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Overview - Part I. INTRODUCTION
States Patient Safety Reporting Options

  • •  37 States with Patient Safety Initiatives

    State initiatives addressing patient safety exist in many recognizable forms. In this summary, an attempt has been made to assess involvement in public and private initiatives that are designed to reach out to every facility and/or healthcare provider.1 For purposes of this analysis, 5 different forms of public or private Patient Safety Initiatives are addressed including:

    • 1.  Adverse Event Reporting (with/without Physician Reporting) that has evolved in 28 States beginning in the mid-1970s,
    • 2.  Patient Safety Coalitions (PSC) that evolved in 19 states since their inception in 1997; 16 of these States maintain active PSCs in 2006.
    • 3.  Outcomes Reporting of cardiac and non-cardiac procedure outcomes and outcomes assessment of targetted patient groups or diagnoses that have evolved in 14 States since 1990,
    • 4.  Other Reporting Options that do not fit into other categories – (2 state initiatives reporting medication-errors and 1 reporting JCAHO's National Patient Safety Goals (NPSGs) compliance comprise this category), and
    • 5.  Patient Safety Centers that coordinate public/private patient safety initiatives in 6 states since 2000.]

    1   Not included in this analysis are Patient Safety reporting initiatives that extend to all States and that reflect facility-level initiatives as opposed to initiatives that reflect public policy or privately-supported consensus.

    Examples include CMS' Hospital Compare initiative that grades compliance with healthcare processes in limited numbers of targeted health conditions for over 4,000 participating hospitals nationwide. The participation of facilities in voluntary initiatives sponsored by The Leapfrog Group, the Institute for Healthcare Improvement (IHI), and other private patient safety / medication-reporting groups similarly extend throughout most States.

    HOWEVER, participation in these voluntary initiatives are aimed at facilities, and facilitly participation does not necessarily reflect public policy or consensus across States; decisions regarding participation are made at the facility level. Information regarding participation in these initiatives is available at the websites for these entities.

  • •  32 States with one or more Reporting Programs

    State reporting programs are diverse and often tailored to meet policy or individual goals of the State. As demonstrated in the adjacent map, reporting programs exist in some form in 32 states and do not exist in any form in 18 states and the District of Columbia.

    In States where reporting programs exist, they are 90% mandatory, reflecting public policy of the State. However, in some States, public policy does not support reporting programs and/or gives way to the policy initiatives of private stakeholders. Programs in these States are voluntary and derive from the singular or joint efforts of private organizations, usually the State Hospital Association and/or the State's Quality Improvement Organizations, with occasional private funding from non-public stakeholders. Sometimes pubic and private initiatives are addressed collaboratively with funding and administrative support reflecting local circumstances/compromises.

  • •  Examples of Marked Variations in Public Policy Across States

    Clearly State reporting programs are not monolithic, and they often are in flux and evolve with changes in support and budgets. Public policy often reflects an amalgamation of public and private supports. For example,

    • ◊  Minnesota

      Minnesota has implemented only one type of reporting program, . . . i.e., event reporting. The mandatory Minnesota program began reporting in 2004 using the NQF's 27 ‘Never’ Events. The program was only sustained in its first year of operations because of the generous financial support of private stakeholders and the management of the Minnesota Hospital Association. The program was turned over entirely to the State regulatory authority in December 2004.

    • ◊  Oregon

      Oregon's confidential voluntary reporting of ‘serious adverse events’ evolved from medical error reporting legislation [Oregon Law 2003, Chapter 686] that created the Oregon Patient Safety Reporting Program under management of the The Oregon Patient Safety Commission (OPSC) that was created as a semi-independent, non-regulatory state agency. The legislation was generated by broad sponsorship of multiple key stakeholders who continue to support the program both financially and operationally. Facilities participate voluntarily and contribute to the operational costs, and State legislators are apprised of operations by annual reports.

      Consistent with Oregon's "voluntary" approach, the privately-funded Oregon Hospital Outcome (OHO) Project has provided risk-adjusted Coronary Artery Bypass surgery outcomes for 2002-2004 low-risk patients from 10 of Oregon's 12 heart centers that agreed to participate.

    • ◊  Maryland

      Maryland has a similar collaborative process that includes a mandatory adverse event reporting to the State regulatory authority and a voluntary Maryland Patient Safety Center (MPSC ) that is designed to receive ‘near-miss’ medical errors and promote public/private collaborations. The MPSC is funded and operated in its first 3-years of operation by the Maryland Hospital Association and Delmarva Foundation, the QIO for Maryland. However, state-approved increases in hospital rates [PDF] serve to alleviate the burden on hospitals and exemplifies the collaboration between the State and key healthcare stakeholders.

    • ◊  Pennsylvania

      Maryland's next-door neighbor Pennsylvania, reflects a State in which publicly mandated outcomes reporting and adverse event reporting programs are imposed upon affected stakeholders with a strong regulatory flavor lacking apparent willing collaboration with the provider community. For example, the Pennsylvania Health Care Cost Containment Council (PHC4) publishes facility (and cardiac physician-provider) report cards for costs and/or outcomes performances across multiple sectors of healthcare, using data generated from facility-mandated reporting. Web-published provider responses to these reports commonly reflect defensive, if not adversarial, responses to the State reports and suggest a dirth of willing collaboration with the provider community.

      In addition, an ambitious and outwardly successful Pennsylvania Patient Safety Reporting System (PA-PSRS) was created as part of Medical Malpractice legislation. The mandatory program has been implemented with funding from annual assessments of $2.5M to $3.0M upon healthcare facilities, who also incur additional operational costs to comply with imposed reporting requirements.

    • ◊  New York

      New York policy reflects a very 'hands-on' regulatory flavor with a combination of outcomes reporting and adverse event reporting programs. New York was the first state in 1990 to impose mandatory cardiac procedure reporting of mortality and other outcomes with public identification of the hospitals and the physicians performing those procedures. In addition to documented improvement in mortality outcomes across the State, interventions by State regulatory agencies have led to changes in the mix of physician and facility providers performing cardiac procedures.

      The New York Patient Occurrence Reporting and Tracking System (NYPORTS) is one of the more successful and well-supported adverse event reporting programs across all US States, and New York State officials have made strong efforts to provide meaningful feedback to facility providers. However, the NY State Health Department, in addressing the department's perception of significant under-reporting of adverse events, has often raised the spectre of regulatory authority, and threatened non-reporting facilities, stating,

      "For those hospitals that have ignored these critical reporting requirements, we will identify you, single you out and sanction you in a public forum." [PDF - Health Affairs, p. 287, May/June 2001]

  • •  Organization of Discussion of Reporting Programs

    The analysis of States that follows is segregated into 7 distinct sections (including this Introduction), so as to provide historical perspective and discuss public and private reporting options and those States that have no patient safety initiatives or reporting initiatives under the umbrella of public policy. Patient Safety Coalitions, patient safety initiatives that reflect variable degrees of public and private collaboration and effectiveness across States, are analyzed and discussed elsewhere. Five sections include discussions and links for each of 4 major reporting option categories, plus a discussion of non-reporting States. These reviews are followed by a summary section.


Comparing Adverse Events Definitions

Adverse event reporting programs provide definitions for each of the reported adverse events. Experience has demonstrated that most of these definitions are imprecise with lots of interpretive ‘wiggle room’ that often results in definition ambiguity from multiple perspectives, most importantly from the perspective of the reporting institution. Definitions ambiguity varies by state.

The NQF and JCAHO have provide definitions of reportable events, the NQF providing a list of 27 Serious Reportable Events in Health Care and JCAHO providing Reviewable Sentinel Events, plus other lists of sentinel events on its website.

Some States' definitions preceded NQF and JCAHO definitions. In varying degrees, States with adverse events reporting programs have adopted definitions from NQF, JCAHO, or home-grown sources with the end result that no two states have the same definitions for adverse events and very few States report similar events. Even States with adverse event definitions patterned after NQF and/or JCAHO definitions include significant changes from those definitions.

States with Adverse Event DefinitionsAn Adverse event Definition Database includes over 650 definitions from the NQF, JCAHO, and 30 states that provide definitions for their voluntary and mandatory reporting programs. Included within this adverse event database are outcomes reporting program definitions used in two States. 10 of Ohio's 11 reportable measures are outcomes, so that Ohio does not have a true adverse event reporting program. North Carolina's voluntary medication-related error reporting in nursing homes is also an outcomes reporting program. Kansas and Nebraska report only physicians in association with adverse events and more-properly might be termed "physician-reporting programs."

The definitions have been aggregated into similar topic categories for comparison, and each aggregate group is broken down into groups of similar versions of the adverse event definition. For some definitions, only one or two definition versions may exist, whereas other adverse events may have as many different definition versions as there are contributing states and organizations. Some of the differences are subtle and some are profound. Users are encouraged to peruse definitions to understand the significance of these differences.

Links to the statutes, administrative rules, and/or definition guidelines are provided in the definitions database.



Figure 1.
Number of Specified Reportable Events
– 30 States, JCAHO, and NQF –

STATE DEFINITION ORIGINS NUMBER LISTED EVENTS
ICD-9 Occurence Codes
54
ICD-9 Occurence Codes
48
NQF (modified) + Unique
34
NQF (modified) + Unique
34
NQF + Unique
33
Unique
33
JCAHO + Unique
30
NQF (modified) + JCAHO
30
NQF
27
NQF
27
NQF
27
NQF
27
NQF (modified)
27
Unique
26
JCAHO + Unique
23
JCAHO + Unique
21
JCAHO
19
Quantros, Inc.
18
Unique
17
Unique
14
JCAHO + Unique
14
JCAHO + Unique
13
JCAHO + Unique
12
JCAHO + Unique
11
Ohio***
Unique (10 outcomes)
11
JCAHO, (?NQF in 2007)
10
Unique
10
Unique
7
Unique
5
Unique
3
Unique
1
Unique
1
Unique
0
 
 
*   JCAHO definitions based on JCAHO's ‘voluntary reportable sentinel events’ and other examples of sentinel events published on JCAHO's website. These definitions do not include the myriad of sentinel events defined via JCAHO's policy that requires organization-specific sentinel events.
 
**   West Virginia's definitions are based on the listing of Occurrence Type Categories provided by Quantros, Inc.. The Quantros, Inc. Occurrence Report Management System includes 18 major categories of Occurrence Types, each of which contains one or more reportable adverse event. The Quantros, Inc. system does not provide definitions for these events or the criteria for event reporting.
 
***   Ohio and North Carolina have outcomes reporting programs. Ohio's 11 events are included in this list, but only 1 is an adverse event and 10 of the 11 are outcome measures that are required for 6 types of health care facilities. North Carolina reports aggregate outcomes for medication-related errors in nursing homes. Therefore, while Ohio and North Carolina report patient safety measures, they do not have true adverse event reporting programs.
 
****   Maryland has released partially analyzed aggregate data for Level 1 Adverse Events only [PDF]. As defined by statute, each hospital is required to "list and describe examples of adverse events that shall be reported," thereby developing a unique hospital-specific list of Level 1 adverse events [COMAR 10.07.04B(2)]. As such there is no definition consistency across hospitals in the state, a situation reminiscent of JCAHO's methodology of requiring organization-specific definitions of sentinel events.
 

Summary of Facility Participation in States's
Incident and Outcomes Reporting Programs


  • •  HOSPITALS

    Hospitals compose the largest group of facilities/entities that are targeted to provide and report data. Among the 32 States with some form of reporting program, 30 States have some form of hospital reporting. Among these 32 States, only New Mexico and North Carolina have no hospital reporting options. Reporting Options by hospitals are detailed in the table below.

    TYPES OF HOSPITAL REPORTING
    State Incident
    Reporting
    Non-cardiac
    Outcomes
    Cardiac
    Outcomes
    Other
    1.CAXXXX
    2.COXX
    3.CTX
    4.FLX
    5.GAX
    6.ILXX
    7.INX
    8.KSX
    9.MEXX
    10.MDX
    11.MAXX
    12.MNX
    13.NEX
    14.NVX
    15.NJXX
    16.NM
    17.NYXXX
    18.NC
    19.OHXX
    20.ORXX
    21.PAXXX
    22.RIXXX
    23.SCX
    24.SDX
    25.TNX
    26.TXXX
    27.UTX
    28.VAX
    29.WAX
    30.WVX
    31.WIX
    32.WYX
    TOTALS27 25992
    X  = States (KS, NE) that report physicians only and that have been misclassified historically as incident reporting programs
    • ◊  Mixed Classification of Hospitals

      A hospital in one state is not necessarily a hospital in another State.

      Most States require licensure and recertification based on inspection and maintenance of quality standards, whereas some States like Ohio in abandoning Certificate of Need (CON) have no licensure requirement, except for 6 categories of freestanding health facilities. Consequently, Ohio government has no authority to mandate hospital incident reporting programs, (although the legislature provided that selected hospital sub-specialty services are subject to quality review via outcomes reporting).

      More commonly the differences among States is simply related to how the States choose to classify health facilities. Dissimilar classifications across States are common. Some examples include:

      • √  MARYLAND – Maryland's statute MD Health-General Code §19.307 hospital classification includes four distinct types of hospitals: General hospitals, Special Hospitals (e.g., Orthopedic, Mental Health/Psychiatry, Children's hospitals, etc.), Special Rehabilitation Hospitals, and Limited services hospitals (e.g., Critical Access Hospitals).
      • √  FLORIDA – In defining licensed facilities that must report in its incident reporting program, a Florida hospital "regularly makes available at least clinical laboratory services, diagnostic X-ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent.." By this definition, certain specialty hospitals and rehabilitation hospitals defined as hospitals in Maryland are not hospitals in Florida.
      • √  MINNESOTA – Minnesota law does not segregate hospitals nor provide definitions for subtypes of hospitals so that there is no designation in law for any specialized hospitals, including Psychiatric Hospitals.
      • √  PENNSYLVANIA – Pennsylvania law includes rehabilitiation facilities, but specifically excludes Psychiatric Hospitals from inclusion as "hospitals." Indiana similarly excludes any psychiatric hospital as a type of hospital.

      Therefore, States agree that general acute hospitals meet the definition of "hospitals," there is lack of agreement as to what specialty hospitals (if any) are included as hospitals.

    • ◊  Incident Reporting Hospitals

      The 28 Incident Reporting program States, 27 of which have hospital participation, are discussed in greater detail in the national Overview, Part III. Of all States incident reporting programs, only New Mexico has no hospital incident reporting. The hospital participants in this group includes

      • √  21 States with a single mandatory program,
      • √  1 state with 2 mandatory programs (Massachusetts),
      • √  1 State with both voluntary and mandatory reporting programs (Georgia),
      • √  2 States with voluntary programs (Oregon, West Virginia), and
      • √  2 States that have been historically misclassified as incident reporting states (Nebraska, Kansas).1

      Therefore, 25 States have HOSPITAL incident reporting programs.


      1   Kansas and Nebraska are not true incident reporting programs, although both States have been referenced in literature as having adverse event reporting programs.2 They are more properly termed "physician reporting" programs since only a physician must be reported. In Kansas, the "reportable incident" is "an act by a health care provider," while Nebraska administrative rules require reporting of "gross Incompetence or a pattern of negligent conduct," whether associated with an adverse event or not. Neither State provides lists or definitions of incidents that might qualify as reportable events in State laws or regulations.

      2   Rosenthal J and Booth M, "Defining Reportable Adverse Events: A Guide for States Tracking Medical Errors," National Academy for State Health Policy, GNL50; March 2003. [PDF, p6]


    • ◊  Outcomes Reporting Hospitals

      Unlike most incident reporting programs, outcomes reporting is usually published by facility or provider, as designated by State laws or rules.

      The 13 Outcomes Reporting program States are discussed in greater detail in the national Overview, Part IV. With one exception (Virginia), these 13 States with some form of outcomes reporting also have mandatory or voluntary (Oregon) incident reporting programs. 5 States have more than one type of outcome reporting, as listed below, and California and Pennsylvania have more than one non-cardiac outcome reporting program.

      TYPES OF HOSPITAL OUTCOME REPORTING
      State AHRQ
      IQIs
      Non-cardiac
      Outcomes
      Cardiac Outcomes Reporting
      Facility
      Only
      Facility &
      Physician
      1.CAXX
      2. COX
      3. ILX
      4. MEX
      5. MAX
      6. NJX
      7. NYXX
      8. OHXX
      9.ORX
      10.PAXX
      11. RIXX
      12. TXX
      13.VAX
      TOTALS4554
    • ◊  Hospitals with Other Reporting

      The 3 States with ‘Other’ reporting programs that are not incident reporting or outcomes reporting programs are discussed in greater detail in the national Overview, Part V. Two of these programs (California and Wisconsin) require reporting by hospitals. Wisconsin's voluntary and privately-supported CheckPoint program for reporting of hospital compliance with JCAHO National Patient Safety Goals is the sole reporting program in Wisconsin for hospitals. California's medication-error reporting is a mandatory reporting program that provides multiple options via which to achieve compliance.

  • •  Ambulatory Surgical Centers / Facilities (ASCs / ASFs)
  • •  Birthing Centers
  • •  Psychiatric Hospitals
  • •  Physicians / Clinics
  • •  End Stage Renal Disease (ESRD) Facilities
  • •  Nursing Homes
  • •  Rehabilitation Facilties
  • •  HMOs
  • •  Other

Summary of States' Policy toward Disclosure

  • •  Disclosure to Patient

    Ten (10) states since 2002 have implemented public policy that mandates disclosure of adverse events / medical errors to the patient and/or family.

    By the Tennessee Governor's signature to the Health Data Reporting Act of 2002 on March 19, 2002 . . .(just one day before the MCARE law [PDF] was signed by Pennsylvania's Governor) . . . , the State of Tennessee became the first of ten States through 2005 to require facilities or physicians to notify patients or family of a reported event. In three of these states, policy has been implemented via promulgation of administrative rules. The legislatures in seven (7) other States have passed laws to require notification of patients and/or family of adverse events.

    South Carolina implemented regulations for ambulatory surgery centers only (SC Code Regs. 61-91-601(A)), mandating:

    "Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence."

    Regulations for Maryland were promulgated for hospitals only. Connecticut DPH began on July 1, 2004 to include a separate space within the Adverse Event Reporting Form [PDF] where facilities indicate 1) whether notification of patients and/or the authorized representative occurred, and 2) the date of notification . Since Public Act No. 02-125, §3(e) requires the Commissioner of the DPH to codify an adverse event reporting form and system in regulations, these questions ultimately reflect DPH regulations.

    The 7 States passing statutes to implement this public policy include Florida, with separate requirements for hospitals and physicians, Nevada, New Jersey, Oregon, Pennsylvania, Tennessee, and Washington.

    Several states have passed ‘Apology’ / ‘I'm sorry’ laws that permit providers to extend apologies to patients and/or family for adverse events and errors without permitting these statements to be used against providers in potential future medical malpractice actions. In this analysis, these VOLUNTARYApology’ laws are distinct and separate entities from mandatory notification.

  • •   Morality: The Most Compelling Argument for Disclosure

    A Consensus statement of Harvard Hospitals published in March 2006, "When Things Go Wrong: Responding to Adverse Events" [PDF], makes a strong moral argument for disclosure:

    "We are making a moral argument here, not a business case or an evidence-based clinical guideline. Where there are published data or empirical evidence to support a practice, we cite them, but our primary justification is moral. We are committed to full disclosure because it is the right thing to do. The patient and family have the right to know what happened. In addition, honest communication promotes trust between the patient and provider, so that the primary focus of the clinician-patient relationship remains patient care. Further, open discussion about errors can promote patient safety by encouraging clinicians to seek systems improvements that minimize the likelihood of recurrence."

    The consensus statement also refines the definition of "disclosure:"

    "Disclosure:  Providing information to a patient and/or family about an incident. Because this term suggests revealing of privileged information and implies an element of choice, in this document we use instead the term communication, by which we wish to convey a sense of openness and reciprocity"

    It is highly likely that most providers believe their health care is guided by strong moral values, and it is fruitless to assume that changes in individual behavior addressing disclosure will result from health policy decrees similar to the 10 states enumerated above. Consequently, it is incumbent upon institutions to implement significant institutional requirements that facilitate the management and communications with patients surrounding adverse events. The Harvard consensus document clearly identifies the key and central role of the clinician / physician in disclosure of adverse events to patients, and it identifies opportunities for improvement and a framework for assuring that disclosure is guided by a moral compass. These changes are consistent with positions advocated by several professional physician societies, and they emphasize the need to integrate clinicians into institutional protocols.


Comparative Summary of States' Adverse Event
Reporting and Performance Experiences

Comparative Summary of States' Adverse Event
Reporting and Performance Experiences
  • •  13 states publish Adverse Events / Medical Error Data

    Reporting by States of adverse event data on the Internet did not begin until 1999-2000. Aggregate data of reportable event performance are available for hospitals in 13 states in 2006. However, in Colorado and Washington, these aggregate data are only available to the Public upon request, and this raw facility-identified data must be collated and analyzed to make it interpretable.

    Among these 13 States, facility-identifed data is available in three States. Only Minnesota provides a partial facility-level analysis on the Internet. Colorado publishes redacted adverse event data by occurrence and by facility on the Internet but does not collate or compare facilities. Washington data prior to June 7, 2006 is available for facility-level and aggregate data analysis.1 Although not reporting in 2006, nascent programs in Illinois and Indiana indicate an intent to report facility-identified data on the Internet by 2008.

    Ten (10) States (CT, FL, MA, MD, ME, NY, PA, TN, TX, UT) have published only aggregate State data for reportable events in variable depth. These States provide no facility-identified information. Wyoming's new program will publish only aggregate facility data beginning December 31, 2006, and Washington's revised program will begin reporting aggregate data on January 1, 2008.

  • •  Numbers of Specified Events and Definition Origins

    States collect data with different measures and/or different definition origins, including:

    • ◊  NQF's 27 ‘Never’ Events Definitions: 2 states - (Connecticut and Minnesota) use NQF definitions; Connecticut also reports 6 state-specific adverse events. Illinois and Indiana anticipate reporting facility-identified NQF data beginnning in 2007.
    • ◊  ICD-9CM Occurrence Codes Definitions: 2 States, New York and Tennessee, utilize Occurrence Codes based on International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) taxonomy of administrative data. New York uses 54 discrete measures, whereas Tennessee includes 48 measures.
    • ◊  Unique State-specific Definitions: 5 states (Colorado, Connecticut, Florida, Maryland, Massachusetts) employ unique state reportable event definitions; (Connecticut has 6 state-specific measures, in addition to 27 NQF measures).
    • ◊  JCAHO Definitions: 5 states (Maine, Pennsylvania, Utah, Texas, Washington1) utilize varying numbers and versions of JCAHO's ‘voluntary reportable sentinel events.’

1   Washington facility-identified data are no longer available to the public after mid-2006 due to changes in the reporting program. Washington will provide only aggregate state data after the switch to NQF definitions on June 7, 2006.


– Figure 1.  Specified Reportable Events –
Numbers and Definition Origins in
13 States that Publish Aggregate State Data

 
STATE DEFINITION ORIGINS NUMBER LISTED EVENTS
 
ICD-9 Occurrence Codes
54
ICD-9 Occurrence Codes
48
NQF + Unique
33
Unique
33
NQF
27
NQF
27
JCAHO + Unique
21
JCAHO
19
Unique
17
Unique
14
JCAHO + Unique
13
JCAHO + Unique
12
JCAHO
11
JCAHO
10
Unique
5
 
 
*   JCAHO definitions based on JCAHO's ‘voluntary reportable sentinel events’ and other examples of sentinel events published on JCAHO's website.
**   Maryland has released partially analyzed aggregate data for Level 1 Adverse Events only [PDF]. As defined by statute, each hospital is required to "list and describe examples of adverse events that shall be reported," thereby developing a unique hospital-specific list of Level 1 adverse events [COMAR 10.07.04B(2)]. As such there are no standard definitions for reportable events across hospitals in the state.
  • •  Literature Documenting Medical Errors / Adverse Events Problem

    The two key publications supporting the IOM's To Err is Human are the Harvard Medical Practice Study (HMPS) published in 1991 that utilized 1984 New York discharge data[1] and a study published in 2000 that used 1992 Colorado and Utah discharge data.[2]

    [1] [Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH, "Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I." N Engl J Med 1991; 324:370-6.] (Reprint available at Qual Saf Health Care 2004;13:145-151)
    [2] Thomas EJ, Studdert DM, Burstin HR, Orav EJ, Zeena T, Williams EJ, Howard KM, Weiler PC, Brennan TA, "Incidence and types of adverse events and negligent care in Utah and Colorado." Med Care 2000; 38:261-71

    The HMPS is useful in developing a scheme for standards and/or expectations for interpreting reported adverse events across States. The table below reveals the categories of incident adverse events (AEs) and negligent adverse events (NAEs) by % that were uncovered in the HMPS. A similar categorization was not created in the Utah/Colorado study.

Table 1.  
HMPS Categories of incidence of
Adverse Events (AE) and Negligent Adverse Events (NAE)

Category AE Timing relative to Index Hospitalization AE (%) Negligent
AE (%)
Time of Occurrence Time of Discovery
1
During
During
50.6 % 51.0 %
2
During
After – OutPatient
6.1 % 2.3 %
3
During
After – Later Hospital Stay
5.2 % 6.2 %
4
During or Before
During
13.1 % 19.3 %
5
Before
During
25.0 % 21.2 %

The data published by both New York and Colorado/Utah studies provided incident values for AEs and NAEs for events that were discovered during the index hospitalization and which occurred either during or prior to the index hospitalization. HMPS categories 1, 4, and 5 satisfy this criterion, leaving out categories 2 and 3, and these are the incident categories that make up the data that is used as the foundation for reported incidence of medical errors in the IOM study, To Err is Human.

However, State reporting programs for adverse events and medical errors do not follow this temporal methodology. State programs provide instructions for TEMPORAL monitoring of only HMPS category 1 events that occur during and are discovered during the index hospitalization. In the table below, the temporal category of State reporting (category 1 only) is compared to all event categories identified in the HMPS (categories 1+2+3+4+5), and to the events reported in the HMPS and by the IOM (categories 1+4+5). These category 1 adverse events make up a little over half of all adverse events and negligent adverse events noted in the 1984 New York dataset and slightly more than less than 60% of the AEs and NAEs reported in the IOM study.

Table 2.  
HMPS Adverse Event Incidence Summary by
Category of New York 1984 Discharge Data

Category Category Timing
Relative to Index
Hospitalization
SAMPLE DATA POPULATION DATA*
Total
AEs
Total
NAEs
Total
AEs
Total
NAEs
Events per
100,000 DCs
Occurrence Discovery AEs NAEs
Sum
(1,2,3,4,5)
During or Before During or After 1,278 306 111,461 29,812 4,172 1,116
Sum
(1,4,5)
During or Before During 1,133 280 98,608 27,179 3,691 1,017
1 During During 647 156 55,046 15,257 2,060 571
 
* Population numbers based on 1984 New York Discharge volume of 2,671,863

Based upon this data from the HMPS, the interpretation of this table is that State adverse event reporting programs that predominantly measure events that both occur and are discovered during an index hospitalization will yield

2,060 Adverse events per 100,000 hospital discharges AND

571 Negligent Adverse Events per 100,000 hospital discharges.

These numbers assume that all categories and types of adverse events that were measured in the HMPS are measured and properly recorded. Since most State programs report a subset of all recognized adverse events, it is unlikely that most States' reporting programs would ever satisfy these criteria, even under an assumption of full reporting compliance.

  • •  Comparison of State Reported Medical Errors / Adverse Events

Table 3.  
Adverse Events and Hospital Discharges
with Indexed Incidence Values

State /
Entity
Reporting
Year(s) and
Reportable
Events
Population Totals Events per
100,000 Discharges
Hospital
AEs
Hospitals
Discharges
Aggregate
Number
Indexed to
MN (NQF)*
HMPS-NY1 1984 All 55,046 2,671,863 2,060 141
New York 2001 54 28,689 2,473,930 1,160 80
Pennsylvania 2004-2005 21 28,689 1,702,971 407 28
Tennessee 2004 48 1,313 773,598 170 12
Massachusetts 2001-2004 33 2,010 3,305,147 60.8 4.2
Colorado 2000-2004 14 1,404 2,314,649 60.7 4.2
Connecticut2 2004-2005 33 206 500,169 41.2 2.8
Florida 2000-2004 17 4,287 11,838,434 36.2 2.5
Maryland 2004-2005 5 237 1,340,508 17.7 1.2
Minnesota3 2004-2005 27 202 1,384,892 14.6 1.0
Connecticut3 2004-2005 27 72 500,169 14.4 1.0
Maine 2004-2005 10 50 315,624 15.8 1.1
Utah 2002-2004 13 108 780,780 13.8 0.9
Washington 2000-2004 12 269 2,775,574 9.7 0.7
Texas4 2004-2005 11 184 2,565,007 7.2 0.5
* Events per 100,000 discharges are indexed to Minnesota's NQF-based event definitions
1 Harvard Medical Practice Study Events numbers based solely upon events that occurred and were discovered during index hospitalization
2 NQF + 6 Connecticut-specific Events
3 NQF Events only
4 Texas collects data with each facility's annual license renewal, so that first year of data represents composite of 12 different monthly collection periods.
Negligent Adverse Events
NY (1984) – HMPS
TX
All Adverse Events
Occurring and Discovered during Hospitalization
NY (1984) – HMPS

Figure 2.  
Index Of Hospital Reportable Events
per 100,000 Discharges by State

STATE & YEAR INDEX RELATIVE TO MN
New York - HMPS (1984)
Discharges - Adverse Events
Discharges - Negligent AEs

141
39

Based upon projections from the Harvard Medical Practice Study, these adverse events represent the same proportion of adverse events that occurred during and were discovered during the index hospitalization. The HMPS did not measure adverse events per patient-day.
New York (2001)
Discharges
Patient-days

80
60

Pennsylvania (2004)
Discharges
Patient-days

28
26

Tennessee (2004)
Discharges
Patient-days

12
11

Massachusetts (2002-04)
Discharges
Patient-days

8.3
7.7

Colorado (2000-04)
Discharges
Patient-days

4.2
4.8

Florida (2000-04)
Discharges
Patient-days

2.5
2.3

Connecticut ALL (2004-05)
Discharges
Patient-days

2.8
2.6

Connecticut NQF (2004-05)
Discharges
Patient-days

1.0
0.9

Maryland (2004-05)
Discharges
Patient-days

1.2
1.1

Maine (2004)
Discharges
Patient-days

1.1
1.0

Minnesota (2004-05)
Discharges
Patient-days

1.0
1.0

Utah (2002-04)
Discharges
Patient-days

0.9
1.1

Washington (2004)
Discharges
Patient-days

0.7
0.8

Texas (2004-05)
Discharges
Patient-days

0.5
0.4

 
†   Minnesota used as Referent Group (MN = 1.0)

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