Agency for Health Care Administration

Transcription

1 Page 1 of 69 ST - O Initial Observations Title Initial Observations Statute or Rule Type Memo Tag These guidelines are meant solely to provide guidance to surveyors in the survey process. ST - O Licensure Title Licensure Statute or Rule ;(1-4) FS; 59A-002(1) FAC , F.S. (1) Any person or entity that holds itself out to the public as providing home medical equipment and services or accepts physician orders for home medical equipment and services is subject to licensure under this part. (2) Any person or entity that holds itself out to the public as providing home medical equipment that typically requires home medical services is subject to licensure under this part. (3) The requirements of part II of chapter 408 apply to the provision of services that require licensure pursuant to this part and part II of chapter 408 and to entities licensed by or applying for such licensure from the agency pursuant to this part. A license issued by the agency is required in order to provide home medical equipment and services in this state. (4) A separate license is required of all home medical equipment providers operating on separate premises, even if the providers are operated under the same management. Some providers are exempt from HME licensure as referenced in (5), which is pasted below, if they hold another state license and run their home medical equipment business from that same licensed location. However some providers, that own a HHA for example, may operate a HME under the same corporation management; have a different business name for the HME business and choose to obtain a separate HME license because they want to operate the HME business as a separate entity (5), F.S., The following are exempt from home medical equipment provider licensure, unless they have a separate company, corporation, or division that is in the business of providing home medical equipment and services for sale or rent to consumers at their regular or temporary place of residence pursuant to the provisions of this part: (a) Providers operated by the Department of Health or Federal Government. (b) Nursing homes licensed under part II. (c) Assisted living facilities licensed under chapter 429, when serving their residents. (d) Home health agencies licensed under part III. (e) Hospices licensed under part IV. (f) Intermediate care facilities, homes for special services, and transitional living facilities licensed under part V. (g) Hospitals and ambulatory surgical centers licensed under chapter 395. (h) Manufacturers and wholesale distributors when not selling directly to consumers.

2 Page 2 of 69 59A (1), Florida Administrative Code (F.A.C.) Home medical equipment locations requiring a license are any locations that sell, rent, or distribute, or offer to sell or rent to or for a consumer any home medical equipment that requires services. These locations can be identified as follows: (a) Any location providing or distributing home medical equipment requiring services to consumers in Florida; (b) Any location where an intake person takes calls from consumers in Florida and offers to sell or rent home medical equipment requiring services; (c) Any location where a consumer in Florida may call in response to a provider advertising to sell or rent home medical equipment requiring services,; e.g., television advertisements, toll-free telephone numbers, phone books, newspapers, flyers or any other forms of public advertisement;. (d) Any location out of state that offers to sell or rent home medical equipment requiring services to consumers in Florida; (e) Any location in state or out of state, with sales representatives working in Florida, that offers to sell or rent home medical equipment requiring services to consumers in Florida, i.e., the sales representatives themselves do not need to be licensed; and (f) Any buildings, that are not located at the licensed central service center address, called shops, warehouses, distribution centers, or called by any other name, are required to have a license if that site location provides selection (via telephone, showroom or sales representative), delivery, set up, consumer instruction or maintenance of equipment to consumers in Florida. 1. A central service centers must provide the names and locations of all of its designated distribution centers on the licensure application. 2. A distribution centers must submit a separate licensure application and must specify the name of its central service (i) Licensed health care practitioners who utilize home medical equipment in the course of their practice, but do not sell or rent home medical equipment to their patients. (j) Pharmacies licensed under chapter A (2), F.S., Home medical equipment locations that do not require a license: Diabetic monitors and disposable supplies, e.g., diabetic, ostomy, urological and wound care supplies have been identified as equipment and supplies that do not require services as defined in Section (9), F.S.; therefore, locations that supply these items only will not require a HME license. See below for probes that may be used to determine if the person or entity is holding itself out to the public as selling or renting home medical equipment to consumers in Florida. What is the purpose of this business location? Does this location distribute home medical equipment to the surrounding community if based in Florida or near the Florida state line? Does this location take calls from Florida consumers and offer to sell or rent home medical equipment? Does this location advertise to sell or rent home medical equipment requiring services to Florida consumers from this location? Refer to the definition of home medical equipment above, the definition of ' life-supporting or life-sustaining equipment ' at (10), F.S. and 59A (2), F.A.C., for examples of home medical equipment. Does this location provide selection, (via telephone, showroom, storefront or sales representative), delivery, set up, consumer instruction and/or maintenance to Florida consumers? Do any brochures, stationery, insurance documents, accrediting documents, etc. list other locations that may need a license? Note: If the surveyor has questions as to whether a business should be licensed, call the Home Care Unit and discuss with HME staff.

3 Page 3 of 69 center on the application. 3. Each licensed distribution center is required to meet all standards for licensure but may be determined to meet the standards through the activities of its designated central service center as referenced in paragraph 59A (1)(b), F.A.C. ST - O Definitions Title Definitions Statute or Rule FS; 59A FAC Type Memo Tag Definitions.-As used in this part, the term: (1) " Accrediting organization " means an organization whose standards incorporate licensure regulations required by this state. (2) " Agency " means the Agency for Health Care Administration. (3) " Consumer " or " patient " means any person who uses home medical equipment in his or her place of residence. (4) " Department " means the Department of Children and Families. (5) " General manager " means the individual who has the general administrative charge of the premises of a licensed home medical equipment provider. (6) " Home medical equipment " includes any product as defined by the Federal Drug Administration ' s Drugs, Devices and Cosmetics Act, any products reimbursed under the Medicare Part B Durable Medical Equipment benefits, or any products reimbursed under the Florida Medicaid durable medical equipment program. Home medical equipment includes oxygen and related respiratory equipment; manual, motorized, or customized wheelchairs and related seating and positioning, but does not include prosthetics or orthotics or

4 Page 4 of 69 any splints, braces, or aids custom fabricated by a licensed health care practitioner; motorized scooters; personal transfer systems; and specialty beds, for use by a person with a medical need. (7) " Home medical equipment provider " means any person or entity that sells or rents or offers to sell or rent to or for a consumer: (a) Any home medical equipment and services; or (b) Home medical equipment that requires any home medical equipment services. (8) " Home medical equipment provider personnel " means persons who are employed by or under contract with a home medical equipment provider. (9) " Home medical equipment services " means equipment management and consumer instruction, including selection, delivery, setup, and maintenance of equipment, and other related services for the use of home medical equipment in the consumer ' s regular or temporary place of residence. (10) " Life-supporting or life-sustaining equipment " means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life. Life-supporting or life-sustaining equipment includes apnea monitors, enteral feeding pumps, infusion pumps, portable home dialysis equipment, and ventilator equipment and supplies for all related equipment, including oxygen equipment and related respiratory equipment. (11) " Moratorium " means a mandated temporary cessation or suspension of the sale, rental, or offering of equipment after the imposition of the moratorium, in accordance with part II of chapter 408. Services related to equipment sold or rented prior to the moratorium must be continued without interruption, unless determined otherwise by the agency. (12) " Premises " means those buildings and equipment which are located at the address of the licensed home medical

5 Page 5 of 69 equipment provider for the provision of home medical equipment services, which are in such reasonable proximity as to appear to the public to be a single provider location, and which comply with zoning ordinances. (13) " Residence " means the consumer ' s home or place of residence, which may include nursing homes, assisted living facilities, transitional living facilities, adult family-care homes, or other congregate residential facilities. 59A Definitions. In addition to definitions contained in Chapter 400, Part VII and Chapter 408, Part II, F.S., the following terms shall apply to this rule chapter: (1) " AHCA " means Agency for Health Care Administration. (2) " Central Service Center " means the licensed premises that are in charge of taking consumer orders, dispatching the orders to licensed distribution centers owned and operated by the same licensee that provide home medical equipment services, and maintaining consumer and personnel records. The central service center is responsible for the operation of its designated distribution centers. (3) "Distribution centers" means those licensed premises that are not located at the address of the central service center but are owned and operated by the same licensee, receive orders from the central service center and are utilized to provide home medical equipment services. (4) HME means home medical equipment. ST - O Change of General Manager Title Change of General Manager Statute or Rule (4)

6 Page 6 of 69 When a change of the general manager of a home medical equipment provider occurs, the licensee must notify the agency of the change within 45 days. Verify that the general manager at the location is the same as the person listed on the most recent application or that the provider has notified the Home Care Unit of the change. Note: If the general manager has changed since the last notification to the Home Care Unit, the surveyor must inform the Home Care Unit as soon as possible. The Home Care Unit will require the provider to attest to the new general manager's qualifications and provide proof of level 2-background screening. Refer to Tag O-0023 for qualifications of general manager. CROSS REFERENCE tag O-0062 Emergency management plan - ANNUAL UPDATE ST - O Insurance Title Insurance Statute or Rule (3); (7); 59A (5) (3), F.S. As specified in part II of chapter 408, the home medical equipment provider must also obtain and maintain professional and commercial liability insurance. Proof of liability insurance, as defined in s , must be submitted with the application. The agency shall set the required amounts of liability insurance by rule, but the required amount must not be less than $250,000 per claim. In the case of contracted services, it is required that the contractor have liability insurance not less than $250,000 per claim. Ask for a copy of the provider's insurance policy. Make sure both professional and commercial coverage has been obtained and that the coverage is current. Check to see that the address of the licensed location is listed on the policy or is listed as an addendum to the policy showing their multiple locations. (Professional liability is liability exposure due to procedures or services, such as consumer instruction and management. Commercial is liability due to bodily injury caused by product failure.) (7), F.S. If proof of insurance is required by the authorizing statute, that insurance must be in compliance with chapter 624, chapter 626, chapter 627, or chapter 628 and with agency rules.

7 Page 7 of 69 59A (5), F.A.C.... A corporation can provide a blanket policy, which indicates that each of its licensed locations is insured under one policy, verifying not less than $250,000 per claim for each location. ST - O Contracts Title Contracts Statute or Rule (1)(c) FS; 59A (5) , F.S. (1)(c) A listing of those with whom the applicant contracts, both the providers the applicant uses to provide equipment or services to its consumers and the providers for whom the applicant provides services or equipment. 59A (5), F.A.C. Contracts: Services provided by contract for consumers must be through a written agreement between the provider and the business providing any equipment and services for a consumer, herein referred to as the contractor. Contracts must be retained for a minimum of 5 years. The contract must include the following at a minimum: (a) A description of any of the equipment or services to be provided by the contractor; (b) Designation if the HME provider or the contractor is responsible for monitoring the equipment and services provided by the contractor; (c) Charges for any contracted equipment and services and designation of who will be billing the consumer, the HME provider or the contractor; (d) Responsibility of the HME provider to retain and maintain all records of consumers served by a contractor; -Determine if the provider is in a contractual relationship with any other persons or entities, either as a supplier or recipient of equipment and/or services. If so, -Review each contract for language regarding the specific equipment and or services being provided such as type of equipment and type of services (delivery, setup, consumer education, clinical staff, etc.); and -Check to see if the contract includes the requirements listed in 59A (5), F.A.C.; and Ask what is expected of the contractor with specific regard to services provided. cross reference tag O-0005 Insurance Note: A HME provider sells or rents directly to a consumer; a true contractor would not bill a consumer. Equipment provided and/or services rendered by a contractor would be reimbursed by the HME provider and then HME provider bill the consumer. If a HME provider claims to have a contract and the contractor is selling or renting equipment directly to a consumer; then the person or entity referred to as the ' contractor ' needs a separate HME license. If the person or entity does not possess a HME provider license, then a referral for unlicensed activity must be made. CROSS REFERENCE TAG O-0001 LICENSE AND O-Z827 UNLICENSED ACTIVITY A contract is not required when a business does maintenance or repair only directly for a licensed HME provider. For example, a maintenance company that maintains equipment at its place of business and then returns the equipment to the HME provider rather than directly to the consumer.

8 Page 8 of 69 (e) Evidence that the contractor has professional and commercial liability insurance coverage (the licensee is responsible for making sure that the contractor has liability insurance); (f) Period of the contract between the HME provider and the contractor; (g) Procedures for reporting service and maintenance notes and any clinical or progress notes by the contractor to the HME provider; (h) Date and signatures of all parties;, and (i) Contracts must be retained for a minimum of five years. Note: Providers that supply dialysis equipment to patients that receive home dialysis have an agreement with an End Stage Renal Disease (ESRD) back-up facility (the agreement is not technically called a contract but is referred to as a negotiated agreement). The important point is that all HME providers of home dialysis equipment must have an agreement with an ESRD that is serving as a backup to the patients receiving home dialysis treatment. The ESRD is responsible for monitoring the work of the HME provider and the health outcome of the patient. See tag O for more probes regarding equipment service for home dialysis equipment. The surveyor must verify an agreement is in place between the HME provider and the ESRD facility. ST - O Inventory Title Inventory Statute or Rule (2); (1)(a); 59A (1) , F.S. As a requirement of licensure, home medical equipment providers shall: (2) Provide at least one category of equipment directly, filling orders from its own inventory (1)(a), F.S.... Categories of equipment include: 1. Respiratory modalities. 2. Ambulation aids. 3. Mobility aids. 4. Sickroom setup. 5. Disposables. 59A (1)(c), F.A.C. (c) All providers must have available, at the time of survey, at least one category of equipment that is provided directly, Determine which category of equipment is provided directly (providing directly means ordering the equipment from a manufacturer and supplying the equipment directly to the consumer in the home). If there is a question as to whether one category of equipment is provided directly, ask the general manager to produce invoices that show equipment was ordered from a manufacturer rather than provided via a contract. Here are some examples to show the types of equipment in each category: -RESPIRATORY MODALITIES - positive airway pressure machines, apnea monitors, oxygen & related respiratory equipment, ventilator equipment -AMBULATION AIDS - walkers, walking canes, crutches -MOBILITY AIDS- motorized scooters, wheelchairs, passive motion devices, electrostimulation equipment -SICKROOM SETUP - hospital beds, lifts, suction machines, phototherapy lights, pressure ulcer care equipment, enteral feeding pumps, infusion pumps, portable home dialysis equipment, trapeze equipment

9 Page 9 of 69 filling orders from its own inventory as referenced in Section (2), F.S. Failure to have, at the time of survey, at least one category of equipment that is provided directly will result in the provider ' s application being denied or the provider ' s license being revoked. A licensed central service center may be determined to meet this standard through the inventory available at its designated distribution center. -DISPOSABLE SUPPLIES - diabetic, ostomy, urological, wound care Note: Look for evidence that equipment is provided directly such as the specific inventory itself and recent records showing orders and invoices from manufacturers and/or proof of shipment or delivery of the same product to consumers. If the provider makes custom equipment, look for tools. At least one CATEGORY of equipment must be available on the premises at the time of survey. If it is not, then denial of the application or revocation of the provider ' s license is required. There can be no plan of correction and no follow-up visit. ST - O Business Identification Title Business Identification Statute or Rule 59A (1)(a), F.A.C. Minimum standards: Each home medical equipment provider must: (a) Have a visible sign with the name of the business, business hours, and a phone number where the business can be contacted during business hours. Look for a sign, visible to the public at the location, which includes the required business information. ST - O Hours of Operation Title Hours of Operation Statute or Rule (6) FS; (7)(d) FS (6), F.S. Ensure that patients are made aware of service hours and emergency service procedures. Are the hours of operation the same as those posted on the sign as observed under Tag O-0009 and as listed on the application? How does the provider inform consumers of the service hours? If the general manager is not on the premises, ask a staff person to contact them to let them know that the Agency is

10 Page 10 of (7)(d), F.S. If a provider is not available when an inspection is attempted, the application shall be denied. on site and the survey process has started, obtain information from office personnel and interview other staff present to complete as many items as possible. If the general manager never appears during the survey and you are unable to satisfactorily complete the survey, you can either cite those areas you are unable to review or you can indicate that the survey was discontinued and a determination was unable to be made. If the provider is not open during the hours listed on the current application, the field office should recommend denial of the application to the Home Care Unit. Contact the Unit if you are unsure of the hours of operation. ST - O Safety & Infection Control Title Safety & Infection Control Statute or Rule 59A (1)(i), F.A.C. Be able to demonstrate the safety and infection control measures that follow: 1. Procedures that identify safety precautions to be followed in the handling and use of each type of equipment and its related supplies; 2. Equipment is routinely inspected for safety and stability prior to delivery; 3. The electrical adequacy and safety of a home is assessed prior to placing any electrical or electronic equipment, and instructions are provided to consumers regarding applicable precautions and safety measures; 4. Compliance with bedding and mattress reuse regulations; 5. Specific cleaning or sanitizing requirements between usage for each type of equipment according to the manufacturers ' guidelines; 6. Storage of unclean equipment separate from clean equipment; 7. Transportation of unclean equipment separate from clean equipment; 8. Storage of equipment to prevent dust accumulation, water damage, and vermin contact; and Ask the general manager to describe the measures taken to meet these requirements including: The process for inspecting equipment for functionality, intactness and accuracy prior to use; Instruction given to employees and consumers regarding safety precautions related to equipment and services; and Policies and procedures related to infection control and manner of storing equipment when clean and unclean. Examples of positive responses from the provider may be: The provider can describe and show that clean equipment is stored and transported separately from unclean. Delivery personnel evaluate electrical adequacy and document that the consumer is informed of any problems before placing electrical or electronic equipment in consumer ' s place of residence. The best documentation procedure would be to have a customer sign a statement informing them of any electrical safety issues; The provider can describe and show examples of documentation of equipment maintenance and installation (if necessary) in accordance with the manufacturer ' s guidelines. Delivery personnel clean rental mattresses for bedding curbside before placing it with clean equipment for travel. Used bedding is cleaned with a germicidal agent before being rented to another consumer. The provider can describe and show that storage areas are clean, safe and have adequate temperature control.

11 Page 11 of Equipment is safely maintained and installed based upon the manufacturers ' instructions. ST - O Periodic Follow-up Title Periodic Follow-up Statute or Rule (7-8), F.S. As a requirement of licensure, home medical equipment providers shall: (7) At the time of the initial delivery, set up an appropriate followup home medical equipment service schedule as needed for such times as, but not limited to, periodic maintenance, supply delivery, and other related activities. (8) Arrange for emergency service after normal business hours; provide refresher and review training for appropriate personnel; establish a system for resolution of complaints and service problems; and provide for timely replacement or delivery of disposable or consumable equipment supplies. Ask the provider to identify any rental or purchased equipment with a service contract that needs additional supplies delivered to the consumer after initial set up such as disposable, consumable and/or perishable supplies (for example, batteries). How is a schedule for replenishing these items determined? What system is used to ensure supplies are replenished timely? Examples of positive responses from the provider may be: Upon initial delivery, personnel determine the need for follow-up. If ongoing supplies and/or maintenance are necessary, the next date for delivery or servicing is established. The provider sends personnel to deliver new supplies or perform maintenance on time. Note: Periodic follow-up for home dialysis equipment is necessary and all of the probes above for equipment in general would apply. The provider is responsible for the equipment maintenance; however, an End Stage Renal Disease (ESRD) back-up facility would be responsible for patient health care outcome and would monitor the equipment provider with which they have an agreement. The patient should be instructed to rely upon the ESRD for any necessary backup service due to a power outage. Typically, home medical equipment providers are contracted by a manufacturer to provide equipment for peritoneal dialysis treatment and the patient is instructed to call the manufacturer directly when the equipment malfunctions; replacement equipment is shipped by the manufacturer directly to the patient ' s home. When contacting consumers during survey, ask what happens if a machine/cycler breaks down. Determine if the patient is pleased with the services received. If a valid complaint is received regarding equipment maintenance, follow up with a POC directed at the home medical equipment provider selling or renting directly to the patient; the provider is responsible for any equipment provided via a contract with a manufacturer; i.e., the provider is held accountable for contracted services provided by a manufacturer.

12 Page 12 of 69 If the patient has a complaint regarding the ESRD, refer the complaint to the appropriate ESRD surveyor team to investigate. ST - O Servicing Equipment Title Servicing Equipment Statute or Rule (11) FS; 59A (1)(e) & (3) , F.S. (11) Maintain and repair directly, or through a service contract with another company, items rented to consumers. 59A (1)(e), F.A.C. Be ultimately responsible for the management of all equipment and services even if a contractor is involved. 59A (3), F.A.C. Minimum service standards required for equipment are as follows: (a) Services for all home medical equipment must be based upon the current recommended manufacturers ' standards. (b) The provider must prioritize consumer service needs based upon the urgency of the situation. Any equipment utilized to provide a therapy treatment, as prescribed by the consumer ' s physician, shall require urgent attention. Also, any equipment in general that is completely non-functional shall be serviced with urgency. Any equipment that is functional, but needs minor repair may be serviced in a less urgent time frame. All service requests must be responded to in a timely manner that satisfies the consumer ' s needs. (d) Services may be provided for non-life supporting or life-sustaining equipment during regular business hours. Requests for consumer instruction or any needed repair shall be responded to by telephone within the same working day. Ask for a copy of the manufacturers ' standards/guidelines for each type of equipment sold by the HME that is serviced. If they provide many different types of equipment that require service, select a sample of a few types of equipment to review. On subsequent surveys sample other equipment. Review manufacturer standards because they may vary. Compare the manufacturer standards to the provider's maintenance logs and verbal demonstration explaining maintenance to determine if manufacturer recommendations are being followed. Check samples of consumer ' s records or equipment maintenance logs to make sure that equipment is being serviced, maintained, or cleaned according to the manufacturers' recommendations. Ask the provider how they handle consumer calls regarding equipment that may require repair or maintenance. Do they have a system for prioritizing calls? Do they have a timeframe they set for themselves to repair or replace equipment? Do they repair equipment, do they contract out repair? Under what circumstances will they replace equipment? Do they meet the requirements in 59A (3)(b)(d)? Note: If equipment maintenance is a contracted service the provider should be responsible for monitoring of the contractor with regard to maintenance services. If any contractor supplying equipment is not maintaining the equipment according to manufacturer's guidelines, the provider selling or renting directly to the consumer should be held accountable for any necessary POC. Providers typically keep maintenance logs by utilizing serial numbers on the equipment to identify the specific piece of equipment and dates any maintenance has been performed. Purchased equipment is covered via a manufacturer ' s warranty and the provider should honor all warranties. Some providers may offer service contracts between themselves and the consumer for purchased equipment.

13 Page 13 of 69 The consumer may bring to the provider's place of business any small equipment item requiring consumer instruction or repair. ST - O hour & Emergency Service Provision Title 24-hour & Emergency Service Provision Statute or Rule (6 & 8) FS; 59A-003(3)(c) FAC , F.S. As a requirement of licensure, home medical equipment providers shall: (6) Ensure that patients are made aware of service hours and emergency service procedures. (8) Arrange for emergency service after normal business hours... 59A (3)(c), F.A.C. Service must be provided for life-supporting or life-sustaining equipment 24 hours, 7 days per week. Emergency service requests, as referenced in Section (8), F.S., must be responded to with a telephone call, within 30 minutes and back up service provided at the consumer ' s home within two hours or less due to equipment failure or power outages. Providers must offer assistance regarding registration with emergency management services for consumers who use life-supporting or life-sustaining equipment.? How do they meet the emergency needs of any consumers who live further than 2 hours away? (best response: through contract) Ask the general manager to describe the emergency process e.g. how does the consumer contact the business after hours? What response does the consumer hear when contacting the after hours number? In what time frame will the business respond to the call? Note: Providers must have emergency services after normal business hours if they supply equipment that typically requires emergency services. Equipment that typically would require emergency services is listed in the definition above and would also include suctioning equipment per 59A (2)(a), F.A.C.. In the case of home dialysis, the provider should coordinate emergency dialysis equipment services with the consumer and the ESRD back-up facility.

14 Page 14 of 69 ST - O General Manager Title General Manager Statute or Rule (4&8&10); 59A , F.S. As a requirement of licensure, home medical equipment providers shall: (4) Maintain trained personnel to coordinate order fulfillment and schedule timely equipment and service delivery. (8)...provide refresher and review training for appropriate personnel... (10) Answer any questions or complaints a consumer has about an item or the use of an item that the consumer purchases or rents. 59A (1), F.A.C. General Manager, as defined in Section (7), F.S.: (a) Qualifications: A minimum of two years experience in business management or a college degree in business or a health care related field can substitute for the required experience year for year. (b) Duties: The general manager is responsible for the following areas either directly or by clear delegation in writing: 1. Assuring the maintenance of consumer records including equipment repair and maintenance records as referenced in Section , F.S.; 2. Maintain job descriptions of staff; 3. Assuring trained and qualified staff essential to the services provided as referenced in Sections (4), (5), (15), F.S.; 4. Keeping program personnel up to date with health care information and practices; Ask the general manager to describe: all the duties and responsibilities of the job (These must be listed in a written job description and include all duties as required in rule. The areas of direct responsibility of the general manager and/or clear delegation to other specific employee positions must be documented and available for review at time of survey.); training given to delivery personnel (Who trains them? What are they trained to do?); training given to intake personnel (Who trains them? What are they trained to do?); any employee refresher training such as training given by the provider or training offered by a manufacturer of products sold; the coordination of order fulfillment and equipment service delivery; how equipment and services are provided appropriately and timely (Who assures this?); and how the business respond to questions and/or complaints a consumer has about an item or the use of an item.

15 Page 15 of Directing staff in performance of their duties; 6. Assuring that staff can accommodate consumer ' s language; 7. Assuring an adequate inventory of equipment and supplies to provide consumers currently being served; 8. Assuring that policies are developed and implemented as required in state law and rule; 9. Maintaining and updating procedure manuals related to business functions; 10. Maintain customer service complaint records containing the specifics related to the complaint and how the complaint was resolved as referenced in Sections (8) and (10), F.S.; 11. Evaluating services, and personnel; 12. Establishing and maintaining effective channels of communication; 13. Maintaining training manuals and records verifying all training that personnel has received or is scheduled to receive thus assuring staff development including orientation, in-service education, and continuing education; 14. Assuring adequate staff supervision during all service hours. ST - O Delivery Personnel Title Delivery Personnel Statute or Rule (5-6&8); 59A (1)(c&h) & , F.S. As a requirement of licensure, home medical equipment providers shall: (5) As necessary in relation to the sophistication of the equipment and services being provided, ensure that delivery personnel are appropriately trained to conduct an environment and equipment compatibility assessment; appropriately and Ask for a driver's license from delivery personnel. Ask what kind of vehicle is used to deliver the equipment. The license must be appropriate for the vehicle being driven. [A regular operators license is needed if the vehicle weight is between 2,000-8,000 lbs.; A class " C " (Chauffeurs) license is needed if carrying hazardous material e.g. oxygen; class " D " license is required for a vehicle over 8,000 lbs. but less than 26,000 lbs.]; Ask delivery personnel if they are able to effectively communicate any instructions, invoices or any paperwork given to the consumer.

16 Page 16 of 69 safely set up the equipment; instruct patients and caregivers in the safe operation and client maintenance of the equipment; and recognize when additional education or followup patient compliance monitoring is appropriate. (6) Ensure that patients are made aware of service hours and emergency service procedures. (8)... provide for timely replacement or delivery of disposable or consumable equipment supplies. 59A (1), F.A.C. Each home medical equipment provider must: (c) Provide management and consumer instruction regarding the use of home medical equipment requiring services, as referenced in Section (11), F.S. Delivery services include transportation of equipment and supplies to and from consumer homes, equipment setup, and record keeping. (h) Provide the consumer with user instructions as required in Section (13), F.S. 59A (3), F.A.C. Delivery personnel: (a) Qualifications: A driver ' s license as required by law for the vehicle being driven and the physical capacity to handle the equipment assigned. Delivery persons must be able to accommodate the consumer ' s language and have the ability to work without continuous direct supervision. (b) Training: Delivery and equipment service staff shall have successfully completed a documented training program covering all components of their assigned jobs including training for each type of equipment they are responsible for delivering. (c) Duties: Delivery personnel are responsible for providing safe and clean transport of equipment and supplies to and from consumer homes, setting up equipment safely, and record keeping of the equipment delivered. They must provide in Ask if they have ever received any initial or refresher training provided via the manufacturer or any on the job training in relation to the equipment they deliver and set up; Ask them to describe how they set up equipment; Ask how they keep a record of equipment delivered or set up; Ask them to show you what they leave with the consumer that provides the consumer with a phone number for the HME provider and a phone number to use in case of an emergency; Ask what they inspect to determine environmental compatibility; e.g., equipment that requires electricity requires grounded outlets; (they would need a ground meter sensor to plug in the outlet to check this); Ask what instructions are given to the consumer verbally and in writing regarding how the equipment functions safely; Ask what instructions are given regarding how to contact the provider during regular business hours or after hours if emergency service is necessary (providers may not offer emergency services if they do not supply equipment that requires emergency services (see tag O-0017); Ask what verbal communication takes place between the delivery person and the consumer regarding any future services to be done in the home setting, e.g., how often will the provider need to return to the home to monitor the equipment? Ask if they have consumers that speak different languages, e.g., Spanish, English, and if so can they communicate instructions to consumers verbally and do they provide any necessary written instructions in the specific language of the consumer. Documentation of training provided to delivery personnel must be identified in the employee ' s personnel file to avoid a citation. Note: Some rental equipment will need service on a regularly scheduled basis such as life-supporting or life-sustaining equipment, e.g., infusion and oxygen therapy. Rental equipment such as hospital beds and wheelchairs will not need service on a set scheduled basis.

17 Page 17 of 69 writing to the consumer a telephone number for use during business hours and an emergency number for after business hours when life supporting or life sustaining equipment is provided. ST - O Intake Coordinator Title Intake Coordinator Statute or Rule (15) F.S. (15)(a) Designate appropriate staff as intake coordinators, and ensure that order intake personnel are appropriately trained in the types of equipment and products, commonly occurring medical conditions, service procedures, third-party billing, and insurance requirements and coverage. (b) Train intake coordinators in a basic understanding of the following areas: dealing with patient and caregiver needs; other, nonhome medical equipment provider services as they relate to home medical equipment services and home care patient crisis management. Ask the intake person to describe: What training they receive upon initial orientation; What equipment products the business sells and what services are offered with the products (if they are able to explain this to you they should also be able to share this information with a consumer). What response do they give to the consumer who calls to report what they believe to be a patient crisis, e.g., do they ask the consumer specific questions to determine if the crisis is something the HME provider can assist with or perhaps determine that it is a serious enough crisis to have the patient call 911. Note: Some providers may not use the term " intake coordinator " ; the responsibilities are required regardless of the job title used. ST - O Licensed Health Care Professionals Title Licensed Health Care Professionals Statute or Rule 59A (2), F.A.C. Licensed health care professionals, such as respiratory therapists, certified respiratory therapy technicians, registered nurses, and licensed practical nurses that may be on staff or contracted with as needed for service provision: Ask the general manager if they have any licensed health care professionals working for the home medical equipment business. If they do, ask to see a copy of their professional license to make sure it is current; Ask to see a copy of the job description of any licensed health care professional to see that it describes their required

18 Page 18 of 69 (a) Qualifications: Current professional license(s). (b) Training: Clinical staff must have required experience or training relative to the specific service they are providing. (c) Duties: Provider policies must clearly identify that the respective duties of each type of clinical professional worker are within the scope of the described clinical responsibilities. duties and that the duties are within the scope of their practice act to perform; and Ask to see if the licensed health care professional has had any additional training or education related to their responsibilities working with the home medical equipment provider. ST - O Maintenance Personnel Title Maintenance Personnel Statute or Rule 59A (4), F.A.C. 59A (4), F.A.C. Maintenance personnel: (a) Qualifications: The ability to maintain and coordinate the repair of all equipment and to work without continuous direct supervision. (b) Training: Attend any training required by the manufacturer regarding equipment maintenance. (c) Duties: Coordinate maintenance of equipment, complete and sign maintenance logs that verify equipment has been maintained and repaired as required by manufacturer standards. Ask maintenance personnel to demonstrate that they meet qualifications by asking them to describe: How he/she maintains and coordinates repair of equipment; Any required manufacturer training or on the job training provided in relation to any equipment maintained, e.g., establishment and coordination of records of maintenance or repairs; Is there a maintenance log identifying equipment that goes into the home that requires maintenance due to any rental agreement or any maintenance contract for purchased equipment? Ask to see these logs to verify that personnel have maintained equipment as directed by the manufacturer. Note: Maintenance logs are generally kept by using the serial number on the equipment. ST - O Filing for Third Party Payment Title Filing for Third Party Payment Statute or Rule (17), F.S. Upon request by the consumer or as otherwise required by How do they handle questions and concerns from the consumer regarding filing insurance or what steps are taken to

19 Page 19 of 69 state law and rules, or federal law and regulations, assist consumers with meeting the necessary filing requirements to obtain third-party payment to which a consumer may be entitled. file third party payment? ST - O Resolution of Complaints Title Resolution of Complaints Statute or Rule (8), F.S. As a requirement of licensure, home medical equipment providers shall: (8)... establish a system for resolution of complaints and service problems... Ask the general manager or other staff person in charge: In the event a consumer is not satisfied with the resolution offered by an employee, are they given the option of talking to the general manager? How are complaints regarding the equipment and services handled, e.g., malfunctioning, unclean, non-usable? Will the equipment be repaired or replaced as soon as reasonably possible? Is the consumer notified of when the equipment will be replaced or repaired? How does the provider handle complaints from consumers about HME personnel? Do they interview the staff member? Will the consumer receive a follow up call to settle the complaint? If an error in billing is found will the account be audited will the billing be adjusted? Will the consumer receive an explanation of all charges and payments posted? How are delivery service complaints handled? Is the source of the complaint investigated and the issue settled with the consumer? Note: Providers may use other terms to refer to complaints such as "Incident Reports" or "Opportunities for Improvement."

20 Page 20 of 69 ST - O Personnel Records Title Personnel Records Statute or Rule (16); 59A (1)(b) , F.S., As a requirement of licensure, home medical equipment providers shall: (16) Establish procedures for maintaining a record of the employment history, including background screening as required by ss and (1) and chapter 435 of all home medical equipment provider personnel. A home medical equipment provider must require its personnel to submit an employment history to the home medical equipment provider and must verify the employment history for at least the previous 5 years, unless through diligent efforts such verification is not possible. There is no monetary liability on the part of, and no cause of action for damages arising against a former employer, a prospective employee, or a prospective independent contractor with a licensed home medical equipment provider, who reasonably and in good faith communicates his or her honest opinions about a former employee ' s job performance. This subsection does not affect the official immunity of an officer or employee of a public corporation. Review a sample of at least two employee files. Do they contain a 5-year work history either via the employment application, resume or some other means? Do the files include proof of required background screening? 59A (2), F.A.C. Complaint investigations: (a)... Distribution centers will be allowed forty-eight hours to obtain patient or personnel records from their central service center and to submit the records to the area office when related to a complaint investigation. Cross reference tag O-Z815 background screening; PROHIBITED OFFENSES Note: Review the detailed background-screening portion of the employee files. The surveyor is not required to return to a provider location for follow up to view any records requested at the time of the initial complaint investigation; instead, it is the responsibility of the provider to get records to the field office address within 48 hours. 59A (1), F.A.C. Each home medical equipment provider must: (b) Maintain personnel records that must include the following: employment history for the past 5 years, proof of background screening including a signed copy of the good moral character form and a license of any professional that may work from that location. A distribution center will not be required to maintain personnel records but its central service

21 Page 21 of 69 center shall be responsible for maintaining personnel records. ST - O Patient Dumping Title Patient Dumping Statute or Rule 59A (1)(d), F.A.C. Coordinate services with another provider in the event the HME cannot ensure the provision of equipment and services as required in Section (7), F.S. What is the provider ' s policy for termination of equipment and/or services? What kind of notice is given to the consumer? Is anything documented in the record? What if the consumer still requires services? Are services from another provider arranged? Pull two consumer records that were closed within the last six months and review to determine the reason for termination and whether another provider was found if the consumer still needed services. Cross reference tag O-0041 CONSUMER record retention/transfer ST - O Consumer record confidentiality Title Consumer record confidentiality Statute or Rule 59A (4)(b), F.A.C. Consumer information may not be disclosed from the consumer ' s file without the written consent of the consumer, the consumer ' s guardian or the consumer ' s power of attorney. All information received by any employee, contractor or AHCA employee regarding a consumer of the HME is confidential. Are records kept in a manner that protects confidentiality? Is patient consent required to release information? How are records protected from destruction or unauthorized use?

22 Page 22 of 69 ST - O Consumer Records Title Consumer Records Statute or Rule (1); ; 59A (3e&4) FAC (1), F.S. The home medical equipment provider must maintain, for each patient, a patient record that includes the home medical equipment and services the home medical equipment provider has provided. Such records must contain: (a) Any physician ' s order or certificate of medical necessity, if the equipment was ordered by a physician. (b) Signed and dated delivery slips verifying delivery. (c) Notes reflecting all services and maintenance performed, and any equipment exchanges. (d) The date on which rental equipment was retrieved. (e) Such other information as is appropriate to specific patients in light of the particular equipment provided to them (5), F.S. Ensuring that the home medical equipment and services provided by a home medical equipment provider are in accordance with the plan of treatment established for each patient, when provided as a part of a plan of treatment. 59A (3)(e), F.A.C. Minimum service standards required for equipment are as follows: (e) Life-support or life-sustaining equipment and related supplies must be provided to the consumer in the home environment based on initial and periodic reassessments of the consumer ' s equipment needs. Life supporting or life sustaining equipment shall be provided based upon physician orders including any physician order for medically necessary If any equipment was ordered by a physician, review consumer records for a plan of care, Certificate of Medical Necessity (CMN form used by Medicare) or physician order that would describe equipment and services ordered; Look for proof of delivery, e.g., signed and dated delivery slips. Look for records reflecting equipment maintenance that are generally recorded in a maintenance log using serial numbers to identify each piece of equipment. Note: A home medical equipment provider should be able to describe the service schedule for any equipment sold or rented with a service contract. The provider should be able to verify what he/she describes to the surveyor regarding maintenance schedules by showing the surveyor specific information in the manufacturer's recommended service maintenance guide related to a specific type of equipment and the brand name. PLAN OF TREATMENT Ask the general manager for a list of all their patients that are provided with life-supporting or life-sustaining equipment and review 2 files. Review any plan of treatment, Certificate of Medical Necessity (CMN used by Medicare) or prescription from the physician and compare it to the equipment and services that are being provided by the HME, i.e., the consumer's equipment and services should match the medical documentation; Determine if equipment and supplies reassessments are done when the plan of treatment or CMN expires for patients that receive life-supporting or life-sustaining equipment; and Determine if the provider is supplying any medically necessary backup equipment and supplies for life-supporting or life-sustaining equipment prescribed by the physician (10), F.S., "Life-supporting or life-sustaining equipment" means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life. Life supporting or life-sustaining equipment includes apnea monitors, enteral feeding pumps, infusion pumps, portable home dialysis equipment, and ventilator equipment and supplies for all related equipment, including oxygen equipment and related respiratory equipment.

23 Page 23 of 69 back-up equipment and supplies. 59A (4)(a&c), F.A.C. Consumer records: (a) A record must be maintained for each consumer that documents the home medical equipment and any services received as required in Section (1), F.S. (c) Consumer records must be made available to AHCA representatives when an inspection or a complaint investigation is done. Note: Some providers may not provide life-supporting or life-sustaining equipment. Notice the law states "when provided as a part of a plan of treatment." Unless the equipment is used to support or sustain life, there may not be a plan of treatment. ST - O Consumer Record Retention/Transfer Title Consumer Record Retention/Transfer Statute or Rule (2), F.S.; 59A (4)(d) (2), F.S. Such records are considered patient records under s and must be maintained by the home medical equipment provider for 5 years following termination of services. If a patient transfers to another home medical equipment provider, a copy of his or her record must be provided to the other home medical equipment provider, upon request. 59A (4), F.A.C. Retained records can be stored as hard paper copy, microfilm, computer discs or tapes as long as they are retrievable for use during unannounced inspections or complaint investigations. Ask where active and inactive consumer records are stored How long are inactive consumer records kept and are these readily retrievable for inspection? Does the provider transfer consumer records to a new provider upon request? Choose two consumer records that have been placed in the closed files and verify the reason for closure. Providers should not discontinue service to a consumer unless the consumer requests discontinuation of services or the consumer ' s physician does not renew an expired prescription or plan of treatment for the service; the record should document the reason for closure. Cross reference tag O-0034 Patient Dumping

24 Page 24 of 69 ST - O Accept Returns Title Accept Returns Statute or Rule (12), F.S. Accept returns of substandard or unsuitable items from consumers. As used in this subsection, the term " substandard " means less than full quality for the particular item and the term " unsuitable " means inappropriate for the consumer at the time it was fitted or sold. How does the business respond to a consumer that states a piece of equipment is unsuitable? Do they accept returns of substandard and unsuitable items? Ask the provider if they replace rental equipment when it's unsuitable or needs repair. ST - O Warranties Title Warranties Statute or Rule (9)&(13) FS; 59A (1)(f-g) , F.S., As a requirement of licensure, home medical equipment providers shall: (9) Honor all warranties expressed and implied under applicable state law. (13) Disclose consumer information to each consumer who rents or purchases items, including all applicable warranty information. This information consists of the provider standards to which the item must conform. 59A (1), F.A.C. (f) Honor all express warranties regarding assistive technology devices. The duration of the express warranty must be at least one year after first delivery of the assistive technology device Ask if all warranties are honored and if manufacturer warranty information is provided to the consumer. When sampling consumer records, look for evidence of equipment warranty work done. This may be kept in separate files rather than in consumer records; if so, request to review the files that show warranty work and sample at least two files. Make sure the provider is honoring the manufacturer warranty on new equipment and is giving at least a 30-day warranty on any used equipment. Note: Examples of assistive technology devices that are also considered home medical equipment include wheelchairs, motorized scooters, communication devices that enable persons with speech disabilities to speak, transfer devices and specialty beds.

25 Page 25 of 69 to the consumer as required in Section , F.S. (g) Honor all warranties as required in Section (9), F.S., and warranty used equipment at least 30 days. ST - O Special needs registry - Assistance Title Special needs registry - Assistance Statute or Rule (1)&(6) FS; 59A (6) FAC , (1) In order to meet the special needs of persons who would need assistance during evacuations and sheltering because of physical, mental, cognitive impairment, or sensory disabilities, the division, in coordination with each local emergency management agency in the state, shall maintain a registry of persons with special needs located within the jurisdiction of the local agency. The registration shall identify those persons in need of assistance and plan for resource allocation to meet those identified needs. (2) In order to ensure that all persons with special needs may register, the division shall develop and maintain a special needs shelter registration program. The registration program must be developed by January 1, 2015, and fully implemented by March 1, (a) The registration program shall include, at a minimum, a uniform electronic registration form and a database for uploading and storing submitted registration forms that may be accessed by the appropriate local emergency management agency. The link to the registration form shall be easily accessible on each local emergency management agency ' s website. Upon receipt of a paper registration form, the local emergency management agency shall enter the person ' s registration information into the database. (b) To assist in identifying persons with special needs, home health agencies, hospices, nurse registries, home medical Determine if the provider serves any persons with special needs. Persons with special needs are generally people who need help due to being dependent on equipment that requires power such as oxygen concentrators or ventilator equipment. Also, disabled persons who live alone or with other disabled persons are considered special needs persons and may need assistance with any necessary evacuation; Determine if the provider educates consumers about the need to register with the County Emergency Management Agency in order to receive assistance, should the need to evacuate their home become necessary. It is especially important for consumers using equipment that requires electricity to have a backup plan should the power fail. Determine if the provider has contacted the County Emergency Management Agency to obtain information on the registration process in each county where they offer equipment. The home medical equipment provider should have information available for consumers on how to register with the County Emergency Management Agency. Determine if the provider collects registration information from consumers in order to offer assistance with registration for special needs sheltering and evacuation. The County Emergency Management Agency should be notified through the special needs registration process of those consumers who are electricity dependent. If the county does not allow outside persons to submit information and requires direct contact with special needs persons, then the home medical equipment provider should have a copy of the county ' s instructions that states this requirement. Regardless of the individual county ' s process, the provider is still expected to inform consumers who would need assistance in an evacuation of the special needs registry.

26 Page 26 of 69 equipment providers, the Department of Children and Families, the Department of Health, the Agency for Health Care Administration, the Department of Education, the Agency for Persons with Disabilities, the Department of Elderly Affairs, and memory disorder clinics shall, and any physician licensed under chapter 458 or chapter 459 and any pharmacy licensed under chapter 465 may, annually provide registration information to all of their special needs clients or their caregivers. The division shall develop a brochure that provides information regarding special needs shelter registration procedures. The brochure must be easily accessible on the division ' s website. All appropriate agencies and community-based service providers, including aging and disability resource centers, memory disorder clinics, home health care providers, hospices, nurse registries, and home medical equipment providers, shall, and any physician licensed under chapter 458 or chapter 459 may, assist emergency management agencies by annually registering persons with special needs for special needs shelters, collecting registration information for persons with special needs as part of the program intake process, and establishing programs to educate clients about the registration process and disaster preparedness safety procedures. A client of a state-funded or federally funded service program who has a physical, mental, or cognitive impairment or sensory disability and who needs assistance in evacuating, or when in a shelter, must register as a person with special needs. The registration program shall give persons with special needs the option of preauthorizing emergency response personnel to enter their homes during search and rescue operations if necessary to ensure their safety and welfare following disasters. 59A (6), F.A.C. Home medical equipment providers must assist consumers receiving HME services who would need assistance and

27 Page 27 of 69 sheltering during evacuations because of physical, mental, cognitive impairment, or sensory disabilities in registering with the local emergency management agency, as required in Section (1), F.S., and as determined by the established procedures of the local emergency management agency related to special needs registration. (a) Each home medical equipment provider must, pursuant to Section and , F.S., inform consumers and consumer caregivers, by the best method possible as it pertains to the person ' s disability, of the special needs registry and procedures for registration at the special needs registry maintained by their county emergency management office. (b) If the consumer is to be registered with the special needs registry, the home medical equipment provider must assist the consumer with registering, pursuant to Sections and , F.S., and the established procedures of the local emergency management agency. The home medical equipment provider must document in the consumer ' s file if the consumer plans to evacuate or remain at home and if the consumer ' s caregiver or family can take responsibility during the emergency for equipment services normally provided by HME staff or independent contractors referred by the home medical equipment provider or if the home medical equipment provider needs to make referrals in order for equipment services to continue. If the consumer is also receiving services through any other licensed health care provider or federal or state funded program designated in Section , F.S., to help clients register with the special needs registry, then the home medical equipment provider will check with the other service provider or program case manager to verify if the consumer has already been registered. If so, a note will be made in the consumer ' s file by the home medical equipment provider that the consumer ' s need for registration has already been reviewed and handled by the other provider or program. Home medical equipment providers are not required to assist

28 Page 28 of 69 consumers residing in skilled nursing facilities, assisted living facilities or adult family care homes with special needs registration as those licensed facilities are responsible for evacuation and alternative sheltering of their clients. (c) The collected registration information must be furnished to the county emergency management agency pursuant to Section , F.S., and as determined by the established procedures of the local emergency management agency related to special needs registration. ST - O Special needs registry - Consumer records Title Special needs registry - Consumer records Statute or Rule 59A (6)(b), F.A.C. If the consumer is to be registered with the special needs registry, the home medical equipment provider must assist the consumer with registering, pursuant to Sections and , F.S., and the established procedures of the local emergency management agency. The home medical equipment provider must document in the consumer ' s file if the consumer plans to evacuate or remain at home and if the consumer ' s caregiver or family can take responsibility during the emergency for equipment services normally provided by HME staff or independent contractors referred by the home medical equipment provider or if the home medical equipment provider needs to make referrals in order for equipment services to continue. If the consumer is also receiving services through any other licensed health care provider or federal or state funded program designated in Section , F.S., to help clients register with the special needs registry, then the home medical equipment provider will check with the other service provider or program case manager to verify if the consumer has already been registered. If so, a note will be If the provider serves persons on the special needs registry, check a sample of those consumers ' files for documentation of: -assistance provided by the home medical equipment provider or another provider or program with the special needs registration -whether the consumer intends to evacuate or remain at home who will take responsibility for services normally provided by the home medical equipment provider, such as family or other caregivers, or if the provider needs to continue services

29 Page 29 of 69 made in the consumer ' s file by the home medical equipment provider that the consumer ' s need for registration has already been reviewed and handled by the other provider or program. Home medical equipment providers are not required to assist consumers residing in skilled nursing facilities, assisted living facilities or adult family care homes with special needs registration as those licensed facilities are responsible for evacuation and alternative sheltering of their clients. ST - O Emergency management plan - Preparation Title Emergency management plan - Preparation Statute or Rule (9) 59A (1) (9), F.S. Preparation of the comprehensive emergency management plan under s and the establishment of minimum criteria for the plan, including the maintenance of patient equipment and supply lists that can accompany patients who are transported from their homes. Such rules shall be formulated in consultation with the Department of Health and the Division of Emergency Management. 59A (1), F.A.C. Pursuant to Section (20)(a), F.S., each home medical equipment provider must prepare and maintain a written comprehensive emergency management plan, that meets the minimum criteria in these rules and the Comprehensive Emergency Management Plan (CEMP) Format for Home Medical Equipment (HME) Providers, AHCA Form , December 2006, incorporated by reference. This document is available from the Agency for Health Care Administration at under Licensing & Certification, Home Medical Equipment Provider. The Does the provider have a written comprehensive emergency management plan prepared following the required Comprehensive Emergency Management Plan (CEMP) Format for Home Medical Equipment (HME) Providers, AHCA Form , Dec. 06? Are all sections of the format completed appropriately or has the provider adequately explained on the plan why a specific section is not applicable to its business? A CEMP must be prepared by every licensed home medical equipment provider. Refer to Tag O-0017 for definition and discussion of life-supporting or life-sustaining equipment. Licensing & Certification should read Licensing & Regulation. PENDING RULE REVISION

30 Page 30 of 69 CEMP Format contains the minimum criteria that must be included in each home medical equipment provider emergency management plan, as required in Section (20), F.S. The plan must describe how the home medical equipment provider establishes and maintains an effective response to emergencies and disasters. The completed plan will be ed or mailed to the local county health department for each county listed on the home medical equipment provider ' s license as required in Section (20)(b), F.S., unless the county health department does not require submission of home medical equipment provider emergency management plans per Section (7), F.S. ST - O Emergency management plan - Local review Title Emergency management plan - Local review Statute or Rule (20)(b), F.S.; 59A (1) (20)(b), F.S. The plan is subject to review and approval by the county health department. During its review, the county health department shall contact state and local health and medical stakeholders when necessary. The county health department shall complete its review to ensure that the plan is in accordance with the criteria in the Agency for Health Care Administration rules within 90 days after receipt of the plan. If a home medical equipment provider fails to submit a plan or fails to submit requested information or revisions to the county health department within 30 days after written notification from the county health department, the county health department shall notify the Agency for Health Care Administration. The agency shall notify the home medical equipment provider that such failure constitutes a deficiency, subject to a fine of $5,000 per occurrence. If the plan is not Note: The "County Health Department Points of Contact for CEMP Review" are listed on the Agency's website at ; click on 'Licensing & Certification' and then 'Home Medical Equipment Provider.' Due to funding constraints, county health departments have the option to (1) require submission of home medical equipment providers' plans to review for compliance; (2) require submission but not review for compliance; or (3) not require submission at all. It is the provider ' s responsibility to contact the county health department for each county listed on its license in order to determine and document whether the plan should be submitted to that county and, if submission is required, whether the county health department will be reviewing the plan for compliance. Has the provider submitted a completed Comprehensive Emergency Management Plan (CEMP) Format for Home Medical Equipment (HME) Providers, AHCA Form , Dec. 06 to the county health department for each county listed on its license that requires submission? Note: If the provider has not submitted its plan to a county health department that requires submission or has not submitted requested information or revisions to a county health department that reviews plans for compliance within 30 days of written notice, then the surveyor must cite and require correction. If not corrected, the field office may

31 Page 31 of 69 submitted, information is not provided, or revisions are not made as requested, the agency may impose the fine. 59A (1), F.A.C.... The completed plan will be ed or mailed to the local county health department for each county listed on the home medical equipment provider ' s license as required in Section (20)(b), F.S., unless the county health department does not require submission of home medical equipment provider emergency management plans per Section (7), F.S. complete a Request for Sanction in the amount of a $5,000 fine. Remember, a CEMP must be prepared by every licensed home medical equipment provider regardless of whether it will be reviewed by any local county health department. ST - O Emergency management plan - Annual update Title Emergency management plan - Annual update Statute or Rule (20)(a), F.S.; 59A (2) , F.S., As a requirement of licensure, home medical equipment providers shall: (20)(a) Prepare and maintain a comprehensive emergency management plan that meets minimum criteria established by agency rule under s The plan shall be updated annually and shall provide for continuing home medical equipment services for life-supporting or life-sustaining equipment, as defined in s , during an emergency that interrupts home medical equipment services in a patient ' s home. Is the CEMP reviewed and updated annually? If 'substantive changes' as defined in this standard have been made, were those changes reported to each county health department reviewing entity that requires submission and each county emergency management office designated on the license? CROSS REFERENCE tag O-0004 Change of GENERAL MANAGER 59A (2-3), F.A.C. (2)The home medical equipment provider must review its emergency management plan on an annual basis, make any substantive changes and inform their staff of those changes. For the purposes of this section, ' substantive changes ' would include, but not be limited to, change of address, change of

32 Page 32 of 69 administrative staff who are responsible for coordinating the home medical equipment provider ' s emergency response or their contact telephone numbers and change of type of equipment or equipment services provided. (3) The substantive changes as defined in subsection 59A (2), F.A.C., must be reported to the county emergency management office and to the county health department. For home medical equipment providers with multiple counties on their license, the changes must be reported to each county health department and each county emergency management office designated on the license. The telephone numbers must include numbers where the coordinating staff can be contacted outside of the home medical equipment provider ' s regular office hours. All home medical equipment providers must report these changes, whether their plan has been previously reviewed or not, as defined in subsection (1). ST - O Emergency mgmt plan - Change of ownership Title Emergency mgmt plan - Change of ownership Statute or Rule 59A (4), F.A.C. When a home medical equipment provider goes through a change of ownership, the new owner must review the emergency management plan and make any substantive changes, including changes noted in subsection (3). Those home medical equipment providers will need to report any substantive changes in their plans to the reviewing entity in subsection (1). If a CHOW has occurred was the CEMP reviewed and updated? Were substantive changes including, but not limited to, change of address, change of administrative staff who are responsible for coordinating the home medical equipment provider ' s emergency response or their contact telephone numbers and change of type of equipment or equipment services provided reported to the local county health department reviewing entity in each county listed on the license? CROSS REFERENCE tag O-Z812 Change of ownership

33 Page 33 of 69 ST - O Emergency Management Plan - Prioritized list Title Emergency Management Plan - Prioritized list Statute or Rule (21), F.S. Each home medical equipment provider shall maintain a current prioritized list of patients who need continued services during an emergency. The list shall indicate the means by which services shall be continued for each patient in the event of an emergency or disaster, whether the patient is to be transported to a special needs shelter, and whether the patient has life-supporting or life-sustaining equipment, including the specific type of equipment and related supplies. The list shall be furnished to county health departments and local emergency management agencies upon request. Does the provider maintain a current prioritized list of patients who will need continued services during an emergency? How does the provider keep the list current? Does the prioritized list indicate: how services will be continued; whether patient is to be transported to the special needs shelter; and, if applicable, the specific type of life-supporting or life-sustaining equipment and related supplies? If the provider serves a county that requests this list be supplied to local emergency management personnel, was it furnished? ST - O Emergency management plan - Implementation Title Emergency management plan - Implementation Statute or Rule 59A (5) & (7-9) FAC (5) In the event of an emergency, the home medical equipment provider must implement the emergency management plan pursuant to Section (20), F.S. (7) The home medical equipment provider must provide the same type and quantity of equipment services to its consumers, which must include those being served in assisted If an emergency situation that could have impacted this provider has occurred or has threatened the geographic service area since the last survey, check for documentation that the CEMP was implemented. Was staff informed that emergency response measures were initiated? Is there evidence of communication between staff and local emergency management personnel? Was there an alternative means of communication if phone service was down? Were patients, who were in need of continued medical equipment services and supplies, prioritized appropriately

34 Page 34 of 69 living facilities and adult family care homes, who evacuate to special needs shelters which were being provided prior to evacuation, pursuant to Section (20)(a), F.S. Home medical equipment providers are not required to continue to provide services to consumers in emergency situations that are beyond their control and that make it impossible to provide services, such as when roads are impassable or when consumers do not go to the location specified in their consumer records. (8) If the home medical equipment provider is unable to provide equipment services to consumers who are special needs registry patients, including any assisted living facility and adult family care home special needs registry patients, then the provider will make reasonable efforts to find another resource for the consumer, pursuant to Section (20) (a), F.S. This would include arranging for services for consumers who have been forced to relocate outside of the geographic service area of the home medical equipment provider. (9) During emergency situations, when there is not a mandatory evacuation order issued by the local county emergency management office, some consumers, registered pursuant to Section , F.S., may decide not to evacuate and will stay in their homes. The home medical equipment provider must establish procedures, prior to the time of an emergency, which will delineate to what extent the provider will continue to arrange for essential equipment services during and immediately following an emergency pursuant to Section (20)(a), F.S. and contacted? Did staff attempt to follow procedures in the plan including providing the same level of care to patients who went to special needs shelters? Were procedures for continuing home medical equipment services for life-supporting or life-sustaining equipment, as defined in s , during an emergency that interrupts home medical equipment services in a patient's home followed? Were written agreements with other organizations implemented, if necessary, to continue essential care or services? ST - OZ800 - Applicability; Definitions Title Applicability; Definitions Statute or Rule ; 59A ; 59A (1)

35 Page 35 of Applicability.- The provisions of this part apply to the provision of services that require licensure as defined in this part and to the following entities licensed, registered, or certified by the agency, as described in chapters 112, 383, 390, 394, 395, 400, 429, 440, 483, and 765: (1) Laboratories authorized to perform testing under the Drug-Free Workplace Act, as provided under ss and (2) Birth centers, as provided under chapter 383. (3) Abortion clinics, as provided under chapter 390. (4) Crisis stabilization units, as provided under parts I and IV of chapter 394. (5) Short-term residential treatment facilities, as provided under parts I and IV of chapter 394. (6) Residential treatment facilities, as provided under part IV of chapter 394. (7) Residential treatment centers for children and adolescents, as provided under part IV of chapter 394. (8) Hospitals, as provided under part I of chapter 395. (9) Ambulatory surgical centers, as provided under part I of chapter 395. (10) Mobile surgical facilities, as provided under part I of chapter 395. (11) Health care risk managers, as provided under part I of chapter 395. (12) Nursing homes, as provided under part II of chapter 400. (13) Assisted living facilities, as provided under part I of chapter 429. (14) Home health agencies, as provided under part III of chapter 400. (15) Nurse registries, as provided under part III of chapter 400. (16) Companion services or homemaker services providers, as provided under part III of chapter 400.

36 Page 36 of 69 (17) Adult day care centers, as provided under part III of chapter 429. (18) Hospices, as provided under part IV of chapter 400. (19) Adult family-care homes, as provided under part II of chapter 429. (20) Homes for special services, as provided under part V of chapter 400. (21) Transitional living facilities, as provided under part XI of chapter 400. (22) Prescribed pediatric extended care centers, as provided under part VI of chapter 400. (23) Home medical equipment providers, as provided under part VII of chapter 400. (24) Intermediate care facilities for persons with developmental disabilities, as provided under part VIII of chapter 400. (25) Health care services pools, as provided under part IX of chapter 400. (26) Health care clinics, as provided under part X of chapter 400. (27) Clinical laboratories, as provided under part I of chapter 483. (28) Multiphasic health testing centers, as provided under part II of chapter 483. (29) Organ, tissue, and eye procurement organizations, as provided under part V of chapter Definitions.-As used in this part, the term: (1) "Agency" means the Agency for Health Care Administration, which is the licensing agency under this part. (2) "Applicant" means an individual, corporation, partnership, firm, association, or governmental entity that submits an application for a license to the agency. (3) "Authorizing statute" means the statute authorizing the

37 Page 37 of 69 licensed operation of a provider listed in s and includes chapters 112, 383, 390, 394, 395, 400, 429, 440, 483, and 765. (4) "Certification" means certification as a Medicare or Medicaid provider of the services that require licensure, or certification pursuant to the federal Clinical Laboratory Improvement Amendment (CLIA). (5) "Change of ownership" means: (a) An event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number; or (b) An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange. A change solely in the management company or board of directors is not a change of ownership. (6) "Client" means any person receiving services from a provider listed in s (7) "Controlling interest" means: (a) The applicant or licensee; (b) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the applicant or licensee; or (c) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the management company or other entity, related or unrelated, with which the applicant or licensee contracts to manage the provider. The term does not include a voluntary board member. (8) "License" means any permit, registration, certificate, or license issued by the agency. (9) "Licensee" means an individual, corporation, partnership,

38 Page 38 of 69 firm, association, governmental entity, or other entity that is issued a permit, registration, certificate, or license by the agency. The licensee is legally responsible for all aspects of the provider operation. (10) "Moratorium" means a prohibition on the acceptance of new clients. (11) "Provider" means any activity, service, agency, or facility regulated by the agency and listed in s (12) "Services that require licensure" means those services, including residential services, that require a valid license before those services may be provided in accordance with authorizing statutes and agency rules. (13) "Voluntary board member" means a board member or officer of a not-for-profit corporation or organization who serves solely in a voluntary capacity, does not receive any remuneration for his or her services on the board of directors, and has no financial interest in the corporation or organization. 59A Definitions. (1) "Address of record" means the location that is printed on the license and is the address at which the provider is licensed to operate. In the event a license displays multiple locations including branch offices, satellite offices, or off-site locations, the address of record is the main or principle office address. (2) "Agency notification" or "Agency request" means the Agency sends notification by: (a) Mail or personal delivery to the address of record for a licensee or applicant, (b) Mail to an alternative mailing address if requested by the licensee or applicant, or (c) Electronic mail if an electronic mail address has been provided. (3) "Days" means calendar days. (4) "Management company" means an entity retained by a

39 Page 39 of 69 licensee to administer or direct the operation of a provider. This does not include an entity that serves solely as a lender or lien holder. 59A Background Screening. (1) Definitions: (a) "Arrest Report" means the detailed narrative written by the arresting law enforcement officer explaining the circumstances of the arrest. (b) "Disposition" means the sentencing or other final settlement of a criminal case which shall include, regardless of adjudication, a plea of nolo contendere or guilty, or a conviction by a judge or jury. (c) "Disqualifying Offense" means any criminal offense prohibited in Section or (5), F.S. (d) "Exemption from Disqualification" means an exemption granted by the Agency following a review of the Application for Exemption, AHCA Form , May 2015, hereby incorporated by reference, and available at, and an informal teleconference, during which the individual must present clear and convincing evidence to support a reasonable belief that he or she has been rehabilitated and does not present a danger to the health, safety, and welfare of the patient or individual as described in Section , F.S. (e) "FBI" means the Federal Bureau of Investigation. (f) "FDLE" means the Florida Department of Law Enforcement. (g) "Level 2 Screening" means an assessment of the criminal history record obtained through a fingerprint search through the FDLE and FBI to determine whether screened individuals have any disqualifying offenses pursuant to Section or (5), F.S. An analysis and review of court dispositions and arrest reports may be required to make a final determination. (h) "Livescan Service Provider" means an entity that scans fingerprints electronically and submits them to FDLE.

40 Page 40 of 69 ST - OZ802 - License or application denial; revocation Title License or application denial; revocation Statute or Rule , FS License or application denial; revocation.- (1) In addition to the grounds provided in authorizing statutes, grounds that may be used by the agency for denying and revoking a license or change of ownership application include any of the following actions by a controlling interest: (a) False representation of a material fact in the license application or omission of any material fact from the application. (b) An intentional or negligent act materially affecting the health or safety of a client of the provider. (c) A violation of this part, authorizing statutes, or applicable rules. (d) A demonstrated pattern of deficient performance. (e) The applicant, licensee, or controlling interest has been or is currently excluded, suspended, or terminated from participation in the state Medicaid program, the Medicaid program of any other state, or the Medicare program. (2) If a licensee lawfully continues to operate while a denial or revocation is pending in litigation, the licensee must continue to meet all other requirements of this part, authorizing statutes, and applicable rules and file subsequent renewal applications for licensure and pay all licensure fees. The provisions of ss (1) and (3)(c) do not apply to renewal applications filed during the time period in which the litigation of the denial or revocation is pending until that litigation is final. (3) An action under s or denial of the license of the transferor may be grounds for denial of a change of ownership The program unit is responsible for issuing notification of enforcement action for licensure actions.

41 Page 41 of 69 application of the transferee. (4) Unless an applicant is determined by the agency to satisfy the provisions of subsection (5) for the action in question, the agency shall deny an application for a license or license renewal based upon any of the following actions of an applicant, a controlling interest of the applicant, or any entity in which a controlling interest of the applicant was an owner or officer when the following actions occurred: (a) A conviction or a plea of guilty or nolo contendere to, regardless of adjudication, a felony under chapter 409, chapter 817, chapter 893, 21 U.S.C. ss , or 42 U.S.C. ss , Medicaid fraud, Medicare fraud, or insurance fraud, unless the sentence and any subsequent period of probation for such convictions or plea ended more than 15 years before the date of the application; or (b) Termination for cause from the Medicare program or a state Medicaid program, unless the applicant has been in good standing with the Medicare program or a state Medicaid program for the most recent 5 years and the termination occurred at least 20 years before the date of the application. ST - OZ803 - License Required; Display Title License Required; Display Statute or Rule , F.S License required; display.- (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the - Check to see that the license is for the facility and location where it is displayed. Contact the appropriate licensure unit if there are questions about the license. - During tour determine if the license is displayed in a conspicuous location. - If applicable, check to make sure the category of testing being done is reflected on the license, the ownership given on the face of the license is accurate, that the location of the facility is the address printed on the license, and that the license is properly displayed. Look at Z0827 Unlicensed Activity , F.S. as unlicensed activity should be cited if there has been a change of ownership, or for clinical laboratories, testing outside of the specialty/subspecialties printed on the license are being performed.

42 Page 42 of 69 license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. (3) Any person who knowingly alters, defaces, or falsifies a license certificate issued by the agency, or causes or procures any person to commit such an offense, commits a misdemeanor of the second degree, punishable as provided in s or s Any licensee or provider who displays an altered, defaced, or falsified license certificate is subject to the penalties set forth in s and an administrative fine of $1,000 for each day of illegal display. - Regarding Nursing Homes, refer to (2) which states: Separate licenses shall be required for facilities maintained in separate premises, even though operated under the same management. However, a separate license shall not be required for separate buildings on the same grounds. - Regarding Labs, refer to 59A-7.021(3) which states: Separate licensure shall be required for all laboratories maintained on separate premises, as defined under subsection 59A-7.020(27), F.A.C., including mobile laboratory units, even though operated under the same management. Separate licensure shall not be required for separate buildings on the same or adjoining grounds. ST - OZ806 - Change of Address Title Change of Address Statute or Rule 59A (2-5), FAC (2) Any request to amend a license must be received by the Agency in advance of the requested effective date as detailed below. Requests to amend a license are not authorized until the license is issued. (a) Requests to change the address of record must be received by the Agency 60 to 120 days in advance of the requested effective date for the following provider types: 1. Birth Centers, as provided under Chapter 383, F.S.; 2. Abortion Clinics, as provided under Chapter 390, F.S.; 3. Crisis Stabilization Units, as provided under Parts I and IV of Chapter 394, F.S.; 4. Short Term Residential Treatment Units, as provided under Parts I and IV of Chapter 394, F.S. 5. Residential Treatment Facilities, as provided under Part IV of Chapter 394, F.S.; - The licensure unit handles change of address, but surveyors may find that the provider has moved and therefore could cite this.

43 Page 43 of Residential Treatment Centers for Children and Adolescents, as provided under Part IV of Chapter 394, F.S.; 7. Hospitals, as provided under Part I of Chapter 395, F.S.; 8. Ambulatory Surgical Centers, as provided under Part I of Chapter 395, F.S.; 9. Nursing Homes, as provided under Part II of Chapter 400, F.S.; 10. Hospices, as provided under Part IV of Chapter 400, F.S.; 11. Homes for Special Services as provided under Part V of Chapter 400, F.S.; 12. Transitional Living Facilities, as provided under Part V of Chapter 400, F.S.; 13. Prescribed Pediatric Extended Care Centers, as provided under Part VI of Chapter 400, F.S.; 14. Intermediate Care Facilities for the Developmentally Disabled, as provided under Part VIII of Chapter 400, F.S.; 15. Assisted Living Facilities, as provided under Part I of Chapter 429, F.S.; 16. Adult Family-Care Homes, as provided under Part II of Chapter 429, F.S.; 17. Adult Day Care Centers, as provided under Part III of Chapter 429, F.S. (b) Requests to change the address of record must be received by the Agency 21 to 120 days in advance of the requested effective date for the following provider types: 1. Drug Free Workplace Laboratories as provided under Sections and , F.S.; 2. Mobile Surgical Facilities, as provided under Part I of Chapter 395, F.S.; 3. Health Care Risk Managers, as provided under Part I of Chapter 395, F.S.; 4. Home Health Agencies, as provided under Part III of Chapter 400, F.S.; 5. Nurse Registries, as provided under Part III of Chapter 400, F.S.;

44 Page 44 of Companion Services or Homemaker Services Providers, as provided under Part III of Chapter 400, F.S.; 7. Home Medical Equipment Providers, as provided under Part VII of Chapter 400, F.S.; 8. Health Care Services Pools, as provided under Part IX of Chapter 400, F.S.; 9. Health Care Clinics, as provided under Part X of Chapter 400, F.S., including certificate of exemption; 10. Clinical Laboratories, as provided under Part I of Chapter 483, F.S.; 11. Multiphasic Health Testing Centers, as provided under Part II of Chapter 483, F.S.; 12. Organ and Tissue Procurement Agencies, as provided under Chapter 381, F.S. (c) All other requests to amend a license including but not limited to services, licensed capacity, and other specifications which are required to be displayed on the license by authorizing statutes or applicable rules must be received by the Agency 60 to 120 days in advance of the requested effective date. This deadline does not apply to a request to amend hospital emergency services defined in Section (2), F.S. (3) Failure to submit a timely request shall result in a $500 fine. (4) A licensee is not authorized to operate in a new location until a license is obtained which specifies the new location. Failure to amend a license prior to a change of the address of record constitutes unlicensed activity. (5) The licensee shall return the license certificate to the Agency upon the rendition of a final order revoking, cancelling or denying a license, and upon the voluntary discontinuance of operation.

45 Page 45 of 69 ST - OZ809 - Proof of Financial Ability to Operate Title Proof of Financial Ability to Operate Statute or Rule 59A (3)(e),&(7), (7), A (3)(e) FAC Proof of Financial Ability to Operate. "Financial instability" means the provider cannot meet its financial obligations. Evidence such as the issuance of bad checks, an accumulation of delinquent bills, or inability to meet current payroll needs shall constitute prima facie evidence that the ownership of the provider lacks the financial ability to operate. Evidence shall also include the Medicare or Medicaid program's indications or determination of financial instability or fraudulent handling of government funds by the provider (7) FS Definitions. "Controlling interest" means: (a) The applicant or licensee; (b) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the applicant or licensee; or (c) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the management company or other entity, related or unrelated, with which the applicant or licensee contracts to manage the provider. The term does not include a voluntary board member FS (8) Upon application for initial licensure or change of ownership licensure, the applicant shall furnish satisfactory proof of the applicant's financial ability to operate in - This standard would be used by surveyors if evidence of financial instability is found and the licensee or any controlling interest in the licensee withholds information from the surveyor. - The financial schedules and documentation of correction of the financial instability are submitted to the AHCA Home Care Unit in the state office and reviewed by AHCA state office financial reviewers in the Financial Analysis Unit. Further administrative action may be taken by the state office. - This standard applies to the following provider types: Nursing Home Facilities, as specified in Part II, Chapter 400, F.S.; Assisted Living Facilities, as specified in Part I, Chapter 429, F.S.; Home Health Agencies, as specified in Part III, Chapter 400, F.S.; Hospices, as specified in Part IV, Chapter 400, F.S.; Adult Day Care Centers, as specified in Part III, Chapter 429, F.S.; Prescribed Pediatric Extended Care Centers, as specified in Part VI, Chapter 400, F.S.; Home Medical Equipment Providers, as specified in Part VII, Chapter 400, F.S.; Intermediate Care Facilities for the Developmentally Disabled, as specified in Part VIII, Chapter 400, F.S.; Health Care Clinics, as specified in Part X, Chapter 400, F.S.; - The standard applies to Nurse Registries as specified in 59A (7) which states: - An application for renewal of a license shall not be required to provide proof of financial ability to operate, unless the applicant has demonstrated financial instability at any time, pursuant to Section , F.S., in which case AHCA shall require the applicant for renewal to provide proof of financial ability to operate by submitting information as described in 59A (7)(b), F.A.C. and documentation of correction of the financial instability, to include evidence of the payment in full of any bad checks, delinquent bills or liens and all associated fees, costs, and changes related to the instability. If complete payment cannot be made, evidence must be submitted of partial payment along with a plan for payment of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal, state, or district court, an accepted plan of repayment must be provided. If the licensed nurse registry has demonstrated financial instability as outlined above at any time the AHCA will request proof of financial ability to operate. - None of the Hospital Unit Programs nor the Lab Unit Programs would have this requirement.

46 Page 46 of 69 accordance with the requirements of this part, authorizing statutes, and applicable rules. The agency shall establish standards for this purpose, including information concerning the applicant's controlling interests. The agency shall also establish documentation requirements, to be completed by each applicant, that show anticipated provider revenues and expenditures, the basis for financing the anticipated cash-flow requirements of the provider, and an applicant's access to contingency financing. A current certificate of authority, pursuant to chapter 651, may be provided as proof of financial ability to operate. The agency may require a licensee to provide proof of financial ability to operate at any time if there is evidence of financial instability, including, but not limited to, unpaid expenses necessary for the basic operations of the provider. 59A FS (7) An applicant for renewal of a license shall not be required to provide proof of financial ability to operate, unless the licensee or applicant has demonstrated financial instability. If an applicant or licensee has shown signs of financial instability, as provided in Section (9), F.S., at any time, the Agency may require the applicant or licensee to provide proof of financial ability to operate by submission of: (a) AHCA Form , July 2009, Proof of Financial Ability Form, that includes a balance sheet and income and expense statement for the next 2 years of operation which provide evidence of having sufficient assets, credit, and projected revenues to cover liabilities and expenses, and (b) Documentation of correction of the financial instability, including but not limited to, evidence of the payment of any bad checks, delinquent bills or liens. If complete payment cannot be made, evidence must be submitted of partial payment along with a plan for payment of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal or state court, an accepted plan of repayment must be provided.

47 Page 47 of 69 ST - OZ812 - Change of Ownership Title Change of Ownership Statute or Rule (5) F.S., F.S (5) FS "Change of ownership" means: (a) An event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number; or (b) An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange. A change solely in the management company or board of directors is not a change of ownership. - This tag may be cited for unreported changes of ownership Change of ownership.-whenever a change of ownership occurs: (1) The transferor shall notify the agency in writing at least 60 days before the anticipated date of the change of ownership. (2) The transferee shall make application to the agency for a license within the timeframes required in s (3) The transferor shall be responsible and liable for: (a) The lawful operation of the provider and the welfare of the clients served until the date the transferee is licensed by the agency. (b) Any and all penalties imposed against the transferor for violations occurring before the date of change of ownership. (4) Any restriction on licensure, including a conditional

48 Page 48 of 69 license existing at the time of a change of ownership, shall remain in effect until the agency determines that the grounds for the restriction are corrected. (5) The transferee shall maintain records of the transferor as required in this part, authorizing statutes, and applicable rules, including: (a) All client records. (b) Inspection reports. (c) All records required to be maintained pursuant to s , if applicable. ST - OZ813 - Results of Screening & Notification In File Title Results of Screening & Notification In File Statute or Rule 59A (3)(c), FAC 59A (3) Results of Screening and Notification. (c) The eligibility results of employee screening and the signed Attestation referenced in subsection 59A (2), F.A.C., must be in the employee's personnel file, maintained by the provider. ST - OZ814 - Background Screening Clearinghouse Title Background Screening Clearinghouse Statute or Rule (2)(b-d), FS (2) Care Provider Background Screening Clearinghouse.- (b) Until such time as the fingerprints are enrolled in the - Review employee files for verification that any break in service was less than 90 days or a new screening was completed. - Verify that the facility has an updated employee roster listed in the clearinghouse.

49 Page 49 of 69 national retained print arrest notification program at the Federal Bureau of Investigation, an employee with a break in service of more than 90 days from a position that requires screening by a specified agency must submit to a national screening if the person returns to a position that requires screening by a specified agency. (c) An employer of persons subject to screening by a specified agency must register with the clearinghouse and maintain the employment status of all employees within the clearinghouse. Initial employment status and any changes in status must be reported within 10 business days. (d) An employer must register with and initiate all criminal history checks through the clearinghouse before referring an employee or potential employee for electronic fingerprint submission to the Department of Law Enforcement. The registration must include the employee's full first name, middle initial, and last name; social security number; date of birth; mailing address; sex; and race. Individuals, persons, applicants, and controlling interests that cannot legally obtain a social security number must provide an individual taxpayer identification number. ST - OZ815 - Background Screening; Prohibited Offenses Title Background Screening; Prohibited Offenses Statute or Rule , (2), Background screening; prohibited offenses.- (1) Level 2 background screening pursuant to chapter 435 must be conducted through the agency on each of the following persons, who are considered employees for the purposes of conducting screening under chapter 435: (a) The licensee, if an individual. (b) The administrator or a similarly titled person who is - Employees and independent contractors hired or contracted before August 1, 2010, must be screened according to the schedule in (5), F.S. included in this standard. - Persons already hired or under contract before August 1, 2010 would have received level 1 screening. - Employees and contractors who do not meet the background screening requirements cannot be retained in a direct care capacity, unless an exemption from disqualification has been approved by AHCA or the Department of Health (when a licensed or certified health care professional or certified nursing assistant). - The employee or contractor with a disqualifying offense must have a copy of an exemption [granted by either DOH

50 Page 50 of 69 responsible for the day-to-day operation of the provider. (c) The financial officer or similarly titled individual who is responsible for the financial operation of the licensee or provider. (d) Any person who is a controlling interest if the agency has reason to believe that such person has been convicted of any offense prohibited by s For each controlling interest who has been convicted of any such offense, the licensee shall submit to the agency a description and explanation of the conviction at the time of license application. (e) Any person, as required by authorizing statutes, seeking employment with a licensee or provider who is expected to, or whose responsibilities may require him or her to, provide personal care or services directly to clients or have access to client funds, personal property, or living areas; and any person, as required by authorizing statutes, contracting with a licensee or provider whose responsibilities require him or her to provide personal care or personal services directly to clients. Evidence of contractor screening may be retained by the contractor's employer or the licensee. (3) All fingerprints must be provided in electronic format. Screening results shall be reviewed by the agency with respect to the offenses specified in s and this section, and the qualifying or disqualifying status of the person named in the request shall be maintained in a database. The qualifying or disqualifying status of the person named in the request shall be posted on a secure website for retrieval by the licensee or designated agent on the licensee's behalf. (4) In addition to the offenses listed in s , all persons required to undergo background screening pursuant to this part or authorizing statutes must not have an arrest awaiting final disposition for, must not have been found guilty of, regardless of adjudication, or entered a plea of nolo contendere or guilty to, and must not have been adjudicated delinquent and the or AHCA] in their personnel file before the employee or contractor can be hired. - There is a new staggered schedule: (a) Individuals for whom the last screening was conducted on or before December 31, 2004, must be rescreened by July 31, (b) Individuals for whom the last screening conducted was between January 1, 2005, and December 31, 2008, must be rescreened by July 31, (c) Individuals for whom the last screening conducted was between January 1, 2009, through July 31, 2011, must be rescreened by July 31, An employer may hire an employee to a position that requires background screening before the employee completes the screening process for training and orientation purposes. However, the employee may not have direct contact with vulnerable persons until the screening process is completed and the employee demonstrates that he or she exhibits no behaviors that warrant the denial or termination of employment. - Individuals may be provisionally employed in positions requiring background screening. They may be in training or orientation, but may NOT have access to residents/patients until the background screening process is completed. - An employer of persons subject to screening by a specified agency must register with the clearinghouse and maintain the employment status of all employees within the clearinghouse. Initial employment status and any changes in status must be reported within 10 business days. - If an individual is in the Clearinghouse and are working then they must be on that provider's employee roster within 10 days of their hire date. The same for once a person is no longer working for that provider. If they are in the Clearinghouse then their status in the employee roster must be updated within 10 days of a change. Surveyor Probes: - Level 2 includes FDLE and FBI screening. - Staff who do not have access to client property, funds, or living areas or who do not have contact with clients are not required to be screened. - If an employee or contractor's responsibility requires him or her to have contact with clients, a Level 2 background screening is required. - Was the employee or contractor hired on or after August 1, 2010? - Does the licensee have evidence of contractor and employee screening?

51 Page 51 of 69 record not have been sealed or expunged for any of the following offenses or any similar offense of another jurisdiction: (a) Any authorizing statutes, if the offense was a felony. (b) This chapter, if the offense was a felony. (c) Section , relating to Medicaid provider fraud. (d) Section , relating to Medicaid fraud. (e) Section , relating to domestic violence. (f) Section , relating to attempts, solicitation, and conspiracy to commit an offense listed in this subsection. (g) Section , relating to fraudulent acts through mail, wire, radio, electromagnetic, photoelectronic, or photooptical systems. (h) Section , relating to false and fraudulent insurance claims. (i) Section , relating to obtaining goods by using a false or expired credit card or other credit device, if the offense was a felony. (j) Section , relating to fraudulently obtaining goods or services from a health care provider. (k) Section , relating to patient brokering. (l) Section , relating to criminal use of personal identification information. (m) Section , relating to obtaining a credit card through fraudulent means. (n) Section , relating to fraudulent use of credit cards, if the offense was a felony. (o) Section , relating to forgery. (p) Section , relating to uttering forged instruments. (q) Section , relating to forging bank bills, checks, drafts, or promissory notes. (r) Section , relating to uttering forged bank bills, checks, drafts, or promissory notes. (s) Section , relating to fraud in obtaining medicinal drugs.

52 Page 52 of 69 (t) Section , relating to the sale, manufacture, delivery, or possession with the intent to sell, manufacture, or deliver any counterfeit controlled substance, if the offense was a felony. (u) Section , relating to racketeering and collection of unlawful debts. (v) Section , relating to the Florida Money Laundering Act. If, upon rescreening, a person who is currently employed or contracted with a licensee as of June 30, 2014, and was screened and qualified under ss and , has a disqualifying offense that was not a disqualifying offense at the time of the last screening, but is a current disqualifying offense and was committed before the last screening, he or she may apply for an exemption from the appropriate licensing agency and, if agreed to by the employer, may continue to perform his or her duties until the licensing agency renders a decision on the application for exemption if the person is eligible to apply for an exemption and the exemption request is received by the agency no later than 30 days after receipt of the rescreening results by the person. (5) A person who serves as a controlling interest of, is employed by, or contracts with a licensee on July 31, 2010, who has been screened and qualified according to standards specified in s or s must be rescreened by July 31, 2015, in compliance with the following schedule. If, upon rescreening, such person has a disqualifying offense that was not a disqualifying offense at the time of the last screening, but is a current disqualifying offense and was committed before the last screening, he or she may apply for an exemption from the appropriate licensing agency and, if agreed to by the employer, may continue to perform his or her duties until the licensing agency renders a decision on the application for exemption if the person is eligible to apply for an exemption and the exemption request is received by the agency within 30

53 Page 53 of 69 days after receipt of the rescreening results by the person. The rescreening schedule shall be: (a) Individuals for whom the last screening was conducted on or before December 31, 2004, must be rescreened by July 31, (b) Individuals for whom the last screening conducted was between January 1, 2005, and December 31, 2008, must be rescreened by July 31, (c) Individuals for whom the last screening conducted was between January 1, 2009, through July 31, 2011, must be rescreened by July 31, (6) The costs associated with obtaining the required screening must be borne by the licensee or the person subject to screening. Licensees may reimburse persons for these costs. The Department of Law Enforcement shall charge the agency for screening pursuant to s (3). The agency shall establish a schedule of fees to cover the costs of screening. (7)(a) As provided in chapter 435, the agency may grant an exemption from disqualification to a person who is subject to this section and who: 1. Does not have an active professional license or certification from the Department of Health; or 2. Has an active professional license or certification from the Department of Health but is not providing a service within the scope of that license or certification. (b) As provided in chapter 435, the appropriate regulatory board within the Department of Health, or the department itself if there is no board, may grant an exemption from disqualification to a person who is subject to this section and who has received a professional license or certification from the Department of Health or a regulatory board within that department and that person is providing a service within the scope of his or her licensed or certified practice. (8) The agency and the Department of Health may adopt rules pursuant to ss (1) and to implement this

54 Page 54 of 69 section, chapter 435, and authorizing statutes requiring background screening and to implement and adopt criteria relating to retaining fingerprints pursuant to s (2). (9) There is no reemployment assistance or other monetary liability on the part of, and no cause of action for damages arising against, an employer that, upon notice of a disqualifying offense listed under chapter 435 or this section, terminates the person against whom the report was issued, whether or not that person has filed for an exemption with the Department of Health or the agency Exclusion from employment.- (1) If an employer or agency has reasonable cause to believe that grounds exist for the denial or termination of employment of any employee as a result of background screening, it shall notify the employee in writing, stating the specific record that indicates noncompliance with the standards in this chapter. It is the responsibility of the affected employee to contest his or her disqualification or to request exemption from disqualification. The only basis for contesting the disqualification is proof of mistaken identity. (2)(a) An employer may not hire, select, or otherwise allow an employee to have contact with any vulnerable person that would place the employee in a role that requires background screening until the screening process is completed and demonstrates the absence of any grounds for the denial or termination of employment. If the screening process shows any grounds for the denial or termination of employment, the employer may not hire, select, or otherwise allow the employee to have contact with any vulnerable person that would place the employee in a role that requires background screening unless the employee is granted an exemption for the disqualification by the agency as provided under s (b) If an employer becomes aware that an employee has been arrested for a disqualifying offense, the employer must remove

55 Page 55 of 69 the employee from contact with any vulnerable person that places the employee in a role that requires background screening until the arrest is resolved in a way that the employer determines that the employee is still eligible for employment under this chapter. (c) The employer must terminate the employment of any of its personnel found to be in noncompliance with the minimum standards of this chapter or place the employee in a position for which background screening is not required unless the employee is granted an exemption from disqualification pursuant to s (d) An employer may hire an employee to a position that requires background screening before the employee completes the screening process for training and orientation purposes. However, the employee may not have direct contact with vulnerable persons until the screening process is completed and the employee demonstrates that he or she exhibits no behaviors that warrant the denial or termination of employment. (3) Any employee who refuses to cooperate in such screening or refuses to timely submit the information necessary to complete the screening, including fingerprints if required, must be disqualified for employment in such position or, if employed, must be dismissed. (4) There is no reemployment assistance or other monetary liability on the part of, and no cause of action for damages against, an employer that, upon notice of a conviction or arrest for a disqualifying offense listed under this chapter, terminates the person against whom the report was issued or who was arrested, regardless of whether or not that person has filed for an exemption pursuant to this chapter Definitions.-For the purposes of this chapter, the term: (2) "Employee" means any person required by law to be screened pursuant to this chapter, including, but not limited to, persons who are contractors, licensees, or volunteers.

56 Page 56 of 69 ST - OZ816 - Background Screening-Compliance Attestation Title Background Screening-Compliance Attestation Statute or Rule (2)(a-c) FS (2) Every 5 years following his or her licensure, employment, or entry into a contract in a capacity that under subsection (1) would require level 2 background screening under chapter 435, each such person must submit to level 2 background rescreening as a condition of retaining such license or continuing in such employment or contractual status. For any such rescreening, the agency shall request the Department of Law Enforcement to forward the person's fingerprints to the Federal Bureau of Investigation for a national criminal history record check unless the person's fingerprints are enrolled in the Federal Bureau of Investigation ' s national retained print arrest notification program. If the fingerprints of such a person are not retained by the Department of Law Enforcement under s (2)(g) and (h), the person must submit fingerprints electronically to the Department of Law Enforcement for state processing, and the Department of Law Enforcement shall forward the fingerprints to the Federal Bureau of Investigation for a national criminal history record check. The fingerprints shall be retained by the Department of Law Enforcement under s (2)(g) and (h) and enrolled in the national retained print arrest notification program when the Department of Law Enforcement begins participation in the program. The cost of the state and national criminal history records checks required by level 2 screening may be borne by the licensee or the person fingerprinted. Until a specified agency is fully implemented in the clearinghouse created under s , the agency may accept as satisfying the requirements of this section proof of compliance with level 2 screening standards - Is AHCA Recommended Form , September 2013, Affidavit of Compliance with Background Screening Requirements, in the employee's personnel file? - Or, does the employee have a similar document attesting under penalty of perjury that they are in compliance with Chapter 435, F.S.

57 Page 57 of 69 submitted within the previous 5 years to meet any provider or professional licensure requirements of the agency, the Department of Health, the Department of Elderly Affairs, the Agency for Persons with Disabilities, the Department of Children and Families, or the Department of Financial Services for an applicant for a certificate of authority or provisional certificate of authority to operate a continuing care retirement community under chapter 651, provided that: (a) The screening standards and disqualifying offenses for the prior screening are equivalent to those specified in s and this section; (b) The person subject to screening has not had a break in service from a position that requires level 2 screening for more than 90 days; and (c) Such proof is accompanied, under penalty of perjury, by an attestation of compliance with chapter 435 and this section using forms provided by the agency. ST - OZ817 - Minimum Licensure Requirement - Inform AHCA Title Minimum Licensure Requirement - Inform AHCA Statute or Rule (3-4) FS; 59A (1) FAC Minimum licensure requirements.-in addition to the licensure requirements specified in this part, authorizing statutes, and applicable rules, each applicant and licensee must comply with the requirements of this section in order to obtain and maintain a license. (3) Unless otherwise specified in this part, authorizing statutes, or applicable rules, any information required to be reported to the agency must be submitted within 21 calendar days after the report period or effective date of the information, whichever is earlier, including, but not limited to, - Refer to s , F.S. regarding the Exemptions for this regulation. - Regarding Nursing Homes, note that the closing of a nursing facility ( (4)(a)) must comply with (1), F.S. instead which states: (1) Whenever a licensee voluntarily discontinues operation, and during the period when it is preparing for such discontinuance, it shall inform the agency not less than 90 days prior to the discontinuance of operation. The licensee also shall inform the resident or the next of kin, legal representative, or agency acting on behalf of the resident of the fact, and the proposed time, of such discontinuance and give at least 90 days' notice so that suitable arrangements may be made for the transfer and care of the resident. In the event any resident has no such person to represent him or her, the licensee shall be responsible for securing a suitable transfer of the resident before the discontinuance of operation. The agency shall be responsible for arranging for the transfer of those residents requiring transfer who are receiving assistance under the Medicaid program.

58 Page 58 of 69 any change of: (a) Information contained in the most recent application for licensure. (b) Required insurance or bonds. (4) Whenever a licensee discontinues operation of a provider: (a) The licensee must inform the agency not less than 30 days prior to the discontinuance of operation and inform clients of such discontinuance as required by authorizing statutes. Immediately upon discontinuance of operation by a provider, the licensee shall surrender the license to the agency and the license shall be canceled. (b) The licensee shall remain responsible for retaining and appropriately distributing all records within the timeframes prescribed in authorizing statutes and applicable rules. In addition, the licensee or, in the event of death or dissolution of a licensee, the estate or agent of the licensee shall: 1. Make arrangements to forward records for each client to one of the following, based upon the client's choice: the client or the client's legal representative, the client's attending physician, or the health care provider where the client currently receives services; or 2. Cause a notice to be published in the newspaper of greatest general circulation in the county in which the provider was located that advises clients of the discontinuance of the provider operation. The notice must inform clients that they may obtain copies of their records and specify the name, address, and telephone number of the person from whom the copies of records may be obtained. The notice must appear at least once a week for 4 consecutive weeks. 59A Minimum Licensure Requirements. Provider location. A licensee must maintain proper authority for operation of the provider at the address of record. If such authority is denied, revoked or otherwise terminated by the local zoning or code enforcement authority, the Agency may deny or revoke an application or license, or impose sanctions.

59 Page 59 of 69 ST - OZ818 - Minimum Licensure Requirement - Client Notice Title Minimum Licensure Requirement - Client Notice Statute or Rule (5) FS Minimum licensure requirements. In addition to the licensure requirements specified in this part, authorizing statutes, and applicable rules, each applicant and licensee must comply with the requirements of this section in order to obtain and maintain a license. During observation, interview and record review determine if client, immediate family or representative have been informed of the right to report. - Refer to s , F.S. regarding the Exemptions for this regulation. (5)(a) On or before the first day services are provided to a client, a licensee must inform the client and his or her immediate family or representative, if appropriate, of the right to report: 1. Complaints. The statewide toll-free telephone number for reporting complaints to the agency must be provided to clients in a manner that is clearly legible and must include the words: "To report a complaint regarding the services you receive, please call toll-free (phone number)." 2. Abusive, neglectful, or exploitative practices. The statewide toll-free telephone number for the central abuse hotline must be provided to clients in a manner that is clearly legible and must include the words: "To report abuse, neglect, or exploitation, please call toll-free (phone number)." 3. Medicaid fraud. An agency-written description of Medicaid fraud and the statewide toll-free telephone number for the central Medicaid fraud hotline must be provided to clients in a manner that is clearly legible and must include the words: "To report suspected Medicaid fraud, please call toll-free (phone number)." The agency shall publish a minimum of a 90-day advance notice of a change in the toll-free telephone numbers.

60 Page 60 of 69 (b) Each licensee shall establish appropriate policies and procedures for providing such notice to clients. ST - OZ819 - Minimum Licensure Req - Financial Viability Title Minimum Licensure Req - Financial Viability Statute or Rule (9), FS FS (9) A controlling interest may not withhold from the agency any evidence of financial instability, including, but not limited to, checks returned due to insufficient funds, delinquent accounts, nonpayment of withholding taxes, unpaid utility expenses, nonpayment for essential services, or adverse court action concerning the financial viability of the provider or any other provider licensed under this part that is under the control of the controlling interest. A controlling interest shall notify the agency within 10 days after a court action to initiate bankruptcy, foreclosure, or eviction proceedings concerning the provider in which the controlling interest is a petitioner or defendant. Any person who violates this subsection commits a misdemeanor of the second degree, punishable as provided in s or s Each day of continuing violation is a separate offense. Refer to s , F.S. regarding the Exemptions for this regulation. ST - OZ821 - Reporting Requirements; Electronic Submission Title Reporting Requirements; Electronic Submission Statute or Rule 59A , FAC

61 Page 61 of 69 59A Reporting Requirements; Electronic Submission. (1) During the two year licensure period, any change or expiration of any information that is required to be reported under Chapter 408, Part II, F.S., or authorizing statutes for the provider type as specified in Section (3), F.S., during the license application process must be reported to the Agency within 21 days of occurrence of the change, including: (a) Insurance coverage renewal, (b) Bond renewal, (c) Change of administrator or the similarly titled person who is responsible for the day-to-day operation of the provider, (d) Annual sanitation inspections, (e) Fire inspections, (f) Approval of revisions to emergency management plans. (2) Electronic submission of information. (a) The following required information must be reported through the Agency's Internet site at 1. Nursing homes: a. Semi-annual staffing ratios required pursuant to Section (1)(o), F.S. and Rule 59A-4.103, F.A.C. b. Adverse incident reports required pursuant to Sections (7) and (8), F.S. and Rule 59A-4.123, F.A.C. c. Liability claim reports required pursuant to Section (10), F.S. and Rule 59A-4.123, F.A.C. 2. Assisted living facilities: a. Adverse incident reports required pursuant to Sections (3) and (4), F.S. and Rule 58A , F.A.C. b. Liability claim reports required pursuant to Section (5), F.S. and Rule 58A , F.A.C. (b) The licensee must retain the receipt issued from the Internet site indicating that their transaction was accepted. (c) If the Agency's Internet site is temporarily out of service, the required reports may be submitted by mail or facsimile as follows: During entrance conference, determine if there has been a "CHOW". - Regarding 59A (1)(f), this does not apply to Home Care Unit programs since there is a different process through the Department of Health in chapter 400 Part III & IV, F.S. - Regarding 59A (2), this only applies to nursing homes and assisted living facilities. 59A FAC does not apply to Abortion Clinics

62 Page 62 of Semi-annual staffing ratios and liability claim reports are sent to the Agency for Health Care Administration, Central Systems Management Unit, 2727 Mahan Drive, MS #47, Tallahassee, FL or facsimile to (850) Adverse incident reports are sent to the Agency for Health Care Administration, Florida Center for Health Information and Policy Analysis, 2727 Mahan Drive, MS #16, Tallahassee, FL or facsimile to (850) ST - OZ824 - Right of Inspection; Inspection Reports Title Right of Inspection; Inspection Reports Statute or Rule FS; 59A FAC Right of inspection; copies; inspection reports; plan for correction of deficiencies.- (1) An authorized officer or employee of the agency may make or cause to be made any inspection or investigation deemed necessary by the agency to determine the state of compliance with this part, authorizing statutes, and applicable rules. The right of inspection extends to any business that the agency has reason to believe is being operated as a provider without a license, but inspection of any business suspected of being operated without the appropriate license may not be made without the permission of the owner or person in charge unless a warrant is first obtained from a circuit court. Any application for a license issued under this part, authorizing statutes, or applicable rules constitutes permission for an appropriate inspection to verify the information submitted on or in connection with the application. (a) All inspections shall be unannounced, except as specified in s (b) Inspections for relicensure shall be conducted biennially unless otherwise specified by authorizing statutes or

63 Page 63 of 69 applicable rules. (2) Inspections conducted in conjunction with certification, comparable licensure requirements, or a recognized or approved accreditation organization may be accepted in lieu of a complete licensure inspection. However, a licensure inspection may also be conducted to review any licensure requirements that are not also requirements for certification. (3) The agency shall have access to and the licensee shall provide, or if requested send, copies of all provider records required during an inspection or other review at no cost to the agency, including records requested during an offsite review. (4) A deficiency must be corrected within 30 calendar days after the provider is notified of inspection results unless an alternative timeframe is required or approved by the agency. (5) The agency may require an applicant or licensee to submit a plan of correction for deficiencies. If required, the plan of correction must be filed with the agency within 10 calendar days after notification unless an alternative timeframe is required. (6)(a) Each licensee shall maintain as public information, available upon request, records of all inspection reports pertaining to that provider that have been filed by the agency unless those reports are exempt from or contain information that is exempt from s (1) and s. 24(a), Art. I of the State Constitution or is otherwise made confidential by law. Effective October 1, 2006, copies of such reports shall be retained in the records of the provider for at least 3 years following the date the reports are filed and issued, regardless of a change of ownership. (b) A licensee shall, upon the request of any person who has completed a written application with intent to be admitted by such provider, any person who is a client of such provider, or any relative, spouse, or guardian of any such person, furnish to the requester a copy of the last inspection report pertaining to the licensed provider that was issued by the agency or by an

64 Page 64 of 69 accrediting organization if such report is used in lieu of a licensure inspection. 59A Inspections. (1) When regulatory violations are identified by the Agency: (a) Deficiencies must be corrected within 30 days of the date the Agency sends the deficiency notice to the provider, unless an alternative timeframe is required or approved by the Agency. (b) The Agency may conduct an unannounced follow-up inspection or off-site review to verify correction of deficiencies at any time. (2) If an inspection is completed through off-site record review, any records requested by the Agency in conjunction with the review, must be received within 7 days of request and provided at no cost to the Agency. Each licensee shall maintain the records including medical and treatment records of a client and provide access to the Agency. (3) Providers that are exempt from Agency inspections due to accreditation oversight as prescribed in authorizing statutes must provide: (a) Documentation from the accrediting agency including the name of the accrediting agency, the beginning and expiration dates of the provider's accreditation, accreditation status and type must be submitted at the time of license application, or within 21 days of accreditation. (b) Documentation of each accreditation inspection including the accreditation organization's report of findings, the provider's response and the final determination must be submitted within 21 days of final determination or the provider is no longer exempt from Agency inspection.

65 Page 65 of 69 ST - OZ827 - Unlicensed Activity Title Unlicensed Activity Statute or Rule , F.S Unlicensed activity.- (1) A person or entity may not offer or advertise services that require licensure as defined by this part, authorizing statutes, or applicable rules to the public without obtaining a valid license from the agency. A licenseholder may not advertise or hold out to the public that he or she holds a license for other than that for which he or she actually holds the license. (2) The operation or maintenance of an unlicensed provider or the performance of any services that require licensure without proper licensure is a violation of this part and authorizing statutes. Unlicensed activity constitutes harm that materially affects the health, safety, and welfare of clients. The agency or any state attorney may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of the unlicensed provider or the performance of any services in violation of this part and authorizing statutes, until compliance with this part, authorizing statutes, and agency rules has been demonstrated to the satisfaction of the agency. (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (4) Any person or entity that fails to cease operation after agency notification may be fined $1,000 for each day of - This tag can be cited in conjunction with Z0803 License Required; Display, F.S. - License required when the provider is offering services not authorized and printed on the face of the license, when the licensed owner is not operating and it is being operated by another entity that is not licensed to operate. - It may also be cited if the Agency has notified the provider to cease unlicensed activity and the provider continues to operate.

66 Page 66 of 69 noncompliance. (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. (6) In addition to granting injunctive relief pursuant to subsection (2), if the agency determines that a person or entity is operating or maintaining a provider without obtaining a license and determines that a condition exists that poses a threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the same actions and fines imposed against a licensee as specified in this part, authorizing statutes, and agency rules. (7) Any person aware of the operation of an unlicensed provider must report that provider to the agency. ST - OZ828 - Administrative Fines; Violations Title Administrative Fines; Violations Statute or Rule (3) FS (3) The agency may impose an administrative fine for a violation that is not designated as a class I, class II, class III, or class IV violation. Unless otherwise specified by law, the amount of the fine may not exceed $500 for each violation. Unclassified violations include: (a) Violating any term or condition of a license. (b) Violating any provision of this part, authorizing statutes, or applicable rules. (c) Exceeding licensed capacity. - Review the license, including the capacity. - What services is the facility licensed to provide? - Is the facility under a moratorium? - Is the facility providing services for 24 hours or more to a census that exceeds their capacity? - Observe the number of residents, sleeping arrangements and medications. - Review records, including the admission/discharge log, medication records and resident records. - Review staff qualifications, including licensure. - Interview residents, staff, family members, case managers and any third party providers, including health care providers and home health to determine what services are provided and by whom.

67 Page 67 of 69 (d) Providing services beyond the scope of the license. (e) Violating a moratorium imposed pursuant to s The Central Office program unit is responsible for preparation of requests for sanctions for licensure actions. ST - OZ829 - Moratorium; Emergency Suspension Title Moratorium; Emergency Suspension Statute or Rule , F.S Moratorium; emergency suspension.- (1) The agency may impose an immediate moratorium or emergency suspension as defined in s on any provider if the agency determines that any condition related to the provider or licensee presents a threat to the health, safety, or welfare of a client. (2) A provider or licensee, the license of which is denied or revoked, may be subject to immediate imposition of a moratorium or emergency suspension to run concurrently with licensure denial, revocation, or injunction. (3) A moratorium or emergency suspension remains in effect after a change of ownership, unless the agency has determined that the conditions that created the moratorium, emergency suspension, or denial of licensure have been corrected. (4) When a moratorium or emergency suspension is placed on a provider or licensee, notice of the action shall be posted and visible to the public at the location of the provider until the action is lifted. Determine through observations if the facility has posted the moratorium visible to the public. ST - OZ830 - Emergency Management Planning Title Emergency Management Planning Statute or Rule , F.S.

68 Page 68 of Emergency management planning; emergency operations; inactive license.- (1) A licensee required by authorizing statutes to have an emergency operations plan must designate a safety liaison to serve as the primary contact for emergency operations. (2) An entity subject to this part may temporarily exceed its licensed capacity to act as a receiving provider in accordance with an approved emergency operations plan for up to 15 days. While in an overcapacity status, each provider must furnish or arrange for appropriate care and services to all clients. In addition, the agency may approve requests for overcapacity in excess of 15 days, which approvals may be based upon satisfactory justification and need as provided by the receiving and sending providers. (3)(a) An inactive license may be issued to a licensee subject to this section when the provider is located in a geographic area in which a state of emergency was declared by the Governor if the provider: 1. Suffered damage to its operation during the state of emergency. 2. Is currently licensed. 3. Does not have a provisional license. 4. Will be temporarily unable to provide services but is reasonably expected to resume services within 12 months. (b) An inactive license may be issued for a period not to exceed 12 months but may be renewed by the agency for up to 12 additional months upon demonstration to the agency of progress toward reopening. A request by a licensee for an inactive license or to extend the previously approved inactive period must be submitted in writing to the agency, accompanied by written justification for the inactive license, which states the beginning and ending dates of inactivity and includes a plan for the transfer of any clients to other providers and appropriate licensure fees. Upon agency approval, the licensee shall notify clients of any necessary - Four of the Home Care programs have major state laws that have extensive emergency management requirements - home health agencies, hospices, nurse registries and home medical equipment providers - and their associated regulation sets have specific standards.

69 Page 69 of 69 discharge or transfer as required by authorizing statutes or applicable rules. The beginning of the inactive licensure period shall be the date the provider ceases operations. The end of the inactive period shall become the license expiration date, and all licensure fees must be current, must be paid in full, and may be prorated. Reactivation of an inactive license requires the prior approval by the agency of a renewal application, including payment of licensure fees and agency inspections indicating compliance with all requirements of this part and applicable rules and statutes. (4) The agency may adopt rules relating to emergency management planning, communications, and operations. Licensees providing residential or inpatient services must utilize an online database approved by the agency to report information to the agency regarding the provider's emergency status, planning, or operations.