Licensure, Administration and Fiscal Management, Facility Policies, Physician Services, Medical Director, Nursing Services, Resident Assessment and Care Plan, Dietary Services, Pharmacy Services, Medical Records, Physical Environment, Disaster ...
AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing
RULE NOS.:RULE TITLES:
59A-4.103Licensure, Administration and Fiscal Management
59A-4.106Facility Policies
59A-4.107Physician Services
59A-4.1075Medical Director
59A-4.108Nursing Services
59A-4.109Resident Assessment and Care Plan
59A-4.110Dietary Services
59A-4.112Pharmacy Services
59A-4.118Medical Records
59A-4.122Physical Environment
59A-4.126Disaster Preparedness
59A-4.130Fire Prevention, Fire Protection, and Life Safety
59A-4.133Plans Submission and Review and Construction Standards
59A-4.134Plans Submission and Fee Requirements
59A-4.150Geriatric Outpatient Nurse Clinic
59A-4.165Nursing Home Guide
59A-4.202Quality of Care
59A-4.204Turnover Ratio
59A-4.206Termination and Frequency of Review
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40 No. 247, December 23, 2014 issue of the Florida Administrative Register.
59A-4.103 Licensure, Administration and Fiscal Management.
(1) through (3) No change.
(3)(a) Upon receipt of written approval by the Agency, as required in Section 408.808, F.S., to continue with the plan for the partial inactive license, the licensee must submit a completed Health Care Licensing Application, Nursing Homes, AHCA Form 3110-6001, July 2014, to the Agency within 60 days of the approval and a bed change request form for beds certified through the Centers for Medicare and Medicaid Services. The appropriate facility licensure application for the alternative use must accompany this application, unless the space will be utilized for services authorized under the existing nursing home licensure.
(3)(b) through (5)(b) No change.
(5)(c) A licensee must obtain a surety bond as required by Section 400.162 Chapter 400, Part II, F.S.; it must be based on twice the average monthly balance in the resident trust fund during the prior fiscal year or $5,000, whichever is greater. A licensee who owns more than one nursing home may purchase a single surety bond to cover the residents’ funds held in nursing homes located within the state. A surety bond must contain substantially the same language as is found in the Nursing Home Patient Trust Surety Bond, AHCA Form 3110-6002, May 2008, which is incorporated by reference and may be obtained at http://www.flrules.org/Gateway/reference.asp?No+Ref-XXXXX and from the Agency online at http://ahca.myflorida.com. The surety bond must be filed with the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #33, Tallahassee, Florida 32308.
(5)(d) through (5)(e) No change.
Rulemaking Authority 400.062, 400.0712(3), 400.162(5)(c), 400.23, 408.034 408.810(8), 408.819 FS. Law Implemented 400.022, 400.062, 400.071, 400.0712, 400.102, 400.111, 400.141, 400.147, 400.162, 400.179, 400.20, 408.033, 408.20, 408.805, 408.806, 408.808, 408.810(8) FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, 1-1-86, 11-12-89, 12-25-90, 10-6-91, Formerly 10d-29.103, Amended 4-18-94, 2-6-97, 5-5-02,_________.
59A-4.106 Facility Policies.
(1) through (1)(e) No change.
(1)(f) All resident transfers and discharges must be in accordance with the facility’s policies and procedures, provisions of Sections 400.022 and 400.0255, F.S., this rule and Title 42 Code of Federal Regulations Ssection 483.12(a), revision date October 1, 2014 January 7, 2011, herein incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-12.xml and will include notices provided to residents by using the Nursing Home Transfer and Discharge Notice, AHCA Form 3120-0002, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference. asp?No=Ref-XXXXXX, the Fair Hearing Request for Transfer or Discharge From a Nursing Home, AHCA Form 3120-0003, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXXX, the Long-Term Care Ombudsman Program Request for Review of Nursing Home Discharge and Transfer, AHCA Form 3120-0004, April 2014, herein incorporated by reference and available at http:// www.flrules.org/Gateway/reference.asp?No=Ref-XXXXXX, or the Spanish language version, Solicitud de Revisión de Long-Term Care Ombudsman de la Dada de Alta o El Traslado de un Hogar de Ancianos, AHCA Form 3120-0004A, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXXX. These forms may also be obtained from the Agency for Health Care Administration, Long Term Care Unit, 2727 Mahan Drive, Mail Stop# 33, Tallahassee, FL 32308 or at the web address: http://ahca.myflorida.com/.
(2) No change.
(3) All policies and procedures must be reviewed at least annually and revised as needed with input from, at minimum, the facility Administrator, Medical Director, and Director of Nursing.
(4) through (5)(c)4. No change.
(5)(c)5. Federal law, 42 CFR 483, Requirements for State and Long Term Care Facilities, October 1, 2014 2011, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-part483.xml http://ecfr. gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl, Chapter 400, Part II, F.S., and subsection 59A-4.106(5), F.A.C.;
(5)(d) through (6)(b)2. No change.
(6)(b)3. Providing The requirement that documentation of the existence of an advance directive be contained in the medical record. A nursing home licensee that is provided with the individual’s advance directive must make the advance directive, or a copy thereof, a part of the individual’s medical record.
Rulemaking Authority 400.0255(16), 400.142(3), 400.23, 765.110 FS. Law Implemented 400.022, 400.0255, 400.142(3), 400.151, 400.23, 765.110 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10d-29.106, Amended 4-18-94, 1-10-95, 2-6-97, 5-5-02,__________.
59A-4.107 Physician Services.
(1) through (3) No change.
(4) Physician orders may be transmitted by facsimile machine, email or electronic medical record as required by Section 501.171, F.S. and 45 Code of Federal Regulation, Section 164, effective October 1, 2014, which incorporated by reference and is available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title45-vol1/xml/CFR-2014-title45-vol1-part164.xml state health information security and privacy laws and federal HIPAA laws. It is not necessary for a physician to re-sign a facsimile order when he or she visits a facility.
(5) through (8) No change.
Rulemaking Authority 400.23 FS. Law Implemented 400.022, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.107, Amended 10-5-92, 4-18-94, 1-10-95,__________.
59A-4.1075 Medical Director.
(1) through (2)(a) No change.
(2)(b) A Medical Director who does not have hospital privileges must be certified or credentialed through a recognized certifying or credentialing body, such as Tthe Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American Medical Directors Association, the Healthcare Facilities Accreditation Program of the American Osteopathic Association, the Bureau of Osteopathic Specialists of the American Osteopathic Association, the Florida Medical Directors Association or a health maintenance organization licensed in Florida.
(c) A physician must have his or her principal office within 60 miles of all facilities for which he or she serves as Medical Director. The principal office is the office maintained by a physician as required by Section 458.348 or 459.025(3)(c)(1), F.S. and where the physician delivers the majority of medical services. The physician must specify the address of his or her principal office at the time of becoming Medical Director. The agency may approve a request to waive this requirement for rural facilities that exceed this distance requirement as outlined in Section 120.542(2), F.S. A rural facility is a facility located in a county with a population density of no greater than 100 persons per square mile, which is at least 30 minutes of travel time, on normally traveled roads under normal traffic conditions, from any other nursing home facility within the same county.
(2)(d) through (5) No change.
Rulemaking Authority 400.141, 400.23 FS. Law Implemented 400.141(1)(b), 400.23 FS. History–New 8-2-01, Amended___________.
59A-4.108 Nursing Services.
(1) through (3) No change.
(4) In accordance with addition to the requirements outlined in subsection 400.23(3)(a), F.S., the nursing home licensee must have sufficient nursing staff, on a 24-hour basis, to provide nursing and related services to residents in order to maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care.
(5) through (6) No change.
(7) Upon approval by the Agency, a nursing home licensee may allow a licensed nurse that performs both licensed nursing and certified nursing assistant duties during the same shift to divide the hours of patient care provided between the licensed nurse and certified nursing assistant staffing ratio requirements consistent with services provided, as referenced in Section 400.23(3)(a)4., F.S. Approval to utilize licensed nurses to perform certified nursing assistant duties must be requested in writing. This request may be submitted upon license renewal on the Health Care Licensing Application, Nursing Homes, AHCA Form 3110-6001, July 2014, incorporated by reference in paragraph 59A-4.103(1)(a), F.A.C. or by letter from the facility administrator. The Agency’s approval depends upon review of the last three years inspections from the date of the request to determine if there were deficiencies cited related to staffing. The licensee must document daily the time the licensed nurse performed personal care services to comply with minimum staffing requirements. The hours of a licensed nurse with dual job responsibilities may not be counted twice.
Rulemaking Authority 400.23 FS. Law Implemented 400.022, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, 7-1-88, 7-10-91, Formerly 10D-29.108, Amended 4-18-94,___________.
59A-4.109 Resident Assessment and Care Plan.
(1) through (1)(c)1. No change.
2. Reviewed promptly after a significant change, which is a need to stop a form of treatment because of adverse consequences (e.g., an adverse drug reaction), or commence a new form of treatment to deal with a problem, in the resident’s physical or mental condition;
(1)(c)3. through (5) No change.
59A-4.110 Dietary Services.
(1) through (4) No change.
Rulemaking Authority 400.022, 400.141, 400.23 FS. Law Implemented 400.23 FS. History–New 4-1-82, Amended 4-1-84, 7-1-88, 7-10-91, Formerly 10D-29.110, Amended 4-18-94, 2-6-97,__________.
59A-4.112 Pharmacy Services.
(1) No changes
(2) As required by the Department of Health, the facility must employ, or obtain, the services of a state licensed consultant pharmacist. A consultant pharmacist is a pharmacist who is licensed by the Department of Health, Board of Pharmacy, and registered as a consultant pharmacist by the Board of Pharmacy in accordance with Rules 64B16-26.300 and 64B16-28.501, F.A.C., and who provides consultation on all aspects of the provision of pharmacy services in the facility.
(3) through (4) No change.
(5) Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, as required by Chapter 499, F.S., and Rules 64B16-28.108 and 64B16-28.502, F.A.C., as required by the Department of Health.
(6) Prescription drugs and non-prescription medications requiring refrigeration must be stored in a refrigerator. The refrigerator must be locked or located within a locked medication room and accessible only to licensed staff as required by state and federal laws.
(7) All controlled substances must be disposed of as required by Department of Health Rule 64B16-28.303, F.A.C. state and federal laws. All non-controlled substances may be destroyed in accordance with the facility’s policies and procedures. Records of the disposition of all substances must be maintained in sufficient detail to enable an accurate reconciliation and a copy of the disposition must be filed in the resident’s record or maintained electronically in a readily accessible format.
(8) through (10) No change.
59A-4.118 Medical Records.
No change.
59A-4.122 Physical Environment and Physical Plant Maintenance.
(1) through (2)(b) No change.
(2)(c) Furniture, such as a bed-side cabinet, drawer space;
(d) Adequate and comfortable lighting levels in all areas;
(e)(c) Comfortable and safe room temperature levels in accordance with 42 CFR, Section 483.15(h)(6), which is effective October 1, 2014 and is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-15.xml; and
(f)(d) The maintenance of comfortable sound levels. Individual radios, TVs and other such transmitters belonging to the resident will be tuned to stations of the resident’s choice.
(3) through (5) No change.
(6) All heating, ventilation and air conditioning (HVAC) systems must be maintained in accordance with the manufacturer's recommendation to ensure they are operating within specified parameters to meet manufacturers’ specifications. Operation manuals and as-built drawings Permanent records must be maintained for equipment installed after June 1, 2015 December 31, 2014.
Rulemaking Authority 400.23 FS. Law Implemented 400.102, 400.141, 400.232 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.122, Amended 4-18-94,_________.
59A-4.126 Disaster Preparedness.
(1) through (2) No change.
(2)(a) Criteria, as shown, in Section 400.23(2)(g), F.S.; and
(2)(b) No change.
(3) The plan, including the “Emergency Management Planning Criteria for Nursing Homes,” must be submitted annually, at the time of a change of ownership of the facility and after significant modification to previously approved of the plan., This plan must be submitted to the county emergency management agency for review and approval.
(4) through (12) No change.
59A-4.130 Fire Protection, Fire Prevention, and Life Safety, Systems Failure and External Emergency Communications.
(1) Each nursing home licensee must provide fire protection through the elimination of fire hazards as evidenced by compliance with the fire codes adopted by the State Fire Marshall. The fire codes adopted by the State Fire Marshal for nursing homes is contained Rule Chapter 69A-53, F.A.C., and is known as “Uniform Fire Safety Standards for Hospitals and Nursing Homes.”. All portions of the existing facility must comply with the requirements of the Existing Health Care Occupancy chapter of the National Fire Protection Association (NFPA) Life Safety Code 101, as adopted by the State Fire Marshall and described in Chapter 69A-53, Florida Administrative Code.
(2) through (3)(c)3. No change.
(4) External Emergency Communication. Each newly constructed facility that has not received a Preliminary Stage II Plan Approval from the Office of Plans and Construction by June January 1, 2015, shall provide for external electronic communication not dependent on terrestrial telephone lines, cellular, radio, or microwave towers, such as an on-site radio transmitter, satellite communication systems or a written agreement with an amateur radio operator volunteer group. This agreement must provide for a volunteer operator and communication equipment to be relocated into the facility in the event of a disaster until communications are restored. Other methods that can be shown to maintain uninterrupted electronic communications not dependent on a land-based transmission must be approved by the Agency’s Office of Plans and Construction.
59A-4.133 Physical Plant Codes and Standards for Nursing Homes.
(1) through (2) No change.
(3) National Fire Protection Association (NFPA) 101A: Guide on Alternative approaches to Life Safety shall not be used to meet the required codes and standards for new construction or for conversion of newly licensed nursing homes may only be used for a nursing home facility licensed before January 1, 2015.
(4) No change.
(5) A licensed nursing home and any portion of a licensed nursing home that was reviewed and approved by the Agency for Health Care Administration prior to March 1, 2002 October 1, 2005, must be maintained in compliance with the requirements of this rule and the requirements of the NFPA 101 Life Safety code for Existing Health Care Occupancy, incorporated in rule 69A-3.012, F.A.C. and the requirements of Tables I, II and III, incorporated by reference and available at http://www. flrules.org/Gateway/reference.asp?No=Ref-XXXXXX or at the web address at http://ahca.myflorida.com/plansandconstruction. The requirements in Table I identified by an asterisk do not apply.
(6) A licensed nursing home, and any portion of a licensed nursing home, that was reviewed and approved by the Agency for Health Care Administration after March 1, 2002 October 1, 2005, must be maintained in compliance with the requirements of the NFPA 101 Life Safety code for Existing Health Care Occupancies and the design requirements for Nursing Homes of the Florida Building Code in effect at the date of initial licensure.
(7) through (8) No change.
(9) All hazards to life and safety and all areas of noncompliance with applicable codes and regulations must be corrected in accordance with a plan of correction approved in advance by the Agency’s Office of Plans and Construction. Facility plans of correction will be approved only when the plan corrects all deficiencies or provides acceptable alternate systems, methods, or devises that provide equivalent or superior quality, strength, fire resistance, effectiveness, durability and safety as the requirements prescribed by code.
(10) Projects that have not received at least a Stage II Preliminary Plan approval from the Office of Plans and Construction by October 31, 2015 December 31, 2014, must conform to the requirements set forth in these rules.
Rulemaking Authority 400.23 FS. Law Implemented 400.011(2), 400.23, 400.232 FS. History–New 4-1-82, Amended 4-1-84, 4-29-92, Formerly 10D-29.120, 59A-4.120, Amended 2-6-97, 10-21-99,__________.
59A-4.134 Plans Submission and Fee Requirements.
(1) through (5) No change.
(6) Plans and specifications submitted for review shall be are subjected subject to plan review fees pursuant to as required in section 400.232, F.S. A non-refundable initial fee of $2,000 will be charged for all projects. The agency will also collect a fee, not to exceed 1 percent of the estimated construction cost or the actual cost of review, whichever is less, for the portion of the review which encompasses initial review through the initial revised construction document review. Additionally, the Agency will collect its actual costs on all subsequent portions of the review and construction inspections. All fees must be paid to the Agency for Health Care Administration, with notation of the Office of Plans and Construction facility log number and identified that it is for the Agency’s Health Care Trust Fund. Plan review fees must be included with the application.
(7) Plans and specifications may shall be submitted in three stages of development described in this rule. Approval of a Stage III submission is required to begin construction (except as permitted by Section 59A-4.134(2)). These stages are as follows:
(7)(a) through (7)(c) No change.
(8) For each stage of submission, a program or scope of work must be submitted. It must consist of a detailed word description of all contemplated work and any required phasing to be provided in the proposed construction.
(9) For projects involving only equipment changes or system renovations, only Stage III, construction documents need be submitted. These documents must include the following:
(9)(a) through (10)(c) No change.
(11) Stage II, Preliminary Plans – Stage II preliminary plans will be approved by the Agency upon successful demonstration that the construction will comply with applicable life safety code requirements, flood requirements and that the layout will accommodate all required functional space as evidenced by a thorough examination of the documents submitted as required by this subsection. Stage II approval, the following must be incorporated into the preliminary plans must include:
(11)(a) through (11)(i) No change.
(12) Stage III, Construction Documents – The Stage III construction documents shall be an extension of the Stage II preliminary plan submission and shall provide a complete description of the contemplated construction. Stage III construction documents will be approved by the Agency upon successful demonstration that the construction will comply with all applicable codes and standards as evidenced by a thorough examination of the documents submitted as required by this subsection. Construction documents shall be signed, sealed, dated and submitted for written approval to the Agency’s Office of Plans and Construction submitted by a Florida registered architect and Florida registered professional engineer. An architecture or engineering firm, not practicing as a sole proprietor, must provide proof of registration as an architecture or engineering firm with the Florida Department of Business and Professional Regulation. The documents must consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following must be incorporated into the construction documents:
(12)(a) through 12(j) No change.
(12)(k) Signed, sealed and dated subsequent addenda, change orders, field orders and other documents altering the above must be submitted for review to for advance written approval from the Agency’s Office of Plans and Construction. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and will provide a listing of deficiencies in writing.
(13) No change.
(14) Additions or revisions that increase the substantially change the original scope of the project by greater than fifty percent or revisions that change greater than fifty percent of the original scope of a project or are submitted by different design professionals will be required to be submitted as a new project.
(15) No change.
Rulemaking Authority 400.23 FS. Law Implemented 400.011(2), 400.141, 400.232 FS. History–New_________.
59A-4.150 Geriatric Outpatient Clinic.
(1) through (2)(a) No change.
(2)(b) The licensee must be compliant with all applicable laws, rules, regulations, Chapter 400, Part II and Chapter 408, Part II, F.S., this rule chapter and Florida Building Code during an inspection by the Agency.
(2)(c) through (4)(a)4. No change.
(4)(a)5. Compliance with the requirements of Title VI of the Civil Rights Act of 1964, Section 2000, effective date July 2, 1964, is incorporated herein by reference at http://www.gpo.gov/fdsys/pkg/USCODE-2008-title42/html/USCODE-2008-title42-chap21-subchapV.htm http://www.justice.gov/crt/cor/coord/titlevistat.php.
(4)(b) No change.
(4)(b)1. Maintain the confidentiality of clinical records for each patient as required in this rule, section 400.022(m) 400.0222, F.S., Title 42 Code of Federal Regulation section 483.10, effective October 1, 2003, Title 45 Code of Federal Regulation chapters 160, 162 and 164 with an effective date of August 14, 2002, which is incorporated by reference and available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl.
(4)(b)2. through (4)(c)3. No change.
4. Administer and handle drugs and biological as required in this rule, Chapter 400 Part II, F.S., Title 42 C.F.R. 483.25(1) and Title 42 C.F.R. 483.25(m), effective October 1, 2014 and incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-25.xml;, effective October 7, 2005 and 42 C.F.R. 483.60, effective October 1, 2014 September 23, 1992, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-60.xml http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%Findex.tpl.
(4)(b)5. through (6) No change.
(6)(a) Staff in the geriatric outpatient clinic must be governed by the personnel standards in this rule, Section 400.141, F.S., Title 42 Code of Federal Regulation 483.75, effective October 1, 2014 May 5, 2002 and incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-75.xml, 42 CFR 483.75, effective August 11, 2009, 42 CFR 483.30, effective October 1, 2014 28, 2005, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-30.xml http://ecfr.gpoaccess. gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl.
(6)(b) through (10)(i) No change.
(10)(j) When staffed by an ARNP or physician’s assistant, additional services may be provided dependent upon their respective certification authority. (Sections 458.347 and, 459.022, F.S.)
(11) through (11)(a)4.j. No change.
(12) Medications. The clinic must have policies and procedures for the administration of medications by health care professionals acting within the scope of practice defined by laws and rules of the Department of Health, Chapter 464, Part , I F.S. and Rule 64B9-15.002, F.A.C. and the Department of Business and Professional Regulation which must include the following:
(12)(a) through (12)(f)3. No change.
Rulemaking Authority 400.141, 400.23 FS. Law Implemented 400.33, 400.141 FS. History–New 4-27-78, Formerly 10D-29.71, 10D-29.071, 59A-4.071, Amended 2-6-97,__________.
59A-4.165 Nursing Home Guide.
No change.
59A-4.202 Quality of Care.
No change.
59A-4.204 Turnover Ratio.
(1) No change.
(1)(a) Have a turnover rate no greater than 50 percent for the most recent 12 month period ending on the last workday of the most recent calendar quarter prior to submission of an application. The turnover rate is the total number of terminations or resignations of certified nursing assistants (CNAs) and licensed nurses during the quarter divided by the number of CNAs and licensed nurses employed at the end of the quarter, or
(1)(b) through (2) No change.
59A-4.206 Termination and Frequency of Review.
No change.
