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– KANSAS –
Public and Private Policy
Medical Errors and Patient Safety

Overview

  • •  1986 Medical Malpractice Policy Sets Tone

    The foundation for Kansas' mandatory reporting of ‘incident reporting’ program was started in 1986 in response to a crisis in the availability of medical malpractice insurance. As part of the overall package, the Kansas Legislature enacted comprehensive risk management and patient care quality assessment laws [K.S.A. 4921 → K.S.A. 4930] that were promulgated into regulations by the Secretary of the Kansas Department of Health and Environment (KDHE), requiring hospitals and ambulatory surgical centers to establish risk management plans [K.A.R. 28-52-1] to address and manage reportable incidents within the medical facility. Medical facilities were required to submit the plan to the KDHE for approval. The legislation mandated quarterly filing with the proper licensing agency of incident reports, which included the identification of all licensed individuals involved in a reportable incident.

    Additional regulations were promulgated based upon this legislation through 1998. The additional regulations [K.A.R. 28-52-2 through K.A.R. 28-52-4(a)] added structure to the incidence reporting and risk management committees, plus provided new Standard Of Care (SOC) guidelines to the regulations.

    (a) "Each facility shall assure that analysis of patient care incidents complies with the definition of a “reportable incident” set forth at K.S.A. 65-4921. Each facility shall use categories to record its analysis of each incident, and those categories shall be in substantially the following form:

    • (1) Standards of care met;
    • (2) standards of care not met, but with no reasonable probability of causing injury;
    • (3) standards of care not met, with injury occurring or reasonably probable; or
    • (4) possible grounds for disciplinary action by the appropriate licensing agency."
  • •  Healthcare Provider Reporting Program – No Event Reporting

    Per K.S.A. 65-4921(f), a "reportable incident" is defined as "an act by a health care provider which: (1) Is or may be below the applicable standard of care and has a reasonable probability of causing injury to a patient; or (2) may be grounds for disciplinary action by the appropriate licensing agency."

    These incidents are those that meet SOC guidelines provided in section (a)(3) and (a)(4) above. Therefore, as stated in K.A.R. 28-52-4(b)

    ". . . Any incident determined by the designated risk management committee to meet category (a)(3) or (a)(4) shall be considered a “reportable incident” and reported to the appropriate licensing agency in accordance with K.S.A. 65-4923."

    Hence, from the very beginning and to current day, Kansas' “reportable incident” was tied to the medical malpractice and the monitoring and identification of health professionals by licensing agencies. Public reporting of these incidents is not performed and accessability to this information is limited by the Kansas State laws governing Public Records, Documents, and Information.

  • •  No Adverse Event Reporting Program

    Kansas does not report "adverse events." Kansas has no list of events, nor does it define any adverse events, that might qualify as ‘reportable incidents’ anywhere in statutes or regulations for any facilities. Since reportable incidents are defined only by association with the health providers, presumed ‘system’ errors within the medical facility that are not attributed to any health care provider are either not reported or do not require reporting. Kansas truly reports only providers that do not meet the K.A.R. 28-52-4 §(a)(3) and §(a)(4) Standard of Care guidelines.


Rationale

The Kansas Legislature, in response to a 1986 crisis in the availability of medical malpractice insurance, enacted a comprehensive risk management legislation that required all medical care facilities to develop risk management plans for approval by the Kansas Department of Health and Environment (KDHE). The primary focus of these risk management plans was to mandate quarterly submissions of “reportable incidents” to the proper licensing agency of all licensed health care providers, whose identifications were included in the reports. The reports provided information as to whether or not the “reportable incidents” met the Standard of Care and whether the incidents provided possible grounds for disciplinary action by the appropriate licensing agency.

Under the regulations of the KDHE, the focus of this reporting program from the provider's perspective, is punitive, as it serves to address accountability and medical malpractice concerns within Kansas. The program, as defined by laws and regulations, does not provide a truly systematic approach to medical errors, nor does it include non-punitive educational or analytic processes that contribute to errors.

Also, the purpose of the risk management legislation is stated in K.S.A. 65-4929.

“The legislature of the state of Kansas recognizes the importance and necessity of providing and regulating certain aspects of health care delivery in order to protect the public's general health, safety and welfare.”


Statutes and Administrative Rules

  • •  General Information
    • ◊  Kansas Administrative Regulations (K.A.R.)

      Key provisions for medical errors reporting in the State of Kansas are provided in administrative regulations, which are designated as the Kansas Administrative Regulations (K.A.R.). The Kansas legislature provides web access to individual regulations by numerical designation, but useful searching via this search method requires a knowledge of the table of contents, which is not provided. Regulations are otherwise available in electronic format through the Kansas state deparments, agencies, commissions, state-supported institutions, and other entities.

      Kansas regulations are referenced by a concatenation of ‘K.A.R. [Title #]–[Article #]–[Regulation/Section #].’

      Example: K.A.R. 28-52-4 is the designation for ‘Standard-of-care determinations’ [Regulation/Section 4] of ‘Medical Care Facilities’ [Article 52] of the KDHE [Title 28].

      The relevant Kansas Administrative Regulations (K.A.R.) addressing patient safety and error reporting in healthcare facilities are provided within Title 28 regulations of the Kansas Department of Health and Environment (KDHE), under enforcement of the Bureau of Health Facilities (BHF).

      The Kansas regulations are provided in PDF format only with links to hospitals [PDF], Ambulatory Surgical Centers [PDF], and Long Term Care [PDF], and others.

    • ◊  Kansas Laws and Statutes

      Kansas laws addressing patient safety and quality are provided in 2 categories of laws. Session Laws are laws that are enacted by the Legislature, and signed by the Governor. The legislative sessions are available on the web from 1996 through 2005.

      Kansas statutes, available at the legislature website, represent the codified compilation of all permanent laws now in force. The statutes are arranged by topic in 84 distinct chapters, each of which contains several Articles and statutes, and a table of contents by chapter and article is provided for these unannotated laws, which are individually available in PDF format. Westlaw provides annotated statutes, designated as Kansas Statutes Annotated (K.S.A.).

      Citation of Kansas statutes used on this website is a concatenation of ‘K.S.A. [Chapter #]–[Article/Statute#].’

      Example: K.S.A. 65-4923 is the designation for ‘Reporting Requirements’ [Statute 4923] of ‘Health Care Providers’ [Article 49] of the Public Health Code [Chapter 65].

  • •  Laws and Regulations Governing Kansas Programs

    The Kansas Legislature created K.S.A. 65-4921 → 65-4929 in 1986 with mandatory “reportable incidents” and the creation of mandatory risk management plans for all medical facilities.

    Based on these laws, regulations were promulgated within the Kansas Department of Health and Environment in Title 28, Article 52, between 1986 and 1998. [K.A.R. 28-52-1 through K.A.R. 28-52-4] Similar regulations addressing risk managment in Ambulatory Surgical Centers are found in K.A.R. 28-34-50 → K.A.R. 28-34-55 [PDF].

    Whereas, Kansas does not publish this information or provide it on the Internet, Kansas also has laws defining what documents, records, and information are available to the public.

    The following is a selected list of laws and regulations addressing incident reporting and patient safety in Kansas.

KANSAS LAWS / STATUTES
SECTION   DESCRIPTION
Chapter 45 – Public Records, Documents, & Information
Chapter 45, Article 2 – Records Open to Public
Certain records not required to be open; separation of open and closed information required; statistics and records over 70 years old open.
 
Chapter 65 – Public Health
Chapter 65, Article 4 – Hospitals and Other Facilities
Licensure of critical access hospitals; definitions.
 
Chapter 65, Article 28 – Healing Arts
Reports by hospitals and others; administrative fines for failure to report.
Person licensed to practice healing arts required to report knowledge of violation of 65-2836 to state board of healing arts.
 
Chapter 65, Article 42 – Examination , Licensure and Regulation of Mental Health Technicians
Report of certain actions of mental health technician; persons required to report; medical care facility which fails to report subject to civil fine; definitions.
 
Chapter 65, Article 49 – Health Care Providers
Limited liability for certain associations of health care providers, review organizations, committee members and individuals or entities acting at request thereof; good faith requirement; "health care provider" defined.
Peer review; health care providers, services and costs; definitions; authority of peer review officer or committee; records and testimony of information contained therein privileged; licensing agency disciplinary proceedings; exceptions.
Definitions.
Medical Care facilities – Risk Management Programs.
Reporting requirements.
Reports relating to impaired providers; procedures.
Reports, records and proceedings confidential and privileged; licensing agency disciplinary proceedings.
Immunity from civil liability for report or investigation, limits.
Failure to report; remedies; immunity from civil liability.
Employer retribution for reporting; prohibition; remedy.
Purpose of risk management programs; status of entities conducting programs; antitrust immunity.
Act supplemental to existing law.
 
KANSAS ADMINISTRATIVE CODE
Title 28 – Kansas Department of Health & Environment
Title 28, Article 4 – Health Care Policies [PDF]
Health Care Policies.
(Authorized by and implementing K.S.A. 65-508; effective May 1, 1979; amended May 1, 1985; amended Aug. 23, 1993.)
 
Title 28, Article 52 – Medical Care Facilities [PDF]
General requirements.
(Authorized by and implementing L. 1986, Chapter 229, Sec. 3; effective, T-87-50, Dec. 19, 1986;effective May 1, 1987.)
Incident Reporting
(Authorized by and implementing K.S.A. 65-4922;effective Feb. 27, 1998.)
Risk management committee.
(Authorized by and implementing K.S.A. 65-4922;effective Feb. 27, 1998.)
Standard-of-care determinations.
(Authorized by and implementing K.S.A. 65-4922;effective Feb. 27, 1998.)
 

Definitions

Kansas uses ‘reportable incident’ as the reportable event for the patient safety / medical error reporting program. The complete definition of “reportable incident” is provided in K.S.A. 65-4921(f):

(f)  “Reportable incident” means an act by a health care provider which: (1) Is or may be below the applicable standard of care and has a reasonable probability of causing injury to a patient; or (2) may be grounds for disciplinary action by the appropriate licensing agency.

A key aspect of this definition is that the “reportable incident” is an act by a health care provider. Kansas does not provide a list of events to define “reportable incident.”

The Kansas definition does not specifically address errors that might be system errors. In this regard, the Kansas definition does not provide a comprehensive approach to medical errors. The philosophy expressed in these regulations appears contrary to recommendations of the IOM report and contrary to characteristics of successful reporting programs that advocate ‘independence’ from any authority with power to punish the reporter or reportee, and ‘non-punitive’ and ‘system-oriented’ approaches to evaluating adverse event reporting. From a strictly health-provider perspective, the reporting program implementation has a distinctly punitive flavor, which is consistent with the medical malpractice legislation under which it was formulated.

A March 2003 NASHP publication addressed the issue of adverse event definitions across multiple states. [PDF]2 NASHP systematically compared state definitions against the 27 NQF 'Never' Events. Kansas was represented as having an Adverse Event Reporting program. Kansas was represented as having definitions for 21 of the 27 NQF definitions, and each alleged definition was repeatedly classified in the category "State includes this event but not explicitly."

However, based on Kansas' regulations and documents available from Kansas, this position appears misleading, if not mis-stated. Kansas has neither an adverse event reporting program nor definitions to support it. Kansas has a Health Provider/health professional reporting program that is tied to the ‘reportable incident’ definition. This definition is tied to compliance with a medical malpractice ‘standards-of-care’ concept rather than compliance with a patient safety concept of reportable events.

Indeed, the Risk Management Incident Report Form has spaces for Provider ID and Kansas State certification number [PDF]. In addition, the Quarterly Risk Management Report form that facilities must file with the Burea of Health Facilities includes item #5, which requires a summary of all reported health professionals by licensing agency:

"Specify the number of reports sent to each of the following licensing agencies ... ___ Board of Healing Arts; ___ Board of Nursing; ___ Board of Pharmacy; ___ Other (specify):_____." [PDF]


1  Leape LL, "Reporting of Adverse Events," N Engl J Med, (2002); 347(20):1633-38 [PDF]

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]


Facility Participation

There is some confusion as to what facilities must report adverse events to the Kansas DHE Bureau of Facilities. According to K.S.A. 65-4922, participation is mandatory for “each medical care facility.” As defined in K.S.A.65-4921(e), participating institutions include "medical care facilities," which

"means: (1) A medical care facility licensed under K.S.A. 65-425 et. seq. and amendments thereto; (2) a private psychiatric hospital licensed under K.S.A. 75-3307b* and amendments thereto; and (3) state psychiatric hospitals and state institutions for the mentally retarded, as follows: Larned state hospital, Osawatomie state hospital, Rainbow mental health facility, Kansas neurological institute and Parsons state hospital and training center."

According to K.S.A. 65-425(h), "medical care facility"

"means a hospital, ambulatory surgical center or recuperation center, but shall not include a hospice which is certified to participate in the medicare program under 42 code of federal regulations, chapter IV, section 418.1 et seq. and amendments thereto and which provides services only to hospice patients."

Therefore, these laws suggest that participating facilities include:

  • ◊  hospitals,
  • ◊  ambulatory surgical centers (ASCs),
  • ◊  recuperation centers
  • ◊  private psychiatric hospitals
  • ◊  state psychiatric hospitals (Larned state hospital, Osawatomie state hospital, Rainbow mental health facility, Kansas neurological institute, and Parsons state hospital and training center)

* "all psychiatric hospitals, community mental health centers or facilities for the mentally retarded and facilities serving other handicapped persons receiving assistance through the department of social and rehabilitation services."

Regulations requiring risk managment have been established only for hospitals [K.A.R. 28-52-1 through K.A.R. 28-52-4] and Ambulatory Surgical Centers (K.A.R. 28-34-50 through K.A.R. 28-34-62 – [PDF]). In the ASC regulations, separate detail regarding ‘reportable incidents’ is not provided, but there is reference to the ‘Medical Care Facilities’ regulations [K.A.R. 28-52-1 through 28-52-4].

Contradicting these regulation-directed reporting requirements is a report from the KDHE appearing in Kansas Health Statistics Volume 1, No. 1, August 2000 [PDF, p6], which appears to reference KDHE information appearing in a NASHP report as its source:

"In To Err is Human, the Institute of Medicine reported on the high number of medical errors and adverse events that occur in the U.S. health care system each year. As a follow up, the National Academy for State Health Policy surveyed states on how they were addressing the issue. The academy details its findings in a copyrighted report, State Reporting of Medical Errors and Adverse Events: Results of a 50-State Survey."1

. . .

"Kansas is one of the 15 states with a mandatory reporting law. Hospitals are the only entities required to report, with no reporting requirement for labs, home health agencies, pharmacies, individual health professionals and outpatient mental health centers. Long term care facilities must report adverse events under nursing home licensing requirements."

On first glance, this statement from the KDHE is contrary to language in its own regulations that require reporting from ASCs, psychiatric centers, etc., but it may reflect the reality of Kansas reporting in 2000.

The Risk Management Quarterly Report Form [PDF] suggests, however, that the NASHP article is in error and that the form should be completed by all medical facilities. This quarterly form provide facilities with an opportunity to report all medical error and patient safety activity including a summary of all the incident reports that were filed and the number of corrective actions taken against providers, listed by reporting agency, which include hospitals, psychiatric hospitals, ambulatory care centers, and "Other" facilities.


1  "Rosenthal J, Riley T, Booth M, "Medical Errors and Adverse Events: A Report of a 50-State Survey ," National Academy for State Health Policy, GNL31; April 2000. [PDF]


Physician Participation

  • •  Physician Role in ‘Reportable Incident’ Reporting

    K.S.A. 65-4923(a) stipulates that if a health care provider, or a medical care facility agent or employee has “knowledge that a health care provider has committed a reportable incident”, then [he / she] “shall report such knowledge...

    Furthermore, it is clear that the definition of a “reportable incident” is “an act by a health care provider.” As such, health care providers are the target of the error reporting system.

    Based on the definitions provided in K.A.R. 28-52-4, presumed ‘system’ errors within the medical facility that are not attributed to any health care provider or errors that meet the ‘standard-of-care’ test are not reported and/or do not require reporting.

    Perusal of the ‘Reportable Incident Information’ that is required on the Risk Management Report Form confirms that the only information required is the Incident Number, the date, the name and certification number of the physician provider, a narrative description of the incident, and questions addressing the Standard Of Care (SOC) guidelines of the regulations. Those incidents satisfying guideline criteria #3 or #4 must be reported.

    • 1.  Standard of Care (SOC) met
    • 2.  Standard of Care (SOC) not met, but with no reasonable probability of causing injury;
    • 3.  Standard of Care (SOC) not met, with injury occurring or reasonably probable; or
    • 4.  Possible grounds for disciplinary action by the appropriate licensing agency.
  • •  Physician Profiles

    Physicians, along with 13 other types of healthcare professionals, are licensed and regulated by The Kansas State Board of Healing Arts (KSBHA). It is independent of the Kansas Department of Health and Environment. Kansas has no requirement for reporting detailed physician profile information to the Public.


State Agency Roles

  • •  Bureau of Health Facilities (BHF) within KDHE

    The Bureau of Health Facilities within the Kansas Department of Health and Environment is responsible for enforcement of regulations for medical facilities and therefore is responsible for managing reporting of medical errors.

  • •  Other State Agencies

    According to K.S.A. 65-4923(a)(2),

    ". . . The [professional practices peer review] committee shall have the duty to report to the appropriate state licensing agency any finding by the committee that a health care provider acted below the applicable standard of care which action had a reasonable probability of causing injury to a patient, or in a manner which may be grounds for disciplinary action by the appropriate licensing agency, so that the agency may take appropriate disciplinary measures."

    The Risk Management Quarterly Report Forms [PDF] that must be filed by health facilities includes a partial list of independent agencies that are advised of reportable incidents including:

  • •  Center for Health and Environmental Statistics (CHES).

    Any reporting of educational information regarding ‘Reportable incidents’ would appear to lie with the Center for Health and Environmental Statistics (CHES).

    Starting in 1999, CHES began publishing a quarterly report called " Kansas Health Statistics." which provides data and perspective for topical Kansas health care issues. While Kansas was cited by the 2000 NASHP report [PDF] as a state that shared patient safety lessons learned among facilities in this or other KDHE periodicals, this information is not substantiated. Only the August 2000 edition of the 27 editions of Kansas Health Statistics through 2005 includes information regarding incident reporting, and that article cited 448 reported events in 1997. No patient safety lessons learned or educational information has appeared in this publication.


Operational Features of Programs

  • •  Beginning in 1987, every medical facility has been required to establish an internal risk management plan [K.S.A. 65-4922]
  • •  A medical facility must report any reportable incident to appropriate agencies within 30 days or face sanctions [K.S.A. 65-4216(b)]
  • •  A professional peer review committee shall investigate all reportable incidents occurring within a medical facility [K.S.A. 65-4923]
  • •  Any incident in which the standards of care are not met (with injury occurring or reasonably probable) or in which there are possible grounds for disciplinary action by the appropriate licensing agency meets the definition of "reportable incident" and must be reported. [K.A.R. 28.52(b)]
  • •  According to K.S.A. 65-4925, all reports, records, and procedings are confidential and priveleged. Furthermore, all participants have immunity from civil liability [K.S.A. 65-4926]
  • •   No public reporting of reportable incidences is permitted.

Provider-Identified Information – Transparency

As part of the ‘reportable incident’ program, only individual healthcare providers are identified and reported. Furthermore, unless a ruling of the licensing board creates a sanction against the individual practitioner, no information is released to the Public.

Kansas has no process for identification of facilities involved in adverse events, and all existing protections within the ‘reportable incident’ program prohibit public disclosure of any facility and individual providers.


Disclosure

  • •  Disclosure to PatientNot Addressed
  • •  Public Disclosure – Kansas prohibits public disclosure of medical errors and ‘reportable incidents.’
  • •  Provider Identification

    "A licensing agency in conducting a disciplinary proceeding in which admission of any peer review committee report, record or testimony is proposed shall hold the hearing in closed session."

    Records identifying medical facility or healthcare professional remain confidential in this setting. [K.S.A. 65-4925(e)]. However, providers who are sanctioned with disciplinary action are reported publicly on the Kansas State Board of Health Arts (KSBHA) ‘Board Actions’ website.

  • •  Content of Report

    By Kansas State regulatory authority (KDHE) definition, all submitted reports for ‘reportable incidents’ imply a breach of Standard Of Care (SOC) guidelines. These reports and Peer-review information is not available to the public [K.S.A. 65-4925(e)].


Patient Safety Coalitions

Kansas has no operational public or public/private patient safety coalitions.


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