Senate Bill sb2218
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Florida Senate - 2005 SB 2218
By Senator Saunders
37-1027-05
1 A bill to be entitled
2 An act relating to patients' right to know
3 about adverse medical incidents; creating s.
4 381.028, F.S.; providing a short title;
5 providing a purpose; providing definitions;
6 requiring health care facilities and health
7 care providers to observe certain delineated
8 rights of patients; providing that certain
9 records obtained through the act may not be
10 subject to discovery or introduced into
11 evidence in any civil or administrative
12 proceeding; providing that the person
13 responsible for providing or preparing such
14 records cannot be compelled to testify about
15 the information in the records in any civil or
16 administrative proceeding; providing that the
17 limited use of records obtained through this
18 act does not alter or repeal other statutory
19 restrictions regarding discoverability or
20 admissibility; providing that the limited use
21 of records in this act does not require
22 disclosure of documents regarding
23 attorney-client communications or attorney work
24 product; authorizing a patient to waive his or
25 her right to request records under certain
26 conditions; providing for applicability of the
27 act to certain records; amending s. 381.0271,
28 F.S.; authorizing the Florida Patient Safety
29 Corporation to use hypothetical cases to
30 evaluate quality assurance and safety programs;
31 prohibiting the investigations, proceedings,
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1 and records of the corporation from being
2 discovered or introduced into evidence in any
3 civil or administrative proceeding under
4 certain circumstances; providing that the
5 person in attendance at a meeting of the
6 corporation cannot be compelled to testify
7 about the information, findings, opinions, or
8 recommendations of the corporation in any civil
9 or administrative proceeding; providing that
10 certain information is not immune from
11 discovery; providing for severability;
12 providing an effective date.
13
14 Be It Enacted by the Legislature of the State of Florida:
15
16 Section 1. Section 381.028, Florida Statutes, is
17 created to read:
18 381.028 Florida Patients' Right to Know About Adverse
19 Medical Incidents Act.--
20 (1) SHORT TITLE.--This section may be cited as the
21 "Florida Patients' Right to Know About Adverse Medical
22 Incidents Act."
23 (2) PURPOSE.--It is the purpose of this section to
24 implement the provisions of Article X, s. 22 of the Florida
25 Constitution which the Legislature finds not to be
26 self-executing. The Legislature finds that the intent of the
27 voters was to provide patients and prospective patients with
28 access to quality of care information relating to adverse
29 medical incidents to assist patients and prospective patients
30 in evaluating the quality of care that they receive or can
31 reasonably expect to receive from health care facilities and
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1 health care providers in this state. In enacting this section,
2 it is the intent of the Legislature to maintain all existing
3 provisions concerning criminal and civil immunity for persons
4 providing information to quality of care committees or
5 organizations or to render any records of any adverse medical
6 incident discoverable or admissible into evidence in any
7 judicial or administrative proceeding. Records required to be
8 made available under this section are not public records
9 inasmuch as they are to be made available only to patients and
10 prospective patients and not the public at large.
11 (3) DEFINITIONS.--As used in this section, the term:
12 (a) "Adverse medical incident" means medical
13 negligence, intentional misconduct, and any other act of
14 medical neglect, or default of a health care facility or
15 health care provider which caused or could foreseeably have
16 caused injury to or the death of a patient, including, but not
17 limited to, those medical incidents that are required by state
18 or federal law to be reported to any governmental agency or
19 body, and incidents that are reported to or reviewed by any
20 health care facility peer review, risk management, quality
21 assurance, credentials, or similar committee, or any
22 representative of any such committees.
23 (b) "Agency" means the Agency for Health Care
24 Administration.
25 (c) "Department" means the Department of Health.
26 (d) "Have access to any records" means making the
27 records available for inspection and copying them upon written
28 request by the patient or a representative of the patient if
29 any current records that have been made publicly available by
30 publication or on the Internet may be provided by reference to
31 the location at which the records are publicly available. Any
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1 health care facility or health care provider responding to a
2 request for records has a reasonable amount of time to respond
3 to the request. In addition, in responding to a request for
4 records, any health care facility or health care provider has
5 that time which is necessary to make sure that all patient
6 identifying information and other information required to be
7 made private under state or federal law is not improperly
8 disclosed. Any record that contains information about a health
9 care facility or health care provider must be disclosed to the
10 health care facility or the health care provider named in the
11 record sufficiently before it is made available to the patient
12 or the patient's representative so as to allow the health care
13 facility or health care provider to correct any errors in the
14 record and to correct any errors in the required redaction of
15 patient identifying information or other information required
16 to be made private under state or federal law. Patients or any
17 representative of a patient requesting records shall pay in
18 advance all anticipated costs of preparing requested records
19 for inspection and copying, including, but not limited to,
20 clerical and administrative costs of locating, assembling,
21 reviewing for, and redacting any patient identifying and other
22 private information, reviewing for and redacting any attorney
23 client or attorney work product information, and producing
24 such records for inspection and copying. Patients and
25 representatives of patients shall pay in advance all
26 anticipated costs of copying, including labor and supplies,
27 any records selected for copying by the patient or the
28 representative of the patient. A request for information must
29 be written and must identify the patient requesting access to
30 records by name, address, date of birth, and social security
31 number, describe the condition, treatment, or diagnosis for
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1 which the patient is undergoing, has undergone, or is seeking
2 health care, and specify the name of each health care facility
3 or health care provider from whom the patient is undergoing,
4 has undergone, or is seeking health care relating to the
5 condition, treatment, or diagnosis identified. Requests for
6 access to information shall be made directly to health care
7 facilities and health care providers that made or received the
8 records and not to the department or to the agency.
9 (e) "Health care facility" means a facility licensed
10 under chapter 395.
11 (f) "Health care provider" means a physician licensed
12 under chapter 458, an osteopathic physician licensed under
13 chapter 459, or a podiatric physician licensed under chapter
14 461.
15 (g) "Identity of patient" means any individually
16 identifiable health information as defined by the Health
17 Insurance Portability and Accountability Act of 1996 or its
18 implementing regulations.
19 (h) "Patient" means an individual who has sought, is
20 seeking, is undergoing, or has undergone care or treatment in
21 a health care facility or by a health care provider.
22 (i) "Privacy restrictions imposed by federal law"
23 means the requirements with respect to disclosure of
24 information under federal law, including, but not limited to,
25 the Health Insurance Portability and Accountability Act of
26 1996, Public Law 104-91 (HIPAA) and its implementing
27 regulations, and the Federal Privacy Act, 5 U.S.C. s. 552(a)
28 and its implementing regulations, and any privilege,
29 including, but not limited to, the attorney-client, the
30 attorney work product, or the self-critical analysis
31
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1 privilege, that has been recognized under federal law that
2 prohibits disclosure of information contained in the record.
3 (j) "Record" means the final report of any adverse
4 medical incident occurring after November 2, 2004, that
5 involves the patient who is seeking access to the report, or
6 that involves the treatment, condition, or diagnosis of the
7 patient and involves the health care facility or health care
8 provider identified in the request for records, excluding,
9 however, any medical records that are not the final report of
10 any adverse medical incident, drafts, or other nonfinal
11 versions, notes, or any documents that constitute, contain, or
12 reflect any attorney-client communications or any attorney
13 work product, or any information that would be protected from
14 disclosure by any privacy restrictions imposed by federal law.
15 The identities of reviewers, complainants, or any other
16 persons who provided information relied upon in the
17 preparation of the final report, or who otherwise participated
18 in the creation of the final report shall be redacted from the
19 report before it is provided to the patient.
20 (k) "Relating to" means either directly involving the
21 patient who is requesting access to records or directly
22 involving the treatment, condition, or diagnosis for which the
23 patient has undergone, is undergoing, or is seeking health
24 care and the health care facility or health care provider from
25 whom records are requested.
26 (l) "Representative of the patient" means a parent of
27 a minor patient, a court appointed guardian for the patient,
28 or a person holding a power of attorney or notarized consent
29 appropriately executed by the patient reflecting the patient's
30 permission to disclose the patient's health care information
31 to that person.
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1 (m) "Seeking access" means actively requesting access
2 to a health care provider or health care facility as
3 demonstrated either by documented appointments or
4 consultations with a health care provider or health care
5 facility, or by a written referral to a health care provider
6 or health care facility by another licensed health care
7 practitioner.
8 (4) RIGHTS OF PATIENTS.--Each health care facility or
9 health care provider shall observe the following requirements:
10 (a) In addition to any other similar rights provided
11 herein or by general law, patients have a right to have access
12 to any records made or received in the course of business by a
13 health care facility or provider relating to any adverse
14 medical incident involving the patient or the provider to
15 which the patient is seeking access.
16 (b) In providing such access, the identity of patients
17 involved in the adverse medical incidents may not be
18 disclosed, and any privacy restrictions imposed by state or
19 federal law shall be maintained.
20 (5) USE OF RECORDS.--Records obtained through this
21 section and any of the information contained in those records,
22 including information relating to performance or quality
23 improvement initiatives, the identities of reviewers,
24 complainants, or other persons providing information contained
25 in or participating in the creation of records of adverse
26 medical incidents, may not, without limitation or exception,
27 be subject to discovery or introduction into evidence, for any
28 purpose, including impeachment, in any civil or administrative
29 action in whatever form or cause of action against a health
30 care facility or health care provider, and a person who
31 provided information that was used in the preparation of the
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1 record or who participated in the creation of the record is
2 not permitted or required to testify in any such civil or
3 administrative action as to any evidence or other matters used
4 in the preparation of the record or that relate to the adverse
5 medical incident covered by the record. However, information
6 or documents otherwise available from other sources are not
7 immune from discovery or use in any such civil or
8 administrative action under this section. This section does
9 not repeal or otherwise alter any existing restrictions on the
10 discoverability or admissibility of records relating to
11 adverse medical incidents otherwise provided by law,
12 including, but not limited to, ss. 395.0191(8), 395.0193(8),
13 and 766.101(5) nor to repeal or otherwise alter any immunity
14 provided to persons providing information or participating in
15 any peer review, medical review, or hospital committee
16 otherwise provided by law, including, but not limited to, ss.
17 395.0191(7), 395.0193(5) and 766.101. This section does not
18 require disclosure of documents that constitute or contain
19 attorney-client communications or attorney work product
20 information.
21 (6) WAIVER.--A patient may waive the right to request
22 the records that are subject to the provisions of this section
23 and Article X, s. 22, Florida Constitution, if any such waiver
24 is in writing and signed by the patient or the patient's
25 representative.
26 (7) APPLICABILITY.--This section shall apply to all
27 records of adverse medical incidents made after November 2,
28 2004, and to all actions pending on or filed after November 3,
29 2004. A request for records which is made on or before
30 November 3, 2006, is only eligible to receive records created
31 on or after November 3, 2004. A request for records which is
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1 made on or after November 3, 2006, is only eligible to receive
2 records created within 24 months of the date of the request.
3 Section 2. Subsection (7) of section 381.0271, Florida
4 Statutes, is amended and subsection (11) is added to that
5 section, to read:
6 381.0271 Florida Patient Safety Corporation.--
7 (7) POWERS AND DUTIES.--
8 (a) In addition to the powers and duties prescribed in
9 chapter 617, and the articles and bylaws adopted under that
10 chapter, the corporation shall, directly or through contract:
11 1. Secure staff necessary to properly administer the
12 corporation.
13 2. Collect, analyze, and evaluate patient safety data
14 and quality and patient safety indicators, medical malpractice
15 closed claims, and adverse incidents reported to the Agency
16 for Health Care Administration and the Department of Health
17 for the purpose of recommending changes in practices and
18 procedures that may be implemented by health care
19 practitioners and health care facilities to improve health
20 care quality and to prevent future adverse incidents.
21 Notwithstanding any other provision of law, the Agency for
22 Health Care Administration and the Department of Health shall
23 make available to the corporation any adverse incident report
24 submitted under ss. 395.0197, 458.351, and 459.026. To the
25 extent that adverse incident reports submitted under s.
26 395.0197 are confidential and exempt, the confidential and
27 exempt status of such reports shall be maintained by the
28 corporation.
29 3. Establish a "near-miss" patient safety reporting
30 system. The purpose of the near-miss reporting system is to:
31 identify potential systemic problems that could lead to
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1 adverse incidents; enable publication of systemwide alerts of
2 potential harm; and facilitate development of both
3 facility-specific and statewide options to avoid adverse
4 incidents and improve patient safety. The reporting system
5 shall record "near misses" submitted by hospitals, birthing
6 centers, and ambulatory surgical centers and other providers.
7 For the purpose of the reporting system:
8 a. The term "near miss" means any potentially harmful
9 event that could have had an adverse result but, through
10 chance or intervention in which, harm was prevented.
11 b. The near-miss reporting system shall be voluntary
12 and anonymous and independent of mandatory reporting systems
13 used for regulatory purposes.
14 c. Near-miss data submitted to the corporation is
15 patient safety data as defined in s. 766.1016.
16 d. Reports of near-miss data shall be published on a
17 regular basis and special alerts shall be published as needed
18 regarding newly identified, significant risks.
19 e. Aggregated data shall be made available publicly.
20 f. The corporation shall report the performance and
21 results of the near-miss project in its annual report.
22 4. Work collaboratively with the appropriate state
23 agencies in the development of electronic health records.
24 5. Provide for access to an active library of
25 evidence-based medicine and patient safety practices, together
26 with the emerging evidence supporting their retention or
27 modification, and make this information available to health
28 care practitioners, health care facilities, and the public.
29 Support for implementation of evidence-based medicine shall
30 include:
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1 a. A report to the Governor, the President of the
2 Senate, the Speaker of the House of Representatives, and the
3 Agency for Health Care Administration by January 1, 2005, on:
4 (I) The ability to join or support efforts for the use
5 of evidence-based medicine already underway, such as those of
6 the Leapfrog Group, the international group Bandolier, and the
7 Healthy Florida Foundation.
8 (II) The means by which to promote research using
9 Medicaid and other data collected by the Agency for Health
10 Care Administration to identify and quantify the most
11 cost-effective treatment and interventions, including disease
12 management and prevention programs.
13 (III) The means by which to encourage development of
14 systems to measure and reward providers who implement
15 evidence-based medical practices.
16 (IV) The review of other state and private initiatives
17 and published literature for promising approaches and the
18 dissemination of information about them to providers.
19 (V) The encouragement of the Florida health care
20 boards under the Department of Health to regularly publish
21 findings related to the cost-effectiveness of
22 disease-specific, evidence-based standards.
23 (VI) Public and private sector initiatives related to
24 evidence-based medicine and communication systems for the
25 sharing of clinical information among caregivers.
26 (VII) Regulatory barriers that interfere with the
27 sharing of clinical information among caregivers.
28 b. An implementation plan reported to the Governor,
29 the President of the Senate, the Speaker of the House of
30 Representatives, and the Agency for Health Care Administration
31 by September 1, 2005, that must include, but need not be
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1 limited to: estimated costs and savings, capital investment
2 requirements, recommended investment incentives, initial
3 committed provider participation by region, standards of
4 functionality and features, a marketing plan, and
5 implementation schedules for key components.
6 6. Develop and recommend core competencies in patient
7 safety that can be incorporated into the undergraduate and
8 graduate curricula in schools of medicine, nursing, and allied
9 health in the state.
10 7. Develop and recommend programs to educate the
11 public about the role of health care consumers in promoting
12 patient safety.
13 8. Provide recommendations for interagency
14 coordination of patient safety efforts in the state.
15 (b) In carrying out its powers and duties, the
16 corporation may also:
17 1. Assess the patient safety culture at volunteering
18 hospitals and recommend methods to improve the working
19 environment related to patient safety at these hospitals.
20 2. Inventory the information technology capabilities
21 related to patient safety of health care facilities and health
22 care practitioners and recommend a plan for expediting the
23 implementation of patient safety technologies statewide.
24 3. Recommend continuing medical education regarding
25 patient safety to practicing health care practitioners.
26 4. Study and facilitate the testing of alternative
27 systems of compensating injured patients as a means of
28 reducing and preventing medical errors and promoting patient
29 safety.
30 5. Conduct other activities identified by the board of
31 directors to promote patient safety in this state.
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1 (c) In lieu of any specific cases reported by any
2 health care facility licensed under chapter 395 or any health
3 care provider licensed under chapter 458 or chapter 459, the
4 corporation may rely upon and use hypothetical cases in order
5 to evaluate the quality assurance and patient safety programs
6 of the health care facility and the health care provider.
7 (11) The investigations, proceedings, and records of
8 the corporation as described in this section may not be
9 subject to discovery or introduced into evidence in any civil
10 or administrative action against a health care facility or
11 health care provider arising out of the matters that are the
12 subject of evaluation and review by the corporation or any of
13 its committees, and any person who was in attendance at a
14 meeting of the corporation or any of its committees are not
15 permitted or required to testify in any such civil or
16 administrative action as to any evidence or other matters
17 produced or presented during the proceedings of the
18 corporation or any of its committees as to any findings,
19 recommendations, evaluations, opinions, or other actions of
20 the corporation or any of its committees. However, except as
21 otherwise provided by statute, information, documents, or
22 records otherwise available from original sources are not
23 immune from discovery or use in any such civil or
24 administrative action merely because they were presented
25 during proceedings of the corporation or any of its
26 committees, and any person who testifies before or
27 participates in the meetings of the corporation or any of its
28 committees are not prevented from testifying as to matters
29 within his or her knowledge. Such witness may not be asked
30 about his or her testimony or participation in the proceedings
31 of the corporation or any of its committees or opinions formed
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1 by him or her as a result of participation in such
2 proceedings.
3 Section 3. If any provision of this act or its
4 application to any person or circumstance is held invalid, the
5 invalidity does not affect other provisions or applications of
6 the act which can be given effect without the invalid
7 provision or application, and to this end the provisions of
8 this act are declared severable.
9 Section 4. This act shall take effect upon becoming a
10 law.
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13 SENATE SUMMARY
14 Requires health care facilities and health care providers
to observe certain delineated rights of patients.
15 Provides that certain records obtained through the act
may not be subject to discovery or introduced into
16 evidence. Provides that the person responsible for
providing or preparing such records cannot be compelled
17 to testify about the information in the records. Provides
that the limited use of records obtained through this act
18 does not alter or repeal other statutory restrictions
regarding discoverability or admissibility. Provides that
19 the limited use of records in this act does not require
disclosure of documents regarding attorney-client
20 communications or attorney work product. Authorizes a
patient to waive his or her right to request records
21 under certain conditions. Provides for the applicability
of the act to certain records. Authorizes the Florida
22 Patient Safety Corporation to use hypothetical cases to
evaluate quality assurance and safety programs. Prohibits
23 investigations, proceedings, and records of the
corporation from being discovered or introduced into
24 evidence in any civil or administrative proceeding under
certain circumstances. Provides that the person in
25 attendance at a meeting of the corporation cannot be
compelled to testify about the information, findings,
26 opinions, or recommendations of the corporation.
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