Current through Reg. 50, No. 187; September 24, 2024
(1) Each hospital must establish processes to
obtain, manage, and utilize information to enhance and improve individual and
organizational performance in patient care, governance, management, and support
processes. Such processes must:
(a) Be
planned and designed to meet the hospital's internal and external information
needs;
(b) Provide for
confidentiality, security and integrity;
(c) Provide uniform data definitions and
methods for capturing and storing data, including electronic mediums and
optical imaging;
(d) Provide
education and training in information management principles to decision-makers
and other hospital personnel who generate, collect, and analyze
information;
(e) Transmit
information in a timely and accurate manner; and
(f) Provide for the manipulation,
communication and linkage of information.
(2) All hospitals involved in the
transplantation of organs or tissues must maintain a centralized tracking
system to record the receipt and disposition of all organs and tissues
transplanted within the hospital.
(a) The
tracking system must be kept separate from patients' medical records, and must
include:
1. The organ or tissue
type;
2. The donor identification
number;
3. The name and license
number of the procurement or distribution center supplying the organ or
tissue;
4. Recipient information,
including, at a minimum the patient's name and identification number;
5. The name of the physician who performed
the transplant;
6. The date the
organ or tissue was received by the hospital; and
7. The date the organ or tissue was
transplanted.
(b) This
information must be provided, on a quarterly basis, to the organ procurement
organization or tissue bank that originally provided the organ or
tissue.
(3) Each hospital
must maintain a current and complete medical record for every patient seeking
care or service. The medical record must contain information required for
completion of birth, death and stillbirth certificates, and must, contain the
following information:
(a) Identification
data;
(b) Chief complaint or reason
for seeking care;
(c) Present
illness;
(d) Personal medical
history;
(e) Family medical
history;
(f) Physical examination
report;
(g) Provisional and
pre-operative diagnosis;
(h)
Clinical laboratory reports;
(i)
Radiology, diagnostic imaging, and ancillary testing reports;
(j) Consultation reports;
(k) Medical and surgical treatment notes and
reports;
(l) Evidence of
appropriate informed consent;
(m)
Evidence of medication and dosage administered;
(n) A copy of the Patient Care Record, in
accordance with subsection
64J-1.001(18),
F.A.C., if the patient was delivered to the hospital by ambulance;
(o) Tissue reports;
(p) Physician, APRN, PA and nurse progress
notes;
(q) Principal diagnosis,
secondary diagnoses and procedures when applicable;
(r) Discharge summary;
(s) Appropriate social work services reports,
if provided;
(t) Autopsy findings
when performed;
(u) Individualized
treatment plan;
(v) Clinical
assessment of the patients needs;
(w) Certifications of transfer of the patient
between hospitals as specified by rule
59A-3.255, F.A.C.;
and,
(x) Routine Inquiry Form
regarding request for organ donation in the event of the death of the
patient.
(y) A copy of the Hospital
Outpatient Observation Notice or Medicare Outpatient Observation Notice as
required by Section 395.301(3),
F.S., if the patient was placed on observation status.
(4) For patients undergoing operative or
other invasive procedures the medical record policies must also require:
(a) The recording of preoperative diagnoses
prior to surgery;
(b) That
operative reports be recorded in the health record immediately following
surgery or that an operative progress note is entered in the patient record to
provide pertinent information; and,
(c) Postoperative information must include
vital signs, level of consciousness, medications, blood components,
complications and management of those events, identification of direct
providers of care, discharge information from the post-anesthesia care
area.
(5) Medical records
for ambulatory care patients must consist of the information specified in
paragraph 59A-3.244(1)(i),
F.A.C.
(6) Each hospital must have
a patient information system, medical records department or similarly titled
unit with administrative responsibility for medical records. The medical
records department must:
(a) Maintain a system
of identification and filing to ensure the prompt location of a patient's
medical record. Patient records may be stored on electronic medium such as
optical imaging, computer, or microfilm;
(b) Centralize all appropriate clinical
information relating to a patient's hospital stay in the patient's medical
record;
(c) Index, and maintain on
a current basis, all medical records according to disease, operation and
physician.
(7) Patient
records must have a privileged and confidential status and must not be
disclosed without the consent of the person to whom they pertain unless
disclosed in accordance with Section
395.3025(4),
F.S.
(8) Any licensed facility
must, upon request, and only after discharge of the patient, furnish to any
patient admitted or treated in the facility, or to any patient's guardian,
curator, or personal representative, or to anyone designated by the patient in
writing, a true and correct copy of all of the patient's records, including
X-rays, which are in the possession of the licensed facility, provided the
person requesting such records agrees to pay a reasonable charge for copying
the records, pursuant to section
395.3025, F.S. The per page fee
is applicable to each page generated during copying of the medical record by
the facility or from a copy service providing these services on behalf of the
facility. Progress notes and consultation reports of a psychiatric or substance
abuse nature concerning the care and treatment performed by the licensed
facility are exempted from this requirement. The licensed facility shall
further allow any such person to examine the original records in its
possession, or microfilms or other suitable reproductions of the records stored
on electronic mediums, upon such reasonable terms imposed to assure that the
records will not be damaged, destroyed, or altered.
(a) The provisions of this section do not
apply to any licensed facility whose primary function is to provide psychiatric
care or substance abuse treatment to its patients.
(b) Disclosure of the medical records of
inmates of any institution, facility or program of the Department of
Corrections must be made in conformance with Section
945.10, F.S., and applicable
rules adopted thereunder.
(9) Each hospital operated by the Department
of Corrections must use a problem oriented medical record for each patient,
which must be initiated at the time of intake or admission and which must
contain all pertinent information required by this section.
(10) Each problem oriented medical record
maintained by hospitals operated by the Department of Corrections must be
standardized within each hospital and must be capable of providing easy
comparison of basic information on medical records at all such hospitals. Each
problem oriented medical record maintained by these hospitals must contain at
least the following information:
(a) A patient
data base which compiles all known facts about the patient which have relevance
to his health care, and which in addition to the other requirements of this
section contains:
1. Comments and complaints
as spoken by the patient or other persons significant in the patient's life,
including relatives, friends and caretakers;
2. A patient profile, including health
related habits, social, nutritional and educational information, and a review
of physical systems;
3. Relevant
legal documents, including but not limited to status forms, forensic forms,
consent forms, authority permits, and Baker Act forms; and
4. A medical diagnosis listed according to
the International Classification of Diseases and a mental illness diagnosis
listed according to the Diagnosis and Statistical Manual of Mental Disorders,
as relevant to the patient's condition.
(b) A problem list, which is a table of
contents to the patient's record, which identifies by number, date and
description of the patients problems.
(c) A plan of care which must specify the
specific course of action to be taken to address the problem(s) described,
including diagnosis, diagnostic and therapeutic orders, treatment, examination,
patient education, referral, and other necessary activities.
(d) Progress notes which must document the
activity and follow-up undertaken for each problem in a structured format which
is dated, titled and numbered according to the problem to which it
relates.
(11) The
discharge summary of each problem oriented medical record in hospitals operated
by the Department of Corrections must be completed, signed and dated within 15
days following the patient's discharge. The summary must include:
(a) The reason for admission;
(b) A recapitulation of the patient's
hospitalization;
(c) A statement of
the patient's progress and condition upon discharge;
(d) The facility or person, including the
patient themself when relevant, assuming responsibility for the patient after
discharge; and,
(e)
Recommendations, when necessary, for after care, follow-up, referral or other
action necessary to help the patient deal with problems.
(12) Each hospital must immediately notify a
non-Medicare patient or the patient's representative when the patient is placed
on observation status. Notification must utilize the Hospital Outpatient
Observation Notice, AHCA Form 3190-2000, April 2021, incorporated by reference
and available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-13012.
The form is available online at
http://www.ahca.myflorida.com/HQAlicensureforms.
(a) A hospital may provide AHCA Form
3190-2000 in electronic format, including electronic signature, unless the
patient requests a paper version.
(b) The signed version must be incorporated
into the patient's medical record and provided to the patient, patient's
survivor, or legal guardian through discharge papers.
(13) Information provided pursuant to Section
395.1012(3)(a),
F.S., must be provided on Quality Measures and Patient Safety Information, AHCA
Form 3190-2001OL, April 2021, incorporated by reference and available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-13013.
The form is available online at
https://www.floridahealthfinder.gov/index.html.
(14) The Agency will review this rule five
years from the effective date and repromulgate, amend or repeal the rule as
appropriate, in accordance with Section
120.54, F.S., and Chapter 1-1,
F.A.C.
Rulemaking Authority 395.1012, 395.1055, 395.301, 395.3015
FS. Law Implemented 395.1055, 395.301, 395.1012, 395.3015, 395.3025
FS.
New 9-4-95, Formerly
59A-3.214, Amended 10-16-14,
5-17-21.
