The Florida Senate

395.0197  Internal risk management program.--

(1)  Every licensed facility shall, as a part of its administrative functions, establish an internal risk management program that includes all of the following components:

(a)  The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents causing injury to patients.

(b)  The development of appropriate measures to minimize the risk of injuries and adverse incidents to patients, including, but not limited to:

1.  Risk management and risk prevention education and training of all nonphysician personnel as follows:

a.  Such education and training of all nonphysician personnel as part of their initial orientation; and

b.  At least 1 hour of such education and training annually for all nonphysician personnel of the licensed facility working in clinical areas and providing patient care.

2.  A prohibition, except when emergency circumstances require otherwise, against a staff member of the licensed facility attending a patient in the recovery room, unless the staff member is authorized to attend the patient in the recovery room and is in the company of at least one other person. However, a hospital is exempt from the two-person requirement if it has:

a.  Live visual observation;

b.  Electronic observation; or

c.  Any other reasonable measure taken to ensure patient protection and privacy.

(c)  The analysis of patient grievances that relate to patient care and the quality of medical services.

(d)  The development and implementation of an incident reporting system based upon the affirmative 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.

(2)  The internal risk management program is the responsibility of the governing board of the health care facility. Each licensed facility shall hire a risk manager, licensed under part IX of chapter 626, who is responsible for implementation and oversight of such facility's internal risk management program as required by this section. A risk manager must not be made responsible for more than four internal risk management programs in separate licensed facilities, unless the facilities are under one corporate ownership or the risk management programs are in rural hospitals.

(3)  In addition to the programs mandated by this section, other innovative approaches intended to reduce the frequency and severity of medical malpractice and patient injury claims shall be encouraged and their implementation and operation facilitated. Such additional approaches may include extending internal risk management programs to health care providers' offices and the assuming of provider liability by a licensed health care facility for acts or omissions occurring within the licensed facility.

(4)  The agency shall, after consulting with the Department of Insurance, adopt rules governing the establishment of internal risk management programs to meet the needs of individual licensed facilities. Each internal risk management program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each licensed facility, such as an insurance coordinator, or who is retained by the licensed facility as a consultant. The individual responsible for the risk management program shall have free access to all medical records of the licensed facility. The incident reports are part of the workpapers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court. A person filing an incident report is not subject to civil suit by virtue of such incident report. As a part of each internal risk management program, the incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas.

(5)

(a)  Each licensed facility subject to this section shall submit an annual report to the agency summarizing the incident reports that have been filed in the facility for that year. The report shall include:

1.  The total number of adverse incidents causing injury to patients.

2.  A listing, by category, of the types of operations, diagnostic or treatment procedures, or other actions causing the injuries, and the number of incidents occurring within each category.

3.  A listing, by category, of the types of injuries caused and the number of incidents occurring within each category.

4.  A code number using the health care professional's licensure number and a separate code number identifying all other individuals directly involved in adverse incidents causing injury to patients, the relationship of the individual to the licensed facility, and the number of incidents in which each individual has been directly involved. Each licensed facility shall maintain names of the health care professionals and individuals identified by code numbers for purposes of this section.

5.  A description of all malpractice claims filed against the licensed facility, including the total number of pending and closed claims and the nature of the incident which led to, the persons involved in, and the status and disposition of each claim. Each report shall update status and disposition for all prior reports.

6.  A report of all disciplinary actions pertaining to patient care taken against any medical staff member, including the nature and cause of the action.

(b)  The information reported to the agency pursuant to paragraph (a) which relates to persons licensed under chapter 458, chapter 459, chapter 461, or chapter 466 shall be reviewed by the agency. The agency shall determine whether any of the incidents potentially involved conduct by a health care professional who is subject to disciplinary action, in which case the provisions of s. 455.225 shall apply.

(c)  The report submitted to the agency shall also contain the name and license number of the risk manager of the licensed facility, a copy of its policy and procedures which govern the measures taken by the facility and its risk manager to reduce the risk of injuries and adverse or untoward incidents, and the results of such measures. The annual report is confidential and is not available to the public pursuant to s. 119.07(1) or any other law providing access to public records. The annual report is not discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board. The annual report is not available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause.

(6)  If an adverse or untoward incident, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility, results in:

(a)  The death of a patient;

(b)  Brain or spinal damage to a patient;

(c)  The performance of a surgical procedure on the wrong patient; or

(d)  A surgical procedure unrelated to the patient's diagnosis or medical needs being performed on any patient, including the surgical repair of injuries or damage resulting from the planned surgical procedure, wrong site or wrong procedure surgeries, and procedures to remove foreign objects remaining from surgical procedures,

the licensed facility shall report this incident to the agency within 15 calendar days after its occurrence. The agency may require an additional, final report. These reports shall not be available to the public pursuant to s. 119.07(1) or any other law providing access to public records, nor be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board, nor shall they be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause. 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. 455.225 shall apply.

(7)  The internal risk manager of each licensed facility shall:

(a)  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;

(b)  Investigate every allegation of sexual misconduct which is made against a member of the facility's personnel who has direct patient contact, when the allegation is that the sexual misconduct occurred at the facility or on the grounds of the facility; and

(c)  Report every allegation of sexual misconduct to the administrator of the licensed facility.

(8)  Any witness who witnessed or who possesses actual knowledge of the act that is the basis of an allegation of sexual abuse shall:

(a)  Notify the local police; and

(b)  Notify the hospital risk manager and the administrator.

For purposes of this subsection, "sexual abuse" means acts of a sexual nature committed for the sexual gratification of anyone upon, or in the presence of, a vulnerable adult without the vulnerable adult's informed consent. "Sexual abuse" includes, but is not limited to, the acts defined in s. 794.011(1)(h), fondling, exposure of a vulnerable adult's sexual organs, or the use of the vulnerable adult to solicit for or engage in prostitution or sexual performance. "Sexual abuse" does not include any act intended for a valid medical purpose or any act which may reasonably be construed to be a normal caregiving action.

(9)  A person who, with malice or with intent to discredit or harm a licensed facility or any person, makes a false allegation of sexual misconduct against a member of a licensed facility's personnel is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.

(10)  In addition to any penalty imposed pursuant to this section, the agency may impose an administrative fine, not to exceed $5,000, for any violation of the reporting requirements of this section.

(11)  The agency shall have access to all licensed facility records necessary to carry out the provisions of this section. The records obtained are not available to the public under s. 119.07(1), nor shall they be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board, nor shall records obtained pursuant to s. 455.223 be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause, except that, with respect to medical review committee records, s. 766.101 controls.

(12)  The meetings of the committees and governing board of a licensed facility held solely for the purpose of achieving the objectives of risk management as provided by this section shall not be open to the public under the provisions of chapter 286. The records of such meetings are confidential and exempt from s. 119.07(1), except as provided in subsection (11).

(13)  The agency shall review, as part of its licensure inspection process, the internal risk management program at each licensed facility regulated by this section to determine whether the program meets standards established in statutes and rules, whether the program is being conducted in a manner designed to reduce adverse incidents, and whether the program is appropriately reporting incidents under subsections (5) and (6).

(14)  There shall be no monetary liability on the part of, and no cause of action for damages shall arise against, any risk manager, licensed under part IX of chapter 626, for the implementation and oversight of the internal risk management program in a facility licensed under this chapter or chapter 390 as required by this section, for any act or proceeding undertaken or performed within the scope of the functions of such internal risk management program if the risk manager acts without intentional fraud.

(15)  If the agency, through its receipt of the annual reports prescribed in subsection (5) or through any investigation, has a reasonable belief that conduct by a staff member or employee of a licensed facility is grounds for disciplinary action by the appropriate regulatory board, the agency shall report this fact to such regulatory board.

(16)  The agency shall annually publish a report summarizing the information contained in the annual incident reports submitted by licensed facilities and any serious incident reports submitted by licensed facilities. The report must, at a minimum, summarize:

(a)  Adverse and serious incidents, by service district of the department as defined in s. 20.19, by category of reported incident, and by type of professional involved.

(b)  Types of malpractice claims filed, by service district of the department as defined in s. 20.19, and by type of professional involved.

(c)  Disciplinary actions taken against professionals, by service district of the department as defined in s. 20.19, and by type of professional involved.

History.--s. 3, ch. 75-9; s. 3, ch. 76-168; s. 2, ch. 76-260; s. 1, ch. 77-64; s. 1, ch. 77-457; s. 286, ch. 79-400; s. 3, ch. 81-318; ss. 9, 52, ch. 85-175; s. 2, ch. 86-287; s. 6, ch. 88-1; s. 3, ch. 88-97; s. 3, ch. 88-277; s. 14, ch. 89-527; s. 16, ch. 90-344; s. 23, ch. 92-33; ss. 15, 16, 98, ch. 92-289; s. 1, ch. 95-319; s. 214, ch. 96-406.

Note.--Former ss. 395.18, 768.41; s. 395.041.