The Agency proposes to revise the rule based on changes to sections 395.1012 and 395.301, F.S., pursuant to HB843 effective July 1, 2019. The changes require the creation of forms to be adopted by rule. The form required ....

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-3.270Health Information Management

PURPOSE AND EFFECT: The Agency proposes to revise the rule based on changes to sections 395.1012 and 395.301, F.S., pursuant to HB843 effective July 1, 2019. The changes require the creation of forms to be adopted by rule. The form required by the revision to s. 395.1012, F.S. will provide specified information and data relating to patient safety and quality measures. The form required by the revision to s. 395.301, F.S. will be used to notify non-Medicare patients of observation status.

SUMMARY: This rule will address required hospital forms to be used for notification of observation status and patient safety/quality measures.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 395.1055, 395.3015 FS.

LAW IMPLEMENTED: 395.1055, 395.1012, 395.301, 395.3015, 395.3025 FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: Thursday, January 14, 2021, 3:00 p.m. – 4:30 p.m.

PLACE: No public face-to-face meeting. This hearing will be conducted via teleconference. Participate by dialing the Open Voice conference line, 1(888)585-9008, then enter the conference room number followed by the pound sign, 476-211-242#.

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Jessica Munn, Hospital & Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, Florida, [phone].. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: A copy of the agenda may be obtained by contacting: Jessica Munn, Hospital and Outpatient Services Unit, Bureau of Health Facility Regulation, [e-mail] or [phone]. The agenda and related materials can also be found on the web at: https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Rulemaking.shtml.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-3.270 Health Information Management.

(1) Each hospital must shall 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 shall:

(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 shall 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 shall 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 shall maintain a current and complete medical record for every patient seeking care or service. The medical record must shall contain information required for completion of birth, death and stillbirth still birth certificates, and must shall, 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 subsection 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 shall 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 shall 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 shall consist of the information specified in paragraph 59A-3.244(1)(i), F.A.C.

(6) Each hospital must shall have a patient information system, medical records department or similarly titled unit with administrative responsibility for medical records. The medical records department must shall:

(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 shall have a privileged and confidential status and must shall 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 shall, 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 must 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 shall 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 shall use a problem oriented medical record for each patient, which must shall be initiated at the time of intake or admission and which must shall contain all pertinent information required by this section.

(10) Each problem oriented medical record maintained by hospitals operated by the Department of Corrections must shall be standardized within each hospital and must shall 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 shall 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 shall 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 shall 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 shall be completed, signed and dated within 15 days following the patient’s discharge. The summary must shall 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 himself 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 their representative when the patient is placed on observation status. Notification must utilize the Hospital Outpatient Observation Notice, AHCA Form 3190-2000, September 2020, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.  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 3190-2001, September 2020, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.  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, 395.3015 FS. Law Implemented 395.1055, 395.301, 395.1012, 395.3015, 395.3025 FS. History–New 9-4-95, Formerly 59A-3.214, Amended 10-16-14,                    .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jack Plagge

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Shevaun L. Harris

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 12/09/2020

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 10/31/2019