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72scan10D0677CHAPI'ER 10D-82 IDENTIFICATION OF DRUG PRODUCI'S 127No. Sapp. RULES OF THE DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES CHAPTER 101).82 IDENTIFICATION OF DRUG PRODUCTS IN FINISHED SOLID ORAL DOSAGE FORM Services Department of Health and Rehabilitative a Products Drug Certain lOD-82.01 Exemption of the the product for which sworn statement describing reasons the requested. and stating been exemption has Products. Drug l0D-82.01 Exemption of Certain the particular product win. not accept the mark or why be 11) No product covered by this rule may imprint. marketed in this State without imprint unless exempt fnrm Upon receipt of an exemption request (3) to prior marketing. When an exemption as provided under manufacturer. the Department of Health aDd section 500.462(3). Florida Statutes. is desired. the ~bilitative within act upon such request shall Services absence of any action. Department of the to be request for exemption made must thirty (30) days. In the the request to Health and Rehabilitative Services. prior a new product be for exemption shall deemed granted. being marketed in State. the Imp1emeDted 600.482 F8. Law Authority 500.482(8. FS. SpecifIc manufacturer shall submit to the (2) The Hlatory-New &-1+81. 517

72scan10D0676126Supp. No. ACUPUNCTURE CLINICS 10D-81 HAPTER (c) Be responsible for maintaining compliance with 2. by pressure I!ooker, utilizing the same and these Statutes l provisions of Chapter 389, Florida procedures as noted in #lOD-81.06(1)(b)1 above. 3. by dry heat, 350 degrees F for one hour. les. (d) Ensure that all personnel performing (c) Following sterilization by whichever method, needles shall be stored in such a manner upuncture hold a current acupuncturist certificate as to assure sued maintenance of sterile conditions. of Professional by the Florida Department gulations or comply with the Medical Practice Act (2) Employees shall be free of any communicable hapter 458, F.S.) or are exempt from certification under disease which would present the hazard transmission of to rt II, Chapter 486, Florida Statutes. patients or other employees. (Such diseases would include the (e) Provide equipment and supplies to meet Infectious Hepatitis, Acute Skin Infections, Active any employee is found to have, If to patients. quirements of service Venereal Disease, etc.). procedures (f) Develop and implement policies and or is suspected of having such disease, he will be removed signed adequately provide for uniformity, safety, and to from his assigned tasks until certification is received from clinic operations and care and the ality assurance in a Florida licensed physician that such risk no longer of patients. eatment exists., Laws of 8(H68, FS. Law Implemented Chapter 389.012Specific Authority a in license (g) Be responsible for displaying the 2'1781. Florida. History-New nspicuous place in the clinic where it may be readily en by persons entering the clinic facility. 10D-81.07 Sanitation, Housekeeping and (h) Develop and implement procedures for Maintenance. referral for medical patients and ergency care of (1) The clinic shall be maintained at all times to tention. provide a clean and sanitary environment. Laws of 8CH68, FS. Law Implemented Chapter 389.012ecific Authority (2) All equipment for acupuncture services and the 2-17-81. rida. History-New general clinic furnishings shall be maintained in a safe and 10D-81.05 Medical Records. functional condition. record shall be maintained on all (1) A patient be All patient areas shall (3) well lighted and tients under treatment. In addition to identifying ventilated. formation, record shall incude medical history, and this (4) Disposal of any potentially infectious materials mplaint, as well as the treatment provided and progress shall be by incineration or burial in conformance with tes. Such records must be maintained for three years State and local standards, Laws of 8CH68, FS. Law Implemented Chapter 389.012Specific Authority llowing completion of treatment of a patient. 2'1781. History-New Florida. Laws of SO168, FS. Law Implemented Chapter 389.012ecific Authority 2-1781. History-New orida. 10D-81.08 Physical Environment. be (1) Treatment areas shall 100-81.06 Infection Control. constructed so as to Written procedures shall be implemented and ensure the privacy of patients. -1serve to (2) There shall be toilet facilities sufficient nitored prevention of infection. to assure the ocedures shall address as a minimum following: the both patients and staff. Laws of So-168, FS. Law Implemented Chapter 389.012Specific Authority Needles -and other equipment or materials (a) 2-17-81. Florida. History-New pable of transmitting possible infection shall be erilized prior to each use. Prior to sterilization such 10D-81.09 Advertisement. ticles shall be thoroughly cleansed. Clinics may advertise services in an appropriate -1Acupuncture needles shall be solid and shall be (b) professional manner for the purpose of informing and stainless steel or other metallic construction and easily educating the public concerning acupuncture, No clinic be thoroughly eanable. Acupuncture needles shall shall utilize advertisements which have the tendancy to to eansed with anti-septic soap and hot water prior deceive patients concerning the personnel, equipment, following methods: erilization by one of the care, the services nor the quality thereof. No at least 20 minutes by autoclave, assuring 1advertisement shall contain any statement or claim that to a temperature of 250 degrees F at 15 p.s.i. posure acupuncture is useful in curing any disease. essure. (Use indicator tape or device to assure other Laws of 80-168, FS. Law Implemented Chapter 389.019Specific Authority equate sterilization.) Needles so sterilized shall be 2-17-81. History-New Florida. apped in such a manner to assure free permeation of as to the needles. team 526

72scan10D0675CHAPTER 101>-81 ACUPUNCTURE CLINICS Sapp. No. 125 RULES OF THE DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES HEALTH PROGRAM OFFICE CHAPTER 101)..81 ACUPUNCTURE CLINICS license suspension, license revocation, or upon voluntary 10D81.0l Licensed Required Procedures cessation of operations. 10D81.02 License Procedures (4, Each acupuncture clinic license, unless sooner lOD81.03 Surveys and Evaluations year from III or revoked, shall be valid for one suspended 10D81.04 Management Responsibilities the date of issuance. Applications for license renewal shall 10D81.05 Medical Records to the applicant by the licensing agency at least be mailed 10D81.06 Infection Control 60 days prior to expiration of the license and shall be and Maintenance lOD81.07 Sanitation, Housekeeping submitted to the licensing agency, accompanied by the lOD81.08 Physical Environment renewal fee of $150.00, within thirty days prior to the 10D81.09 Advertisement expiration date. A clinic must be found in compliance with the provisions of Chapter 389, Florida Statutes, and these lOD-81.01 License Required Procedures. rules to be eligible for license renewal. Before any person, association or corporation (1, (5, The license of any clinic may be suspended, shall operate provisions of an acupuncture clinic under the revoked, or denied by the Department of Health and Statutes, they shall make Chapter 389, Florida Rehabilitative Services in any case where the licensing receive a license from the Department application for and to comply with the agency finds substantial failure of Health and Rehabilitative Services which shall be based provisions of Chapter 389, Florida Statutes and these upon compliance with all applicable laws, rules and zoning rules. An administrative penalty may be assessed against ordinances, building and fire safety codes. the clinic in lieu of suspension or revocation of the license of Law. Implemented Chapter 80-168 Law Specific Authority 389.014 FS. the opinion of the licensing authority, such a penalty if, in History-New 217-81. Florida. is in the best interests of the public or is a more equitable will penalty against clinic and the in no way endanger the lOD-81.02 License Procedures. will or safety or patients. Such penalty health be assessed an Application for a license to operate (1' following an administrative hearing held by acupuncture clinic shall be made on forms furnished for and in the district for that purpose. the Department of Health and that purpose by Implemented Chapter Law Specific Authority 389.014. 389.015. 389.016 FS. shall be submitted to the Rehabilitative Services and 21781. History-New of Florida. Law. 80-168 county in which the clinic is county health unit in the located. The application shall be accompanied by the applicable license fee. The application, which shall be 10D-81.03 Surveys and Evaluations. the following: made under oath, shall contain Representatives of the licensing agency shall (1' applicant, if the (a' The name and address of the have the right to enter upon the premises of each licensed applicant is an individual, or, if the applicant is a firm, at any reasonable time, in order to determine the clinic, of compliance with association, the name and address of each or partnership, state the provisions of Chapter 389, applicant is a corporation, its the member thereof, or, if Florida Statutes and these rules. its name and address and the name and address each of of (2, Representatives of the licensing agency shall officers. and evaluations of conduct unannounced periodic surveys least annually (b, The name by which the clinic is to be known. each licensed acupuncture clinic at to clinic for which application is (c' The location of the evaluate safety and sanitation features in relationship to made. compliance with Chapter 389, Florida Statutes and these person or persons under whose (d, The name of the rules. will management or supervision the be operated. clinic (3, No member of the clinic staff, representing the (e, The following document shall constitute a part licensee, shall prevent representatives of the licensing of the initial application: A local zoning compliance agency from inspecting any area of the facility nor from statement. any clinic record required to determine reviewing operation of an (2, The license fee for the Statutes and these compliance with Chapter 389, Florida acupuncture clinic is $150.00 annually. Checks shall be rules so long as such inspection is conducted at a county health unit of the county in to the made payable and without disruption of clinic services. reasonable hour is located and shall be remitted with the the clinic which of Law. Implemented Chapter 90-168. Law Specific Authority 389.021 FS. application. History-New 217-81. Florida. (3, Each clinic license shall be valid only for the 10D-81.04 Management Responsibilities. to whom is issued it and shall not be subject to applicant or other transfer, voluntary or sale, assignment, (1, The ownership of the clinic, through the appointed manager or supervisor shall: involuntary, nor shall a license be valid for premises any other than for that which it was originally issued. An (a' Be legally responsible for the operation of the clinic. application for a new license shall be made in each case of (b, Be responsible for applying for a license or of to the change ownership. Each license shall be returned renewal to operate the facility. licensing agency immediately upon change in ownership, 525

72scan10D0674TABLE I General Pressure Rclationships and Venti lation of Ccrtain lIospice Areil5 Minimum Minimum Changes Air All Ai r Air Total of Outdoor Pressure Ikc i rcul atcd tcd E:-80 HOSPICE APTER 10D-80.19 Purchase/Shared Services. to this Section no later than January I, 1981, or have their A hospice may contract with other providers or licenses immediately revoked. Services provided by a -1provision of services to the propriate parties for the or any other hospital, nursing home, home health agency, spice program. provider will not be considered to constitute a hospice for sharing of services must (2) Any arrangement program of care unless provided by establishing a free-and clearly delineate the authority in contractual form standing or distinct part hospice unit to provide such services, in which case these regulations shall apply only sharing parties, including the d responsibility of the to such free-standing or distinct part hospice units. care by the hospice uirement for the direct patient Plans Submission - construction work shall not -1agree contract must am. Providers with whom hospices at staff working with hospice patients will be be started until written approval has been given by the of the hospice team. to and function as a part Office of Licensure and Certification and must be started sponsible e hospice administrator, director or manager must within one year following approval of construction must be obtained. When documents, otherwise reapproval responsibility for coordinating and intain construction is contemplated either for new buildings or hospice program. ministering the additions, or alterations to existing buildings, plans and (3) Any and all personnel provided to the hospice of contracted services shall be qualified the terms specifications shall be prepared by a Florida registered der to architect or professional engineer (attention is directed if they d credentialed in the same minimal manner as the hospice. No such contracted service re employees of the Joint Resolution of Florida State Board of Architecture and Florida State Board of Architecture and the the hospice from responsibility for all absolve availability, documentation, or overall ality, Florida Board of Professional Engineers and Land ordination of patient-family care or from responsibility Surveyors of May 28, 1971). All alterations, conversions, r compliance with federal, state, or local law or these any additions and renovations shall be submitted for approval or exemption from the plan review process. Plans and and regulations. es specifications shall be submitted in three stages FS. Law Implemented 400.615(4) FS. cific Authority 400.605, 400.615 42780. tory-New schematic plans (2) preliminary plans and -1consisting of (3) construction documents as described below: 10D-80.20 Bereavement Services. The hospice shall (a) First Stage - Schematic Plans services to the and ovide bereavement counseling Program 1following the ilies of hospice patients both before and a. List services to be provided in the proposed ient's death. Bereavement services shall be available construction. the family for at least one year following the death of total number of beds; types b. A schedule showing patient. e of bed rooms (private, semi-private, etc.) and types of shall be provided Bereavement services -1ancillary spaces. the interdisciplinary patient-family care nsistent with 2. Schematic Plans an and shall be documented in the record of care. Such the a. Single line drawings of each floor shall show treatment cumentation shall include dates, times, relationship of the various activities or services to each Members of dalities, and progress notes. other and the room arrangement in each. The name of each erdisciplinary team involved in bereavement care shall room shall be noted. The proposed roads and walks, gn bereavement entries. service and entrance courts, parking and orientation, may have as their (2) Bereavement services shall be shown on either a small plot plan or the first floor plan. ability of family members to understand and jective the A simple cross section diagram shall be submitted at this fulfilling pe with their grief and to live as normal and state. members of the as possible. To this end, the es the project is an addition, or is otherwise If b. involved in bereavement care shall erdisciplinary team related to existing buildings on the site, the plans shall vide specific counseling opportunities. show the facilities and general arrangement of those Bereavement services shall be coordinated (3) buildings. ofar as practicable with the family's cleric, if any, as (b) Second Stage - Preliminary plans shall include other community resources judged by the l as with the following as a minimum: the family. erdisciplinary team to be useful to Civil engineering plans - show existing grade 1ific Authority 400.605, 400.615 FS. Law Implemented 400.608(8) FS. structure and proposed improvements. Provide a vicinity 42780. tory-New map. 10D-80.21 Housekeeping Service. The hospice shall 2. Architectural Plans - provide floor plans (118" the cleaning of ve written policies and procedures for scale preferred). Show door swings, windows, case work physical plant and equipment of the inpatient unit. e and millwork, fixed equipment and plumbing fixtures. icies procedures shall also include the separate and Indicate function of each space. Provide large scale plan of linen, with special ndling and storage of clean and dirty typical new bedrooms with a tabulation of gross and new to identification, separation and tention being given square footage of each bedroom. Provide typical large dling of isolation linens. and exterior sections and exterior wall scale wall interior 400.605. 400.615 FS. Law Implemented 400.615(2) FS. cific Authority elevations. tory-New 427-80. 3. Life Safety Plans - single sheet floor plans Requirements (Inpatient 10D-80.22 Physical Plant showing fire and smoke compartmentation, all means of part t). A free standing hospice facility and a distinct egress and all exit marking. Additionally dimension compartments and calculate and tabulate exit units. Show spice unit shall provide all the elements described sprinklered areas. the rein and shall be built in accordance with part units of nstruction requirements outlined. Distinct 4. Mechanical Engineering Plans - Provide one line diagram of to include outpatient, inpatient and pice facilities, the ventilating system with relative pressures of each space. Provide at least in outline form, a provisions spice based care programs, shall include the description of drawings of the anticipated emergency scribed herein. All hospice programs shall fully smoke control and system operation, correlated with item plement home-like inpatient hospice service conforming 520

72scan10D0669lOD-80 CHAPTER HOSPICE Supp. No. Ilg (c) request and approval for care. together with to in- and within twenty-four i24} hours of admission dated and signed by the patient or informed consent. are hospice patient care. This shall be obtained by the by an individual legally responsible for the patient; and by physician, referring physician, and/or copies of existing a member of the patient's family. if any. records. patient (5) Continued association by the personal physician All interdisciplinary records of care shall be (5) with the patient admitted to the hospice program and prepared accurately and completed concurrently with with the hospice medical director. justify the to sufficient information and progress notes (6) A log of requests for services which shall and warrant treatment and palliation. diagnosis the hospice's provision of services to patient-document Physicians' orders, nurses' notes, notes from other families irrespective of ability to pay. Such log shall disciplines, notes from the patient-family's cleric, if any, the action taken regarding each request for indicate kept current in a and notes from volunteers shall be If hospice services. the decision of the hospice is to not professional manner and all entries shall be signed with accept a patient-family for care. documentation of the the person responsible for legally acceptable signature by basis of the decision shall be made in the log. In no case them. it be acceptable to refuse or discontinue hospice shall (6) The interdisciplinary records of care shall be services only because of inability to pay. patient, kept confidential. Written consent of the (7) The hospice program shall provide notice to the guardian shall be required for patient's family or patient's public that it provides its services regardless of inability release patient information. of to pay by: and stored in a secure The records shall be filed -7(a) stating so in all brochures. pamphlets and other manner and shall be kept for such time as determined by publications describing its services and program; governing body. the (b) by posting notices in all appropriate areas of its -8the patient portion Completion of offices and facilities. including but not limited to the interdisciplinary records of care shall be accomplished admissions area. reception area and business office; and. days after discharge, referral. or death. (7) within seven (c) by verbally informing the patient and their ~S. 400.611FS. l.aw Implemented 400.605. 400.615 Specific Authority family during the initial interview. 4-21-~O. N-pw History-~S. 400.608FS. Law Implemented 400.605, 400.416 Specific Authority Out-Patient Services. lOD-80.16 42780. History-New Each hospice shall provide out-patient services. (l) to patients and families who as medically appropriate. may require services which should not be provided in the Utilization Review. lOD-80.18 in the in- home but which do not require an overnight stay Each hospice shall document the number of -1an patient hospice unit. The hospice shall provide days of inpatient hospice care and the number of days adeq uate location for the provision of such services and during which hospice services are actually provided in shall maintain regular hours of business as indicated by patients' homes during each year. The hospice shall also the patient-family population. the needs of the total "term of care" days (total number of document outpatient services (2) The accessibility of hospice calendar days from the time a patient-family is admitted the quality of those services shall be periodically and until discharge. referral. or death of the patient) Practice Committee. by the Joint reviewed accumulated in the program of hospice care during each The utilization of out-patient services shall be (3) year. the interdisciplinary care record. documented in (2) The hospice shall be considered to be in FS. 400.6(913) FS. l.aw Implemented 400.605. 400.615 Specific Authority 42780. New Hiswry-compliance in utilizing inpatient services on a short-term basis if the ratio of total inpatient hospice days to the Admission Policies. There shall be lOD-80.17 total "term of care" days during a given year does not and procedures which set forth criteria for written policies exceed one to five or twenty per cent of total "term of admission a hospice program of care. Such policies and to care" days for the entire patient population. procedures shall. at a minimum. provide for: (3) The hospice shall prepare and have available for the medical community. Methods whereby -1inspection by any citizen an annual financial summary and general public potential patient-family population. including. as a minimum: will be appraised of availability of hospice care; the (a) number of patient-families served dUring the (2) Notification of the patient's personal physician. preceding year; request for as named by the patient and/or family. of the (b) average length of stay in the hospice in-patient request; (72) hours of the admission within seventy-two unit; (3) In no case shall a patient/family be admitted to a the prior consent of the hospice program of care without (c) average term of care (number of total calendar the patient patient's personal physician as named by days between admission and discharge. referral. or death); and/or family. (d) average number of home care visits per patient-(4) Documentation of informed consent for family; admission by the patient and personal and treatment (e) a schedule of fees. charges for each service; the patient/family. A record of as defined by physician (f) number of patient-families served for less than informed consent shall be included in the patient-family the customary and usual charges; as a and shall include. interdisciplinary record of care (g) dollar amount and percentage of care provided minimum. provisions assuring that: at less than the customary and usual charges; patient and family understand the hospice (a) the (h) an audited financial statement; concept of care as being palliative in its goals; (4) a copy of the annual financial summary shall be understand the hospice (b) the patient and family submitted to the Department within ninety (90) days after the as requiring the active participation of concept of care the close of the hospice fiscal year. provide care twenty-four family. guardian or caregiver to 400.609. FS. Law Implemented 400.605. 400.615 Authority Specific 4-2780. History-New FS. 400.61512) hours a day. seven-days-a-week. when indicated. (24) 519

72scan10D0668Supp. No. 118 HOSPICE 10D-80 HAPTER (d) arrange for psycho-social support mechanisms Clergy and/or Counseling Services. l0D-80.11 for the volunteers. an organized clergy The hospice shall maintain -1(e) coordinate utilization of volunteers with other d/or counseling service with clearly defined written program directors. the icies for the delivery of such service in maintain a roster of volunteers which includes (f) plementation of the interdisciplinary plan of care. assignments, hours of service and availability, addresses (2) The hospice shall employ, at a minimum, one and telephone numbers. ergyperson or counselor who shall be qualified by the (3) The volunteer providing direct patient-family mpletion of graduate a level degree in either ministry or services shall: an approved college or university or unseling from (a) be an active caregiving member of the inity school. interdisciplinary hospice care team. (3) The scope of clergy/counseling services shall (b) be included in the process of identifying the patient- as a minimum: active liaison with the lude, needs of the patient-family and in designing and or spiritual community as appropriate; direct ily cleric implementing strategies for meeting such needs. patient-family as indicated by the to the unseling (c) be required to record progress notes in the terdisciplinary plan of care; and other related functions interdisciplinary record of care. assigned. mplem~nt.-d ~S. 4011.61 [,121 Law I rs. If, Authority 400.605. 400.6 Specific the (4) The clergyperson/counselor shall document History-New 427-1\0. care provided. terdisciplinary record of any Infection Control. l0D-80.14 cific Authority 400.605. 400.615 FS. l.aw Implemented 400.61512) f'S. 42780. story-New Each hospice shall develop an infection control -1program which shall have as its purpose the protection of Social Services. lOD-80.12 patient, family and personnel from hospice or community The hospice shall maintain an organized social -1patients admitted to the hospice associated infections in delivery of the k service with clerly defined policies for and home-care program. in-patient, out-patient cial services in the implementation of the (2) The hospice's regulations governing the erdisciplinary plan of care. structure and function of this program must be approved a minimum, one (2) The hospice shall employ, at by the medical committee and then by the governing body ll-time social worker who shall have a degree in social and become part of the rules of the hospice. and at least three (3) years rk from an approved school (3) A hospice infection control committee shall be erience in social work. established to supervise the infection control program and Social work services shall be provided in (3) report on its activities with recommendations on at least a cordance with interdisciplinary plan of care. The the quarterly basis, to the medical director and administrator. of the cial worker as an active caregiving member the committee shall include a The membership of erdisciplinary team, shall participate in identifying physician who shall be chairman, a registered nurse care. to gnificant social and emotional factors related employed by the hospice, a pharmacist and a a scope of social work services shall include as representative from administration, dietary, laundry and nimum: assisting in pre-admission and discharge housekeeping services. conducting medico-social assessment; anning; (4) The infection control committee shall: the patient and family on an individual and unseling (a) adopt working definitions of hospice-associated working to develop up basis; identifying, utilizing, and infections; and maintaining propriate community resources; (b) develop standards for surveillance of incidents mplete records relating to social work services provided of hospice related infection and conditions predisposing to inclusion in interdisciplinary care record. the infection; cific Authority 400.605. 400.615 FS. Law Implemented 400.615(2) FS. (c) monitor and report infections in all patients, 4-27-80. story-New including home care program, and environmental Volunteer Service. Each hospice shall lOD-80.13 conditions with infection potential. a comprehensive, organized program of intain Specific Authority 400.605. 400.615 FS. Idlw Implemented 400.615(2) FS. availability of care, unteer services to promote the History--New 4-27-80. the broadest range of patient-family needs, and et Interdisciplinary Care Records. lOD-80.15 operation of the hospice. fect financial economy in the An interdisciplinary care record on each -1A full-time director of volunteer services shall be (1) kept in a systematic manner by patient/family shall be and be responsible for developing, ployed qualified personnel. plementing and documenting a volunteer services (2) An interdisciplinary record of care shall be the ogram which meets both operational needs of maintained for every individual who is evaluated or and to provide direct patient-family service as ogram as a hospice inpatient, out-patient or who receives treated icated in the interdisciplinary plan of care. services in a hospice home-care program. The director shall have as a minimum, the (2) The interdisciplinary nature of the record shall (3) lowing responsibilities: be assured by including medical, nursing, psycho-social, (a) recruitment of volunteers religious information and observations by any and the hospice concept (b) orientation of volunteers to of the hospice care team, the patient-family's member to the role of the volunteer as a member of the care, the referring physician. and by cleric, if any, the terdisciplinary hospice care team, and to An interdisciplinary record of care shall be (4) volunteer within the hospice ponsibilities of the at the time of admission with identification, date started ogram; nurse's notation of condition on admission. To this and to (c) provide ongoing opportunities for volunteers an admission note and shall be added immediately ntify, request, and receive skills designed to make physician's orders. A complete history and physical assisting with the operational unteers more effective in (72) recorded within seventy-two be examination shall the hospice and/or providing direct patient- ctions of to home care and out-patient services; hours of admission ily care. 518

72scan10D0667CHAPTER 10D-80 HOSPICE 118 Supp. No. the patient and/or family are discharged or referred from (c) Counseling patient and family concerning hospice program. the normal or modified diets and encouraging patients to (d) An incident/accident report shall be made in participate in planning their own modified diets and every instance of error in treatment, adverse reaction to instructing patient and family in food preparation. or injury to the patient. All treatment or medication (4) The dietary service shall provide maximum by the Joint reports shall be reviewed incident/accident practicable freedom of choice of diet to hospice in-patients Practice Committee. and shall assure that patients' favorite foods are included The interdisciplinary hospice care plan shall in their diets. -7Specific Authority 400.605, 400.615 FS. Law Implemented 400.615(2) FS. include but is not limited to: History-New 42780. the terminally ill (a) skilled palliative care for which shall control physical pain and other patient and symptoms of illness. distressing signs 10D-80.09 Pharmaceutical Services. bereavement (b) skilled psychosocial, spiritual and Each hospice shall establish as a mmmlUm, -1the patient and family for those problems counseling for institutional pharmacies as defined in Chapter 465, impact of the terminal and needs which result from the Florida Statutes and such rules and regulations as may be illness on the patient-family. and death promulgated thereunder. the interdisciplinary care All care provided by -8(2) The pharmaceutical service shall be directed by shall be documented in the interdisciplinary clinical team a pharmacist registered in the State of Florida. record. Such records shall be regularly periodically and be The scope of pharmaceutical services shall -3audited by the Joint Practice Committee utilizing consistent with the drug therapy needs of the patients as approved medical record shall audit methods. The master determined by the medical director and primary the hospice office. be retained in physician. team shall: The interdisciplinary care -9(4) There shall be an active pharmacy committee, and (a) provide a mechanism whereby patient the hospice medical director, another licensed composed of communicate directly family members shall be able to physician, the pharmacist, the patient/family care on a the interdisciplinary care team with a member of and a representative from administration. coordinator, (24) hourseven-days-a-week basis. twenty-four at Specific functions of this committee, which shall meet (b) document in a call log all such communication least quarterly, shall include: including requests for hospice care and the disposition of (a) developing broad professional policies regarding such requests. the evaluation, selection, procurement, distribution, use, (c) be staffed in such a manner as to be able to drugs; to safe practices matters pertinent and other provide hospice receive and respond to such requests and (b) developing a basic formulary system of drugs; hour, seven-days-a-week (24) service on a twenty-four (c) monitoring and reporting adverse drug basis. reactions and introducing proper measures to minimize its services without (d) provide a continuity of their incidence; interruption through all modes of care delivery in the (d) reviewing and analyzing medication incidents a hospice program means hospice program. Admission to and taking appropriate action to minimize the hospice components and services to all its admission recurrence of such incidents; but not limited to,: in-patient, out-patient, including, (e) determining drug use patterns and assisting in home-care, bereavement and educational services. the setting of drug-use criteria relative to the drug provide a continuity of care-givers for each (e) utilization review program. the hospice by maintaining a admitted to patient-family (f) reporting through the administrator to the practicable from constancy of team members insofar as medical committee and then to the governing body. the time of admission through the bereavement period in (5) There shall be a current, written policy and all modes of hospice care delivery. procedure manual approved by the medical committee Specific Authority 400.605, 400.615 FS. Law Implemented 400.608. 400.611. and governing body pertaining to the drug control system 42780. History-New 400.615(2) FS. in the hospice. (6) There shall be a current, written methodology 10D-SO.08 Dietary Services. for access to medications twenty-four(24) hours a day by organized dietetic service There shall be an -1legally qualified members of the interdisciplinary care in-patient unit or the premises of the provided either on team. contracted. The service shall employ an adequate number Specific Authority 400.605, 400.615 FS. Law Implemented 400.615(2) FS. reponsibilities and of individuals to perform its duties and History-New 42780. an experienced food service shall be directed by supervisor. 10D-80.10 Diagnostic Services. Equipment and procedures (2) There shall be written policies and qualified personnel, under competent medical supervision, governing all dietetic activities. shall be provided for necessary diagnostic procedures at least one The service must have available -3adequate to meet the needs of the hospice in-patient, out-qualified dietitian, with a baccalaureate degree and major patient and home care program. This shall include the studies in food nutrition or who is qualified for services of a clinical laboratory and radiological services membership in and registration by the American Dietetic which shall meet all applicable standards of the State of nutritional aspects the Association. The administration of Florida. Unless provided on the premises of the hospice, patient care shall be under the direction of said of there shall be written agreements for blood bank and by a physician, whose duties shall dietitian, when ordered pathological services. All contracts shall specify twenty-include: four (24) hour on-call availability. (a) Recording nutritional histories of in-patients; Specific Authority 400.605. 400.615 FS. Law Implemented 400.615(2) FS. regarding their food (b) Interviewing patients History-New 42760. preferences; habits and 517

72scan10D0666Supp. No. I III HOSPICE 101>-80 HAPTER (d) a framework to insure twenty-four (24) hour, director who shall, after making appropriate notations physician availability, ven-days-a-week, on call report such findings and recommendations to the medical cluding physician home visits; then to the governing body on a timely committee and basis. Such committee shall meet quarterly medical committee (e) provision for at least quarterly. director. Pertinent nferences with the medical Attendance of members shall be documented. reported formation from such conferences is to be (b) The Joint Practice Committee shall consist of at least the following employees of the hospice: governing body. gularly to the minimum (6) The medical committee shall adopt 1. The hospice medical director or a qualified and attendance at committee meetings. Minutes les for hospice physician. kept. 2. A registered nurse. be record of attendance shall 3. A social worker. cific Authority 400.605.400.615 FS. Law Implemented 400.608, 400.611. 0.61512) FS. History-New 42780. 4. A clergy person or counselor. 5. A hospice volunteer. 100-80.07 Coordinated Care Program. The overall Patient or family member who is being currently 6. ogram of patient-family care in a hospice shall be cared for or who received the services of the hospice. has a Patient-Family Care Coordinator by ordinated A licensed physician not employed by the 7. . on a full-time basis by the hospice. Such ployed but who has referred a patient to the hospice hospice pursuant ordinator shall be a registered nurse licensed preceding twelve months. the within State of Florida and who shall have the laws of the A clergy person not employed by the hospice but 8. years of supervisory experience in community ree (3) has had a member of his/her parish or congregation who rsing, geriatric or acute care unit of a hospital. cared for by hospice within the preceding twelve the The Patient-Family Care Coordinator shall be -1months. developing, implementing and esponsible for The membership of the Joint Practice (c) for all ocumenting a nursing staffing pattern Committee may also include: a hospice program (in-patient, out-patient, of mponents pharmacist A 1pattern shall, as a d home care). Such staffing A dietitian 2. inimum, have the following characteristics: A housekeeper 3. (a) The ratio of in-patients registered nurses shall to A medical records practitioner 4. t be less than one registered nurse to ten patients per A physical therapist or an occupational therapist 5. hour shift. ght 6. A speech pathologist to all licensed nursing (b) The ratio of in-patients Interdisciplinary patient care - The patient and (5) five in-patients per aff shall be not less than one nurse to the unit of care. Care shall be family shall comprise shift. eight hour interdisciplinary team which shall consist by an provided not be less (c) The ratio of all patient care staff shall minimally of a physician, registered nurse, social worker, one staff member to three in-patients per an eight an clergy person/counselor a volunteer. and ur shift. A hospice care program shall consider the family (a) care nursing ratio: (d) Hospice home a~d patient to be the unit of care. The family, along the to A hospice home care shift shall be considered 1With patient, shall insofar as practicable, define the the hours. A hospice care nursing ratio shall be eight to be addressed as well as provide significant needs nsidered minimally appropriate when a registered effective plan an information and assistance in developing rse, licensed practical nurse, home health aide or of care. than four home to make no more ilizes such eight hours Hospice shall identify the patient's family to be (b) sits. only those persons who are legally related, but those not (2) The Patient-Family Care Coordinator shall as family by the patient. persons regarded mplement, current written plan that and document a A patient-family, upon admission to a hospice (6) lineates cooperative planning and decision making interdisciplinary hospice to an program, will be assigned mong members of the the disciplines represented in the care team. Such shall be the primary and direct team terdisciplinary care team. that patient-family to delivery mechanism for hospice care (3) The Patient-Family Coordinator shall develop, all components of the hospice program lin- through and procedures and document written policies mplement, out-patient, home-care). A hospice program of patient, staff with practical methods of provide the nursing at least one and may consist of several care shall consist of individual responsibilities as eeting collective and interdisciplinary hospice care teams. assigned in the interdisciplinary plan of care tlined and The interdisciplinary hospice care team shall (a) procedures shall and r each patient-family. Such policies develop a written (palliative supportive) care plan and the following: a minimum, include w~i~h assessment of physical, psychosocial and includes physical symptoms (a) Methods of controlling the the patient, coping ability of the patient spIrItual needs of terminal illness together with methods of evaluating family, specific goals with plans for implementation and such methods. nd studying be rendered, drug therapy, and bereavement to services family (b) Methods of teaching patients and plan when indicated. accomplish to administer medications and embers how . The patient-family shall be encouraged and (b) patient-family ther hospice skills in order to promote the permIt~ed participate in developing and implementing to the and enhance the independence of elationships th~ and shall have privity to the written plan of care atient-family. plan of care upon request. wntten hospice shall appoint a Joint Practice (4) Each The interdiSciplinary hospice care team shall (c) ommittee. the implementation of such physical, document committee shall provide ongoing (a) Such strategies of the patient- psychosocial, and spiritUal care review of hospice services and patient- valuation and and continual consultation with the team and family unit amily care and shall report its findings and the patient-family regarding those strategies until with administrator and medical ecommendations to the 516

72scan10D0665CHAPTEIitUII>o80 HOSPICE Supp. No. 118 direction' and quality of the medical' care rendered to the patient-family level. patient-family by the interdisciplinary team. The patient' s (el Development and implementation of financial attending personal physician remains the primary policies and practices including not limited to the but physician care giver of following: the patient/family unit, but may elect to have the hospice medical director/physician the governing 1. an annual budget for approval by or instead, act assume all primary medical care functions, body. as a consultant, with the concurrence of the statement for approval by 2. an annual financial the governing body. patient/family. However, the attending personal physician shall maintain liaison with the patient/family ongoing bookkeeping and financial an 3and hospice interdisciplinary care team in either case. sound business management system according to (al Duties of the medical director shall include but practice. limited to: be system according to sound not an ongoing payroll 41. Reviewing or performing an admission history business practice. accounting for gifts 5. procedures for accepting and and physical for each patient. and donations. 2. Validating the prognosis and time frame of the patient anticipated by the patient's personal physician. Maintaining familiarity with applicable federal, (fl and medically validating 3. Assisting in developing State and municipal laws and regulations governing responsible for the interdisciplinary plan of care for each patient-family be them in the-hospice, hospices; maintain familiariziDg employees and volunteers with these laws the coordination of the patient's personal or with regu.tatioDs; and. have opies available for their use. and attending physician. 4. Attending and actively participating in patient-(gl Maintenance of an office facility for the hospice family care conferences. which is large enough for efficient work, adequately staff equipped, and which provides a safe-working environment or supervising active physician care 5. Rendering, patients' homes, in the in-patient hospice unit and out-in meeting local ordinances and fire regulations. completion, keeping and (hI Responsibility for the patient hospice service; and maintaining a record of such required by the as submission of such reports, and records care. other authorized agencies. Department and 6. Maintaining a regular schedule of participation in all components to be his Designate in writing an employee of the hospice care program; and (i} hour, seven-day-a-week (241 authorized representative in his absence. maintaining twenty-four Employment of all personnel. to the hospice program coverage of and ready availability (j) Establish policies governing the maintenance, (kl through himself or his qualified hospice physician designee. confidentiality and retention of clinical records, visitation by family and friends, sliding fee schedule. 7. Acting as a consultant to attending, including Establish a complaint mechanism. personal, physicians and other members of the (l} Develop a plan for coordination and continum (ml interdisciplinary care team; helping to develop and review of services. and procedures; serving on patient-family care policies Identify and make public all services provided (nl to the appropriate committees; and reporting regularly hospice program, the geographic area in which the by the administrator and the medical committee regarding services are available, and admission criteria. medical care delivered to hospice patients. Where applicable, maintenance of written 8. Maintenance of liaison with the personal or (01 other providers of care to service contracts executed with attending physician. The personal physician may continue the hospice services with insure coordination of to provide primary care to his patient even though the professional and nonprofessional services already in the patient also receives hospice care. The hospice physician community. These contracts shall contain but not be to the patient. will provide palliative care limited following: to the 9. Establish written protocols for symptom control, 1. services to be provided. or other symptoms. i.e., pain, nausea, vomiting, to all applicable hospice 2. provision for adherence In addition to the hospice medical director, the (31 program policies and personnel requirements. hospice may appoint additional hospice physician(sl who 3. designation of full responsibility for the hospice shall perform duties precribed herein. Any appointed control over contracted services. the same licensing physician shall be subject to submitting clinical and progress 4. procedures for qualifications as the hospice medical director. notes. (4) Each hospice shall have a medical committee availability of the contracted service twenty four 5. the medical director and not fewer than four consisting of days a week. (71 hours a day, seven (241 physicians, one of whom shall serve as a chief for (41 6. charges for the contracted service, if applicable. chairman of the medical committee and all of whom shall evidence of liability and insurance coverage. 7. be licensed and all of whom shall be licensed to practice in 8. period of time in effect. Florida pursuant to Chapter 458 or 459, F.S. of appropriate authorities. 9. date and signatures The medical committee shall recommend written (51 by-laws and rules pertaining to its own activities to the FS. Law Implemented 400.608, 400.6lO. Specific Authority 400.605. 400.615 FS. History-New 42780. 400.615(2) governing body, which shall include at least the following: (al requirements for the delineation and retention of 10D-80.06 Medical Direction. clinical privileges; the hospice shall employ a medical director who (1) (bl method of control of clinical work, including shall be a hospice physician and who is licensed in the written consultations for all clinical sevices which shall be and State of Florida pursuant to Chapter 458 or 459, F.S., the patient's chart; properly entered in at one or more hospitals has admission privileges (c) analysis, review and evaluation of clinical commonly served by that community. patients in practices within hospice in-patient, out-patient and The medical director is a member of the (2) hospice-based home care programs, to promote and and is reponsible for the interdisciplinary care team maintain high quality medical care; 515

72scan10D0664Supp. No. US HOSPICE IOJ).8() HAPTER 14) The fonowing information is required on the e. a mechanism for approval of the appointments of censure application: the administrator, medical director, patient care the facility's administrator, la) The name of coordinator, and professional and ancillary personnel; nager or supervisor; name and license number of the f. qualifications for appointment to the medical patient care coordinator and all other e medical director, committee based upon background, competence. the number and censed personnel; the number of aides; adherence to the ethics of the profession and physical and mental other professional and supportive personnel pes of status; ving responsibilities for care given any part of the g. a schedule of monthly meetings during each calendar year; tients. The number of beds for which a license is being Ib) h. a specific policy governing conflict of interest of quested. No facility may operate a number of beds members. including a prohibition against the employment eater than the number for which the facility is licensed. by the hospice of anyone related by blood or the spouse of censed beds may be different locations Isatellite at the administrator. director or manager. the medical director ds). In those instances where a licensed designated part or the patient-family care coordinator. the application shaD specifically requested for licensure, Ib) The appointment of a qualified administrator. entify director the physical area to be used, and such area must or manager who shall be responsible to the as an entire ward, wing, floor or physically identifiable governing body for the management and operation of the facility. The administrator, director. or manager shall be a part thereof. or a distinct ilding, For initial licensure only, not for renewal, Ic) but full-time employee with at least three 13) years experience with a health care system. e Certificate of Need together with certificates of proval signed by local authorized zoning, building, and 13) Duties of the administrator, director or manager application. to the but not be limited to: ectrical agencies shall be attached shall include r initial and renewal, a separate survey for fire safety la) Attendance at meetings of the governing body ll Department. the staff and the provision of regular reports to and medical be made by For initial licensure, where there are no Id) those bodies regarding the operation of the hospice. Ib) The development and implementation of written county building or electrical agencies or or nicipal administrative policies and practices to insure the applicant shall provide a written statement of des, the provisions of safe and adequate care of the patient-family. mpliance with these regulations from a registered Such policies and practices shall include, as a minimum. or professional engineer who shall substitute for chitect the following: e authorities specified above. personnel policies applicable to all full-time and 1cific Authority 400.605. 400.606 FS. Law Implemented 381.493. 381.494. 1.495,400.606,400.609(21,400.612 FS. History-New 427-80. part-time employees and volunteers which shall include but not be limited to the following: Man~gement_ IOD-80.05 Governing Body and a. wage scales, hours of work. vacation. and sick writUm by ere shall be a governing body established leave. authority for the -laws of the hospice with autonomous b. requirements for a pre-employment physical the hospice program. nduct of and a periodic physical examination at least examination years. The governing body shall satisfy the following UI 12) every two quirements: c. each hospice must have a written plan for The governing body shall consist of no fewer la) orientation and training all staff. of to include volunteers. the members who shall be representative of m an seven and which shall insure that all staff receive this training mmunity at large. prior to their delivering services of any kind to patients the health Ib) Members shall reside or work in and their families. rvice area or areas in which the hospice is licensed to d. job descriptions for all employees. erate. e. annual performance evaluation for all employees. Ic) No person shall be denied membership on the f. compliance with the requirements of Title VI of verning body by reason of race, creed, color, age or sex. 1964Civil Rights Act of the 12) Duties of the governing body shall include, but g. personal folder for each employee which shall be limited to the following: t include names and addresses. social security number, date the following documents la) Adoption in writing of or guardian. job kin and address of next of of birth. name compliance with provisions of Part V, the be ich shall description. evidence of qualifications. sufficient liability apter 400, F.S., and these rules: insurance. licensure and/or registration. if applicable, admission criteria defining eligibility for hospice 1and contracts if applicable. dates of employment separation from the agency and reason for separation. rvices; guidelines for community relations; 2Ic) The development of a written procedure for and informed consent of and 3. request for service implementation of education and training programs for all family; tient and full-time and part-time employees which shall include but 4medical by-laws lafter considering the not be restricted to the following: commendations, if any, of the medical committee); introduction to the philosophy. goals. and 15. rules and by-laws which include at least the objectives of hospice care. llowing: 2. specific instruction for each team member hospice; the purpose of the a. to the particular job descriptions of that member related b. annual review rules and by-laws which of the the hospice care team. of all be by the chairman of the dated and signed 3. regularly scheduled education programs and verning body; opportunities for continuing education including c. the powers and duties of the officers and programmed education in the interdisciplinary team mmittees of the governing body; approach to hospice care. qualifications, method of selection and terms the d. Id) Maintenance of a current organizational chart of the board of office of members and chairmen showing lines of authority and responsibility to the and committees; rectors 514

72scan10D066310n-SO CHAPTER HOSPICE 118 Supp. No. RULES OF THE DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES HEALTH PROGRAM OFFICE 100-80 CHAPTER HOSPICE Purpose inpatient unit. The site may be in the same city or may be 100-80.01 in other cities. Operational responsibility for satellite beds Definitions 100-80.02 License Required must remain with the parent unit. 100-80.03 Specific Authority 400.065(3). 400.615 FS. Law Implemented 400.601. Licensure Procedure 100-80.04 400.61512) FS. History-New 4,2780. Governing Body and Management 100-80.05 Medical Direction 100-80.06 License Required. Before any person 100-80.03 Coordinated Care Program 100-80.07 shall operate a hospice, he shall make application for and Dietary Service 100-80.08 receive a license from the Department. A license shall not Pharmaceutical Services 100-80.09 be required for any facility specifically exempted in Diagnostic Services 100-80.10 Florida Statutes. 400.604, Chapter Clergy/Counseling Services 100-80.11 The face of the license shall contain the -1Social Services 100-80.12 following information: the name and address of the Volunteer Services 100-80.13 facility, the name of the owner, the beginning and Infection Control 100-80.14 expiration dates. Interdisciplinary Care Records 100-80.15 (2) In the event contemplated of change of Out-Patient Services 100-80.16 ownership, the new owner shall submit, or cause to be Admission Policies 100-80.17 submitted, an application for license and receive a license Utilization Review 100-80.18 prior to commencement of operation of the hospice. Purchase/Shared Services 100-80.19 (31 In the case of application for license after Bereavement Services 100-80.20 purchase of a hospice previously licensed under other Housekeeping Services 100-80.21 correct any existing to ownership, a signed agreement Plant Requirements (Inpatient Physical 100-80.22 licensure deficiencies shall accompany the license Unitl application, together with appropriate documentation to Purpose. 100-80.01 evidence that the ownership change has taken place, and a Hospice facilities licensed in Florida for the care (II statement that essential records pertaining to the ill and of the terminally treatment perform a most needed be retained will the facility administrative operation of professional service. The people Florida have a right to of and available for official inspection by the Department. expect any licensed facility meets, as a minimum, that Specific Authority 400.605. 400.615 FS. Law Implemented 400.602, 400.606 and the essentials of standards of care professional FS. History-New 42780. comfort in a safe and sanitary surrounding. These hospice rules provide for the care, safety (21 operate to Licensure Procedure. Licenses 100-80.04 and humane of persons in such facilities. They treatment be based upon the will a hospice issued by the Department Part V, Florida Statutes. They 400, are based on Chapter results of a physical plant and operational survey are applicable both new and existing facilities. to determine compliance to conducted Department by the Part SpecifIC Authority 400.605. 400.615 FS. Law Implemented Chapter 400. Part V, F.S., and 400, requirements of Chapter the with 42780. V. FS. History-New with these rules. the to Application for license shall be made -1definitions Definitions_ In addition to 100-80.02 Department on forms prescribed by the Department. The . the following Part V, F.S 400, contained in Chapter shall apply: terms by a license fee of one application shall be accompanied 400.605. required by Section as ($100.00)hundred dollars One who is licensed Registered Nurse -(II the Department to F.S., in check or money order, payable practice professional F.S., to 464, Chapter to pursuant nursing. of Health and Rehabilitative Services. (2) Applications for renewal shall be submitted on One licensed (21 Licensed Practical Nurse -forms furnished by the Department, annually at least to practice practical F.S., 464, Chapter pursuant to the expiration date appearing on to days prior -60nursing. sixty (31 Employ - To engage the services of, on either a the currently held license. Application shall be made in salary accordance with volunteer basis. or the detailed procedures contained in F.S. 400.606, Those persons directly (41 Patient Care Staff -Section a to is leased by the owner (3) When a hospice involved in direct care of the patient, including registered second nurses, practical nurses and nursing aides. party for operation, said second party shall apply As used in these rules, (51 Autonomous - to the Department for a new license and obtain same prior autonomous means independent of organization any other to assuming operation. A copy of the lease agreement be held responsible for the to showing which the party is and operating under specific by-laws relating only to particular hospice. organization, operation, fiscal management, and Licensed hospice inpatient (6) Satellite Beds -maintenance of the facility shall be filed with the beds located a site other than the parent hospice at application. 513

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72scan10D0661lOD-79 CHAPTER NONEMERGENCY MEDICAL TRANSPORTATION SuPP. No. 113 Every insurance policy or contract for such Insurance. lOD-79.08 insurance shall provide for the payment and Every operator shall carry bodily injury (1) satisfaction of any financial judgement entered solvent and and property damage insurance with against the operator and present insured, or any the responsible insurers licensed to do business in person driving the insured vehicle. All such of Florida, to secure payment for any loss or State insurance policies, certificates thereof or certified of damage resulting from any occurrence arising out of such insurance policies shall contain the copies prescribed limits and provide operation or use of any of the or caused by the above for thirty (30) vehicles. Each vehicle shall be operator's motor day cancellation notice to the Department. In lieu one hundred insured for the sum of at least thereof, a self-insurance plan approved by the ($100,000) for injuries to or death thousand dollars Insurance Commissioner of the State of Florida will person arising out of anyone accident of anyone an acceptable substitute. The provider shall be the sum of at ietst three hundred thousand and current self-insurance certificate to the furnish a of more than ($300,000) for injuries to or death Department prior to the commencement of accident and for the sum of one person in anyone operations. ($50,000) for at least fifty thousand dollars Specific Authority 401.35 FS. Law Implemented property arising from anyone accident. damages to 401.25(3)(c), 401.35 FS. HistOrY-New 2-5-80. 511

72scan10D0660CHAPTER 10D-79 NONEMERGENCY MEDICAL TRANSPORTATION SuPP. No. 113 rear-vision mirror which shall enable the driver to A statement reasonably describing the (f) view the entire passenger compartment. geographic area or areas to be served by the doors shall be (d) Vehicle entry and exit applicant. to restrain equipped with latching devices sufficient ( g) A cop y of the certificate of public the individual passenger conveyances within convenience and necessity from the County of the vehicle. Striker plates passenger compartment Commission in each county in which the applicant will be used in conjunction with latching devices. will operate. smooth floor (e) Each vehicle must have a (3) The department shall issue a license for pockets at the which has a minimum of voids or operation within 60 days of the flling of the or moisture can floor to side wall areas where water application to any applicant complying with the trapped. become following requirements: one (f) The floor covering shall be seamless (a) The applicant has paid the $30.00 fee waxing type linoleum or vinyl not less piece no required by Section 401.34 of the Florida Statutes. 16-Janshall than inch thick, permanently applied and (b) The vehicles meet the requirements of of the patient extend the full length and width Chapter 401 Part III, F .S. and these rules. (c) The applicant has furnished evidence of compartment. Where side panels and covering meet, adequate insurance coverage for claims arising out side walls, they shall be sealed at the joints and the of injury or death of persons and damage to the and bordered with rustproof, corrosion-resistant cove moulding. metal property of others resulting from any cause for driver's Each vehicle shall carry in the which the owner of said business or service would (g) lA:10B:C fire extinguisher as .a compartment a be liable. The applicant shall provide insurance in minimum. such sums and under such terms as required in patient compartment shall provide a (h) The Section 10D-79.08 of these rules. 41 inches height measured from the minimum of (4) All advertising or other solicitation for floor to the finished ceiling. finished business by a nonemergency medical transportation service shall emphasize in a conspicous manner that 401.26. FS. Law Implemented 401.35Authority Specific 2-5-80. FS. History-New 401.31. 401.35(3) the service does not provide medical attention, and the service provided is designed for those persons 10D-79.04 Reserved. whose physical impairments render it impractical to use regular common carrier or taxi services. 10D-79.05 Reserved. (5) Drivers shall be trained in the correct use of the special equipment required herein, and shall Licensure Requirements. 10D-79.06 ensure that such equipment is in good repair, and person, firm, corporation, ( 1) Every that each passenger is properly secured in place by or acting association or governmental entity owning latching and restraining devices before the vehicle is owner of any business or service s agent for the placed in motion and throughout the transportation which furnishes, operates, conducts, maintains, performed. proposes to engage in the advertises, engages in, (6) A nonemergency medical transportation service of transporting sick, injured, business or vehicle shall be staffed by personnel sufficient for or otherwise incapacitated persons handicapped, safe loading and unloading of the patient. upon the streets, highways, waterways, or airways 401.25. Implemented FS. Law 401.35Specific Authority shall submit a written application to of this state 2-5-80. History-New FS. 401.35and Rehabilitative the Department of Health 10D-79.07 Records. ervices. Hospitals transporting their own patients in under these ( 1 ) Licensees providing service if heir own vehicles are exempt from this section rules shall be responsible for the supervision, charge a fee for this service. hey do not pre paration, filing and maintenance of records. include: (2) The application shall Records shall be maintained and preserved by the The name and business address of the (a) carrier for period of not less than (3) years. a shall three for the nonemergency medical perator and owner records be indexed and filed ready All of or nonemergency ransportation service, proposed access. All response and data records and other medical transportation service. records shall be accessible to Department will (b) The name under which the applicant representatives during normal working hours. Each perate. service shall maintain the following information: and addresses of all (c) A list of the names (a) Current personnel records of each fficers, directors, shareholders. and employee which shall indicate date of employment of each vehicle to be used, (d) A description and qualifications held by the employee. manufacture, ncluding the make, model, year of (b) Vehicle record on each nonemergency ileage, chassis numbers, passenger capacity, size medical transportation vehicle operated, vehicle or federal nd gross weight of each vehicle, state registration records and records of safety inspection. where aviation or marine registration number (2) Every service shall keep a trip report upon color scheme, insignia, name, pplicable; and the which shall be recorded the time, place and origin, other distinguishing characteristics to monogram or name of passenger and destination. Every service the applicant's vehicle or e used to designate retain and preserve all daily trip logs for at shall ehicles. least three (3) years and such logs shall be available place (e) The location and description of the for inspection by the Department, upon request, medical r places from which the nonemergency during normal working hours. service, or proposed nonemergency ransportation 401.3Law Implemented FS. 401.35Authority Specific service will operate. edical transportation 2-5-80. History-New FS. 510

72scan10D0659NONEMERGENCY MEDICAL TRANSPORTATION CHAPTER 10D-79 113 SuPP. No. RULES OF THE DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES HEALTH PROGRAM OFFICE CHAPTER 10D-79 NONEMERGENCY MEDICAL TRANSPORTATION SERVICES 10D-79.01 Purpose (b) Each vehicle shall have, for each passenger Maintenance 10D-79.02 Sanitation and sec~re~y (2) positive means of transported, two Vehicle Design 10D-79.03 latching or locking to the vehicle the .wheelchaIr. m Reserved 10D-79.04 which a passenger will ride. The latchmg or lockmg 10D-79.05 Reserved devices shall be designed to prevent any lateral, Requirements 101)-79.06 Licensure longitudinal or vertical motion of the passenger 10D-79.07 Records conveyance within the vehicle. 10D-79.08 Insurance ~assenger for each (c) Each vehicle shall have, are issued 10D-79.01 Purpose. These rules transported, restraining belts or straps deSIgned to "Florida pursuant to the provisions of the securely confine passengers to wheelchairs in which Medical Services Emergency and Nonemergency they are transported. establish Act." The purpose of these rules is to (d) Each vehicle shall have, in addition to the standards for the transport of minimum rear-vision mirror required by Chapter 316 F.S., an persons handicapped or otherwise incapacitated inside rear-vision mirror which will enable the driver on a re q u iring specialized transportation to view the entire passenger compartment. nonemergency basis. (e) Vehicle entry and exit doors shall be t~ ~estrain sufficient equipped with latching devices Law Implemented 401.21, Specific Authority 401.35 FS. History-New 2-5-80. 401.25, 401.26, 401.35 FS. individual passenger conveyances wlthm the passenger compartment of the vehicle. Striker plates 10D-79.02 Sanitation and Maintenance. All will be used in conjunction with latching devices. transportation vehicles shall: nonemergency medical (f) Each vehicle must have a smooth floor equipment which is smooth (1) Have interior which has a minimum of voids or pockets at the and easily cleaned. floor to side wall areas where water or moisture can (2) Have interior lights which function become trapped. (g) The floor covering shall be seamless, one properly. Be free hazards (including but not (3) of piece no waxing type linoleum or vinyl not less limited to slippery floors, sharp edges, unpadded than 1/16 inch thick, permanently applied and shall interior door head clearances). extend the full length and width of the patient rust, which interfere (4) Be free of dents and compartment. Where side panels and covering meet, of the vehicle. with the operation at the joints and the side walls, they shall be sealed safe all times, At meet the requirements of -5and bordered with rustproof, corrosion-resistant 325, Part II, F.S. Chapter cove mOUlding. metal (h) (6) Have all equipment in passenger Each vehicle shall carry in the driver's and adequately secured. compartment safely compartment a lA:lOB:C fire extinguisher as a all doors, latches, and handles (7) Assure that proper working order. are in minimum. (i) The patient compartment shall provide a transport stretcher patients, (8) When used to minimum of 50 inches height, measured from the sheets shall be clean blankets, linen, or disposable finished floor to the finished ceiling. each patient. used for (2) N onemergency medical transportation patients, (9) When used to transport stretcher vehicles which are intended to be used for or are airtight storage compartments for soiled linen. have used for the transportation of persons on a stretcher Implemented 401.26, Specific Authority 401.35 FS. Law 2-5-80. 401.31, 401.35(1) FS. History-New shall be designed and equipped as follows: litter fasteners as a (a) Each vehicle shall have Vehicle Design. N onemergency 1 0 D -7 9 .03 means of latching and/or locking a stretcher positive vehicles shall not be required medical transportation to the vehicle. Crash-stable fasteners of the quick adhere to any vehicle design criteria except as to release adjustable type shall secure the litter to the side walls, where a single patient may be ~r and as cited in Chapter 316 and established herein floor 325 F.S. centered in the area on the wheeled litter, medical transportation (1) Nonemergency additional attachments (cups and locks) shall be vehicles which are intended to be used for or are provided. Attachments shall be near flush with individuals in used for the transportation of surrounding surface not in use. when (2) strap equipped as wheelchairs shall be designed and (b) At least two type restraining devices shall be provided per stretcher, cot and litter follows: or a lift (a) Each vehicle shall have a ramp to prevent longitudinal or transverse dislodgement operated electrically, hydraulically facility which is of the patient during transit. safely or mechanically, with sufficient capacity to ( c) Each vehicle shall have, in addition to the and smoothly lift passengers into the vehicle. rear-vision mirrors required by Chapter 316 F.S. 509

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72scan10D0657CHAPTER 10D-78 DISTRIBUTION ANTI-CONVULSANT DRUG 107 SuPP. No. RULES OF THE DEPARTMENT OF REHABILITATIVE SERVICES CHAPTER 10D-78 ANTI-CONVULSANT DRUG DISTRIBUTION (c) Having no applicable health insurance or of Anti-Convulsant Drugs 10D-78.01 Distribution Social Security Administration benefits. . 10D-78.02 Criteria for Eligibility (d) Having no private funds, such as saVings accounts, to defray the costs. Distribution of Anti-Convulsant 10D-78.01 (e) Having an annual gross income below the of Health and Rehabilitative Drugs. The Department following levels: Services shall provide anti-convulsant drugs to all procedures persons who qualify under guidelines and GROSS INCOME and as developed by the Department of Health Family Size Weekly Monthly Annual Rehabilitative Services, 1 $117.69 $ 510 $ 6,120 Specific Authority 20.05(5), 381.031(1)(a)(g)11 FS. Law 2 145.38 630 7,560 Chapter Implemented 20.05(5), 381.031(1)(a)(g)11 FS. 3 173.08 750 9,000 643A, Chapter 78-401, Section 1, 77-465, section 1, Item 4 200.00 870 10,440 Laws of Item 668, and Chapter 79-212, Section 1, Item 671, History-New 8-26-79. Florida. 5 228.46 990 11,880 6 233.77 1,013 12,156 10D-78.02 Criteria for Eligibility 7 238.85 1,035 12,420 following services who (1) Recipients- of the 8 244.15 1,053 12,696 are diagnosed as having epilepsy are automatically 9 249.23 1,058 12,960 eligible for program: 10 254.54 1,080 13,236 (a) Supplemental Security Income(SSI) 259.62 1,125 13,500 11Families with Dependent Children (b) Aid to 12 264.69 1,147 13,764 NOTE: For families of more than twelve (AFDC). Children's Medical Services (CMS). (c) members, add $366.40 to the gross annual income for (d) One-time, non-domiciled, emergencies. a family of twelve for each additional person. than the above meeting all of (2) Persons other Specific Authority 20.05(5), 381.031(1)(a)(g)11 FS; Law Implemented 20.05(5), 381.031(1)(a)(g)11 FS., Chapter the following cri teria are also eligi ble: 77-465 Section 1, Item 643A, Chapter 78-401, Section 1, Diagnosed as having epilepsy and requiring (a) Item 668 and Chapter 79-212,Section 1, Item 671, Laws of anti-convulsant drugs. Florida. History-New 8-26-79! Domiciled in Florida. (b) 507

72scan10D0656Supp. No. 124 PHYSICIANS IN STATE INSTITUTIONS LICENSURE OF lOD77 HAPTER ME _______ DATE ______ _ Unusual Expertise _____________ _ CILITY _____________ _ Length of Service Quality of Service _____________ _ TOTAL SCORE _________ _ ********** REQUIRED STANDARDS PREFERENCES in Months of service class ___________ _ COMMENT STATUS QUIRED STANDARDS ____________ _ Total months of service rk Performance Name of Position of Rater __________ _ ensure rida Eligibility Specific Authority 409.352 FS. Law Implemented 460.263 FS. History-New ency 19-80. SCORE LECTION STANDARDS 506

72scan10D0655LICENSURE OF PHYSICIANS IN STATE INSTITUTIONS CHAPTER 100.77 Supp. No. 124 RULES OF THE DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES HEALTH PROGRAM OFFICE CHAPTER 10D-77 LICENSURE OF PHYSICIANS IN STATE INSTITUTIONS (2) In determining selections for recommendation, Purpose IOD-77.01 the following criteria shall be considered: Definitions IOD-77.02 for Selection Standards (a) Professional educational qualifications IOD-77.03 (b) Formal Specialty Training Procedure for Selection IOD-77.04 for Institutional Practice Standard I. Internship and residency programs lOD-77.041 2. Specialty Board certification or eligibility Form for Reporting IOD-77.05 3. Unusual expertise or experience, and Purpose. The Department of Health and IOD-77.01 (c) Professional work experience within the past 10 Rehabilitative Service adopts the following rules for years to include: Where worked 1complying with Section 409.352, Florida Statutes, certain "exempt physicians" pertaining to employment of 2. Type of work performed State institution. at 3. Quality of work performed FS. History-New 409.352FS. Law Implemented 409.352Specific Authority History-New FS. 409.352FS. Law Implemented 409.352Specific Authority 122280. Amended 1980. 1222-80. Amended 19110. 10D-77.02 Definitions. As used in this part: 10D-77.04 Procedure for Selection. reviewed be All unlicensed physicians shall -1Boards (1) Appropriate Licensing Board -license empowered under Chapter 458, Florida Statutes to pursuant to this rule by an appropriate Credentials at the institution, comprised of not fewer than Committee State to practice medicine; under individuals in this 3 members who shall make recommendations, by Chapter 459 Florida Statutes to practice osteopathic physician priority for exemption, to the Administrator of Statutes to medicine; and, under Chapter 460 Florida practice chiropractic medicine. the facility. The Credentials Committee shall maintain a its priority listing detailed record of review to support a graduate unlicensed (2) Exempt Physician -physician who: has been certified by the appropriate (a) recommendations. -2The administrator shall make his licensing board as being eligible for admission to (b) has been recommended by examination in this State; recommendations to the District Administrator. Should Secretary of HRS for employment under the 10 the the facility administrator make changes to the priority authorization; and, (c) has otherwise percent statutory listing submitted by the Credentials Committee, he shall been determined fully qualified to practice hislher healing the District Administrator a detailed rationale provide to the direct art in a singular State institution under this rationale for for such change in priority. A copy of supervision of a licensed physician. change in priority shall accompany the District state owned and operated (3) Institution - A Administrator's recommendations to the Department. part of a (3) The District Administrator shall submit hislber medical care facility, either free standing or a larger facility, which provides in-patient care on a 24-hour recommendations to the Assistant Secretary for or longer basis. Operations, Tallahassee. Should the District arts as (4) Physician - A practitioner of a healing Administrator make changes to the priority listing shall helshe defined by submitted by the facility administrator, Chapter 458, 459, or 460 of Florida Statutes. of the number of (5) 10 percent - A 1/lOth part the Department a detailed rationale for such provide to by an institution; or in those physicians employed change in priority. institutions employing less than 10 physicians, the (4) The Secretary of HRS shall make to the percent of 5-9 physician nearest whole number (Le. 10 appropriate board final recommendations on physicians to employees is one). institutions with less than five In selected for employment in an exempt status. be FS. History-New 409.352FS. Law Implemented 409.352Specific Authority must be licensed. physicians, all 122280. Amended HI80. Unusual Expertise - A medical speciality of (6) specific defined value the institution. to 10D-77.041 Standard for Institutional Practice. FS. History-New 409.352FS. Law Implemented 409.352Specific Authority (1) Each unlicensed (exempted) physician employed 122280. Amended 1980. by the Department of HRS shall work under the direct supervision of a physician licensed in the Standards for Selection. 10D-77.03 State. FS. History-New 409.352FS. Law Implemented 409.352Specific Authority The Secretary of HRS shall make his final -1122280. status to the recommendations for exempt physician pursuant to Section 409.352 appropriate licensing board IOD-77.05 Form for Reporting. has Florida Statutes only after the following standard PHYSICIAN SELECTION been met: (a) The physician must be certified to the Eligibility for Continuing Employment as Department of HRS by the appropriate licensing board Without a Professional License eligible for admission to examination in this State. 505

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72scan10D0653CHAPTER IOD76 INFANT SCREENING No. 109Supp. Appendix C Institutional Report INFANT SCREENING PROGRAM FOR PHENYLKETONURIA MAPLE SYRUP URINE DISEASE HYPOTHYROIDISM GALACTOSEMIA Name of Laboratory __________________________________________________________ _ ~~--~--~~~~--~------~~~--------~~--~--------~~~----__ Address (Street or P.O. Box) (City) (State) (Zip) Date of Report ______________________ __ Period Covered Number of Live Births reported by facility during this period Number of newborns for whom kit was submitted for initial screening *Number of newborns who were referred to an appropriate facility for screening Number of newborns for whom kit was submitted for retest Specimens were submitted to: State Laboratory Other Laboratories (specify) Signed: Title of person submitting report) & (Name return to: Please of Florida State HRS/PDHEH Health Family Winewood Boulevard 1317 32301 Tallahassee, Florida *If your facility has no mechanism for collecting specimens, the person in attendance at birth is responsible for referring the infant to an appropriate facility for screening. 504C

72scan10D0652109SuPP. No. . INFANT SCREENING TER 10D-76 APPENDIX B LABOR