216 R.I. Code R. 216-RICR-40-10-4.3 - Definitions

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.

Notes

216 R.I. Code R. 216-RICR-40-10-4.3