House File 2165 HOUSE FILE BY HUNTER, GREIMANN, and FOEGE Passed House, Date Passed Senate, Date Vote: Ayes Nays Vote: Ayes Nays Approved A BILL FOR 1 An Act relating to the regulation of renal dialysis facilities 2 and providing for injunctive relief. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 5907HH 80 5 pf/gg/14 PAG LIN 1 1 Section 1. NEW SECTION. 135M.1 DEFINITIONS. 1 2 For the purposes of this chapter, unless the context 1 3 otherwise requires: 1 4 1. "Department" means the department of inspections and 1 5 appeals. 1 6 2. "Dialysis" means a process by which substances are 1 7 removed from a patient's body by diffusion from one fluid 1 8 compartment to another across a semipermeable membrane. 1 9 3. "End=stage renal disease" means end=stage renal disease 1 10 as defined in section 135.45. 1 11 4. "Renal dialysis facility" means an outpatient facility 1 12 which offers staff=assisted dialysis or training and support 1 13 services for self=dialysis at home to end=stage renal disease 1 14 patients, but does not include: 1 15 a. Facilities operated by the state or federal government. 1 16 b. Renal dialysis services provided by a licensed 1 17 hospital. 1 18 5. "Self=dialysis at home" means dialysis performed by a 1 19 patient at home when the patient has completed a course in 1 20 self=dialysis. 1 21 6. "Staff=assisted dialysis" means dialysis performed by 1 22 qualified staff of a renal dialysis facility. 1 23 Sec. 2. NEW SECTION. 135M.2 REGULATION OF RENAL DIALYSIS 1 24 FACILITIES. 1 25 1. The department of inspections and appeals shall adopt 1 26 rules for the regulation of renal dialysis facilities located 1 27 in this state. The rules shall be consistent with the end= 1 28 stage renal disease requirements for participation in the 1 29 Medicare program. 1 30 2. In addition to and consistent with the end=stage renal 1 31 disease requirements for participation in the Medicare 1 32 program, the rules adopted by the department under this 1 33 chapter shall include, but are not limited to, regulation of 1 34 all of the following: 1 35 a. Qualifications of renal dialysis facility personnel. 2 1 b. Medical staffing. 2 2 c. Transfer agreements with hospitals to provide for the 2 3 transfer of a patient for the provision of inpatient care and 2 4 other hospital services. 2 5 d. The rights and responsibilities of patients. 2 6 e. Disaster preparedness. 2 7 f. Infection control. 2 8 g. Incident and accident reports. 2 9 3. The rules relating to disaster preparedness shall 2 10 include all of the following: 2 11 a. That a renal dialysis facility have written policies 2 12 and procedures for emergencies that address fire, natural 2 13 disaster, and medical emergencies. The emergency procedures 2 14 developed shall be individualized for each patient to include 2 15 an appropriate evacuation from the facility or the patient's 2 16 home and the emergency telephone numbers needed for each 2 17 patient. 2 18 b. That a renal dialysis facility familiarize personnel 2 19 and patients with the policies and procedures developed 2 20 pursuant to paragraph "a". 2 21 c. That the renal dialysis facility familiarize each 2 22 patient with the procedure for disconnecting the patient's 2 23 dialysis equipment in the event of an emergency. 2 24 d. That in the event of a medical emergency, renal 2 25 dialysis facility personnel shall contact the patient's 2 26 physician or surgeon, as designated by the patient, and follow 2 27 the instructions provided by the physician or surgeon. If the 2 28 patient's physician or surgeon is not available, the renal 2 29 dialysis facility personnel shall contact the hospital with 2 30 which the facility has a transfer agreement to seek 2 31 instructions and shall follow the instructions provided by the 2 32 hospital personnel. 2 33 Sec. 3. NEW SECTION. 135M.3 INSPECTIONS == INJUNCTION. 2 34 1. The department shall coordinate efforts with the end= 2 35 stage renal disease network established by federal law to 3 1 provide for inspection of renal dialysis facilities. The 3 2 facilities shall be inspected on at least an annual basis. 3 3 2. The department may request that the attorney general 3 4 bring an action to enjoin the operation of a renal dialysis 3 5 facility if the department finds that the facility is in 3 6 violation of this chapter and the department determines that 3 7 an imminent threat to the health and safety of a patient of 3 8 the facility exists. 3 9 EXPLANATION 3 10 This bill relates to the regulation of renal dialysis 3 11 facilities, defined by the bill as outpatient facilities which 3 12 offer staff=assisted dialysis or training and support services 3 13 for self=dialysis at home to end=stage renal disease patients. 3 14 Renal disease facilities under the bill do not include 3 15 facilities operated by the state or federal government or 3 16 renal dialysis services provided by a licensed hospital. 3 17 The bill directs the department of inspections and appeals 3 18 to adopt rules for the regulation of renal dialysis facilities 3 19 located in this state. The rules are to be consistent with 3 20 the end=stage renal disease requirements for participation in 3 21 the Medicare program. 3 22 The rules are to include, but are not limited to, 3 23 qualifications of renal dialysis facility personnel, medical 3 24 staffing, transfer agreements with hospitals, the rights and 3 25 responsibilities of patients, disaster preparedness, infection 3 26 control, and incident and accident reports. 3 27 The bill specifies that the rules relating to disaster 3 28 preparedness are to include that a renal dialysis facility 3 29 have written policies and procedures for emergencies that 3 30 address fire, natural disaster, and medical emergencies; that 3 31 such a facility familiarize personnel and patients with the 3 32 policies and procedures; that the facility familiarize each 3 33 patient with the procedure for disconnecting the patient's 3 34 dialysis equipment in the event of an emergency; and whom 3 35 facility personnel are to contact in the event of a medical 4 1 emergency. 4 2 The bill directs the department to coordinate efforts with 4 3 the end=stage renal disease network established by federal law 4 4 to provide for inspection of renal dialysis facilities. The 4 5 network contracts with the centers for Medicare and Medicaid 4 6 services of the United States department of health and human 4 7 services to ensure the administration of the end=stage renal 4 8 disease program under the Medicare program. The bill requires 4 9 the facilities to be inspected on at least an annual basis. 4 10 The bill also provides for injunctive relief if the 4 11 department finds that a facility is in violation of the Code 4 12 chapter and the department determines that an imminent threat 4 13 to the health and safety of a patient of the facility exists. 4 14 LSB 5907HH 80 4 15 pf/gg/14