Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 10 - Facility regulation › Part 4 - Licensing of Hospitals › Section 216-RICR-40-10-4.3 - Definitions

Current through June 14, 2024
A. Wherever used in these rules and
				  regulations, the following terms shall be construed as follows:
1. "Advanced practice clinician," as used in
				  these regulations, means an advanced practice nurse licensed in accordance with
				  R.I. Gen. Laws Chapter 5-34, and/or a certified registered nurse anesthetist
				  licensed in accordance with R.I. Gen. Laws Chapter 5-34.2; and/or a midwife
				  licensed in accordance with R.I. Gen. Laws §
											23-13-9;
				  and/or a physician assistant licensed in accordance with R.I. Gen. Laws Chapter
				  5-54.
2. "After-care," as used in
				  §4.6.33 of this Part, means any assistance provided by a caregiver to a
				  patient after the patient's discharge from a hospital that is related to the
				  patient's condition at the time of discharge. Such assistance may include, but
				  is not limited to, assisting with basic activities of daily living,
				  instrumental activities of daily living, or other tasks as determined to be
				  appropriate by the discharging physician or other health care
				  professional.
3. "The bed
				  complement" of a hospital refers to the number of beds a hospital has in actual
				  use, equal to or less than the licensed capacity.
4. "Bilingual" means having fluency in
				  English and in another language.
5.
				  "Birth center service" means a distinct and identifiable unit in a hospital
				  with an obstetrical service, staffed, equipped and operated to provide services
				  to low risk mothers-to-be (as defined in §4.6.23(B)(1) of this Part), or
				  mothers during pregnancy, labor, birth and puerperium.
6. "Caregiver" means any individual duly
				  designated as a caregiver by a patient under §4.6.33 of this Part who
				  provides after-care assistance to a patient living in his or her residence. A
				  designated caregiver may include, but is not limited to, a relative, partner,
				  friend, or neighbor who has a significant relationship with the
				  patient.
7. "Change in operator"
				  means a transfer by the governing body or operator of a hospital to any other
				  person (excluding delegations of authority to the medical or administrative
				  staff of the facility) of the governing body's authority to:
a. hire or fire the chief executive officer
				  of the hospital;
b. maintain and
				  control the books and records of the hospital;
c. dispose of assets and incur liabilities on
				  behalf of the hospital; or
d. adopt
				  and enforce policies regarding operation of the hospital.
e. This definition is not applicable to
				  circumstances wherein the governing body of a hospital retains the immediate
				  authority and jurisdiction over the activities enumerated in §§
												4.3(A)(7)(a) through
				  (d)   of this Part above.
8. "Change in owner" means:
a. in the case of a hospital which is a
				  partnership, the removal, addition or substitution of a partner which results
				  in a new partner acquiring a controlling interest in such
				  partnership;
b. in the case of a
				  hospital which is an unincorporated solo proprietorship, the transfer of the
				  title and property to another person;
c. in the case of a hospital which is a
				  corporation:
(1) a sale, lease, exchange or
				  other disposition of all, or substantially all, of the property and assets of
				  the corporation; or
(2) a merger of
				  the corporation into another corporation; or
(3) the consolidation of two or more
				  corporations, resulting in the creation of a new corporation; or
(4) in the case of a hospital which is a
				  business corporation, any transfer of corporate stock which results in a new
				  person acquiring a controlling interest in such corporation; or
(5) in the case of a hospital which is a
				  non-business corporation, any change in membership which results in a new
				  person acquiring a controlling vote in such corporation.
9. "Charity care" means health
				  care services provided by a hospital without charge to a patient and for which
				  the hospital does not and has not expected payment. Said health care services
				  shall be rendered to patients determined to be uninsured, underinsured or
				  otherwise deemed to be eligible at the time of delivery of services. Charity
				  care services are those health care services that are not recognized as either
				  a receivable or as revenue in the hospital's financial statements. Charity care
				  shall not include health care services provided to individuals for the purpose
				  of professional courtesy without charge or for reduced charge. Under no
				  circumstances shall bad debt be deemed to be charity care. Charity care shall
				  be cost adjusted by applying a ratio of cost to charges from the hospital's
				  Medicare Cost Reports to charity care charges-foregone.
10. "Clinician" means a physician licensed
				  under R.I. Gen. Laws Chapter 5-37; a nurse licensed under R.I. Gen. Laws
				  Chapter 5-34; a psychologist licensed under R.I. Gen. Laws Chapter 5-44, a
				  social worker licensed under R.I. Gen. Laws Chapter 5-39.1; a physical
				  therapist licensed under R.I. Gen. Laws Chapter 5-40; and a speech language
				  pathologist or audiologist licensed under R.I. Gen. Laws Chapter
				  5-48.
11. "Conscious sedation"
				  means a drug-induced depression of consciousness during which patients respond
				  purposefully (reflex withdrawal from a painful stimulus is not considered a
				  purposeful response) to verbal commands, either alone or accompanied by light
				  tactile stimulation. No interventions are required to maintain a patent airway,
				  and spontaneous ventilation is adequate. Cardiovascular function is usually
				  maintained.
12. "Conversion" means
				  any transfer by a person or persons of an ownership or membership interest or
				  authority in a hospital, or the assets thereof, whether by purchase, merger,
				  consolidation, lease, gift, joint venture, sale, or other disposition which
				  results in a change of ownership or control or possession of twenty percent
				  (20%) or greater of the members or voting rights or interests of the hospital
				  or of the assets of the hospital or pursuant to which, by virtue of such
				  transfer, a person, together with all persons affiliated with such person,
				  holds or owns, in the aggregate, twenty percent (20%) or greater of the
				  membership or voting rights or interests of the hospital or of the assets of
				  the hospital, or the removal, addition or substitution of a partner which
				  results in a new partner gaining or acquiring a controlling interest in the
				  hospital, or any change in membership which results in a new person gaining or
				  acquiring a controlling vote in the hospital.
13. "Coronary artery bypass graft," as used
				  in these regulations, pertains to surgical operations for the purpose of
				  constructing new pathways around stenosing or obstructing lesions in segments
				  of coronary arteries for the purpose of bringing blood to the myocardium that
				  is otherwise made ischemic by these lesions. These grafted conduits shall
				  include autologous blood vessels, allograft vessels, and synthetic
				  tubes.
14. "Degradation (of
				  performance)" means an undesired departure in the operational performance of
				  any equipment and/or system from its intended performance. "Degradation" can
				  apply to temporary or permanent failure.
15. "Director" shall mean the Director of the
				  Rhode Island Department of Health.
16. "Discharge" means a patient's exit or
				  release from a hospital to the patient's residence following an inpatient
				  admission.
17. "Door-to-balloon
				  time," as used in these regulations, means the time that elapses from the point
				  in time at which the patient arrives at the percutaneous coronary intervention
				  (PCI) hospital to the point in time at which there is balloon inflation in
				  patients who receive primary angioplasty or primary coronary intervention.
				  Reported statistics shall follow applicable guidelines issued by the American
				  College of Cardiology and the American Heart Association.
18. "Elective percutaneous coronary
				  intervention," as used in these regulations, means all percutaneous coronary
				  intervention procedures except primary percutaneous coronary
				  intervention.
19. "Electromagnetic
				  compatibility" or "EMC" means the ability of an equipment and/or system to
				  function satisfactorily in its electromagnetic environment without introducing
				  intolerable electromagnetic disturbance (EMD) to anything in that
				  environment.
20. "Electromagnetic
				  disturbance" or "EMD" means any electromagnetic phenomenon that may degrade the
				  performance of an equipment and/or system. An EMD may be an electromagnetic
				  noise, an unwanted signal, or a change in the propagation medium
				  itself.
21. "Electromagnetic
				  interference" or "EMI" means degradation of the performance of a piece of
				  equipment, transmission channel, or system caused by an EMD.
22. "Entry" means a patient's admission into
				  a hospital for the purpose of medical care.
23. "Esophageal cancer surgery," as used in
				  these regulations, means esophageal surgical procedures, performed for the
				  purpose of treating known or suspected cancer, including esophageal resection,
				  partial or total esophagectomy, esophageal anastomosis, and other related
				  procedures excluding endoscopic procedures.
24. "Equity" means non-debt funds contributed
				  towards the capital costs related to a change in owner or change in operator of
				  a hospital which funds are free and clear of any repayment or liens against the
				  assets of the proposed owner and/or licensee and that result in a like
				  reduction in the portion of the capital cost that is required to be financed or
				  mortgaged.
25. "Fluency" means the
				  ability to converse freely in a language.
26. "Health care provider" means any person
				  licensed by this state to provide or otherwise lawfully providing health care
				  services, including, but not limited to, a physician, hospital, intermediate
				  care facility or other health care facility, dentist, nurse, optometrist,
				  podiatrist, physical therapist, psychiatric social worker, pharmacist, or
				  psychologist, and any officer, employee or agent of that provider acting in the
				  course and scope of his or her employment or agency related to or supportive of
				  health services.
27. "Health
				  Services Council" shall mean the advisory body to the Rhode Island Department
				  of Health established in accordance with R.I. Gen. Laws §
											23-17-13.1,
				  appointed and empowered in accordance with R.I. Gen. Laws §
											23-15-7 to serve as the advisory body to the state agency in its review
				  functions.
28. "Heart transplant,"
				  as used in these regulations, shall include the grafting of a replacement heart
				  into a person with a heart obtained from another person. These standards do not
				  apply to xenografts, nor to artificial or mechanical replacement
				  organs.
29. "High managerial agent"
				  means an officer of the hospital, the chief executive officer, director of risk
				  management, director of nursing services, or any other agent designated by the
				  hospital in a position of comparable authority with respect to the formulation
				  of hospital policies or the supervision of subordinate employees.
30. "Home care services" shall mean a program
				  which is currently administered, and through coordinated planning, evaluation,
				  and follow-up procedures, provides for physician-directed medical, nursing,
				  social, and related services made available either directly or through
				  participating agencies to selected patients having a nexus with a hospital at
				  their place of residence.
31.
				  "Hospital" shall mean a facility with a governing body, an organized medical
				  staff and a nursing service providing equipment and services primarily for
				  inpatient care to persons who require definitive diagnosis and treatment for
				  injury, illness or other disabilities or pregnancy. A hospital shall provide
				  psychiatric and/or medical and/or surgical care and at least the following
				  services: dietetic, infection control, medical records, laboratory,
				  pharmaceutical and radiology, except that a psychiatric facility need not
				  provide radiology services.
32.
				  "Laboratory station" means a facility for the collection, processing and
				  transmission of specimens derived from the human body.
33. "The licensed capacity" of a hospital
				  refers to the number of beds a hospital is licensed to operate.
34. "Licensing agency" shall mean the Rhode
				  Island Department of Health.
35.
				  "Lift team" means hospital employees specially trained to perform patient
				  lifts, transfers, and repositioning in accordance with safe patient handling
				  policy.
36. "Liver transplant," as
				  used in these regulations, shall include the grafting of a replacement liver
				  into a person with a liver obtained from another person. These standards do not
				  apply to xenografts, nor to artificial or mechanical replacement
				  organs.
37. "Local anesthesia"
				  means the injection of a local anesthetic agent (e.g., Lidocaine) into and
				  around the operative site to achieve numbness in the area where a painful
				  procedure is to be performed. This type of anesthesia does not involve any
				  systemic sedation.
38.
				  "Musculoskeletal disorders" means conditions that involve the nerves, tendons,
				  muscles, and supporting structures of the body.
39. "Neonatal intensive care unit" or "NICU"
				  means a unit that provides a comprehensive range of specialty and subspecialty
				  services to severely ill infants, including infants who have an elevated risk
				  of mortality as a consequence of very low birth weight (less than or equal to
				  1500 grams), surgical conditions, or other forms of severe illness in full-term
				  newborns.
40. "Net operating
				  revenue" means net patient revenue plus other operating revenue.
41. "Non-English speaker" means a person who
				  cannot speak or understand, or has difficulty in speaking or understanding, the
				  English language, because he/she uses only or primarily a spoken language other
				  than English, and/or a person who uses a sign language and requires the use of
				  a sign language interpreter to facilitate communication.
42. "Pancreatic cancer surgery", as used in
				  these regulations, means pancreatic surgical procedures, performed for the
				  purpose of treating known or suspected cancer, including resection of the
				  pancreas, partial or total pancreatectomy, radical pancreaticoduodenectomy, and
				  other related procedures excluding endoscopic procedures.
43. "Percutaneous coronary intervention" or
				  "PCI", as used in these regulations, shall include not only conventional
				  balloon angioplasty but also non-balloon procedures including, but not limited
				  to, directional antherectomy, excimer laser, transluminal extraction catheter,
				  rotablation, and coronary stenting and thrombus aspiration.
44. "Person" shall mean any individual, trust
				  or estate, partnership, corporation (including associations, joint stock
				  companies), limited liability companies, state, or political subdivision or
				  instrumentality of a state.
45.
				  "Physician" means any person licensed to practice allopathic or osteopathic
				  medicine pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
46. "Premises" means a tract of land and the
				  buildings thereon where direct patient care services are provided.
47. "Primary percutaneous coronary
				  intervention", as used in these regulations, means percutaneous coronary
				  intervention used as the primary reperfusion strategy, with or without
				  thrombolysis, for known or suspected acute myocardial infarction.
48. "Qualified interpreter" means a person
				  who, through experience and/or training, is able to translate/interpret a
				  particular foreign language into English with the exception of sign language
				  interpreters who must be licensed in accordance with R.I. Gen. Laws Chapter
				  5-71.
49. "Qualified sign language
				  interpreter" means one who has been licensed in accordance with the provisions
				  of R.I. Gen. Laws Chapter 5-71.
50.
				  "Radio frequency" means a frequency in the portion of the electromagnetic
				  spectrum that is between the audio-frequency portion and the infrared portion.
				  The present practical limits of radio frequency are roughly 9 kHz to 3000
				  GHz.
51. "Regional anesthesia"
				  means the use of local anesthetic agents to block nerves leading to the area
				  where a painful procedure is to be done. There are many examples of regional
				  anesthesia, including, but not limited to, spinal, interscalene, ankle, etc.
				  Generally, regional anesthesia involves more of a physiological reaction
				  because of the larger area blocked and/or the dose of local anesthesia. This
				  type of anesthesia may or may not involve sedation.
52. "Renovation" means moving a wall or
				  otherwise changing a structure such that life safety codes or other structural
				  requirements are affected. Normal maintenance of an existing structure is
				  excluded from this definition.
53.
				  "Reportable event" means:
a. fire or internal
				  disaster in the facility which disrupts the provision of patient care services
				  or causes harm to patients or personnel;
b. poisoning involving patient(s) of the
				  facility;
c. infection outbreak as
				  may be defined by and in accordance with rules and regulations pertaining to
				  the Reporting and Testing of Infectious, Environmental and Occupational
				  Diseases (Part 30-05-1 of this Title);
d. kidnapping;
e. elopements from inpatient psychiatric
				  units and elopements by minors who are inpatients, (reportable to the
				  Department of Health at the time the local municipal police are informed);
				  elopements of psychiatric patients from outpatient or emergency departments who
				  are reasonably thought to be a danger to themselves or to others;
f. strikes, official strike notices, or other
				  personnel actions that may disrupt services;
g. disasters or other emergency situations
				  external to the hospital environment which adversely affect facility
				  operations; and
h. unscheduled
				  termination of any health care service or utilities vital to the continued safe
				  operation of the facility or to the health and safety of its patients and
				  personnel (including any unanticipated interruption in power to a facility, as
				  well as any event that triggers the use of a backup generator).
54. "Reportable incidents" are
				  those which result in patient injury as defined in §§
											4.3(A)(53)(a)
				    though (j) or which involve matters described in §§
											4.3(A)(53)(k) through
				  (o):
a.
				  brain injury;
b. mental
				  impairment;
c.
				  paraplegia;
d.
				  quadriplegia;
e. any
				  paralysis;
f. loss of use of limb
				  or organ;
g. any serious or
				  unforeseen complication, that is not expected or probable, resulting in an
				  extended hospital stay or death of the patient;
h. birth injury;
i. impairment of sight or hearing;
j. surgery on the wrong patient;
k. subjecting a patient to a
				  procedure/treatment not ordered or intended by the patient's attending
				  physician, excluding procedures not requiring a physician's order, medication
				  errors, and collection of specimen, for laboratory study, obtained by non-
				  invasive means or routine phlebotomy;
l. suicide of a patient during treatment or
				  within five (5) days of discharge from inpatient or outpatient units (if
				  known);
m. blood transfusion
				  error;
n. medication error that
				  necessitates a clinical intervention other than monitoring; or
o. any other incident reported to the
				  malpractice insurance carrier or self-insurance program.
55. "Residence" means a dwelling that the
				  patient considers to be his or her home. A "residence" for the purposes of
				  §4.6.33 of this Part shall not include any rehabilitation facility,
				  hospital, nursing home, assisted-living facility, or group home licensed by
				  Rhode Island.
56. "R.I. Gen. Laws"
				  means General Laws of Rhode Island, as amended.
57. "Root cause analysis" means a process for
				  identifying the causal factor(s) that underlie variation in
				  performance.
58. "Safe patient
				  handling" means the use of engineering controls, transfer aids, or assistive
				  devices whenever feasible and appropriate instead of manual lifting to perform
				  the acts of lifting, transferring, and/or repositioning health care patients
				  and residents.
59. "Safe patient
				  handling policy" means protocols established to implement safe patient
				  handling.
60. "State agency" shall
				  mean the Rhode Island Department of Health.
61. "Tertiary care" means services provided
				  by highly specialized providers (e.g.,neonatologists, neurosurgeons, thoracic
				  surgeons). Such services frequently require highly sophisticated equipment and
				  support facilities. As used in these regulations, this care is defined as
				  including, but is not limited to, those services provided in a neonatal
				  intensive care unit.
62. "These
				  Regulations" means this Part.