The purpose of the proposed rule amendments is to incorporate additional definitions; changes in licensure requirements; specific definitions regarding reporting requirements; changes to the reporting requirements pursuant to Chapter 2006-155, ...

DEPARTMENT OF ELDER AFFAIRS
Federal Aging Programs

RULE NO: RULE TITLE
58A-2.002: Definitions
58A-2.003: License Required
58A-2.005: Administration of the Hospice
58A-2.010: Quality Assurance and Utilization Review (QAUR) Committee and Plan
58A-2.012: Program Reporting
58A-2.014: Medical Direction
58A-2.0232: Advance Directives
PURPOSE AND EFFECT: The purpose of the proposed rule amendments is to incorporate additional definitions; changes in licensure requirements; specific definitions regarding reporting requirements; changes to the reporting requirements pursuant to Chapter 2006-155, Section 7, Laws of Florida, including a reporting form incorporated by reference in Rule 58A-2.012, F.A.C; changes in accordance with Chapter 2006-155, Section 7, Laws of Florida, requiring development of outcome measures and adoption of national initiatives such as those developed by the National Hospice and Palliative Care Organization; and additional language, clarification of terms and update of the Health Care Advance Directives form incorporated by reference in Rule 58A-2.0232, F.A.C.
SUMMARY: The proposed rule amendments add definitions; change licensure requirements; specific definitions regarding reporting requirements; changes in reporting requirements including a new reporting form incorporated by reference; development of outcome measures; adoption of national initiatives developed by the National Hospice and Palliative Care Organization; and additional language, clarification of terms, and updating the Health Care Advance Directives form incorporated by reference.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 400.605, 400.60501, 765.110 FS.
LAW IMPLEMENTED: 400.602, 400.605, 400.60501, Ch. 765 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 28, 2007, 9:30 a.m. – 12:00 Noon EST.
PLACE: Department of Elder Affairs, 4040 Esplanade Way, Conference 225F, Tallahassee, FL 32399-7000
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 72 hours before the workshop/meeting by contacting: Jim Crochet, Department of Elder Affairs, 4040 Esplanade Way, Tallahassee, FL 32399-7000; telephone number [phone], SunCom 994-2000; Email address: [e-mail]. 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: Jim Crochet, Department of Elder Affairs, 4040 Esplanade Way, Tallahassee, FL 32399-7000; telephone number [phone], SunCom 994-2000; Email address: [e-mail]

THE FULL TEXT OF THE PROPOSED RULE IS:

58A-2.002 Definitions.

In addition to definitions contained in Chapter 400, Part IV VI, F.S., the following terms shall apply:

(1) Advertising: The delivery, distribution, publication or display of an item, document, or medium initiated by the hospice that is intended to offer, describe, or advertise hospice or hospice-like services to the general public. A type of listing, which is formatted to only include a licensed hospice provider’s name, address, and telephone number in the telephone directory, shall not be considered advertising.

(2) Agency: Agency for Health Care Administration.

(3) AHCA: Agency for Health Care Administration.

(4)(1) Autonomous: A means a separate and distinct operational entity, which functions under its own administration and bylaws, either within or independently of a parent organization.

(5)(2) Branch office: means Aan office or other physical location serving as a contact point for patients, which is remote from the provider’s principal office of the provider, but is not separately licensed, and which shares administration with the principal office which serves as a contact point for patients.

(6) Department: Department of Elder Affairs.

(7)(3) Employ: means Tto engage the services of an individual, on either a salary or volunteer basis.

(8)(4) Home: means Tthe patient’s current primary place of residence, including a private residence, assisted living facility, nursing home, hospice residential unit, or other place of permanent or temporary residence.

(9)(5) Home Health Aide: means Aan individual who provides personal health care services for a patient in the patient’s home or place of residence under the supervision of a registered nurse.

(10)(6) Licensed Practical Nurse: means Aan individual licensed pursuant to Chapter 464, F.S., to practice practical nursing.

(11)(7) Patient Care Staff: means those Ppersons involved in direct care of the patient, including registered nurses, practical nurses and home health aides, social workers and other mental health professionals, and clergy or pastoral counselors.

(12)(8) Patient’s Family: The means that person or those persons designated by the patient as having primary responsibility for care, or persons who are closely linked with the patient and are involved in the health and supportive care of the patient.

(13)(9) Patient and Family Unit: means Tthe patient and the patient’s family.

(14)(10) Registered Nurse: means Aan individual who is licensed pursuant to Chapter 464, F.S., to practice professional nursing.

Specific Authority 400.605 FS. Law Implemented 400.602, 400.605 Ch. 400, Part VI FS. History–New 5-6-82, Formerly 10A-12.02, 10A-12.002, Amended 4-27-94, Formerly 59A-2.002, Amended 6-5-97,_________.

 

58A-2.003 License Requirements Required.

(1) The face of the license must shall contain the following information:

(a) The name and address of the provider, including the principal office and all branch offices;

(b) All freestanding hospice inpatient facilities and residential units;

(c) All counties served by the hospice;

(d) The name of the owner; and

(e) The effective and expiration dates of the license.

(2) The hospice must notify the department and the agency in writing at least sixty (60) days before making a change in name or address of the provider’s principal or branch offices. the name and address of the provider, including the principal office and all branch offices, all hospice residences and inpatient facilities, all counties served by the hospice, the name of the owner, and the effective and expiration dates of the license. The hospice shall notify AHCA and the Department in writing at least sixty (60) days before making a change in name or address of the provider.

(3)(2) If a change of ownership as defined in Section 408.803(5), F.S., is contemplated, the new owner must shall submit, or cause to be submitted, a an license application for license and must receive a license prior to commencement of operation of the hospice. The following materials must accompany the license application:

(a) A signed agreement to correct any existing licensure deficiencies;

(b) Documented evidence that the change of ownership has taken place or will take place upon approval of the license; and

(c) A statement that records pertaining to the administrative operation of the provider must be retained and made available for official inspection by the agency.

A signed agreement to correct any existing licensure deficiencies shall accompany the license application, together with documentation to evidence that the ownership change has taken place, and a statement that records pertaining to the administrative operation of the provider will be retained and available for official inspection by the AHCA.

(4)(3) If a merger of two or more hospice providers is contemplated, the legal and incorporated entity that will be responsible for the operational function of the hospice after the merger must shall notify the agency AHCA prior to the merger. Notification must will include the anticipated date for the merger and the reason for the merger. The agency AHCA shall require the legal entity to submit a license an application for license, including a revised plan for the delivery of hospice care to terminally ill patients and their families who will be affected by the merger.

Specific Authority 400.605 FS. Law Implemented 400.602, 400.605 Ch. 400, Part VI FS. History–New 5-6-82, Formerly 10A-12.03, 10A-12.003, Amended 4-27-94, Formerly 59A-2.003, Amended 6-5-97,_________.

 

58A-2.005 Administration of the Hospice.

(1) Governing Body. – The hospice must establish written bylaws for There shall be a governing body established by written bylaws of the hospice with autonomous authority for the conduct of the hospice program. The governing body must and which shall satisfy the following requirements:

(a) Members of the governing body must shall reside or work in the hospice’s service area as defined in paragraph 59C-1.0355(2)(k), F.A.C.

(b) No change.

(c) Duties of the governing body must shall include:

1. Adoption in writing, with updates as necessary, of the following documents which must shall be in compliance with provisions of Chapter 400, Part IV VI, F.S., and these rules, with updates as necessary:

a. through c. No change.

d. A comprehensive emergency management plan for all administrative, residential, free-standing inpatient facilities, and hospice services designed to protect the safety of patients and their families and hospice staff; and

e. No change.

2. Promulgation of rules and bylaws which include at least the following:

a. through c. No change.

d. The qualifications, method of selection and terms of office of members and chairpersons of the governing body and committees; and

e. A mechanism for the administrator’s appointment by the administrator of the medical director and other professional and ancillary personnel.

(2) Administrative Officer. – The hospice must shall employ an administrator whose duties must shall be outlined enumerated in a written job description, including job qualifications., The administrator must which shall be approved by the governing body. and The job description must be kept in an administrative file.

(a) No change.

(b) The administrator must shall be responsible for maintaining an administrative office facility for the purpose of the operations of the hospice.

(3) Administrative Policies and Practices.

(a) The administrator must shall be responsible for developing, documenting and implementing administrative policies and practices which are consistent with these rules, and the bylaws by-laws, and the plans and decisions adopted by the governing body., These policies and practices must and which ensure the most efficient operation of the hospice program and the safe and adequate care of the patient and family units. At a minimum, tThese policies and practices must shall include:

1. through 2. No change.

3. A plan for orientation and training of all staff, including volunteers, which must shall ensure that all staff receive this training prior to the delivery of their delivering services of any kind to patients and their families. This plan must shall describe the method of assessing training needs and designing training to meet those needs, and must shall include a curriculum outline with specific objectives.

4. No change.

5. Policies for administering drugs and biologicals in the home which must shall include:

a. through b. No change.

c. All verbal orders for medication or treatments, or changes in medication or treatment must orders shall be taken by a licensed health professional and recorded in the patient’s record reduced to writing., Verbal orders must be and signed by the physician within thirty (30) calendar days from the date of the order.

d. The use of experimental drugs or any FDA or Chapter 500, F.S., approved drug in a non-approved manner shall not be given without the written consent of the patient or the patient’s legal representative, surrogate or proxy. The program administering such drugs must shall be fully informed the patient or the patient’s legal representative, surrogate or proxy of any risks, and be prepared to invoke remedial action should an adverse reaction occur. A copy of the signed consent must be kept in the patient’s record.

6. No change.

7. Policies and procedures approved by the medical director and governing body pertaining to the drug control system in the hospice including which shall include specific policies and procedures for disposal of Class II drugs upon the death of a patient.

8. No change.

9. Policies and procedures for mMaintenance, confidentiality, and retention of clinical records for a minimum five-year period following the patient’s death.

10. through 11. No change.

12. Notice to the public that the hospice provides services regardless of ability to pay.

13. through 14. No change.

15. Policies and procedures for cCompletion, retention, and submission of reports and records as required by the dDepartment, the agency, AHCA and other authorized agencies.

16. No change.

(b) Equipment and personnel, under medical supervision, must shall be provided for diagnostic procedures to meet the needs of the hospice inpatient, residential and home-care programs. This must shall include the services of a clinical laboratory and radiological services, which must shall meet all standards of the State of Florida. There must be written agreements or contracts for such services uUnless provided on the premises of the hospice, there shall be written agreements or contracts for such services. The hospice program must shall ensure that the sum of services are available under contract and services provided directly by the hospice shall assure twenty-four (24) hours a day, seven (7) days a week, either through contractual agreement, written agreement, or direct service provision by the hospice availability.

(c) No change.

(4) Outcome Measures.

Effective 2009, hospices must report the outcome measures outlined in this subsection on DOEA Form H-002, State of Florida Department of Elder Affairs Hospice Annual Report, July 2007, incorporated by reference in Rule 58A-2.012, F.A.C. The reporting time frame is prescribed in paragraph 58A-2.012(2)(a), F.A.C. In addition to the outcome measure regarding pain management pursuant to Section 400.60501, F.S., each hospice must conduct the National Hospice and Palliative Care Organization (NHPCO) Patient/Family Satisfaction Survey, or a similar survey, with its patients and families.

(a) Each hospice must report results from survey questions that inquire about the following areas of concern:

1. Did the patient receive the right amount of medicine for his or her pain?

2. Based on the care the patient received, would the patient and/or family member/caregiver/legal representative/surrogate/proxy recommend hospice services to others?

(b) The acceptable standard for this measure must be an affirmative response on at least fifty (50) percent of the survey responses received by the hospice.

(5) National Initiatives.

(a) In accordance with Section 400.60501, F.S., and as referenced in subsection 58A-2.005(4), F.A.C., the department adopts the national initiative of utilizing patient/family surveys as a tool to set benchmarks for measuring quality of hospice care in the State of Florida.

(b) The department has also considered the national initiatives that are under evaluation and development by the Centers for Medicare and Medicaid Services (CMS) in consultation with the NHPCO. These initiatives include patient-centered outcome measures, quality assessment and performance improvement (QAPI), and infection control. Upon adoption of these initiatives by CMS in final regulation, all hospices shall be required to implement the initiatives consistent with this regulation.

(c) Hospices must maintain documentary evidence of their compliance with these national initiatives and demonstrate their operations to the department or the agency during the survey process:

Specific Authority 400.605, 400.60501 FS. Law Implemented 400.605(1)(c), 400.60501 FS. History–New 5-6-82, Formerly 10A-12.05, 10A-12.005, Amended 4-27-94, Formerly 59A-2.005, Amended 6-5-97, 8-6-02, 8-10-03,_________.

 

58A-2.010 Quality Assurance and Utilization Review (QAUR) Committee and Plan.

Each hospice must shall appoint a committee which must shall develop, document and implement a comprehensive quality assurance and utilization review plan pursuant to Section 400.610(2), F.S. The QAUR plan must shall include goals and objectives, provisions for identifying and resolving problems, methods for evaluating the quality and appropriateness of care, and the effectiveness of actions taken to resolve identified problems. The QAUR plan must shall establish a process for revising policies, procedures and practices when reviews have identified problems. The QAUR committee must shall review the QAUR plan and report findings and recommendations to the governing body annually. Dated and signed minutes of those meetings of the governing body at which QAUR findings and recommendations are presented must shall be kept in an administrative file.

(1) through (2) No change.

(3) The QAUR committee must shall audit patient records, including interdisciplinary care records, on a regular and periodic basis. All records must shall be stored in secured areas to protect patient confidentiality.

(a) No change.

(b) After the patient’s death and the end of the bereavement period, Tthe master record may be moved to storage shall be stored in a secure and accessible location after termination of bereavement services or a minimum of one year after the patient’s death.

(4) No change.

(5) Activities undertaken in the QUAR process must shall demonstrate a systematic collection, review, and evaluation of information and must shall result in proposed actions to correct any identified problems. The information used by the QUAR committee must shall include:

(a) through (e) No change.

(f) High-risk, high-volume and problem-prone activities that would have a significant impact on patients, staff or the organization, even if adverse incidents occur infrequently, if at all. For example, high-risk activities may include review and evaluation of protocols for containment of communicable diseases, emergency evacuations and continuity of operations; high-volume activites might include collection of information regarding timely patient intake assessments, administration of medications; lastly, identifying problem-prone activities might be deterioration or malfunction of equipment, including security of informations systems, disposal of contaminated materials or other bio-medical waste; and

(g) Appropriateness of team services and levels of care measured by whether:;

1. If Tthe plan of care was directly related to the identified physical and psychosocial needs of the patient and the patient’s family;

2. If the Sservices, medications and treatments prescribed were in accordance with the current hospice plan of care; and

3. If Tthe hospice program of care was primarily a home-care program that utilized inpatient hospice care on a short-term or respite basis only.

(6) through (7) No change.

Specific Authority 400.605 FS. Law Implemented 400.605 FS. History–New 5-6-82, Formerly 10A-12.10, 10A-12.010, Amended 4-27-94, Formerly 59A-2.010, Amended 6-5-97,________.

 

(Substantial rewording of Rule 58A-2.012 follows. See Florida Administrative Code for the present text.)

58A-2.012 Program Reporting Requirements.

(1) Definitions.

The following definitions pertain specifically to program reporting for DOEA Form H-002, State of Florida Department of Elder Affairs Hospice Annual Report, incorporated by reference in this rule:

(a) Accreditation: Name of the specific accrediting organization.

(b) Agency Type: Hospice type based on Medicare filing status. Valid options are: Free standing, hospital based, home health based (private residence) or nursing home based.

(c) Discharge Disposition: The patient’s condition upon discharge. Options are death or non-death.

(d) Facility License Number: The facility’s license number provided by the Agency for Health Care Administration.

(e) Hospice operated inpatient facility: An inpatient facility consisting of one or more beds that is owned or leased by the hospice, is staffed by hospice personnel, and has policies and procedures set by the hospice. This includes beds in hospitals or nursing homes that comply with the conditions set forth in this paragraph.

(f) Ownership Type: The type of ownership of the hospice. It can be for profit, not for profit or government operated.

(g) Patient Days: The number of days elapsed during which hospice services were provided for the period of time comprising from start of services until final discharge.

(h) Payor Source: Options are Medicare, Medicaid, third party, self-pay, uncompensated, and other.

(i) Race/ethnicity – A classification based on the patient’s race or self -declared ethnic identity. Options are Asian, Black, Caucasian, Hispanic, and Other.

(2) Reporting Criteria.

(a) Each hospice must complete an annual report for the period January 1 through December 31 of each year and must submit the report to the department no later than February 28 of the following year.

(b) The report must be submitted electronically to the following Web site address: [e-mail]. The report may alternately be submitted to the following address: Department of Elder Affairs, Planning and Evaluation Unit, 4040 Esplanade Way, Tallahassee, FL 32399-7000.

(c) Effective with the report due in 2009, the information must be recorded on DOEA Form H-002, State of Florida Department of Elder Affairs Hospice Annual Report, July 2007.

1. The form is hereby incorporated by reference and may be obtained from the following address: Department of Elder Affairs, Planning and Evaluation Unit, 4040 Esplanade Way, Tallahassee, Florida 32399-7000. The form may be also obtained from the department’s Web site at http://elderaffairs.state.fl.us/english/forms/DOEAformH002.pdf.

2. The form must be completed in its entirety.

(d) A copy of the report must be available to the public during all hours of operation of the hospice principal office and the department.

Specific Authority 400.605, 400.60501 FS. Law Implemented 400.605, 400.60501 Ch. 400, Part VI FS. History–New 5-6-82, Formerly 10A-12.12, 10A-12.012, Amended 4-27-94, Formerly 59A-2.012, Amended 6-5-97,________.

 

58A-2.014 Medical Direction.

(1) No change.

(2)(a) The medical director or his or her designee, a physician licensed under Chapter 458 or 459, F.S., must shall be a member of the hospice care team and must shall be responsible for the direction and quality of the medical component of the care rendered to the patient by the hospice care team. The patient’s attending physician(s) may remain the primary physician(s) to the patient, depending upon the preferences of the patient and the patient’s family. The patient and the patient’s family may elect to have the hospice medical director assume all or part of the primary medical care functions, or act as a consultant to the patient’s attending physician(s). In either case, the hospice care team must shall maintain liaison and a reporting relationship with the patient’s attending physician(s).

(b) No change.

(3) through (4) No change.

Specific Authority 400.605 FS. Law Implemented 400.605 FS. History–New 5-6-82, Formerly 10A-12.14, 10A-12.014, Amended 4-27-94, Formerly 59A-2.014, Amended 6-5-97,________.

 

58A-2.0232 Advance Directives.

(1) The administrator must shall ensure the development, documentation and implementation of policies and procedures which delineate the hospice’s compliance with the state law and rules relative to advance directives. The hospice must shall not base condition treatment or admission upon whether or not the patient has executed or waived an advance directive. In the event of a conflict between the hospice’s policies and procedures and the patient’s advance directive, resolution must provision shall be made in accordance with Chapter 765, F.S.

(2) The hospice’s policies and procedures must shall include:

(a) At the time of admission to a hospice program, providing each patient, or the patient’s surrogate or proxy, with a copy of Form SCHS-4-2006, “Health Care Advance Directives – The Patient’s Right to Decide,” as prepared by the Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee, FL 32308, effective 4-2006 (April 2006) 1-11-93, which is hereby incorporated by reference, or with a copy of some other substantially similar document which incorporates information regarding advance directives included in is a written description of Chapter 765, F.S., regarding advance directives. The form is hereby incorporated by reference and is available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 34, Tallahassee, FL 32308, or the agency’s Web site at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/HC_Advance_Directives/docs/adv_dir.pdf.

(b) through (c) No change.

Specific Authority 765.110, 400.605 FS. Law Implemented 400.605, Ch. 765 FS. History–New 1-11-93, Formerly 59A-2.025, Amended 4-27-94, Formerly 58A-2.0232, Amended 6-5-97,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Jim Crochet
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: E. Douglas Beach, Ph.D., Secretary
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 18, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: November 22, 2006 and May 11, 2007