The Crisis of Non-Reporting:Where does this go

JH Lange - PresenterCo-authors/contributors

Luca CegolonGiuseppe Mastrangelo

The Institute of Medicine (IOM) Report in 1999

To Err is Human

Raised the issue of preventable deaths as related to medical care

The IOM report described two different systems for disclosing and reporting errors.

There are two types of reporting systems:

Mandatory reporting

Voluntary reportingMarschev, et al., 2003

VOLUNTARY- Confidential- Fully protected

- Improve patient safety and quality- Broad set of errors – usually no or minimal

harm(used to detect weakness in systems)

Marschev, et al., 2003

Mandatory-Serious/adverse events

-State government collect data-Available to public

publics right to information on unsafe conditions

question how to protect the publicMarschev, et al., 2003

Mandatory Requirements Greatly Vary

• Different definitions• Different time frames• Different information to be reported• Different consequences (criminal, civil,

administrative)• Different confidentiality

Health Compliance Association, 2008

Comparison of IOM recommendations for mandatory and voluntary systems

What is purpose of system

Mandatory Accountability

Voluntary Quality improvement

Marschev, et al., 2003

Comparison of IOM recommendations for mandatory and voluntary systems

Who administers system

Mandatory State

Voluntary Private

Marschev, et al., 2003

State reporting - Pennsylvania

• The Medical Care Availability and Reduction of Error (Mcare) Act. Act 13 of 2002, Act of March 185 2002, PX,. 5 No, 13 (40 P.S. §13G3-101-1303,910),(also Act 52 of 2007)

• Tied to medical liability - Medical Professional Liability Catastrophe Loss

• Patient safety through Department of Health

State reporting - Pennsylvania

Report serious events and incidentsApplies to 525 health care facilities and 700 Nursing homes

Comparing apples and orangesthese are not all the same form of

institution

Examples of errors - Pennsylvania

• Errors in the prescribing, transcribing, dispensing, administering, and monitoring of medications;

• Wrong drug, wrong strength, or wrong dose errors;• Wrong patient errors;• Confusion over look-alike/sound-alike drugs or

similar packaging; • Wrong route of administration errors; • Calculation or preparation errors; and• Misuse of medical equipment.

Examples of errors - Pennsylvania

• Requirements says, not limited to these types of errors

• This information is health care work product

• Disclosure requires identifiers removed• Are rates reported uniform?

Federal Requirements

• Device users facility adverse events (21 CFR 803)• Vaccines health care providers

reports (42 USC 300aa-25)• Blood products (7 CFR 606)Health Compliance Association, 2008

Balancing protection and disclosures

What are the potential dangers of too much disclosure?

• - disclosure of useless information – scare public without explanation

• Potential exists for encouraging under reporting• Fear of malpractice• Lack of due process for reporting• Potential for harm to reputationMarschev, et al., 2003

Blame for errors

Mistakes happen

Most put blame on an individualCommon is intimidation – blame for errorProtection of institution and managementLack of real/practical trainingCreates a culture of under-reportingTied to punishment rather than improvement

Non-reporting - Nurses

In nursing career recall error of medication was 2.2

For incident report, Nurse Managers rate of medication errors was 42.1 percent

Where are the rest? – Bullying, Fear of Punishment, Lack of Training, Non-cooperation with Management

Majd, 2007

Is reporting the real problem

Hospitals capture and report only 14 percent of adverse events

From a sample of 780 patients out of 1 million Medicare beneficiaries in 2008

Roehr, 2012

How much is really missed

The issue is unquestionably under reported

50 to 96 percent unreported

One million errors are preventable annually

Medical judgment of what a medical errorChamberlain et al., 2012

Colorado – under reporting

First two years – 17 reportsNext ten years – 1,000 reports

New York – 20,000 reports annuallyJournal Editorial Staff, 2008

Rate per resident/100,000

Indiana – 1.75Minnesota – 2.25Wyoming – 2.75

Washington – 2.85Connecticut – 4.75New Jersey – 5.20

Journal Editorial Staff, 2008 (approximate rates)

Variation in what is reported

Hospital -Acquired infectionsCalifornia – not necessary (related to adverse

event)Colorado – Yes

Florida – NoIndiana – Optional

Pennsylvania – Yes, but through a separate system

Journal Editorial Staff, 2008

Solutions to what is missed

• Capture-recapture method (CRM)• used in epidemiology and ecology• Determines ascertainment and

undercounts• Can provide a statistical confidence

Lange, 2003

Capture-Recapture Method (CRM)

• Has been applied to counting hazardous waste sites• Considered the gold standard for

counting• Has limitations• Must have at least two independent

sources of data (counts)Lange, 2003; 2003a

CRM - application

• Has been applied to identifying causes of deaths for an accurate estimate

• Could be used for Pharmacy errors – one source from end users and other from preparers

• Here the question is - how many missed medication errors occur (originating from Pharmacy)

• Could use subsamples of dataPorapakkham, 2010

Harm

• What constitutes harm or even a near miss

• What is disclosure?

• Defining criteria for voluntary and mandatory

• Who does this?

Comparisons

Possibly only trends for states

Maybe comparisons among similar reporting items alone

Acquired infectious diseasesColorado and Connecticut

Do they both have the same infectious diseases?

Payment Systems

Pay for performanceCalifornia - None

Florida - NonePennsylvania – Yes (Department of Welfare will provide quality improvement payment

for facility with 10 percent reduction)

Journal Editorial Staff, 2008

Mandatory Reporting

27 States require hospital reporting(2007 – 30 states had some form of reporting requirement)

17 State mandate Pharmacy quality improvement

Brought about by IOM report (1999)

National Association of Boards of Pharmacy, 2011; Health Compliance Association, 2008

Funding

Disparity in funding makes reporting inconsistent among

states• Pennsylvania – $5 million• Minnesota - $410K• Washington - $127KNalder, 2010

Purpose of reporting system determines disclosure - Colorado

Purpose of System

“…to improve access to reliable, helpful, unbiased information concerning the quality of care and the safety of the environment offered by each health care facility.”Marschev, et al., 2003

Disclosure

State disclosures facility-identified and individual incident data.

Purpose of reporting system determines disclosure - Utah

Purpose of System

“…to help the Department and health care providers to understand patterns of systems’ failures in the health care delivery system.”

Marschev, et al., 2003

DisclosureState limits access to identifiable information that facilities reports to the Department in order to enhance compliance and use data for state and system-wide improvement.”

Rhode Island

Here the Department of Health wants to apply these hospital reports for license investigations and for purposes of allowing the public access to aggregated information for all hospitals to track trendsThe information would be included in health care quality reporting systemsThis is a some what epidemiological approachMarschev, et al., 2003

Mandatory reporting – What information is disclosed

What type and amount of information provided?

Individual

Incident-specific

AggregateMarschev, et al., 2003

Type of Information Disclosed

Type of report Colo Minn Penn Utah

Periodic Aggregate reports X X X X

Facility specificAggregate information X X

Individual Incidents XMarschev, et al., 2003

Comparison advantage of aggregate and individual incident reports

Aggregate reports

• Show trends• Enable consumers to

see broad range of possible problems and thus ask appropriate questions about given procedures

• Marschev, et al., 2003Marschev, et al., 2003

Incident-specific report

• Hold individual facilities accountable

• Give customers information that will facilitate choosing safest facility

• Provide sufficient detail to allow through analysis of case

Variation among states

Individual reporting may be a result of no protections setup when first established

This does create accountabilityAlso depends on who can access

informationWhy report to be listed

Most state only report aggregate dataMarschev, et al., 2003

Content of reports - Examples

Content Colorado UtahDescription information X XAuthority reporting system XDefine reportable events XNumber incidents reported XNumber/type incidents-facil XUnder-reporting as problem XRecommendation-improv X XMarschev, et al., 2003

Minnesota/Indiana – reportable events

Has 28 types of eventsCategories

SurgicalProduct or devicePatient protection

Case Management eventsEnvironmental events

Criminal events

Patient

• Type of patient varies

• Type of facility varies

• Amount of services vary

• Conditions vary

How information released

•Website – Colorado (Individual report)

•Website – Most states (aggregate reports)• Request for data – Freedom of

InformationMarschev, et al., 2003

Disclosure Barriers

• Concern data would be invalid and misleading due to underreporting

• Fear of malpractice litigation (creates opposition regarding disclosure)

• State establish cooperation and relationship that is not seen as punitive

Marschev, et al., 2003

Under Reporting

• Lack of effective internal systems• Unclear definitions or requirements• Reporting burden and lack of perceived

usefulness• Fear of liability and negative publicity• Lack of enforcementMarschev, et al., 2003

Why Protect Data

• To encourage full compliance• Legal protections when reporting• Business damage• Fairness and due process• Individual privacy• Why really report – no benefitMarschev, et al., 2003

Common Data Protections

• HIPAA regulations• Individual incident reports• Provider identifiers

(individual/institutional)• Material generated in peer reviewMarschev, et al., 2003

Trend relating to greater protection

Pre-1999 Post-1999Comprehensive Colorado ConnecticutProtection – specific Florida Georgia

Kansas Maine New York Minnesota

NevadaPennsylvaniaTennesseeTexas

Trend relating to greater protection

Pre-1999 Post-1999Unprotected data California UtahOr depends on peer OhioReview Massachusetts

New JerseyRhode IslandSouth CarolinaSouth Dakota

WashingtonMarschev, et al., 2003

Legal Protections – problem with comparison

Colo PA UtahData excluded from open X X XRecordNot discoverable X X XNot subject to subpoena X XAdmissible in disciplinary X XProcedureData confidential X X X Marshev, 2008

Summary

Personnel afraid to reportInstitution create culture for under-reportingInconsistent criteria among statesLower rates hide problems

References• Chamberlain CJ. (2012). Disclosure of “nonharmful”

medical errors and other events: duty to disclose. Arch Surg 147:282-286.

• Health Compliance Association (2008). HCCA’s 12th Annual Compliance Institute (April 13-16, 2008), New Orleans, LA (www.ebglaw.com/.../19269_health-event-anderson-hcca_compliance...)

• Journal Editorial Staff. (2008). A national survey of medical error reporting laws. Yale Journal of Health Policy, Law and Ethics. IX:1

• Lange JH, Chang YF, LaPorte RE, Mastrangelo G.(2003). Hazardous waste site frequency: use of the capture-recapture method. Toxicol Ind Health. 2003;19:109-13.

• Lange JH, LaPorte RE. (2003a). Severe acute respiratory syndrome: capture-recapture method should be used to count how many cases of SARS really exist. BMJ. 21;326 (7403):1396.

• Majd T et al., (2007). Rate, causes and reporting of medication errors in Jordan: nurses’ perspectives. J Nursing Mgt. 15:659-70.

• Marshev M, et al., (2003). How states report medical errors to the public: issues and barriers. National Academy for State Health Policy, Portland, (www.nashp.org)

• Nalder E. (2010). Lawmaker: state’s medical-error reporting needs upgrade. www.seattlepi.com/.../Despite-law-medical-errors-likely-go-unreporte...

• National Association of Boards of Pharmacy (Jan., 2011). Medication error reporting: CQI programs offer avenue to vital follow-up. (NABP News Letter)

Porapakkham Y, Rao C, Pattaraarchachai J, Polprasert W, Vos T, Adair T, Lopez AD. (2010). Estimated causes of death in Thailand, 2005: implications for health policy. Popul Health Metr. 8:14

Roehr B. (2012). US hospital incident reporting systems do not capture adverse events. BMJ, Jan 13, 2012:e386