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

Overview

  • •  Medical Malpractice Reforms → ‘Internal Risk Management’

    Florida's “adverse incident” reporting program was integrated with medical malpractice legislation when passage of the Medical Malpractice Reform Act of 1985 required hospitals and ambulatory surgical centers to report irreparable injuries within 15 days to the Division of Health Quality within the Florida Agency for Health Care Administration (AHCA) and to track, but not report, ‘near-misses.’ These serious adverse events are referenced and tracked in AHCA annual reports as Code 15 Injuries. In 1998, the legislature revised the law, defining the term “adverse incident” [section 395.0197(5)], increasing the state's ability to impose fines [section 395.0197(12)], and adding a 24-hour reporting provision that was only to be repealed in the 2003 Laws of Florida [2003-416, §4 – PDF, p10].

    The reporting requirement is very broad. The internal risk management program [section 395.0197] extends to all licensed facilities that include hospitals, ambulatory surgical centers, mobile surgical facilities, and HMOs. In addition, the legislature in 1999 extended mandatory reporting to medical physician and osteopathic physician offices.

  • •  State seeks help from Academia

    The legislature has tapped the private / academic world for advice on two separate occasions in 2000 and 2003. At the request of the Directors of Florida's two health agencies, the Department of Health and the Agency for Health Care Administration, the 2000 Legislature created the Florida Commission on Excellence in Health Care to facilitate the development of a comprehensive statewide strategy for improving the health care delivery system through meaningful reporting standards, data collection and review, and quality measurement. The 43-member commission, under co-chairmenship of the directors of the DOH and the AHCA, was sunsetted with the delivery of a 2001 report [PDF] that included recommendations for enhancing and improving health care. The report was submitted to the Governor and the legislature in February 2001. Among the major recommendations were the creation by the Legislature of two new health care entities: the Interagency Council for Patient Safety and Excellence in Health Care and the Center for Patient Safety and Excellence in Health Care.

    The second legislative appeal to the private community (or more correctly the academic community) arose as part of 2003 Medical Malpractice reform. As part of the “Medical Incidents” Bill CS/SB2D [PDF] that was signed in September 2003, special provisions in sections 35 and 36 of the bill called for the Agency for Health Care Administration (AHCA) to seek outside help to address 2 major questions.

    Section 35 of the bill required the AHCA to . . “conduct or contract for a study . .” whereas Section 36 required the AHCA to consult . . “with the Department of Health and existing patient safety centers in the state universities.”

    For both of the requirements, the AHCA selected Dr. Paul Barach of the University of Miami/Jackson Memorial Hospital Center for Patient Safety as the Principal Investigator, who in turn . . “assembled a multi-disciplinary group of researchers, policy makers and patient safety leaders from the Universities of Florida, Central Florida, Miami, South Florida, Florida State University, and Nova Southeastern College of Medicine,” [see Miami Center for Patient Safety website] a group self-referred to as the Florida Patient Safety Academic Task Force [PDF and the Florida Patient Safety Network [PDf]. In response to the questions from the legislature, this group submitted an authoritative tome of 12 separate reports.

  • •  Lots of Feedback to the Legislature

    The first 4 reports addressed the legislatures requests from Section 35 of the “Medical Incidents” Bill, which requested a report addressing . . “what information is most feasible to provide to the public comparing . . hospitals on certain inpatient quality indicators developed by the federal Agency for Healthcare Research and Quality. [for] . . specific procedures performed in hospitals for which there is strong evidence of a link to quality of care.” The legislature further instructed the AHCA or the study contractor to investigate . . “the hospital quality reports published in New York and Texas as guides during the evaluation.” It is clear that the legislature was referencing the AHRQ's Inpatient Quality Indicators (IQIs) that were released in 2002 with free software for users. In response to this issue 3 separate reports and an Executive Summary were released in January 2004, strongly recommending Florida's adoption of AHRQ's Inpatient Quality Indicators, complete with a recommended format and a release date for 2002 data by August 2004.

    The latter 8 reports addressed support for a “Patient Safety Authority,” i.e., the same patient safety center that had been recommended by the Florida Commission on Excellence in Health Care three years earlier. The findings and recommendations of these 8 reports were in keeping with Section 36 of the “Medical Incidents” Bill, which requested a report addressing . . “the implementation requirements of establishing a statewide Patient Safety Authority . . [that] . . would be responsible for performing activities and functions designed to improve patient safety and the quality of care delivered by health care facilities and health care practitioners.”

  • •  Legislative Action creates Patient Safety Corporation

    In response to these reports that were delivered to the legislature in January 2004, the legislature passed HB 1629 [PDF], also known as ‘The 2004 Affordable Health Care for Floridians Act.’ It was signed on June 14, 2004 creating the Florida Patient Safety Corporation (FPSC), which is designed to provide a “center for sharing of learning for providers.”

    The bill also calls for electronic medical records for all Floridians. The bill is codified from Section 18 of Chapter No. 2004-297 [PDF] to Section 381.0271, FS.

    The State of Florida has provided appropriations in the amount of $350,000 for startup funds for the Florida Patient Safety Corporation and $300,000 for the “near-miss” project within the Florida Patient Safety Corporation. These funds truly are 'startup' funds only. Ultimately, the program is to be funded entirely with private funds. The FPSC has no regulatory authority, even though there are a number of mandated requirements including an annual report to the governor and the legislature. This June 2004 legislation also provided a legislatively defined Board of Directors and advisory committees. The powers and duties of the Florida Patient Safety Corporation will likely dictate Florida's approach to medical errors and patient safety for years to come. Further information is available at the FPSC website. Expectations of health facility participants are addressed in Participation - Medical Facilities.


Rationale

  • •  Rationale for Adverse Incident Reporting

    Much of Florida's medical error reporting laws have been bundled with major medical malpractice legislation that dates to the mid 1980s. The stated purpose for the 1998 Internal Risk Management Program legislation, as provided in (§ 0395.001, FS – Legislative Intent), is

    . . .“ to provide for the protection of public health and safety in the establishment, construction, maintenance, and operation of hospitals, ambulatory surgical centers, and mobile surgical facilities by providing for licensure of same and for the development, establishment, and enforcement of minimum standards with respect thereto.”

    The ‘Internal risk management’ legislation for hospitals (§395.0197(3)) and HMOs (§641.55(3)) encourages any initiatives that are “intended to reduce the frequency and severity of medical malpractice and patient injury claims . . .

    In keeping with these goals, the legislature in 2003 amended the Internal Risk Management laws, adding patient safety mandates that created institutional patient safety committees, identifiable patient safety officers, and formulation of institutional patient safety plans. These regulatory measures were imposed upon health facilities as a means of addressing both patient safety and medical malpractice concerns.

  • •  Rationale for Patient Safety Corporation

    The purpose of this corporation is

    “. . . to serve as a learning organization dedicated to assisting health care providers in this state to improve the quality and safety of health care rendered and to reduce harm to patients. The corporation shall promote the development of a culture of patient safety in the health care system in this state. The corporation shall not regulate health care providers in this state.”


Statutes and Administrative Rules

  • •  General Information
    • ◊  Florida Administrative Code (FAC)

      The Florida Administrative Code (F.A.C.) is a compilation of rules and regulations of state agencies/ public entities that is available at the FAC website. A series of Florida statutes (usually appended with ‘F.S.’ to indicate general laws / Florida Statute) have provided the authority for administrative rules. FAC Chapter 59 provides administrative rules for the Agency for Health Care Administration (AHCA), while FAC Chapter 64 provides administrative rules for the Department of Health (DOH).

      Each chapter of FAC is a combination of one of the 69 major chapter numbers for an entity or department, followed by a letter(s) designating an agency/activity, followed by a hyphen and a numerical function designation. Proper citation of Florida Administrative Code [PDF] is a concatenation of [Chapter# + Activity/agency-letter + hyphen + function#].[section#]([sub-section]), FAC. For example, definitions for the AHCA Internal Risk Management program are provided in Chapter 59A-10, in section 002, i.e., 59A-10.002, FAC.

    • ◊  Florida Laws and Statutes

      Florida's laws addressing patient safety and quality are provided in 2 categories of laws. Session Laws | Laws of Florida are general laws that are enacted by the Legislature and signed by the Governor. The legislative sessions are available on the web from 1997 through the present. Florida Statutes (FS) is the codified compilation of all permanent laws now in force. Florida Statutes Annotated (FSA) are published by the West Group Publishing Company. Florida Statutes are arranged in 48 Titles (Titles I through XLVIII), each title containing one or more of the 1,013 chapters of Florida code. Title XXIX is the Public Health Code containing Chapters 381 through 408, each addressing a designated sub-section of Florida Public Health code.

      On this website, Florida statutes are cited as § [section].[sub-section], FS. For example, law addressing Patient safety is found in section 1012 of chapter 395 of the Florida Public Health code, designated as § 395.1012, FS.

  • •  Laws and Regulations Governing Florida Programs

    Medical Error Reporting in Florida was developed over the past decade via the ‘Internal risk management program.’ In 1998, the definition of ‘adverse event’ was added to the legislation, and the program has grown under the Agency for Health Care Administration (AHCA), which credentials and licenses health care facilities, with support of the Department of Health (DOH), which provides licensure and credentialling for all health professionals. A report to the legislature and governor in 2001 from the DOH and the AHCA ‘Florida Commission on Excellence in Health Care Report’ [PDF], provided a strategy and recommendations for legislative action.

    The following list of statutes and administrative rules provide the authority and regulatory philosophy that underlies Florida's patient safety and medical error reporting programs.

FLORIDA LAWS / STATUTES
 
SECTION   DESCRIPTION
Public Health – Title XXIX
Chapter 381 – General Provisions
Florida Patient Safety Corporation
Chapter 395 – Part I - Hospitals and Other Licensed Facilities
Definitions used in this Chapter
Litigation notice requirement
Internal Risk Management Program
Patient Safety
Duty to notify patient
Chapter 408 – Health Care Administration
State Center for Health Statistics
 
Regulation of Professions & Occupations – Title XXXII
Chapter 456 – General Provisions
Accountability and liability of board members
Department; general licensing provisions.
Reports of professional liability actions; bankruptcies; Department of Health's responsibility to provide.
Publication of information
Disclosure of Confidential Information
Duty to notify patients
Chapter 458 – Medical Malpractice
Reports of adverse incidents in office practice settings.
Chapter 459 – Osteopathic Medicine
Reports of adverse incidents in Osteopath office practice settings
 
Regulation of Insurance – Title XXXVII
Chapter 641 – Health Care Service Programs
Internal risk management program (HMOs).
 
K-20 Education Code – Title XXXVIII
Chapter 1004 – Public Postsecondary Education - General Provisions
Patient safety instructional requirement.
Chapter 1005 – Nonpublic Postsecondary Education - General Provisions
Patient safety instructional requirement.
 
Torts – Title XLV
Chapter 766 – Medical Malpractice And Related Matters
Civil immunity for members of or consultants to certain boards, committees, or other entities.
Patient safety data privilege.
 
2000 Session Laws of Florida
Chapter 256 – passage of CS/HB 2339 [PDF]
Florida Commission on Excellence in Health Care.
Chapter 367 – passage of CS/SB 2034 [PDF].
Florida Commission on Excellence in Health Care.
Appropriation for Florida Commission on Excellence in Health Care.
 
2003 Session Laws of Florida
Chapter 416 – passage of SB 2-D [PDF] [HTML-Enrolled Version].
AHCA Directed to Conduct Study on Patient Safety
Study for Creation of Patient Safety Commission
12 Reports Responding to Sections 35 and 36
Comments on Reports for 2003 Senate Bill 2-D, §35 and §36
 
 
FLORIDA ADMINISTRATIVE CODE
Agency for Health Care Administration – Chapter 59
59A-10, F.A.C. – Internal Risk Management Program [PDF, p204].
Definitions.
Incident Reporting System.
Fifteen Day Reports.
 
Department of Health – Chapter 64
Chapter 64B-8-9, F.A.C. – Standards Of Practice For Medical Doctors.
Physician Office Incident Reporting.
Physician Office Incident Reporting.
Chapter 64B-15-14, F.A.C. – Osteopathic Practice Requirements.
Physician Office Incident Reporting.

Definitions

  • •  Three ‘Adverse Events’ Versions

    A reportable health care event in Florida is known as an ‘untoward’ or ‘adverse incident,’ and the administrative rules for hospitals/ASCs also define reportable outcomes from injuries. Three versions of the definitions are provided in Florida Statutes and Administrative code for multiple different practice settings.

    The table below includes the definitions of ‘adverse incidents’ and injuries that are listed in the administrative rules for hospitals and ambulatory surgery centers [§59A-10.002(4), FAC]. Using comparative definitions for office practices of Medical / Osteopathic practitioners (which are the same), and adding the definitions for HMOs, one can compare the definition inclusions for each type of point of care.

Comparison of 3 Versions of Florida Definitions of Adverse Events

No.
Def
Name / Description
Versions
Hospital Office HMO
1. 4(c)
Unconsented Intervention
X
2. 4(e)
Wrong surgical patient
X X X
3. 4(f)
Wrong surgical site / body part
X X
4. 4(f)
Unexpected Procedure
X X X
5. 4(f)
Wrong Procedure
X X X
6. 4(f)
Retained Foreign Body requiring procedure
X X
7. 5(a)
Injury → Death
X X X
8. 5(b)
Injury → Brain Damage
X X X
9. 5(c)
Injury → Spinal Damage
X X X
10. 5(d)
Injury → Permanent Disfigurement
X X
11. 5(e)
Injury → Fracture or dislocation
X X
12. 5(f)
Injury → Unplanned additional care requirement
X X
13. 5(g)
Injury → Condition requiring surgery
X
14. 5(h)
Injury → Transfer to higher acuity care
X X X
15. 5(i)
Injury → Increased LOS
X
16. 5(j)
Injury → persisting physical impairment
X X
17. 5(j)
Injury → persisting neurological/sensory deficit
X X
  • •  Near-Miss Definition Added

    In June 2004, the Florida legislature passed legislation authorizing the Florida Patient Safety Corporation. As part of this legislation, a “near-miss” patient safety reporting system is to be created within the Florida Patient Safety Corporation [§ 0381.0271(7)(a3), FS].

    The definition of “near-miss” is . .

    “any potentially harmful event that could have had an adverse result but, through chance or intervention in which, harm was prevented.” [§381.0271(7a.3), FS]

  • •  Editorial / Comments on Potential Florida Definitions Misclassification.

Facility Participation

Participation is mandatory, and “every licensed facility shall . . .establish an internal risk management program . . ” (§ 395.0197(1) FS). According to § 395.002(17), FS a ‘licensed facility’ is defined as

a hospital, ambulatory surgical center, or mobile surgical facility licensed in accordance with this chapter.

Because the definition of hospital includes requirements for ‘treatment facilities for surgery or obstetrical care,’ psychiatric and rehabilitation hospitals would not be included in this definition of a ‘licensed facility.’

In addition to medical facilities, §641.55, FS mandates that HMOs participate in an ‘Internal Risk Management’ program.

Furthermore, as detailed under Physician Participation, MD and DO physician offices are also required to report an abbreviated list of adverse incidents.

The creation of the Patient Safety Corporation in June 2004 has multiple implications for facilities that participate, but none of them have regulatory sanctions behind them. The program is to be funded entirely with private funds, and it has no regulatory authority, even though there are a number of mandated requirements including an annual report to the governor and the legislature. This program established the corporation with start-up assistance from the AHCA. The program, as defined in law, calls for appointment of a Board of Directors, which is carefully prescribed by law to include members of the medical provider community. In addition, the law calls for advisory committees, and a description of powers and duties.

Amongst those powers and duties, the corporation

“shall . . collect, analyze, and evaluate patient safety data and quality and patient safety indicators, medical malpractice closed claims, and adverse incidents reported to the Agency for Health Care Administration and the Department of Health for the purpose of recommending changes in practices and procedures that may be implemented by health care practitioners and health care facilities to improve health care quality and to prevent future adverse incidents.”

It appears, therefore, that the State of Florida desires to have the Patient Safety Corporation include the data from the “adverse incident” reporting program. Furthermore, the inclusion of “medical malpractice closed claims” suggest that a need for collaboration with the ‘Physician Profiling’ program and/or the Office of Insurance regulation.

One might speculate that the inclusion of “patient safety indicators” leaves open the possibility that the corporation might embrace AHRQ's safety indicators that were embraced two years ago by the Texas Health Care Information Council with AHRQ's free software and that were recommended strongly by the Florida Patient Safety Academic Task Force in the first four of its 12 reports that were delivered in January 2004.

Other duties include voluntary submission of “near-misses” in a program with anonymous participants, and an expectation to “work collaboratively with the appropriate state agencies in the development of electronic health records.” This latter expectation underscores Florida's three-year pilot project charged with developing ‘a statewide electronic infrastructure.’

The purpose of the Patient Safety Corporation is

“. . . to serve as a learning organization dedicated to assisting health care providers in this state to improve the quality and safety of health care rendered and to reduce harm to patients. The corporation shall promote the development of a culture of patient safety in the health care system in this state. The corporation shall not regulate health care providers in this state.”

The degree to which medical facilities participate and embrace this voluntary, quasi-coercive, ‘the-state-is-watching-you’ initiative will likely vary tremendously. Facilities realize that the legislature has “Performance Expectations” that will be evaluated by the Office of Program Policy Analysis and Government Accountability, the Agency for Health Care Administration (AHCA), and the Department of Health in 2006 with a report to the Governor and the legislature by January 1, 2007.


Physician Participation

  • •  Mandatory Participation in Adverse Incident Reporting Program

    Florida is one of the few state that explictly mandates the participation of physicians in the adverse event reporting program.   According to § 395.0197, §(1)(e), FS, it is

    ". . . the affirmative duty of all health care providers and all agents and employees of the licensed health care facility to report adverse incidents . . .”

    Not only must physicians report and participate within licensed facilities, but the 1999 Laws of Florida, Chapter 99-397 [PDF] mandate reports of adverse incidents in office practice settings for both physicians [§458.351(4), FS] and osteopaths [§459.026, FS]. In the office practice setting, an ‘adverse incident’ has fewer inclusion criteria than noted in the hospital's definitions. In addition, patients who are transferred to hospitals from surgical centers or the office practice setting meet the definition of a reportable ‘adverse incident’.

    In addition to physicians identified in these centers, §641.55, FS mandates that HMOs participate in an ‘Internal Risk Management’ program, which has its own set of reportable events definitions for HMO physicians.

  • •  Physician Profiles

    While not necessarily related to adverse incidents, Florida has a physician profile law that requires that physicians 'tell all' for publication on a publicly-accessible website. Florida officials require doctors to report any malpractice award of at least $5,000 and any conviction or disciplinary action occurring within the last 10 years. The Web site receives more than 130,000 hits a month. The information that is reported is sensitive information and may bear little relationship to the practice of medicine. According to the Florida DOH [Parizek, DOH], which appeared in February 2002 Physician Practice], the Florida Board of Medicine in June 2002 fined 16 doctors $250 each for lying about their records when providing information to the state-run profiling Internet site. Half of those charged had failed to report convictions for driving while under the influence of alcohol, while others had been convicted of crimes ranging from resisting arrest and tax fraud to marijuana possession and illegal possession of fireworks. When Florida officials ran FBI fingerprint checks to verify information submitted by some of its 45,000 doctors, they found that about 2,000 of them had criminal records.

    The anonymity of physicians in AHCA's web reports is trumped by DOH Medical Quality Assurance, which provides for publication of physician-identified and physician-specific sanctions under ‘Physician Profiling.’ Furthermore, if a physician is involved with an ‘adverse incident’ subject to a probable cause for investigation by the AHCA, both physician and facility providers are identified publicly within 10 days, apparently in the MQA newsletter and/or the Physician Profiling website. [§456.081, FS]


State Agency Roles

The Florida legislature has played a prominent role in establishing the medical error reporting program, as the list of statutes will attest. Most of these laws give regulatory authority to either the AHCA or the DOH.

  • •  Agency for Health Care Administration (AHCA)

    The Florida Agency for Health Care Administration (AHCA), under statutory authority and by its administrative rules, manages the ‘adverse incident’ reporting program. The data is maintained, analyzed, and prepared for web publication by the AHCA. (However, the State Center for Health Statistics (SCHS), which manages much of the AHCA data under legislative authority (§ 408.5, FS) has nothing to do with the Risk Management Data program.) The Florida Agency for Health Care Administration (AHCA) has licensure authority for medical facilities.

  • •  Department of Health (DOH)

    The Florida Department of Health maintains physician licensing authority, and has ultimate control of sanctions related to ‘adverse incident’ reporting via Medical Quality Assurance (MQA), which has the responsibility for maintaining ‘Practitioner profiling’. The ‘Practitioner profiling’ is a web-based tool that provides information on all practicing physicians including the practitioner's reported financial responsibility (including reported bankruptcies), legal actions against the practitioner, final disciplinary action taken against the practitioner, and any liability claims filed against the practitioner that exceed $5,000.

    While ‘adverse incident’ reporting is not reported primarily in the ‘Practitioner profiling’ website, ‘adverse incidents’ that meet ‘probable cause’ criteria are published “10 days after probable cause is found” on the ‘Practitioner profiling’ website (§456.081, FS). The legislature has written many of the laws so as to integrate the ‘adverse incident’ reporting program with medical malpractice.

  • •  Licensing Standards Investigations

    Licensing standards investigations of both hospitals and health professionals are conducted by the AHCA as part of its authority in managing the ‘adverse incident’ reporting program. Hospitals and ambulatory surgery centers are licensed under the authority of the AHCA, whereas health professionals are licensed under the authority of the Department of Health, where disciplinary actions regarding ‘adverse incident’ reporting are tightly integrated with the licensing authority under the Medical Quality Assurance (MQA) in the Department of Health and with legislative mandates regarding medical practice. The MQA regulates 37 professions and 6 facilities and works with 22 boards and 6 councils.

  • •  Other Agencies are affected by this rule. The Division of Consumer Services, under the Department of Agriculture and Consumer Services, prominently provides a web link to the Practitioner Profile Information. Tort laws also mandate that courts notify the Department of health and other agencies of any medical malpractice action.

Operational Features of Program

  • •  Characteristics of Reporting Program

    Every “licensed facility’ is mandated to have an incidence reporting program [FAC §59a.10.005(1 - 3)]. Noteworthy features of the process are:

    • ◊  Health Risk Manager Position created

      The law created the position of Health Care Risk Manager, who must be properly credentialed and licensed by the Agency for Health Care Administration (AHCA). The risk manager manages reporting responsibilities for no more than 4 sites for a medical facility. The risk manager, who is employed by the medical facility “as an insurance coordinator . . . or a consultant”, is responsible to the standards established by the AHCA, including responsibility for the regular and systematic reviewing of all incident reports (see §59A-10.031 to §59A-10.037, FAC for credentialing and training requirements [PDF, p205-10].) The risk manager provides an annual confidential report to the AHCA, which includes “the measures taken by the facility and its risk manager to reduce the risk of injuries and adverse incidents, and the results of such measures . . .” [§395.0197(6)(c), FS]

    • ◊  NO ANONYMITY IN REPORT TO AHCA

      No anonymity exists in reports since a “listing of all persons . . . known to be involved directly in the incident” is included in the report along with “corrective actions”, which might include punitive actions or fines against health providers or hospitals.

    • ◊  ANONYMITY IN WEB-REPORTING

      Anonymity is observed in the web-reporting process for incidents, which does “not include information that would identify the patient, the reporting facility, or the health care practitioners involved” (§395.0197(8), FS).

    • ◊  NO ANONYMITY FOR PROVIDERS, IF ‘PROBABLE CAUSE’

      The anonymity of physicians and facilities in AHCA's web reports is trumped by DOH Medical Quality Assurance, which provides for publication of physician-identified and physician-specific sanctions under ‘Physician Profiling.’ Furthermore, if a physician is involved with an ‘adverse incident’ subject to a probable cause for investigation by the AHCA, both physician and facility providers are identified publicly within 10 days, apparently in the MQA newsletter and/or the Physician Profiling website. [§456.081, FS]

    • ◊  Transparency

      Transparency of ‘adverse incident’ reporting to physician peer review and medical malpractice, as the numerous legislative efforts confirm. Information regarding providers is shared across regulatory agencies and punitive action against physicians may occur outside of peer-review processes.

    • ◊  Patient Safety Plan, Committee and Officer

      An emphasis on Patient Safety is manifest in 2003 legislation that required that each facility have a Patient Safety Plan, complete with a Patient Safety Committee and a Patient Safety Officer. The Patient Safety Plan was added on to existing Internal risk management program, quality assurance / peer review programs. The intent of the legislation was related to medical malpractice [per §395.0193, FS – History]. The patient safety program is tied legislatively to the ‘Incident Reporting program’ via the references to ‘medical incident’ and ‘malpractice’ issues.

  • •  Processes of Reporting Program
    • ◊  Initial Notification:

      It is the “ . . duty of all health care providers and all agents and employees of the licensed health care facility to report adverse incidents to the risk manager, or to his or her designee, within 3 business days after their occurrence” [§395.0197(1), FS]

    • ◊  Report to Agency for Health Care Administration (AHCA)

      ...adverse incidents, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility, shall be reported by the facility to the agency within 15 calendar days after its occurrence” (§395.0197(7), FS) These reports are known as the Code 15 Report. The law also states that justifiable extensions to the 15-day deadline are possible, possibly requiring additional reports.

    • ◊  24 Hour Report to Agency for Health Care Administration (AHCA) Cancelled in 2003

      With the passage of 2003 Laws of Florida, Chapter 2003-416 [PDF, p10], the ‘24 Hour Report ’ requirement (§395.0197(7), FS) was repealed from the the Internal Risk Management program. The 24 hour Report constituted duplicative work to the Code 15 Report and was perceived as beaurocratic waste. 24 Hour Reports ceased to be prepared on the Medical Errors Resolution And Tracking Programs website.

    • ◊  Follow-up by Agency for Health Care Administration (AHCA)

      “The agency may investigate, as it deems appropriate, any such incident and prescribe measures that must or may be taken in response to the incident. The agency shall review each incident and determine whether it potentially involved conduct by the health care professional who is subject to disciplinary action, in which case the provisions of s. 456.073 shall apply.” [§395.0197(7), FS]

    • ◊  Publishing Reports on Web:

      The agency shall publish on the agency's website, no less than quarterly, a summary and trend analysis of adverse incident reports received pursuant to this section, which shall not include information that would identify the patient, the reporting facility, or the health care practitioners involved. The agency shall publish on the agency's website an annual summary and trend analysis of all adverse incident reports and malpractice claims information provided by facilities in their annual reports, which shall not include information that would identify the patient, the reporting facility, or the practitioners involved.” [§395.0197(8), FS]

      The AHCA publishes annual, quarterly, and ‘Code 15 Reports’ on the Medical Errors Resolution And Tracking Programs website.

  • •  Education

    The State of Florida addresses education in facilities and for health providers in a number of different ways, including a mandate for inclusion of patient safety curricula in private and public schools that affect all allied health fields:

    • ◊  Nonphysician Personnel: . . .At least 1 hour of such education and training annually for all personnel of the licensed facility working in clinical areas and providing patient care.” (§395.0197(1)(b) FS)
    • ◊  Physicians:The boards, or the department when there is no board, shall require the completion of a 2-hour course relating to prevention of medical errors as part of the licensure and renewal process.” (§456.013, FS - Department; general licensing provisions
    • ◊  Institutional Curricula, Public schools:Each public school, college, and university that offers degrees in medicine, nursing, or allied health shall include in the curricula applicable to such degrees material on patient safety, including patient safety improvement.” (§1004.08, FS - Patient safety instructional requirements)
    • ◊  Institutional Curricula, Private Schools:Each private school, college, and university that offers degrees in medicine, nursing, and allied health shall include in the curricula applicable to such degrees material on patient safety, including patient safety improvement.” (§1005.07, FS - Patient safety instructional requirements)
    • ◊  Education Related to Risk Management Program: The risk manager uses the incident reports “as a part of each internal risk management program . . . to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas.” (§395.0197(4), FS) Correction of problem areas requires on-going education within the facility as part of the internal risk management program.

Transparency – Facility-Identified Information

  • •  No Provider-Identified Information in Reports

    The AHCA has responsibility for the Incident Report program. One of the requirements is that the AHCA

    ". . . publish on the agency's website, no less than quarterly, a summary and trend analysis of adverse incident reports received pursuant to this section, which shall not include information that would identify the patient, the reporting facility, or the health care practitioners involved. The agency shall publish on the agency's website an annual summary and trend analysis of all adverse incident reports and malpractice claims information provided by facilities in their annual reports, which shall not include information that would identify the patient, the reporting facility, or the practitioners involved.” [§395.0197(8), FS]

    The AHCA publishes aggregate annual, quarterly, and ‘Code 15 Reports’ on the Medical Errors Resolution And Tracking Programs website. In early 2006, the Risk Management Statistical Reports are available through 2003. It is evident that Florida has a minimum two-years interval between the reported events and issuance of the reports.

  • •  Physician Idenfication for investigated ‘adverse incident’

    Although the Florida AHCA does not identify facilities or physicians in any of its web reports, the identifies of physicians and facilities become publicly available within 10 days of an ‘adverse incident’ via the Florida DOH:

    "The department and the boards shall have the authority to advise licensees periodically, through the publication of a newsletter on the department's website, about information that the department or the board determines is of interest to the industry. The department and the boards shall maintain a website which contains copies of the newsletter; information relating to adverse incident reports without identifying the patient, practitioner, or facility in which the adverse incident occurred until 10 days after probable cause is found, at which time the name of the practitioner and facility shall become public as part of the investigative file; . . . "[ §456.081, FS]

    It is not stated how much public investigative file information regarding the physician is published in the newsletter or on the Physician Profiling website.

    Editorial comments / Questions on Role of Peer Review amid ‘Incident Reporting’


Disclosure

  • •  Disclosure to Patient

    The State of Florida mandates that both physicians (§456.0575, FS) and health facilities (§395.1051, FS) notify the patient or the patient's representative, “in person about adverse incidents that result in serious harm to the patient.” In situations of sexual assault, the risk manager is required to “notify the family or guardian of the victim, if a minor, that an allegation of sexual misconduct has been made and that an investigation is being conducted.” (§395.0197(9)(c), FS)

    With the passage of this law in 2003, the State of Forida joins nine (9) other states through 2005 with laws or regulations that monitor or mandate notification of patients or family of a reported event. Whereas the State of South Carolina regulations SC Code Regs. 61-91-601(A) mandate reporting in the Ambulatory Surgery Center setting only, regulations in Maryland were promulgated for hospitals only. As part of the regulation adopted by Connecticut [PDF] in 2004 was an Adverse Event Reporting Form [PDF] that included separate data entry for facilities to indicate 1) whether notification of patients and/or the authorized representative occurred, and 2) the date of notification. Therefore, even though Connecticut has no law mandating disclosure to a patient, this reporting form is approved by regulations of the Connecticut Department of Public Health, which intends to monitor this issue.

    Similar to Florida, broad disclosures of an “incident” or “event” to the patient or patient's family is specifically addressed by statutes in Tennessee, Pennsylvania, New Jersey, Nevada, Oregon, and Washington.

  • •  Public Disclosure: Information related to ‘adverse event’ reporting that is available to the public includes:
    • ◊  No Disclosure of identified information by AHCA

      The Agency for Health Care Administration (AHCA) publishes “ . . . on the agency's website, no less than quarterly, a summary and trend analysis of adverse incident reports received pursuant to this section, which shall not include information that would identify the patient, the reporting facility, or the health care practitioners involved. The agency shall publish on the agency's website an annual summary and trend analysis of all adverse incident reports and malpractice claims information provided by facilities in their annual reports, which shall not include information that would identify the patient, the reporting facility, or the practitioners involved.” [§395.0197(8), FS]

    • ◊  Reports of Professional Liability

      The report of a claim or action for damages for personal injury which is required to be provided to the Department of Health under s. 456.049 or s. 627.912 is public information except for the name of the claimant or injured person, which remains confidential as provided in ss. 456.049(2)(d) and 627.912(2)(e). The Department of Health shall, upon request, make such report available to any person. The department shall make such report available as a part of the practitioner's profile within 30 calendar days after receipt.” (§456.051, FS) This information is available on the Medical Quality Assurance (MQA) ‘Practitioner Profiling’ websites.

    • ◊  Reports of Professional Bankruptcy

      As part of the same law, (§456.051(2), FS), any information in the possession of the Department of Health which relates to a bankruptcy proceeding by a practitioner of medicine, an osteopathic physician, a podiatrist, or a dentist is “public information”. It is available on the ‘Practitioner Profiling’ websites.

    • ◊  Identification of Facility and Practitioners Under Investigation for ‘Adverse Incident’

      As part of §456.081, FS, “The department and the boards shall maintain a website which contains . . . information relating to adverse incident reports without identifying the patient, practitioner, or facility in which the adverse incident occurred until 10 days after probable cause is found, at which time the name of the practitioner and facility shall become public as part of the investigative file . . .

    • ◊  Inspection Reports of Facilities:

      0395.0162, FS provides that all records of all inspection reports pertaining to that facility should be available upon request.

  • •  Provider Identification
    • ◊  ID of Medical Facility.

      Except as noted in public disclosure above, neither the Medical facility ID or HMO ID are publicized or made available to the public, unless a probably cause for investigation following an ‘adverse event’ is determined by the AHCA. Medical facilities and HMO are not identified in the Medical Errors Resolution And Tracking Programs.

    • ◊  ID of Physician

      The physician is included in the process of a medical facility's risk management program. If the physician is involved with an ‘adverse incident’ subject to a probable cause for investigation by the AHCA, the provider is identified within 10 days, and the name of the practitioner becomes public as part of the investigative file. All legal, malpractice, and disciplinary actions are available for every provider at the Provider Profiling website. The physician ID is withheld only from the Medical Errors Resolution And Tracking Programs.

  • •  Content of Report

    Reports on aggregate facility data for ‘adverse incidents’ are available at the website for the Medical Errors Resolution And Tracking Programs. The identifications of patients, health professional providers, hospitals, and HMOs are not included in these reports. Reports include annual reports, quarterly reports, and Code 15 Reports for health facilities and ambulatory surgery centers, which includes HMOs.

    These Medical Errors Resolution And Tracking Programs reports should not be confused with the Internal Risk Management Program Reports that are provided as part of the Internal Risk Management program. These reports are confidential and provided legislative protections from discovery. [§395.0197(6)(c), FS]

  • •  Other disclosable Information

    §395.0056, FS stipulates that upon notice of a complaint for medical malpractice action against a facility, the “the agency shall . . . [r]eview its adverse incident report files pertaining to the licensed facility . . ” This disclosure is provided only to the AHCA.


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