State-Mandated Prevention of Medical Errors

Christopher L. Nuland, Esq. October 5, 2013

WHY ARE WE HEREWHY ARE WE HEREWHY ARE WE HEREWHY ARE WE HERE

Medical errors statute Medical errors statute 456.013 (7)456.013 (7)

456 013 (7)456 013 (7)456.013 (7)456.013 (7)

(7) Th b d h d h h i b d h ll(7) Th b d h d h h i b d h ll•• (7) The boards, or the department when there is no board, shall (7) The boards, or the department when there is no board, shall require the completion of a 2require the completion of a 2--hour course relating to prevention of hour course relating to prevention of medical errors as part of the licensure and renewal processmedical errors as part of the licensure and renewal process. The 2. The 2--hour course shall count towards the total number of continuing hour course shall count towards the total number of continuing d i h i d f h f i Th h ll bd i h i d f h f i Th h ll beducation hours required for the profession. The course shall be education hours required for the profession. The course shall be

approved by the board or department, as appropriate, and shall approved by the board or department, as appropriate, and shall include a study of rootinclude a study of root--cause analysis, error reduction and cause analysis, error reduction and prevention, and patient safety. In addition, the course approved by prevention, and patient safety. In addition, the course approved by th B d f M di i d th B d f O t thi M di ith B d f M di i d th B d f O t thi M di i h llh llthe Board of Medicine and the Board of Osteopathic Medicine the Board of Medicine and the Board of Osteopathic Medicine shall shall include information relating to the five most misdiagnosedinclude information relating to the five most misdiagnosedconditions during the previous biennium,conditions during the previous biennium, as determined by the as determined by the board. If the course is being offered by a facility licensed pursuant board. If the course is being offered by a facility licensed pursuant t h t 395 f it l th b d t 1t h t 395 f it l th b d t 1to chapter 395 for its employees, the board may approve up to 1 to chapter 395 for its employees, the board may approve up to 1 hour of the 2hour of the 2--hour course to be specifically related to error hour course to be specifically related to error reduction and prevention methods used in that facility. reduction and prevention methods used in that facility.

BOARD RULEBOARD RULE64B8-13.005 Continuing Education for Biennial Renewal.(1) Every physician licensed pursuant to Chapter 458, F.S., shall be required to complete 40 hours of continuing medicaleducation courses approved by the Board in the 24 months preceding each biennial renewal period as established by theDepartment.

O UO U

(a) As part of every third biennial renewal licensure period, all licensees shall complete two (2) hours of training in domesticviolence which includes information on the number of patients in that professional’s practice who are likely to be victims ofdomestic violence and the number who are likely to be perpetrators of domestic violence, screening procedures for determiningwhether a patient has any history of being either a victim or a perpetrator of domestic violence, and instruction on how toprovide such patients with information on, or how to refer such patients to, resources in the local community, such as domesticviolence centers and other advocacy groups, that provide legal aid, shelter, victim counseling, batterer counseling, or childy g p , p g , , g, g,protection services, and which is approved by any state or federal government agency, or nationally affiliated professionalassociation, or any provider of Category I or II American Medical Association Continuing Medical Education. Home study coursesapproved by the above agencies will be acceptable.(b) Upon a licensee’s first renewal of licensure, the licensee must document the completion of one (1) hour of Category IAmerican Medical Association Continuing Medical Education which includes the topics of Human Immunodeficiency Virus andAcquired Immune Deficiency Syndrome; the modes of transmission, including transmission from healthcare worker to patientAcquired Immune Deficiency Syndrome; the modes of transmission, including transmission from healthcare worker to patientand patient to healthcare worker; infection control procedures, including universal precautions; epidemiology of the disease;related infections including TB; clinical management; prevention; and current Florida law on AIDS and its impact on testing,confidentiality of test results, and treatment of patients. Any hours of said CME may also be counted toward the CME licenserenewal requirement. In order for a course to count as meeting this requirement, licensees practicing in Florida must clearlydemonstrate that the course includes Florida law on HIV/AIDS and its impact on testing, confidentiality of test results, andtreatment of patients Only Category I hours shall be acceptedtreatment of patients. Only Category I hours shall be accepted.(c) Completion of two hours of continuing medical education relating to prevention of medical errors which includes a study ofroot cause analysis, error reduction and prevention, and patient safety, and which is approved by any state or federalgovernment agency, or nationally affiliated professional association, or any provider of Category I or II American MedicalAssociation Continuing Medical Education. One hour of a two hour course which is provided by a facility licensed pursuant toChapter 395, F.S., for its employees may be used to partially meet this requirement. The course must include informationrelating to the five most mis diagnosed conditions during the previous biennium as determined by the Board While wrongrelating to the five most mis-diagnosed conditions during the previous biennium, as determined by the Board. While wrongsite/wrong procedure surgery continues to be the most common basis for quality of care violations, the following areas havebeen determined as the five most mis-diagnosed conditions: cancer; neurological conditions; acute abdomen related conditions;timely diagnosis of surgical complications; and failing to identify pregnancy or and diagnosis of pregnancy related conditions.

CURRENT CME REQUIREMENTSCURRENT CME REQUIREMENTSCURRENT CME REQUIREMENTSCURRENT CME REQUIREMENTS

•• 40 hours every two years40 hours every two years–– Two hours of Domestic Violence every six Two hours of Domestic Violence every six yy

years****years****–– Two hours of Prevention of Medical Errors Two hours of Prevention of Medical Errors

every two yearsevery two years

456.031 Requirement for 456.031 Requirement for qqinstruction on domestic violence.instruction on domestic violence.----

456 031 R i f i i d i i l456 031 R i f i i d i i l•• 456.031 Requirement for instruction on domestic violence.456.031 Requirement for instruction on domestic violence.----•• (1)(a) The appropriate board shall require each person licensed or certified (1)(a) The appropriate board shall require each person licensed or certified

under chapter 458, chapter 459, part I of chapter 464, chapter 466, under chapter 458, chapter 459, part I of chapter 464, chapter 466, chapter 467, chapter 490, or chapter 491 to complete a 2chapter 467, chapter 490, or chapter 491 to complete a 2--hour continuing hour continuing education course approved by the board on domestic violence as definededucation course approved by the board on domestic violence as definededucation course, approved by the board, on domestic violence, as defined education course, approved by the board, on domestic violence, as defined in s. 741.28, in s. 741.28, as part of every third biennial relicensure or as part of every third biennial relicensure or recertification.recertification. The course shall consist of information on the number of The course shall consist of information on the number of patients in that professional's practice who are likely to be victims of patients in that professional's practice who are likely to be victims of domestic violence and the number who are likely to be perpetrators ofdomestic violence and the number who are likely to be perpetrators ofdomestic violence and the number who are likely to be perpetrators of domestic violence and the number who are likely to be perpetrators of domestic violence, screening procedures for determining whether a patient domestic violence, screening procedures for determining whether a patient has any history of being either a victim or a perpetrator of domestic has any history of being either a victim or a perpetrator of domestic violence, and instruction on how to provide such patients with information violence, and instruction on how to provide such patients with information on, or how to refer such patients to, resources in the local community, such on, or how to refer such patients to, resources in the local community, such

d ti i l t d th d th t id l ld ti i l t d th d th t id l las domestic violence centers and other advocacy groups, that provide legal as domestic violence centers and other advocacy groups, that provide legal aid, shelter, victim counseling, batterer counseling, or child protection aid, shelter, victim counseling, batterer counseling, or child protection services. services.

Root Cause AnalysisRoot Cause Analysis--What What yyCauses ErrorsCauses Errors•• Physician ErrorPhysician Error-- Mental or PhysicalMental or Physical•• Patient ChoicePatient ChoicePatient ChoicePatient Choice•• Anesthesia or Surgery?Anesthesia or Surgery?•• Condition or Intervention?Condition or Intervention?•• Condition or Intervention?Condition or Intervention?•• Flawed Protocols or Flawed Performance?Flawed Protocols or Flawed Performance?

Error DefinitionError Definition

•• Adverse Event:Adverse Event:I j d b di l t th thI j d b di l t th thInjury caused by medical management rather thanInjury caused by medical management rather thanthe underlying illness or condition of the patientthe underlying illness or condition of the patient

•• Medical Error:Medical Error:A preventable adverse eventA preventable adverse event

•• Malpractice:Malpractice:Failure to exercise that degree of care used Failure to exercise that degree of care used by reasonably prudent physicians in the same orby reasonably prudent physicians in the same orby reasonably prudent physicians in the same or by reasonably prudent physicians in the same or similar circumstancessimilar circumstances

Most prevalent root cause of medical Most prevalent root cause of medical errors is communicationerrors is communication

RCA of Medical ErrorsRCA of Medical Errors

•• Communication factorsCommunication factors

•• Unclear lines of authority Unclear lines of authority

•• Highly variable physical settingsHighly variable physical settingsHighly variable physical settingsHighly variable physical settings

•• Varied healthcare processesVaried healthcare processes

•• Time pressured environmentTime pressured environment•• Time pressured environmentTime pressured environment

•• System deficienciesSystem deficiencies

V l bl d f b iV l bl d f b i•• Vulnerable defense barriersVulnerable defense barriers

•• Human fallibilityHuman fallibility

National Patient Safety Foundation

Five Most Misdiagnosed ConditionsFive Most Misdiagnosed ConditionsFive Most Misdiagnosed ConditionsFive Most Misdiagnosed Conditions

•• WrongWrong--Site/Wrong Patient SurgerySite/Wrong Patient Surgery•• CancerCancerCancerCancer•• Neurological Neurological •• Failure to Diagnose Surgical ComplicationsFailure to Diagnose Surgical Complications•• Failure to Diagnose Surgical ComplicationsFailure to Diagnose Surgical Complications•• Acute AbdomenAcute Abdomen•• Failure to diagnose pregnancy prior to Failure to diagnose pregnancy prior to

treatment/surgerytreatment/surgery

Wrong site wrong patient surgeryWrong site wrong patient surgeryWrong site, wrong patient surgeryWrong site, wrong patient surgery

1.1. Delay in treatment, biopsy site healedDelay in treatment, biopsy site healed2.2. Multiple patients with same nameMultiple patients with same name2.2. Multiple patients with same nameMultiple patients with same name3.3. Incorrect documentationIncorrect documentation44 Referral to another MD for surgeryReferral to another MD for surgery4.4. Referral to another MD for surgeryReferral to another MD for surgery

CANCERCANCERCANCERCANCER

1.1. Failure to diagnoseFailure to diagnose2.2. Failure to adequately treatFailure to adequately treat-- what iswhat is2.2. Failure to adequately treatFailure to adequately treat what is what is

surgeon’s responsibility?surgeon’s responsibility?33 Failure to refer to specialistFailure to refer to specialist3.3. Failure to refer to specialistFailure to refer to specialist4.4. Failure to follow up with biopsy resultFailure to follow up with biopsy result55 F il f llF il f ll5.5. Failure to follow up treatmentFailure to follow up treatment

CARDIACCARDIACCARDIACCARDIAC

1.1. Coronary disease, MI, pulmonary emboli, Coronary disease, MI, pulmonary emboli, anneurysmanneurysm

2.2. Preventive care: ASA, statins, etcPreventive care: ASA, statins, etc33 AntiAnti--coagulant complicationscoagulant complications——bleedingbleeding3.3. AntiAnti coagulant complicationscoagulant complications bleeding bleeding

vs embolivs emboli

Surgical complicationsSurgical complicationsSurgical complicationsSurgical complications

1.1. Failure to see patient timelyFailure to see patient timely2.2. BleedingBleeding2.2. BleedingBleeding3.3. InfectionInfection44 NecrosisNecrosis4.4. NecrosisNecrosis5.5. Poor scarringPoor scarring

ACUTE ABDOMENACUTE ABDOMENACUTE ABDOMENACUTE ABDOMEN

•• ER, PCP, GYN, SurgeonsER, PCP, GYN, Surgeons——delay in delay in evaluation or interventionevaluation or intervention

NOT SO CUTE ABDOMENNOT SO CUTE ABDOMENNOT SO CUTE ABDOMENNOT SO CUTE ABDOMEN

PREGNANACY ISSUESPREGNANACY ISSUESPREGNANACY ISSUESPREGNANACY ISSUES

•• Failure to diagnose pregnancyFailure to diagnose pregnancy•• Failure to recognize stage of pregnancyFailure to recognize stage of pregnancyFailure to recognize stage of pregnancyFailure to recognize stage of pregnancy•• Surgical procedures during pregnancySurgical procedures during pregnancy•• Prescribing medications to pregnantPrescribing medications to pregnant•• Prescribing medications to pregnant Prescribing medications to pregnant

patientpatient

Error ReductionError ReductionError ReductionError Reduction

•• Standardize approachStandardize approach•• Electronic PrescribingElectronic PrescribingElectronic PrescribingElectronic Prescribing•• TimeTime--Out RuleOut Rule•• VerificationVerification•• VerificationVerification

STANDARDIZE APPROACHSTANDARDIZE APPROACHSTANDARDIZE APPROACHSTANDARDIZE APPROACH

•• Pre op check listPre op check list•• Printed post op instructionsPrinted post op instructionsPrinted post op instructionsPrinted post op instructions•• Written follow up instructionsWritten follow up instructions•• Biopsy and lab follow up:Biopsy and lab follow up:•• Biopsy and lab follow up:Biopsy and lab follow up:

MD / staff responsibilityMD / staff responsibilitypatient responsibilitypatient responsibility

ELECTRONIC PRESCRIBINGELECTRONIC PRESCRIBINGEMR / EHREMR / EHR

•• Avoid calling in NEW prescriptionsAvoid calling in NEW prescriptions•• Be careful with default programsBe careful with default programsa u d au p og aa u d au p og a

TIMETIME OUT RULEOUT RULETIMETIME--OUT RULEOUT RULE

•• Wrong Site, Wrong Patient Incidents Wrong Site, Wrong Patient Incidents Continue at Unacceptable PaceContinue at Unacceptable Pace

•• OBEY TIMEOUT RULEOBEY TIMEOUT RULE

TIMETIME OUT RULEOUT RULETIMETIME--OUT RULEOUT RULE

•• Applies to anesthesiologists and surgeons;Applies to anesthesiologists and surgeons;•• Prior to Initiating Procedure, the Prior to Initiating Procedure, the

responsible physician will verbally confirm:responsible physician will verbally confirm:Patient’s identificationPatient’s identificationIntended ProcedureIntended ProcedureCorrect Procedure SiteCorrect Procedure SiteCo ec ocedu e S eCo ec ocedu e S e

•• Procedural Notes Procedural Notes (which may be in the (which may be in the Nursing note)Nursing note) Must Include When Each Must Include When Each g )g )Was Confirmed and By Whom.Was Confirmed and By Whom.

Surgical Pause RuleSurgical Pause RuleSurgical Pause RuleSurgical Pause RuleF.S. 458.331(1)(t),456.072,and F.A.C. 64B8F.S. 458.331(1)(t),456.072,and F.A.C. 64B8--9.0079.007

•• Must Document Pause in Chart;Must Document Pause in Chart;•• Physician ResponsibilityPhysician ResponsibilityPhysician ResponsibilityPhysician Responsibility•• Must Notify Patient of Adverse IncidentMust Notify Patient of Adverse Incident•• Exception for minor dermatologyException for minor dermatology•• Exception for minor dermatology Exception for minor dermatology

proceduresprocedures

Surgeon ResponsibilitySurgeon ResponsibilitySurgeon ResponsibilitySurgeon Responsibility

•• Surgeon is responsible for postSurgeon is responsible for post--surgical surgical followfollow--up, which may be delegated.up, which may be delegated.

UPDATE YOUR PROFILE UPDATE YOUR PROFILE F.S. 456.052F.S. 456.052

•• Within 15 Days with changes to:Within 15 Days with changes to:–– AddressAddress–– Staff PrivilegesStaff Privileges–– Medical Malpractice HistoryMedical Malpractice History–– Financial ResponsibilityFinancial Responsibility–– Board CertificationBoard Certification–– EducationEducation–– Disciplinary/Criminal HistoryDisciplinary/Criminal Historysc p a y/C a sto ysc p a y/C a sto y

Change of AddressChange of AddressChange of AddressChange of AddressF.S. 456.035, 458.319(3), 458.327(2)(e)F.S. 456.035, 458.319(3), 458.327(2)(e)

•• In addition to Profile Rule, lack of address In addition to Profile Rule, lack of address means you may not get renewal means you may not get renewal information.information.

Presigning PrescriptionsPresigning PrescriptionsPresigning PrescriptionsPresigning PrescriptionsF.S. 458.331(1)(aa)F.S. 458.331(1)(aa)

•• ReprimandReprimand•• $5,000 fine$5,000 fine$5,000 fine$5,000 fine•• 2 years probation2 years probation

RenewalsRenewalsRenewalsRenewalsF.S. 458.319F.S. 458.319

•• Handle It Personally!!Handle It Personally!!•• CME and Financial Responsibility CME and Financial Responsibility

Statements are Audited.Statements are Audited.•• Keep CME Certificates at least 2 yearsKeep CME Certificates at least 2 years•• Preventing Medical Errors Course MUST Preventing Medical Errors Course MUST

INCLUDE: study of root cause analysis; INCLUDE: study of root cause analysis; error reduction, prevention and patient error reduction, prevention and patient safety, and the 5 most misdiagnosed safety, and the 5 most misdiagnosed

ditiditiconditionsconditions

Friends and FamilyFriends and FamilyFriends and FamilyFriends and FamilyF.S. 458.331(1)(r) and 458.331(1)(m)F.S. 458.331(1)(r) and 458.331(1)(m)

•• Prescription creates physician/patient Prescription creates physician/patient relationshiprelationship

•• Even family members need recordsEven family members need records•• Spouses/friends are not alwaysSpouses/friends are not always•• Spouses/friends are not always Spouses/friends are not always

spouses/friendsspouses/friends•• No selfNo self prescribing of controlledprescribing of controlled•• No selfNo self--prescribing of controlled prescribing of controlled

substancessubstances

Internet PrescribingInternet PrescribingInternet PrescribingInternet PrescribingF.S. 458.331(t) and F.A.C. 64B8F.S. 458.331(t) and F.A.C. 64B8--9.0149.014

•• NO Prescribing without History and InNO Prescribing without History and In--person Physicalperson Physical

•• Exception for Call CoverageException for Call Coverage

Records RetentionRecords RetentionRecords RetentionRecords RetentionF.A.C. 64B8F.A.C. 64B8--10.00210.002

•• Must maintain records for at least five Must maintain records for at least five years (statute of repose is seven)years (statute of repose is seven)

•• Must notify patient by sign or letter where Must notify patient by sign or letter where records may be obtained if physician records may be obtained if physician eco ds ay be obta ed p ys c aeco ds ay be obta ed p ys c amovesmoves

•• Newspaper notice and notify BOM 30 daysNewspaper notice and notify BOM 30 days•• Newspaper notice and notify BOM 30 days Newspaper notice and notify BOM 30 days BEFORE you moveBEFORE you move

•• Complete hospital charts before moveComplete hospital charts before move•• Complete hospital charts before moveComplete hospital charts before move

Impaired PractitionersImpaired PractitionersImpaired PractitionersImpaired PractitionersF.S. 456.076F.S. 456.076

•• No discipline if physician selfNo discipline if physician self--reports to reports to PRN before problem is reported to BOMPRN before problem is reported to BOM

•• Must comply with PRN contractMust comply with PRN contract•• Excellent Track RecordExcellent Track Record•• Excellent Track RecordExcellent Track Record•• PRN will help at BOM if physician complies PRN will help at BOM if physician complies

with contractwith contractwith contractwith contract