Source: http://www.qups.org/med_errors.php?c=internal&id=202
Timestamp: 2019-02-21 23:54:31
Document Index: 6775557

Matched Legal Cases: ['§ 1', '§ 34', '§ 34', '§ 34', '§ 41', '§ 42', '§ 43', '§ 44', '§ 62', '§ 11', '§ 17', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 34', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 41', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 43', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', 'art 486', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 44', '§ 62', '§62', '§ 11', '§ 11', '§ 17', '§ 17']

Home > Medical Errors and Patient Safety > Statutes/Rules > Misc. DOH Regulations – Rhode Island
Rhode Island Regulations Governing
Selected Department of Health Rules
R23-17-HOSP – Licensing of Hospitals [PDF]
Definition: “Hospitals”
Definition: “Reportable Events”
§ 1.42
Definition: “Reportable Incidents”
§§ 34.1 to 34.2
Reporting of Hospital Events & Incidents:
§§ 34.3 to 34.5
§§ 34.6 to 34.11
§§ 41.0 to 41.16
Tertiary Care Services:
§§ 42.0 to 42.17
Coronary Angioplasty Programs
§§ 43.0 to 43.18
Coronary Artery Bypass Graft Surgical Programs
§§ 44.0 to 44.16
Heart and/or Liver Transplant Programs
§ 62.0
R23-17-PASC – Licensing of Physician Ambulatory Surgery Centers
and Podiatry Ambulatory Surgery Centers [PDF]
§ 11.0
§ 17.0
R23-17-HOSP [PDF]
§ 1.0 – Definitions.
Wherever used in these rules and regulations, the following terms shall be construed as follows:
§ 1.1 . . .
§ 1.22 – “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.
§ 1.24 – “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.
§ 1.41 – “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 reference 21;
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).
§ 1.42 – “Reportable incidents” are those which result in patient injury as defined in a) though j) or which involve matters described in 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.
Section 34.0 – Reporting of Hospital Events & Incidents
§ 34.1 All patient deaths occurring within the hospital, which are reportable in accordance with reference 30, shall be reported to the Office of State Medical Examiners.
§ 34.2 In addition to the above, hospitals shall be subject to the appropriate requirements of reference 30.
§ 34.3 The hospital shall, within 24 hours of receipt of such information, notify the licensing agency of any reportable event as defined in section 1.41 herein.
§ 34.4 In cases of kidnapping or elopement, the report to the licensing agency shall include: patient medical record number; date and circumstances of the kidnapping/elopement; and outcome (e.g., return to hospital, adverse effect, etc.) Peer review and follow-up reporting shall be conducted as required in sections 34.10 and 34.11 herein.
§ 34.5 Health care facilities shall provide the licensing agency with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. Health care facilities shall provide a plan, acceptable to the Director, for continued operation of the facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action.
§ 34.6 The hospital shall ensure that any employee who has reasonable cause to believe a reportable incident, as defined in section 1.42 herein, has occurred reports such information to a high managerial agent within twenty-four (24) hours of receipt of such information.
§ 34.7 The hospital must maintain records of such reports including all subsequent actions taken.
§ 34.8 Any reportable incident occurring on or after June 30, 1994 shall be reported in writing to the Department of Health within seventy-two (72) hours of when the hospital has reasonable cause to believe an incident has occurred. Any incident(s) occurring prior to June 30, 1994 need not be reported.
§ 34.9 Written report shall be in compliance with section 62.0 herein and shall include a patient medical record number but no personal identifier.
§ 34.10 The hospital shall ensure an appropriate committee or multidisciplinary group conducts peer review for all reportable incidents. The hospital shall notify the licensing agency of the outcome of the internal review as soon as this information is available but in no case later than six (6) months after the initial report and if the findings determine that the incident was within the normal range of outcomes, no further action shall be required.
§ 34.11 If findings conclude that the incident was not within said normal range, the hospital will provide the licensing agency the following information:
a) an explanation of the circumstances surrounding the incident;
b) an updated assessment of the effect of the incident on the patient;
c) a summary of current patient status including follow-up care and post incident diagnosis; and
d) a summary of all actions taken to correct identified problems to prevent recurrence of the incident and/or improve overall patient care.
§ 34.12 The hospital shall forward to the licensing agency copies of all hospital notifications and reports made in compliance with the federal Safe Medical Devices Act of 1990.
§ 34.13 The hospital shall report within 24 hours, to the licensing agency, allegations of patient abuse, neglect or mistreatment as defined in Chapter 23-17.8 of the Rhode Island General Laws, as amended.
Section 41.0 – Tertiary Care Services: Neonatal Intensive Care Units (NICUs)
Approval to Operate a NICU and General Requirements
§ 41.1 In order to use the designation “neonatal intensive care unit” or “NICU”, a hospital shall obtain approval from the Department's Division of Facilities Regulation. Said approval shall be issued by the Department if the NICU meets the requirements defined herein.
a) Each hospital shall renew this NICU designation annually.
§ 41.2 Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described herein, the Department shall approve the hospital's designation as a NICU.
§ 41.3 A hospital that has not received approval by the Department under this section shall not use the designation “neonatal intensive care unit” to describe any such services provided.
§ 41.4 A hospital that operates a neonatal intensive care unit approved by the Department shall maintain capabilities and provide services that include, but are not limited to, those capabilities and services described in sections 41.13, 41.14 and 41.15 (below).A hospital that operates a neonatal intensive care unit approved by the Department shall upgrade its capabilities and services as needed to meet the recommendations of the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
§ 41.5 A NICU shall provide consultation, transportation, and professional educational offerings to staff of other obstetrical facilities in the state.
§ 41.6 A hospital that operates a neonatal intensive care unit approved by the Department shall have written protocols in place that incorporate the following components:
a) continuous involvement of parents in an infant's care to maximize pre-discharge education regarding care of the infant;
b) nursing orientation and ongoing inservice education in the theory and skills necessary to function in a neonatal intensive care unit environment;
c) emergency transport of infants to the neonatal intensive care unit from other facilities;
d) administration, credentialing of staff, and staffing patterns of the neonatal intensive care unit.
Minimum Standards: Volume
§ 41.7 An existing neonatal intensive care unit shall maintain an average daily census of at least fifteen (15) neonates. Failure to maintain this volume level shall result in the penalties set forth in section 41.16 herein.
§ 41.8 As part of the approval process for a new (or proposed) neonatal intensive care unit, the hospital shall provide data to the Department demonstrating a reasonable expectation of referrals of high risk maternity patients so that an average daily census of at least fifteen (15) neonates is achievable within two (2) years of its opening date.
§ 41.9 As part of the approval process for a new (or proposed) neonatal intensive care unit, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed neonatal intensive care unit is likely to result in the average daily census falling below fifteen (15) neonates at any existing neonatal intensive care unit(s) in the state. If this outcome	is likely, the proposal shall describe how the overall quality of care for all very low birth weight neonates in the state will be improved with the addition of the proposed unit.
Minimum Standards: Survival Rates
§ 41.10 Each hospital that has an approved neonatal intensive care unit shall maintain a record of the neonatal survival rate (i.e., the rate at twenty-eight [28] days after delivery) and survival rate at discharge for very low birth weight neonates by 250 gram weight groups (i.e., 501--750 grams, 751--1000 grams, 1001--1250 grams, 1251--1500 grams).
§ 41.11 Each hospital shall maintain records of morbidity rates of neonates for nosocomial infections, necrotizing enterocolitis, bronchopulmonary dysplasia, and intraventricular hemorrhage.
§ 41.12 Each hospital shall report annually to the Department its survival rates for the hospital fiscal year as compared with the most recent rates reported by the National Institute of Child Health and Human Development Neonatal Network and the morbidity rates specified in section 41.11 (above). If the survival rate for the hospital's neonatal intensive care unit is lower than the survival rates reported by the National Institute of Child Health and Human Development Neonatal Network by more than twenty-five percent (25%), the neonatal intensive care unit shall file a written plan with the Department for the identification of the cause(s) of excess mortality and for correction of the rates.
§ 41.13 A hospital that operates a neonatal intensive care unit approved by the Department shall be in compliance with the following staffing requirements:
a) A board-certified neonatologist licensed in Rhode Island shall be designated as the medical director of the neonatal intensive care unit;
b) The registered nurse who has responsibility and accountability for the twenty-four (24) hour nursing management of the neonatal intensive care unit shall, at a minimum, be licensed in Rhode Island, have earned a bachelor's degree in nursing with additional education in neonatology, and have three (3) years of clinical experience, two (2) of which are in the specialty area of neonatology;
c) A registered dietitian licensed in Rhode Island with experience in neonatal nutrition shall actively participate in the management of neonates in the neonatal intensive care unit;
d) A respiratory therapist licensed in Rhode Island and trained in the neonatology specialty area shall be available to the neonatal intensive care unit twenty-four (24) hours per day.
§ 41.14 A hospital that operates a neonatal intensive care unit approved by the Department shall provide services that include but are not limited to the following:
a) twenty-four (24) hour emergency transport team for transferring sick newborns from the birth facility to the neonatal intensive care unit;
b) ventilatory assistance and/or complex respiratory management;
c) capability of continuous intravenous administration of vasopressor agents;
d) insertion and maintenance of all types of venous and arterial lines;
e) phototherapy;
f) exchange transfusions;
g) continuous cardiorespiratory monitoring;
h) complex nutritional and metabolic management including total parenteral nutrition;
i) extensive pediatric radiology, diagnostic imaging, and subspecialty services;
j) full range of laboratory services including microchemistry available on a twenty-four (24) hour basis;
k) pharmacy services experienced in neonatal medications and dosage;
l) surgical therapies and post-surgical care for the neonate;
m) access to pediatric subspecialty consultation;
n) availability of developmental consultation;
o) organized interdisciplinary process for continuous quality monitoring;
p) crisis-oriented support and ongoing psychosocial services, including social work services and the availability of psychiatric consultation for the parents of the neonate.
§ 41.15 A hospital that operates a neonatal intensive care unit approved by the Department shall maintain equipment in good working order that includes but is not limited to the following:
a) incubators;
b) cardiorespiratory monitors with high/low alarm and oximeters;
c) warming tables;
d) infusion pumps;
e) oxygen humidification and warming systems;
f) oxygen analyzer;
g) transcutaneous blood gas monitors;
h) arterial and venous catheterization equipment;
i) resuscitation and other life support medications and equipment;
j) ventilators with heated humidity and alarm systems;
k) transducers for invasive cardiac monitoring;
l) transport incubators.
§ 41.16 The penalties for violations of the standards set forth in section 40.0 herein shall be in accordance with those set forth in Chapter 23-17 of the Rhode Island General Laws, as amended. Failure to maintain the minimal neonatal intensive care unit standards set forth herein shall result in the revocation or suspension of the hospital's neonatal intensive care unit designation and/or cessation of its activities.
Section 42.0 – Tertiary Care Services: Coronary Angioplasty Programs
Approval to Operate a Coronary Angioplasty Program and General Requirements
§ 42.1 In order to use the designation “coronary angioplasty program”, a hospital shall obtain approval from the Department's Division of Facilities Regulation. Said approval shall be issued by the Department if the coronary angioplasty program meets the requirements defined herein.
a) Each hospital shall renew this coronary angioplasty program designation annually.
§ 42.2 Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described herein, the Department shall approve the hospital's designation as a coronary angioplasty program.
§ 42.3 A hospital that has not received approval by the Department under this section shall not use the designation “coronary angioplasty program”, or any substantially similar phrase, to describe any such services provided and shall not perform coronary angioplasty.
§ 42.4 A hospital that operates a coronary angioplasty program approved by the Department shall maintain capabilities and provide services that include, but are not limited to, those capabilities and services described in sections 42.11, 42.12 and 42.13 (below). A hospital that operates a coronary angioplasty program approved by the Department shall maintain its capabilities and services as needed to meet the recommendations of the American College of Cardiology and the American Heart Association.
§ 42.5 Facilities that had previously held the designation as a coronary angioplasty program and that no longer meet volume standards for a coronary angioplasty program shall propose to the Department a plan to achieve optimum volume standards or to refer patients to other appropriate facilities. The facility shall post notice and otherwise notify patients, physicians, and payers that its status as an approved coronary angioplasty program has been suspended.
§ 42.6 An existing coronary angioplasty program shall maintain an annual utilization rate of at least four hundred (400) angioplasty procedures per year. Failure to maintain this volume level shall result in the penalties set forth in section 42.17 herein.
§ 42.7 As part of the approval process for a new (or proposed) coronary angioplasty program, the hospital shall provide data to the Department demonstrating a reasonable expectation of attaining and maintaining a utilization rate of four hundred (400) angioplasty procedures per year within two (2) years of its opening date.
§ 42.8 As part of the approval process for a new (or proposed) coronary angioplasty program, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed coronary angioplasty program is likely to result in the annual volume of procedures performed by existing angioplasty programs falling below four hundred (400) angioplasty procedures per year. If this outcome is likely, the proposal shall describe how the overall quality of care for all angioplasty patients in the state will be improved with the addition of the proposed program.
§ 42.9 Each hospital that has an approved coronary angioplasty program shall maintain a record of the inhospital mortality rate and emergency coronary artery bypass graft (CABG) rate (i.e., bypass operation during the same hospital stay) for patients having angioplasty. To the extent possible, risk adjusted rates, based on data from nationally recognized databases and methods acceptable to the Director, shall be used.
§ 42.10 If it is determined that the hospital's coronary angioplasty program's mortality rate exceeds that of seventy-five percent (75%) of all hospitals doing this procedure based on data from nationally recognized databases for the most recent year for which data are available, then the hospital shall file a plan for identification of the cause of the excess mortality and a plan for correction in accordance with the requirements set forth in section 64.0 herein. (If the mortality rate of the hospital's coronary angioplasty program does not exceed the average rate reported by the nationally recognized databases by more than five (5) deaths per one thousand (1,000) cases, then the rate for the hospital shall be considered to be in a statistically acceptable range).
§ 42.11 A hospital that operates a coronary angioplasty program approved by the Department shall be in compliance with the following staffing requirements:
a) A board-certified cardiologist licensed in Rhode Island shall be designated as the director of the cardiac catheterization laboratory that includes the coronary angioplasty program.
b) Physicians doing angioplasty procedures shall have training in cardiology, pediatric cardiology, or cardiovascular radiology.
c) Each hospital that has an approved coronary angioplasty program shall have a written procedure for granting and renewing privileges for physician-operators that specifies the required training, experience, board certification, annual volume of procedures, and other factors which will indicate acceptable proficiency.
d) The hospital shall monitor annual procedural volume, complication rates, emergency CABG rates, and inhospital mortality for each operator.
i) For the purpose of counting procedures, an interventional procedure is defined as a single session with a patient in the procedure room, irrespective of how many or what types of interventions are performed during the session. Only one physician may claim credit for a particular procedure. A physician-operator who claims credit for a procedure is the physician in charge of it. In a teaching program, the trainee will take an active role in the procedure under the direction of the supervising physician, who is responsible. The attending physician who takes primary responsibility for the procedure shall be credited with performing it.
e) The nursing supervisor shall be a registered nurse licensed in Rhode Island familiar with the overall function of the cardiac catheterization laboratory with critical care experience, knowledge of cardiovascular medications, ability to start intravenous solutions, and experience in operating room techniques.
f) At least one (1) technologist, who may or may not be a certified radiological technologist, shall be skilled in radiographic and angiographic imaging principles and techniques.
§ 42.12 A hospital that operates a coronary angioplasty program approved by the Department shall have available in the facility a coronary artery bypass graft surgery program approved by the Department.
§ 42.13 A hospital that operates a coronary angioplasty program approved by the Department shall have a catheterization laboratory that shall have proper equipment that is appropriate for the types of procedures performed in the laboratory and is in accordance with the guidelines issued periodically by the American College of Cardiology and the American Heart Association.
§ 42.14 The coronary angioplasty program shall have regular, frequent, and formal review in a multidisciplinary conference of all deaths and major complications.
§ 42.15 The coronary angioplasty program shall maintain a database, acceptable to the Director, that collects and analyzes patient data sufficient to analyze utilization and outcome data and to determine the reasons for substantial deviations from the average utilizations and outcomes reported by nationally recognized databases.
§ 42.16 Each hospital with an approved coronary angioplasty program shall report to the Department for each hospital fiscal year:
a) the number of coronary angiographies;
b) the number of coronary angioplasties by primary operator;
c) the number of coronary artery bypass graft surgeries by principal surgeon;
d) the number of emergency coronary artery bypass graft surgeries in the same hospital stay following coronary angioplasty;
e) the inhospital mortality rate for coronary angioplasty patients;
f) the inhospital mortality rate for coronary artery bypass graft surgical patients;
g) the number of coronary angioplasties by indication for performing the procedure; and
h) such other data as specified by the Director.
§ 42.17 The penalties for violations of the standards set forth in section 42.0 herein shall be in accordance with those set forth in Chapter 23-17 of the Rhode Island General Laws, as amended. Failure to maintain the minimal coronary angioplasty program standards set forth herein shall result in the revocation or suspension of the hospital's coronary angioplasty program designation and/or cessation of its activities.
Section 43.0 – Tertiary Care Services: Coronary Artery Bypass Graft Surgical Programs
Approval to Operate a Coronary Artery Bypass Graft Surgical Program and General Requirements
§ 43.1 In order to use the designation “coronary artery bypass graft surgical program”, a hospital shall obtain approval from the Department's Division of Facilities Regulation. Said approval shall be issued by the Department if the coronary artery bypass graft surgical program meets the requirements defined herein.
a) Each hospital shall renew this coronary artery bypass graft surgical program designation annually.
§ 43.2 Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described herein, the Department shall approve the hospital's designation as a coronary artery bypass graft surgical program.
§ 43.3 A hospital that has not received approval by the Department under this section shall not use the designation “coronary artery bypass graft surgical program”, or any substantially similar phrase, to describe any such services provided and shall not perform coronary artery bypass graft surgeries.
§ 43.4 A hospital that operates a coronary artery bypass graft surgical program approved by the Department shall maintain capabilities and provide services that include, but are not limited to, those capabilities and services described in sections 43.11, 43.12, 43.13 and 43.14 (below). A hospital that operates a coronary artery bypass graft surgical program approved by the Department shall maintain its capabilities and services as needed to meet the recommendations of the Society of Thoracic Surgery, American College of Cardiology, and the American Heart Association.
§ 43.5 Facilities that had previously held the designation as a coronary artery bypass graft surgical program and that no longer meet volume standards for a coronary artery bypass graft surgical program shall propose to the Department a plan to achieve optimum volume standards or to refer patients to other appropriate facilities. The facility shall post notice and otherwise notify patients, physicians, and payers that its status as an approved coronary artery bypass graft surgical program has been suspended.
§ 43.6 An existing coronary artery bypass graft surgical program shall maintain an annual utilization rate of at least five hundred (500) surgical patients per year who require cardiopulmonary bypass capability, the majority of whom have coronary artery bypass grafts. Patients who have minimally-invasive coronary artery bypass graft operations shall be included in the counted patients. Failure to maintain this volume level shall result in the penalties set forth in section 43.18 herein.
§ 43.7 As part of the approval process for a new (or proposed) coronary artery bypass graft surgical program, the hospital shall provide data to the Department demonstrating a reasonable expectation, within three (3) years of its opening date, of attaining and maintaining a utilization rate of five hundred (500) surgical patients per year who require the availability of cardiopulmonary bypass.
§ 43.8 As part of the approval process for a new (or proposed) coronary artery bypass graft surgical program, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed coronary artery bypass graft surgical program is likely to result in the annual volume of procedures performed by existing coronary artery bypass graft surgical programs falling below five hundred (500) procedures per year. If this outcome is likely, the proposal shall describe how the overall quality of care for all coronary artery bypass graft patients in the state will be improved with the addition of the proposed program.
§ 43.9 Each hospital that has an approved coronary artery bypass graft surgical program shall maintain a record of the inhospital mortality rate for patients having coronary artery bypass graft surgery. To the extent possible, risk adjusted rates, based upon data from nationally recognized databases and methods acceptable to the Director, shall be used.
§ 43.10 If it is determined that the hospital's coronary artery bypass graft surgical program's mortality rate exceeds that of seventy-five percent (75%) of all hospitals doing this procedure based on data from nationally recognized databases for the most recent year for which data are available, then the hospital shall file a plan for identification of the cause of the excess mortality and a plan for correction, in accordance with the requirements set forth in section 64.0 herein. (If the mortality rate of the hospital's coronary artery bypass graft surgical program does not exceed the average rate reported by the nationally recognized databases by more than five (5) deaths per one thousand (1,000) cases, then the rate for the hospital shall be considered to be in a statistically acceptable range).
§ 43.11 A hospital that operates a coronary artery bypass graft surgical program approved by the Department shall be in compliance with the following staffing requirements:
a) A cardiac surgeon certified by the American Board of Thoracic Surgery or equivalent certifying body shall be designated as director of the coronary artery bypass graft surgical program.
b) A hospital coronary artery bypass graft surgical program should have a minimum of two (2) qualified cardiac surgeons.
c) Each hospital that has an approved coronary artery bypass graft surgical program shall have a written procedure for granting and renewing privileges for surgeons that specifies the required training, experience, board certification, annual volume of open heart procedures, and other factors that will indicate acceptable proficiency. The hospital shall monitor annual procedural volume, complication rates, and inhospital mortality for each surgeon.
d) Other specially trained physicians assisting the cardiac surgeon shall be cardiac surgical assistants, cardiac anesthesiologists, cardiologists, and other qualified consultants.
e) Nursing personnel shall include surgical nurses specially trained in cardiac surgical nursing, cardiac surgery intensive care nursing, and cardiac nurse educators.
f) Perfusionists shall be trained in the preparation, maintenance, and operation of pumpoxygenators and related equipment during open heart surgery and shall be knowledgeable about red blood cell-saving procedures and circulatory assist devices. The perfusionist shall work under the direction of the cardiac surgeon or the cardiac anesthesiologist or both.
g) Other personnel required shall be a full complement of hospital professionals including pharmacists, dietitians, respiratory therapists, social workers and physical therapists with cardiac rehabilitation skills.
§ 43.12 Coronary angiography of diagnostic quality shall be available. Facilities that treat pediatric patients shall provide for biplane angiography.
§ 43.13 The cardiac operating room shall be a room with requisite space and equipment for open heart surgery. It shall have adequate electrical grounding, oxygen and vacuum supply, proper illumination, and capability of supporting the technical equipment used in cardiopulmonary bypass, including the pump-oxygenators, heat exchange equipment, cell saver, anesthetic apparatus and assist devices.
§ 43.14 The cardiac intensive care units shall be operated under the direction of a qualified physician and have a unit nurse director. It shall have typical intensive care capabilities including continuous electrocardiographic and hemodynamic monitoring and recording and equipment and personnel for full ventilatory support. The space shall accommodate multiple life support systems, such as intraaortic balloon pumps, ventricular and total circulatory assist devices, and hemodialysis machines. Portable chest x-rays should be available twenty-four (24) hours per day. The unit shall be able to obtain immediate reports on blood gas analysis, serum electrolyte measurements, and certain other lab tests. The number of beds shall be one-half (1/2) the number of open heart operations performed each week.
§ 43.15 The cardiac surgery program shall have regular, frequent, and formal review in a multidisciplinary conference of all deaths and major complications.
§ 43.16 The cardiac surgery program shall maintain a registry, acceptable to the Director, that collects and analyzes patient data sufficient to analyze utilization and outcome data and to determine the reasons for substantial deviations from the average utilizations and outcomes reported by nationally recognized databases. The database shall be sufficient to perform adequate risk stratification.
§ 43.17 Each hospital with an approved coronary artery bypass graft surgical program shall report to the Department for each hospital fiscal year:
g) the number of coronary artery bypass graft operations by indication for performing the surgery; and
§ 43.18 The penalties for violations of the standards set forth in section 43.0 herein shall be in accordance with those set forth in Chapter 23-17 of the Rhode Island General Laws, as amended. Failure to maintain the minimal coronary artery bypass graft surgical program standards set forth herein shall result in the revocation or suspension of the hospital's coronary artery bypass graft surgical program designation and/or cessation of its activities.
Section 44.0 – Tertiary Care Services: Heart and/or Liver Transplant Programs
Approval to Operate a Heart and/or Liver Transplant Program and General Requirements
§ 44.244.1 In order to use the designation “heart transplant program” or “liver transplant program”, a hospital shall obtain approval from the Department's Division of Facilities Regulation. Said approval shall be issued by the Department if the heart and/or liver transplant program meets the requirements defined herein.
a) Each hospital shall renew this heart and/or liver transplant program designation annually.
§ 44.2 Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described herein, the Department shall approve the hospital's designation as a heart and/or liver transplant program.
§ 44.3 A hospital that has not received approval by the Department under this section shall not use the designation “heart transplant program” or “liver transplant program,” or any substantially similar phrase, to describe any such services provided and shall not perform heart and/or liver transplant procedures.
§ 44.4 A hospital that operates a heart and/or liver transplant program approved by the Department shall maintain capabilities and provide services in accordance with the requirements described herein.
§ 44.5 A hospital that operates a heart and/or liver transplant program approved by the Department shall maintain its membership in good standing with the United Network for Organ Sharing (UNOS).
§ 44.6 A hospital that operates a heart and/or liver transplant program shall perform mandatory HIV testing, and counseling, as appropriate, in accordance with the HIV regulations of reference 71 herein and 42 Code of Federal Regulations Part 486, Subpart G (Guidelines for Preventing Transmission of HIV through Transplantation of Human Tissue and Organs) (see reference 72 herein) for the prevention of HIV transmission.
§ 44.7 A hospital that had previously held the designation as a heart and/or liver transplant program and that no longer meets volume standards for a heart and/or liver transplant program but treat patients at high risk for needing these services shall propose to the Department a plan to achieve optimum volume standards or to refer patients to other appropriate facilities. The facility shall post notice and otherwise notify patients, physicians, and payers that its status as an approved heart and/or liver transplant program has been suspended.
§ 44.8 A new or proposed heart transplant program shall provide data showing a reasonable expectation of attaining and maintaining a utilization rate of nine (9) transplant procedures per year within two (2) years of its opening. If a second or subsequent program is proposed, it shall also report whether the addition of the new heart transplant program is likely to result in the annual volume of procedures performed by existing heart transplant programs falling below nine (9) heart transplants per year. If this outcome is likely, it will explain how the overall quality of care for all heart transplant patients in the state will be improved by the addition of the proposed program.
§ 44.9 A new or proposed liver transplant program shall provide data showing a reasonable expectation of attaining and maintaining a utilization rate of twenty (20) transplant procedures per year within two (2) years of its opening. If a second or subsequent program is proposed, it shall also report whether the addition of the new liver transplant program is likely to result in the annual volume of procedures performed by existing liver transplant programs falling below twenty (20) liver transplants per year. If this outcome is likely, it will explain how the overall quality of care for all liver transplant patients in the state will be improved by the addition of the proposed program.
§ 44.10 Each hospital that has a heart transplant program shall maintain a record of the rates of mortality at three (3) months, one (1) year and three (3) years. Risk-adjusted rates, based on data from the UNOS database and methods acceptable to the Director of Health, shall be used. If patient or graft outcomes decline to a level mandating UNOS review, then the hospital shall notify the Department of Health and file a plan of correction.
§ 44.11 Each hospital that has a liver transplant program shall maintain a record of the rates of mortality at three (3) months, one (1) year and three (3) years. Risk-adjusted rates, based on data from the UNOS database and methods acceptable to the Director of Health, shall be used. If patient or graft outcomes decline to a level mandating UNOS review, then the hospital shall notify the Department of Health and file a plan of correction.
§ 44.12 Each hospital that has a heart transplant program and/or a liver transplant program shall become a member of the UNOS and shall maintain its membership in good standing. The program shall follow the procedures designated by the current bylaws of UNOS. (See reference 70 herein).
§ 44.13 The personnel and facilities used by the transplant program shall conform to the bylaws of UNOS for heart transplantation and/or for liver transplantation, as appropriate.
§ 44.14 The program shall document its acceptance as a member of UNOS before commencing transplantation and shall inform the Department immediately in writing if it has been notified by UNOS that the program is in jeopardy of becoming a member not in good standing.
§ 44.15 Each hospital that provides heart transplantation and/or liver transplantation services shall report to the Department for each hospital fiscal year:
• the number of heart and/or liver transplants, respectively;
• the number of heart and/or liver transplants by principal surgeon;
• the mortality rate for heart and/or liver patients at three (3) months, one (1) year, and three (3) years.
§ 44.16 The penalties for violations of the standards set forth in section 44.0 herein shall be in accordance with those set forth in Chapter 23-17 of the Rhode Island General Laws, as amended. Failure to maintain the minimal heart and/or liver transplant program standards set forth herein shall result in the revocation or suspension of the hospital's heart and/or liver transplant program designation and/or cessation of its activities.
§ 62.0 – Confidentiality.
§62.1 Disclosure of any health care information relating to individuals shall be subject to the provisions of all relevant statutory and federal requirements governing confidentiality of health care information including but not limited to the provisions of reference 38.
RULES AND REGULATIONS FOR THE LICENSURE OF
PHYSICIAN AMBULATORY SURGERY CENTERS AND
PODIATRY AMBULATORY SURGERY CENTERS (R23-17-PASC)
PART II ORGANIZATION AND MANAGEMENT
Section 11.0 – Peer Review
§ 11.1 An organized process of peer review shall be conducted in accordance with the requirements of the accreditation agency. At a minimum, peer review shall provide for:
a) regular review of reportable events (see section 17.5 herein) with formal determination of strategies to improve outcomes and assessment of change accomplished; and
b) formal review of credentials and privileges of all surgeons, certified registered nurse anesthetists, and anesthesiologists.
§ 11.2 Medical peer review shall be conducted in accordance with sections 5-37-1 (10)(a) and (b) of the Rhode Island General Laws, as amended, and subject to the confidentiality provisions of section 5-37.3-7 of the Rhode Island General Laws, as amended.
PART III PATIENT CARE SERVICES
SECTION 17.0 – PATIENT CARE MANAGEMENT
§ 17.1 . . . .
§ 17.5 The physician ambulatory surgery center/ podiatry ambulatory surgery center shall, within seventy-two (72) hours of receipt of such information, notify the licensing agency of any reportable event as follows:
a) transfer of the patient from the physician ambulatory surgery center/ podiatry ambulatory surgery center to a hospital emergency department;
b) unscheduled hospital admission of the patient within seventy-two (72) hours of discharge from the physician ambulatory surgery center/ podiatry ambulatory surgery center;
c) extension of the surgical procedure beyond four (4) hours;
d) unplanned readmission to the physician ambulatory surgery center/ podiatry ambulatory surgery center within seventy-two (72)hours;
e) death of the patient within thirty (30) days;
f) subjecting a patient to a procedure not ordered or intended by the patient's physician, excluding: procedures not requiring a physician's order, medication errors, and collection of specimens, for laboratory study, obtained by non-invasive means or routine phlebotomy;
g) or any other incident reported to the malpractice insurance carrier.