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