Evaluation of InformationFollow-up letters will be sent to facilities if yourreports are not received by your license renewaldateData may be confirmed through an onsite visitBest practice reports can be sent anytime – if youhave a great best practice to share, please don’twait until the “due date”
63 Collection & Evaluation of Information The Reporting ProcessCollection & Evaluation of InformationThe Texas Hospital Association’s Quality andPatient Safety Committee will be assisting us inevaluating the best practices and safety measureswhich are submittedThe best examples will be posted to the TDHPatient Safety website
64 Evaluating Compliance What to expect when theTexas Department of HealthInspectorsarrive at your facility...
65 Evaluating Compliance Complaint InvestigationsA 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 InvestigationsIn evaluating the RCA, we will look for:Any immediate actions takenA thorough description of the eventsDescriptions of the root causes and contributingfactorsRecommended actions for addressing the rootcauses and contributing factorsResponsibility for implementing actionsDescription of the outcome measures for the actionsTarget dates for completion
67 Evaluating Compliance Complaint InvestigationsRemember that the RCA must focus on systems and processes, including an analysis ofunderlying cause and effectActions must be clear and have direct relevance to the root causeOutcome measures should be specific and quantifiable, and must measure the impact of the action on the root cause
68 Evaluating Compliance Surveys, Inspections and InvestigationsReview 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 InvestigationsReview 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 InvestigationsThe goal of the department is to improve patient safety, not to use the RCA against youThe 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 InvestigationsYou are encouraged to share RCAs covering other types of occurrences as a means of demonstrating you have an active, effective patient safety programDon’t “hide” behind the RCA processIf 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 InvestigationsYou could be cited for failing to complete an RCA and action plan on one of the required reportable eventsYou could be cited if your safety program and RCA process does not meet the intent of the law and the rulesYou could be cited if you fail to report to the department in accordance with the law