105 CMR 145.020
Definitions
Back-up Dialysis means dialysis given to a patient in a situation other than the patient's usual
dialysis environment.
Chronic Maintenance Dialysis means the usual periodic dialysis treatments of a patient who has
chronic renal disease.
Commissioner means the Commissioner of Public Health or his or her designee.
Department means the Department of Public Health.
Direct Care Staff means registered nurses, licensed practical nurses, and trained dialysis
technicians who provide direct care to patients undergoing dialysis in the unit. Direct care staff
may include charge nurses, but shall not include the nurse manager, nurses assigned to dialysis
training, or technicians assigned to dialyzer preparation or reuse, equipment maintenance, and
water testing and purification.
Governing Body means, in the case of a corporation, the board of directors, or an executive
committee thereof empowered under the bylaws of the corporation to supervise the operation of
the unit; or in every other case, the owner and such other individuals as are associated with the
owner in the management of the unit.
Healthcare-associated Infection (HAl) means a localized or systemic condition that results from
an adverse reaction to the presence of an infectious agent or its toxins that:
(1) occurs in a patient in an out-of-hospital dialysis unit; and
(2) was not present or incubating at the time of the admission during which the reaction
occurs;
(3) meets the criteria for a specific infection as defined by the federal Centers for Disease
Control and Prevention and its National Healthcare Safety Network; and
(4) any additional elements as set forth in administrative guidelines of the Department based
on the National Healthcare Safety Network.
Home Hemodialysis means chronic maintenance dialysis performed at home by a trained patient
with the assistance of a trained partner.
Home Peritoneal Dialysis means chronic maintenance dialysis performed at home by a trained
patient with or without the assistance of a trained partner.
Licensed or Approved Hospital means any hospital licensed under M.G.L. c. 111, § 51.
Licensed Practical Nurse means an individual who is currently licensed pursuant to
M.G.L. c. 112, § 74A, to practice practical nursing in Massachusetts.
National Healthcare Safety Network NHSN means the HAI tracking system by the federal
Centers for Disease Control and Prevention.
Nurse Practitioner means a nurse who is authorized to practice advanced practice registered
nursing as a nurse practitioner by the Board of Registration in Nursing.
Original License means the first license issued to a person to maintain the premises named
therein, whether upon the initial establishment of the unit or subsequently upon the relocation
or transfer of ownership of the unit.
11/30/18
105 CMR - 723
145.020: continued
Out-of-hospital Dialysis Unit or Unit means a unit, however named, maintained separate from
a licensed or approved hospital or license issued thereto, whether conducted for charity or for
profit, for the purpose of providing chronic maintenance dialysis to persons suffering from
chronic renal disease and other dialysis as permitted by law. It shall not include a dialysis unit
maintained as part of a licensed or approved hospital.
Person means any individual or his estate upon his death; or a partnership, corporation, or trust
or other unincorporated association; or any receiver, trustee, or other liquidating agent of any of
the foregoing while acting in such capacity.
Physician means an individual who is currently licensed pursuant to M.G.L. c. 112, § 2, to
practice medicine or osteopathy in Massachusetts.
Physician Assistant means a person who is licensed by the Board of Registration of Physician
Assistants.
Registered Nurse means an individual who is currently registered pursuant to M.G.L. c. 112,
§ 74, to practice professional nursing in Massachusetts.
Renewal License means the first and each subsequent renewal of the original license to maintain
premises named therein as an out-of-hospital dialysis unit.
Transfer of Ownership includes, in the case of a partnership, any change in partners, and, in the
case of a corporation, any transfer of 50% or more of the outstanding shares of stock in such
corporation.