59A-12.002: The Agency is proposing to use a standardized term for Staff Model HMO by reference to comply with the statutory requirements pursuant to Section 641.55, F.S. 59A-12.012: The Agency is proposing to establish a standardized form by ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-12.002Definitions

59A-12.012Internal Risk Management Program

PURPOSE AND EFFECT: Rule 59A-12.002, F.A.C.: The Agency is proposing to use a standardized term for Staff Model HMO by reference to comply with the statutory requirements pursuant to Section 641.55, F.S.

Rule 59A-12.012, F.A.C.: The Agency is proposing to establish a standardized form by reference for submitting adverse incident reports to the Agency and to comply with the statutory requirements pursuant to Section 641.55, F.S.

SUMMARY: Rule 59A-12.002, F.A.C.: The rule incorporates the term and its meaning by reference pursuant to Section 641.55, F.S.

Rule 59A-12.012, F.A.C.: The rule incorporates a standardized form by reference pursuant to Section 641.55, F.S.

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.

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: 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.

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: 641.55 and 641.56, FS.

LAW IMPLEMENTED: 641.55 and 641.56, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: August 18, 2017, 2:00 p.m. – 3:00 p.m.

PLACE: Agency for Health Care Administration 2727 Mahan Drive, Fort Knox Building 3, Conference Room B, Tallahassee, FL 32308.

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: Sean Massey, Bureau of HQA, 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: Sean Massey, email: [e-mail] [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-12.002 Definitions.

(1) No change.

(2) HMO. Health Maintenance Organization shall be abbreviated as HMO in these rules.

(a) Individual Practice Assocation (IPA) Model HMO. A type of health care provider organization composed of a group of independent practicing physicians who maintain their own offices and band together for the purpose of contracting their services to HMOs.

(b) Staff Model HMO. Physicians and medical professionals are employees of the HMO and have offices in HMO owned or leased buldings.  The physicians and medical professionals only see members of the HMO employer.

(c) Mixed Model HMO.  A Staff Model HMO that also contracts with providers organized as IPAs.

(3) through (10) No changes.

(11) ICD-10 9-CM. The International Classification of Diseases, 109th Revision, Clinical Modifications shall be abbreviated as ICD-10 9-CM in these rules.

(12) through (13) No change. 

Rulemaking Authority 641.56 FS. Law Implemented 641.51 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.002, Amended 4-10-03, _______.

 

59A-12.012 Internal Risk Management Program.

(1) Every health maintenance organization certified under this part shall, as a part of its administrative function, establish an internal risk management program. Such program shall include as a minimum: as defined in section 641.55, F.S.

(a) The investigation and analysis of the frequency and causes of general categories and specific types of incidents;

(b) The development of appropriate measures to minimize the risk of injuries and incidents to patients;

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

(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 health care facility to report injuries and incidents.

(2) The risk management program shall be the ultimate responsibility of the governing body of the HMO.

(3) Every Sstaff Mmodel and combination of individual practice association and staff Mixed Mmodel HMO certified under this part which has an annual premium volume of $10 million or more shall employ or contract with a licensed risk manager who shall be responsible for implementation and oversight of the organization’s internal risk management program. A part-time risk manager shall not be responsible for risk management programs in more than four organizations or facilities. Every IPA individual practice association Mmodel and every HMO with an annual premium volume of less than $10 million shall designate an officer or employee of the HMO to serve as risk manager.

(4)(3) Incident Reporting System. As part of the internal risk management program aAn incident reporting system shall be established for each HMO. Procedures shall be detailed in writing and disseminated to all employees of the HMO. All new employees, Wwithin 30 days of employment, all new employees shall be instructed in the operation and responsibilities of the incident reporting system. At least annually Aall non physician personnel who provide direct patient care in clinical areas of a Staff or Mixed Model HMO employed by the organization working in clinical areas and providing patient care shall receive 1 hour annually of risk management and risk prevention education and training including the importance of accurate and timely incident reporting. The incident reporting system shall include the prompt, within 3 business calendar days, reporting of incidents to the risk manager. Incident reports shall be on a form developed by the HMO for the purpose and shall contain at least the following information:

(a) The patient’s name, date of birth, sex, physical findings or diagnosis and, if hospitalized; locating information, admission time and date, and the facility’s name;

(b) A clear and concise description of the incident including time, date, exact location, and coding elements as needed for the annual report based on ICD-10 9-CM;

(c) Whether or not a physician was called and, if so, a brief statement of said physician’s recommendations as to medical treatment, if any;

(d) A listing of all persons known to be involved directly in the incident, including witnesses, along with locating information for each; and

(e) The name, signature and position of the person completing the report, along with date and time that the report was completed.

(5)(4) Incident Report and Patient Grievance Review and Analysis. The HMO shall be responsible for regular and systematic review of all incident reports and written patient grievances for the purpose of identifying trends or patterns as to time, place or persons and, upon emergence of any trend or pattern in incident occurrence, shall develop recommendations for appropriate corrective action and risk management prevention education and training. Summary data shall be systematically maintained for 3 years.

(a) At least quarterly or more often as may be required by the governing body, the risk manager shall provide a summary report to the governing body which includes information about activities of risk management.

(b) Evidence of the incident reporting and analysis system and copies of summary reports and evidence of recommended and accomplished corrective actions shall be made available for review to Agency upon request during normal business hours.

(6) Annual reports must be submitted to the Agency summarizing the incident reports that were filed in the organization during the preceding calendar year pertaining to services rendered on the premises of the organization as as defined in Section 641.55, F.S. Annual reports must be submitted electronically to the Agency as required in Section 641.55, F.S., on Annual Report, AHCA Form 3140-5002 OL, Dec 2001, which is hereby incorporated by reference and may be obtained from the Agency’s annual reporting system located at: https://apps.ahca.myflorida.com/adverseincidentreport/.

(7)(5) Fifteen Day Reports. If an All adverse or untoward incidents, whether occurring in the facilities of the Staff Model or Mixed Model organization or arising from health care prior to admission to the facilities of the organization or in the facility of one of its providers, results in: must be reported to the Agency as defined in section 641.55, F.S.

(a) The death of a patient; or Adverse incident reports must be submitted electronically to the Agency within 3 working days after its occurrence, with a more detailed followup within 10 days of the first report as required in Section 641.55, F.S., on Health Maintenance Organization Adverse Incident Report, HMO Adverse Incident, AHCA Form 3140-5003 OL, June 2017, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and may be obtained from the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at   https://apps.ahca.myflorida.com/SingleSignOnPortal.

(b) Severe brain or spinal damage to a patient; or

(c) A surgical procedure being performed on the wrong patient; or

(d) A surgical procedure unrelated to the patient’s diagnosis or medical needs being performed on any patient, the organization shall report this incident to the department within 15 calendar days of its occurrence. The report shall be made on HRS Form 1654, “Code 15”, effective 12-89 which is incorporated by reference. Any reportable incidents, pursuant to this section that are submitted more than 15 calendar days from occurrence by the organization must be justified in writing by the organization administrator.

(6) Summary Reports. At least quarterly or more often as may be required by the governing body, the risk manager shall provide a summary report to the governing body which includes information about activities of risk management.

(7) System Review by the AHCA. Evidence of the incident reporting and analysis system and copies of summary reports and evidence of recommended and accomplished corrective actions shall be made available for review to the AHCA upon request during the normal business hours.

RulemakingSpecific Authority 641.55, 641.56 FS. Law Implemented 641.44, 641.45 FS. History–New 1-28-88, Amended 3-11-92,_______ Formerly 10D-100.012.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Sean Massey

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Justin M. Senior, Secretary, Agency for Health Care Administration

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 17, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 09/15/2015