The Crisis of Non-Reporting:
Where does this go
JH Lange - Presenter
Co-authors/contributors
Luca Cegolon
Giuseppe 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 reporting
Marschev, 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 public
Marschev, 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
Marschev, et al., 2003
Quality improvement
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. §13G3-1011303,910),(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 incidents
Applies to 525 health care facilities and 700
Nursing homes
Comparing apples and oranges
these 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?
Marschev, et al., 2003
Blame for errors
Mistakes happen
Most put blame on an individual
Common is intimidation – blame for error
Protection of institution and management
Lack of real/practical training
Creates a culture of under-reporting
Tied 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 error
Chamberlain et al., 2012
Colorado – under reporting
First two years – 17 reports
Next ten years – 1,000 reports
New York – 20,000 reports
annually
Journal Editorial Staff, 2008
Rate per resident/100,000
Indiana – 1.75
Minnesota – 2.25
Wyoming – 2.75
Washington – 2.85
Connecticut – 4.75
New Jersey – 5.20
Journal Editorial Staff, 2008 (approximate rates)
Variation in what is reported
Hospital -Acquired infections
California – not necessary (related to adverse
event)
Colorado – Yes
Florida – No
Indiana – 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 data
Porapakkham, 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 diseases
Colorado and Connecticut
Do they both have the same infectious diseases?
Payment Systems
Pay for performance
California - None
Florida - None
Pennsylvania – 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 - $127K
Nalder, 2010
Purpose of reporting system
determines disclosure - Colorado
Purpose of System
Disclosure
“…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.”
State disclosures
facility-identified and
individual incident
data.
Marschev, et al., 2003
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
Disclosure
State 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
trends
The information would be included in health
care quality reporting systems
This is a some what epidemiological approach
Marschev, et al., 2003
Mandatory reporting – What
information is disclosed
What type and amount of information
provided?
Individual
Incident-specific
Aggregate
Marschev, et al., 2003
Type of Information Disclosed
Type of report
Periodic
Aggregate reports
Colo Minn Penn Utah
X
X
Facility specific
Aggregate information X
X
Individual Incidents X
Marschev, et al., 2003
X
X
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., 2003
Marschev, 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 accountability
Also depends on who can access
information
Why report to be listed
Most state only report aggregate data
Marschev, et al., 2003
Content of reports - Examples
Content
Colorado
Utah
Description information
X
X
Authority reporting system
X
Define reportable events
X
Number incidents reported
X
Number/type incidents-facil X
Under-reporting as problem
X
Recommendation-improv
X
X
Marschev, et al., 2003
Minnesota/Indiana – reportable
events
Has 28 types of events
Categories
Surgical
Product or device
Patient protection
Case Management events
Environmental 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
Information
Marschev, 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 enforcement
Marschev, 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 benefit
Marschev, et al., 2003
Common Data Protections
• HIPAA regulations
• Individual incident reports
• Provider identifiers
(individual/institutional)
• Material generated in peer review
Marschev, et al., 2003
Trend relating to greater protection
Pre-1999
Comprehensive
Colorado
Protection – specific Florida
Kansas
New York
Post-1999
Connecticut
Georgia
Maine
Minnesota
Nevada
Pennsylvania
Tennessee
Texas
Trend relating to greater protection
Unprotected data
Or depends on peer
Review
Marschev, et al., 2003
Pre-1999 Post-1999
California Utah
Ohio
Massachusetts
New Jersey
Rhode Island
South Carolina
South Dakota
Washington
Legal Protections – problem with
comparison
Data excluded from open
Record
Not discoverable
Not subject to subpoena
Admissible in disciplinary
Procedure
Data confidential
Marshev, 2008
Colo
X
PA
X
Utah
X
X
X
X
X
X
X
X
X
X
X
Summary
Personnel afraid to report
Institution create culture for
under-reporting
Inconsistent criteria among
states
Lower 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-eventanderson-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-likelygo-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